[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Rules and Regulations]
[Pages 59452-60303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24170]
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Vol. 83
Friday,
No. 226
November 23, 2018
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared
Savings Program Requirements; Quality Payment Program; Medicaid
Promoting Interoperability Program; Quality Payment Program--Extreme
and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year;
Provisions From the Medicare Shared Savings Program--Accountable Care
Organizations--Pathways to Success; and Expanding the Use of Telehealth
Services for the Treatment of Opioid Use Disorder Under the Substance
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act; Final Rules and Interim
Final Rule
Federal Register / Vol. 83 , No. 226 / Friday, November 23, 2018 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 425, and 495
[CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F]
RIN 0938-AT31, 0938-AT13, & 0938-AT45
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2019;
Medicare Shared Savings Program Requirements; Quality Payment Program;
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the
Use of Telehealth Services for the Treatment of Opioid Use Disorder
Under the Substance Use-Disorder Prevention That Promotes Opioid
Recovery and Treatment (SUPPORT) for Patients and Communities Act
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rules and interim final rule.
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SUMMARY: This major final rule addresses changes to the Medicare
physician fee schedule (PFS) and other Medicare Part B payment policies
to ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services, as well as changes
in the statute. This final rule also finalizes policies included in the
interim final rule with comment period in ``Medicare Program; CY 2018
Updates to the Quality Payment Program; and Quality Payment Program:
Extreme and Uncontrollable Circumstance Policy for the Transition
Year'' that address the extreme and uncontrollable circumstances MIPS
eligible clinicians faced as a result of widespread catastrophic events
affecting a region or locale in CY 2017, such as Hurricanes Irma,
Harvey and Maria. In addition, this final rule addresses a subset of
the changes to the Medicare Shared Savings Program for Accountable Care
Organizations (ACOs) proposed in the August 2018 proposed rule
``Medicare Program; Medicare Shared Savings Program; Accountable Care
Organizations--Pathways to Success''. This final rule also addresses
certain other revisions designed to update program policies under the
Shared Savings Program.
The interim final rule implements amendments made by the SUPPORT
for Patients and Communities Act to the Medicare telehealth provisions
in the Social Security Act and regarding permissible telehealth
originating sites for purposes of treatment of a substance use disorder
or a co-occurring mental health disorder for telehealth services
furnished on or after July 1, 2019 to an individual with a substance
use disorder diagnosis.
DATES: Effective Dates: These regulations are effective on January 1,
2019, except for the following:
Revisions to Sec. Sec. 414.1415(b)(2) and (3), and
414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
Amendments to Part 425, which are effective on December
31, 2018.
Applicability Date: The following provisions related to Section
II.I. of this final rule, Evaluation and Management Services, are
applicable beginning January 1, 2021: Implementation of a blended
payment rate for E/M visits levels 2-4; Payment to adjust the base E/M
visit rate(s) upward to account for visit complexity associated with
non-procedural specialty care and primary care; Payment to adjust the
base visit rate(s) upward to account for the additional resource costs
when practitioners need to spend significantly more time with
particular patients; and Flexible documentation requirements related to
Medical Decision Making, Time or Current E/M visit documentation
framework. The amendment to the definition of ``low-volume criteria''
at Sec. 414.1305 is applicable at the start of the first Merit-based
Incentive Payment System (MIPS) determination period for CY 2018 MIPS
performance period.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 31, 2018.
ADDRESSES: In commenting, please refer to file code CMS-1693-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1693-IFC, P.O. Box 8010,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1693-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Jamie Hermansen, (410) 786-2064, for any physician payment issues
not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804,
for issues related to evaluation and management (E/M) payment,
communication technology-based services and telehealth services.
Lindsey Baldwin, (410) 786-1694, for issues related to sections
2001(a) and 2005 of the SUPPORT for Patients and Communities Act.
Kathy Bryant, (410) 786-3448, for issues related to global surgery
data collection.
Isadora Gil, (410) 786-4532, for issues related to payment rates
for nonexcepted items and services furnished by nonexcepted off-campus
provider-based departments of a hospital, and work relative value units
(RVUs).
Ann Marshall, (410) 786-3059, for issues related to E/M
documentation guidelines.
Geri Mondowney, (410) 786-1172, for issues related to potentially
misvalued services, geographic price cost indices (GPCIs), and
malpractice RVUs.
Donta Henson, (410) 786-1947, for issues related to geographic
price cost indices (GPCIs).
Tourette Jackson, (410) 786-4735, for issues related to malpractice
RVUs.
Patrick Sartini, (410) 786-9252, for issues related to radiologist
assistants.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, impacts, and conversion factor.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Edmund Kasaitis, (410) 786-0477, for issues related to reduction of
wholesale acquisition cost (WAC)-based payment.
Marcie O'Reilly, (410) 786-9764, for issues related to the
Potential Model for Radiation Therapy.
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Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584,
for issues related to aggregate reporting of applicable information for
clinical laboratory fee schedule.
Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for
issues related to the ambulance fee schedule.
Corinne Axelrod, (410) 786-5620, for issues related to care
management services and communication technology-based services in
Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs).
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749,
for issues related to appropriate use criteria for advanced diagnostic
imaging services.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality Measures.
Matthew Edgar, (410) 786-0698, for issues related to the physician
self-referral law.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Benjamin Chin, (410) 786-0679, for inquiries related to Alternative
Payment Models (APMs).
David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816
for issues related to the Medicaid Promoting Interoperability Program.
Elizabeth November, (410) 786-8084, for inquiries related to the
Medicare Shared Savings Program [Pathways to Success].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Provisions of the Final Rule for PFS
A. Background
B. Determination of Practice Expense (PE) Relative Value Units
(RVUs)
C. Determination of Malpractice Relative Value Units (RVUs)
D. Modernizing Medicare Physician Payment by Recognizing
Communication Technology-Based Services and Interim Final Rule
Expanding the Use of Telehealth Services for the Treatment of Opioid
Use Disorder and Other Substance Use Disorders Under the Substance
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act
E. Potentially Misvalued Services Under the PFS
F. Radiologist Assistants
G. Payment Rates Under the Medicare PFS for Nonexcepted Items
and Services Furnished by Nonexcepted Off-Campus Provider-Based
Departments of a Hospital
H. Valuation of Specific Codes
I. Evaluation & Management (E/M) Visits
J. Teaching Physician Documentation Requirements for Evaluation
and Management Services
K. GPCI Comment Solicitation
L. Therapy Services
M. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments
N. Potential Model for Radiation Therapy
III. Other Provisions of the Final Rule
A. Clinical Laboratory Fee Schedule
B. Changes to the Regulations Associated With the Ambulance Fee
Schedule
C. Payment for Care Management Services and Communication
Technology-Based Services in Rural Health Clinics (RHCs) and
Federally Qualified Health Centers (FQHCs)
D. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
E. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals
F. Medicare Shared Savings Program Quality Measures
G. Physician Self-Referral Law
H. Physician Self-Referral Law: Annual Update to the List of
CPT/HCPCS Codes
I. CY 2019 Updates to the Quality Payment Program (Includes the
Extreme and Uncontrollable Circumstances MIPS Eligible Clinicians
Faced as a Result of Widespread Catastrophic Events Affecting a
Region or Locale in CY 2017 IFC Policies)
IV. Requests for Information
V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Finalized MIPS Quality Measures
Appendix 2: Improvement Activities
Addenda Available Only Through the Internet on the CMS Website
The PFS Addenda along with other supporting documents and tables
referenced in this final rule are available on the CMS website at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the
link on the left side of the screen titled, ``PFS Federal Regulations
Notices'' for a chronological list of PFS Federal Register and other
related documents. For the CY 2019 PFS final rule, refer to item CMS-
1693-F. Readers with questions related to accessing any of the Addenda
or other supporting documents referenced in this final rule and posted
on the CMS website identified above should contact Jamie Hermansen at
(410) 786-2064.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2018 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.
I. Executive Summary
A. Purpose
This major final rule makes payment and policy changes under the
Medicare PFS and implements certain provisions of the Bipartisan Budget
Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for
Patients and Communities Act (Pub. L. 115-271, October 24, 2018)
related to Medicare Part B payment, and except as specified otherwise,
applicable to services furnished in CY 2019. This final rule also
revises certain policies under the Medicare Shared Savings Program.
1. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work;
practice expense (PE); and malpractice (MP) expense. In addition, the
statute requires that we establish by regulation each year's payment
amounts for all physicians' services paid under the PFS, incorporating
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas. In this major final
rule, we establish RVUs for CY 2019 for the PFS, and other Medicare
Part B payment policies, to ensure that our payment systems are updated
to reflect changes in medical practice and the relative value of
services, as well as changes in the statute. This final rule includes
discussions regarding:
Potentially Misvalued Codes.
Communication Technology-Based Services.
Provisions Expanding Telehealth Services for the Treatment
of Opioid Use Disorder and Other Substance Use Disorders under the
SUPPORT Act.
Valuation of New, Revised, and Misvalued Codes.
Payment Rates under the PFS for Nonexcepted Items and
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments
of a Hospital.
Evaluation & Management (E/M) Visits.
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Therapy Services.
Part B Drugs: Application of an Add-on Percentage for
Certain Wholesale Acquisition Cost (WAC)-based Payments.
Potential Model for Radiation Therapy.
Clinical Laboratory Fee Schedule.
Ambulance Fee Schedule--Provisions in the Bipartisan
Budget Act of 2018.
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs).
Appropriate Use Criteria for Advanced Diagnostic Imaging
Services.
Medicaid Promoting Interoperability Program Requirements
for Eligible Professionals.
Medicare Shared Savings Program Quality Measures.
Physician Self-Referral Law.
Physician Self-Referral Law: Annual Update to the List of
CPT/HCPCS Codes.
CY 2019 Updates to the Quality Payment Program (including
the extreme and uncontrollable circumstances MIPS eligible clinicians
faced as a result of widespread catastrophic events affecting a region
or locale in CY 2017).
Comments in response to the Request for Information on
Promoting Interoperability and Electronic Healthcare Information
Exchange through Possible Revisions to the CMS Patient Health and
Safety Requirements for Hospitals and Other Medicare- and Medicaid-
Participating Providers and Suppliers.
Comments in response to the Request for Information on
Price Transparency: Improving Beneficiary Access to Provider and
Supplier Charge Information.
This rule also finalizes certain provisions from the ``Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Pathways to Success'' proposed rule that appeared in the
August 17, 2018 Federal Register (83 FR 41786). Under the Medicare
Shared Savings Program, providers of services and suppliers that
participate in an ACO continue to receive traditional Medicare fee-for-
service (FFS) payments under Parts A and B, but the ACO may be eligible
to receive a shared savings payment if it meets specified quality and
savings requirements. ACOs participating under a two-sided shared
savings and shared losses model of the program may also be responsible
for repaying shared losses if the Parts A and B FFS expenditures for
their assigned beneficiaries exceed the ACO's historical benchmark. The
revised policies for ACOs participating in the Medicare Shared Savings
Program will ensure continuity of program participation for ACOs whose
agreement periods expire on December 31, 2018 by allowing these ACOs
the opportunity to elect a voluntary 6-month extension of their current
agreement periods; supporting coordination of care across settings and
strengthening beneficiary engagement; providing relief for ACOs
impacted by extreme and uncontrollable circumstance in performance year
2018 and subsequent years; and promoting interoperable electronic
health record technology among ACO providers/suppliers. We plan to
address the remaining proposals from the August 2018 proposed rule (83
FR 41786) in a forthcoming second final rule.
2. Summary of Costs and Benefits
We have determined that this major final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII. of this final rule.
B. Determination of Practice Expense (PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the Five-Year Review of Work Relative
Value Units under the PFS and Proposed Changes to the Practice Expense
Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007
PFS final rule with comment period (71 FR 69629).
Comment: Several commenters requested that CMS include pharmacists
as active qualified health care providers for purposes of calculating
physician PE direct costs. The commenters stated that pharmacists need
to be included in the calculation of direct PE expenses as an element
of the clinical labor variable relating to physicians' services. The
commenter stated that pharmacists are key members of the healthcare
team supporting the advent of digital medicine and telehealth services
and suggested that pharmacists should be recognized as staff included
in practice expense inputs.
Response: The direct PE input database contains the service-level
costs in clinical labor based on the typical service furnished to
Medicare beneficiaries. When these resource costs are typically
incurred in furnishing services, we do not have any standing policies
that would prohibit the inclusion of the costs in the direct PE input
database used to develop PE RVUs for individual services, to the extent
that inclusion of such costs would not lead to duplicative payments.
Therefore, we welcome more detailed information regarding the typical
clinical labor costs involving pharmacists for particular PFS services.
We note, however, that in the case of many PFS services, especially
care management services, certain elements of the services could be
provided by clinicians other than the billing professionals, which
could include services provided by pharmacists. As such, we encourage
interested stakeholders to provide information through the RUC process
or directly to us by February 10th prior to annual rulemaking about the
inclusion of additional clinical labor costs for specific services
described by HCPCS codes for which payment is made under the PFS, as
opposed to clinical labor costs that may be typical only under certain
circumstances.
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b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file called ``CY 2019 PFS Final Rule PE/HR'' on the
CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Several commenters recommended that it was time to
consider a new nationwide all specialty PE/HR survey, given the amount
of time that has passed since the last survey was conducted. The
commenters stated that the practice of medicine has significantly and
substantially evolved in the past decade and that many specialties have
had extensive changes in physician employment models during that time.
The commenters stated that continued use of the outdated PPIS survey
leads to an inappropriate and inaccurate distortion of the PE RVUs for
current practice.
Response: We have previously identified several concerns regarding
the underlying data used in determining PE RVUs in the CY 2014 PFS
final rule with comment period (78 FR 74246 through 74247). While we
continue to believe that the PPIS survey data are the best data
currently available, we continue to seek the best broad based,
auditable, routinely updated source of information regarding PE costs.
To that end, we have engaged a contractor, the RAND Corporation, to
explore the feasibility of updating the data used in the development of
PE RVUs.
Comment: One commenter requested that CMS consider studying
indirect PE associated with emergency departments including Emergency
Medical Treatment & Labor Act (EMTALA)-mandated uncompensated care. The
commenter stated that emergency physicians are not able to schedule
their patients and therefore cannot maximize the use of staff and
resources, and that there are costs associated with being open and
having to pay shift differentials over nights, weekends, and holidays.
Response: We will take the information under consideration for
future rulemaking.
For CY 2019, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2017. These specialties are Hospitalists and Advanced
Heart Failure and Transplant Cardiology. We proposed to use proxy PE/HR
values for these new specialties, as there are no PPIS data for these
specialties, by crosswalking the PE/HR as follows from specialties that
furnish similar services in the Medicare claims data:
Hospitalists from Emergency Medicine, and
Advanced Heart Failure and Transplant Cardiology from
Cardiology.
These updates are reflected in the ``CY 2019 PFS Final Rule PE/HR''
file available on the CMS website under the supporting data files for
the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments we received on
our proposal to use proxy PE/HR values for these two new specialties.
Comment: One commenter stated that they supported the CMS proposal
to crosswalk the Advanced Heart Failure and Transplant specialty to the
cardiology PPIS data.
Response: We appreciate the support from the commenter for our
proposal.
Comment: A few commenters wrote to detail their concerns with the
current PE/HR assigned to home PT/INR monitoring services. Commenters
stated that these services are provided by entities that are enrolled
in Medicare as independent testing facilities because there is no other
specialty category that currently describes these suppliers; however,
home PT/INR monitoring services are fundamentally different in nature.
Commenters stated that home PT/INR monitoring services tend to be
[[Page 59456]]
more therapeutic than diagnostic in nature, typically utilize different
staffing types, and have a different ratio of direct to indirect costs.
The commenters encouraged CMS to consider home PT/INR monitoring as a
distinct specialty from independent testing facilities and to survey
suppliers to determine accurate indirect cost factors for these
services, while using either the Pathology or All Physicians specialty
as a proxy for PE/HR in the meantime. One commenter suggested that CMS
should consider holding payments harmless for home PT/INR monitoring
services while additional analysis is completed.
Response: We welcome suggestions from interested parties regarding
new indirect PE surveys and the use of PE/HR proxies that could be
considered for future rulemaking. Interested parties may wish to submit
a physician specialty designation request per the instructions found in
Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section
10.8 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf). This section of
the Medicare Claims Processing Manual includes the criteria that CMS
uses to evaluate physician specialty designation requests.
After consideration of the public comments, we are finalizing our
proposal to use proxy PE/HR values for Hospitalists and Advanced Heart
Failure and Transplant Cardiology as described above.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion (see section
II.B.2.b of this final rule). The general approach to developing the
indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
Comment: One commenter stated that it was not clear why the PE
change would differ so greatly between the office and facility settings
for CPT code 37227 (Revascularization, endovascular, open or
percutaneous, femoral, popliteal artery(s), unilateral; with
transluminal stent placement(s) and atherectomy, includes angioplasty
within the same vessel, when performed). The commenter stated that the
facility PE RVU for this CPT code was proposed to decrease by 4.8
percent while the non-facility PE RVU was proposed to decrease by 10.6
percent, and the commenter could not understand how these payment rates
were determined.
Response: As detailed above, the methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. It is not unusual
for facility and nonfacility RVUs for a CPT code to change at different
rates from year to year, as the direct costs associated with the
facility and nonfacility settings are typically distinct from one
another. For a more detailed description of the PE RVU methodology, we
refer readers to the CY 2007 PFS final rule with comment period (71 FR
69630 through 69643) and the CY 2010 PFS final rule with comment period
(74 FR 61745 through 61746).
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be
[[Page 59457]]
furnished together as a global service. When services have separately
billable PC and TC components, the payment for the global service
equals the sum of the payment for the TC and PC. To achieve this, we
use a weighted average of the ratio of indirect to direct costs across
all the specialties that furnish the global service, TCs, and PCs; that
is, we apply the same weighted average indirect percentage factor to
allocate indirect expenses to the global service, PCs, and TCs for a
service. (The direct PE RVUs for the TC and PC sum to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file called ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we
instead use the expected specialty that we identify on a list developed
based on medical review and input from expert stakeholders. We display
this list of expected specialty assignments as part of the annual set
of data files we make available as part of notice and comment
rulemaking and consider recommendations from the RUC and other
stakeholders on changes to this list on an annual basis. Services for
which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) are unaffected by the list of expected
specialty assignments. We also finalized in the CY 2018 PFS final rule
(82 FR 52982 through 59283) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
For CY 2019, we proposed to add 28 additional codes that we
identified as low volume services to the list of codes for which we
assign the expected specialty. Based on our own medical review and
input from the RUC and from specialty societies, we proposed to assign
the expected specialty for each code as indicated in Table 1. For each
of these codes, only the professional component (reported with the -26
modifier) is nationally priced. The global and technical components are
priced by the Medicare Administrative Contractors (MACs) which
establish RVUs and payment amounts for these services. The list of
codes that we proposed to add is displayed in Table 1.
Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
2017
CPT code Modifier Short descriptor Expected specialty utilization
----------------------------------------------------------------------------------------------------------------
70557.............. 26................. Mri brain w/o dye......... Diagnostic Radiology...... 126
70558.............. 26................. Mri brain w/dye........... Diagnostic Radiology...... 32
74235.............. 26................. Remove esophagus Gastroenterology.......... 10
obstruction.
74301.............. 26................. X-rays at surgery add-on.. Diagnostic Radiology...... 73
74355.............. 26................. X-ray guide intestinal Diagnostic Radiology...... 11
tube.
74445.............. 26................. X-ray exam of penis....... Urology................... 26
74742.............. 26................. X-ray fallopian tube...... Diagnostic Radiology...... 5
74775.............. 26................. X-ray exam of perineum.... Diagnostic Radiology...... 80
75801.............. 26................. Lymph vessel x-ray arm/leg Diagnostic Radiology...... 114
75803.............. 26................. Lymph vessel x-ray arms/ Diagnostic Radiology...... 41
leg.
75805.............. 26................. Lymph vessel x-ray trunk.. Diagnostic Radiology...... 50
75810.............. 26................. Vein x-ray spleen/liver... Diagnostic Radiology...... 46
[[Page 59458]]
76941.............. 26................. Echo guide for transfusion Obstetrics/Gynecology..... 15
76945.............. 26................. Echo guide villus sampling Obstetrics/Gynecology..... 31
76975.............. 26................. Gi endoscopic ultrasound.. Gastroenterology.......... 49
78282.............. 26................. Gi protein loss exam...... Diagnostic Radiology...... 8
79300.............. 26................. Nuclr rx interstit colloid Diagnostic Radiology...... 2
86327.............. 26................. Immunoelectrophoresis Pathology................. 24
assay.
87164.............. 26................. Dark field examination.... Pathology................. 30
88371.............. 26................. Protein western blot Pathology................. 2
tissue.
93532.............. 26................. R & l heart cath Cardiology................ 28
congenital.
93533.............. 26................. R & l heart cath Cardiology................ 36
congenital.
93561.............. 26................. Cardiac output measurement Cardiology................ 28
93562.............. 26................. Card output measure subsq. Cardiology................ 38
93616.............. 26................. Esophageal recording...... Cardiology................ 38
93624.............. 26................. Electrophysiologic study.. Cardiology................ 51
95966.............. 26................. Meg evoked single......... Neurology................. 72
95967.............. 26................. Meg evoked each addl...... Neurology................. 61
----------------------------------------------------------------------------------------------------------------
The complete list of expected specialty assignments for individual
low volume services, including the assignments for the codes identified
in Table 1, is available on our website under downloads for the CY 2019
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments we received on
our proposal to update the list of expected specialty assignments for
low volume services.
Comment: Several commenters supported the continued use of service-
level overrides for low volume codes, and stated that they agreed with
the addition of the proposed 28 codes to the list of expected
specialties.
Response: We appreciate the support from the commenters.
Comment: Several commenters stated that CPT code 22857 (Total disc
arthroplasty (artificial disc), anterior approach, including discectomy
to prepare interspace (other than for decompression), single
interspace, lumbar) was missing from the proposed list. These
commenters requested that CMS include CPT code 22857 in the low
utilization category and permanently assign it to the orthopaedic
surgery specialty to maintain payment stability and minimize annual
fluctuations.
Response: We agree with the commenters that CPT code 22857
qualifies as a low volume code, with an annual Medicare utilization of
roughly 20 services. We agree with the commenters that assigning this
code to the orthopaedic surgery specialty will help to maintain payment
stability, and we are finalizing the addition of CPT code 22857 to the
low volume services list.
Comment: One commenter stated that several of the proposed low
volume services would be more accurately assigned to different expected
specialties based on their practice patterns. The commenter stated that
CPT codes 70557 and 70558 are intraoperative exams and are most often
performed by neurosurgeons and that CPT code 74235 is a diagnostic
radiology code rather than a gastroenterology code. The commenter
stated that CPT code 75810 should be assigned to interventional
radiology rather than diagnostic radiology, and that CPT codes 78282
and 79300 should be assigned to nuclear medicine rather than diagnostic
radiology.
Response: We agree that these codes would be more accurately
assigned to the expected specialties described by the commenter based
on an examination of the claims data. We are finalizing changes in
expected specialty to these six codes as described by the commenter.
Comment: One commenter stated that there are four codes that are
still not included in the proposed CY 2019 low volume override list and
recommended that the following low volume procedures be added to the
override list with the indicated specialty assignment:
Cardiac Surgery: CPT code 35812, and
Thoracic Surgery: CPT codes 32654, 33025 and 33251
Response: We agree with the inclusion of CPT codes 32654 and 33251.
These are services with very low annual utilization, and we are
finalizing their addition to the low volume services list with the
expected specialty as described by the commenter. We note that CPT code
33251 is already on the low volume services list with an expected
specialty of Cardiac Surgery; we are finalizing a change to the
Thoracic Surgery specialty as requested by the commenter. We are not
finalizing the addition of CPT code 35812 to the list, as it does not
appear to be a current CPT code. We are also not finalizing the
addition of CPT code 33025 to the list, as the code had a utilization
of more than 5,000 services in the most recent year of claims data, and
this would not qualify as a low volume service under the criteria that
we have previously finalized through rulemaking.
Comment: One commenter stated that the appropriate low volume
overrides were not applied to a series of congenital/pediatric cardiac
surgery codes. The commenter stated that each of these operations can
only be performed by congenital heart surgeons classified as either
cardiac or thoracic surgeons, and that they believe the malpractice
RVUs had been improperly decreased as a result of the low volume
service overrides not being applied.
Response: Each of the CPT codes identified by the commenter was
already present on the low volume services list with an expected
specialty assignment of either Cardiac Surgery or Thoracic Surgery. The
shifts in malpractice RVUs identified by the commenter were a result of
proposed policies associated with E/M visits. We refer readers to
section II.I. of this final rule for additional details on these
policies.
After consideration of the public comments, we are finalizing the
addition of the proposed 28 codes to the low volume services list, with
the expected specialty as proposed except where modified in response to
comments. We are also finalizing the addition of CPT codes 32654 and
33251 to the list with an expected specialty of Thoracic Surgery as
detailed previously.
[[Page 59459]]
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
The following is a summary of the public comments we received on
the indirect practice cost indices.
Comment: Many commenters stated that they were opposed to the
proposed significant shifts in the indirect practice cost indices at
the specialty level. Commenters stated that the creation of a separate
PE/HR rate for the E/M visits resulted in large unintended effects on
specialties given the way that indirect PE is allocated, and that this
was inconsistent with CMS' intent to maintain stability in payment. One
commenter stated that the proposal to create a separate PE/HR rate for
the E/M visits was based on statistically unsound methodology, had
opaque analytics, and was not resource-based. Many commenters stated
that the effects of the proposed changes to the indirect practice cost
indices had not been sufficiently detailed in the proposed rule to
allow for proper feedback from commenters. Commenters expressed concern
that a reduction in payment due to shifts in the indirect PE allocation
could affect patient access to critical services, such as but not
limited to CPT codes 96360 (intravenous infusion, hydration; initial,
31 minutes to 1 hour), 96372 (therapeutic, prophylactic, or diagnostic
injection (specify substance or drug); subcutaneous or intramuscular),
96374 (therapeutic, prophylactic or diagnostic injection IV push,
single or initial substance/drug), 96375 (therapeutic, prophylactic or
diagnostic injection; each additional sequential IV push of a new
substance/drug), and HCPCS code G0416 (Surgical pathology, gross and
microscopic examinations, for prostate needle biopsy, any method). A
few commenters stated that the proposed indirect practice cost indices
ignored statutory requirements that payments under the PFS must be
resource based and failed to meet the transparency requirements of the
Protecting Access to Medicare Act of 2014 (PAMA). Commenters urged CMS
not to finalize the proposed changes to the indirect practice cost
indices.
Response: The proposed changes in the indirect practice cost
indices identified by the commenters were a result of proposed policies
associated with E/M visits, and specifically the proposal to establish
a separate specialty for E/M visits. We refer readers to section II.I.
of this final rule for additional discussion of these policies.
Comment: One commenter stated that the level of detail in the CY
2019 PFS proposed rule was insufficient to comment on several aspects
of the proposed changes in coding and payment related to office/
outpatient E/M visits, which was a departure from past rules. The
commenter specifically stated that there was insufficient information
to model how the proposed changes in the office/outpatient E/M visit
codes affected the indirect practice cost indices for all other
services. Similarly, the commenter suggested that not enough
information was provided to simulate the PFS ratesetting in a way that
would isolate the impact of the proposed multiple procedure payment
reduction (MPPR), in the proposed rates and associated estimates of
specialty-level impact. The commenter requested that CMS provide
additional technical information and files going forward to enable the
commenter to better model proposed and future policies.
Response: We agree with commenters regarding the importance of
transparency and the need for detailed
[[Page 59460]]
information about proposed policies so that public commenters can
provide a full and informed response. We also understand that there is
merit to providing as much information as possible that would allow for
complete reproduction of our proposed and final ratesetting
methodologies. We also understand that the proposals related to office/
outpatient E/M visits are of great importance to the medical community
and represent a significant portion of spending under the PFS. We do
not agree with the commenter that the level of detail provided in the
proposed rule, including the data provided as publicly available
download files, was insufficient for public comment due to the
extensive documentation associated with the E/M policy proposals, or
that it represented a departure from past practice. Over several years,
we have invested significant resources in improving the transparency of
the data we use in developing proposed and final PFS rates. We intend
to maintain a focus on increasing transparency, and believe the
commenters' concerns will help us understand the kind of information
that can be most helpful to stakeholders interested in the underlying
data sets. While we are not finalizing the MPPR element of the E/M
proposal, we appreciate the commenter's interest in the use of code-
level assumptions regarding proposed payment adjustments that are
reflected in the discounts in the setup file, as discussed in section
II.B.2.(5)(e) of this final rule.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
Comment: We received many comments regarding the ongoing decrease
in the technical component of CPT code 76881 (Ultrasound, complete
joint (i.e., joint space and peri-articular soft tissue structures)
real-time with image documentation). Commenters stated that this
procedure is essential for making appropriate diagnosis and managing
patients with various rheumatologic conditions and musculoskeletal
disorders. Commenters stated that cutting the reimbursement for the
code would not only result in poor patient care but also increase total
costs through the use of more expensive MRI procedures. Commenters also
disagreed with the RUC's recommended direct PE inputs for CPT code
76881 from the CY 2018 rule cycle, citing concerns with the RUC's use
of workforce data, and urged CMS not to make further reductions in
payment.
Response: The comments regarding CPT code 76881 are out of scope,
as we did not make any proposals involving this code for CY 2019. The
reductions in payment described by the commenters for CPT code 76881
were finalized as part of the CY 2018 PFS final rule (82 FR 53058-
53059), and are continuing to be phased in over time as part of the
transition policy described above. For a more detailed description of
the methodology for the phase-in of significant RVU changes, we refer
readers to the CY 2016 PFS final rule with comment period (80 FR 70927
through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain NPPs paid at a percentage of the PFS and low-volume
specialties, from the calculation. These specialties are included for
the purposes of calculating the BN adjustment. They are displayed in
Table 2.
Table 2--Specialties Excluded From Ratesetting Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Specialty code Specialty description
--------------------------------------------------------------------------------------------------------------------------------------------------------
49................................. Ambulatory surgical center.
50................................. Nurse practitioner.
51................................. Medical supply company with certified orthotist.
52................................. Medical supply company with certified prosthetist.
53................................. Medical supply company with certified prosthetist[dash]orthotist.
54................................. Medical supply company not included in 51, 52, or 53.
55................................. Individual certified orthotist.
56................................. Individual certified prosthetist.
57................................. Individual certified prosthetist[dash]orthotist.
58................................. Medical supply company with registered pharmacist.
59................................. Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60................................. Public health or welfare agencies.
61................................. Voluntary health or charitable agencies.
73................................. Mass immunization roster biller.
74................................. Radiation therapy centers.
87................................. All other suppliers (e.g., drug and department stores).
88................................. Unknown supplier/provider specialty.
[[Page 59461]]
89................................. Certified clinical nurse specialist.
96................................. Optician.
97................................. Physician assistant.
A0................................. Hospital.
A1................................. SNF.
A2................................. Intermediate care nursing facility.
A3................................. Nursing facility, other.
A4................................. HHA.
A5................................. Pharmacy.
A6................................. Medical supply company with respiratory therapist.
A7................................. Department store.
B2................................. Pedorthic personnel.
B3................................. Medical supply company with pedorthic personnel.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 3 details the manner in which the
modifiers are applied.
Table 3--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
----------------------------------------------------------------------------------------------------------------
80, 81, 82...................... Assistant at Surgery... 16%......................... Intraoperative portion.
AS.............................. Assistant at Surgery-- 14% (85% * 16%)............. Intraoperative portion.
Physician Assistant.
50 or LT and RT................. Bilateral Surgery...... 150%........................ 150% of work time.
51.............................. Multiple Procedure..... 50%......................... Intraoperative portion.
52.............................. Reduced Services....... 50%......................... 50%.
53.............................. Discontinued Procedure. 50%......................... 50%.
54.............................. Intraoperative Care Preoperative + Preoperative +
only. Intraoperative Percentages Intraoperative
on the payment files used portion.
by Medicare contractors to
process Medicare claims.
55.............................. Postoperative Care only Postoperative Percentage on Postoperative portion.
the payment files used by
Medicare contractors to
process Medicare claims.
62.............................. Co-surgeons............ 62.5%....................... 50%.
66.............................. Team Surgeons.......... 33%......................... 33%.
----------------------------------------------------------------------------------------------------------------
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
[[Page 59462]]
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) [supcaret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that would support an alternative rate.
Comment: A few commenters stated that equipment time associated
with payment for diagnostic imaging services is not aligned with
practice. The commenters disagreed with the CMS statement that certain
highly technical equipment is less likely to be used during all of the
preservice or postservice tasks performed by clinical labor staff, and
stated that the CMS analysis of equipment time is not accurate based on
their experience with imaging centers. Commenters stated that there are
non-imaging functions that are required by CMS for payment, such as
documentation requirements and the need for enrollment in Medicare by
professionals, which add to their administrative burden and increase
costs yet are underrepresented in the PE methodology. Commenters stated
that they disagreed with how CMS defined room time as inconsistent with
how imaging centers actually function, and indicated a preference for
assigning equipment time based on the total technologist time.
Response: We disagree with the commenters regarding the equipment
time assigned to highly technical equipment. We continue to believe
that certain highly technical pieces of equipment and equipment rooms
are less likely to be used during all of the preservice or postservice
tasks performed by clinical labor staff on the day of the procedure and
are typically available for other patients even when one member of
clinical staff may be occupied with a preservice or postservice task
related to the procedure. For a more detailed description of this
topic, we refer readers to the CY 2015 PFS final rule with comment
period (79 FR 67639 through 67640).
Maintenance: This factor for maintenance was finalized in the CY
1998 PFS final rule with comment period (62 FR 33164). As we previously
stated in the CY 2016 final rule with comment period (80 FR 70897), we
do not believe the annual maintenance factor for all equipment is
precisely 5 percent, and we concur that the current rate likely
understates the true cost of maintaining some equipment. We also
believe it likely overstates the maintenance costs for other equipment.
When we solicited comments regarding sources of data containing
equipment maintenance rates, commenters were unable to identify an
auditable, robust data source that could be used by CMS on a wide
scale. We do not believe that voluntary submissions regarding the
maintenance costs of individual equipment items would be an appropriate
methodology for determining costs. As a result, in the absence of
publicly available datasets regarding equipment maintenance costs or
another systematic data collection methodology for determining a
different maintenance factor, we do not believe that we have sufficient
information at present to propose a variable maintenance factor for
equipment cost per minute pricing. We continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Comment: A commenter stated that they continue to believe that
maintenance costs for imaging equipment are much higher than the
current 5 percent assumption. The commenter stated that they were
hopeful that the market-based research into equipment and supply
pricing would result in a broad range, systematic data collection
methodology that could be applied to collecting information on
equipment maintenance costs.
Response: As detailed above, we continue to believe that the
current 5 percent maintenance factor likely understates the true cost
of maintaining some equipment and overstates the maintenance costs for
other equipment. We continue at this time to lack publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining maintenance factor. With
regards to the market-based study, the StrategyGen contractors were
tasked with updating the commercial pricing of supplies and equipment,
and did not include an investigation of equipment maintenance rates as
part of their research.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation (see 77 FR 68902 for a thorough
discussion of this issue). The interest rate was based on the Small
Business Administration (SBA) maximum interest rates for different
categories of loan size (equipment cost) and maturity (useful life). We
did not propose any changes to these interest rates for CY 2019. The
interest rates are listed in Table 4.
Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
Useful
Price life Interest
(years) rate (%)
------------------------------------------------------------------------
<$25K............................................. <7 7.50
$25K to $50K...................................... <7 6.50
>$50K............................................. <7 5.50
<$25K............................................. 7+ 8.00
$25K to $50K...................................... 7+ 7.00
>$50K............................................. 7+ 6.00
------------------------------------------------------------------------
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2019 direct PE input database, which is
available on the CMS website under downloads for the CY 2019 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640-67641), we continue to make improvements to the direct PE
input database to provide the number of clinical labor minutes assigned
for each task for every code in the database
[[Page 59463]]
instead of only including the number of clinical labor minutes for the
preservice, service, and postservice periods for each code. In addition
to increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS.'' Exam completed in RIS system
to generate billing process and to populate images into Radiologist
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through
80186), we finalized a policy to establish a range of appropriate
standard minutes for the clinical labor activity, ``Technologist QCs
images in PACS, checking for all images, reformats, and dose page.''
These standard minutes will be applied to new and revised codes that
make use of this clinical labor activity when they are reviewed by us
for valuation. We finalized a policy to establish 2 minutes as the
standard for the simple case, 3 minutes as the standard for the
intermediate case, 4 minutes as the standard for the complex case, and
5 minutes as the standard for the highly complex case. These values
were based upon a review of the existing minutes assigned for this
clinical labor activity; we determined that 2 minutes is the duration
for most services and a small number of codes with more complex forms
of digital imaging have higher values.
We also finalized standard times for clinical labor tasks
associated with pathology services in the CY 2016 PFS final rule with
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble
other light microscopy slides, open nerve biopsy slides, and clinical
history, and present to pathologist to prepare clinical pathologic
interpretation'', 1 minute for ``Clean room/equipment following
procedure'', 1 minute for ``Dispose of remaining specimens, spent
chemicals/other consumables, and hazardous waste'', and 1 minute for
``Prepare, pack and transport specimens and records for in-house
storage and external storage (where applicable).'' We do not believe
these activities would be dependent on number of blocks or batch size,
and we believe that these values accurately reflect the typical time it
takes to perform these clinical labor tasks.
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did for CY 2018, to facilitate rulemaking for
CY 2019, we are continuing to display two versions of the Labor Task
Detail public use file: one version with the old listing of clinical
labor tasks, and one with the same tasks cross-walked to the new
listing of clinical labor activity codes. These lists are available on
the CMS website under downloads for the CY 2019 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. These RUC-reviewed codes do
not currently have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we do not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets.
As a result, we proposed to maintain the 3 minutes of clinical
labor time for the ``Prepare room, equipment and supplies'' activity
and remove the clinical labor time for the ``Confirm order, protocol
exam'' activity wherever we observed this pattern in the RUC-
recommended direct PE inputs. If we had received RUC recommendations
for codes that currently include clinical labor time for the ``Confirm
order, protocol exam'' clinical labor task, we would have left the RUC-
recommended clinical labor times unchanged, but there were no such
codes reviewed for CY 2019. We note that there is no effect on the
total clinical labor direct costs in these situations, since the same 3
minutes of clinical labor time is still being used in the calculation
of PE RVUs.
The following is a summary of the public comments we received on
our proposal to maintain the 3 minutes of clinical labor time for the
``Prepare room, equipment and supplies'' activity and remove the
clinical labor time for the ``Confirm order, protocol exam'' activity
wherever we observed the aforementioned pattern in the RUC-recommended
direct PE inputs.
Comment: Several commenters supported CMS' proposal and requested
that these clinical labor refinements should be finalized wherever the
refinement had been proposed. These commenters noted that there was no
change in the total clinical labor direct costs in these situations and
urged CMS to finalize the proposal.
[[Page 59464]]
Response: We appreciate the support for the proposal from the
commenters.
Comment: Other commenters disagreed with the proposal. Commenters
stated that the standard clinical labor time for the CA013 ``Prepare
room, equipment and supplies'' activity has always been 2 minutes, and
that the occasional assignment of additional clinical labor time in
individual procedures has not changed this standard.
Response: We agree with the commenters that the standard clinical
labor time for the CA013 activity code is 2 minutes. We noted in the
proposed rule that 3 minutes has often traditionally been assigned for
this clinical labor activity, and our proposal was intended to reflect
this common practice pattern. In our table of direct PE refinements, we
listed many of these clinical labor refinements using the refinement
code ``L1: Refined time to standard for this clinical labor task.''
This was the incorrect refinement code to use in these situations, and
we acknowledge that this was a technical error. The direct PE
refinements would have more accurately employed the general refinement
code ``G1: See preamble text'' instead. We wish to clarify that
although we agree that the standard clinical labor time for the CA013
activity is 2 minutes, we continue to believe that 2 minutes would not
be typical for many of the codes currently under discussion.
Comment: Commenters explained that when the new version of the PE
worksheet introduced the activity codes for clinical labor, there was a
need to translate old clinical labor tasks into the new activity codes.
In the old version of the PE worksheet, there was a clinical labor task
named ``Patient clinical information and questionnaire reviewed by
technologist, order from physician confirmed and exam protocoled by
radiologist.'' Commenters stated that this clinical labor task was
split into two of the new clinical labor activity codes: CA007
(``Review patient clinical extant information and questionnaire'') in
the preservice period, and CA014 (``Confirm order, protocol exam'') in
the service period. Commenters stated that the same clinical labor from
the old PE worksheet is now divided into the CA007 and CA014 activity
codes, with a standard of 1 minute for each activity. The commenters
stated that they recognized that the proposal had no effect on the
total clinical labor direct costs, but urged CMS not to finalize anyway
due to concerns over inaccuracy and long term effects on the direct
practice expense inputs across the PFS.
Response: We agree with the commenters that in situations where a
CPT code under review had the old clinical labor task ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'' on a
prior version of the PE worksheet, and where that old clinical labor
task was divided into the new CA007 and CA014 activity codes as
described by the commenters, we will not finalize our proposed
refinements to maintain 3 minutes of clinical labor time for the
``Prepare room, equipment and supplies'' activity and remove the
clinical labor time for the ``Confirm order, protocol exam'' activity,
as we agree that the old clinical labor task is adequately accounted
for by being divided into the new activity codes. In these cases, we
will finalize the RUC-recommended 2 minutes of clinical labor time for
the CA007 activity code and 1 minute for the CA014 activity code.
However, when reviewing the clinical labor for the reviewed codes
affected by this issue, we found that several of the codes did not
include the old clinical labor task ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' on a prior version of the PE
worksheet. We also noted that several of the reviewed codes that
contained the CA014 clinical labor activity code for ``Confirm order,
protocol exam'' did not contain any clinical labor for the CA007
activity (``Review patient clinical extant information and
questionnaire''). In these situations, we believe that it is more
accurate to finalize our direct PE refinements to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity as proposed, since the
rationale provided by the commenters does not appear to be the case.
These codes do not appear to be an instance where the old clinical
labor task was split into two new clinical labor activities. We do not
understand how time assigned to an old clinical labor task could be
divided between the CA007 and CA014 activity codes, as the commenters
suggested, in situations where the code under review does not contain
any clinical labor for the CA007 activity. We continue to believe that
in these cases the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, as these codes do not currently have clinical
labor time assigned for the CA014 ``Confirm order, protocol exam''
clinical labor activity.
After consideration of the public comments, we are finalizing our
proposal for the reviewed codes that did not include the old clinical
labor task described above and do not contain any clinical labor for
the CA007 clinical labor activity. We are therefore finalizing our
proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and
92274. We are not finalizing our proposal for the reviewed codes where
we were able to determine that the old clinical labor task had been
divided into the CA007 and CA014 activity codes as described by the
commenters. We are therefore finalizing the RUC-recommended CA013 and
CA014 clinical labor for CPT codes 76978, 76981, and 76982.
b. Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during the review of the
recommended direct PE inputs for the CY 2017 PFS proposed rule, we
developed a structure that separates the scope, the associated video
system, and any scope accessories that might be typical as distinct
equipment items for each code. Under this approach, we proposed
standalone prices for each scope, and separate prices for the video
systems and accessories that are used with scopes.
(1) Scope Equipment
Beginning in the CY 2017 proposed rule (81 FR 46176 through 46177),
we proposed standardizing refinements to the way scopes have been
defined in the direct PE input database. We believe that there are four
general types of scopes: Non-video scopes; flexible
[[Page 59465]]
scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-
rigid scopes, and rigid scopes would typically be paired with one of
the scope video systems, while the non-video scopes would not. The
flexible scopes can be further divided into diagnostic (or non-
channeled) and therapeutic (or channeled) scopes. We proposed to
identify for each anatomical application: (1) A rigid scope; (2) a
semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled
flexible video scope; and (5) a channeled flexible video scope. We
proposed to classify the existing scopes in our direct PE database
under this classification system, to improve the transparency of our
review process and improve appropriate relativity among the services.
We planned to propose input prices for these equipment items through
future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. We did not propose
to apply these policies to codes with inputs reviewed prior to CY 2017.
We also solicited comment on this separate pricing structure for
scopes, scope video systems, and scope accessories, which we could
consider proposing to apply to other codes in future rulemaking. We did
not finalize price increases for a series of other scopes and scope
accessories, as the invoices submitted for these components indicated
that they are different forms of equipment with different product IDs
and different prices. We did not receive any data to indicate that the
equipment on the newly submitted invoices was more typical in its use
than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY
2017 to allow the RUC's PE Subcommittee the opportunity to provide
feedback. However, we believed there was some miscommunication on this
point, as the RUC's PE Subcommittee workgroup that was created to
address scope systems stated that no further action was required
following the finalization of our proposal. Therefore, we made further
proposals in CY 2018 (82 FR 33961 through 33962) to continue clarifying
scope equipment inputs, and sought comments regarding the new set of
scope proposals. We considered creating a single scope equipment code
for each of the five categories detailed in this rule: (1) A rigid
scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a
non-channeled flexible video scope; and (5) a channeled flexible video
scope. Under the current classification system, there are many
different scopes in each category depending on the medical specialty
furnishing the service and the part of the body affected. We stated our
belief that the variation between these scopes was not significant
enough to warrant maintaining these distinctions, and we believed that
creating and pricing a single scope equipment code for each category
would help provide additional clarity. We sought public comment on the
merits of this potential scope organization, as well as any pricing
information regarding these five new scope categories.
After considering the comments on the CY 2018 PFS proposed rule, we
did not finalize our proposal to create and price a single scope
equipment code for each of the five categories previously identified.
Instead, we supported the recommendation from the commenters to create
scope equipment codes on a per-specialty basis for six categories of
scopes as applicable, including the addition of a new sixth category of
multi-channeled flexible video scopes. Our goal is to create an
administratively simple scheme that will be easier to maintain and help
to reduce administrative burden. We look forward to receiving detailed
recommendations from expert stakeholders regarding the scope equipment
items that would be typically required for each scope category, as well
as the proper pricing for each scope.
(2) Scope Video System
We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through
46177) to define the scope video system as including: (1) A monitor;
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a
printer. We believe that these equipment components represent the
typical case for a scope video system. Our model for this system was
the ``video system, endoscopy (processor, digital capture, monitor,
printer, cart)'' equipment item (ES031), which we proposed to re-price
as part of this separate pricing approach. We obtained current pricing
invoices for the endoscopy video system as part of our investigation of
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a
digital capture device to the endoscopy video system (ES031) in the CY
2017 PFS final rule (81 FR 80188). We finalized our proposal to price
the system at $33,391, based on component prices of $9,000 for the
processor, $18,346 for the digital capture device, $2,000 for the
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did
not finalize, a proposal to add an LED light source into the cost of
the scope video system (ES031), which would remove the need for a
separate light source in these procedures. We also described a proposal
to increase the price of the scope video system by $1,000 to cover the
expense of miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories (such as cables, microphones, foot pedals, etc.). With the
addition of the LED light (equipment code EQ382 at a price of $1,915),
the updated total price of the scope video system would be set at
$36,306. We did not finalize this updated pricing to the scope video
system in CY 2018, and indicated our intention to address these changes
in CY 2019 to incorporate feedback from expert stakeholders.
(3) Scope Accessories
We understand that there may be other accessories associated with
the use of scopes. We finalized a proposal in the CY 2017 PFS final
rule (81 FR 80188) to separately price any scope accessories outside
the use of the scope video system, and individually evaluate their
inclusion or exclusion as direct PE inputs for particular codes as
usual under our current policy based on whether they are typically used
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2019
We understand that the RUC has convened a Scope Equipment
Reorganization Workgroup that will be incorporating feedback from
expert stakeholders with the intention of making recommendations to us
on scope organization and scope pricing. Since the workgroup was not
convened in time to submit recommendations for the CY 2019 PFS
rulemaking cycle, we proposed to delay proposals for any further
changes to scope equipment until CY 2020 so that we can incorporate the
feedback from the aforementioned workgroup. However, we proposed to
update the price of the scope video system (ES031) from its current
price of $33,391 to a price of $36,306 to reflect the addition of the
LED light and miscellaneous small equipment associated with the system
that falls below the threshold of individual equipment pricing as scope
accessories, as we explained in detail in the CY 2018 PFS final rule
(82 FR 52992 through 52993). We also proposed to update the name of the
ES031
[[Page 59466]]
equipment item from ``video system, endoscopy (processor, digital
capture, monitor, printer, cart)'' to ``scope video system (monitor,
processor, digital capture, cart, printer, LED light)'' to reflect the
fact that the use of the ES031 scope video system is not limited to
endoscopy procedures.
The following is a summary of the public comments we received on
our proposals involving scopes and scope systems.
Comment: Several commenters supported the decision to delay
proposals for any further changes to scope equipment until CY 2020 in
order to incorporate the feedback from the RUC's Scope Equipment
Reorganization Workgroup. One commenter thanked CMS for adding a scope
category for multi-channeled flexible video scopes. A different
commenter supported the proposal to increase the price of the scope
video system (ES03l) from its current price of $33,391 to a price of
$36,306 and also supported the proposed update to the name of the ES03l
equipment item since the use of the scope video system is not limited
to endoscopy procedures.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter stated that they were concerned that the
proposed pricing for both the scope video system (ES03l) and the
stroboscopy system (ES065) are less than the true cost of the equipment
items, and therefore do not accurately reimburse physicians for their
direct overhead costs. The commenter stated that they had supplied more
recent invoices for these equipment items, which should be taken into
consideration for pricing, and reiterated their disagreement with the
CMS proposal from the previous calendar year to create single scope
equipment categories for all specialties, as scope equipment is not
always comparable across specialties. A different commenter supplied
invoices for several other scope equipment items and requested that CMS
update the prices for these equipment codes and that the new pricing
take effect for CY 2019.
Response: We continue to believe that any further changes to scope
equipment, including invoice submissions to update scope pricing,
should be delayed until CY 2020 so that we can incorporate the feedback
from the RUC's Scope Equipment Reorganization Workgroup.
After consideration of the public comments, we are finalizing our
scope proposals for CY 2019 without refinement.
c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation
Several stakeholders contacted CMS with regard to the use of the
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106)
supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with
dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal
or via canine fossa), 31296 (Nasal/sinus endoscopy, surgical; with
dilation of frontal sinus ostium (e.g., balloon dilation)), and 31297
(Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus
ostium (e.g., balloon dilation)). The stakeholders stated that the
price of the SA106 supply (currently $2,599.86) had decreased
significantly since it was priced through rulemaking for CY 2011 (75 FR
73351 through 75532), and that the Medicare payment for these three CPT
codes using the supply no longer seemed to be in proportion to what the
kits cost. They also indicated that the same catheter could be used to
treat multiple sinuses rather than being a disposable one-time use
supply. The stakeholders stated that marketing firms and sales
representatives are advertising these CPT codes as a method for
generating additional profits due to the payment for the procedures
exceeding the resources typically needed to furnish the services, and
requested that CMS investigate the use of the SA106 supply in these
codes.
When CPT codes 31295 through 31297 were initially reviewed during
the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR
73184 through 73186, respectively), we expressed our reservations about
the pricing and the typical quantity of this supply item used in
furnishing these services. The RUC recommended for the CY 2012
rulemaking cycle that CMS remove the balloon sinus surgery kit from
each of these codes and implement separately billable alpha-numeric
HCPCS codes to allow practitioners to be paid the cost of the
disposable kits per patient encounter instead of per CPT code. We
stated at the time, and we continue to believe, that this option
presents a series of potential problems that we have addressed
previously in the context of the broader challenges regarding our
ability to price high cost disposable supply items. (For a discussion
of this issue, we direct the reader to our discussion in the CY 2011
PFS final rule with comment period (75 FR 73251)). We stated at the
time that since the balloon sinus surgery kits can be used when
furnishing more than one service to the same beneficiary on the same
day, we believed that it would be appropriate to include 0.5 balloon
sinus surgery kits for each of the three codes, and we have maintained
this 0.5 supply quantity when CPT codes 31295-31297 were recently
reviewed again in CY 2018.
In light of the additional information supplied by the
stakeholders, we solicited comments on two aspects of the use of the
balloon sinus surgery kit (SA106) supply. First, we solicited comments
on whether the 0.5 supply quantity of the balloon sinus surgery kit in
CPT codes 31295-31297 would be typical for these procedures. We are
concerned that the same kit can be used when furnishing more than one
service to the same beneficiary on the same day, and that even the 0.5
supply quantity may be overstating the resources typically needed to
furnish each service. Second, we solicited comments on the pricing of
the balloon sinus surgery kit, given that we have received letters
stating that the price has decreased since the initial pricing in the
CY 2011 final rule. See Table 5 for the current component pricing of
the balloon sinus surgery kit.
Table 5--Balloon Sinus Surgery Kit (SA106) Price
----------------------------------------------------------------------------------------------------------------
Supply components Quantity Unit Price
----------------------------------------------------------------------------------------------------------------
kit, sinus surgery, balloon (maxillary, frontal, .............. kit......................... $2,599.86
or sphenoid).
Sinus Guide Catheter.............................. 1 item........................ 444.00
Sinus Balloon Catheter............................ 1 item........................ 820.80
Sinus Illumination System (100 cm lighted 1 item........................ 454.80
guidewire).
Light Guide Cable (8 ft).......................... 1 item........................ 514.80
ACMI/Stryker Adaptor.............................. 1 item........................ 42.00
Sinus Guide Catheter Handle....................... 1 item........................ 66.00
Sinus Irrigation Catheter (22 cm)................. 1 item........................ 150.00
Sinus Balloon Catheter Inflation Device........... 1 item........................ 89.46
Extension Tubing (High Pressure) (20 in).......... 1 item........................ 18.00
----------------------------------------------------------------------------------------------------------------
[[Page 59467]]
We are interested in any information regarding possible changes in
the pricing for this kit or its individual components since the initial
pricing we adopted in CY 2011. The following is a summary of the public
comments we received on our comment solicitation regarding the balloon
sinus surgery kit supply.
Comment: Several commenters stated that the variability inherent in
the underlying patient anatomy makes it extremely difficult to reliably
assign a fixed number of sinuses that can be dilated per balloon or
establish a supply quantity that would constitute the typical case.
These commenters urged CMS to create a separate HCPCS code for the
balloon sinus surgery kit that would be billable based on the number of
balloons used per patient.
Response: As we stated in the proposed rule, we continue to believe
that this option presents a series of potential problems that we have
addressed previously in the context of the broader challenges regarding
our ability to maintain appropriate relativity while pricing high cost
disposable supply items. For a discussion of this issue, we direct the
reader to our discussion in the CY 2011 PFS final rule with comment
period (75 FR 73251).
Comment: One commenter provided extensive information regarding the
pricing and composition of the balloon sinus surgery kit. This
commenter stated that the components of the supply kit have changed
from those listed in Table 5, and that there are multiple different
types of this kit available for purchase. The commenter stated that the
total cost of the balloon sinus surgery kit varies by sinus dilated,
whether navigation is used, and by manufacturer, with the average price
of a basic kit costing $2,204 and the average price of the kit used for
navigation costing $2,850, not including the navigation device itself.
The commenter stated that the kit components should not be individually
priced and that invoices could be made available upon request.
With regards to the number of sinus dilation procedures that
typically can be performed per balloon, the commenter repeated that the
variability inherent in the underlying patient anatomy makes it
extremely difficult to assign a fixed number of sinuses that can be
dilated per balloon. The commenter also urged CMS to consider a shift
away from the current supply methodology and instead create a separate
HCPCS code for the balloon sinus surgery kit which would be billable
based on the number of balloons used per patient. The commenter stated
that should CMS elect to preserve the current policy of assigning a
fixed number of sinus dilations per kit, they recommended maintaining
the current supply quantity that allows one kit for every two sinuses,
as they were unable to find compelling evidence to support a more
appropriate supply amount.
Response: We are particularly interested in the feedback suggesting
that there may be multiple types of balloon sinus surgery kits that
have different prices, and we would be interested in further
information, including invoice submissions, on this subject for future
rulemaking.
After consideration of the public comments, we are not finalizing
any changes to the balloon sinus surgery kit (SA106) supply for CY
2019, outside of the market-based supply and equipment pricing update
to the supply cost. We do not believe that we have sufficient
information to finalize any other changes to the supply cost or supply
quantity in the associated CPT codes at this point in time.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2018 PFS final rule,
stakeholders alerted us to several clerical inconsistencies in the
direct PE database. We proposed to correct these inconsistencies as
described below and reflected in the CY 2019 final direct PE input
database displayed on the CMS website under downloads for the CY 2019
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2019, we proposed to address the following inconsistencies:
The RUC alerted us that there are 165 CPT codes billed
with an office E/M code more than 50 percent of the time in the
nonfacility setting that have more minimum multi-specialty visit supply
packs (SA048) than post-operative visits included in the code's global
period. This indicates that either the inclusion of office E/M services
was not accounted for in the code's global period when these codes were
initially reviewed by the PE Subcommittee, or that the PE Subcommittee
initially approved a minimum multi-specialty visit supply pack for
these codes without considering the resulting overlap of supplies
between SA048 and the E/M supply pack (SA047). The RUC regarded these
overlapping supply packs as a duplication, due to the fact that the
quantity of the SA048 supply exceeded the number of postoperative
visits, and requested that CMS remove the appropriate number of supply
item SA048 from 165 codes. After reviewing the quantity of the SA048
supply pack included for the codes in question, we proposed to refine
the quantity of minimum multi-specialty visit packs as displayed in
Table 6.
Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)
----------------------------------------------------------------------------------------------------------------
Proposed CY
CY 2018 2019
Number of post- nonfacility nonfacility
CPT code op office quantity of quantity of
visits minimum visit minimum visit
pack (SA048) pack (SA048)
----------------------------------------------------------------------------------------------------------------
10040........................................................... 1 2 1
10060........................................................... 1 2 1
10061........................................................... 2 3 2
10080........................................................... 1 2 1
10120........................................................... 1 2 1
10121........................................................... 1 2 1
10180........................................................... 1 2 1
11200........................................................... 1 2 1
11300........................................................... 0 1 0
11301........................................................... 0 1 0
11302........................................................... 0 1 0
[[Page 59468]]
11303........................................................... 0 1 0
11306........................................................... 0 1 0
11307........................................................... 0 1 0
11310........................................................... 0 1 0
11311........................................................... 0 1 0
11312........................................................... 0 1 0
11400........................................................... 1 2 1
11750........................................................... 1 2 1
11900........................................................... 0 1 0
11901........................................................... 0 1 0
12001........................................................... 0 1 0
12002........................................................... 0 1 0
12004........................................................... 0 1 0
12011........................................................... 0 1 0
12013........................................................... 0 1 0
16020........................................................... 0 1 0
17000........................................................... 1 2 1
17004........................................................... 1 2 1
17110........................................................... 1 2 1
17111........................................................... 1 2 1
17260........................................................... 1 2 1
17270........................................................... 1 2 1
17280........................................................... 1 2 1
19100........................................................... 0 1 0
20005........................................................... 1 2 1
20520........................................................... 1 2 1
21215........................................................... 6 7 6
21550........................................................... 1 2 1
21920........................................................... 1 2 1
22310........................................................... 1.5 2.5 1.5
23500........................................................... 2.5 3.5 2.5
23570........................................................... 2.5 3.5 2.5
23620........................................................... 3 4 3
24500........................................................... 4 5 4
24530........................................................... 4 5 4
24650........................................................... 3 4 3
24670........................................................... 3 4 3
25530........................................................... 3 4 3
25600........................................................... 5 6 5
25605........................................................... 5 6 5
25622........................................................... 3.5 4.5 3.5
25630........................................................... 3 4 3
26600........................................................... 4 5 4
26720........................................................... 2 3 2
26740........................................................... 2.5 3.5 2.5
26750........................................................... 2 3 2
27508........................................................... 4 5 4
27520........................................................... 3.5 4.5 3.5
27530........................................................... 4 5 4
27613........................................................... 1 2 1
27750........................................................... 3.5 4.5 3.5
27760........................................................... 4 5 4
27780........................................................... 3.5 4.5 3.5
27786........................................................... 3.5 4.5 3.5
27808........................................................... 4 5 4
28190........................................................... 1 2 1
28400........................................................... 3 4 3
28450........................................................... 2.5 3.5 2.5
28490........................................................... 1.5 2.5 1.5
28510........................................................... 1.5 2.5 1.5
30901........................................................... 0 1 0
30903........................................................... 0 1 0
30905........................................................... 0 1 0
31000........................................................... 1 2 1
31231........................................................... 0 1 0
31233........................................................... 0 1 0
31235........................................................... 0 1 0
[[Page 59469]]
31238........................................................... 0 1 0
31525........................................................... 0 1 0
31622........................................................... 0 1 0
32554........................................................... 0 1 0
36600........................................................... 0 1 0
38220........................................................... 0 1 0
40490........................................................... 0 1 0
42800........................................................... 1 2 1
43200........................................................... 0 1 0
45330........................................................... 0 1 0
46040........................................................... 3 4 3
46050........................................................... 1 2 1
46083........................................................... 1 2 1
46320........................................................... 0.5 1.5 0.5
46600........................................................... 0 1 0
46604........................................................... 0 1 0
46900........................................................... 1 2 1
51102........................................................... 0 2 0
51701........................................................... 0 1 0
51702........................................................... 0 1 0
51703........................................................... 0 1 0
51710........................................................... 0 1 0
51725........................................................... 0 1 0
51736........................................................... 0 1 0
51741........................................................... 0 1 0
51792........................................................... 0 1 0
51798........................................................... 0 1 0
52000........................................................... 0 1 0
52001........................................................... 0 1 0
52214........................................................... 0 1 0
52265........................................................... 0 1 0
52281........................................................... 0 1 0
52285........................................................... 0 1 0
53601........................................................... 0 1 0
53621........................................................... 0 1 0
53660........................................................... 0 1 0
53661........................................................... 0 1 0
54050........................................................... 1 2 1
54056........................................................... 1 2 1
54100........................................................... 0 1 0
54235........................................................... 0 1 0
54450........................................................... 0 1 0
55000........................................................... 0 1 0
56405........................................................... 1 2 1
56605........................................................... 0 1 0
56820........................................................... 0 1 0
57061........................................................... 1 2 1
57100........................................................... 0 1 0
57420........................................................... 0 1 0
57500........................................................... 0 1 0
57505........................................................... 1 2 1
62252........................................................... 0 1 0
62367........................................................... 0 1 0
62368........................................................... 0 1 0
62370........................................................... 0 1 0
64413........................................................... 0 1 0
64420........................................................... 0 1 0
64450........................................................... 0 1 0
64611........................................................... 1 2 1
69000........................................................... 1 2 1
69100........................................................... 0 1 0
69145........................................................... 1.5 2.5 1.5
69210........................................................... 0 1 0
69420........................................................... 1 2 1
69433........................................................... 1 2 1
69610........................................................... 1 2 1
93292........................................................... 0 1 0
[[Page 59470]]
93303........................................................... 0 1 0
94667........................................................... 0 1 0
95044........................................................... 0 0.028 0
95870........................................................... 0 1 0
95921........................................................... 0 1 0
95922........................................................... 0 1 0
95924........................................................... 0 1 0
95972........................................................... 0 1 1
96904........................................................... 0 1 1
----------------------------------------------------------------------------------------------------------------
In general, we proposed to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits
included in these codes. We did not propose any supply pack quantity
refinements for CPT codes 11100, 95974, or 95978 since they are being
deleted for CY 2019. We also did not propose any supply pack quantity
refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405,
95970, or HCPCS code G0268 since these codes were reviewed by the RUC
this year and their previous direct PE inputs will be superseded by the
new direct PE inputs we establish through this rulemaking process for
CY 2019.
Comment: One commenter stated that they supported this effort as it
serves to remedy any discrepancies/errors that may be in the PFS
related to postoperative visits and the required multi-specialty packs
needed to render those visits.
Response: We appreciate the support for our proposal from the
commenter.
Comment: One commenter stated that removal of the SA048 supply pack
was inappropriate for CPT code 43200 (Esophagoscopy, flexible,
transoral; diagnostic, including collection of specimen(s) by brushing
or washing, when performed (separate procedure)) as it is required for
the esophagoscopy procedure and the supply is included in the other
codes in the family (CPT codes 43201-43233) as well as for the other GI
endoscopy code families. The commenter requested that CMS not remove
the SA048 supply from CPT code 43200.
Response: After reviewing the supply inputs for the group of codes
identified by the commenter, we agree that it would not be consistent
to remove the SA048 multi-specialty pack from CPT code 43200 while
retaining the supply pack in CPT codes 43201-43233. As a result, we are
not finalizing the removal of the SA048 multi-specialty pack from CPT
code 43200. However, we note that many of the CPT codes in this range
also contain SA048 supply packs without having any postoperative office
visits included in their global periods. We believe that it may be more
accurate to achieve consistency within this range of CPT codes by
removing the SA048 supply pack from all of these codes, as opposed to
adding the SA048 supply pack to CPT code 43200. In regard to this
topic, stakeholders can always provide data to us if they believe the
code is not bundled/valued/etc. correctly.
After consideration of the public comments, we are finalizing our
proposal to align the number of minimum multi-specialty visit packs
with the number of post-operative office visits included in these CPT
codes listed in Table 6, with the exception of CPT code 43200 as
detailed above.
A stakeholder notified us regarding a potential rank order anomaly
in the direct PE inputs established for the Shaving of Epidermal or
Dermal Lesions code family through PFS rulemaking for CY 2013. Three of
these CPT codes describe benign shave removal of increasing lesion
sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single
lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion
diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or
dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous
membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving
of epidermal or dermal lesion, single lesion, face, ears, eyelids,
nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of
these codes has a progressively higher work RVU corresponding to the
increasing lesion diameter, and the recommended direct PE inputs also
increase progressively from CPT codes 11310 to 11311 to 11312. However,
the nonfacility PE RVU we established for CPT code 11311 is lower than
the nonfacility PE RVU for CPT code 11310, which the stakeholder
suggested may represent a rank order anomaly.
We reviewed the direct PE inputs for CPT code 11311 and found that
there were clerical inconsistencies in the data entry that resulted in
the assignment of the lower nonfacility PE RVU for CPT code 11311. We
proposed to revise the direct PE inputs to reflect the ones previously
finalized through rulemaking for CPT code 11311.
Comment: One commenter agreed that a significant clerical error
occurred after the RUC recommended its valuation of CPT code 11311 and
its final acceptance by CMS. The commenter recommended that the direct
PE inputs of CPT code 11310 be replicated for CPT code 11311 and
submitted a table with recommended values.
Response: After reviewing this information, we found that the
direct PE inputs requested by the commenter mostly, but do not
entirely, match the direct PE inputs that CMS finalized through
rulemaking for CY 2013. The commenter requested the inclusion of an
additional SB007 (drape, sterile barrier 16in x 29in) supply and a
SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving
out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022
(sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and
4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise
the direct PE inputs to match the ones previously finalized through
rulemaking for CPT code 11311, we are not finalizing these five changes
to the direct PE inputs requested by the commenter. In all other
respects, the direct PE inputs recommended by the commenter matched the
direct PE inputs previously finalized through
[[Page 59471]]
rulemaking. We are therefore finalizing our proposal to revise the
direct PE inputs to reflect the ones previously finalized in CY 2013
for CPT code 11311.
In CY 2018, we inadvertently assigned too many minutes of
clinical labor time for the ``Obtain vital signs'' task to three
therapy codes, given that these codes are typically billed in multiple
units and in conjunction with other therapy codes for the same patient
on the same day, and we do not believe that it would be typical for
clinical staff to obtain vital signs for each time a code is reported.
The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas,
each 15 minutes; massage, including effleurage, petrissage and/or
tapotement (stroking, compression, percussion)); CPT code 97750
(Physical performance test or measurement (e.g., musculoskeletal,
functional capacity), with written report, each 15 minutes); and CPT
code 97755 (Assistive technology assessment (e.g., to restore, augment
or compensate for existing function, optimize functional tasks and/or
maximize environmental accessibility), direct one-on-one contact, with
written report, each 15 minutes).
Therefore, we proposed to refine the ``Obtain vital signs''
clinical labor task for these three codes back to their previous times
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code
97755. We also proposed to refine the equipment time for the table,
mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the
change in the clinical labor time.
Comment: Several commenters agreed with the CMS rationale for
refining the clinical labor task times for each of these codes.
Response: We appreciate the support for our proposal from the
commenters.
Comment: One commenter opposed the CMS proposal to refine the
equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for
CPT code 97124 to reflect the change in the clinical labor time.
Response: We continue to believe that changes in clinical labor
time should be matched with corresponding changes in equipment time.
Since the commenter did not supply a rationale as to why the EF028
equipment time should not match the change in clinical labor time, we
are finalizing our proposal to refine the ``Obtain vital signs''
clinical labor task for these three codes back to their previous times
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code
97755.
We received a letter from a commenter alerting us to an anomaly in
the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate
procedure)). The commenter stated that the inclusion of an endoscope
disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was
inadvertently overlooked in the recommendations for CPT code 52000 when
it was reviewed during PFS rulemaking for CY 2017, and that the
equipment would be necessary for endoscope sterilization. The commenter
requested that this piece of equipment should be added to the direct PE
inputs for CPT code 52000.
After reviewing the direct PE inputs for this code, we agreed with
the commenter and we proposed to add the endoscope disinfector (ES005)
to CPT code 52000, and to add 22 minutes of equipment time for that
item to match the equipment time of the other non-scope items included
in this code.
Comment: One commenter supported the CMS proposal to add an
endoscope disinfector to CPT code 52000 and to add 22 minutes of
equipment time to match the equipment time of the other non-scope items
included in the code. This commenter requested that this addition apply
to all endoscopic urologic procedures that do not already include the
endoscope disinfector.
Response: We do not agree that the endoscope disinfector should be
added to all endoscopic urologic procedures that lacked the equipment,
as the addition of this equipment to CPT code 52000 is a technical
correction to address a specific anomaly with the recommendations for
CPT code 52000 and not the implementation of a new policy. After
consideration of the public comments, we are finalizing the addition of
22 minutes of equipment time for the endoscope disinfector (ES005) to
CPT code 52000 as proposed.
The following is a summary of the public comments we received on
additional technical corrections to the direct PE input database and
supporting files.
Comment: A commenter stated that they had reviewed the CY 2019
Proposed Rule physician work time file and discovered an issue with 13
CPT codes that had incorrect work times. The commenter stated that
these were technical errors in which the current work time values did
not match what CMS had finalized through rulemaking, and the commenter
requested that these services be corrected in the CY 2019 CMS work time
file for the CY 2019 Final Rule.
Response: We agree with the commenter that some of these CPT codes
are subject to technical corrections, while disagreeing with the
commenter with regards to other CPT codes, as described in more detail
below.
Listed in order, the commenter identified these issues:
Comment: For CPT code 15220 (Full thickness graft, free, including
direct closure of donor site, scalp, arms, and/or legs; 20 sq cm or
less), the commenter stated that their records showed CMS missing 15
min of positioning time from the Harvard study.
Response: We are not finalizing a change in the work time of this
code at this time, as we were unable to verify the positioning time of
CPT code 15220 as originally measured by the Harvard study.
Comment: For CPT code 22558 (Arthrodesis, anterior interbody
technique, including minimal discectomy to prepare interspace (other
than for decompression); lumbar), the commenter stated that the CMS
work time file accidentally double counted postoperative visit time in
the immediate postoperative time field.
Response: We agree with the commenter that this is subject to a
technical correction, and we are finalizing an immediate postservice
work time of 25 minutes for CPT code 22558.
Comment: For CPT code 43760 (Change of gastrostomy tube,
percutaneous, without imaging or endoscopic guidance), the commenter
stated that the code is being deleted for CY 2019 and should not appear
in the work time file.
Response: We agree with the commenter, and we are finalizing the
removal of this code from the work time file.
Comment: For CPT codes 61645 (Percutaneous arterial transluminal
mechanical thrombectomy and/or infusion for thrombolysis, intracranial,
any method, including diagnostic angiography, fluoroscopic guidance,
catheter placement, and intraprocedural pharmacological thrombolytic
injection(s)) and 61650 (Endovascular intracranial prolonged
administration of pharmacologic agent(s) other than for thrombolysis,
arterial, including catheter placement, diagnostic angiography, and
imaging guidance; initial vascular territory), the commenter stated
that CMS incorrectly applied 23 hour stay rule for these codes even
though the RUC recommended these services as typically inpatient. The
commenter stated that there are now available data to see that these
CPT codes are done on an inpatient basis 98 percent and 86 percent of
the time respectively.
Response: We do not believe that the work times of these codes are
subject to
[[Page 59472]]
a technical correction, as the work times finalized for these codes in
the CY 2017 PFS final rule (81 FR 80307-08) were based on a
disagreement in policy with the commenter and not a technical error.
Comment: For CPT code 91200 (Liver elastography, mechanically
induced shear wave (e.g., vibration), without imaging, with
interpretation and report), the commenter stated that the RUC
recommended 5 minutes of immediate postservice work time, not 3
minutes, and that CMS had finalized the code without a time refinement.
The commenter stated that the immediate postservice work time for CPT
code 91200 should be 5 minutes in accordance with the RUC
recommendations.
Response: We investigated the RUC recommendations from the April
2015 RUC meeting when CPT code 91200 was reviewed, and we found that
the RUC recommended an immediate postservice work time of 3 minutes on
the code family's cover sheet and the accompanying summary spreadsheet.
Although the RUC may have intended to recommend an immediate
postservice work time of 5 minutes for this code, we proposed and
finalized an immediate postservice work time of 3 minutes for CPT code
91200 without receiving any comments on the issue. Therefore we are not
finalizing any changes to the work time of CPT code 91200 at this time,
which will remain 3 minutes.
Comment: For CPT codes 93281 (Programming device evaluation (in
person) with iterative adjustment of the implantable device to test the
function of the device and select optimal permanent programmed values
with analysis, review and report by a physician or other qualified
health care professional; multiple lead pacemaker system), 93284
(Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select
optimal permanent programmed values with analysis, review and report by
a physician or other qualified health care professional; multiple lead
transvenous implantable defibrillator system), and 93286 (Peri-
procedural device evaluation (in person) and programming of device
system parameters before or after a surgery, procedure, or test with
analysis, review and report by a physician or other qualified health
care professional; single, dual, or multiple lead pacemaker system),
the commenter stated that CMS has the wrong intraservice work times,
despite the CY 2018 final rule indicating no time refinement for these
codes.
Response: After reviewing the work times for these codes, we agree
with the commenter and we are finalizing a technical correction to the
intraservice work times as recommended.
Comment: For CPT code 97166 (Occupational therapy evaluation,
moderate complexity), the commenter stated that the HCPAC recommended
15 min of immediate postservice work time, not 10 minutes, and that CMS
had finalized the code without a time refinement.
Response: We investigated the RUC recommendations from the October
2015 RUC meeting when CPT code 97166 was reviewed, and we found that
the HCPAC recommendations contained two different values for the
immediately postservice work time. The written recommendations stated
that the immediate postservice work time was recommended at 15 minutes,
while the data on the summary spreadsheet stated that the immediate
postservice work time was recommended at 10 minutes. Although there
were two conflicting HCPAC recommendations for this code, we finalized
in the CY 2017 PFS final rule (81 FR 80331) an immediate postservice
work time of 10 minutes for CPT code 97166 without receiving any
comments on the issue. Therefore we are not finalizing any changes to
the work time of CPT code 97166 at this time.
Comment: For CPT code 33866 (Aortic hemiarch graft including
isolation and control of the arch vessels, beveled open distal aortic
anastomosis extending under one or more of the arch vessels, and total
circulatory arrest or isolated cerebral perfusion (List separately in
addition to code for primary procedure)), the commenter stated that the
RUC recommendation was rescinded and that the code should be removed
from the work time file.
Response: We disagree with the commenter, and we are not finalizing
the removal of CPT code 33866 from the work time file; we refer readers
to the code valuation section of this final rule for additional details
regarding CPT code 33866.
Comment: For CPT code 96X11 (Psychological or neuropsychological
test administration using single instrument, with interpretation and
report by physician or other qualified health care professional and
interactive feedback to the patient, family member(s), or
caregivers(s), when performed), the commenter stated that the code is
not being created for CY 2019 by the CPT Editorial Panel and should be
removed from the work time file.
Response: We agree with the commenter and we are finalizing the
removal of this code from the work time file.
Comment: For HCPCS code G0281 (Electrical stimulation,
(unattended), to one or more areas, for chronic stage iii and stage iv
pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis
ulcers not demonstrating measurable signs of healing after 30 days of
conventional care, as part of a therapy plan of care), the commenter
stated that their records show an intraservice time for this code of 11
minutes and not 7 minutes as currently listed in the work time file.
Response: We disagree with the commenter. As we stated in the CY
2003 PFS final rule with comment period (67 FR 80014), the work,
practice expense, and malpractice values G0281 are based on a crosswalk
to CPT code 97014 (Application of a modality to 1 or more areas;
electrical stimulation (unattended)), and the intraservice work time of
CPT code 97014 remains 7 minutes.
Comment: Many commenters raised concerns about the use of the
portable X-ray machine (EF041) equipment in CPT code 71045 (Radiologic
examination, chest; single view). Commenters stated that the use of the
portable X-ray machine in CPT code 71045 understated the price of the
equipment typically used in the service, and that the default equipment
utilization rate of 50 percent did not reflect the experience of
portable X-ray suppliers. Commenters supplied an invoice for a Digital
Radiography portable X-ray machine, which they stated would be typical
for use in this procedure, along with data on the equipment utilization
rate that suggested a utilization rate significantly lower than 50
percent would be typical. Commenters requested modifying the direct PE
inputs for CPT code 71045 to include the use of the Digital Radiography
portable X-ray machine at a distinctive utilization rate of
approximately 22 percent, or alternatively, to use the same equipment
as the other three codes in the Chest X-Ray code family (CPT codes
71046-71048) as direct PE inputs for CPT code 71045.
Response: We agree with the commenters and we are finalizing the
replacement of the 9 minutes of equipment time for the portable X-ray
machine (EF041) with 9 minutes of equipment time for a basic radiology
room (EL012) for CPT code 71045. The equipment cost per minute of the
basic radiology room (48.4 cents) is nearly identical to the equipment
cost per
[[Page 59473]]
minute of the proposed Digital Radiography portable X-ray machine (46.0
cents), and we believe that it would better serve the interests of
relativity for CPT code 71045 to match the same equipment inputs as the
rest of the Chest X-Ray code family. We previously updated the PE RVU
of this code in the July 2018 Quarterly Update (CMS Change Request
10644) based on the same information previously supplied by the
commenters, and due to a technical error, this update to the direct PE
inputs of CPT code 71045 was not included in the CY 2019 PFS proposed
rule. We are finalizing this technical correction to the direct PE
inputs of CPT code 71045 for CY 2019.
Comment: One commenter stated that there was a typographical error
in Attachment B of the proposed rule, which resulted in the
misstatement of the total RVUs for CPT code 48554 (Transplantation of
pancreatic allograft). The commenter recommended that we include 74.81
total RVUs for CPT code 48554 to correct the error of 73.70 total RVUs.
Response: We do not agree with the commenter that there was a
typographical error in Addendum B for CPT code 48554, which appears to
sum its component parts of the work RVU (37.80), PE RVU (27.72), and
malpractice RVU (9.29) to the correct total RVU of 74.81.
We also received comments regarding a variety of subjects about
which we did not make proposals for CY 2019. These included comments
regarding: The level of physician supervision for CPT code 99091, the 7
percent reduction to the technical component of computed radiography
services not performed using digital radiography, a request to migrate
the RUC recommended RVU assignment of CPT code 77387 to HCPCS code
G6017, a request that CMS not finalize the proposed changes in payment
for the revascularization codes (CPT codes 37225-37231) that were a
byproduct of the E/M proposals and the supply/equipment pricing update,
a request that CMS should assign direct cost inputs and PE RVUs to
several disposable negative pressure wound therapy codes (CPT codes
97607-97608), a disagreement with previous reductions in the payment
rate for HCPCS code G0416 from past calendar years, a request for
clarification regarding the facility PE RVUs for CPT code 99153, a
request for CMS to provide additional reimbursement stability for
vascular access services by increasing the work RVUs and direct PE
inputs for these codes (CPT codes 36901-36909), and a request for CMS
to study the possible effect of tariffs on the cost of imaging
equipment manufactured overseas. These comments are considered out of
scope for the CY 2019 PFS final rule, as we did not make any proposals
on these issues in the CY 2019 PFS Proposed Rule. We will take the
feedback from the commenters under consideration for future rulemaking.
After consideration of the public comments, we are finalizing
technical corrections to the direct PE input database and supporting
files as described above.
e. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019,
we proposed the following price updates for existing direct PE inputs.
We proposed to update the price of four supplies and one equipment
item in response to the public submission of invoices. As these pricing
updates were each part of the formal review for a code family, we
proposed that the new pricing take effect for CY 2019 for these items
instead of being phased in over 4 years. For the details of these
proposed price updates, please refer to section II.H. of this final
rule, Table 15: Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) provides that the Secretary may collect or
obtain information from any eligible professional or any other source
on the resources directly or indirectly related to furnishing services
for which payment is made under the PFS, and that such information may
be used in the determination of relative values for services under the
PFS. Such information may include the time involved in furnishing
services; the amounts, types and prices of PE inputs; overhead and
accounting information for practices of physicians and other suppliers,
and any other elements that would improve the valuation of services
under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, as
added by PAMA, we initiated a market research contract with StrategyGen
to conduct an in-depth and robust market research study to update the
PFS direct PE inputs (DPEI) for supply and equipment pricing for CY
2019. These supply and equipment prices were last systematically
developed in 2004-2005. StrategyGen has submitted a report with updated
pricing recommendations for approximately 1300 supplies and 750
equipment items currently used as direct PE inputs. This report is
available as a public use file displayed on the CMS website under
downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
Federal Register, current DPEI data, historical proposed
and final rules prior to FY 2018, and other resources; that is, AMA RUC
reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
1. If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of
[[Page 59474]]
equipment and a more precise reference for the RP.
2. If StrategyGen did not have market share for commercial
products, then they used a weighted average (weighted by sample size)
of the commercial price and GSA price for the RP. The impact of the GSA
price may be nominal in some of these cases since it is proportionate
to the commercial samples sizes.
3. Otherwise, if single price points existed from alternate
supplier sites, the RP was the weighted average of the commercial price
and the GSA price.
4. Finally, if no data were available for commercial products, the
GSA average price was used as the RP; and when StrategyGen could find
no market research for a particular piece of equipment or supply item,
the current CMS prices were used as the RP.
After reviewing the StrategyGen report, we proposed to adopt the
updated direct PE input prices for supplies and equipment as
recommended by StrategyGen. For the reasons subsequently discussed, the
GSA price was not incorporated into the calculation for the StrategyGen
recommended prices printed in the proposed rule. The proposed
recommended price was developed as follows:
Recommended CMS Price: The StrategyGen proposed recommended price
was the researched-commercial price, when available. If not, the
StrategyGen proposed recommended price was the current CMS price.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current CMS price.
Specifically, preliminary data indicate that there was no statistically
significant difference between the estimated commercial prices and the
current CMS prices for both equipment and supplies. This cumulative
stable pricing for medical equipment and supplies appears similar to
the pricing impacts of non-medical technology advancements where some
historically high-priced equipment (that is, desktop PCs) has been
increasingly substituted with current technology (that is, laptops and
tablets) at similar or lower price points. However, while there were no
statistically significant differences in pricing at the aggregate
level, medical specialties will experience increases or decreases in
their Medicare payments if CMS were to adopt the pricing updates
recommended by StrategyGen. At the service level, there may be large
shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, we proposed to phase in our use of the new direct PE input
pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50
percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022)
split between new and old pricing. This approach is consistent with how
we have previously incorporated significant new data into the
calculation of PE RVUs, such as the 4-year transition period finalized
in CY 2007 PFS final rule with comment period when changing to the
``bottom-up'' PE methodology (71 FR 69641). This transition period will
not only ease the shift to the updated supply and equipment pricing,
but will also allow interested parties an opportunity to review and
respond to the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the proposed transition from the
current to the fully-implemented new pricing is provided in Table 7.
Table 7--Example of Direct PE Pricing Transition
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Current Price...................... $100 ...........................................................
Final Price........................ 200 ...........................................................
Year 1 (CY 2019) Price............. 125 \1/4\ difference between $100 and $200.
Year 2 (CY 2020) Price............. 150 \1/3\ difference between $125 and $200.
Year 3 (CY 2021) Price............. 175 \1/2\ difference between $150 and $200.
Final (CY 2022) Price.............. 200 ...........................................................
----------------------------------------------------------------------------------------------------------------
For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and
[[Page 59475]]
equipment are adopted without a formal review of the HCPCS codes that
include them (as is the case for the many updated prices we proposed to
phase in over the 4-year transition period), we believe it is important
to include them in the remaining transition toward the updated price.
We also proposed to phase in any updated pricing we establish during
the 4-year transition period for very commonly used supplies and
equipment that are included in 100 or more codes, such as sterile
gloves (SB024) or exam tables (EF023), even if invoices are provided as
part of the formal review of a code family. We would implement the new
prices for any such supplies and equipment over the remaining years of
the proposed 4-year transition period. Our proposal was intended to
minimize any potential disruptive effects during the proposed
transition period that could be caused by other sudden shifts in RVUs
due to the high number of services that make use of these very common
supply and equipment items (meaning that these items are included in
100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer time frame will allow more opportunities for public
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration. We were particularly interested in comments regarding
the supply and equipment pricing for CPT codes 95165 and 95004 that are
frequently used by the Allergy/Immunology specialty. The Allergy/
Immunology specialty was disproportionately affected by the updated
pricing, even with a 4-year phase-in. The direct PE costs for CPT code
95165 would go down from $8.43 to $8.17 as a result of the updated
supply and equipment pricing information. This would result in the PE
RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking
feedback on the supply and equipment pricing for the affected codes
typically performed by this specialty and whether the direct PE inputs
should be reviewed along with the pricing. The full report from the
contractor, including the updated supply and equipment pricing that we
proposed to be implemented over the proposed 4-year transition period,
will be made available as a public use file displayed on the CMS
website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments we received on
our proposals associated with the market research study to update the
PFS direct PE inputs for supply and equipment pricing.
Comment: Many commenters were concerned with the transparency of
the data used to calculate medical equipment and supply prices. The
commenters were particularly concerned about the use of a subscription-
based benchmark database as a source for pricing data. The commenters
stated that without identification of the database and access to the
precise data used in determining the pricing update, they would have no
systematic way to evaluate pricing accuracy. In addition, these
commenters were concerned that small physician practices are not well
represented in benchmark databases, with the consequence that the
proposed repricing did not reflect the typical price paid by smaller
stakeholders. Commenters stated a general concern that any methodology
that more heavily weighs larger physician groups, group purchasing
organizations (GPOs), or even hospital contract pricing would result in
pricing that is significantly depressed compared to the pricing that
can be obtained by an individual practitioner. The commenters asserted
that this has the potential to pressure the financial viability of
smaller physician practices and to force lower cost non-facility
procedures into hospital outpatient or inpatient sites of service.
Response: As to whether there is sufficient transparency to enable
others to replicate and validate the proposed pricing, the StrategyGen
contractors carried out a market research plan designed to estimate the
typical discounted prices that physicians and other providers normally
pay. The proprietary database of buyer reported pricing is one of the
few sources of typical discounted price data available. Other potential
sources of typical discounted pricing were other proprietary databases
and the publicly available GSA pricing. For each item priced, the
analysis from the contractors included research on as many as five
current sources of prices: (1) A proprietary database of buyer reported
pricing, (2) Prices reported by GSA, (3) Amazon Business, (4) Cardinal
Healthcare, and (5) Vendors' and manufacturers' catalogs.
The proprietary database of buyer reported pricing offers three
advantages: (1) It represents discounted prices as opposed to retail
pricing, (2) It has the largest sample sizes to represent a wider range
of pricing as opposed to single invoices, and (3) The database provides
variety with respect to the purchaser's geographic location, purchasing
method, procedure volume and other purchasing arrangements. We
initially assumed that GSA also represents typical discounted pricing
across regions with smaller sample sizes, but subsequently rejected GSA
data because we did not believe that its prices were typically
representative of commercially available pricing. As a result, GSA data
were not used to calculate the StrategyGen recommended prices included
in the proposed rule. Amazon Business and Cardinal Healthcare represent
typical retail pricing, with smaller sample sizes. In addition, the
StrategyGen contractors utilized vendors' and manufacturers' catalogs
to identify publicly available pricing. Table 8 summarizes sources of
online pricing and characteristics of each source:
Table 8--Market-Based Supply and Equipment Pricing Update Data Sources
----------------------------------------------------------------------------------------------------------------
Variety (that is,
Source of pricing data Discounted pricing Sample size geography, purchasing
arrangement, etc.)
----------------------------------------------------------------------------------------------------------------
Buyers database..................... Actual discounts....... Largest.................. National footprint.
GSA................................. Wholesale price........ 3-5...................... Government purchasers
only.
Amazon Business (on-line)........... Retail price........... 3-5...................... National footprint.
Cardinal Healthcare (on-line)....... Retail price........... 3-5...................... National footprint.
Catalogs (on-line).................. Retail price........... 3-5...................... National footprint.
----------------------------------------------------------------------------------------------------------------
[[Page 59476]]
The Buyers database provides the most accurate market pricing
estimates that include market discounts for a range of buyer
organizations. Its larger sample sizes provide more confidence that the
proposed pricing is not skewed toward higher or lower pricing but
toward the actual market price paid by purchasers.
The StrategyGen contractors chose not to include invoice research
in the market research plan as there is already an existing process to
modify Direct Practice Expense Input (DPEI) prices based on invoices.
Additionally, the contractors determined that providing specific models
and other identifying data with the researched prices would offer a
broader and more consistent source of pricing data. We do not agree
with the commenters that the updated supply and equipment prices will
pressure the financial viability of smaller physician practices, as we
believe that the larger sample sizes obtained by StrategyGen's research
provide more accurate and more consistent pricing of actual market
conditions than the single invoices that we have traditionally been
reliant upon for pricing.
As to whether the proposed pricing is representative of prices
available to small physician practices and non-facility practitioners
generally, one of the objectives of the primary market research was to
understand what kind of discounts are available to small physician
practices similar to discounted pricing available to large health
systems under GPOs. The market research plan included a series of
questions to vendors designed to illuminate typical discounts they
offer to large and small providers other than GPOs. This market
research indicates that there are a variety of discount purchasing
options available. Vendors indicated that both volume and timing can
influence pricing discounts. Approximately 80 percent of respondents
indicated that timing has some impact on the price of equipment, and
about half of respondents indicated that timing had some impact on the
price of supplies. Discussions with other subject matter experts also
indicated that timing of purchase is an important factor in pricing.
For example, the end of the sales cycle can drive discounts. Less than
10 percent of vendors indicated that these timing discounts may not be
available to smaller practices outside of a GPO. The vendor research
also indicated that other factors beyond ``size and timing'' influence
discounted pricing, such as service agreements and bundled purchases.
Research indicates that service agreements often include discounts
for equipment and supplies. For example, longer term service agreements
generally result in larger discounts. However, some vendors indicated
that the effect of service agreements was to reduce the size of the
discounts, negatively impacting providers. This may be a difference in
service agreement strategies across different vendors. Regardless, only
3 percent of respondents indicated that the availability of service
agreement discounts was dependent on a GPO.
The vendors identified other factors that impact pricing decisions
including:
Market demand and competitive pricing;
Contract renewal;
Customer history and contract history; and
Vendor considerations independent of the purchaser such as
manufacturer and sales incentives, revenue goals, and new product
releases.
In conclusion, while volume purchasing and GPOs can drive down
prices for many large providers, these are not the only drivers of
discounts for providers. A number of additional factors applicable to
large, small, and non-facility practices may result in discounts for
the buying organizations. We believe that the pricing update required
looking at a broad range of data that was collected from different
sources, which included pricing data from both large and small
organizations. We note that not all private practices are small in
nature, and we do not agree that it would be more accurate to obtain
prices only from small practices as opposed to the broader data
collection undertaken by the StrategyGen contractor.
Comment: Some commenters were concerned that the researched GSA
price was incorporated into the recommended commercial price. These
commenters expressed concern as to how the GSA price fit into the
calculation of new recommended prices.
Response: We want to clarify how the GSA price was used in
developing the new recommended DPEI prices for equipment and supplies.
We regret the confusion on this issue, which was due to a technical
error in the drafting of the language in the proposed rule. We wish to
clarify that the GSA price was not used to calculate the StrategyGen
recommended prices printed in the proposed rule. Our use of the GSA
website to research supply and equipment pricing was found to have a
number of limitations. Only suppliers that meet stringent
qualifications and that complete a lengthy and detailed application
process are eligible to participate in GSA Advantage, GSA's online
shopping and ordering system. These requirements sharply curtail the
number and type of suppliers whose products may be accessed on the GSA
Advantage website. In addition, only products that are purchased by
federal agencies or other qualified government entities are listed on
the GSA Advantage website, which has the effect of eliminating a number
of medical supplies and equipment that are reflected in the CMS DPEI
codes. This limitation was especially acute when researching bundled
codes for equipment rooms and lanes, and supply packs, kits, and trays.
The GSA website does not record comparable bundled purchasing of
medical equipment or supplies, so no GSA pricing could be recovered for
products included in the bundled codes organized as rooms, lanes,
packs, kits or trays. Finally, the prices listed on the GSA Advantage
website are required to be the supplier's best offer, which may often
be lower than prices that are available to non-governmental purchasers.
For these reasons, the GSA price was not incorporated into the
calculation for the StrategyGen recommended prices printed in the
proposed rule. The final recommended price for CY 2019 was the
commercially researched price, if available. Otherwise the current CY
2018 CMS price remained in place as the CY 2019 CMS price.
Comment: Several commenters were concerned with the methodology
used by StrategyGen to conduct market research to determine an updated
price for medical equipment and supplies. There were significant
concerns with the use of market research to supplement the current AMA/
Specialty Society RVS Update Committee (RUC) process. A number of
commenters stated that CMS should only use invoices supplied by the
specialty society via the RUC process, and should not finalize the
updated prices researched by the StrategyGen contractor.
Response: We determined that the most effective way to update the
DPEI for CY 2019 was through comprehensive market research. The current
RUC process has resulted in updates to many of the equipment and supply
codes, but many of the prices in the CY 2018 DPEI are over a decade
old, and a significant number date back to research conducted 15 years
ago. Therefore, we requested a market research plan from the
StrategyGen contractor designed to research current pricing to estimate
the typical discounted prices that physicians and other providers
normally pay.
[[Page 59477]]
The comprehensive market research plan to update DPEI equipment and
supplies was designed to supplement the AMA RUC process, not replace
it. The current RUC process, while indispensable, does not provide for
comprehensive pricing updates. Under the current process, physicians
and other providers voluntarily submit invoices for items to RUC for
consideration, and after review, the RUC submits these invoices to us.
This process results in inherent biases due to the limited number of
items represented by submitted invoices and due to the voluntary
selection of reported invoices.
The StrategyGen market research plan examined up to five online
sources of current prices for each item of equipment or supply
researched, including: (1) A proprietary database of buyer reported
pricing, (2) Prices offered on GSA (Note: This data was subsequently
excluded from the recommended 2019 CMS prices), (3) Amazon Business,
(4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs.
Each of these sources contains nationally reported vendor and buyer
pricing data. The research plan also included vendor interviews to
clarify the variety of discount programs available to physicians and
other providers.
The comprehensive research plan for the 2019 DPEI required
researching approximately 2,000 supply and equipment codes. Qualitative
and potentially quantitative research to include all the specialty
societies impacted by the DPEI updates was beyond the resources and
time allocated to this update. The market research plan did include a
physician panel with specialists and a general practitioner to review
the reasonableness of the researched data. In addition, the regulatory
process remains available to all specialty societies to comment on the
recommended prices. We encouraged interested stakeholders to continue
to provide feedback on supply and equipment pricing, including the
submission of invoices, throughout the 4-year pricing transition.
Comment: Several commenters stated that there is an inherent bias
to prioritizing the medical equipment and supplies based on spending
and code utilization. These commenters stated that any attempt to
accurately price items in the supply and equipment list should devote
equal effort to each item of equipment or supply and should not devote
additional attention to the most utilized codes. These commenters
stated that using utilization data as the primary driver for
identifying supply and equipment items to review suggests that there
may have been specific intent to lower the cost of high utilization
items, perhaps to the detriment of pricing accuracy. In addition, there
was concern that some underutilized codes were not researched.
Response: To control for potential research bias, the StrategyGen
market research team used an identical online methodology to research
commercial pricing data for each of the supply and equipment codes,
regardless of the code's prioritization. The prioritization of high-
utilization supply and equipment codes was not designed to reduce
prices for these codes.
The prioritization of supply and equipment codes was designed to
facilitate understanding and validation of the researched commercial
prices for these items. Surveying other market entities, including
vendors, as opposed to buyers, was used to more precisely identify the
range of commercial pricing and factors impacting those prices. For
example, additional priority research included a physician panel that
reviewed the researched commercial prices for reasonableness. The
prioritization of research for certain codes did not change the
recommended commercial prices.
In addition, limited time and resources required prioritizing the
codes based on use. We recognize that a few medical supply and
equipment codes do not have updated recommended prices, and we continue
to welcome the submission of updated pricing information from
stakeholders for these and other codes.
Comment: Many commenters were supportive of the proposal to use a
4-year pricing transition. Commenters agreed with using the transition
period as an opportunity for specialty societies and other stakeholders
to continue to evaluate the new pricing and submit invoices and other
pricing data as needed. Commenters who disagreed with the use of the 4-
year pricing transition also requested that CMS not finalize the
proposal. One commenter stated that CMS should phase in the new prices
for equipment and supplies during a shorter transition period than the
proposed 4-year transition, and suggested a 2-year transition instead.
Response: Our proposal was intended to minimize any potential
disruptive effects during the proposed transition period, and we
continue to believe that implementing the proposed updated prices with
a 4-year phase-in will improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer time frame will allow more opportunities for public
comment and submission of additional, applicable data.
Comment: Several commenters stated that CMS should consider
delaying implementation of this proposal until there could be a more
thorough and adequate review of the inputs and give medical societies
and/or practices more time to gather invoices in order to determine if
the proposed pricing is accurate. Some commenters similarly requested
that the 4-year pricing transition should begin in CY 2020 to provide
stakeholders with additional time to evaluate the approach used by
StrategyGen. A few commenters stated that they would prefer a delay of
more than 1 year before implementation began.
Response: We disagree with the commenters that delaying the
implementation of the pricing updates for a year or longer would lead
to more accurate pricing. We believe that our proposal to update the
pricing of direct PE inputs for supplies and equipment over a 4 year-
transition already allows many opportunities for public comment and the
submission of additional, applicable data. We welcomed feedback from
commenters on the proposed updated supply and equipment pricing,
including the submission of additional invoices for consideration, and
many commenters provided detailed feedback regarding the pricing of
individual supply and equipment items. We note that we received
feedback from commenters on approximately 65 individual supply and
equipment codes, which is roughly 3 percent of the total number of
items we proposed to update. We also note that commenters did not
identify an alternative source for pricing information outside of the
sources employed by the StrategyGen contractors, with commenters
largely suggesting that we should continue to rely on invoice
submissions included along with the review of individual codes via the
RUC process.
We continue to believe that a delay in implementation would be
unlikely to result in more accurate pricing information. Therefore, we
are finalizing the 4-year pricing transition, beginning in CY 2019. We
look forward to working with commenters over the 4-year transition for
assistance in identifying individual supply and equipment codes that
may require additional research into their pricing. As a reminder, to
be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th
[[Page 59478]]
deadline used for consideration of RUC recommendations. However, we
would consider invoices submitted as public comments during the comment
period following the publication of the PFS proposed rule, and would
consider any invoices received after February 10th or outside of the
public comment process as part of our established annual process for
requests to update supply and equipment prices for the following year.
Comment: Many commenters addressed the proper pricing of some
multi-component items, including supply kits, packs, and trays as well
as some items of equipment. Several commenters noted some of the
proposed prices for supply and equipment items that contain multiple
components may not accurately reflect all the components, while other
commenters noted that some of the components could be improperly
priced. Commenters expressed concerns that some equipment may not
possess precise components that are necessary for a specific procedure.
Response: Using the information provided by these commenters, the
StrategyGen contractors re-examined the pricing of the multi-component
supply and equipment items that had been identified. In some instances,
the additional research confirmed some commenters' concerns, as the
contractors found that a limited set of these multi-item supply and
equipment kits required further clarification of components. For
example, an item within a kit, pack, or tray may have had an updated
component, resulting in a mispriced item within that kit. To further
clarify the prices of these kits, the kits were broken into their most
basic components and priced individually. The total price of the kit
was determined by adding the specific item prices together. If one of
the items within a kit was misidentified, it resulted in an incorrect
price of the entire kit.
For example, a review of the recommended price for the ``Antigens,
multi'' (SH007) supply code identified the need to add pricing data for
additional antigens and to refine the unit of measurement used in
calculating the price. For SH007, additional antigens were added and
data analyzed for 1 milliliter vials of two allergy antigens. The first
antigen is an allergy antigen for pollen and mites and contains
antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the
mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The
second antigen is an allergy antigen for mold and cats and contains
antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1.
To determine the price of the allergy antigen, the StrategyGen
contractor researched each component of the antigen separately and
averaged the price of the separate vials as the recommended price to
arrive at an updated recommended price of $8.96.
In instances related to equipment, an item may have been improperly
priced because a specific component was omitted but the items priced
could perform the requisite task. An example of this occurred in the
pricing of the ``SRS System, SBRT'' (ER083) equipment item where the
equipment priced would retrofit a system to perform SBRT procedures,
but pricing did not include the linear accelerator. When re-examining
this specific medical equipment, we ensured it was a linear accelerator
with SBRT capabilities and arrived at an updated recommended price of
$2,973,721.83.
We reexamined the recommended price of each multi-component item
cited by a commenter. Table 9 at the conclusion of this section lists
the supply and equipment codes with price changes based on feedback
from the commenters and the resulting additional research into pricing.
Comment: Several commenters questioned the prices of certain supply
codes based on their conclusion that the quantity of the items priced
was inaccurate. Depending on the type of supply, a number of different
units of measurement are used to set prices for DPEI supply codes.
Commenters stated that StrategyGen had used the incorrect unit of
measurement in their recommended prices, and identified specific supply
codes where they believed these errors had taken place.
Response: In each instance in which a commenter questioned the
accuracy of a DPEI code's recommended price based on a concern about
the unit quantity of the item priced, the StrategyGen contractor
conducted further research of the item and its price with special
attention to ensuring that the recommended price was based on the
clarified unit of measure. The price assigned to a given code may be
for a single item, a kit, a tray, or it may be based on a per test or
per ml basis. For example, the price for the SG055 supply is for a
single sterile 4in x 4in gauze sponge; whereas the price for SG056 is
for a tray/pack of 10 sterile 4in x 4in gauze sponges. In other
situations, such as the ``Embedding Mold'' (SL060) supply, the price
for a package of multiple molds was reported instead of the price of a
single embedding mold. After consideration of comments received and
additional price research, we have updated the recommended prices for a
number of relevant supply codes identified by the commenters. Table 9
at the conclusion of this section lists the supply and equipment codes
with price changes based on feedback from the commenters and the
resulting additional research into pricing.
Comment: Several commenters addressed the subject of the proper
pricing for certain items of medical supply and equipment. These
commenters requested these specific CMS codes be reviewed again to
ensure the correct items were being researched and priced accordingly.
Response: Based on the commenters' requests, the StrategyGen
contractor conducted an extensive examination of the pricing of any
supply or equipment items that any commenter identified as requiring
additional review. Invoices submitted by multiple commenters were
greatly appreciated and ensured that medical equipment and supplies
were re-examined and clarified. Multiple researchers reviewed these
specified supply and equipment codes for accuracy and proper pricing.
In most cases, the contractor also reached out to a team of nurses and
their physician panel to further validate the accuracy of the data and
pricing information. In some cases, the pricing for individual items
needed further clarification due to a lack of information or due to
significant variation in packaged items. An example of such
clarification occurred with the ``Covered Stent (Viabahn, Gore)''
(SD254) supply, which encompasses a wide range of stents, with varying
sizes and other qualities. In other cases, such as the ``Patient Worn
Telemetry System'' (EQ340) equipment, an inpatient unit was originally
priced as opposed to an outpatient unit. After an extensive review and
validation process, we updated our recommended prices for a number of
supply and equipment codes. Table 9 at the conclusion of this section
lists the supply and equipment codes with price changes based on
feedback from the commenters and the resulting additional research into
pricing.
Comment: Several commenters expressed concerns with the proposed
prices for individual supply and equipment codes, and recommended that
the price of these codes remain unchanged until additional research can
be conducted.
Response: The StrategyGen contractor investigated the accuracy of
components or features included in an item by researching the identity
of the item based on the description contained in the item's supply or
equipment code, as well as the identity of any item's prices
[[Page 59479]]
in submitted invoices. Additional research into approximately half a
dozen supply/equipment codes failed to produce reliable product data
sufficient to calculate a recommended price. To price these equipment
and supply items accurately, we believe additional information is
required. Therefore, we will continue to use the current CMS price for
these supply and equipment items pending additional research and
analysis. We welcome the submission of updated pricing information
regarding these supply and equipment items through submission of valid
invoices from commenters and other stakeholders. These supply and
equipment codes are also listed in Table 9 at the conclusion of this
section.
Comment: A few commenters stated that CMS should ensure that the
direct practice expenses for HCPCS codes G6001-G6015 are applied
consistent with the directives of the Patient Access and Medicare
Protection Act (PAMPA) (Pub. L. 114-115) and the Bipartisan Budget Act
(BBA) of 2018 (Pub. L. 115-123). Commenters stated that Congress
established via statute that the direct PE inputs for these radiation
treatment delivery services furnished in CY 2017, CY 2018, and CY 2019
shall be the same as such inputs as established for these services in
CY 2016. These commenters stated that the proposed changes to the PE
RVUs for HCPCS codes G6001-G6015 were directly opposed to current law,
and that CMS should revisit its analysis to ensure that the direct PE
inputs are consistent with those used in 2016 as required by Congress.
Response: We disagree with the commenters that the proposed direct
PE inputs for HCPCS codes G6001-G6015 were not applied consistent with
the directives established in the PAMPA and the BBA. The statute at
section 1848(b)(11) of the Act (as added by the PAMPA and amended)
specifies that the code definitions, work RVUs, and direct inputs for
the practice expense RVUs for these services shall be the same as such
definitions, units, and inputs for such services for the fee schedule
established for services furnished in CY 2016. We did not propose to
change the code definitions, work relative value units, or direct
practice expense inputs from those established for CY 2016. We proposed
to update the pricing of those same supply and equipment inputs as part
of the market-based study of commercial pricing undertaken by the
contractor, which was not a subject addressed by the statutory
provisions concerning HCPCS codes G6001-G6015. We did not propose
changes to the direct practice expense inputs for these services. We
simply proposed to update pricing for these inputs; and to adopt the
same prices for these supplies and equipment across the PFS for all
codes that include them. We note that we estimate that the overall
effect of incorporating the new prices in calculating the payment rates
for these services results in higher overall RVUs for these services,
on the whole, than the potential alternative of relying exclusively on
pricing from prior years.
After consideration of the public comments, we are finalizing our
proposals associated with the market research study to update the PFS
direct PE inputs for supply and equipment pricing. We continue to
believe that implementing the proposed updated prices with a 4-year
phase-in will improve payment accuracy, while maintaining stability and
allowing stakeholders the opportunity to address potential concerns
about changes in payment for particular items. We continue to welcome
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration. However, while we are adopting most of the prices for
supplies and equipment as recommended by StrategyGen and included in
the proposed rule, in response to the initial feedback provided by the
commenters, we are finalizing changes to the proposed pricing of
approximately 60 supply and equipment codes as detailed in Table 9:
Table 9--Supply and Equipment Prices Updated in Response to Comments
----------------------------------------------------------------------------------------------------------------
Proposed CY Final CY 2019
Supply/ equipment code Description CY 2018 price 2019 price price
----------------------------------------------------------------------------------------------------------------
ED033.......................... treatment planning system, IMRT $350,545.000 $157,392.835 $197,247.000
(Corvus w-Peregrine 3D Monte
Carlo).
EF031.......................... table, power................... 6,153.630 5,438.120 5,906.760
EL015.......................... room, ultrasound, general...... 369,945.000 130,252.571 369,945.000
EL016.......................... Room--Ultrasound, vascular/ 466,492.000 199,449.308 466,492.000
Original submission.
EP014.......................... flow cytometer................. 119,850.000 147,210.980 192,000.000
EP088.......................... ThermoBrite.................... 6,120.000 3,467.000 4,795.000
EP116.......................... VP-2000 Processor.............. 30,800.000 81,775.462 37,993.000
EQ031.......................... INR monitor, home.............. 2,000.000 6,014.819 635.000
EQ125.......................... glucose continuous monitoring 1,170.540 835.527 850.000
system.
EQ288.......................... ultrasonic cleaning unit....... 895.000 76,725.556 895.000
EQ312.......................... INR analysis and reporting 21,085.000 6,014.819 19,325.000
system w-software.
EQ340.......................... Patient Worn Telemetry System.. 23,537.000 18,565.719 23,494.000
EQ343.......................... Radioaerosol Administration 2,560.250 30.000 623.000
System.
ER003.......................... HDR Afterload System, 375,000.000 111,425.876 132,574.780
Nucletron--Oldelft.
ER083.......................... SRS system, SBRT, six systems, 4,000,000.000 931,965.479 2,973,721.836
average.
ES052.......................... brachytherapy treatment vault.. 175,000.000 134,998.000 193,114.250
SA026.......................... kit, radiofrequency introducer. 50.000 658.700 24.160
SA074.......................... kit, endovascular laser 519.000 313.460 323.330
treatment.
SA081.......................... pack, drapes, ortho, small..... 1.128 1.000 2.250
SA099.......................... Kit, probe, cryoablation, 4,700.000 1,539.560 1,539.560
prostate (Galil-Endocare).
SA100.......................... kit, probe, radiofrequency, XIi- 2,695.000 753.420 1,966.670
enhanced RF probe.
SA105.......................... UroVysion test kit............. 176.800 132.130 129.280
SA106.......................... Balloon Sinus Surgery Kit...... 2,599.860 2,876.220 2,374.330
SA117.......................... Universal Detection Kit........ 4.000 6.510 4.000
SA122.......................... Claravein Kit.................. 890.000 575.000 883.330
SB019.......................... drape-towel, sterile 18in x 0.282 0.920 0.470
26in.
SB026.......................... gown, patient.................. 0.533 3.540 0.590
SD109.......................... probe, radiofrequency, 3 array 2,233.000 871.660 2,289.000
(StarBurstSDE).
SD114.......................... sensor, glucose monitoring 53.080 43.950 59.310
(interstitial).
[[Page 59480]]
SD134.......................... tubing, suction, non-latex 2.961 0.290 2.670
(6ft) with Yankauer tip (1).
SD155.......................... catheter, RF endovenous 725.000 1,010.550 550.000
occlusion.
SD250.......................... introducer sheath, Ansel [45 cm 90.000 64.450 72.640
6 Fr Ansel].
SD251.......................... Sheath Shuttle (Cook).......... 0.000 0.000 109.690
SD253.......................... atherectomy device 4,979.670 2,293.100 3,048.330
(Spectronetics laser or Fox
Hollow).
SD254.......................... covered stent (VIABAHN, Gore).. 3,768.000 2,573.000 3,129.000
SD255.......................... Reentry device (Frontier, 0.000 0.000 2,343.120
Outback, Pioneer).
SD304.......................... IVUS catheter.................. 1,025.000 727.750 858.330
SF040.......................... suture, vicryl, 3-0 to 6-0, p, 7.852 4.310 8.520
ps.
SG055.......................... gauze, sterile 4in x 4in....... 0.159 0.030 0.190
SG056.......................... gauze, sterile 4in x 4in (10 0.798 0.030 1.200
pack uou).
SH007.......................... antigen, multi (pollen, mite, 6.700 4.780 8.960
mold, cat).
SH009.......................... antigen, venom................. 20.140 27.360 30.930
SH010.......................... antigen, venom, tri-vespid..... 44.050 51.320 60.240
SH033.......................... fluorescein inj (5ml uou)...... 5.442 10.310 24.390
SJ055.......................... test strip, INR................ 5.660 3.750 4.710
SL012.......................... antibody IgA FITC.............. 41.180 274.090 30.025
SL060.......................... embedding mold................. 0.149 5.140 0.123
SL182.......................... mounting media (DAPI II 67.000 14.420 54.000
counterstain).
SL184.......................... slide, negative control, Her-2. 29.400 21.240 29.400
SL185.......................... slide, positive control, Her-2. 29.400 25.000 26.200
SL191.......................... ethanol, 85%................... 0.003 0.170 0.021
SL195.......................... kit, FISH paraffin pretreatment 20.850 23.290 20.850
SL196.......................... kit, HER-2/neu DNA Probe....... 105.000 80.450 79.050
SL258.......................... Control slides................. 228.000 279.000 203.730
SL261.......................... FISH pre-treatment kit......... 549.000 454.480 579.210
SL474.......................... Confirm anti-CD15 Mouse 3.610 3.880 3.820
Monoclonal Antibody (Ventana
760-2504).
SL483.......................... Hematoxylin II (Ventana 790- 0.023 0.023 0.780
2208).
SL484.......................... Bluing reagent (Ventana 760- 4.522 0.290 0.450
2037).
SL488.......................... UltraView Universal DAB 10.485 15.390 9.700
Detection Kit.
SL493.......................... Antibody Estrogen Receptor 14.470 322.400 16.117
monoclonal.
SL497.......................... (EBER) DNA Probe Cocktail...... 8.570 420.060 8.189
SL498.......................... Kappa Probe Cocktail........... 0.095 0.070 0.910
----------------------------------------------------------------------------------------------------------------
The updated supply and equipment pricing as it will be implemented
over the 4-year transition period will be made available as a public
use file displayed on the CMS website under downloads for the CY 2019
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
To maintain relativity between the clinical labor, supplies, and
equipment portions of the PE methodology, we believe that the rates for
the clinical labor staff should also be updated along with the updated
pricing for supplies and equipment. We solicited public comment
regarding whether to update the clinical labor wages used in developing
PE RVUs in future calendar years during the 4-year pricing transition
for supplies and equipment, or whether it would be more appropriate to
update the clinical labor wages at a later date following the
conclusion of the transition for supplies and equipment, for example,
to avoid other potentially large shifts in PE RVUs during the 4-year
pricing transition period.
The following is a summary of the public comments we received on
our comment solicitation regarding whether to update of the rates for
the clinical labor staff types during the 4-year pricing transition for
supplies and equipment.
Comment: Most commenters were supportive of the idea of updating
the clinical labor wages during the 4-year pricing transition for
supplies and equipment. Several commenters requested that the updated
pricing for clinical labor should continue to be based on Bureau of
Labor Statistics wage data and remain open for public comment from
interested commenters through the rulemaking process. One commenter
supported updating the prices for the clinical labor staff types and
stated that they had convened an expert physician panel that suggested
that the clinical labor costs for radiation therapists and nurses are
up to 33 percent higher than what is currently included in the CMS
database. A few commenters did not support updating clinical labor
wages during the 4-year pricing transition for supplies and equipment,
in one case stating that the clinical labor pricing should be updated
after the pricing transition for supplies and equipment was complete,
and in another case stating that CMS should not make any changes to
clinical labor costs for the foreseeable future.
Response: We will take this information into account for future
rulemaking on the subject of whether or not to update the clinical
labor wages used in future calendar years alongside the 4-year pricing
transition for supplies and equipment.
(2) Breast Biopsy Software (EQ370)
Following the publication of the CY 2018 PFS final rule, a
stakeholder contacted us and requested that we update the price for the
Breast Biopsy software (EQ370) equipment. This equipment item currently
lacks a price in the direct PE database, and when an invoice for the
Breast Biopsy software was first submitted during CY 2014 PFS
rulemaking, we stated that this item served clinical functions similar
to other items already included in the Magnetic Resonance (MR) room
equipment package (EL008) included in the same CPT codes under review.
Therefore, we did not create new direct PE inputs for this equipment
item (78 FR 74344
[[Page 59481]]
through 74345). The stakeholder suggested that this software is used to
subtract the imaging raw data series from the MRI Scanner, reformat the
images in multiple planes to allow accurate targeting of the lesion to
be biopsied, identify the location of a fiducial marker on the
patient's skin, and then target the location of the enhancing lesion to
be biopsied. The stakeholder requested that EQ370 be renamed as
``Breast MRI computer aided detection and biopsy guidance software''
and added to existing CPT codes 19085 (Biopsy, breast, with placement
of breast localization device(s) (e.g., clip, metallic pellet), when
performed, and imaging of the biopsy specimen, when performed,
percutaneous; first lesion, including magnetic resonance guidance),
19086 (Biopsy, breast, with placement of breast localization device(s)
(e.g., clip, metallic pellet), when performed, and imaging of the
biopsy specimen, when performed, percutaneous; each additional lesion,
including magnetic resonance guidance), 19287 (Placement of breast
localization device(s) (e.g., clip, metallic pellet, wire/needle,
radioactive seeds), percutaneous; first lesion, including magnetic
resonance guidance), and 19288 (Placement of breast localization
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive
seeds), percutaneous; each additional lesion, including magnetic
resonance guidance), as well as adding the equipment to two newly
created MR breast codes with CAD, CPT codes 77048 (Magnetic resonance
imaging, breast, without and with contrast material(s), including
computer-aided detection (CAD-real time lesion detection,
characterization and pharmacokinetic analysis) when performed;
unilateral) and 77049 (Magnetic resonance imaging, breast, without and
with contrast material(s), including computer-aided detection (CAD-real
time lesion detection, characterization and pharmacokinetic analysis)
when performed; bilateral). The stakeholder supplied an invoice with a
purchase price of $52,275 for the equipment.
After reviewing the use of the Breast Biopsy software (EQ370)
equipment in these six codes, we did not propose to update the price or
add the software to these procedures. As we stated in the CY 2014 PFS
final rule with comment period (78 FR 74345), we continue to believe
that equipment item EQ370 serves clinical functions similar to other
items already included in the MR room equipment package (EL008), and
that it would be duplicative to include this Breast Biopsy software as
a separate direct PE input. We also note that the RUC recommendations
for the new CPT codes 77048 and 77049 do not include EQ370 in the
recommended equipment for these procedures, and we do not have any
reason to believe that the inclusion of additional Breast Biopsy
software beyond what is already contained in the MR room equipment
package would be typical. However, we will update the name of the EQ370
equipment item from ``Breast Biopsy software'' to the requested
``Breast MRI computer aided detection and biopsy guidance software'' to
help better describe the equipment in question.
The following is a summary of the public comments we received on
our proposal not to update the price of the Breast Biopsy software or
add the software to the listed procedures.
Comment: Several commenters stated that CAD or biopsy software is
not part of any standard MRI room package available for purchase, and
that these are different equipment items sold by different vendors. One
commenter requested that CMS clarify the equipment items that make up
the MR room (EL008) in order to verify whether or not legitimate
duplication exists with the Breast Biopsy software. Another commenter
stated that the new CAD Software equipment (ED058) in CPT codes 77048
and 77049 is actually synonymous with the ``breast biopsy software''
(EQ370). This commenter stated that there had been a lack of
consistency in identifying the equipment item between the breast biopsy
codes and the MR breast codes, and requested updating the price of the
equipment item consistent with the submitted invoices.
Response: In response to the comment requesting that CMS clarify
the equipment items that make up the MR room (EL008), we can state that
the MR room contains a 1.5T MR Scanner as well as coils, NV array,
torso array, shoulder, wrist, extremity, dual array, power injector,
and a computer workstation.
After consideration of the public comments, we are finalizing our
proposal not to update the price of the Breast Biopsy software (EQ370).
However, we note that in light of the information supplied by the
commenter that the new CAD Software equipment (ED058) is actually
synonymous with the Breast Biopsy software (EQ370), we had already
proposed to include this equipment in CPT codes 77048 and 77049. We are
finalizing the inclusion of the new CAD Software equipment (ED058) in
these procedures, and we are finalizing an update in the price of the
CAD Software to $43,308.12. This is based on a submitted invoice from
the commenters which contained a price of $52,725 as averaged together
with additional invoices for the same CAD Software equipment researched
by the StrategyGen contractor. We are also finalizing the replacement
of the time assigned to the EQ370 Breast Biopsy software in CPT codes
19085, 19086, 19287, and 19288 with an equal amount of time assigned to
the new ED058 CAD Software equipment. Finally, due to the continued
confusion and lack of price for the EQ370 equipment item, and due to
its redundancy with the new ED058 equipment code, we are deleting
EQ370.
(3) Invoice Submission
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. For CY 2019, we noted that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February 10th deadline
established for code valuation recommendations. To be included in a
given year's proposed rule, we generally need to receive invoices by
the same February 10th deadline we noted for consideration of RUC
recommendations. However, we would consider invoices submitted as
public comments during the comment period following the publication of
the PFS proposed rule, and would consider any invoices received after
February 10th or outside of the public comment process as part of our
established annual process for requests to update supply and equipment
prices.
(4) Adjustment to Allocation of Indirect PE for Some Office-Based
Services
In the CY 2018 PFS final rule (82 FR 52999 through 53000), we
established criteria for identifying the services most affected by the
indirect PE allocation anomaly that does not allow for a site of
service differential that accurately reflects the relative indirect
costs involved in furnishing services in nonfacility settings. We also
finalized a modification in the PE methodology for allocating indirect
PE RVUs to better reflect the relative indirect PE resources involved
in furnishing these services. The methodology, as described, is based
on the difference between the ratio of indirect PE to work RVUs for
each of the codes meeting eligibility criteria and the ratio of
indirect PE to work RVU for the most commonly reported visit code. We
refer readers to the CY 2018 PFS final
[[Page 59482]]
rule (82 FR 52999 through 53000) for a discussion of our process for
selecting services subject to the revised methodology, as well as a
description of the methodology, which we began implementing for CY 2018
as the first year of a 4-year transition. For CY 2019, we proposed to
continue with the second year of the transition of this adjustment to
the standard process for allocating indirect PE.
We received no comments specific to our proposal to continue with
the 2nd year of the transition to the standard process for allocating
indirect PE. Therefore, we are finalizing our proposal to proceed with
the second year of implementing an alternative methodology for the
allocation of indirect PE for some office-based services.
C. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that the payment amount for
each service paid under the PFS be composed of three components: Work;
PE; and malpractice (MP) expense. As required by section
1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are
resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that
we review, and if necessary adjust, RVUs no less often than every 5
years. In the CY 2015 PFS final rule with comment period, we
implemented the third review and update of MP RVUs. For a comprehensive
discussion of the third review and update of MP RVUs see the CY 2015
PFS proposed rule (79 FR 40349 through 40355) and final rule with
comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP
methodology is composed of three factors: (1) Specialty-level risk
factors derived from data on specialty-specific MP premiums paid by
practitioners; (2) service level risk factors derived from Medicare
claims data of the weighted average risk factors of the specialties
that furnish each service; and (3) an intensity/complexity of service
adjustment to the service level risk factor based on either the higher
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were
only updated once every 5 years, except in the case of new and revised
codes.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk,
intensity and complexity (using the work RVU or clinical labor RVU). We
also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. Under
this approach, for new and revised codes, we generally assign a
specialty risk factor to individual codes based on the same utilization
assumptions we make regarding the specialty mix we use for calculating
PE RVUs and for PFS budget neutrality. We continue to use the work RVU
or clinical labor RVU to adjust the MP RVU for each code for intensity
and complexity. In finalizing this policy, we stated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the 8th GPCI update, which reflected
updated MP premium data. We did not propose to use the updated MP
premium data to propose updates for CY 2017 to the specialty risk
factors used in the calculation of MP RVUs because it was inconsistent
with the policy we previously finalized in the CY 2016 PFS final rule
with comment period. That is, we indicated that the specialty-specific
risk factors would continue to be updated through notice and comment
rulemaking every 5 years using updated premium data, but would remain
unchanged between the 5-year reviews. However, we solicited comment on
whether we should consider doing so, perhaps as early as for CY 2018,
prior to the fourth review and update of MP RVUs that must occur no
later than CY 2020. After consideration of the comments received, we
stated in the CY 2017 PFS final rule that we would consider the
possibility of using the updated MP data to update the specialty risk
factors used in the calculation of the MP RVUs prior to the next 5-year
update in future rulemaking (81 FR 80191 through 80192).
In the CY 2018 PFS proposed rule, we proposed to use the updated MP
data to update the specialty risk factors used in calculation of the MP
RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018
PFS final rule (82 FR 53000 through 53006), after consideration of the
comments received and some differences we observed in the descriptions
on the raw rate filings as compared to how those data were categorized
to conform with the CMS specialties, we did not finalize our proposal
to use the updated MP data. We are required to review, and if
necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback
provided by commenters in response to the CY 2018 PFS proposed rule.
In the CY 2019 PFS proposed rule, we solicited additional comment
regarding the next MP RVU update which must occur by CY 2020.
Specifically, we solicited comment on how we might improve the way that
specialties in the state-level raw rate filings data are crosswalked
for categorization into CMS specialty codes, which are used to develop
the specialty-level risk factors and the MP RVUs.
We received a few comments in response to the comment solicitation,
and we appreciate the commenters' feedback and input. We will consider
the suggestions and information received for future rulemaking, and in
particular for the CY 2020 statutorily required update to MP RVUs.
D. Modernizing Medicare Physician Payment by Recognizing Communication
Technology-Based Services
The health care community uses the term ``telehealth'' broadly to
refer to medical services furnished via communication technology. Under
current PFS payment rules, Medicare routinely pays for many of these
kinds of services. This includes some kinds of remote patient
monitoring (either as separate services or as parts of bundled
services), interpretations of diagnostic tests when furnished remotely
and, under conditions specified in section 1834(m) of the Act, services
that would otherwise be furnished in person but are instead furnished
via real-time, interactive communication technology. Over the past
several years, we have also established several PFS policies to
explicitly pay for non-face-to-face services included as part of
ongoing care management.
Although all of the kinds of services stated above might be called
``telehealth'' by patients, other payers and health care providers, we
have generally used the term ``Medicare telehealth services'' to refer
to the subset of services defined in section 1834(m) of the Act.
Section 1834(m) of the Act defines Medicare telehealth services and
specifies the payment amounts and circumstances under which Medicare
makes payment for a discrete set of services, all of which must
ordinarily be furnished in-person, when they are instead furnished
using interactive, real-time telecommunication technology. Section
1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth
services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary
to specify
[[Page 59483]]
additional Medicare telehealth services using an annual process to add
or delete services from the Medicare telehealth list. Section
1834(m)(4)(C) of the Act limits the scope of Medicare telehealth
services for which payment may be made to those furnished to a
beneficiary who is located in certain types of originating sites in
certain, mostly rural, areas. Section 1834(m)(1) of the Act permits
only physicians and certain other types of practitioners to furnish and
be paid for Medicare telehealth services. Although section
1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add
services to, and delete services from, the list of telehealth services
based on the established annual process, it does not provide any
authority to change the limitations relating to geography, patient
setting, or type of furnishing practitioner because these requirements
are specified in statute. However, we note that sections 50302, 50324,
and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) (Pub. L. 115-
123) have modified or removed the limitations relating to geography and
patient setting for certain telehealth services, including for certain
home dialysis end-stage renal disease-related services, services
furnished by practitioners in certain Accountable Care Organizations,
and acute stroke-related services, respectively.
In the CY 2018 PFS proposed rule (82 FR 53012), we solicited
information from the public regarding ways that we might further expand
access to telehealth services within the current statutory authority
and pay appropriately for services that take full advantage of
communication technologies. Commenters were very supportive of CMS
expanding access to these kinds of services. Many commenters noted that
Medicare payment for telehealth services is restricted by statute, but
encouraged CMS to recognize and support technological developments in
healthcare.
We believe that the provisions in section 1834(m) of the Act apply
particularly to the kinds of professional services explicitly
enumerated in the statutory provisions, like professional
consultations, office visits, and office psychiatry services.
Generally, the services we have added to the telehealth list are
similar to these kinds of services. As has long been the case, certain
other kinds of services that are furnished remotely using
communications technology are not considered ``Medicare telehealth
services'' and are not subject to the restrictions articulated in
section 1834(m) of the Act. This is true for services that were
routinely paid separately prior to the enactment of the provisions in
section 1834(m) of the Act and do not usually include patient
interaction (such as remote interpretation of diagnostic imaging
tests), and for services that were not discretely defined or separately
paid for at the time of enactment and that do include patient
interaction (such as chronic care management services).
As we considered the concerns expressed by commenters about the
statutory restrictions on Medicare telehealth services, we recognized
that the concerns were not limited to the barriers to payment for
remotely furnished services like those described by the office visit
codes. The commenters also expressed concerns pertaining to the
limitations on appropriate payment for evolving physicians' services
that are inherently furnished via communication technology, especially
as technology and its uses have evolved in the decades since the
Medicare telehealth services statutory provision was enacted.
In recent years, we have sought to recognize significant changes in
health care practice, especially innovations in the active management
and ongoing care of chronically ill patients, and have relied on the
medical community to identify and define discrete physicians' services
through the CPT Editorial Panel (82 FR 53163). In response to our
comment solicitation on Medicare telehealth services in the CY 2018 PFS
proposed rule (82 FR 53012), commenters provided many suggestions for
how CMS could expand access to telehealth services within the current
statutory authority and pay appropriately for services that take full
advantage of communication technologies, such as waiving portions of
the statutory restrictions using demonstration authority. After
considering those comments we recognized that concerns regarding the
provisions in section 1834(m) of the Act may have been limiting the
degree to which the medical community developed coding for new kinds of
services that inherently utilize communication technology. We have come
to believe that section 1834(m) of the Act does not apply to all kinds
of physicians' services whereby a medical professional interacts with a
patient via remote communication technology. Instead, we believe that
section 1834(m) of the Act applies to a discrete set of physicians'
services that ordinarily involve, and are defined, coded, and paid for
as if they were furnished during an in-person encounter between a
patient and a health care professional.
For CY 2019, we aimed to increase access for Medicare beneficiaries
to physicians' services that are routinely furnished via communication
technology by clearly recognizing a discrete set of services that are
defined by and inherently involve the use of communication technology.
Accordingly, we made several proposals for modernizing Medicare
physician payment for communication technology-based services,
described below. These services will not be subject to the limitations
on Medicare telehealth services in section 1834(m) of the Act because,
as we have explained, we do not consider them to be Medicare telehealth
services; instead, they will be paid under the PFS like other
physicians' services. Additionally, we note that in furnishing these
services, practitioners need to comply with any applicable privacy and
security laws, including the HIPAA Privacy Rule.
1. Brief Communication Technology-Based Service, e.g. Virtual Check-In
(HCPCS Code G2012)
The traditional office visit codes describe a broad range of
physicians' services. Historically, we have considered any routine non-
face-to-face communication that takes place before or after an in-
person visit to be bundled into the payment for the visit itself. In
recent years, we have recognized payment disparities that arise when
the amount of non-face-to-face work for certain kinds of patients is
disproportionately higher than for others, and created coding and
separate payment to recognize care management services such as chronic
care management and behavioral health integration services (81 FR
80226). We now recognize that advances in communication technology have
changed patients' and practitioners' expectations regarding the
quantity and quality of information that can be conveyed via
communication technology. From the ubiquity of synchronous, audio/video
applications to the increased use of patient-facing health portals, a
broader range of services can be furnished by health care professionals
via communication technology as compared to 20 years ago.
Among these services are the kinds of brief check-in services
furnished using communication technology that are used to evaluate
whether or not an office visit or other service is warranted. When
these kinds of check-in services are furnished prior to an office
visit, then we would currently consider them to be bundled into the
payment for the resulting visit, such as through an evaluation and
management (E/M) visit
[[Page 59484]]
code. However, in cases where the check-in service does not lead to an
office visit, then there is no office visit with which the check-in
service can be bundled. To the extent that these kinds of check-ins
become more effective at addressing patient concerns and needs using
evolving technology, we believe that the overall payment implications
of considering the services to be broadly bundled becomes more
problematic. This is especially true in a resource-based relative value
payment system. Effectively, the better practitioners are in leveraging
technology to furnish effective check-ins that mitigate the need for
potentially unnecessary office visits, the fewer billable services they
furnish. Given the evolving technological landscape, we believe this
creates incentives that are inconsistent with current trends in medical
practice and potentially undermines payment accuracy.
Therefore, we proposed to pay separately, beginning January 1,
2019, for a newly defined type of physicians' service furnished using
communication technology. We stated this service would be billable when
a physician or other qualified health care professional has a brief
non-face-to-face check-in with a patient via communication technology,
to assess whether the patient's condition necessitates an office visit.
We understand that the kind of communication technology used to furnish
these kinds of services has broadened over time and has enhanced the
capacity for medical professionals to care for patients. We solicited
comment on what types of communication technology are utilized by
physicians or other qualified health care professionals in furnishing
these services, including whether audio-only telephone interactions are
sufficient compared to interactions that are enhanced with video or
other kinds of data transmission.
The following discussion summarizes particular definitions and
billing rules for these services, as proposed, and more detailed
comments we received regarding these aspects of the proposal. Our
responses below include information regarding the service definitions
and billing requirements applicable for CY 2019.
Comment: Many commenters supported the proposal to pay for these
kinds of services. Many commenters offered specific suggestions
regarding the service definitions and associated billing rules, which
we describe in detail below. Several commenters urged CMS to take a
cautious approach in paying for these services, given concerns these
commenters stated regarding potential overutilization, while some noted
that potential overutilization would be mitigated by Medicare's
requirements for the visit to be reasonable and medically necessary/
appropriate. Specific aspects of these comments are detailed below.
Response: Based on the broad support for the proposal, we are
creating coding and finalizing our proposal to make separate payment
for this service. We note that in the proposed rule we referred to this
service as HCPCS code GVCI1, which was a placeholder code. The code
will be described as HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified
health care professional who can report evaluation and management
services, provided to an established patient, not originating from a
related E/M service provided within the previous 7 days nor leading to
an E/M service or procedure within the next 24 hours or soonest
available appointment; 5-10 minutes of medical discussion).
We appreciate commenters' concerns regarding the potential for
overutilization of these services. We plan to monitor utilization with
the intention of determining whether changes, such as a frequency
limitation on the use of this code, are warranted. We would consider
proposing such changes in future rulemaking. We note that, like all
other physicians' services billed under the PFS, each of these services
must be medically reasonable and necessary to be paid by Medicare.
Comment: Many commenters suggested that we not be overly
prescriptive regarding the types of communication technology that are
utilized by physicians or other qualified health care professionals in
furnishing these services. The commenters noted that technology is
evolving at a rapid pace and would require us to have to update our
policies frequently. Several commenters suggested that we permit the
use of email and Electronic Health Record (EHR) patient portals to
qualify. A few commenters stated that audio-visual communication is
ideal. Others acknowledged that not all patients have the same level of
connectivity and therefore recommended allowing audio-only
communication.
Response: We are persuaded by the comments advising us not to be
overly prescriptive about the technology that is used, and are
finalizing allowing audio-only real-time telephone interactions in
addition to synchronous, two-way audio interactions that are enhanced
with video or other kinds of data transmission. We note that telephone
calls that involve only clinical staff could not be billed using HCPCS
code G2012 since the code explicitly describes (and requires) direct
interaction between the patient and the billing practitioner.
We further proposed that in instances when the brief communication
technology-based service originates from a related E/M service provided
within the previous 7 days by the same physician or other qualified
health care professional, that this service would be considered bundled
into that previous E/M service and would not be separately billable,
which is consistent with code descriptor language for CPT code 99441
(Telephone evaluation and management service by a physician or other
qualified health care professional who may report evaluation and
management services provided to an established patient, parent, or
guardian not originating from a related E/M service provided within the
previous 7 days nor leading to an E/M service or procedure within the
next 24 hours or soonest available appointment; 5-10 minutes of medical
discussion), on which this service is partially modeled. We proposed
that in instances when the brief communication technology-based service
leads to an E/M service with the same physician or other qualified
health care professional, this service would be considered bundled into
the pre- or post-visit time of the associated E/M service, and
therefore, would not be separately billable. We also noted that this
service could be used as part of a treatment regimen for opioid use
disorders and other substance use disorders to assess whether the
patient's condition requires an office visit.
We proposed pricing this distinct service at a rate lower than
current E/M in-person visits to reflect the low work time and intensity
and to account for the resource costs and efficiencies associated with
the use of communication technology. We expect that these services will
be initiated by the patient, especially since many beneficiaries would
be financially liable for sharing in the cost of these services. For
the same reason, we believe it is important for patients to consent to
receiving these services. Therefore, we specifically solicited comment
on whether we should require, for example, verbal consent that will be
noted in the medical record for each service.
Comment: Many commenters stated that it would be burdensome to
obtain consent from the patient prior to each occurrence of this
service. Some commenters suggested that the patient be informed through
the use of a service agreement which could be signed once and kept on
file. Several commenters
[[Page 59485]]
expressed concern about the cost to beneficiaries, especially since
they may have previously received this service without financial
liability, and therefore recommended requiring verbal consent that is
documented in the medical record.
Response: We understand the potential burden regarding obtaining
consent for each occurrence of this service. However, we are persuaded
by those commenters who suggest that unexpected cost to beneficiaries
would be particularly problematic. We note that under our current
policy for several types of care management services, verbal consent is
required to be obtained and documented in the medical record. The
consent policy was implemented, in part, based on feedback we received
from practitioners reporting the care management services, to alleviate
burdens of alternative approaches, such as requirements for written
consent or completion of particular forms. Consequently, we believe the
same requirement could be applied here, without imposition of
significant burden. We are finalizing requiring verbal consent that is
noted in the medical record for each billed service.
We also proposed that this service can only be furnished for
established patients because we believe that the practitioner needs to
have an existing relationship with the patient, and therefore, basic
knowledge of the patient's medical condition and needs, in order to
perform this service.
Comment: Many commenters were supportive of our proposal to limit
this service to established patients, while several commenters noted
that there would be instances when it would be appropriate to bill this
service for new patients. MedPAC noted particular concern regarding
potential increases in volume that are not related to ongoing, informed
patient care. A few commenters requested that CMS clarify that
established patients include those patients who have been seen by a
practitioner within the same group practice.
Response: After considering the comments, we are finalizing our
proposal to limit this service to established patients, given the
concern expressed by commenters regarding the degree to which these
services can be furnished without familiarity and experience with
individual patients, and in light of MedPAC's concerns regarding
increases in utilization that are not related to ongoing, informed
patient care. In response to the request for clarification about what
constitutes an established patient, we defer to CPT's definition of
this term. CPT defines an established patient as one who has received
professional services from the physician or qualified health care
professional or another physician or qualified health care professional
of the exact same specialty and subspecialty who belongs to the same
group practice, within the past 3 years. We also emphasize that payment
for this service would not preclude a physician or other qualified
health care professional from having communication via phone or other
modalities with any patient, new or existing, for a variety of reasons.
We believe that much of the pre- and post- work associated with, and
included in the valuation of existing in-person services that are paid
under the PFS can include some types of interactions with patients that
are not in-person.
We did not propose to apply a frequency limit on the use of this
code by the same practitioner with the same patient, but we want to
ensure that this code is appropriately utilized for circumstances when
a patient needs a brief non-face-to-face check-in to assess whether an
office visit is necessary. We solicited comment on whether it would be
clinically appropriate to apply a frequency limitation on the use of
this code by the same practitioner with the same patient, and on what
would be a reasonable frequency limitation.
Comment: Many commenters were opposed to creating a frequency
limitation, suggesting we wait and monitor utilization. Others noted
that it could be clinically appropriate to utilize this service
multiple times in a week. A few commenters stated that this service
could be utilized in behavioral health treatment, and cited an example
of assessing suicidal risk, in which case they suggested the frequency
should not be limited since routine virtual check-ins would be
clinically warranted in some cases. Some commenters suggested a
frequency limit of three times per week whereas others suggested a
limit of once per week.
Response: After considering these comments, we are not implementing
a frequency limitation for CY 2019. However, we plan to monitor
utilization with the intention of determining whether such a limitation
is warranted. In that case, we would consider proposing a limitation in
future rulemaking. We note that, like all other physicians' services
billed under the PFS, each of these services must be medically
reasonable and necessary to be paid by Medicare.
We also solicited comment on the timeframes under which this
service would be separately billable compared to when it would be
bundled. We believe the general construct of bundling the services that
lead directly to a billable visit is important, but we are concerned
that establishing strict timeframes may create unintended consequences
regarding scheduling of care. For example, we do not want to bundle
only the services that occur within 24 hours of a visit only to see a
significant number of visits occurring at 25 hours after the initial
service. In order to mitigate these incentives, we solicited comment on
whether we should consider broadening the window of time and/or
circumstances in which this service should be bundled into the
subsequent related visit. We noted that these services, like any other
physicians' service, must be medically reasonable and necessary in
order to be paid by Medicare.
Comment: Several commenters suggested that we remove the language
in the code descriptor that states ``or soonest available
appointment.'' A few commenters suggested we extend the timeframe to 48
hours following the virtual check-in, while others suggested it would
be reasonable to expand the limit to 14 days before and 72 hours after
the service. Several commenters stated concerns that it might be
difficult to document that a subsequent visit was not the ``soonest
available appointment.'' Several commenters expressed concern about the
potential for overutilization of this code.
Response: We agree with commenters that urged caution regarding
overutilization of this service and believe that the language stating,
`or soonest available appointment' in the code description may serve to
reduce potential perverse payment incentives to delay seeing patients
to ensure payment for this code. We appreciate the concerns regarding
potential difficulty in proving that a particular visit was not the
``soonest available.'' We agree that in each individual case, it might
be challenging to prove whether or not other appointments were
available prior to the visit, especially since beneficiary convenience
is also presumably a factor for when appointments are scheduled.
However, we believe that, as written, the code description could help
to guard against the potential for abuse that would be present if we
instead adopted a purely time-based window for bundling of this
service. We also believe that ``soonest available appointment'' might
allow for clinically appropriate flexibility. Therefore, after
consideration of the public comments, we are finalizing the code
descriptor for HCPCS code G2012 as proposed. However, we plan to
monitor this service with the intention of determining whether changes
are
[[Page 59486]]
necessary to the timeframes under which this service would be
separately billable compared to when it would be bundled. We would
consider any such changes in future rulemaking.
We solicited comment on how clinicians could best document the
medical necessity of this service, consistent with documentation
requirements necessary to demonstrate the medical necessity of any
service under the PFS.
Comment: A few commenters stated that documentation for this
service should be consistent with the requirements for an in-person
encounter and requested appropriate documentation requirements to
ensure that the check-in is fully incorporated into the individual's
medical history. Other commenters urged us not to be overly
prescriptive.
Response: We appreciate the commenters' input. We do not want to
impose undue administrative burden likely to discourage appropriate
provision of these services, and are therefore not requiring any
service-specific documentation requirements for this service. We note
again that these services, like any other physicians' service, must be
medically reasonable and necessary in order to be paid by Medicare.
Comment: Several commenters stated that the proposed payment rate
would be inadequate for modalities that are both audio- and visual-
capable, whereas others stated that the proposed valuation was
appropriate. One commenter suggested we create a second code for a
virtual check-in that only utilizes synchronous audio/video technology,
with a higher reimbursement rate associated with the increased
complexity of technology.
Response: As discussed in section II.H of this final rule, we are
finalizing the valuation for HCPCS code G2012 as proposed. We believe
this valuation reflects the work time and intensity of the service
relative to other PFS services and accounts for the resource costs and
efficiencies associated with the use of communication technology. We
recognize that the valuation of this service is relatively modest,
especially compared to in-person services, however, we believe that the
proposed valuation accurately reflects the resources involved in
furnishing this service. We plan to monitor the utilization of this
code and note that we routinely address recommended changes in values
for codes paid under the PFS.
Comment: A few commenters requested that CMS allow licensed
physical therapists to furnish these services. Additionally, a few
commenters requested that we allow other clinical staff, such as
registered nurses, to furnish this service.
Response: We are finalizing maintaining this code as part of the
set of codes that is only reportable by those that can furnish E/M
services. We believe this is appropriate since the service describes a
check-in directly with the billing practitioner to assess whether an
office visit is needed. We agree that similar check-ins provided by
nurses and other clinical staff can be important aspects of coordinated
patient care. We note that these kinds of non-face-to-face services by
other medical professionals and clinical staff continue to be included
in the RVUs for other codes, including those that describe E/M visits,
and for procedures with global periods. We also note that non-face-to-
face services provided by clinical staff can be explicitly and
separately paid for as part of several care management services, many
of which we have introduced over the past several years. However, this
service is meant to describe, and account for the resources involved,
when the billing practitioner directly furnishes the virtual check-in.
Comment: Several commenters requested that CMS waive the
beneficiary co-payment for this service.
Response: We appreciate the commenters' request; however, we do not
have the statutory authority to make specific changes to the
requirements regarding beneficiary cost sharing for this service.
In summary, we are creating coding and finalizing our proposal to
make separate payment for brief communication technology-based
services. The code will be described as G2012 (Brief communication
technology-based service, e.g. virtual check-in, by a physician or
other qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion). We are finalizing allowing real-time audio-only telephone
interactions in addition to synchronous, two-way audio interactions
that are enhanced with video or other kinds of data transmission. We
are finalizing our proposal to limit this service to established
patients.
We are finalizing that if the service originates from a related E/M
service provided within the previous 7 days by the same physician or
other qualified health care professional, that this service would be
considered bundled into that previous E/M service and would not be
separately billable. In instances when the service leads to an E/M
service with the same physician or other qualified health care
professional, we are finalizing that this service would be considered
bundled into the pre- or post-visit time of the associated E/M service,
and therefore, would not be separately billable. We plan to monitor
this service with the intention of determining whether changes are
necessary to the timeframes under which this service would be
separately billable compared to when it would be bundled. We would
consider any such changes in future rulemaking.
We are finalizing requiring verbal consent from beneficiaries that
is noted in the medical record for each service. We are not
implementing a frequency limitation for CY 2019, however, we plan to
monitor utilization with the intention of determining whether such a
limitation is warranted. In that case, we would consider that for
future rulemaking.
We are finalizing the valuation for HCPCS code G2012 as proposed.
We will monitor the utilization of this code and consider any potential
adjustments to billing rules or valuation for this service through
future rulemaking. We note that cost sharing for these services will
apply.
For details related to developing utilization estimates for this
service, see section VII. of this final rule, Regulatory Impact
Analysis. For additional details related to valuation of this service,
see section II.H. of this final rule, Valuation of Specific Codes.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code
G2010)
Stakeholders have requested that CMS make separate Medicare payment
when a physician uses recorded video and/or images captured by a
patient in order to evaluate a patient's condition. These services
involve what is referred to under section 1834(m) of the Act as
``store-and-forward'' communication technology that provides for the
``asynchronous transmission of health care information.'' We noted in
the proposed rule that we believe these services involve pre-recorded
patient-generated still or video images. Other types of patient-
generated information, such as information from heart rate monitors or
other devices that collect patient health marker data, could
potentially be reported with CPT codes that describe remote patient
monitoring (83 FR 35724). Under section 1834(m) of
[[Page 59487]]
the Act, payment for telehealth services furnished using such store-
and-forward technology is permitted only under federal telemedicine
demonstration programs conducted in Alaska or Hawaii, and these
telehealth services remain subject to the other statutory restrictions
governing Medicare telehealth services. However, much like the brief
communication technology-based service (``virtual check-in service'')
that we are finalizing in this rule as described previously, this
remote evaluation service would not be a substitute for an in-person
service currently separately payable under the PFS. As such, this
remote evaluation service is distinct from the telehealth services
described under section 1834(m) of the Act. Effective January 1, 2019,
we proposed to create specific coding that describes the remote
professional evaluation of patient-transmitted information conducted
via pre-recorded ``store and forward'' video or image technology.
Because this service would not be considered a Medicare telehealth
service, it would not be subject to the geographic and other
restrictions on telehealth services under section 1834(m) of the Act;
and the proposed valuation reflects the resource costs associated with
furnishing services utilizing communication technology.
Also like the virtual check-in service we are finalizing as
described previously, this service would be used to determine whether
or not an office visit or other service is warranted. When the remote
evaluation of pre-recorded patient-submitted images and/or video
results in an in-person E/M office visit with the same physician or
qualified health care professional, we proposed that this remote
service will be considered bundled into that office visit and therefore
not be separately billable. We further proposed that in instances when
the remote service originates from a related E/M service provided
within the previous 7 days by the same physician or qualified health
care professional that this service will be considered bundled into
that previous E/M service and not be separately billable. In summary,
we proposed this service to be a stand-alone service that could be
separately billed to the extent that there is no resulting E/M office
visit and there is no related E/M office visit within the previous 7
days of the remote service being furnished. We believe the coding and
separate payment for this service is consistent with the progression of
technology and its impact on the practice of medicine in recent years,
and would result in increased access to services for Medicare
beneficiaries. We note that in the proposed rule we referred to this
service as HCPCS code GRAS1, which was a placeholder code. The code for
this service is G2010 (Remote evaluation of recorded video and/or
images submitted by an established patient (e.g., store and forward),
including interpretation with follow-up with the patient within 24
business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment). We
solicited comment as to whether these services should be limited to
established patients; or whether there are certain cases, like
dermatological or ophthalmological services, where it might be
appropriate for a new patient to receive these services. For example,
when a patient seeks care for a specific skin condition from a
dermatologist with whom she does not have a prior relationship, and
part of the inquiry is an assessment of whether the patient needs an
in-person visit, the patient could share, and the dermatologist could
remotely evaluate, pre-recorded information. We also noted that this
service is distinct from the virtual check-in service described
previously in that this service involves the practitioner's evaluation
of a patient-generated still or video image transmitted by the patient,
and the subsequent communication of the practitioner's response to the
patient; while the virtual check-in service describes a service that
occurs in real time and does not involve the asynchronous transmission
of any recorded image.
The following discussion summarizes particular definitions and
billing rules we proposed for this service and the more detailed
comments we received regarding these aspects of the proposal. Our
responses below include information regarding the service definitions
and billing requirements applicable for 2019. We additionally address
comments we received regarding whether these services should be limited
to established patients; or whether there are certain cases, like
dermatological or ophthalmological services, where it might be
appropriate for a new patient to receive these services.
Comment: Several commenters were supportive of the proposal to pay
for these kinds of services. Several commenters urged CMS to take a
cautious approach in paying for these services, given concerns these
commenters expressed regarding potential overutilization.
Response: We appreciate the many thoughtful comments regarding this
proposal. Based on our review of the comments received, especially the
broad support for the proposal, we are creating coding and finalizing
our proposal to make separate payment for this service. The code will
be described as G2010 (Remote evaluation of recorded video and/or
images submitted by an established patient (e.g., store and forward),
including interpretation with follow-up with the patient within 24
business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment).
We appreciate commenters' concerns regarding the potential for
overutilization of these services. We plan to monitor utilization. We
note that, like all other physicians' services billed under the PFS,
each of these services must be medically reasonable and necessary to be
paid by Medicare.
Comment: Many commenters supported allowing this service to be
furnished to new patients, noting that an established relationship is
not required for the practitioner to remotely evaluate an image or
video to consider whether an office visit or other service is
warranted, particularly in dermatology and ophthalmology. One commenter
stated that allowing new patients to receive this service would also be
of value in urology, as it would provide a way to assess patients with
conditions such as hematuria (that is, blood in the urine) in a timely
manner. The AMA and other commenters urged CMS to limit these services
to established patients. The AMA also suggested that, at some point
before a physician or practitioner furnishes a virtual service, the
clinician (or another clinician with whom the furnishing clinician has
a cross-coverage agreement in place) should conduct a face-to-face
examination (either in-person or via telehealth) with the patient,
noting that the existence of a valid patient-physician relationship
ensures that the treating physician or qualified health professional
meets a threshold standard of care, enhances care coordination/
continuity of care, and ensures that patients are afforded advance
notice of when the relationship is being established and that such a
patient-initiated service may result in out-of-pocket expenses
including deductibles and co-insurance, and additionally serves to
minimize the potential for program integrity concerns.
Response: We are persuaded by comments urging us to permit separate
[[Page 59488]]
payment for these services only for established patients. Since this
service is furnished directly by the billing practitioner, we believe
it should be furnished in the context of an existing patient-clinician
relationship. Therefore, we are finalizing the reporting and billing of
HCPCS code G2010 only for established patients.
Comment: Many commenters stated that it would be burdensome to
obtain consent from the patient prior to each occurrence of this
service. Some commenters suggested that the patient could be informed
through the use of a service agreement which could be signed once and
kept on file. Several commenters expressed concern about the cost to
beneficiaries and therefore recommended requiring verbal consent that
is documented in the medical record.
Response: As noted previously regarding HCPCS code G2012, we
believe it is important for patients to consent to receive these
services, especially since many beneficiaries would be financially
liable for sharing in the cost of these services. We understand the
potential burden regarding obtaining consent for each occurrence of
this service. However, we are persuaded by those commenters who suggest
that unexpected cost to beneficiaries would be particularly
problematic. We are finalizing requiring beneficiary consent that could
be verbal or written, including electronic confirmation that is noted
in the medical record for each billed service for HCPCS code G2010.
We acknowledge that verbal consent could be obtained using more
than one communication modality, especially since this service is
initiated by the patient and involves submission of an image or video.
Therefore, we do not intend to include the word ``verbal'' in the
descriptor for the code that describes this services, since ``verbal''
could imply written or electronic consent.
Comment: Several commenters stated that the proposed payment rate
is too low, citing that it is below market compared to the rate many
asynchronous telemedicine companies pay their contracted/employed
physician staff, and noted that new patients in particular require more
resources, whereas others stated that the proposed valuation was
appropriate. One commenter suggested that CMS should encourage
clinicians to recommend that patients have virtual or in-person visits
if the clinician has concerns about the quality of the pre-recorded
patient information, such as still or video images.
Response: As discussed in section II.H. of this final rule, we are
finalizing the valuation for HCPCS code G2010 as proposed. As stated
previously regarding the valuation of the brief communication
technology-based service code, HCPCS code G2012, we believe that the
proposed valuation accurately reflects the resources involved in
furnishing this service. We will monitor the utilization of this code
and consider any potential adjustments to billing rules or valuation
for this service through future rulemaking.
Comment: A few commenters requested that CMS clarify that the
``verbal follow-up'' that occurs after the billing practitioner
evaluates the images or video submitted by the patient may take place
via any mode of communication, including secure text messaging, phone
call, or live/asynchronous video chat, so as not to restrict a
clinician's interaction with patients. One commenter suggested that CMS
should encourage clinicians to recommend that patients have a face-to-
face visit (in-person or via telehealth) if the clinician has concerns
about the quality of the pre-recorded patient information, such as
still or video images.
Response: We are finalizing that the follow-up could take place via
phone call, audio/video communication, secure text messaging, email, or
patient portal communication and note that accordingly, we do not
intend to include the word ``verbal'' in the code descriptor. We note
that any such communications must be compliant with HIPAA and other
relevant laws. Additionally, we agree that in instances in which the
quality of the pre-recorded information submitted by a patient is
insufficient for the clinician to assess whether an office visit or
other medical service is warranted, the clinician could not fully
furnish a remote evaluation service and, therefore, could not bill for
the service. We anticipate that in such a circumstance, the clinician
would attempt other methods of communication with the patient to either
obtain sufficient images to enable a remote evaluation service or
suggest other appropriate alternatives.
Comment: Several commenters suggested that we remove the language
in the code descriptor for this service that states ``or soonest
available appointment,'' and stated that it might be difficult to
document that a subsequent visit was not the ``soonest available
appointment.''
Response: As noted previously regarding similar comments on HCPCS
code G2012, we appreciate the concerns regarding potential difficulty
in proving that a particular visit was not the ``soonest available.''
We agree that in each individual case, it might be challenging to prove
whether or not other appointments were available prior to the visit,
especially since beneficiary convenience is also presumably a factor in
when appointments are scheduled. However, we believe that, as written,
the code description would guard against the potential for abuse that
would be present if we instead adopted a purely time-based window for
bundling of this service. Therefore, in response to the comments, we
are finalizing retaining this language in the code descriptor for HCPCS
code G2010 as proposed. However, we plan to monitor this service with
the intention of determining if changes are necessary to the timeframes
under which this service would be separately billable compared to when
it would be bundled. We would consider any such changes in future
rulemaking.
Comment: A few commenters suggested that CMS consider inclusion of
email/messaging or questionnaires/assessments that do not include an
image or other visual item in the scope of this code.
Response: The scope of this service is limited to the evaluation of
pre-recorded video and/or images. We note that there is separate coding
under the PFS for several types of formal assessments, such as CPT code
96160 (Administration of patient-focused health risk assessment
instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument), many of which can be
reported when the form is completed by the patient and submitted using
remote communication technology for subsequent evaluation by the
clinician. Additionally, behavioral health assessments are included in
coding and payment for the behavioral health integration services that
were finalized for separate payment beginning in CY 2017.
In summary, we are creating coding and finalizing our proposal to
make separate payment for remote evaluation of recorded video and/or
images submitted by the patient. The code will be described as G2010
(Remote evaluation of recorded video and/or images submitted by an
established patient (e.g., store and forward), including interpretation
with follow-up with the patient within 24 business hours, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment). We are finalizing that
[[Page 59489]]
HCPCS code G2010 may be billed only for established patients. We are
finalizing that the follow-up with the patient could take place via
phone call, audio/video communication, secure text messaging, email, or
patient portal communication.
When the review of the patient-submitted image and/or video results
in an in-person E/M office visit with the same physician or qualified
health care professional, we are finalizing that this remote service
will be considered bundled into that office visit and therefore will
not be separately billable. We are further finalizing that in instances
when the remote service originates from a related E/M service provided
within the previous 7 days by the same physician or qualified health
care professional that this service will be considered bundled into
that previous E/M service and also will not be separately billable.
We are finalizing requiring beneficiary consent that could be
verbal or written, including electronic confirmation that is noted in
the medical record for each billed service for HCPCS code G2010.
We are finalizing the valuation for HCPCS code G2010 as proposed.
We will monitor utilization of this code and consider any potential
adjustments to billing rules or valuation of this service through
future rulemaking. We note that cost sharing for these services will
apply.
For details related to our utilization estimates for this service,
see section VII. of this final rule, Regulatory Impact Analysis. For
further discussion related to valuation of this service, please see the
section II.H. of this final rule, Valuation of Specific Codes.
3. Interprofessional Internet Consultation (CPT Codes 99451, 99452,
99446, 99447, 99448, and 99449)
As part of our standard rulemaking process, we received
recommendations from the RUC to assist in establishing values for six
CPT codes that describe interprofessional consultations. In 2013, CMS
received recommendations from the RUC for CPT codes 99446
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 5-10 minutes of medical
consultative discussion and review), 99447 (Interprofessional
telephone/internet assessment and management service provided by a
consultative physician including a verbal and written report to the
patient's treating/requesting physician or other qualified health care
professional; 11-20 minutes of medical consultative discussion and
review), 99448 (Interprofessional telephone/internet assessment and
management service provided by a consultative physician including a
verbal and written report to the patient's treating/requesting
physician or other qualified health care professional; 21-30 minutes of
medical consultative discussion and review), and 99449
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 31 minutes or more of medical
consultative discussion and review). CMS declined to adopt these codes
for separate payment, stating in the CY 2014 PFS final rule with
comment period that these kinds of services are considered bundled (78
FR 74343). For CY 2019, the CPT Editorial Panel created two new codes
to describe additional consultative services, including a code
describing the work of the treating physician when initiating a
consult, and the RUC recommended valuation for new codes, CPT codes
99452 (Interprofessional telephone/internet/electronic health record
referral service(s) provided by a treating/requesting physician or
qualified health care professional, 30 minutes) and 99451
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician
including a written report to the patient's treating/requesting
physician or other qualified health care professional, 5 or more
minutes of medical consultative time). The RUC also reaffirmed their
prior recommendations for the existing CPT codes. The six codes
describe assessment and management services conducted through
telephone, internet, or electronic health record consultations
furnished when a patient's treating physician or other qualified
healthcare professional requests the opinion and/or treatment advice of
a consulting physician or qualified healthcare professional with
specific specialty expertise to assist with the diagnosis and/or
management of the patient's problem without the need for the patient's
face-to-face contact with the consulting physician or qualified
healthcare professional. Currently, the resource costs associated with
seeking or providing such a consultation are considered bundled, which
in practical terms means that specialist input is often sought through
scheduling a separate visit for the patient when a phone or internet-
based interaction between the treating practitioner and the consulting
practitioner would have been sufficient. We believe that proposing
payment for these interprofessional consultations performed via
communications technology such as telephone or internet is consistent
with our ongoing efforts to recognize and reflect medical practice
trends in primary care and patient-centered care management within the
PFS.
Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have
recognized the changing focus in medical practice toward managing
patients' chronic conditions, many of which particularly challenge the
Medicare population, including heart disease, diabetes, respiratory
disease, breast cancer, allergies, Alzheimer's disease, and factors
associated with obesity. We have expressed concerns that the current E/
M coding does not adequately reflect the changes that have occurred in
medical practice, and the activities and resource costs associated with
the treatment of these complex patients in the primary care setting. In
the years since 2012, we have acknowledged the shift in medical
practice away from an episodic treatment-based approach to one that
involves comprehensive patient-centered care management, and have taken
steps through rulemaking to better reflect that approach in payment
under the PFS. In CY 2013, we established new codes to pay separately
for transitional care management (TCM) services. Next, we finalized new
coding and separate payment beginning in CY 2015 for chronic care
management (CCM) services provided by clinical staff (81 FR 80226). In
the CY 2017 PFS final rule, we established separate payment for complex
CCM services, an add-on code to the visit during which CCM is initiated
to reflect the work of the billing practitioner in assessing the
beneficiary and establishing the CCM care plan, and established
separate payment for Behavioral Health Integration (BHI) services (81
FR 80226 through 80227).
As part of this shift in medical practice, and with the
proliferation of team-based approaches to care that are often
facilitated by electronic medical record technology, we believe that
making separate payment for interprofessional consultations undertaken
for the benefit of treating a patient will contribute to payment
accuracy for primary care and care management services. We proposed
[[Page 59490]]
separate payment for these services, discussed in section II.H. of this
final rule, Valuation of Specific Codes.
Although we proposed to make separate payment for these services
because we believe they describe resource costs directly associated
with seeking a consultation for the benefit of the beneficiary, we do
have concerns about how these services can be distinguished from
activities undertaken for the benefit of the practitioner, such as
information shared as a professional courtesy or as continuing
education. We do not believe that those examples will constitute a
service directly attributable to a single Medicare beneficiary, and
therefore neither the Medicare program nor the beneficiary should be
responsible for those costs. We therefore solicited comment on our
assumption that these are separately identifiable services, and the
extent to which they can be distinguished from similar services that
are nonetheless primarily for the benefit of the practitioner. We noted
that there are program integrity concerns around making separate
payment for these interprofessional consultation services, including
around CMS's or its contractors' ability to evaluate whether an
interprofessional consultation is reasonable and necessary under the
particular circumstances. As the beneficiary would be liable for any
cost sharing associated with these services, we also sought comment on
the necessity of requiring patient consent for these, and whether than
consent should be written or verbal. We solicited comment on how best
to minimize potential program integrity issues, and noted we were
particularly interested in information on whether these types of
services are paid separately by private payers and if so, what controls
or limitations private payers have put in place to ensure these
services are billed appropriately.
The following is a summary of the comments we received regarding
how best to minimize potential program integrity issues.
Comment: Almost all commenters were very supportive of CMS
proposing separate payment for these services. Commenters pointed out
that these are discrete physician services undertaken for the benefit
of the patient, and easily distinguished from consultations undertaken
for the edification of the practitioner. One commenter stated as
medical care moves toward more comprehensive patient-centered care
management, frequent consultation with multiple specialists is
necessary. Under the current model this means separate visits for the
patients that are costly and inconvenient. Internet-based consultations
between the treating practitioner and the consulting specialists
provide appropriate, convenient and cost effective alternatives.
Commenters were clear that, by not making separate payment for these
services, CMS would not be accurately paying for the work of both the
treating and consulting physicians in a consultative scenario.
Many commenters provided helpful responses to CMS' request for
information on how to minimize program integrity concerns for these
services. A few commenters provided suggestions as to how CMS could
verify the medical necessity of the consultation, including verifying
that the treating and consulting physician were of different medical
specialties, requiring patient identifiers and documentation of how the
interaction improved patient care, defining a time period under which
an E/M visit and an Interprofessional Consultation cannot both be
billed for the same diagnosis, and creating frequency limitations on
billing. Others suggested that the treating physician must document
that they acted on the recommendation of the consulting physician prior
to billing for CPT code 99452. Commenters had a number of suggestions
for items that CMS should require, including that Interprofessional
Consultations should consist of focused questions that are answerable
solely from information in the EMR; that they be answered in 3 business
days; and that the consulting physician should restate the question in
their response, provide recommendations for evaluation, management,
and/or ongoing monitoring, provide a rationale for recommendations, and
provide recommendations for contingencies. Other commenters suggested
that CMS could make separate payment contingent upon whether the
underlying condition was urgent or related to critical care and that
the consultation helped avoid transfer or interruption of care or that
internal expertise was sought and was not available. Many commenters
also encouraged CMS to avoid imposing overly restrictive documentation
requirements. One commenter stated that, due to potential program
integrity concerns, these services should be subject to the Medicare
telehealth restrictions on beneficiary location and site of service.
Another commenter recommended that CMS delay implementation until the
program integrity concerns have been addressed. Other commenters
encouraged CMS to monitor utilization for abuse.
Response: We thank commenters for their support and additional
information on the ways in which these services are distinct physician
services. We note that because these services are inherently non face-
to-face (the patient need not be present in order for the service to be
furnished in its entirety), they would not be considered as potential
Medicare telehealth services under section 1834(m) of the Act. We
appreciate the wealth of information and suggestions from commenters;
however, we also agree with the many commenters who pointed out that
adding many additional billing requirements may inhibit uptake for
these services. As we note below, we are requiring documentation of
verbal patient consent to receive these services, and are adopting
existing CPT prefatory language. We plan to monitor utilization of
these services and will consider making refinements to billing rules,
documentation requirements or claims edits, including those suggested
by commenters, through future rulemaking as necessary.
Comment: Many commenters suggested that CMS limit or eliminate
beneficiary cost sharing for these services to obviate the question of
patient consent entirely.
Response: Under current statute, we do not have the authority to
change the requirements for the beneficiary cost sharing for these
services.
Additionally, since these codes describe services that are
furnished without the beneficiary being present, we proposed to require
the treating practitioner to obtain verbal beneficiary consent in
advance of these services, which would be documented by the treating
practitioner in the patient's medical record, similar to the conditions
of payment associated with separately billable care management services
under the PFS. Obtaining advance beneficiary consent includes ensuring
that the patient is aware of applicable cost sharing.
The following is a summary of the comments we received regarding
whether to require the treating practitioner to obtain verbal
beneficiary consent in advance of these services, which would be
documented by the treating practitioner in the medical record similar
to the conditions of payment associated with the care management
services under the PFS, as well as comments on other aspects of this
proposal.
Comment: Many commenters stated that verbal patient consent was an
appropriate safeguard against unnecessary utilization, while others
disagreed, stating that the requirement
[[Page 59491]]
to obtain consent may cause unnecessary burden in cases where the
patient is unresponsive or the need for the interprofessional
consultation is urgent such as in a critical care or emergency setting.
Other commenters stated that a single blanket patient consent to
receive interprofessional consultation services would be preferable to
minimize the need to obtain consent for each of what may be multiple
consultations. One commenter questioned whether the consulting
physician would need to verify that the beneficiary had consented,
given that only the treating physician is in contact with the
beneficiary.
Response: We understand the potential burden regarding obtaining
consent. However, we believe that it is important for beneficiaries to
consent to the service and thus be notified of their cost-sharing
obligations. We note that under our current policy for several care
management services, consent is required to be documented in the
medical record. That policy was implemented, in part, based on feedback
we received from practitioners reporting the care management services,
to alleviate burdens of alternative approaches. Consequently, we
believe the same requirement could be applied here, without imposition
of significant burden.
We are finalizing that the patient's verbal consent is required,
and that consent must be noted in the medical record for each service,
consistent with the policy we are finalizing for the brief
communication technology-based services (HCPCS code G2012) as noted
above, as well as with the patient consent policies in place for care
management services, under the PFS.
Comment: Commenters requested that CMS clarify whether billing for
these services is limited to physicians or if other healthcare
practitioners, such as nurses or physical therapists, may bill for
these services as well.
Response: We appreciate commenters' request for clarification. We
believe that billing of these services should be limited to those
practitioners that can independently bill Medicare for E/M visits, as
interprofessional consultations are primarily for the ongoing
evaluation and management of the patient, including collaborative
medical decision making among practitioners. We are therefore not
finalizing any expansion of these services beyond their current scope.
Comment: A few commenters requested that CMS adopt CPT prefatory
language for these services as is CMS' longstanding practice when
adopting most new CPT coding.
Response: We agree with the commenters and confirm that we will be
adopting existing CPT prefatory language regarding these services.
In summary, we are finalizing separate payment for CPT codes 99451,
99452, 99446, 99447, 99448, and 99449 describing Interprofessional
consultations. We are finalizing a policy to require the patient's
verbal consent that is noted in the medical record for each
interprofessional consultation service. We note that cost sharing will
apply for these services. These interprofessional services may be
billed only by practitioners that can bill Medicare independently for
E/M services.
For further discussion related to the valuation of these services,
please see section II.H. of this final rule, Valuation of Specific
Codes.
4. Medicare Telehealth Services Under Section 1834(m) of the Act
a. Billing and Payment for Medicare Telehealth Services Under Section
1834(m) of the Act
As discussed in this rule and in prior rulemaking, several
conditions must be met for Medicare to make payment for telehealth
services under the PFS. For further details, see the full discussion of
the scope of Medicare telehealth services in the CY 2018 PFS final rule
(82 FR 53006).
b. Adding Services to the List of Medicare Telehealth Services
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a process for adding services to or deleting services from
the list of Medicare telehealth services in accordance with section
1834(m)(4)(F)(ii) of the Act. This process provides the public with an
ongoing opportunity to submit requests for adding services, which are
then reviewed by us. Under this process, we assign any submitted
request to add to the list of telehealth services to one of the
following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current list of telehealth services. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
The list of telehealth services, including the proposed additions
described later in this section, is included in the Downloads section
to this proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Historically, requests to add services to the list of Medicare
telehealth services had to be submitted and received no later than
December 31 of each calendar year to be considered for the next
rulemaking cycle. However, for CY 2019 and onward, we intend to accept
requests through February 10, consistent with the deadline for our
receipt of code valuation recommendations from the RUC. To be
[[Page 59492]]
considered during PFS rulemaking for CY 2020, requests to add services
to the list of Medicare telehealth services must be submitted and
received by February 10, 2019. Each request to add a service to the
list of Medicare telehealth services must include any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the list of Medicare telehealth services,
requesters should be advised that any information submitted as part of
a request is subject to public disclosure for this purpose. For more
information on submitting a request to add services to the list of
Medicare telehealth services, including where to mail these requests,
see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
c. Submitted Requests To Add Services to the List of Telehealth
Services for CY 2019
Under our current policy, we add services to the telehealth list on
a Category 1 basis when we determine that they are similar to services
on the existing telehealth list for the roles of, and interactions
among, the beneficiary, physician (or other practitioner) at the
distant site and, if necessary, the telepresenter. As we stated in the
CY 2012 PFS final rule with comment period (76 FR 73098), we believe
that the Category 1 criteria not only streamline our review process for
publicly requested services that fall into this category, but also
expedite our ability to identify codes for the telehealth list that
resemble those services already on this list.
We received several requests in CY 2017 to add various services as
Medicare telehealth services effective for CY 2019. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2019 telehealth list. Of the requests received, we
found that two services were sufficiently similar to services currently
on the telehealth list to be added on a Category 1 basis. Therefore, we
proposed to add the following services to the telehealth list on a
Category 1 basis for CY 2019:
HCPCS codes G0513 and G0514 (Prolonged preventive
service(s) (beyond the typical service time of the primary procedure),
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; first 30 minutes (list separately in
addition to code for preventive service) and (Prolonged preventive
service(s) (beyond the typical service time of the primary procedure),
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; each additional 30 minutes (list
separately in addition to code G0513 for additional 30 minutes of
preventive service).
We found that the services described by HCPCS codes G0513 and G0514
are sufficiently similar to office visits currently on the telehealth
list. We believe that all the components of this service can be
furnished via interactive telecommunications technology. Additionally,
we believe that adding these services to the telehealth list will make
it administratively easier for practitioners who report these services
in connection with a preventive service that is furnished via
telehealth, as both the base code and the add-on code would be reported
with the telehealth place of service.
We also received requests to add services to the telehealth list
that do not meet our criteria for Medicare telehealth services. We did
not propose to add to the Medicare telehealth services list the
following procedures for chronic care remote physiologic monitoring,
interprofessional internet consultation, and initial hospital care; or
to change the requirements for subsequent hospital care or subsequent
nursing facility care, for the reasons noted in the paragraphs that
follow.
(1) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454,
and 99457)
CPT code 99453 (Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory
flow rate), initial; set-up and patient education on use of equipment).
CPT code 99454 (Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory
flow rate), initial; device(s) supply with daily recording(s) or
programmed alert(s) transmission, each 30 days).
CPT code 99457 (Remote physiologic monitoring treatment
management services, 20 minutes or more of clinical staff/physician/
other qualified healthcare professional time in a calendar month
requiring interactive communication with the patient/caregiver during
the month).
In the CY 2016 PFS final rule with comment period (80 FR 71064), we
responded to a request to add CPT code 99490 (Chronic care management
services, at least 20 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month, with the following required elements: Multiple (two or more)
chronic conditions expected to last at least 12 months, or until the
death of the patient; chronic conditions place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline; comprehensive care plan established, implemented,
revised, or monitored) to the Medicare telehealth list. We discussed
that the services described by CPT code 99490 can be furnished without
the beneficiary's face-to-face presence and using any number of non-
face-to-face means of communication. We stated that it was therefore
unnecessary to add that service to the list of Medicare telehealth
services. Similarly, CPT codes 99453, 99454, and 99457 describe
services that are inherently non face-to-face. As discussed in section
II.H. of this final rule, Valuation of Specific Codes, we instead
proposed to adopt CPT codes 99453, 99454, and 99457 for payment under
the PFS. Because these codes describe services that are inherently non
face-to-face, we do not consider them Medicare telehealth services
under section 1834(m) of the Act; therefore, we did not propose to add
them to the list of Medicare telehealth services.
(2) Interprofessional Internet Consultation (CPT Codes 99451and 99452)
CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30
minutes).
CPT code 99451 (Interprofessional telephone/internet/
electronic health record assessment and management service provided by
a consultative physician including a written report to the patient's
treating/requesting physician or other qualified health care
professional, 5 or more minutes of medical consultative time).
As discussed in section II.H. of this final rule, Valuation of
Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for
payment under the PFS as these are distinct services furnished via
communication technology. Because these codes describe services that
are inherently non face-to-face, we do not consider them as Medicare
telehealth services under section 1834(m) of the Act; therefore we did
not propose to add them to the list of Medicare telehealth services for
CY 2019.
(3) Initial Hospital Care Services (CPT Codes 99221-99223)
CPT code 99221 (Initial hospital care, per day, for the
evaluation and
[[Page 59493]]
management of a patient, which requires these 3 key components: A
detailed or comprehensive history; A detailed or comprehensive
examination; and Medical decision making that is straightforward or of
low complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the problem(s) requiring admission are
of low severity.)
CPT code 99222 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of moderate complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity.)
CPT code 99223 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of high complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of high severity.)
We have previously considered requests to add these codes to the
telehealth list. As we stated in the CY 2011 PFS final rule with
comment period (75 FR 73315), while initial inpatient consultation
services are currently on the list of approved telehealth services,
there are no services on the current list of telehealth services that
resemble initial hospital care for an acutely ill patient by the
admitting practitioner who has ongoing responsibility for the patient's
treatment during the course of the hospital stay. Therefore, consistent
with prior rulemaking, we did not propose that initial hospital care
services be added to the Medicare telehealth services list on a
category 1 basis.
The initial hospital care codes describe the first visit of the
hospitalized patient by the admitting practitioner who may or may not
have seen the patient in the decision-making phase regarding
hospitalization. Based on the description of the services for these
codes, we believed it is critical that the initial hospital visit by
the admitting practitioner be conducted in person to ensure that the
practitioner with ongoing treatment responsibility comprehensively
assesses the patient's condition upon admission to the hospital through
a thorough in-person examination. Additionally, the requester submitted
no additional research or evidence that the use of a telecommunications
system to furnish the service produces demonstrated clinical benefit to
the patient; therefore, we also did not propose adding initial hospital
care services to the Medicare telehealth services list on a Category 2
basis.
We noted that Medicare beneficiaries who are being treated in the
hospital setting can receive reasonable and necessary E/M services
using other HCPCS codes that are currently on the Medicare telehealth
list, including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well
as initial and follow-up critical care telehealth consultations.
Therefore, we did not propose to add the initial hospital care
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services (CPT Codes 99231-99233)
CPT code 99231 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: A problem focused interval history; A problem
focused examination; Medical decision making that is straightforward or
of low complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is stable, recovering or
improving. Typically, 15 minutes are spent at the bedside and on the
patient's hospital floor or unit.).
CPT code 99232 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: An expanded problem focused interval history;
an expanded problem focused examination; medical decision making of
moderate complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is responding inadequately
to therapy or has developed a minor complication. Typically, 25 minutes
are spent at the bedside and on the patient's hospital floor or unit.).
CPT code 99233 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: A detailed interval history; a detailed
examination; Medical decision making of high complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient is unstable or has developed a significant
complication or a significant new problem. Typically, 35 minutes are
spent at the bedside and on the patient's hospital floor or unit.).
CPT codes 99231-99233 are currently on the list of Medicare
telehealth services, but can only be billed via telehealth once every 3
days. The requester requested that we remove the frequency limitation.
We stated in the CY 2011 PFS final rule with comment period (75 FR
73316) that, although we still believed the potential acuity of
hospital inpatients is greater than those patients likely to receive
Medicare telehealth services that were on the list at that time, we
also believed that it would be appropriate to permit some subsequent
hospital care services to be furnished through telehealth in order to
ensure that hospitalized patients have frequent encounters with their
admitting practitioner. We also noted that we continue to believe that
the majority of these visits should be in-person to facilitate the
comprehensive, coordinated, and personal care that medically volatile,
acutely ill patients require on an ongoing basis. Because of our
concerns regarding the potential acuity of hospital inpatients, we
finalized the addition of CPT codes 99231-99233 to the list of Medicare
telehealth services, but limited the provision of these subsequent
hospital care services through telehealth to once every 3 days. We
continue to believe that admitting practitioners should continue to
make appropriate in-person visits to all patients who need such care
during their hospitalization. Our concerns and position on the
provision of subsequent hospital care services via telehealth have not
changed. Therefore, we did not propose to remove the frequency
limitation on these codes.
[[Page 59494]]
(5) Subsequent Nursing Facility Care Services (CPT Codes 99307-99310)
CPT code 99307 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A problem focused interval history; A
problem focused examination; Straightforward medical decision making.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 10 minutes are spent at the bedside and on the
patient's facility floor or unit.).
CPT code 99308 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: An expanded problem focused interval
history; an expanded problem focused examination; Medical decision
making of low complexity. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
Typically, 15 minutes are spent at the bedside and on the patient's
facility floor or unit.).
CPT code 99309 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A detailed interval history; a detailed
examination; Medical decision making of moderate complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient has developed a significant complication or a
significant new problem. Typically, 25 minutes are spent at the bedside
and on the patient's facility floor or unit.).
CPT code 99310 (Subsequent nursing facility care, per day,
for the evaluation and management of a patient, which requires at least
2 of these 3 key components: A comprehensive interval history; a
comprehensive examination; Medical decision making of high complexity.
Counseling and/or coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. The patient may be unstable or may have developed a
significant new problem requiring immediate physician attention.
Typically, 35 minutes are spent at the bedside and on the patient's
facility floor or unit.).
CPT codes 99307-99310 are currently on the list of Medicare
telehealth services, but can only be billed via telehealth once every
30 days. The requester requested that we remove the frequency
limitation when these services are provided for psychiatric care. We
stated in the CY 2011 PFS final rule with comment period (75 FR 73317)
that we believed it would be appropriate to permit some subsequent
nursing facility care services to be furnished through telehealth to
ensure that complex nursing facility patients have frequent encounters
with their admitting practitioner, but because of our concerns
regarding the potential acuity and complexity of SNF inpatients, we
limited the provision of subsequent nursing facility care services
furnished through telehealth to once every 30 days. Since these codes
are used to report care for patients with a variety of diagnoses,
including psychiatric diagnoses, we do not think it would be
appropriate to remove the frequency limitation only for certain
diagnoses. The services described by these CPT codes are essentially
the same service, regardless of the patient's diagnosis. We also
continue to have concerns regarding the potential acuity and complexity
of SNF inpatients, and therefore, we did not propose to remove the
frequency limitation for subsequent nursing facility care services in
CY 2019.
In summary, we proposed to add the following codes to the list of
Medicare telehealth services beginning in CY 2019 on a category 1
basis:
HCPCS code G0513 (Prolonged preventive service(s) (beyond
the typical service time of the primary procedure), in the office or
other outpatient setting requiring direct patient contact beyond the
usual service; first 30 minutes (list separately in addition to code
for preventive service).
HCPCS code G0514 (Prolonged preventive service(s) (beyond
the typical service time of the primary procedure), in the office or
other outpatient setting requiring direct patient contact beyond the
usual service; each additional 30 minutes (list separately in addition
to code G0513 for additional 30 minutes of preventive service).
Comment: Commenters were unanimously supportive of our proposal to
add HCPCS codes G0513 and G0514 to the Medicare telehealth list. A few
commenters noted they were disappointed that we did not propose to add
the initial hospital care codes to the telehealth list and that we did
not propose to lift the frequency limitation on the subsequent hospital
care and subsequent nursing facility care codes.
Response: We are finalizing adding HCPCS codes G0513 and G0514 to
the Medicare telehealth list. We are not adding the initial hospital
care codes to the telehealth list and we are not removing the frequency
limitations on the subsequent hospital care and subsequent nursing
facility care codes for the reasons noted above.
Comment: Several commenters suggested that CMS conduct a pilot or
demonstration program to evaluate the clinical benefit of physical
therapists, occupational therapists, and speech-language pathologists
furnishing telehealth services to Medicare beneficiaries in states that
permit such services, noting that this would improve beneficiary access
to therapy services, and help to inform policymakers as they consider
whether to recognize such healthcare professionals as authorized
providers of telehealth under the Social Security Act.
Response: While we did not include any proposals on this topic in
the proposed rule, we reiterate our commitment to expanding access to
telehealth services consistent with statutory authority, and paying
appropriately for services that maximize telecommunications technology.
Regarding the possibility of a model or demonstration, we will consider
the comments as we develop new models through the Center for Medicare
and Medicaid Innovation. We note that we would need to determine
whether such a model or demonstration would meet the statutory
requirements, which generally require that the test be expected to
reduce Medicare expenditures and preserve or enhance the quality of
care for beneficiaries.
5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of
2018
a. Expanding Access to Home Dialysis Therapy Under the Bipartisan
Budget Act of 2018
Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and
1834(m) of the Act to allow an individual determined to have end-stage
renal disease receiving home dialysis to choose to receive certain
monthly end-stage renal disease-related (ESRD-related) clinical
assessments via telehealth on or after January 1, 2019.
[[Page 59495]]
The new section 1881(b)(3)(B)(ii) of the Act requires that such an
individual must receive a face-to-face visit, without the use of
telehealth, at least monthly in the case of the initial 3 months of
home dialysis and at least once every 3 consecutive months after the
initial 3 months.
As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX)
and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal
dialysis facility and the home of an individual as telehealth
originating sites but only for the purposes of the monthly ESRD-related
clinical assessments furnished through telehealth provided under
section 1881(b)(3)(B) of the Act. Section 50302(b)(1) of the BBA of
2018, also added a new section 1834(m)(5) of the Act which provides
that the geographic requirements for telehealth services under section
1834(m)(4)(C)(i) of the Act do not apply to telehealth services
furnished on or after January 1, 2019 for purposes of the monthly ESRD-
related clinical assessments where the originating site is a hospital-
based or critical access hospital-based renal dialysis center, a renal
dialysis facility, or the home of an individual. Section 50302(b)(2) of
the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require
that no originating site facility fee is to be paid if the home of the
individual is the originating site.
Our current regulation at Sec. 410.78 specifies the conditions
that must be met in order for Medicare Part B to pay for covered
telehealth services included on the telehealth list when furnished by
an interactive telecommunications system. In accordance with the new
subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we
proposed to revise our regulation at Sec. 410.78(b)(3) to add a renal
dialysis facility and the home of an individual as Medicare telehealth
originating sites, but only for purposes of the home dialysis monthly
ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act.
We proposed to amend Sec. 414.65(b)(3) to reflect the requirement in
section 1834(m)(2)(B)(ii) of the Act that there is no originating site
facility fee paid when the originating site for these services is the
patient's home. Additionally, we proposed to add new Sec.
410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of
the Act, added by section 50302 of the BBA of 2018, specifying that the
geographic requirements described in section 1834(m)(4)(C)(i) of the
Act do not apply with respect to telehealth services furnished on or
after January 1, 2019, in originating sites that are hospital-based or
critical access hospital-based renal dialysis centers, renal dialysis
facilities, or the patient's home, respectively under sections
1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section
1881(b)(3)(B) of the Act.
Commenters supported our proposals to revise the regulation text at
Sec. Sec. 410.78 and 414.65 to implement the requirements of section
50302 of the BBA of 2018 for expanding access to home dialysis therapy
through telehealth. We are finalizing these regulation text changes as
proposed.
b. Expanding the Use of Telehealth for Individuals With Stroke Under
the Bipartisan Budget Act of 2018
Section 50325 of the BBA of 2018 amended section 1834(m) of the Act
by adding a new paragraph (6) that provides special rules for
telehealth services furnished on or after January 1, 2019, for purposes
of diagnosis, evaluation, or treatment of symptoms of an acute stroke
(acute stroke telehealth services), as determined by the Secretary.
Specifically, section 1834(m)(6)(A) of the Act removes the restrictions
on the geographic locations and the types of originating sites where
acute stroke telehealth services can be furnished. Section
1834(m)(6)(B) of the Act specifies that acute stroke telehealth
services can be furnished in any hospital, critical access hospital,
mobile stroke units (as defined by the Secretary), or any other site
determined appropriate by the Secretary, in addition to the current
eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act
limits payment of an originating site facility fee to acute stroke
telehealth services furnished in sites that meet the usual telehealth
restrictions under section 1834(m)(4)(C) of the Act.
To implement these requirements, we proposed to create a new
modifier that would be used to identify acute stroke telehealth
services. The practitioner and, as appropriate, the originating site,
would append this modifier when clinically appropriate to the HCPCS
code when billing for an acute stroke telehealth service or an
originating site facility fee, respectively. We note that section 50325
of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act,
which limits the scope of telehealth services to those on the Medicare
telehealth list. Practitioners would be responsible for assessing
whether it would be clinically appropriate to use this modifier with
codes from the Medicare telehealth list. By billing with this modifier,
practitioners would be indicating that the codes billed were used to
furnish telehealth services for diagnosis, evaluation, or treatment of
symptoms of an acute stroke. We believe that the adoption of a service
level modifier is the least administratively burdensome means of
implementing this provision for practitioners, while also allowing CMS
to easily track and analyze utilization of these services.
In accordance with section 1834(m)(6)(B) of the Act, as added by
section 50325 of the BBA of 2018, we also proposed to revise Sec.
410.78(b)(3) to add mobile stroke unit as a permissible originating
site for acute stroke telehealth services. We proposed to define a
mobile stroke unit as a mobile unit that furnishes services to
diagnose, evaluate, and/or treat symptoms of an acute stroke and
solicited comment on this definition, as well as additional information
on how these units are used in current medical practice. We therefore
proposed that mobile stroke units and the current eligible telehealth
originating sites, which include hospitals and critical access
hospitals as specified in section 1834(m)(6)(B) of the Act, but
excluding renal dialysis facilities and patient homes because they are
only allowable originating sites for purposes of home dialysis monthly
ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act,
would be permissible originating sites for acute stroke telehealth
services.
We also solicited comment on other possible appropriate originating
sites for telehealth services furnished for the diagnosis, evaluation,
or treatment of symptoms of an acute stroke. Any additional sites would
be adopted through future rulemaking. As required under section
1834(m)(6)(C) of the Act, the originating site facility fee would not
apply in instances where the originating site does not meet the
originating site type and geographic requirements under section
1834(m)(4)(C) of the Act. Additionally, we proposed to add Sec. 410.78
(b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C)
of the Act do not apply with respect to telehealth services furnished
on or after January 1, 2019, for purposes of diagnosis, evaluation, or
treatment of symptoms of an acute stroke.
Comment: Commenters supported the expansions to Medicare
telehealth. The majority of commenters agreed with our proposed
definition of a mobile stroke unit. However, the AMA suggested that CMS
specify in the definition that a mobile stroke unit must include a
computed tomographic (CT) scanner and a telehealth (audio and video)
connection or an in-person physician who is able to interpret the CT
scan and prescribe an intravenous thrombolysis and also have a
qualified health
[[Page 59496]]
professional who is able to administer an intravenous thrombolysis if
the physician interpreting the CT scan and prescribing the treatment
does so via telehealth. The AMA also suggested that CMS add as an
originating site Emergency Medical Service (EMS) transports equipped
with a telehealth connection to stroke specialists in order to provide
faster national access to patients who require an accurate stroke
diagnosis and decision about eligibility for intravenous or
endovascular therapy, and to determine where to take them (such as a
primary stroke or comprehensive stroke center). One commenter urged CMS
to distinguish between a mobile stroke unit and a standard ambulance
that is equipped with telemedicine capability and to establish separate
payment for each, noting that a telemedicine consult on a mobile stroke
unit may involve much greater complexity and critical care treatment
than on a standard ambulance that is equipped with telemedicine
capability. Another commenter recommended that CMS require specially
trained paramedics who can evaluate an acute ischemic stroke patient
based on national standards.
Response: We are finalizing the changes to the regulation text and
the definition of a mobile stroke unit as proposed without
modification. We believe that clinicians are in the best position to
make decisions about what equipment and professional support are
required in furnishing these services. We plan to monitor utilization
of these services and will consider making refinements, including those
suggested by commenters, through future rulemaking as necessary. We
would welcome additional information to help us understand the merits
of the commenters' suggestions, including those regarding specific
equipment and staffing requirements for mobile stroke units.
In summary, we are finalizing a new modifier that will be used to
identify acute stroke telehealth services. The practitioner and, as
appropriate, the originating site, will append this modifier to the
HCPCS code as clinically appropriate when billing for an acute stroke
telehealth service or an originating site facility fee, respectively.
We are finalizing the regulation text changes at Sec. Sec. 410.78 and
414.65 as proposed to implement the requirements of section 50325 of
the BBA of 2018 for acute stroke telehealth services. Mobile stroke
units, with the definition as proposed, and the current eligible
telehealth originating sites, which include hospitals and critical
access hospitals, but exclude renal dialysis facilities and patient
homes because they are originating sites only for purposes of home
dialysis monthly ESRD-related clinical assessments in section
1881(b)(3)(B) of the Act, will be permissible originating sites for
acute stroke telehealth services.
6. Requirements of the Substance Use-Disorder Prevention That Promotes
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities
Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid
Use Disorder and Other Substance Use Disorders--Interim Final Rule With
Comment Period
Section 2001(a) of the SUPPORT for Patients and Communities Act
(Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several
revisions to section 1834(m) of the Act. First, it removes the
originating site geographic requirements under section 1834(m)(4)(C)(i)
for telehealth services furnished on or after July 1, 2019 for the
purpose of treating individuals diagnosed with a substance use disorder
or a co-occurring mental health disorder, as determined by the
Secretary, at an originating site described in section
1834(m)(4)(C)(ii) of the Act, other than an originating site described
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site
described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is
a renal dialysis facility, which is only an allowable originating site
for purposes of home dialysis monthly ESRD-related clinical assessments
in section 1881(b)(3)(B) of the Act. It also adds the home of an
individual as a permissible originating site for these telehealth
services. Section 2001(a) of the SUPPORT Act for Patients and
Communities Act additionally amends section 1834(m) of the Act to
require that no originating site facility fee will be paid in instances
when the individual's home is the originating site. Section 2001(b) of
the SUPPORT for Patients and Communities Act grants the Secretary
specific authority to implement the amendments made by section 2001(a)
through an interim final rule.
Under the authority of section 2001(b) of the SUPPORT for Patients
and Communities Act, we are issuing an interim final rule with comment
period to implement the requirements of section 2001(a) of the SUPPORT
for Patients and Communities Act. In accordance with section
1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the
SUPPORT for Patients and Communities Act, we are revising Sec.
410.78(b)(3) on an interim final basis, by adding Sec.
410.78(b)(3)(xii), which adds the home of an individual as a
permissible originating site for telehealth services furnished on or
after July 1, 2019 to individuals with a substance use disorder
diagnosis for purposes of treatment of a substance use disorder or a
co-occurring mental health disorder. We are amending Sec. 414.65(b)(3)
on an interim final basis to reflect the requirement in section
1834(m)(2)(B)(ii) of the Act that there is no originating site facility
fee paid when the originating site for these services is the
individual's home. Additionally, we are adding Sec.
410.78(b)(4)(iv)(C) on an interim final basis to specify that the
geographic requirements in section 1834(m)(4)(C)(i) of the Act do not
apply for telehealth services furnished on or after July 1, 2019, to
individuals with a substance use disorder diagnosis for purposes of
treatment of a substance use disorder or a co-occurring mental health
disorder at an originating site other than a renal dialysis facility.
We note that section 2001 of the SUPPORT for Patients and
Communities Act did not amend section 1834(m)(4)(F) of the Act, which
limits the scope of telehealth services to those on the Medicare
telehealth list. Practitioners would be responsible for assessing
whether individuals have a substance use disorder diagnosis and whether
it would be clinically appropriate to furnish telehealth services for
the treatment of the individual's substance use disorder or a co-
occurring mental health disorder. By billing codes on the Medicare
telehealth list with the telehealth place of service code,
practitioners would be indicating that the codes billed were used to
furnish telehealth services to individuals with a substance use
disorder diagnosis for the purpose of treating the substance use
disorder or a co-occurring mental health disorder. We note that we may
issue additional subregulatory guidance in the future for billing these
telehealth services.
We note that there is a 60-day period following publication of this
interim final rule for the public to comment on these interim final
amendments to our regulations. We invite public comment on our policies
to implement section 2001 of the SUPPORT for Patients and Communities
Act.
[[Page 59497]]
b. Medicare Payment for Certain Services Furnished by Opioid Treatment
Programs (OTPs)--Request for Information
Section 2005 of the SUPPORT Act establishes a new Medicare benefit
category for opioid use disorder treatment services furnished by OTPs
under Medicare Part B, beginning on or after January 1, 2020. This
provision requires that opioid use disorder treatment services would
include FDA-approved opioid agonist and antagonist treatment
medications, the dispensing and administration of such medications (if
applicable), substance use disorder counseling, individual and group
therapy, toxicology testing, and other services determined appropriate
(but in no event to include meals and transportation). The provision
defines OTPs as those that enroll in Medicare and are certified by the
Substance Abuse and Mental Health Services Administration (SAMHSA),
accredited by a SAMHSA-approved entity, and meeting additional
conditions as the Secretary finds necessary to ensure the health and
safety of individuals being furnished services under these programs and
the effective and efficient furnishing of such services.
We note that there is a 60-day period for the public to comment on
the provisions of the interim final rule described previously to
implement section 2001 of the SUPPORT for Patients and Communities Act.
During that same comment period, we are requesting information
regarding services furnished by OTPs, payments for these services, and
additional conditions for Medicare participation for OTPs that
stakeholders believe may be useful for us to consider for future
rulemaking to implement this new Medicare benefit category.
7. Modifying Sec. 414.65 Regarding List of Telehealth Services
In the CY 2015 PFS final rule with comment period, we finalized a
proposal to change our regulation at Sec. 410.78(b) by deleting the
description of the individual services for which Medicare payment can
be made when furnished via telehealth, noting that we revised Sec.
410.78(f) to indicate that a list of Medicare telehealth codes and
descriptors is available on the CMS website (79 FR 67602). In
accordance with that change, we proposed a technical revision to also
delete the description of individual services and exceptions for
Medicare payment for telehealth services in Sec. 414.65, by amending
Sec. 414.65(a) to note that Medicare payment for telehealth services
is addressed in Sec. 410.78 and by deleting Sec. 414.65(a)(1).
Comment: Commenters were supportive of CMS making a technical
revision to delete the description of individual services and
exceptions for Medicare payment for telehealth services in Sec.
414.65.
Response: We are finalizing the technical revision to Sec. 414.65
as proposed.
8. Comment Solicitation on Creating a Bundled Episode of Care for
Management and Counseling Treatment for Substance Use Disorders
There is an evidence base that suggests that routine counseling,
either associated with medication assisted treatment (MAT) or on its
own, can increase the effectiveness of treatment for substance use
disorders (SUDs). According to a study in the Journal of Substance
Abuse Treatment,\1\ patients treated with a combination of web-based
counseling as part of a substance abuse treatment program demonstrated
increased treatment adherence and satisfaction. The federal guidelines
for opioid treatment programs describe that MAT and wrap-around
psychosocial and support services can include the following services:
Physical exam and assessment; psychosocial assessment; treatment
planning; counseling; medication management; drug administration;
comprehensive care management and supportive services; care
coordination; management of care transitions; individual and family
support services; and health promotion (https://store.samhsa.gov/shin/content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate
payment for a bundled episode of care for components of MAT such as
management and counseling treatment for substance use disorders (SUD),
including opioid use disorder, treatment planning, and medication
management or observing drug dosing for treatment of SUDs under the PFS
could provide opportunities to better leverage services furnished with
communication technology while expanding access to treatment for SUDs.
---------------------------------------------------------------------------
\1\ Van L. King, Robert K. Brooner, Jessica M. Peirce, Ken
Kolodner, Michael S. Kidorf, ``A randomized trial of Web based
videoconferencing for substance abuse counseling,'' Journal of
Substance Abuse Treatment, Volume 46, Issue 1, 2014, Pages 36-42,
http://www.sciencedirect.com/science/article/pii/S0740547213001876.
---------------------------------------------------------------------------
We also believe making separate payment for a bundled episode of
care for management and counseling for SUDs could be effective in
preventing the need for more acute services. For example, according to
the Healthcare Cost and Utilization Project,\2\ Medicare pays for one-
third of opioid-related hospital stays, and Medicare has seen the
largest annual increase in the number of these stays over the past 2
decades. We believe that separate payment for a bundled episode of care
could help avoid such hospital admissions by supporting access to
management and counseling services that could be important in
preventing hospital admissions and other acute care events.
---------------------------------------------------------------------------
\2\ Pamela L. Owens, Ph.D., Marguerite L. Barrett, M.S., Audrey
J. Weiss, Ph.D., Raynard E. Washington, Ph.D., and Richard Kronick,
Ph.D. ``Hospital Inpatient Utilization Related to Opioid Overuse
Among Adults 1993-2012,'' Statistical Brief #177. Healthcare Cost
and Utilization Project (HCUP). July 2014. Agency for Healthcare
Research and Quality, Rockville, MD, https://www.hcup-us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-Opioid-Overuse.jsp.
---------------------------------------------------------------------------
As indicated earlier, we considered whether it would be appropriate
to develop a separate bundled payment for an episode of care for
treatment of SUDs. We solicited public comment on whether such a
bundled episode-based payment would be beneficial to improve access,
quality and efficiency for SUD treatment. Further, we solicited public
comment on developing coding and payment for a bundled episode of care
for treatment for SUDs that could include overall treatment management,
any necessary counseling, and components of a MAT program such as
treatment planning, medication management, and observation of drug
dosing. Specifically, we solicited public comments related to what
assumptions we might make about the typical number of counseling
sessions as well as the duration of the service period, which types of
practitioners could furnish these services, and what components of MAT
could be included in the bundled episode of care. We were interested in
stakeholder feedback regarding how to define and value this bundle and
what conditions of payment should be attached. Additionally, we
solicited comment on whether the concept of a global period, similar to
the currently existing global periods for surgical procedures, might be
applicable to treatment for SUDs.
We also solicited comment on whether the counseling portion and
other MAT components could also be provided by qualified practitioners
``incident to'' the services of the billing physician who will
administer or prescribe any necessary medications and manage the
overall care, as well as supervise any other counselors participating
in the treatment, similar to the structure of the Behavioral Health
Integration codes which include
[[Page 59498]]
services provided by other members of the care team under the direction
of the billing practitioner on an ``incident to'' basis (81 FR 80231).
We welcomed comments on potentially creating a bundled episode of care
for management and counseling treatment for SUDs, which we will
consider for future rulemaking.
Comment: We received several comments with detailed information on
this topic. Some commenters expressed concern that the format of a
bundled episode of care may fail to take into account the wide
variability in patient needs for treatment of SUDs, especially given
the chronic nature of SUDs, which like other chronic diseases,
typically involves ongoing treatment without a definitive end point.
Some commenters additionally noted that a global period would not lend
itself to treatment of SUDs, because the treatment is not an acute
intervention like surgery; rather, patients with SUDs may require
increasing and decreasing access to care, depending on their progress
in treatment.
Response: We thank the commenters for all of the information
submitted and will consider this feedback for future rulemaking. We
agree with commenters and understand that there is wide variability in
patient needs for treatment of SUDs, and that unlike surgical global
periods, ongoing treatment is often necessary in the treatment of SUDs.
While we do not necessarily believe these characteristics preclude
payment bundles and/or global periods, we do understand they would need
to be taken into account. We reiterate that our intention as we
consider these issues for future rulemaking is to increase access to
necessary care, and that any potential bundled payment would be
developed in consideration of these comments.
We note that there is a 60-day period for the public to comment on
the interim final telehealth policies and revisions to our regulations
we are adopting to implement statutory amendments to section 1834(m) of
the Act that expand access to telehealth services used to treat
substance use disorders. During that same comment period, we are
requesting additional information from stakeholders and the public that
we might consider for future rulemaking regarding payment structure and
amounts for SUD treatment that account for ongoing treatment and wide
variability in patient needs for treatment of SUDs while improving
access to necessary care.
Additionally, we invited public comment and suggestions for
regulatory and subregulatory changes to help prevent opioid use
disorder and improve access to treatment under the Medicare program. We
solicited comment on methods for identifying non-opioid alternatives
for pain treatment and management, along with identifying barriers that
may inhibit access to these non-opioid alternatives including barriers
related to payment or coverage. Consistent with our ``Patients Over
Paperwork'' Initiative, we were interested in suggestions to improve
existing requirements to more effectively address the opioid epidemic.
Comment: We received several comments with detailed information on
this topic.
Response: We thank the commenters for all of the information
submitted and will consider this for future rulemaking.
9. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the Medicare Economic Index
(MEI) as defined in section 1842(i)(3) of the Act. The originating site
facility fee for telehealth services furnished in CY 2018 is $25.76.
The MEI increase for 2019 is 1.5 percent and is based on the most
recent historical update of the MEI through 2018Q2 (2.0 percent), and
the most recent historical multifactor productivity adjustment (MFP)
through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the
payment amount for HCPCS code Q3014 (Telehealth originating site
facility fee) is 80 percent of the lesser of the actual charge or
$26.15. The Medicare telehealth originating site facility fee and the
MEI increase by the applicable time period is shown in Table 10.
Table 10--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
MEI Facility
Time period increase fee
------------------------------------------------------------------------
10/01/2001-12/31/2002............................... N/A $20.00
01/01/2003-12/31/2003............................... 3.0 20.60
01/01/2004-12/31/2004............................... 2.9 21.20
01/01/2005-12/31/2005............................... 3.1 21.86
01/01/2006-12/31/2006............................... 2.8 22.47
01/01/2007-12/31/2007............................... 2.1 22.94
01/01/2008-12/31/2008............................... 1.8 23.35
01/01/2009-12/31/2009............................... 1.6 23.72
01/01/2010-12/31/2010............................... 1.2 24.00
01/01/2011-12/31/2011............................... 0.4 24.10
01/01/2012-12/31/2012............................... 0.6 24.24
01/01/2013-12/31/2013............................... 0.8 24.43
01/01/2014-12/31/2014............................... 0.8 24.63
01/01/2015-12/31/2015............................... 0.8 24.83
01/01/2016-12/31/2016............................... 1.1 25.10
01/01/2017-12/31/2017............................... 1.2 25.40
01/01/2018-12/31/2018............................... 1.4 25.76
01/01/2019-12/31/2019............................... 1.5 26.15
------------------------------------------------------------------------
E. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) of the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.H. of this final rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the RUC, MedPAC,
and other stakeholders. For many years, the RUC has provided us with
recommendations on the appropriate relative values for new, revised,
and potentially misvalued PFS services. We review these recommendations
on a code-by-code basis and consider these recommendations in
conjunction with analyses of other data, such as claims data, to inform
the decision-making process as authorized by law. We may also consider
analyses of work time, work RVUs, or direct PE inputs using other data
sources, such as Department of Veteran Affairs (VA), National Surgical
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
(STS), and the Merit-based Incentive Payment System (MIPS) data. In
addition to considering the most recently available data, we assess the
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also consider information provided by
other stakeholders. We conduct a review to assess the appropriate RVUs
in the context of contemporary medical practice. We note that section
[[Page 59499]]
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE declines. This
can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed approximately
1,700 potentially misvalued codes to refine work RVUs and direct PE
inputs. We have assigned appropriate work RVUs and direct PE inputs for
these services as a result of these reviews. A more detailed discussion
of the extensive prior reviews of potentially misvalued codes is
included in the CY 2012 PFS final rule with comment period (76 FR 73052
through 73055). In the CY 2012 PFS final rule with comment period (76
FR 73055 through 73958), we finalized our policy to consolidate the
review of physician work and PE at the same time, and established a
process for the annual public nomination of potentially misvalued
services.
In the CY 2013 PFS final rule with comment period, we built upon
the work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services.
In the CY 2013 PFS final rule with comment period, we identified
specific Harvard-valued services with annual allowed charges that total
at least $10,000,000 as
[[Page 59500]]
potentially misvalued. In addition to the Harvard-valued codes, in the
CY 2013 PFS final rule with comment period we finalized for review a
list of potentially misvalued codes that have stand-alone PE (codes
with physician work and no listed work time and codes with no physician
work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT codes
95970-95982). We also finalized as potentially misvalued 103 codes
identified through our screen of high expenditure services across
specialties.
In the CY 2017 PFS final rule, we finalized for review a list of
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We
also finalized as potentially misvalued 19 codes identified through our
screen for 0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
In the CY 2018 PFS final rule, we finalized arthrodesis of
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the
use of comment solicitations with regard to specific codes, we also
examined the valuations of other services, in addition to, new
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2019 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that there have been changes in physician work due to one
or more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
We received one submission that nominated several high-volume codes
for review under the potentially misvalued code initiative. In its
request, the submitter noted a systemic overvaluation of work RVUs in
certain procedures and tests based ``on a number of Government
Accountability Office (GAO) and the Medicare Payment Advisory
Commission (MedPAC) reports, media reports regarding time inflation of
specific services, and the January 19, 2017 Urban Institute report for
CMS.'' The submitter suggested that the times CMS assumes in estimating
work RVUs are inaccurate for procedures, especially due to substantial
overestimates of preservice and postservice time, including follow-up
inpatient and outpatient visits that do not take place. According to
the submitter, the time estimates for tests and some other procedures
are primarily overstated as part of the intraservice time. Furthermore,
the submitter stated that previous RUC reviews of these services did
not result in reductions in valuation that adequately reflected
reductions in surveyed times.
Based on these analyses, the submitter requested that the codes
listed in Table 11 be prioritized for review under the potentially
misvalued code initiative.
Table 11--Public Nominations Due to Overvaluation
------------------------------------------------------------------------
CPT code Short description
------------------------------------------------------------------------
27130............................. Total hip arthroplasty.
27447............................. Total knee arthroplasty.
43239............................. Egd biopsy single/multiple.
45385............................. Colonoscopy w/lesion removal.
70450............................. CT head w/o contrast.
93000............................. Electrocardiogram complete.
93306............................. Tte w/doppler complete.
------------------------------------------------------------------------
Another submitter requested that CPT codes 92992 (Atrial septectomy
or septostomy; transvenous method, balloon (e.g., Rashkind type)
(includes cardiac catheterization)) and 92993 (Atrial septectomy or
septostomy; blade method (Park septostomy) (includes cardiac
catheterization)) be reviewed under the potentially misvalued code
initiative in order to establish national RVU values for these services
under the MPFS. These codes are currently priced by the Medicare
Administrative Contractors (MACs).
We received several comments with regard to the nomination of
several high-volume codes for review under the potentially misvalued
code initiative.
Comment: One commenter stated that specific details of the
nomination of the seven high-volume codes were not provided in the CY
2019 PFS proposed rule. Several other commenters, including the RUC,
expressed concern that the source of the nomination of the seven high-
volume codes and its entire nomination letter was not made available.
These commenters requested that CMS provide greater transparency and
publicly provide all nomination requests identifying potentially
misvalued codes.
Response: We believe that we summarized the contents of the public
nomination letter and provided the rationale in the CY 2019 PFS
proposed rule with enough detail for commenters to comment
substantively and provide supporting documentation or data to rebut the
suggestion that these codes are potentially misvalued. We recognize the
importance of transparency and note that under the public nomination
process that was established in CY 2012 rulemaking, the first
opportunity for the public to nominate codes was during the 60-day
comment period for the CY
[[Page 59501]]
2012 final rule with comment period; therefore, public nominations were
received via submission to www.regulations.gov. In the CY 2015 final
rule with comment period (79 FR 67606 through 67608), we finalized a
modified process for identifying potentially misvalued codes (fully
effective in CY 2017), where we established a new deadline of February
10th for receipt of public nominations for potentially misvalued codes
to be considered for inclusion in the proposed rule. Although
stakeholders often include public nominations of misvalued codes for
consideration in a subsequent year's rulemaking as part of their
comments on a current year's proposed rule, the public and stakeholders
may nominate potentially misvalued codes for review by submitting the
code with supporting documentation to CMS by February 10th of each
year. In the future, public nominations that CMS receives by the
February 10th deadline will be made available in the form of a public
use file with the proposed rule, in the downloads section on the CMS
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We remind submitters that any information
that might be considered proprietary or confidential should not be
included. Additionally, we have included the submission that nominated
these high-volume codes for review as potentially misvalued as a public
use file for the CY 2019 PFS final rule.
Comment: One commenter stated that because CMS did not include
these publicly nominated codes in Table 13 of the proposed rule, it
does not appear that CMS has agreed with the commenter on the need to
revisit these codes. Another commenter stated that CMS did not provide
guidance on whether these nominated codes would be considered for
revaluation or retained at their current value.
Response: We clarify that the codes for which we received public
nominations as potentially misvalued were not included in Table 13 of
the proposed rule because that table contains a list of codes for which
we proposed work RVUs for CY 2019 (the list does not include codes for
which we received nominations discussed in the proposed rule for
consideration as potentially misvalued). As previously indicated, in
the proposed rule we publish the list of codes nominated as potentially
misvalued, which allows the public the opportunity to comment on these
codes; then, in the final rule, we finalize our list of potentially
misvalued codes. No new valuations were proposed for these codes in the
CY 2019 PFS proposed rule. Any revaluation of these codes would be
proposed in future rulemaking.
Comment: One commenter stated that the codes in Table 8 in the
proposed rule and their respective code families should be prioritized
for review as potentially misvalued. The commenter suggested revisiting
two recent efforts funded by CMS, reports by Urban Institute and RAND
Corporation (https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_1.pdf, and, https://www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/RAND_RR662.pdf), for prioritization of codes for review to expand the
misvalued codes initiative list. The commenter referenced a June 2018
MedPAC report that stated that CMS' review of potentially misvalued
codes has not addressed services that account for a substantial share
of fee schedule spending and is hampered by the lack of current,
accurate, and objective data on clinician work time and practice
expenses. Consequently, according to the MedPAC report, work RVUs for
procedures, imaging, and tests are systemically overvalued relative to
other services, such as ambulatory evaluation and management (E/M)
services.
Response: We appreciate the commenters' recommendations for
expanding the misvalued codes list. We will consider whether to address
these suggestions in future rulemaking.
Comment: One commenter recommended that additional research be
conducted on the analytic products available that could be used to
create transparency into the RUC process and allow for greater external
participation in misvalued cost evaluation. The commenter also stated
that CMS should reconsider reliance on the RUC altogether given the
inherent conflicts of interest in the RUC-based process.
Response: We acknowledge that the RUC provides critically important
information that factors into our review process. However, our review
of recommended work RVUs and time inputs is also informed by review of
various alternate sources of information, in addition to the RUC.
Examples of these alternate sources of information include information
provided by other public commenters, Medicare claims data, comparative
databases, medical literature, as well as consultation with other
physicians and healthcare professionals within CMS and the federal
government. We also reiterate that we continue to be open to reviewing
additional and supplemental sources of data furnished by stakeholders,
and providing such information to CMS is not limited to the public
nomination process for potentially misvalued codes. We encourage
stakeholders to continue to provide such information for our
consideration in establishing work RVUs.
Comment: One commenter stated concerns with CMS' use of a non-
relative measuring approach for the seven codes nominated for review
when generally the RUC-valued and CMS-approved codes are based on the
concept of relativity. The commenter stated that using such an
inconsistent approach on select codes will potentially cause disruption
and instability in code valuations. The commenter also stated that
determining reimbursement in value-based care delivery models must rely
on the carefully cultivated RUC process for fairness and
accountability.
Response: We are unclear about the commenter's claim that CMS is
using a non-relative measuring approach for the seven high volume codes
that have been nominated as potentially misvalued. We did not propose a
valuation for the nominated codes, nor did we propose to use a non-
relative measuring approach. Rather, as part of our statutory
obligation to identify and review potentially misvalued codes, we
implemented an annual process whereby the public can nominate
potentially misvalued codes with supporting documentation; we then
publish the list of nominated codes and the public has the opportunity
to comment on these nominations. We continue to maintain that
adjustments to work RVUs should be based on the resources involved with
each procedure or service, and reiterate that our review of work RVUs
and time inputs utilizes information from various resources, including
the RUC. We continue to seek information on the best sources of
objective, routinely-updated, auditable, and robust data regarding the
resource costs of furnishing PFS services.
Comment: Several commenters stated that CPT codes 27130 and 27447
should not be considered potentially misvalued and do not warrant any
further action because the current valuation for the codes was
established after review by the RUC and CMS in 2013, and since that
time there are no new data to indicate a change in the work of
performing the procedure or the number of post-operative follow up
visits. Another commenter stated that CMS should not subject
professions to code
[[Page 59502]]
valuations and analysis so frequently, and that doing so calls into
question the validity of the RUC process in the first place.
Response: We do not agree that recent review of a code should
preclude it from being considered as potentially misvalued, nor that it
calls into question the validity of the RUC process. We have a
responsibility to identify and review potentially misvalued codes, and
believe there is value in consistent and routine review of high-volume
services, particularly considering that a minor adjustment to the work
RVU of a high-volume code may have a significant dollar impact. We also
note that review of high-volume services does not need to be predicated
on the suspicion of overvaluation.
Comment: One commenter stated that if CMS decides to reexamine
these nominated codes in the future, then the agency should provide
ample opportunity for public comments, and in the event of such review,
CMS should consider supplemental sources of information, including
hospital anesthesia time in addition to any RUC recommendations in
order to support accurate valuations of these procedures.
Response: Any revaluations of these codes would be undertaken
through notice and comment rulemaking. Notice and comment rulemaking
provides for an open process whereby we welcome input from all
interested parties, and we encourage commenters to provide feedback
including supplemental sources of information regarding potentially
misvalued codes, as well as input on our annual proposed valuations.
Comment: One commenter disagreed that CPT codes 43239 and 45385 are
misvalued and stated that while the Urban Institute report provides
insights into potential flaws in the RUC survey process, it should not
be considered proof that these codes are overvalued. The commenter
stated that these code valuations were recently revised, and the RUC
survey responses from gastroenterologists informed revisions to the
work RVUs for both services. The commenter stated that for CPT code
43239, CMS finalized work RVUs that were less than the RUC's
recommended work RVUs, and for CPT code 45385, CMS finalized the RUC-
recommended work RVUs, which were lower than the work RVUs prior to
reevaluation. Therefore, the commenter stated that CMS should reject
the nominations of these codes as potentially misvalued.
Response: We note that the nomination referenced the Urban
Institute report as only one of the sources regarding the issue of time
inflation of specific services. Additionally, as previously indicated,
we do not agree that recent review of a code should preclude it from
being considered as potentially misvalued. We believe there is value in
consistent and routine review of high-volume services, particularly
considering that a minor adjustment to the work RVU of a high-volume
code may have a significant dollar impact. Therefore, we do not agree
that we should reject nominations of these codes as potentially
misvalued because they were previously reviewed and refinements were
made.
Comment: A few commenters stated that the current work RVU
valuation of 0.85 for CPT code 70450 is inadequate. The commenters
stated that the level of effort associated with CPT code 70450
increased between the time the code was originally valued and the 2012
survey, and this increase continued through 2016. The commenters stated
that over time, advances in technology led to many more images being
created than existed historically. The commenters also stated that
volume acquisitions, a CT scan technique that allows for multiple two-
dimensional images, has resulted in thinner reconstructions and
effortless multiplanar reformats, and other technological advancements
have increased the amount of professional work associated with
interpreting a non-contrast head CT and should be considered in the
work RVU. The commenters expressed concern that the nomination by a
single entity threatens the integrity of how physician services are
valued generally.
Response: We disagree with the commenter that a nomination by a
single entity threatens the integrity of how physician services are
valued generally, and reiterate that a public nomination process was
established through rulemaking as a way for the public and stakeholders
to nominate potentially misvalued codes for consideration. Any future
proposed valuations of specific codes are open for public comment, and
we encourage stakeholders to submit data that would indicate that the
current valuation is insufficient.
Comment: One commenter stated that with regard to CPT code 70450,
the times prior to survey were CMS/other times and were not subdivided
into pre-service, intra-service, and post-service categories.
Therefore, the commenter stated that drawing comparisons between prior
RUC database times and the surveyed times is invalid because the source
of the prior RUC database times are unknown and completely different
from the surveyed times. The commenter also stated that selecting as
potentially misvalued only certain CPT codes that have undergone the
RUC process with validated surveys is not a rational approach because
if the times assumed based on the RUC approved survey data are invalid
for these codes, they should be invalid for the entire fee schedule so
that consistent methodology is applied to all CPT codes.
Response: We typically rely on RUC survey values because we believe
they are the closest to accurate values, as they are the best data
available in some cases. Although we do not agree that we should not
consider comparisons of RUC database times to the newly surveyed times
as described by the commenter, on a case-by-case basis we can consider
the existence of previous inaccuracies. However, we also note that
previous valuations established based on those inaccuracies would also
indicate that the payments would have been inaccurate as well. The goal
of the identification and review of potentially misvalued services is
to facilitate accurate payment for PFS services. We also disagree with
the commenter's characterization that selecting codes that have
undergone the RUC process with validated surveys is not rational, and
note that just because a code has been reviewed by the RUC does not
preclude it from being identified and/or publically nominated as
potentially misvalued.
Comment: With regard to CPT codes 93000 and 93306, one commenter
stated that while the Urban Institute report concludes that the
intraservice time to interpret an electrocardiogram is 6 seconds,
practitioners who furnish the service do not believe it is possible to
completely interpret a study so quickly. The commenter expressed
concern about the large emphasis placed on service time by CMS and some
stakeholders when it comes to valuation. The commenter suggested that
frequent reviews of long-established mature services like
electrocardiography and echocardiography will produce two outcomes--the
inputs will remain the same or circumstances at some point will align
such that it appears they take less time, which will open the window
for payers to try to reduce payment for services that have not actually
changed, and eventually these reductive re-valuations produce
underpayment. A few commenters stated that CPT code 93306 was recently
reviewed and valued in CY 2018. One commenter stated that the current
valuation is reflective of numerous accreditation body requirements
that were implemented since the service was last valued in 2007, which
increased the
[[Page 59503]]
work required per study. The commenter stated that the Urban Institute
report should not be considered proof that the CPT code is overvalued,
and given the recent RUC review of this service, CMS' acceptance of the
RUC recommendation, and no change in the physician work of performing
the service in the past year, this code should not be included in the
potentially misvalued codes list.
Response: We reiterate that it is our practice to consider all
elements of the relative work when we are reviewing and determining
work RVU valuations. Additionally, our review of recommended work RVUs
and time inputs generally includes review of various sources such as
information provided by the RUC, and other public commenters, medical
literature, and comparative databases. As previously stated, we believe
there is great value in consistent and routine review of high-volume
services. Additionally, as previously indicated, we do not agree that
recent review of a code should preclude it from being considered as
potentially misvalued, and therefore, do not agree that CMS should not
include a code in the list of potentially misvalued services because it
was previously reviewed.
Comment: One commenter disagreed that the time allocated to CPT
code 93306 is overstated. The commenter stated that the Intersocietal
Accreditation Commission for Echocardiography Guidelines regarding time
standards indicated that more time is necessary from patient encounter
to departure than is stipulated in the CMS time file. The commenter
also stated there is more and more information being gathered with the
introduction of technology that is labor and time intensive. The
commenter suggested that if anything is revised, CMS times should be
increased, not decreased.
Response: We reiterate that we are interested in receiving
resource-based data from stakeholders and not just the RUC and we
encourage stakeholders to submit data that would indicate that the
current valuations are insufficient.
Although we appreciate the comments that were received regarding
the seven high-volume codes, we believe that the nominator presented
some concerns that have merit, such as the observation that in many
cases time is reduced substantially but the work RVU only minimally,
which results in an implied increase in the intensity of work that does
not appear to be valid, and ultimately creates work intensity anomalies
that are difficult to defend, and further review of these high-volume
codes is the best way to determine the validity of the concerns
articulated by the submitter. Therefore, we are adding CPT codes 27130,
27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially
misvalued codes and anticipate reviewing recommendations from the RUC
and other stakeholders. We reiterate that we do not believe that the
inclusion of a code on a potentially misvalued code list necessarily
means that a particular code is misvalued. Instead, the list is
intended to prioritize codes to be reviewed under the misvalued code
initiative.
In addition to comments on the nomination of the seven high-volume
codes, we also received comments on the nomination of two contractor-
priced codes for review under the potentially misvalued code
initiative.
Comment: We received a few comments with regard to CPT codes 92992
and 92993, which were requested for review under the potentially
misvalued code initiative in order to establish national RVU values for
these services under the PFS. One of the commenters, the RUC, stated
that these contractor-priced services, which are typically performed on
children, would be discussed at the October 2018 Relativity Assessment
Workgroup meeting.
Response: We appreciate the information from the RUC on their plans
to discuss these codes. Given the plans by the RUC to consider CPT
codes 92992 and 92993 we will wait for the RUC's review and will not
add these codes to the list of potentially misvalued codes.
b. Update on the Global Surgery Data Collection
Payment for postoperative care is currently bundled within 10 or 90
days after many surgical procedures. Historically, we have not
collected data on how many postoperative visits are actually performed
during the global period. Section 523 of the MACRA added a new
paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS
to use notice and comment rulemaking to implement a process to collect
data on the number and level of postoperative visits and use these data
to assess the accuracy of global surgical package valuation. In the CY
2017 PFS final rule, we adopted a policy to collect postoperative visit
data. Beginning July 1, 2017, we required practitioners in groups with
10 or more practitioners in nine states (Florida, Kentucky, Louisiana,
Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to
use the no-pay CPT code 99024 (Postoperative follow-up visit, normally
included in the surgical package, to indicate that an E/M service was
performed during a postoperative period for a reason(s) related to the
original procedure) to report postoperative visits. Practitioners who
only practice in groups with fewer than 10 practitioners are exempted
from required reporting, but are encouraged to report if feasible. The
293 procedures for which reporting is required are those furnished by
more than 100 practitioners, and either are nationally furnished more
than 10,000 times annually or have more than $10 million in annual
allowed charges. A list of the procedures for which reporting is
required is updated annually to reflect any coding changes and is
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.
In these nine states, from July 1, 2017 through December 31, 2017,
there were 990,581 postoperative visits reported using CPT code 99024.
Of the 32,573 practitioners who furnished at least one of the 293
procedures during this period and who, based on Tax Identification
Numbers in claims data, were likely to meet the practice size
threshold, only 45 percent reported one or more visit using CPT code
99024 during this 6-month period. The share of practitioners who
reported any CPT code 99024 claims varied by specialty. Among surgical
oncology, hand surgery, and orthopedic surgeons, reporting rates were
92, 90, and 87 percent, respectively. In contrast, the reporting rate
for emergency medicine physicians was 4 percent.
Among 10-day global procedures performed from July 1, 2017 through
December 31, 2017, where it is possible to clearly match postoperative
visits to specific procedures, only 4 percent had one or more matched
visit reported with CPT code 99024. The percentage of 10-day global
procedures with a matched visit reported with CPT code 99024 varied by
specialty. Among procedures with 10-day global periods performed by
hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23
percent, respectively, of procedures had a matched visit reported using
CPT code 99024. In contrast, less than 5 percent of 10-day global
procedures performed by many other specialties had a matched visit
reported using CPT code 99024. Among 90-day global procedures performed
from July 1, 2017 through December 31, 2017, where it is possible to
clearly match postoperative visits to specific procedures, 67 percent
had one or more matched visits reported using CPT code 99024.
In the CY 2019 PFS proposed rule, we suggested one potential
explanation for
[[Page 59504]]
these findings is that many practitioners are not consistently
reporting postoperative visits using CPT code 99024. We sought comment
on how to encourage reporting to ensure the validity of the data
without imposing undue burden. Specifically, we sought comment on
whether we need to do more to make practitioners aware of their
obligation and whether we should consider implementing an enforcement
mechanism.
We sought comment on several other issues. Given the very small
number of postoperative visits reported using CPT code 99024 during 10-
day global periods, we sought comment on whether or not it might be
reasonable to assume that many visits included in the valuation of 10-
day global packages are not being furnished, or whether there are
alternative explanations for what could be a significant level of
underreporting of postoperative visits. Alternatively, we sought
comment on whether it is possible that some or all of the postoperative
visits are occurring after the global period ends and are, therefore,
reported and paid separately.
We sought comment on whether we should consider requiring use of
modifiers -54 and -55 in cases where the surgeon does not expect to
perform the postoperative visits, regardless of whether or not the
transfer of care is formalized. We also sought comment on the best
approach to 10-day global codes for which the preliminary data suggest
that postoperative visits are rarely performed by the practitioner
reporting the global code and whether we should consider changing the
global period and reviewing the code valuation.
The following is a summary of the comments we received on
collecting data on global surgery and reporting.
Comment: The majority of commenters, including the RUC, noted that
more time was needed for physicians to become aware of reporting and
prepare for reporting. Moreover, they opposed implementing an
enforcement mechanism, but supported more efforts by CMS to make
physicians aware of the requirement. A few commenters objected to
reporting and noted that CMS had complied with the statute. MedPAC,
which supported converting all 10- and 90-day global codes to 0-day
global codes and revaluing these codes as 0-day codes, suggested that
these findings are consistent with the OIG's three studies that showed
post-operative visits were not occurring at the rate that we estimated.
MedPAC noted support for converting all codes with 10- and 90-day
global periods to 0-day global codes and revaluing these codes as 0-day
codes, most other commenters were opposed to creating 0-day global
services out of 10-day global services. Of those who commented on
reporting of post-operative visits, most suggested that improving
reporting of these visits is essential if the data is to be used to
improve the accuracy of the existing codes.
Response: We will evaluate the public comments received and
consider whether to propose action at a future date. For the comment
calling for additional efforts to make physicians aware of the
requirement, we sent a letter describing the requirement to
practitioners who are required to report in the 9 affected states and
we plan to send another such letter to these practitioners. We will
also consider other actions to make sure affected practitioners are
aware of the requirement.
F. Radiologist Assistants
In accordance with Sec. 410.32(b)(3), except as otherwise
provided, all diagnostic X-ray and other diagnostic tests covered under
section 1861(s)(3) of the Act and payable under the PFS must be
furnished under at least a general level of physician supervision as
defined in paragraph (b)(3)(i) of that regulation. In addition, some of
these tests require either direct or personal supervision as defined in
paragraphs (b)(3)(ii) or (iii) of Sec. 410.32, respectively. We list
the required minimum physician supervision level for each diagnostic X-
ray and other diagnostic test service along with the codes and relative
values for these services in the PFS Relative Value File, which is
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.html.
For most diagnostic imaging procedures, this required physician
supervision level applies only to the technical component (TC) of the
procedure.
In response to the Request for Information on CMS Flexibilities and
Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82
FR 34172 through 34173), many commenters recommended that we revise the
physician supervision requirements at Sec. 410.32(b) for diagnostic
tests with a focus on those that are typically furnished by a
radiologist assistant (RA) under the supervision of a physician.
Specifically, the commenters stated that all diagnostic tests, when
performed by RAs, can be furnished under direct supervision rather than
personal supervision of a physician, and that we should revise the
Medicare supervision requirements so that when RAs conduct diagnostic
imaging tests that would otherwise require personal supervision, they
only need to do so under direct supervision. In addition to increasing
efficiency, stakeholders suggested that the current supervision
requirements for certain diagnostic imaging services unduly restrict
RAs from conducting tests that they are permitted to do under current
law in many states.
After consideration of these comments on the RFI, as well as
information provided by stakeholders, we proposed to revise our
regulations to specify that all diagnostic imaging tests may be
furnished under the direct supervision of a physician when performed by
an RA in accordance with state law and state scope of practice rules.
Stakeholders representing the radiology community have provided us with
information showing that the RA designation includes registered
radiologist assistants (RRAs) who are certified by The American
Registry of Radiologic Technologists, and radiology practitioner
assistants (RPAs) who are certified by the Certification Board for
Radiology Practitioner Assistants. We proposed to revise our regulation
at Sec. 410.32 to add a new paragraph (b)(4) to state that diagnostic
tests performed by an RRA or an RPA require only a direct level of
physician supervision, when permitted by state law and state scope of
practice regulations. We noted that for diagnostic imaging tests
requiring a general level of physician supervision, this proposal would
not change the level of physician supervision to direct supervision.
Otherwise, the diagnostic imaging tests must be performed as specified
elsewhere under Sec. 410.32(b). We based this proposal on
recommendations from the practitioner community that included specific
recommendations on how to implement the change. Representatives of the
practitioner community submitted information on the education and
clinical experience of RAs, which we took into consideration in
determining whether the proposal would pose a significant risk to
patient safety, and we determined that it would not. In addition, we
considered information provided by stakeholders that indicated that 28
states have statutes or regulations that recognize RAs, and these
states have general or direct supervision requirements for RAs.
Comment: Many commenters supported our proposed changes to the
regulations and stated that they agreed that diagnostic tests performed
by RAs be performed under at most direct supervision rather than
personal
[[Page 59505]]
supervision where permitted by state law and state scope of practice
regulations. According to these commenters, the change would allow for
greater efficiency, improved patient access, more dedicated time with
patients, increased quality of care, and increased patient
satisfaction.
Response: We appreciate the comments received in support of this
proposal. As discussed in the proposed rule, for diagnostic imaging
tests requiring a general level of physician supervision, we are not
changing the level of physician supervision to direct supervision.
Otherwise, the diagnostic imaging tests must be performed as specified
elsewhere under Sec. 410.32(b). In order to provide further clarity,
we are modifying the regulation to clarify that diagnostic tests
performed by an RRA who is certified and registered by the American
Registry of Radiologic Technologists or an RPA who is certified by the
Certification Board for Radiology Practitioner Assistants, and that
would otherwise require a personal level of supervision as specified in
Sec. 410.32(b)(3), may be furnished under a direct level of physician
supervision to the extent permitted by state law and state scope of
practice regulations.
Comment: Many commenters requested that CMS ensure that the
proposed policy be effective January 1, 2019 by providing any necessary
administrative guidance. Many commenters requested that CMS clarify in
its final regulation that all services within the RA scope of practice,
including procedures, may be performed under direct supervision.
Response: In implementing these changes to the regulation, we will
be updating guidance contained in Pub. 100-04, Medicare Claims
Processing Manual, Chapter 23 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/Pub100_23.html). Medicare supervision rules are only
directly applicable to diagnostic tests, not procedures. We note that
for procedures provided by auxiliary personnel (such as a radiologist
assistant) incident to the services of the billing physician or
practitioner, Medicare generally requires direct supervision in
accordance with the regulation at Sec. 410.26(b)(5).
Comment: One commenter suggested that CMS require verbal assurances
to patients as to the credentials of the health care professional
conducting the procedure, when the procedure is performed by an RA. The
commenter stated that requiring this verbal assurance will minimize
confusion about who the physician is when there are multiple
individuals furnishing the procedure.
Response: We believe such a requirement would be unwarranted and
overly restrictive. We do not generally require practitioners to
provide such assurances to Medicare beneficiaries, nor did we propose
such a requirement in the proposed rule.
Comment: Several commenters suggested that CMS should
operationalize the proposal starting January 1, 2019 by using a
radiologist supervision indicator to recognize the RA under direct
supervision rather than personal supervision when they provide Medicare
services under their state scope of practice. These commenters
requested the creation of a new supervision indicator that would be
applied to specific codes and would indicate that the procedure may be
performed under the direct supervision of a radiologist when performed
by an RRA who is certified by The American Registry of Radiologic
Technologists, and an RPA who is certified by the Certification Board
for Radiology Practitioner Assistants.
Response: Our approach to effectuating this policy change was based
on recommendations we received from the practitioner community. Under
this approach, we allow for direct supervision for tests performed in
part by an RA, which avoids the need to identify which CPT codes would
be appropriate for inclusion under a new indicator. We believe our
approach offers the most flexibility, ease of implementation, and
subsequently reduces burden for billing practitioners and radiologist
assistants.
After consideration of the public comments received, we are
finalizing, with refinements for further clarity, our proposed
revisions to Sec. 410.32, by adding a new paragraph (b)(4) that states
that diagnostic tests that are performed by a registered radiologist
assistant (RRA) who is certified and registered by the American
Registry of Radiologic Technologists or a radiology practitioner
assistant (RPA) who is certified by the Certification Board for
Radiology Practitioner Assistants, and that would otherwise require a
personal level of supervision as specified in paragraph (3), may be
furnished under a direct level of physician supervision to the extent
permitted by state law and state scope of practice regulations.
G. Payment Rates Under the Medicare PFS for Nonexcepted Items and
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments
of a Hospital
1. Background
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that
certain items and services furnished by certain off-campus provider-
based departments (PBDs) (collectively referenced here as nonexcepted
items and services furnished by nonexcepted off-campus PBDs) shall not
be considered covered outpatient department (OPD) services for purposes
of payment under the Hospital Outpatient Prospective Payment System
(OPPS), and payment for those nonexcepted items and services furnished
on or after January 1, 2017 shall be made under the applicable payment
system under Medicare Part B if the requirements for such payment are
otherwise met. These requirements were enacted in section 603 of the
Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2,
2015).
In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule
with comment period (81 FR 79699 through 79719), we established several
policies and provisions to define the scope of nonexcepted items and
services in nonexcepted off-campus PBDs. We also finalized the PFS as
the applicable payment system for most nonexcepted items and services
furnished by nonexcepted off-campus PBDs. At the same time, we issued
an interim final rule with comment period (81 FR 79720 through 79729)
in which we established payment policies under the PFS for nonexcepted
items and services furnished on or after January 1, 2017. In the
following paragraphs, we summarize the policies that we adopted for CY
2017 and CY 2018. We also summarize proposals for CY 2019, respond to
public comments, and finalize payment policies for CY 2019. For issues
related to the excepted status of off-campus PBDs or the excepted
status of items and services, please see the CY 2019 OPPS/ASC final
rule.
2. Payment Mechanism
In establishing the PFS as the applicable payment system for most
nonexcepted items and services in nonexcepted off-campus PBDs under
sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that
there was no technological capability, at least in the near term, to
allow off-campus PBDs to bill under the PFS for those nonexcepted items
and services. Off-campus PBDs bill under the OPPS for their services on
an institutional claim,
[[Page 59506]]
while physicians and other suppliers bill under the PFS on a
practitioner claim. The two systems that process these different types
of claims, the Fiscal Intermediary Standard System (FISS) and the
Multi-Carrier System (MCS) system, respectively, were not designed to
accept or process claims of a different type. To permit an off-campus
PBD to bill directly under a different payment system than the OPPS
would have required significant changes to these complex systems as
well as other systems involved in the processing of Medicare Part B
claims. Consequently, we proposed and finalized a policy for CY 2017
and CY 2018 in which nonexcepted off-campus PBDs continue to bill for
nonexcepted items and services on the institutional claim utilizing a
new claim line modifier ``PN'' to indicate that an item or service is a
nonexcepted item or service.
We implemented requirements under section 1833(t)(1)(B) of the Act
for CY 2017 and CY 2018 by applying an overall downward scaling factor,
called the PFS Relativity Adjuster to payments for nonexcepted items
and services furnished in nonexcepted off-campus PBDs. The PFS
Relativity Adjuster generally reflects the average (weighted by claim
line volume times rate) of the site-specific rate under the PFS
compared to the rate under the OPPS (weighted by claim line volume
times rate) for nonexcepted items and services furnished in nonexcepted
off-campus PBDs. As we have discussed extensively in prior rulemaking
(81 FR 97920 through 97929 and 82 FR 53021), we established a new set
of site-specific payment rates under the PFS that reflect the relative
resource cost of furnishing the technical component (TC) of services
furnished in nonexcepted off-campus PBDs. For the majority of HCPCS
codes, these rates are based on either (1) the difference between the
PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or
(3) in instances where payment would have been made only to the
facility or to the physician, the full nonfacility rate. The PFS
Relativity Adjuster refers to the percentage of the OPPS payment amount
paid under the PFS for a nonexcepted item or service to the nonexcepted
off-campus PBD.
To operationalize the PFS Relativity Adjuster as a mechanism to pay
for nonexcepted items and services furnished by nonexcepted off-campus
PBDs, we adopted the packaging payment rates and multiple procedure
payment reduction (MPPR) percentage that applies under the OPPS. We
also incorporated the claims processing logic that is used for payments
under the OPPS for comprehensive Ambulatory Payment Classifications (C-
APCs), conditionally and unconditionally packaged items and services,
and major procedures. As we noted in the CY 2017 PFS final rule (82 FR
53024), we believe that this maintains the integrity of the cost-
specific relativity of current payments under the OPPS compared with
those under the PFS.
In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent
of the OPPS rate for nonexcepted items and services furnished in
nonexcepted off-campus PBDs. For a detailed explanation of how we
developed the PFS Relativity Adjuster of 50 percent for CY 2017,
including assumptions and exclusions, we refer readers to the CY 2017
OPPS/ASC interim final rule with comment period (81 FR 79720 through
79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of
40 percent of the OPPS rate. For a detailed explanation of how we
developed the PFS Relativity Adjuster of 40 percent, we refer readers
to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief
overview of the general approach we took for CY 2018 and how it differs
from the proposal for CY 2019 appears in this section.
3. The PFS Relativity Adjuster
The PFS Relativity Adjuster reflects the overall relativity of the
applicable payment rate for nonexcepted items and services furnished in
nonexcepted off-campus PBDs under the PFS compared with the rate under
the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did
not have all of the claims data needed to identify the mix of items and
services that would be billed using the ``PN'' modifier. Instead, we
analyzed hospital outpatient claims data from January 1 through August
25, 2016, that contained the ``PO'' modifier, which was a new mandatory
reporting requirement for CY 2016 for claims that were billed by an
off-campus department of a hospital. We limited our analysis to those
claims billed on the 13X Type of Bill because those claims were used
for Medicare Part B billing under the OPPS. We then identified the 25
most frequently billed major codes that were billed by claim line; that
is, items and services that were separately payable or conditionally
packaged. Specifically, we restricted our analysis to codes with OPPS
status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'',
``T'', or ``V''. The most frequently billed service with the ``PO''
modifier in CY 2016 was described by HCPCS code G0463 (Hospital
outpatient clinic visit for the assessment and management of a
patient), which, in CY 2016, was paid under APC 5012 at a rate of
$102.12; the total number of claim lines for this service was
approximately 6.7 million as of August 2016. Under the PFS, there are
10 CPT codes describing different levels of office visits for new and
established payments. We compared the payment rate under OPPS for HCPCS
code G0463 ($102.12) to the average of the difference between the
nonfacility and facility rates for CPT code 99213 (Level III office
visit for an established patient) and CPT code 99214 (Level IV office
visit for an established patient) in CY 2016 and found that the
relative payment difference was approximately 22 percent. We did not
include HCPCS code G0463 in our calculation of the PFS Relativity
Adjuster for CY 2017 because we were concerned that there was no
single, directly comparable code under the PFS. As we stated in the CY
2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of
underestimating the overall relativity between the PFS and OPPS rates.
From the remaining top 24 most frequently billed codes, we excluded
HCPCS code 36591 (Collection of blood specimen from a completely
implantable venous access device) because, under PFS policies, the
service was only separately payable under the PFS when no other code
was on the claim. We also removed HCPCS code G0009 (Administration of
Pneumococcal Vaccine) because there was no payment for this code under
the PFS. For the remaining top 22 codes furnished with the ``PO''
modifier in CY 2016, the average (weighted by claim line volume times
rate) of the nonfacility payment rate estimate for the PFS compared to
the estimate for the OPPS was 45 percent. We indicated that, because of
our inability to estimate the effect of the packaging difference
between the OPPS and the PFS, we would assume a 5 percentage point
adjustment upward from the calculated amount of 45 percent; therefore,
we established the PFS Relativity Adjuster of 50 percent for CY 2017.
In establishing the PFS Relativity Adjuster for CY 2018, we still
did not have claims data for items and services furnished reported with
a ``PN'' modifier. However, we updated the list of the 25 most
frequently billed HCPCS codes using an entire year (CY 2016) of claims
data for services submitted with a ``PO'' modifier and we updated the
corresponding utilization weights for the codes used in the analysis.
The order and composition of the top 25 separately payable HCPCS codes,
based on the full year of claims from CY 2016
[[Page 59507]]
submitted with the ``PO'' modifier, changed minimally from the codes we
used in our original analysis for the CY 2017 OPPS/ASC interim final
rule with comment period. For a detailed list of the HCPCS codes we
used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018
PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule
(82 FR 53030 through 53031). As noted earlier, in establishing the PFS
Relativity Adjuster of 50 percent for CY 2017, we did not include in
the weighted average code comparison, the relative rate for the most
frequently billed service furnished in off-campus PBDs, HCPCS code
G0463 (Hospital outpatient clinic visit for assessment and management
of a patient), in part to ensure that we were not underestimating the
overall relativity between the PFS and the OPPS. In contrast, in the CY
2018 PFS final rule, we stated that our objective for CY 2018 was to
ensure that we did not overestimate the appropriate overall payment
relativity, and that the payment made to nonexcepted off-campus PBDs
better aligned with the services that are most frequently furnished in
the setting. Therefore, in addition to using updated claims data, we
revised the PFS Relativity Adjuster to incorporate the relative payment
rate for HCPCS code G0463 into our analysis. We followed all other
exclusions and assumptions that were made in calculating the CY 2017
PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative
difference in payment rates. Similar to our stated rationale in the CY
2017 PFS final rule, we increased the PFS Relativity Adjuster to 40
percent, acknowledging the difficulty of estimating the effect of the
packaging differences between the OPPS and the PFS.
4. Payment Policies for CY 2019
In prior rulemaking, we stated our expectation that our general
approach of adjusting OPPS payments using a single scaling factor, the
PFS Relativity Adjuster, would continue to be an appropriate payment
mechanism to implement provisions of section 603 of the Bipartisan
Budget Act of 2015, and would remain in place until we are able to
establish code-specific reductions that represent the TC of services
furnished under the PFS or until we are able to implement system
changes needed to enable nonexcepted off-campus PBDs to bill for
nonexcepted items and services under the PFS directly (82 FR 53029). As
we continue to explore alternative options related to requirements
under section 1833(t)(21)(C) of the Act, we believed that this overall
approach is still appropriate, and we are finalizing our proposal to
continue to allow nonexcepted off-campus PBDs to bill for nonexcepted
items and services on an institutional claim using a ``PN'' modifier
until we identify a workable alternative mechanism to improve payment
accuracy.
We made several adjustments to our methodology for calculating the
PFS Relativity Adjuster for CY 2019. Most importantly, we had access to
a full year of claims data from CY 2017 for services submitted with the
``PN'' modifier. Incorporating these data allows us to improve the
accuracy of the PFS Relativity Adjuster by accounting for the specific
mix of nonexcepted items and services furnished in nonexcepted off-
campus PBDs. In analyzing the CY 2017 claims data, we identified just
under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs
reported in CY 2017 with status indicators ``J1'', ``J2'', ``Q1'',
``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The data reinforce our previous
observation that the single most frequently reported service furnished
in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half
of all claim lines for separately payable or conditionally packaged
services furnished by nonexcepted off-campus PBDs included HCPCS code
G0463 in CY 2017, representing over 30 percent of total Medicare
payments for separately payable or conditionally packaged services. The
top 30 HCPCS/SI code combinations accounted for over 80 percent of all
claim lines and approximately 70 percent of Medicare payments for
services that are separately billable or conditionally packaged. In
contrast with prior analyses, we also looked at claims units, which
reflect HCPCS/SI code combinations that are billed more than once on a
claim line. Certain HCPCS codes are much more frequently billed in
multiple units than others. The largest differences between the number
of claim lines and the number of claims units are for injections and
immunizations, which are not typically separately payable or
conditionally packaged under the OPPS. For instance, HCPCS code Q9967
(Low osmolar contrast material, 300-399 mg/ml iodine concentration, per
ml) was reported in 12,268 claim lines, but 1,168,393 times (claims
units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator
of ``N'', meaning that there is no separate payment under OPPS (items
and services are packaged into APC rates). To calculate the PFS
Relativity Adjuster using the full range of claims data submitted with
a ``PN'' modifier in CY 2017, we first established site-specific rates
under the PFS that reflect the TC of items and services furnished by
nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect
our best current estimate of the amount that would have been paid for
the service in the office setting under the PFS for practice expenses
(PEs) not associated with the professional component (PC) of the
service. As discussed in prior rulemaking (81 FR 79720 through 79729),
we believe the most appropriate code-level comparison would reflect the
TC of each HCPCS code under the PFS. However, we do not currently
calculate a separate TC rate for all HCPCS codes under the PFS--only
for those for which the PC and TC of the service are distinct and can
be separately billed by two different practitioners or other suppliers
under the PFS. For most of the remainder of services that do not have a
separately payable TC under the PFS, we estimated the site-specific
rate as (1) the difference between the PFS nonfacility rate and the PFS
facility rate, or (2) in instances where payment would have been made
only to the facility or only to the physician, the full nonfacility
rate. As with the PFS rates that we developed when calculating the PFS
Relativity Adjuster for CY 2017 and CY 2018, there were large code-
level differences between the applicable PFS rate and the OPPS rate.
In calculating the proposed PFS Relativity Adjuster for CY 2019, we
employed the same fundamental methodology that we used to calculate the
PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting
our analysis to the items and services billed in CY 2017 with a ``PN''
modifier that are separately payable or conditionally packaged under
the OPPS (status indicator = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'',
``S'', ``T'', or ``V'') and compared the rates for these codes under
the OPPS with the site-specific rates under the PFS. Next, we imputed
PFS rates for a limited number of items and services that are
separately payable or conditionally packaged under the OPPS but are
contractor priced under the PFS. We also imputed PFS rates for some
HCPCS codes that are not separately payable under the OPPS (SI =
``N''), but are separately payable under the PFS. This includes items
and services with an indicator status of ``X'' under the PFS, which are
statutorily excluded from payment under the PFS, but may be paid under
a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS).
We summed the HCPCS-level
[[Page 59508]]
rates under the PFS across all nonexcepted items and services, weighted
by the number of HCPCS code claims units for each service. Next, we
calculated the sum of the HCPCS-level OPPS rate for items and services
that are separately payable or conditionally packaged, also weighted by
the number of HCPCS code claims units. We compared the weighted sum of
the site-specific PFS rate with the weighted sum of the OPPS rate for
items and services reported in CY 2017 and we found that our updated
analysis supports maintaining a PFS Relativity Adjuster of 40 percent.
In view of this analysis, we proposed to continue applying a PFS
Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to
maintain this PFS Relativity Adjuster for future years until updated
data or other considerations indicate that an alternative adjuster or a
change to our approach is warranted, which we will then propose through
notice and comment rulemaking. We discuss some of our ongoing data
analyses and future plans regarding implementation of section 603 of
the Bipartisan Budget Act of 2015 in this section.
Comment: Several commenters were disappointed that CMS did not
provide the same level of detail regarding the data and methodology
used in calculating the PFS Relativity Adjuster for CY 2019 as we had
in prior rulemaking (CY 2017 and CY 2018). In particular, these
commenters noted that we had previously included specific HCPCS codes
that comprised the top 25 reported, the number of claims lines for each
HCPCS code, and the associated PFS payment rates we used to estimate
the appropriate adjuster. Some commenters maintained that the lack of
specific HCPCS codes and associated PFS payment rates prevented them
from replicating our analysis and commenting on the merits of
maintaining the 40 percent PFS Relativity Adjuster.
Response: We understand and appreciate commenters' interest in
replicating our analysis using the full set of claims data and PFS
payment rates we used to conduct our analysis. However, we do not agree
that commenters were not able to conduct their own analysis for
purposes of evaluating our proposal. The principal data sources in the
analysis are the OPPS CY 2017 rates, the CY 2017 PFS rates, and
institutional claims data for items and services furnished in CY 2017
that included the ``PN'' modifier, which are publicly available
resources. We did not receive specific inquiries indicating that
commenters tried to reproduce our results using these data sources (or
other data sources), nor did we receive any specific alternatives for
consideration. As we noted in the proposed rule, the methodological
aspects of our proposed PFS Relativity Adjuster calculation for CY 2019
differ from the calculation for CY 2017 and CY 2018 by the following
two adjustments: (1) Development of site specific technical-equivalent
rates under the PFS for all HCPCS codes reported on a claim with the
``PN'' modifier in CY 2017; and (2) the addition of OPPS SI ``N''
claims data to the PFS component of the PFS Relativity Adjuster
equation to reflect items and services that are packaged under OPPS but
paid separately under the PFS. We imputed certain PFS rates, such as
for codes that are contractor priced under the PFS, because those would
be paid at the contractor price if the claim had been submitted in a
freestanding office. We remind commenters that adding PFS rates to the
analysis, where such rates would not have otherwise been included, has
the effect of increasing the PFS Relativity Adjuster since the
aggregate PFS payment amount increases relative to the aggregate OPPS
payment amount. Nonetheless, we appreciate the commenters' interest in
validating the results of our analysis. For the convenience of
commenters wishing to conduct analysis of differences in payment rates
between off-campus PBDs and freestanding offices for similar services,
we are providing a public use file (PUF), available on the CMS website
under the ``downloads'' section for this final rule containing the CY
2017 PFS technical-equivalent payment rates for all HCPCS codes
reported on an institutional claim with the ``PN'' modifier, as well as
the OPPS payment rate and the number of claims units by OPPS SI (see
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched).
Comment: Commenters posed specific questions about our PFS
Relativity Adjuster calculations and requested that CMS provide
additional detail about the calendar year we used for OPPS and PFS
rates, the specific HCPCS codes for which we imputed PFS rates, our
rationale for weighting the data using claims units instead of claims
lines, and if our analysis accounted for the more extensive packaging
that occurs under the OPPS compared with the PFS.
Response: Although we addressed much, if not all, of the
information requested by these commenters in the discussion of our
methodology in the proposed rule, we provide the following summary,
along with additional detail on specific aspects of our analysis to
respond explicitly to commenters' questions. We began our analysis to
identify the proposed CY 2019 PFS Relativity Adjuster by examining a
full year of claims data for services furnished in CY 2017 that were
reported on an institutional claim form and appended with the ``PN''
modifier. Because claims processed through the institutional setting
are adjudicated based on the OPPS SI, our unit of analysis was the
number of claims units at the HCPCS/SI code level. We used claim units
instead of claim lines because this metric accounts for instances when
a HCPCS code is reported multiple times on the same claim line. We made
this methodological change in formulating our proposal for CY 2019 in
large part to address commenters' concerns from prior years that our
calculations may underrepresent PFS payment for HCPCS codes that would
have been paid multiple times under the PFS if they were reported
separately. For the majority of HCPCS/SI code combinations that were
reported with the ``PN'' modifier, there is little difference between
the number of claim lines and claim units. However, because more units
are separately paid under the PFS than under the OPPS, using claims
units rather than claims lines yielded a slightly higher PFS Relativity
Adjuster.
For CY 2019, our proposed PFS Relativity Adjuster was based on all
HCPCS codes that were submitted on an institutional claim form in CY
2017, appended with the ``PN'' modifier in order to improve the
accuracy of the overall payment comparison using the best data
available regarding the actual mix of services furnished in nonexcepted
off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a
subset of claims from CY 2016 because of known limitations regarding
the data available at the time. In particular, the data from CY 2016
were based on claims that were appended with the ``PO'' modifier, which
was a new reporting requirement for CY 2016. Although the ``PO''
modifier allowed us to distinguish items and services furnished in off-
campus PBDs in CY 2016, it did not allow us to distinguish between
excepted and nonexcepted off-campus PBDs. The ``PN'' modifier, which
was a new reporting requirement for CY 2017, allows us to make the
distinction between excepted and nonexcepted off-campus PBDs.
In updating our analysis for calculating the proposed PFS
Relativity Adjuster for CY 2019 to include all HCPCS codes that were
reported on an institutional claim with the ``PN'' modifier, we also
extended to all HCPCS
[[Page 59509]]
codes our earlier logic with regard to calculating the site specific
rates that represent the technical-equivalent of the resource costs of
furnishing a service under the PFS. This amount, as we discussed in the
proposed rule, generally reflected: (1) The difference between the PFS
nonfacility payment rate and the PFS facility rate; (2) the TC; or (3)
in instances where payment would have been made only to the facility or
only to the physician, the full nonfacility rate. Applying the same
logic to the fuller range of HCPCS codes, we developed site specific
rates for all HCPCS codes that are nationally priced under the PFS and
we referred to them as the technical-equivalent rates.
To continue with our analysis, we combined the CY 2017 OPPS rates
at the HCPCS code level with the CY 2017 claims data representing
nonexcepted items and services furnished in nonexcepted off-campus
PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS
code, calculated using the approach described above. For both the OPPS
and the PFS portions of the PFS Relativity Adjuster calculations, we
weighted our analysis of HCPCS/SI code combinations by the number of
claims units. For the OPPS component of the calculation, we restricted
our analysis to HCPCS/SI code combinations that had OPPS SI indicators
``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'', which
are separately payable or conditionally packaged codes under the OPPS.
We multiplied the number of claims units for each HCPCS/SI code
combination by the OPPS rate for each HCPCS/SI code combination and
summed across the weighted rates. To calculate the PFS component of the
PFS Relativity Adjuster, we used the same OPPS/SI code combinations,
but we also included claims for HCPCS codes with OPPS SI ``N'', which
indicates that, under the OPPS, payment for these services is packaged
into payment for other services. We multiplied the number of claims
units for each HCPCS/SI code combination by the technical-equivalent
PFS rate for each HCPCS code and summed across the HCPCS/SI code
combinations. We believe that adding weighted rates for HCPCS codes
with OPPS SI ``N'' to the PFS allows us to better adjust, although
imprecisely, for the packaging under the OPPS of nonexcepted items and
services for which separate payment would typically be made under the
PFS in the office setting. Although we did not conduct code-level
analysis to estimate packaging under the OPPS, we believe that the
combination of using the full range of claims data for nonexcepted
items and services furnished in nonexcepted off-campus PBDs, using
claim units rather than claim lines to weight rates on both the OPPS
and PFS, and adding PFS rates for HCPCS codes with OPPS status
indicator ``N'' is an improved approach to the PFS Relativity Adjuster
that better accounts for OPPS packaging policies.
To increase the precision of our analysis, we imputed payment rates
under the PFS for certain HCPCS codes for which payment is based on
rates other than national PFS pricing. For services that are
contractor-priced under the PFS, as indicated by a PFS status indicator
of ``C'', we applied the national median allowed charge for these
services in CY 2017. For a limited number of other services, where
appropriate, we incorporated rates from the applicable fee schedule
under which the service may have been paid if furnished in a
freestanding office. For instance, HCPCS codes with a PFS status
indicator of either ``X'' (service is statutorily excluded for payment
under PFS) or ``E'' (service is excluded from payment under PFS by
regulation), may be paid under the CLFS or the National Limitation
Amount (NLA). The imputed values that we used, both from contractor
priced codes and other fee schedules, are included in the data file
that will be posted with this final rule, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Although there remains a certain level of imprecision inherent in
our analysis, we believe the margin of error is relatively small and
would likely affect the PFS and OPPS amounts similarly. For instance,
we did not take into account the several MPPRs that would reduce
payment on the PFS side when multiple codes are billed together. In
many cases, these codes are packaged under the OPPS, so not including
the PFS MPPRs in our analysis has the effect of increasing the PFS
component of the calculation by a marginal amount. Likewise, we
recognize that because of existing packaging rules under the OPPS,
there is likely to be underreporting of codes on institutional claims
for which the hospital does not receive separate payment, but for which
the practitioner might receive separate payment if furnished in a
freestanding office and reported on a professional claim form. This
would effectively reduce the PFS Relativity Adjuster, but only to the
extent hospitals are not appropriately reporting furnished items and
services.
Comment: Many commenters expressed that the appropriate point of
comparison for PFS technical-equivalent rates is the full nonfacility
rate rather than the difference between the nonfacility rate and the
facility rate. The commenters stated that since hospitals, like
freestanding offices, incur both direct and indirect costs when
services are furnished in nonexcepted off-campus PBDs, the difference
between the nonfacility rate and the facility rate does not
appropriately account for indirect costs incurred by the facility.
Response: We believe the commenters misunderstood the methodology
for allocating direct and indirect costs as part of the PFS ratesetting
process. Under the PFS algorithm for allocating indirect costs,
nonfacility PFS rates include indirect PE that is directly related to
the resources associated with the professional portion of the service
alone. In other words, this is the indirect PE that is also paid by
Medicare to professionals like physicians when they report services in
the hospital setting. In addition to these indirect PE RVUs,
nonfacility PFS rates include indirect PE RVUs allocated based on the
direct PE inputs. We believe these indirect costs, those associated
with provision of the technical aspects of the service alone, are
analogous to those incurred by facilities when professionals furnish
services there. To be clear, even when the total nonfacility rates are
reduced by the facility rates, there are remaining PE RVUs that result
from both direct inputs and indirect allocations under the established
PFS methodology. We agree with the commenters that nonexcepted off-
campus PBDs incur indirect costs, but we believe our calculation for
the technical-equivalent PFS rates includes the relative resource costs
of indirect expenses involved in furnishing the services. We also note
that CMS makes corresponding payments under the PFS at the facility
rate for nonexcepted items and services furnished in nonexcepted off-
campus PBD settings, meaning that CMS is already paying for some of the
indirect expenses associated with the PCs of the service. If CMS were
to use the full nonfacility PE RVUs as the basis for comparing PFS
rates to OPPS rates, we would effectively be paying twice for a portion
of indirect costs, once under the PFS for the PC of services and again
through the PFS Relativity Adjusted payment under the OPPS to off-
campus PBDs for the facility part of the same service.
We recognize that the process of allocating indirect costs under
the PFS is built on assumptions about
[[Page 59510]]
organizational practices and healthcare payment structures that may not
fully reflect the current health care delivery environment, especially
where physicians and other professionals are paid under salaried
arrangements by institutions such as hospitals. Under the current PFS
payment methodology, we assume that indirect costs associated with
professional services furnished in institutions like hospital PBDs are
incurred by the individual practitioners and not by the institutions.
We may consider this issue for future rulemaking.
Comment: A commenter requested that CMS clarify how, in calculating
the PFS Relativity Adjuster, CMS treated codes that are valued under
the PFS only in a facility setting. Because these HCPCS codes do not
have PE inputs reflecting the specific costs of furnishing a service in
a freestanding office, the commenter stated concern that these codes
may have been incorrectly incorporated in the analysis at a PFS payment
rate of zero.
Response: We appreciate the commenter's concern and the opportunity
to clarify the way we treated services not priced in the nonfacility
setting in calculating the PFS Relativity Adjuster. Because there are
no PFS payment rates for these services in the nonfacility setting, we
incorporated the OPPS rate as the technical equivalent rate under the
PFS.
Comment: Several commenters were opposed to our proposal to
maintain the PFS Relativity Adjuster at 40 percent, citing both the
lack of transparency in our methodology and prior analyses provided by
the American Hospital Association (AHA) in earlier notice and comment
rulemaking, suggesting that a 65 percent PFS Relativity Adjuster would
appropriately incorporate into the Adjuster the additional packaging
that occurs under the OPPS. Two commenters urged CMS to implement a 75
percent PFS Relativity Adjuster for CY 2019, although no specific
rationale was given.
Response: We accounted for packaging under the OPPS by including
PFS payment rates for HCPCS codes that were reported with OPPS SI
``N''. Our analysis does not support a PFS Relativity Adjuster of 65 or
75 percent, but rather indicates that a PFS Relativity Adjuster of 40
percent appropriately accounts for packaging of services under the
OPPS. For additional discussion of the challenges related to
incorporating the effect of packaging into the PFS Relativity Adjuster,
we refer readers to the CY 2018 PFS final rule (82 FR 53024 through
53022).
Comment: A commenter stated that CMS has not provided sufficient
justification for continuation of a reduction in payment of 60 percent
for nonexcepted items and services furnished in nonexcepted off campus
PBDs. Commenters noted that the first 2017 claims from the initial
period of implementation of this policy are only now being incorporated
into CMS claims files. The commenter indicated that there is an
insufficient volume of claims to determine the impact this policy is
having on beneficiary access to services in the PBD setting,
particularly at the 40 percent Relativity Adjuster. The commenter
stated that CMS should, at minimum, restore the 50 percent PFS
Relativity Adjuster that was in place for CY 2017.
Response: We appreciate the commenter's suggestions, but we do not
agree that there is insufficient data to support the PFS Relativity
Adjuster of 40 percent. We have no reason to believe that the CY 2017
claims data are not as robust as any other claims based analysis and,
to the extent that we recognize, acknowledge, and try to account for
difference in payment policies between the PFS and OPPS, we believe our
analysis demonstrates that a PFS Relativity Adjuster of 40 percent is
appropriate.
Comment: Several commenters supported the 40 percent PFS Relativity
Adjuster for CY 2019 and future years because this will provide
stability for clinicians practicing in these settings and not disrupt
patient access to care. One commenter cited the importance of making
gradual changes to site neutrality policies to ensure alignment with
other rapid changes in Medicare and the private sector regarding
provider payment, including the movement to value-based purchasing and
alternative payment systems.
Response: We agree with the commenter that there is value in the
stability of maintaining the PFS Relativity Adjuster at 40 percent,
particularly to the extent that this enables continuity of care for
beneficiaries. We appreciate the support from commenters.
Comment: Some commenters, rather than opposing any particular PFS
Relativity Adjuster, expressed disappointment that CMS did not propose
to make broader changes to implement site-neutrality under section 603
of the Bipartisan Budget Act of 2015. Commenters were displeased that
CMS is continuing to implement the requirements of the legislation
using a single scaling factor applied to payment rates under the OPPS.
Instead, they stated CMS should revise the applicable payment rates to
appropriately reimburse for services provided by off-campus PBDs.
Commenters did not provide specific suggestions for implementing
alternative policies, but several commenters noted that a single
overall scaling factor was intended by CMS to be an interim, not a long
term policy solution. A few commenters suggested that the PFS
Relativity Adjuster as a mechanism for implementing section 603 of the
Bipartisan Budget Act of 2015 is not consistent with the requirement
under that section to pay for nonexcepted items and services under the
applicable payment system because this approach is still fundamentally
based on OPPS payment rates. Other commenters stated that nonexcepted
off-campus PBDs differ from one another in the mix of services
furnished and the beneficiary population and that CMS payment policies
should reflect those variances.
Despite concerns about the appropriateness of the PFS Relativity
Adjuster for implementing requirements under section 603 of the
Bipartisan Budget Act of 2015, several of the same commenters pointed
out that there are significant advantages of continuing to allow
hospitals to bill for items and services furnished in nonexcepted PBDs
using the institutional claim form. In particular, they stated, this
allows PBDs to properly use cost reporting procedures and to accurately
reconcile the cost report to hospital ledgers for all services and
departments and to correctly allow revenue for nonexcepted PBDs to flow
through the Provider Statistical and Reimbursement (PS&R) report.
Response: We previously expressed interest in exploring how
hospitals might report and receive payment for nonexcepted items and
services furnished in nonexcepted off-campus PBDs using the standard
PFS payment rates based on HCPCS-specific RVUs. However, CMS does not
currently develop as part of the PFS ratesetting process separate
payment rates for the technical aspects of the full range of
nonexcepted items and services furnished in nonexcepted off-campus PBDs
specifically for services for which there are not separately valued PCs
and TCs. As such, we do not have a consistent way for nonexcepted off-
campus PBDs and the professionals who furnish services in those
settings to bill for the respective portions of the services for which
they incurred costs. Additionally, while the statute was amended to
change the nature and payment of nonexcepted items and services
furnished in nonexcepted off-campus PBDs, the amendments did not
[[Page 59511]]
alter the status of non-excepted off-campus PBDs as parts of hospitals.
Nonexcepted off-campus PBDs are still required to follow all reporting
and regulatory policies consistent with hospital settings.
We continue to explore options that would allow hospitals to report
nonexcepted items and services on an institutional claim form but
receive payments that more directly reflect the technical aspect of
services under the PFS. In general, we believe there may be additional
utility, especially in the context of improving price transparency for
Medicare beneficiaries, in establishing and displaying a set of payment
rates, recalculated annually as part of the annual PFS rulemaking
cycle, that reflect the relative resource costs of the technical
aspects of furnishing PFS services.
Along with this final rule, we are including the technical-
equivalent rates that we developed specifically for calculating the PFS
Relativity Adjuster for CY 2019, which is the current mechanism for
implementing the PFS as the applicable payment system for nonexcepted
items and services furnished in nonexcepted off-campus PBDs. This
information is being made available under the downloads section for
this final rule on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Several commenters supported our ongoing efforts to
implement site neutral payments in the context of section 603 of the
Bipartisan Budget Act of 2015. Several commenters indicated their
support for additional policies that would equalize payment across
freestanding offices and hospital PBDs, both on-campus and off-campus.
Response: We recognize that this is a topic of great interest to
many commenters and we welcome the range of perspectives and ideas
posed by commenters.
Comment: Some commenters disagreed with our view that the
amendments under section 603 of the Bipartisan Budget Act of 2015 were
intended to produce site neutral payments between freestanding offices
and off-campus PBDs with the goal of removing incentives for hospitals
to purchase physician offices. These commenters noted that hospital
PBDs face higher costs than freestanding offices, such as those
associated with regulatory requirements, and reducing payment to
nonexcepted off-campus PBDs threatens the viability of hospitals that
serve a vital role in providing services to rural and underserved
communities in these off-campus settings. We received several comment
letters from Medicare beneficiaries expressing concern about reduced
payments to their community's major medical hospital offsite locations.
The commenters stated that without the hospital's offsite locations
community members would be forced to drive unreasonable distances to
seek basic and immediate care.
Response: We understand the commenters' concerns, especially with
regard to maintaining access to appropriate care. CMS continues to
evaluate data regarding beneficiary access to care to identify possible
issues. We also agree that hospitals face additional regulatory and
operational costs not generally incurred by physician offices, and that
OPDs of a hospital function as an important and integral part of the
Medicare care delivery infrastructure. However, many off-campus PBDs
are similar to physician's offices and do not necessarily have the same
operational costs as the main hospital. We believe that the amendments
made to the statute by section 603 of the Bipartisan Budget Act of 2015
were intended to reduce Medicare payment incentives for hospitals to
purchase physician offices, convert them to off-campus PBDs, and bill
under the OPPS for items and services furnished there.
Comment: Several commenters opposed our inclusion of the proposal
related to payment for nonexcepted off-campus PBDs under the CY 2019
PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that
proposals related to the payment rate for nonexcepted items and
services furnished in nonexcepted off-campus PBDs are inseparable from
proposals and comment solicitations in the OPPS/ASC rule related to
service line expansions and other payment policies related to
implementation of the amendments under section 603 of the Bipartisan
Budget Act of 2015. Some commenters suggested that, for purposes of
administrative simplification, the discussion of any changes to site-
of-service payments regarding PBDs of a hospital should be fully
maintained within a single rule and recommended this be included in the
OPPS rule. Some commenters expressed concern that the PFS and OPPS
proposed rules were not released at the same time and that this
presents challenges for them in reconciling and preparing their
comments on each rule.
Response: We appreciate commenters' concerns about responding to
two separate rules for policies associated with payment for nonexcepted
items and services furnished in nonexcepted off-campus PBDs. However,
we note that in finalizing the PFS as the applicable payment system for
most nonexcepted items and services, proposals related to the
implementation of payment rates under the PFS fall reasonably under the
purview of PFS rulemaking, while proposals related to the applicability
of those rates are more appropriately addressed in OPPS/ASC rulemaking.
We will consider these concerns for future rulemaking.
We believe that our proposal to maintain the PFS Relativity
Adjuster at 40 percent for CY 2019 and for future years reflects an
analysis that accounts for many of the concerns expressed by commenters
regarding the PFS Relativity Adjuster in prior rules. Therefore, we are
finalizing the proposal to maintain the PFS Relativity Adjuster at 40
percent for CY 2019 and beyond until there is an appropriate reason and
process for implementing an alternative to our current policy, at which
time we will make a proposal through notice and comment rulemaking.
5. Policies Related to Supervision, Beneficiary Cost-Sharing, and
Geographic Adjustments
In the CY 2018 PFS final rule (81FR 53019 through 53031), we
finalized policies related to supervision rules, beneficiary cost
sharing, and geographic adjustments. We finalized that supervision
rules in nonexcepted off-campus PBDs that furnish nonexcepted items and
services are the same as those that apply for hospitals, in general. We
also finalized that all beneficiary cost sharing rules that apply under
the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the
Act continue to apply when payment is made under the PFS for
nonexcepted items and services furnished by nonexcepted off-campus
PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we
finalized the policy to apply the same geographic adjustments used
under the OPPS to nonexcepted items and services furnished in
nonexcepted off-campus PBDs. We are maintaining these policies for CY
2019, as finalized in the CY 2018 PFS final rule.
6. Partial Hospitalization
a. Partial Hospitalization Services
Partial hospitalization programs (PHPs) are intensive outpatient
psychiatric day treatment programs furnished to patients as an
alternative to inpatient psychiatric hospitalization, or as a stepdown
to shorten an inpatient stay and transition a patient to a less
intensive level of care. Section
[[Page 59512]]
1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished
by a hospital, to its outpatients, or by a community mental health
center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in
the discussion of the proposed implementation of section 603 of
Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish
PHP services and are ineligible to be provider-based to a hospital, a
nonexcepted off-campus PBD would be eligible for PHP payment if the
entity enrolls and bills as a CMHC for payment under the OPPS. We
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and
conditions of participation.
In response to that rule, commenters expressed concern that without
a clear payment mechanism for PHP services furnished by nonexcepted
off-campus PBDs, access to partial hospitalization services would be
limited, and pointed out the critical role PHPs play in the continuum
of mental health care. Many commenters noted that the Congress did not
intend for partial hospitalization services to no longer be paid for by
Medicare when such services are furnished by nonexcepted off-campus
PBDs. Several commenters disagreed with the notion of enrolling as a
CMHC in order to receive payment for PHP services. The commenters
stated that hospital-based PHPs and CMHCs are inherently different in
structure, operation, and payment, and noted that the conditions of
participation for hospital departments and CMHCs are different. Several
commenters requested that CMS find a mechanism to pay hospital-based
PHPs in nonexcepted off-campus PBDs.
We agreed with the commenters' concerns and adopted payment for
partial hospitalization items and services furnished by nonexcepted
off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with
comment period and interim final rule with comment period (81 FR 79715,
79717, and 79727). When billed in accordance with the CY 2017 PFS final
rule, these partial hospitalization services are paid at the CMHC per
diem rate for APC 5853, for providing three or more partial
hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), and the CY
2017 OPPS/ASC final rule with comment period/interim final rule with
comment period (81 FR 79717 and 79727), we noted that when a
beneficiary receives outpatient services in an off-campus department of
a hospital, the total Medicare payment for those services is generally
higher than when those same services are provided in a physician's
office. Similarly, when partial hospitalization services are provided
in a hospital-based PHP, Medicare pays more than when those same
services are provided by a CMHC. Our rationale for adopting the CMHC
per diem rate for APC 5853 as the PFS payment amount for nonexcepted
off-campus PBDs providing PHP services is because CMHCs are
freestanding entities that are not part of a hospital, but they provide
the same PHP services as hospital-based PHPs (81 FR 79727). This is
similar to the differences between freestanding entities paid under the
PFS that furnish other services also provided by hospital-based
entities. Similar to other entities currently paid for their TC
services under the PFS, we believe CMHCs would typically have lower
cost structures than hospital-based PHPs, largely due to lower overhead
costs and other indirect costs such as administration, personnel, and
security. We believe that paying for nonexcepted hospital-based partial
hospitalization services at the lower CMHC per diem rate aligns with
section 603 of Bipartisan Budget Act of 2015, while also preserving
access to PHP services. In addition, nonexcepted off-campus PBDs will
not be required to enroll as CMHCs in order to bill and be paid for
providing partial hospitalization services. However, a nonexcepted off-
campus PBD that wishes to provide PHP services may still enroll as a
CMHC if it chooses to do so and meets the relevant requirements.
Finally, we recognize that because hospital-based PHPs are providing
partial hospitalization services in the hospital outpatient setting,
they can offer benefits that CMHCs do not have, such as an easier
patient transition to and from inpatient care, and easier sharing of
health information between the PHP and the inpatient staff.
In the CY 2018 PFS final rule, we did not require these PHPs to
enroll as CMHCs but instead we continued to pay nonexcepted off-campus
PBDs providing PHP items and services under the PFS. Further, in that
CY 2018 PFS final rule (82 FR 53025 to 53026), we continued to adopt
the CMHC per diem rate for APC 5853 as the PFS payment amount for
nonexcepted off-campus PBDs providing three or more PHP services per
day in CY 2018.
For CY 2019, we proposed to continue to identify the PFS as the
applicable payment system for PHP services furnished by nonexcepted
off-campus PBDs, and proposed to continue to set the PFS payment rate
for these PHP services as the per diem rate that will be paid to a CMHC
in CY 2019. We further proposed to maintain these policies for future
years until updated data or other considerations indicate that a change
to our approach is warranted, which we will then propose through notice
and comment rulemaking.
We received no comments on our PHP proposals for CY 2019 and future
years, and are finalizing our policies as proposed.
7. Future Years
We continue to believe the amendments made by section 603 of the
Bipartisan Budget Act of 2015 were intended to reduce the Medicare
payment incentive for hospitals to purchase physician offices, convert
them to off-campus PBDs, and bill under the OPPS for items and services
they furnish there. Therefore, we continue to believe the payment
policy under this provision should ultimately equalize payment rates
between nonexcepted off-campus PBDs and physician offices to the
greatest extent possible, while allowing nonexcepted off-campus PBDs to
bill in a straight-forward way for services they furnish.
In developing our proposal for CY 2019 as described previously, we
incorporated all HCPCS codes that appeared in CY 2017 claims data from
nonexcepted off-campus PBDs. We also expanded the number of site
specific, technical-equivalent rates for nonexcepted items and services
furnished in nonexcepted off-campus PBDs, in order to ensure that
Medicare payment to hospitals billing for nonexcepted items and
services furnished by nonexcepted off-campus PBDs reflects the relative
resources involved in furnishing the items and services. We recognize
that for certain specialties, service lines, and nonexcepted off-campus
PBDs, total Medicare payments for the same services might be either
higher or lower when furnished by a nonexcepted off-campus PBD rather
than in a physician office.
We intend to continue to examine the claims data in order to assess
whether a different PFS Relativity Adjuster is warranted and also to
consider whether additional adjustments to the methodology are
appropriate. In particular, we are monitoring claims for shifts in the
mix of services furnished in nonexcepted off-campus PBDs that may
affect the relativity between the PFS and OPPS. An increase over time
in the share of nonexcepted items and services with lower technical-
equivalent rates under the PFS compared with APC rates
[[Page 59513]]
under the OPPS might result in a lower PFS Relativity Adjuster, for
example. We will also carefully assess annual payment policy updates to
the PFS and OPPS, respectively, to identify changes in overall
relativity resulting from any new or modified policies, such as
expanded packaging under the OPPS or an increase in the number of HCPCS
codes with global periods under the PFS. As part of these ongoing
efforts, we are also analyzing PFS claims data to identify patterns of
services furnished together on the same day. We anticipate that this
will ultimately allow us to make refinements to the PFS Relativity
Adjuster to better account for the more extensive packaging of services
under the OPPS and the potential underreporting of services that are
not separately payable under the OPPS but are paid separately under the
PFS.
Another dimension of our ongoing efforts to improve implementation
of section 603 of the Bipartisan Budget Act of 2015 is the development
and refinement of a new set of payment rates under the PFS that reflect
the relative resource costs of furnishing the TC of items and services
furnished in nonexcepted off-campus PBDs. Although we believe that our
site-specific HCPCS code-level rates reflect the best available
estimate of the amount that would have been paid for the service in the
office setting under the PFS for practice expenses not associated with
the PC of the service, for the majority of HCPCS codes there is no
established methodology for separately valuing the resource costs
incurred by a provider while furnishing a service from those incurred
exclusively by the facility in which the service is furnished. We
continue to explore alternatives to our current estimates that would
better reflect the TC of services furnished in nonexcepted off-campus
PBDs. We are broadly interested in stakeholder feedback and
recommendations for ways in which CMS can improve pricing and
transparency with regard to the differences in the payment rates across
sites of service.
We expect that our continued analyses of claims data and our
ongoing exploration of systems changes that are needed to allow
nonexcepted off-campus PBDs to bill directly for the TC portion of
nonexcepted items and services may lead us to consider a different
approach for implementing section 603 of the Bipartisan Budget Act of
2015. On the whole, however, we believe that a PFS Relativity Adjuster
for CY 2019 of 40 percent advances efforts to equalize payment rates in
the aggregate between physician offices and nonexcepted off-campus
PBDs. Maintaining our policy of applying an overall scaling factor to
OPPS payments allows hospitals to continue billing through a facility
claim form and permits continued use of the packaging rules and cost
report-based relative payment rate determinations for nonexcepted
services.
H. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
review process, revisions in RVUs were proposed and finalized via
rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
CMS and the RUC identified a number of potentially misvalued codes each
year using various identification screens, as discussed in section
II.E. of this final rule, Potentially Misvalued Services under the PFS.
Historically, when we received RUC recommendations, our process had
been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a
new process for establishing values for new, revised and potentially
misvalued codes. Under the new process, we include proposed values for
these services in the proposed rule, rather than establishing them as
interim final in the final rule with comment period. Beginning with the
CY 2017 PFS proposed rule, the new process was applicable to all codes,
except for new codes that describe truly new services. For CY 2017, we
proposed new values in the CY 2017 PFS proposed rule for the vast
majority of new, revised, and potentially misvalued codes for which we
received complete RUC recommendations by February 10, 2016. To complete
the transition to this new process, for codes for which we established
interim final values in the CY 2016 PFS final rule with comment period,
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period, and re-proposed values for those codes in the CY 2017 PFS
proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values. For CY 2017, we
did not identify any new codes that described such wholly new services.
Therefore, we did not establish any code values on an interim final
basis.
For CY 2018, we generally proposed the RUC-recommended work RVUs
for new, revised, and potentially misvalued codes. We proposed these
values based on our understanding that the RUC generally considers the
kinds of concerns we historically raised regarding appropriate
valuation of work RVUs. However, during our review of these recommended
values, we identified some concerns similar to those we recognized in
prior years. Given the relative nature of the PFS and our obligation to
ensure that the RVUs reflect relative resource use, we included
descriptions of potential alternative approaches we might have taken in
developing work RVUs that differed from the RUC-recommended values. We
sought comment on both the RUC-recommended values, as well as the
alternatives considered. Several commenters generally supported the
proposed use of the RUC-recommended work RVUs, without refinement.
Other commenters expressed concern about the effect of the misvalued
code reviews on particular specialties and settings and disappointment
with our proposed
[[Page 59514]]
approach for valuing codes for CY 2018. A detailed summary of the
comments and our responses can be found in the CY 2018 PFS final rule
(82 FR 53033-53035).
We clarified in response to commenters that we are not
relinquishing our obligation to independently establish appropriate
RVUs for services paid under the PFS. We will continue to thoroughly
review and consider information we receive from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
federal government as part of our process for establishing valuations.
Although generally proposing the RUC-recommended work RVUs for new,
revised, and potentially misvalued codes was our approach for CY 2018,
we note that we also included alternative values where we believed
there was a possible opportunity for increased precision. We also
clarified that as part of our obligation to establish RVUs for the PFS,
we annually make an independent assessment of the available
recommendations, supporting documentation, and other available
information from the RUC and other commenters to determine the
appropriate valuations. Where we concur that the RUC's recommendations,
or recommendations from other commenters, are reasonable and
appropriate and are consistent with the time and intensity paradigm of
physician work, we propose those values as recommended. Additionally,
we will continue to engage with stakeholders, including the RUC, with
regard to our approach for accurately valuing codes, and as we
prioritize our obligation to value new, revised, and potentially
misvalued codes. We continue to welcome feedback from all interested
parties regarding valuation of services for consideration through our
rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conducted a review
that included the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally included, but had not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the federal
government, as well as Medicare claims data. We also assessed the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we used in the building block approach may have
included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building
block components could include the CPT codes that make up the bundled
code and the inputs associated with those codes. We used the building
block methodology to construct, or deconstruct, the work RVU for a CPT
code based on component pieces of the code. Magnitude estimation refers
to a methodology for valuing work that determines the appropriate work
RVU for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilized an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refined the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjusted the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we removed 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also removed a work RVU
of 0.09 (4 minutes x 0.0224 IWPUT) if we did not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. When they exist we also include a summary of
stakeholder reactions to
[[Page 59515]]
our approach. We note that many commenters and stakeholders have
expressed concerns over the years with our ongoing adjustment of work
RVUs based on changes in the best information we had regarding the time
resources involved in furnishing individual services. We have been
particularly concerned with the RUC's and various specialty societies'
objections to our approach given the significance of their
recommendations to our process for valuing services and since much of
the information we used to make the adjustments is derived from their
survey process. We are obligated under the statute to consider both
time and intensity in establishing work RVUs for PFS services. As
explained in the CY 2016 PFS final rule with comment period (80 FR
70933), we recognize that adjusting work RVUs for changes in time is
not always a straightforward process, so we have applied various
methodologies to identify several potential work values for individual
codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we sometimes used the relationship
between the old time values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believed that such changes in time were
already accounted for in the RUC's recommendation, then we did not make
such adjustments. Likewise, we did not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We used the ratios
to identify potential work RVUs and considered these work RVUs as
potential options relative to the values developed through other
options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we have believed that, since the two
components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should be
reflected in decreases to work RVUs. If the RUC's recommendation has
appeared to disregard or dismiss the changes in time, without a
persuasive explanation of why such a change should not be accounted for
in the overall work of the service, then we have generally used one of
the aforementioned methodologies to identify potential work RVUs,
including the methodologies intended to account for the changes in the
resources involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general
objections to our use of these methodologies and deemed our actions in
adjusting the recommended work RVUs as inappropriate; other
stakeholders have also expressed general concerns with CMS refinements
to RUC recommended values in general. In the CY 2017 PFS final rule (81
FR 80272 through 80277) we responded in detail to several comments that
we received regarding this issue. In the CY 2017 PFS proposed rule, we
requested comments regarding potential alternatives to making
adjustments that would recognize overall estimates of work in the
context of changes in the resource of time for particular services;
however, we did not receive any specific potential alternatives. As
described earlier in this section, crosswalks to key reference or
similar codes is one of the many methodological approaches we have
employed to identify potential values that reconcile the RUC-recommend
work RVUs with the recommended time values when the RUC-recommended
work RVUs did not appear to account for significant changes in time.
Following the publication of the CY 2019 PFS proposed rule, we
received several comments noting that there was some confusion in the
terminology between ``reference services'' and ``crosswalks.''
Commenters stated that ``reference services'' are services indicated by
the specialty society or the RUC as a good comparator that demonstrates
relativity using magnitude estimation as requiring similar physician
work, time, intensity and complexity. ``Key reference services'' are
the top two services selected by the survey respondents as most similar
to the code being surveyed. By contrast, ``crosswalks'' are services
that have similar or exact intraservice time and require the same
physician work (that is, have the same work RVU), and the term
``crosswalk'' should only be used when making a comparison to a CPT
code with the identical work RVU. The commenters noted that these terms
were used interchangeably in the proposed rule when they have distinct
and separate meanings.
In response to the commenters, we would like to clarify that the
terms ``reference services'', ``key reference services'', and
``crosswalks'' as described by the commenters are part of the RUC's
process for code valuation. These are not terms that we created, and we
do not agree that we necessarily must employ them in the identical
fashion for the purposes of discussing our valuation of individual
services that come up for review. However, in the interest of
minimizing confusion and providing clear language to facilitate
stakeholder feedback, we will seek to limit the use of the term,
``crosswalk,'' to those cases where we are making a comparison to a CPT
code with the identical work RVU.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the final
valuation considered for specific codes. Table 13 contains a list of
codes for which we are finalizing work RVUs; this includes all codes
for which we received RUC recommendations by February 10, 2018. The
finalized work RVUs, work time and other payment information for all CY
2019 payable codes are available on the CMS website under downloads for
the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html). Table 13 also
contains the CPT code descriptors for all new, revised, and potentially
misvalued codes discussed in this section.
[[Page 59516]]
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 14 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, we address several refinements that
are common across codes, and refinements to particular codes are
addressed in the portions of this section that are dedicated to
particular codes. We note that for each refinement, we indicate the
impact on direct costs for that service. We note that, on average, in
any case where the impact on the direct cost for a particular
refinement is $0.30 or less, the refinement has no impact on the PE
RVUs. This calculation considers both the impact on the direct portion
of the PE RVU, as well as the impact on the indirect allocator for the
average service. We also note that nearly half of the refinements
listed in Table 14 result in changes under the $0.30 threshold and are
unlikely to result in a change to the RVUs.
We also note that the finalized direct PE inputs for CY 2019 are
displayed in the CY 2019 direct PE input database, available on the CMS
website under the downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the final CY 2019 PE RVUs
as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this final rule, Determination
of Practice
[[Page 59517]]
Expense Relative Value Units (PE RVUs), for more information regarding
the collaborative work of CMS and the RUC in improvements in
standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2019, we received invoices for several new supply and
equipment items. Tables 14 and 15 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final rule, we encouraged stakeholders to review the
prices associated with these new and existing items to determine
whether these prices appear to be accurate. Where prices appear
inaccurate, we encouraged stakeholders to submit invoices or other
information to improve the accuracy of pricing for these items in the
direct PE database by February 10th of the following year for
consideration in future rulemaking, similar to our process for
consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 14 and 15 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that stakeholders will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that stakeholders are
more likely to have better pricing information for items used more
frequently. A single invoice may not be reflective of typical costs and
we encourage stakeholders to provide additional invoices so that we
might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we included the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address proposed code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display the services subject to the MPPR lists on
diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services, and therapy services. We also
include a list of procedures that meet the definition of imaging under
section 1848(b)(4)(B) of the Act, and therefore, are subject to the
OPPS cap for the upcoming calendar year. The public use files for CY
2019 are available on the CMS website under downloads for the CY 2019
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule with comment period (78 FR 74261-74263).
For more information regarding the history of the OPPS cap, we refer
readers to the CY 2007 PFS final rule with comment period (71 FR 69659-
69662).
4. Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006,
10007, 10008, 10009, 10010, 10011, 10012, 76492, 77002 and 77021)
CPT code 10021 was identified as part of the OPPS cap payment
proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC
for direct PE inputs only as part of the CY 2016 rule cycle.
Afterwards, CPT codes 10021 and 10022 were referred to the CPT
Editorial Panel to consider adding additional clarifying language to
the code descriptors and to include bundled imaging guidance due to the
fact that imaging had become typical with these services. In June 2017,
the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021,
and created nine new codes to describe fine needle aspiration
procedures with and without imaging guidance. These ten codes were
surveyed and reviewed for the October 2017 and January 2018 RUC
meetings. Several imaging services were also reviewed along with the
rest of the code family, although only CPT code 77021 was subject to a
new survey.
For CY 2019, we proposed the RUC-recommended work RVU for seven of
the ten codes in this family. Specifically, we proposed a work RVU of
0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging
guidance; each additional lesion), a work RVU of 1.00 for CPT code
10006 (Fine needle aspiration biopsy, including ultrasound guidance;
each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine
needle aspiration biopsy, including fluoroscopic guidance; first
lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration
biopsy, including fluoroscopic guidance; each additional lesion), and a
work RVU of
[[Page 59518]]
1.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT
guidance; each additional lesion). We also proposed to assign the
recommended contractor-priced status to CPT codes 10011 (Fine needle
aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine
needle aspiration biopsy, including MR guidance; each additional
lesion) due to low utilization until these services are more widely
utilized. In addition, we proposed the recommended work RVU of 1.50 for
CPT code 77021 (Magnetic resonance guidance for needle placement (e.g.,
for biopsy, fine needle aspiration biopsy, injection, or placement of
localization device) radiological supervision and interpretation), as
well as proposed to reaffirm the current work RVUs of 0.67 for CPT code
76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine
needle aspiration biopsy, injection, localization device), imaging
supervision and interpretation) and 0.54 for 77002 (Fluoroscopic
guidance for needle placement (e.g., biopsy, fine needle aspiration
biopsy, injection, localization device)).
We disagreed with the RUC-recommended work RVU of 1.20 for CPT code
10021 (Fine needle aspiration biopsy; without imaging guidance; first
lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to
CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code
36440 is a recently reviewed code with the same intraservice time of 15
minutes and 2 additional minutes of total time. In reviewing CPT code
10021, we noted that the recommended intraservice time is decreasing
from 17 minutes to 15 minutes (12 percent reduction), and the
recommended total time is decreasing from 48 minutes to 33 minutes (32
percent reduction); however, the RUC-recommended work RVU is only
decreasing from 1.27 to 1.20, which is a reduction of just over 5
percent. Although we did not imply that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be appropriately reflected in decreases to work RVUs. In
the case of CPT code 10021, we believed that it was more accurate to
propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to
account for these decreases in the surveyed work time.
We disagreed with the RUC-recommended work RVU of 1.63 for CPT code
10005 (Fine needle aspiration biopsy, including ultrasound guidance;
first lesion) and proposed a work RVU of 1.46. Although we disagreed
with the RUC-recommended work RVU, we concurred that the relative
difference in work between CPT codes 10021 and 10005 is equivalent to
the recommended interval of 0.43 RVUs. Therefore, we proposed a work
RVU of 1.46 for CPT code 10005, based on the recommended interval of
0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code
10021. The proposed increment of 0.43 RVUs above CPT code 10021 was
also based on the use of two crosswalk codes: CPT code 99225
(Subsequent observation care, per day, for the evaluation and
management of a patient, which requires at least 2 of 3 key
components); and CPT code 99232 (Subsequent hospital care, per day, for
the evaluation and management of a patient, which requires at least 2
of 3 key components). Both of these codes have the same intraservice
time and 1 additional minute of total time as compared with CPT code
10005, and both crosswalk codes share a work RVU of 1.39.
We disagreed with the RUC-recommended work RVU of 2.43 for CPT code
10009 (Fine needle aspiration biopsy, including CT guidance; first
lesion) and we proposed a work RVU of 2.26. Although we disagreed with
the RUC-recommended work RVU, we concurred that the relative difference
in work between CPT codes 10021 and 10009 is equivalent to the
recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of
2.26 for CPT code 10009, based on the recommended interval of 1.23
additional RVUs above our proposed work RVU of 1.03 for CPT code 10021.
The proposed use of the recommended increment from CPT code 10021 was
also based on the use of a crosswalk to CPT code 74263 (Computed
tomographic (CT) colonography, screening, including image
postprocessing), another CT procedure with 38 minutes of intraservice
time and 50 minutes of total time at a work RVU of 2.28.
We noted that the recommended work pool is increasing by
approximately 20 percent for the Fine Needle Aspiration family as a
whole, while the recommended work time pool for the same codes is only
increasing by about 2 percent. Since time is defined as one of the two
components of work, we believed that this indicated a discrepancy in
the recommended work values. We do not believe that the recoding of the
services in this family has resulted in an increase in their intensity,
only a change in the way in which they will be reported, and therefore,
we do not believe that it would serve the interests of relativity to
propose the recommended work values for all of the codes in this
family. We believe that, generally speaking, the recoding of a family
of services should maintain the same total work pool, as the services
themselves are not changing, only the coding structure under which they
are being reported. We also noted that through the bundling of some of
these frequently reported services, it is reasonable to expect that the
new coding system will achieve savings via elimination of duplicative
assumptions of the resources involved in furnishing particular
servicers. For example, a practitioner will not be carrying out the
full preservice work twice for CPT codes 10022 and 76942, but
preservice times were assigned to both of the codes under the old
coding. We believe the new coding assigns more accurate work times and
thus reflects efficiencies in resource costs that existed regardless of
how the services were previously reported.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT code
77021. This code did not previously have clinical labor time assigned
for the ``Confirm order, protocol exam'' clinical labor task, and we do
not have any reason to believe that the services being furnished by the
clinical staff have changed, only the way in which this clinical labor
time has been presented on the PE worksheets. We also noted that there
is no effect on the total clinical labor direct costs in these
situations, since the same 3 minutes of clinical labor time is still
being furnished. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Fine Needle Aspiration family of codes.
Comment: Several commenters disagreed with the CMS statement in the
proposed rule that the RUC-recommended work pool was increasing by
approximately 20 percent for this family of codes. Commenters stated
that the work pool based on the RUC-recommended values would actually
decrease by 15 percent and that the CMS work valuations were based on a
flawed methodology that did not account for the associated savings with
bundling the image guidance codes. One of the commenters supplied a
table with data to support the claim that the work
[[Page 59519]]
pool based on the RUC-recommended values would decrease by 15 percent
rather than increasing by 20 percent.
Response: We disagree with the commenters that the work pool would
decrease by 15 percent if we were to finalize the RUC recommendations.
We investigated the data in the table submitted by the commenters, and
we believe that there are several methodological flaws in the analysis
it contains. First, there are a number of 0.00 work RVUs listed in the
``RUC Recommended RVUs'' column for the new codes, which results in an
incorrect amount of ``New/Rev Total RVUs'' when multiplied by the
utilization for the new codes. As an example, CPT code 10005 has
approximately 135,000 services that are counted as having a work RVU of
0.00 in this table instead of the RUC-recommended work RVU of 1.63,
which undercounts the total number of RVUs by a wide margin. Second,
the values in the ``Total Source RVUs'' include the ratios from the
utilization crosswalk (listed on the table as ``Percent''). We do not
understand why these ratios would be used to calculate the total source
RVUs, as this side of the work pool comparison is calculated from the
utilization of the source codes times the work RVUs of the source
codes. Third, the imaging guidance codes are not fully included in both
sides of the comparison on this table, with their work RVUs included in
the source RVU total but not in the new/revised RVU total. This uneven
comparison results in an inaccurate tally of the work pools from before
and after the coding revisions take place.
In the interest of providing transparency, we are including Table
12 with our work pool comparison for the Fine Needle Aspiration code
family.
Table 12--Fine Needle Aspiration Work Pool Comparison
--------------------------------------------------------------------------------------------------------------------------------------------------------
Utilization Utilization Work RVU Work pool Work RVU Work pool Work pool Work pool %
HCPCS code source destination source source destination destination RVU change change
--------------------------------------------------------------------------------------------------------------------------------------------------------
10021................................... 23,755 21,380 1.27 30,169 1.20 25,655 -4,513 -15
10004................................... 0 2,376 0.00 0 0.80 1,900 1,900 ............
10005................................... 0 270,753 0.00 0 1.63 441,327 441,327 ............
10006................................... 0 30,621 0.00 0 1.00 30,621 30,621 ............
10007................................... 0 6,857 0.00 0 1.81 12,411 12,411 ............
10008................................... 0 873 0.00 0 1.18 1,030 1,030 ............
10009................................... 0 60,665 0.00 0 2.43 147,416 147,416 ............
10010................................... 0 6,831 0.00 0 1.65 11,271 11,271 ............
10011................................... 0 83 0.00 0 C 0 0 ............
10012................................... 0 3 0.00 0 C 0 0 ............
10022................................... 186,455 0 1.27 236,798 0.00 0 -236,798 -100
76942................................... 558,081 488,321 0.67 373,914 0.67 327,175 -46,739 -13
7694226................................. 641,346 561,178 0.67 429,702 0.67 375,989 -53,713 -13
76942TC................................. 8,588 7,515 0.00 0 0.00 0 0 ............
77002................................... 311,280 308,790 0.54 168,091 0.54 166,746 -1,345 -1
7700226................................. 180,964 179,516 0.54 97,721 0.54 96,939 -782 -1
77002TC................................. 7,936 7,873 0.00 0 0.00 0 0 ............
77012................................... 9,343 7,792 1.16 10,838 1.50 11,688 850 8
7701226................................. 194,611 162,306 1.16 225,749 1.50 243,458 17,710 8
77012TC................................. 469 391 0.00 0 0.00 0 0 ............
77021................................... 1,481 1,432 1.50 2,222 1.50 2,148 -73 -3
7702126................................. 1,038 1,004 1.50 1,557 1.50 1,506 -51 -3
77021TC................................. 67 65 0.00 0 0.00 0 0 ............
---------------------------------------------------------------------------------------------------------------
Totals.............................. 2,125,414 2,126,622 ............ 1,576,760 ............ 1,897,282 320,523 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
We continue to believe that the RUC-recommended work pool is
increasing by approximately 20 percent for the Fine Needle Aspiration
family as a whole, and that this percentage increase suggests that CPT
codes 10021, 10005, and 10009 are more accurately valued at the CMS
proposed work RVUs.
Comment: Several commenters disagreed that this code family will
achieve savings via elimination of duplicative assumptions of the
resources involved in furnishing particular services. Commenters stated
that there is no overlap between the current descriptions of work for
the bundled codes, and that CPT code 10022 is never performed on the
same patient without an image guidance code and the image guidance
codes are never performed on the same patient without a corresponding
procedure code. The commenters stated that any associated reduction in
payment would be due to other factors, not due to the code bundling.
Response: We disagree with the commenters that there would be no
savings achieved via elimination of duplicative assumptions of the
resources involved in furnishing particular services. As we stated in
the proposed rule, a practitioner will not be carrying out the full
preservice work twice for CPT codes 10022 and 76942, but preservice
times were assigned to both of the codes under the old coding. In
similar fashion, these codes both separately include immediate
postservice work time for dictating a report in their clinical
vignettes. This is an example of how savings are achieved via
elimination of duplicative assumptions of resources, as the
practitioner will only dictate a single report in the newly created CPT
code 10005 that bundles these two services together. We continue to
believe that the new coding assigns more accurate work times and thus
reflects efficiencies in resource costs that existed regardless of how
the services were previously reported.
Comment: One commenter stated that while it may be true
mathematically that the work pool for this family of codes was
increasing by 20 percent, using this observation as the sole basis to
implement work value relies on incorrect assumptions which do not
adhere to current relativity-based RUC methodologies. The commenter
stated that the rationale proposed by CMS incorrectly implies that the
decrease in time as reflected in survey values must equate to a one to
one or linear decrease in the valuation of work RVUs and fails to
recognize changes in intensity that have taken place over time.
Response: We disagree with the commenter that our analysis of
changes in the work pool for this family of codes was the sole basis
for the proposed refinements to the work RVUs. While
[[Page 59520]]
this was an important factor in our analysis of the work valuation of
individual codes, we also detailed in the proposed rule our use of time
ratios, increments, and crosswalk codes as part of our larger
methodology to determine work RVUs. We specifically stated that we did
not imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, but rather that we believe that since the two components of work
are time and intensity, significant decreases in time should be
appropriately reflected in decreases to work RVUs. We do consider
changes in intensity that have taken place over time as part of our
analysis of work valuation, as demonstrated by the fact that we
proposed the RUC-recommended work RVUs for seven of the ten codes in
this family.
Comment: One commenter disagreed that the work pool for a family of
revised codes should be similar before and after the valuation of the
new codes. The commenter stated that by separating different modalities
into their own codes, the appropriate time and intensity differences
for these services were more accurately reflected in the recommended
RVUs, and the work pool appropriately expanded to reflect these
differences. The commenter cited the example of CPT code 10022 being
unable to account for different patients receiving a biopsy using
ultrasound or CT technology.
Response: We agree with the commenter that the work pool for a
revised code family does not always need to be similar before and after
the valuation of the new codes. However, the commenter did not address
our rationale for why we believe that an increase in the work pool
would be inaccurate for this particular family of codes, which was
based on the observation that the RUC-recommended work pool was
increasing by approximately 20 percent while the RUC-recommended work
time pool for the same codes was only increasing by about 2 percent. In
a situation where prior coding was unable to account for newer and more
complex forms of treatment, we would expect the work time pool to
expand alongside the work pool, since these more complex and intensive
procedures would take more time to furnish.
Comment: A few commenters stated that since CMS changed the
multiple procedure indicator from ``0'' to ``2'' for all Fine Needle
Aspiration biopsy initial lesion codes for CY 2019, the commenter
believes that using XXX global codes as references was incorrect. The
commenter instead recommended that CMS review similar minor procedures
that have a 0-day global designation, which suggested that a higher
work RVU could have been supported.
Response: We continue to believe that codes should generally be
compared to codes with the same global period. Codes with a 0-day
global period bundle other services that take place on the same day as
the procedure into the valuation of the code, whereas such bundling is
not included in codes with an XXX global period. We do not agree that
it would have been more accurate to use codes with a 0-day global
period as references for the codes in this family.
Comment: Many commenters disagreed with the proposed work RVU of
1.03 for CPT code 10021 and stated that CMS should finalize the RUC-
recommended work RVU of 1.20. Commenters stated that this service has a
new coding structure as compared to the past, and that the prior review
was last carried out in 1995 when physician work time was evaluated
with much less rigor. Commenters stated that the old time values were
also based on a crosswalk and not a survey, and that therefore the drop
in work time did not warrant a proportional change in work RVU as the
previous times were inaccurate.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of prior
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 PFS final rule (81 FR 80273 through
80274).
Comment: Several commenters stated the CMS rationale for the
proposed work RVU for CPT code 10021 incorrectly implies that the
decreased time reflected in survey values should have a one-to-one
decrease in value, or a linear decrease in the valuation of work RVUs.
Commenters stated that CMS incorrectly assumed that there are no
differences in how work was valued in 1995 and how it is valued now.
Response: We do not agree with the commenters' characterization of
our statements, and believe it misinterprets our view on this matter.
We specifically stated in the CY 2019 PFS proposed rule that we were
not implying that the decrease in time as reflected in survey values
must necessarily equate to a one-to-one or linear decrease in the
valuation of work RVUs, both generally speaking and with regards to
this particular CPT code (83 FR 35747). We recognize that intensity for
any given procedure may change over several years or within the
intraservice period. Nevertheless, since the two components of work are
time and intensity, we believe that absent an obvious or explicitly
stated rationale for why the relative intensity of a given procedure
has specifically increased or the reduction in time occurs
disproportionally in the less-intensive portions of the procedure,
significant decreases in time should generally be reflected as
decreases to work RVUs.
Comment: Several commenters disagreed with the use of CPT code
36440 as a crosswalk for the work RVU of CPT code 10021. Commenters
stated that there were differences in site of service, patient
population, and utilization between these two codes, which made CPT
code 36440 a poor choice to use for work valuation. One commenter
stated that CPT code 36440 is used to report a push transfusion of
blood through an already established
[[Page 59521]]
access in a vessel, and does not carry the same risk and intensity as
CPT code 10021, which involves accessing a lesion in the neck multiple
times to aspirate biopsy specimens. Commenters supplied a chart
depicting several comparator codes for 10021 that they stated were more
appropriate choices for a crosswalk.
Response: We disagree with the commenters that CPT code 36440 is an
inappropriate choice for a crosswalk code. While it is true that this
code is typically performed on an inpatient basis and the patient
population comprises neonates instead of adults, we note that these
factors suggest that the patient population for CPT code 36440 is
likely sicker and more complex than the patient population for CPT code
10021. These differences would, if anything, be grounds for a lower
work RVU for CPT code 10021, not a higher work RVU. We continue to
believe that CPT code 36440 is an appropriate choice for a crosswalk
due to the highly similar work times and intensity as compared to CPT
code 10021. As for the other comparator codes provided by the
commenters, we do not agree that they would be more appropriate choices
for a crosswalk as we believe that they have a higher intensity than
the service described by CPT code 10021. In more general terms, we
continue to believe that the nature of the PFS relative value system
necessarily involves comparisons of all services to one another.
Although codes that describe clinically similar services are sometimes
stronger comparator codes, we do not agree that codes must share the
same site of service, patient population, or utilization level to serve
as an appropriate crosswalk.
Comment: Many commenters disagreed with the proposed work RVU of
1.46 for CPT code 10005 and stated that CMS should finalize the RUC-
recommended work RVU of 1.63. Commenters stated that CMS should use
valid methods of evaluating services, such as survey data and magnitude
estimation, instead of relying on an incremental difference in work
RVUs between CPT codes 10021 and 10005.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 10005,
supporting our proposed valuation with the use of two reference codes:
CPT codes 99225 and 99232. Both of these codes have the same
intraservice time and 1 additional minute of total time as compared
with CPT code 10005, and both reference codes share a work RVU of 1.39.
Comment: One commenter stated that they did not object to the CMS
designation of 0.43 RVUs as the increment over CPT code 10021 for
adding ultrasound guidance; however, the commenter objected to the
assumption that the work value for CPT code 36440 offers an acceptable
baseline.
Response: We continue to believe that a crosswalk to the work RVU
of CPT code 36440 produces the most accurate valuation for baseline CPT
code 10021.
Comment: Commenters disagreed with the proposed work RVU of 2.26
for CPT code 10009 and stated that CMS should finalize the RUC-
recommended work RVU of 2.43. Commenters provided similar comments for
CPT code 10009 as they provided for CPT code 10005, suggesting that the
use of an incremental methodology was inaccurate and that CMS should
use more valid methods of evaluating services, such as survey data and
magnitude estimation.
Response: We continue to disagree with the commenters that the use
of an increment is a less valid methodology for valuing services. As
detailed in the response to the comment summary above for CPT code
10005, we believe the use of an incremental difference is appropriate,
especially in valuing services within a family of revised codes where
it is important to maintain appropriate intra-family relativity. We
further note that we did not rely solely on an increment for our
proposed work RVU for CPT code 10009, supporting our proposed valuation
with the use of a reference to CPT code 74263.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT codes 77012 and 77021, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We address this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
77012 and 77021, we are finalizing these clinical labor refinements as
proposed.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for all of the codes in the Fine Needle
Aspiration family as proposed.
(2) Biopsy of Nail (CPT Code 11755)
CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix,
hyponychium, proximal and lateral nail folds) (separate procedure)) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, the HCPAC recommended a
work RVU of 1.25 based on the survey median value.
We disagreed with the recommended value and proposed a work RVU of
1.08 for CPT code 11755 based on the survey 25th percentile value. We
noted that the recommended intraservice time for CPT code 11755 is
decreasing from 25 minutes to 15 minutes (40 percent reduction), and
the recommended total time for CPT code 11755 is decreasing from 55
minutes to 39 minutes (29 percent reduction); however, the recommended
work RVU is only decreasing from 1.31 to 1.25, which is a reduction of
less than 5 percent. Although we did not imply that the decrease in
time as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, significant
decreases in time should be reflected in decreases to work RVUs. In the
case of CPT code 11755, we believed that it would be more accurate to
propose the survey 25th percentile work RVU than the survey median to
account for these decreases in the surveyed work time.
The proposed work RVU of 1.08 is also based on a crosswalk to CPT
code 11042 (Debridement, subcutaneous tissue (includes epidermis and
dermis, if performed); first 20 sq cm or less), which has a work RVU of
1.01, the same intraservice time of 15 minutes, and a similar total
time of 36 minutes. We also noted that, generally speaking, working
with extremities like nails tends to be less intensive in clinical
terms than other services, especially as compared to surgical
procedures. We believe that
[[Page 59522]]
this further supports our proposal of a work RVU of 1.08 for CPT code
11755.
We proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 11755.
Comment: A few commenters stated that section 1848(c)(7) of the
Act, as amended by section 220(e) of the Protecting Access to Medicare
Act of 2014 (PAMA), specifies that for services that are not described
by new and revised codes, if the total RVU for a service would be
decreased by 20 percent or more as compared to the total RVUs for the
previous year, the applicable adjustments must be phased in over a 2-
year period. These commenters stated that, according to this
requirement, CPT code 11755 should be subject to the phase-in for CY
2019.
Response: We agree that CPT code 11755 should be subject to the
phase-in for CY 2019. Due to a technical error, we inadvertently
neglected to apply the phase-in to the total RVU of this code in the
facility setting for the proposed rule, and we are correcting this for
the final rule.
Comment: Many commenters disagreed with the proposed work RVU of
1.08 for CPT code 11755 and stated that CMS should finalize the RUC-
recommended work RVU of 1.25. Commenters urged CMS to view the survey
and the HCPAC's recommendation for the survey median work value of 1.25
apart from the current work time and work RVU because the primary
specialty that currently performs the service was not included in the
prior survey conducted in 1993.
Response: We disagree with the commenters that the current work
time and work RVU for CPT code 11755 should be viewed separately from
the new recommended values. We do not pay differentially for services
on the basis of specialty, and a change in the dominant specialty since
the time of the last survey is not a reason to disregard the current
work time and work RVUs in developing proposed work RVUs.
Comment: Commenters compared the proposed work RVU of CPT code
11755 to the work valuation of the top key reference service, CPT code
11730 (Avulsion of nail plate, partial or complete, simple; single).
Commenters stated that the increment of work between CPT code 11730 of
1.05 and the CMS proposed value for CPT code 11755 of 1.08 was only
0.03 RVUs, which was not enough to account for the additional work
involved in CPT code 11755 given that the latter code also had 50
percent more intraservice time. Commenters also expressed concerns with
the CMS reference to CPT code 11042 at a work RVU of 1.01, stating that
it required less physician work time and a less refined technique.
Commenters stated that the service described by CPT code 11755 was more
intense to perform because the physician has to be extremely careful
not to accidentally hit the patient's bone while taking the biopsy.
Commenters stated that the nail plate is typically difficult to remove
during the process of the biopsy performed in the service described by
CPT code 11755, and that the biopsy must be performed with extreme care
to avoid injury to the surgeon or extension of the incision to the
underlying bone, which carries the potential for an osteomyelitis and
significant post-operative pain. Commenters again urged CMS to finalize
the RUC-recommended values for this code.
Response: After reviewing the additional information about the
risks inherent in the service provided by the commenters, we agree that
it would be more accurate to finalize the RUC-recommended work RVU of
1.25 for CPT code 11755 to reflect the intensity of the procedure.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic instrument pack (EQ137) equipment, we
removed the clinical labor for the CA024, CA027, CA029, and CA035
clinical labor activities in accordance with our standard equipment
time formula for surgical instrument packs. For the other three
equipment items, we removed the clinical labor for the CA027 and CA035
clinical labor activity codes in accordance with our standard equipment
time formula for non-highly technical equipment.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing
the direct PE inputs for this code as proposed.
(3) Skin Biopsy (CPT Codes 11102, 11103, 11104, 11105, 11106, and
11107)
In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue
and/or mucous membrane (including simple closure), unless otherwise
listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue
and/or mucous membrane (including simple closure), unless otherwise
listed; each separate/additional lesion) were identified as potentially
misvalued using a high expenditure services screen across specialties
with Medicare allowed charges of $10 million or more. Prior to the
January 2016 RUC meeting, the specialty society notified the RUC that
its survey data displayed a bimodal distribution of responses with more
outliers than usual. The RUC referred CPT codes 11100 and 11101 to the
CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted
these two codes and created six new codes for primary and additional
biopsy based on the thickness of the sample and the technique utilized.
For CY 2019, we proposed the RUC-recommended work RVUs for five of
the six codes in the family. We proposed a work RVU of 0.66 for CPT
code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize,
curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch
biopsy of skin, (including simple closure when performed), single
lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin,
(including simple closure when performed), each separate/additional
lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of
skin (e.g., wedge), (including simple closure when performed), single
lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy
of skin (e.g., wedge), (including simple closure when performed), each
separate/additional lesion).
For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop,
saucerize, curette), each separate/additional lesion), we disagreed
with the RUC-recommended work RVU of 0.38 and proposed a work RVU of
0.29. When we compared the RUC-recommended work RVU of 0.38 to other
add-on codes in the RUC database, we found that CPT code 11103 would
have the second-highest work RVU for any code with 7 minutes or less of
total time, with the recommended work RVU noticeably higher than other
related add-on codes, and we did not agree that the tangential biopsy
service being performed should have an anomalously high work value in
comparison to other similar add-on codes. Our proposed work RVU of 0.29
was based on a crosswalk to CPT code 11201 (Removal of skin tags,
multiple fibrocutaneous tags, any area; each additional 10 lesions, or
part thereof), a clinically related add-on procedure with 5 minutes of
intraservice and total time as opposed to the surveyed 6 minutes for
[[Page 59523]]
CPT code 11103. We also noted that the intraservice time ratio between
CPT code 11103 and the recommended reference code, CPT code 11732
(Avulsion of nail plate, partial or complete, simple; each additional
nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75
percent ratio when applied to the work RVU of CPT code 11732 also
produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we also
supported the proposed work RVU through a crosswalk to CPT code 33508
(Endoscopy, surgical, including video-assisted harvest of vein(s) for
coronary artery bypass procedure), which has a higher intraservice time
of 10 minutes but a similar work RVU of 0.31. We believed that our
proposed work RVU of 0.29 for CPT code 11103 better serves the
interests of relativity, as well as better fitting with the other
recommended work RVUs within this family of codes.
For the direct PE inputs, we proposed to remove the 2 minutes of
clinical labor time for the ``Review home care instructions, coordinate
visits/prescriptions'' (CA035) activity for CPT codes 11102, 11104, and
11106. These codes are typically billed with a same day E/M service,
and we believe that it would be duplicative to assign clinical labor
time for reviewing home care instructions given that this task would
typically be done during the same day E/M service. We also proposed to
refine the equipment times in accordance with our standard equipment
time formulas.
We proposed to refine the quantity of the ``gown, staff,
impervious'' (SB024) and the ``mask, surgical, with face shield''
(SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We
proposed to remove one gown and one surgical mask from these codes as
duplicative since these supplies are also included within the surgical
instrument cleaning pack (SA043). We also proposed to remove all of the
supplies in the three add-on procedures (CPT codes 11103, 11105, and
11107) that were not contained in the previous add-on procedure for
this family, CPT code 11101. We do not believe that the use of these
supplies would be typical for the ``each additional lesion'' add-on
codes, as these supplies are all included in the base codes and are not
currently utilized in CPT code 11101. We noted that the recommended
direct PE costs for the three new add-on codes represent an increase of
approximately 500 percent from the direct PE costs for CPT code 11101,
and believe that this is largely due to the addition of these new
supplies.
The following is a summary of the public comments we received on
our proposals involving the Skin Biopsy family of codes.
Comment: Many commenters disagreed with the proposed work RVU of
0.29 for CPT code 11103 and stated that CMS should finalize the RUC-
recommended work RVU of 0.38. Commenters disagreed that CPT code 11103
would have the second-highest work RVU for any code with 7 minutes or
less of total time, stating that the total number of add-on codes with
RUC total time of 7 minutes or less is 18. Commenters stated that only
five of these services have total time of 6 or 7 minutes and the rest
were lower, thus the majority of the work RVUs among these services
were lower and not comparable. Commenters stressed that the RUC-
recommended work RVU of 0.38 for CPT code 11103 was appropriate since
the service is performed on a separate site than the base code and
there is additional physician work to transition to a different site.
Commenters stated that the RUC's direct crosswalk to CPT code 11732
(Avulsion of nail plate, partial or complete, simple; each additional
nail plate), which describes procedures with significant physician
effort in removing a nail plate with its anesthesia and hemostasis
challenges, was a much better comparator to CPT code 11103 which
involves the biopsy of a vascular tumor, typically on the face.
Commenters stated that the proposed crosswalk to CPT code 11201 at a
work RVU of 0.29 was too low to maintain relativity within the family
of codes. One commenter stated that the type of skin biopsies performed
in CPT code 11103 can result in the detection of carcinoma, melanoma,
sarcoma/lymphoma, and other dangerous pathologies, and that making
these diagnoses can save lives and ultimately decrease Medicare
spending.
Response: After reviewing the additional information provided by
the commenters, we agree that it would be more accurate to finalize the
RUC-recommended work RVU of 0.38 for CPT code 11103 as the proposed
work RVU was too low to maintain relativity within the family of codes.
Comment: Commenters disagreed with many of the refinements made by
CMS to the direct PE inputs for this family of codes. Commenters stated
that it was not appropriate to only include equipment and supply items
in the new biopsy add-on codes that were included in the old add-on
code (CPT code 11101) because the old codes were not specific enough to
accurately distinguish between the three types of biopsies. Commenters
cited as an example the fact that the predecessor CPT code 11101 did
not include supply items that are necessary for the performance of the
incisional biopsy.
Response: We appreciate the feedback from the commenters clarifying
some of the differences between the predecessor code and the newly
created add-on codes. We evaluated these differences on an individual
case-by-case basis when determining whether or not to finalize the
proposed refinements to the direct PE inputs.
Comment: Several commenters disagreed with the proposed refinements
to the ``Review home care instructions, coordinate visits/
prescriptions'' (CA035) clinical labor time. Commenters stated that
home care instructions furnished in an E/M visit do not typically
include wound care instructions, and that this instruction would be
above and beyond instructions proved during an E/M visit in which no
procedure is performed.
Response: We disagree with the commenters that wound care
instructions would not be provided during the same day E/M visit. We
continue to believe that it would be duplicative to assign clinical
labor time for this task given the fact that a same day E/M visit is
typical for these services. We believe that these instructions would be
provided during the same day E/M visit.
Comment: Several commenters disagreed with the CMS proposal to
refine the quantity of the ``gown, staff, impervious'' (SB024) and the
``mask, surgical, with face shield'' (SB034) supplies from 2 to 1 for
CPT codes 11102, 11104, and 11106 since these supplies are also
included within the surgical instrument cleaning pack (SA043).
Commenters stated that the SA043 instrument cleaning pack is used in
the dirty instrument room as part of the instrument cleaning and
sterilization process and therefore cannot be used during a patient
procedure as the instrument cleaning occurs after the procedure has
been completed. Commenters stated that the personal protective
equipment used during the patient procedure is considered contaminated
after the procedure is concluded, and that personal protective
equipment must be removed and disposed of prior to leaving the
procedure room. As a result, these supplies were not duplicative and
should not be removed.
Response: We disagree with the commenter and we continue to believe
that the impervious staff gown and the surgical mask with face shield
would be duplicative supplies given that they are also contained within
the instrument cleaning pack. We do not believe that it
[[Page 59524]]
would be typical to remove the staff gown and face shield used during a
procedure and put on new items afterwards for the purposes of cleaning
instruments.
Comment: Commenters also disagreed with the CMS proposal to remove
all of the supplies in the three add-on procedures (CPT codes 11103,
11105, and 11107) that were not contained in the previous add-on
procedure for this family, CPT code 11101. For the ``drape, sterile,
fenestrated 16in x 29in'' (SB011) supply, commenters stated that
draping the new body site with a new sterile disposable drape was
clinically indicated and would be typically done rather than take a
drape used on one body site and then reposition it to a new body site
for a new procedure. Commenters made the same claim for the sterile
gloves (SB024) supply. For the ``needle, OSHA compliant (SafetyGlide)''
(SC080) and the ``scalpel, safety, surgical, with blade (#10-20)''
(SF047) supplies, commenters stated that the add-on represented a
completely new body site and completely new skin lesion which would not
allow the needle or scalpel to be un-sheathed and then reused at a
separate body site out of fear of contamination. For the ``dressing,
12-7mm (Gelfoam)'' (SG033), ``dressing, 3in x 4in (Telfa, Release)''
(SG035), and ``gauze, sterile 4in x 4in (10 pack uou)'' (SG056)
supplies, commenters stated that the add-on procedure is a second
biopsy of a completely different body location and that these
dressings/gauze pads would not be retained and then used on the second
procedure out of fear of contamination. For the ``tape, surgical paper
1in (Micropore)'' (SG079) supply, commenters stated that the quantity
of this supply in the base code was sufficient for one lesion, but not
more than one lesion due to the simple fact that two lesions required
more surgical tape than one lesion. Finally, for the ``swab, patient
prep, 1.5 ml (chloraprep)'' (SJ081) supply, commenters stated that the
process of skin prep starts with the center of the lesion and moves
outward in concentric circles to avoid bringing pathogens back into the
field. Commenters stated that the prep sponge cannot be reused on a
separate area of skin as it will contaminate that area by transporting
pathogens from the last concentric circle of the prior area, and that
the supply quantity in the base code contained an amount insufficient
to prep more than one area. Commenters requested CMS not to finalize
the proposal to remove these supplies from the add-on codes.
Response: After considering the new information provided by the
commenters regarding the clinical use of these supplies, we will not
finalize our proposal to remove these supplies from the three add-on
procedures (CPT codes 11103, 11105, and 11107). We will restore the
RUC-recommended supplies for these three codes.
Comment: Several commenters disagreed with the refinements to the
equipment time in CPT codes 11102, 11104, and 11106. The commenters
stated that the removal of 2 minutes of equipment time was not
appropriate and that equipment time needs to match clinical staff time.
Response: We agree with the commenter that changes in clinical
labor time should be matched with corresponding changes in equipment
time. However, since we continue to believe that the clinical labor to
the ``Review home care instructions, coordinate visits/prescriptions''
(CA035) clinical labor time should be removed as duplicative with the
same day E/M visit, we also continue to believe that the equipment
times are accurate as proposed.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for all of the codes in the Skin Biopsy
family. We are finalizing the direct PE inputs as proposed, with the
exception of the supplies from the three add-on procedures (CPT codes
11103, 11105, and 11107) as detailed above.
(4) Injection Tendon Origin-Insertion (CPT Code 20551)
CPT code 20551 (Injection(s); single tendon origin/insertion) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 20551.
We proposed to maintain the current work RVU for many of the CPT
codes identified as potentially misvalued on the screen of 0-day global
services reported with an E/M visit 50 percent of the time or more. We
noted that regardless of the proposed work valuations for individual
codes, which may or may not retain the same work RVU, we continue to
have reservations about the valuation of 0-day global services that are
typically billed with a separate E/M service with the use of Modifier
25 (indicating that a significant and separately identifiable E/M
service was provided on the same day). As we stated in the CY 2017 PFS
final rule (81 FR 80204), we continue to believe that the routine
billing of separate E/M services in conjunction with a particular code
may indicate a possible problem with the valuation of the code bundle,
which is intended to include all the routine care associated with the
service. We will continue to consider additional ways to address the
appropriate valuation for these services.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Provide education/obtain consent'' (CA011) and the
``Review home care instructions, coordinate visits/prescriptions''
(CA035) activities for CPT code 20551. This code is typically billed
with a same day E/M service, and we believe that it will be duplicative
to assign clinical labor time for obtaining consent or reviewing home
care instructions given that these tasks will typically be done during
the same day E/M service. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 20551.
Comment: A few commenters supported our proposal to maintain the
current work RVU for this code, as recommended by the RUC.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposed direct PE
refinements to CPT code 20551. Commenters stated that they did not
agree that the clinical labor taking place in activity codes CA011 and
CA035 were duplicative and that the RUC is careful to remove any
duplication with E/M visits. Commenters stated that the home care
instructions in activity code CA035 refer directly to the tendon
injection and may include discussion of care for the affected area and
home restrictions. Commenters stated that this injection is more
involved and invasive than a vaccination such as the ones taking place
in CPT codes 90470 and 90471, which were allowed 3 minutes for ``F/u on
physician's discussion w/patient/parent & obtain actual consent
signature'' and an additional 3 minutes for home care instructions and
recording vaccine information.
Response: For the CA011 clinical labor activity, we agree with the
commenters that there would be a need for some additional time to
obtain consent for the injection, but we do not agree that it would be
typical to require the full 3 minutes because we believe there would be
some overlap with the same day E/M visit. In similar fashion, we
believe that there would also be some overlap with the same-day E/M
[[Page 59525]]
visit for the home care instructions described in activity code CA035.
We also note that there is 1 minute of clinical labor time assigned to
the ``Check dressings & wound/home care instructions/coordinate office
visits/prescriptions'' clinical labor task for CPT code 90471
referenced by the commenters. As a result, we are finalizing the
assignment of 1 minute of clinical labor time to both of the CA011 and
CA035 activities for CPT code 20551. We are also finalizing an increase
of 1 minute in the equipment time for the exam table (EF023) to a total
of 15 minutes, in accordance with our standard time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing our
proposal to maintain the current work RVU for CPT code 20551. We are
finalizing the direct PE inputs with the refinements detailed above.
(5) Structural Allograft (CPT Codes 20932, 20933, and 20934)
In February 2017, the CPT Editorial Panel created three new codes
to describe allografts. These codes were designated as add-on codes and
revised to more accurately describe the structural allograft procedures
they represent. For CY 2019, we proposed the RUC-recommended work RVUs
for all three codes. We proposed a work RVU of 13.01 for CPT code 20932
(Allograft, includes templating, cutting, placement and internal
fixation when performed; osteoarticular, including articular surface
and contiguous bone), a work RVU of 11.94 for CPT code 20933
(Allograft, includes templating, cutting, placement and internal
fixation when performed; hemicortical intercalary, partial (i.e.,
hemicylindrical)), and a work RVU of 13.00 for CPT code 20934
(Allograft, includes templating, cutting, placement and internal
fixation when performed; intercalary, complete (i.e., cylindrical)).
These three new codes are all facility-only procedures with no
recommended direct PE inputs.
We did not receive any comments on our proposals involving the
Structural Allograft family of codes. Therefore we are finalizing the
work RVUs for the codes in this family as proposed.
(6) Knee Arthrography Injection (CPT Code 27369)
CPT code 27370 (Injection of contrast for knee arthrography)
repeatedly appeared on high volume growth screens between 2008 and
2016, and the RUC expressed concern that the high volume growth for
this procedure was likely due to its being reported incorrectly as
arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel
deleted CPT code 27370 and replaced it with a new code, 27369, to
report injection procedure for knee arthrography or enhanced CT/MRI
knee arthrography.
The RUC recommended a work RVU of 0.96 for CPT code 27369, which is
identical to the work RVU for CPT code 27370 (Injection of contrast for
knee arthrography). The RUC's recommendation is based on key reference
service, CPT code 23350 (Injection procedure for shoulder arthrography
or enhanced CT/MRI shoulder arthrography), with identical intraservice
time (15 minutes) and total time (28 minutes) as the new CPT code and a
work RVU of 1.00. The RUC notes that its recommendation is lower than
the 25th percentile from the survey results, but that the work
described by the service should be valued identically with the CPT code
being replaced. We disagreed with the RUC's recommended work RVU for
CPT code 27369. Both the total (28 minutes) and intraservice (15
minutes) times for the new CPT code are considerably lower than the
deleted CPT code 27370. Based on the reduced times and the projected
work RVU from the reverse building block methodology (0.60 work RVUs),
we believe this CPT code should be valued at 0.77 work RVUs, supported
by a crosswalk to CPT code 29075 (Application, cast; elbow to finger
(short arm)), with total time of 27 minutes and intraservice time of 15
minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. The predecessor
code for 27369, CPT code 27370, did not have clinical labor time
assigned for the ``Confirm order, protocol exam'' clinical labor task,
and we do not have any reason to believe that the services being
furnished by the clinical staff have changed, only the way in which
this clinical labor time has been presented on the PE worksheets. We
also noted that there is no effect on the total clinical labor direct
costs in these situations, since the same 3 minutes of clinical labor
time is still being furnished.
We proposed to remove the clinical labor time for the ``Scan exam
documents into PACS. Complete exam in RIS system to populate images
into work queue'' (CA032) activity. CPT code 27369 does not include a
PACS workstation among the recommended equipment, and the predecessor
code 27370 did not previously include time for this clinical labor
activity. We believe that data entry activities such as this task would
be classified as indirect PE, as they are considered administrative
activities and are not individually allocable to a particular patient
for a particular service. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 27369.
Comment: We received one comment regarding our proposed work RVU
for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's
reference to CPT code 27370, which is being deleted, as a basis for
evaluating whether the RUC's proposed work RVU for this CPT code (0.96)
adequately accounts for the large reduction in time between the deleted
code, CPT code 27370 and the new code, CPT code 27369. The commenter
noted that it is particularly inappropriate for CMS to value codes on
the basis of time differences when the comparison code had not been
previously surveyed by the RUC. The commenter urged CMS to finalize the
RUC-recommended work RVU for CPT code 27369 of 0.96.
Response: We use several parameters to review the work RVU for
codes including, where applicable, refining the work RVUs in direct
proportion to either total time or intraservice time based on the best
available information regarding the time resources involved in
furnishing particular services. We note that the reason the CPT
Editorial Panel was asked to review the code was to prevent incorrect
reporting of the code, not to reflect a fundamentally different
service. The work involved in furnishing the service described by CPT
code 27369 is not fundamentally different from the work involved in
furnishing the service described by the deleted code. In such cases we
do not believe it is inappropriate to compare the survey times for the
new code to the existing time for the code that it is intended to
replace as one of several parameters we consider in our review. We are
finalizing a work RVU for CPT code 27369 of 0.77 as proposed.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
[[Page 59526]]
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
27369, we are finalizing these clinical labor refinements as proposed.
Comment: One commenter agreed with the proposed CMS refinement to
the CA032 clinical labor activity.
Response: We appreciate the support for our proposal from the
commenter.
After consideration of the public comments, we are finalizing the
direct PE inputs for CPT code 27369 as proposed.
(7) Application of Long Arm Splint (CPT Code 29105)
CPT code 29105 (Application of long arm splint (shoulder to hand))
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.80 for CPT code 29105. For the direct PE
inputs, we proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 29105.
Comment: Some commenters expressed support for our proposal to
accept the RUC-recommended work RVU for this code.
Response: We appreciate the support for our proposal from the
commenters.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the five equipment items utilized in CPT code 29105,
we removed the clinical labor for the CA035 clinical labor activity
code in accordance with our standard equipment time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 29105 as proposed.
(8) Strapping Lower Extremity (CPT Codes 29540 and 29550)
CPT codes 29540 (Strapping; ankle and/or foot) and 29550
(Strapping; toes) were identified as potentially misvalued on a screen
of 0-day global services reported with an E/M visit 50 percent of the
time or more, on the same day of service by the same patient and the
same practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-
recommended work RVU of 0.25 for CPT code 29550.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Provide education/obtain consent'' (CA011) activity from
3 minutes to 2 minutes for both codes, as this is the standard clinical
labor time assigned for patient education and consent. We also proposed
to remove the 2 minutes of clinical labor time for the ``Review home
care instructions, coordinate visits/prescriptions'' (CA035) activity
for both codes. CPT codes 29540 and 29550 are both typically billed
with a same day E/M service, and we believe that it would be
duplicative to assign clinical labor time for reviewing home care
instructions given that this task would typically be done during the
same day E/M service. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Strapping Lower Extremity family of codes.
Comment: A few commenters supported our proposal to accept the
HCPAC-recommended work RVUs.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposed direct PE
refinements to CPT codes 29540 and 29550. Commenters stated that CMS
mistakenly cited a standard for this activity of 2 minutes, however
there is no set standard for CA011, and that 3 minutes is needed for
clinical staff to perform this clinical activity.
Response: We disagree with the commenters that 3 minutes would be
typically needed for the clinical staff to provide education and obtain
consent in these procedures. We have typically assigned 2 minutes for
this clinical labor activity unless we had a specific rationale for a
higher amount of clinical labor time, and we continue to believe that
this standard amount of clinical labor time would be the most accurate
value for CPT codes 29540 and 29550.
Comment: Several commenters disagreed that the clinical labor for
home care instructions and coordinating visits/prescriptions would be
duplicative with the same day E/M office visit in these services.
Commenters stated that these home care instructions directly pertain to
the strapping procedure and would not be provided during an evaluation
of the patient. Commenters stated that the strappings do not work
unless left alone and taken care of in a specific manner, and that this
important information is included in the home care instructions that
the patient receives from clinical staff.
Response: We disagree with the commenters and we continue to
believe that this clinical labor would be duplicative with the same day
E/M visit. We believe that this clinical labor would take place during
the same day E/M visit. Due to the way patients typically present in
these procedures, we do not believe that the patients would typically
need additional home care instructions above and beyond the E/M visit.
We also note that these strapping procedures are frequently repeated
for the same patient multiple times, and there would not be a need for
repeated home care instructions for subsequent strapping procedures for
the same patient. Any home care instructions taking place outside of
the same day E/M visit would only be needed the first time that these
procedures are performed on a patient, and as a result they would not
be typical. As a result, we continue to believe that this clinical
labor would not be typical.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the two equipment items utilized in these CPT codes,
we removed the clinical labor for the CA035 clinical labor activity
code in accordance with our standard equipment time formula for non-
highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT codes 29540 and 29550 as
proposed.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
CPT code 31623 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; with
[[Page 59527]]
brushing or protected brushings) was identified on a high growth screen
of services with total Medicare utilization of 10,000 or more that have
increased by at least 100 percent from 2009 through 2014. CPT code
31624 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; with bronchial alveolar lavage) was also
included for review as part of the same family of codes. For CY 2019,
we proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623
and 31624.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Complete post-procedure diagnostic forms, lab and x-ray
requisitions'' (CA027) activity from 4 minutes to 2 minutes for CPT
codes 31623 and 31624. Two minutes is the standard time, as well as the
current time for this clinical labor activity, and we have no reason to
believe that the time to perform this task has increased since the
codes were last reviewed. We did not receive any explanation in the
recommendations as to why the time for this activity would be doubling
over the current values. We also proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Bronchoscopy family of codes.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Complete post-procedure diagnostic
forms, lab and x-ray requisitions'' (CA027) activity from 4 minutes to
2 minutes for CPT codes 31623 and 31624. Commenters stated that there
is no standard for the CA027 clinical labor activity and that the CMS
logic to conform to such a standard lacks merit. Commenters also stated
that these services require verification of samples, and completion of
several lab forms and clearly requires more than the standard time for
completing forms.
Response: We disagree with the commenters. While it is true that we
have not formalized 2 minutes as a standard through rulemaking for this
clinical labor activity code, we have typically assigned 2 minutes for
the CA027 activity across a wide variety of codes. Out of the 168 HCPCS
codes that have clinical labor time for the CA027 clinical labor
activity in our database, 64 codes have 2 minutes of assigned clinical
labor time while only 9 codes have 4 minutes of assigned clinical labor
time, which indicates that 2 minutes is far more typical for this
activity. More importantly, commenters did not address our statement
that 2 minutes is the current time for this clinical labor activity,
and we had no reason to believe that the time to perform this task has
increased since the codes were last reviewed. As a result, we are
finalizing our refinement to 2 minutes of clinical labor time for the
CA027 activity.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT codes 31623 and 31624 as
proposed.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and
93264)
In September 2017, the CPT Editorial Panel created a code to
describe pulmonary wireless sensor implantation and another code for
remote care management of patients with an implantable, wireless
pulmonary artery pressure sensor monitor. For CY 2019, we proposed the
RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter
implantation of wireless pulmonary artery pressure sensor for long term
hemodynamic monitoring, including deployment and calibration of the
sensor, right heart catheterization, selective pulmonary
catheterization, radiological supervision and interpretation, and
pulmonary artery angiography, when performed), and the RUC-recommended
work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless
pulmonary artery pressure sensor for up to 30 days including at least
weekly downloads of pulmonary artery pressure recordings,
interpretation(s), trend analysis, and report(s) by a physician or
other qualified health care professional).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Pulmonary Wireless Pressure Sensor Services
family of codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.
(11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)
In February 2017, the CPT Editorial Panel created two new codes
replacing cardiac event recorder codes to reflect new technology. For
CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code
33285 (Insertion, subcutaneous cardiac rhythm monitor, including
programming) and the RUC-recommended work RVU of 1.50 for CPT code
33286 (Removal, subcutaneous cardiac rhythm monitor).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Cardiac Event Recorder Procedures family of
codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and
33286 as proposed.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)
In September 2017, the CPT Editorial Panel created one new code to
combine the efforts of aortic valve and root replacement with
subvalvular left ventricular outflow tract enlargement to allow for an
unobstructed left ventricular outflow tract.
For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for
CPT code 33440 (Replacement, aortic valve; by translocation of
autologous pulmonary valve and transventricular aortic annulus
enlargement of the left ventricular outflow tract with valved conduit
replacement of pulmonary valve (Ross-Konno procedure)). When this code
is re-reviewed in a few years as part of the new technology screen, we
look forward to receiving new recommendations on the whole family,
including the related Ross and Konno procedures (CPT codes 33413 and
33412 respectively) that were used as references for CPT code 33440.
For the direct PE inputs, we proposed to refine the preservice
clinical labor times to match our standards for 90-day global
procedures. We proposed to refine the clinical labor time for the
``Coordinate pre-surgery services (including test results)'' (CA002)
activity from 25 minutes to 20 minutes, to refine the clinical labor
time for the ``Schedule space and equipment in facility'' (CA003)
activity from 12 minutes to 8 minutes, and to refine the clinical labor
time for the ``Provide pre-service education/obtain consent'' (CA004)
activity from 26 minutes to 20 minutes. We also proposed to add 15
minutes of clinical labor time for the ``Perform regulatory mandated
quality assurance activity (pre-service)'' (CA008) activity. We agreed
with the recommendation that the total preservice clinical labor
[[Page 59528]]
time for CPT code 33440 is unchanged from the two reference codes at 75
minutes. However, we believed that the clinical labor associated with
additional coordination between multiple specialties prior to patient
arrival is more accurately described through the use of the CA008
activity code than by distributing this 15 minutes amongst the other
preservice clinical labor activities. We previously established
standard preservice times for 90-day global procedures, and did not
want to propose clinical labor times above those standards for CPT code
33440. We also noted that there is no effect on the total clinical
labor direct costs in this situation, since the same 15 minutes of
preservice clinical labor time is still being furnished.
The following is a summary of the public comments we received on
our proposals involving CPT code 33440.
Comment: A few commenters stated that they had no objections to the
CMS proposal to refine the preservice clinical labor times for the
direct PE inputs for code 33440 to match the 90-day global procedure
standards and to add 15 minutes of clinical labor time to clinical
labor activity code CA008. The commenters stated that they believed the
RUC-recommended allocation of the preservice activities was
appropriate, whereas activity code CA008 was not an accurate
description of the additional work being done, and hoped that CMS would
not use the allocation of time to CA008 as a way to reduce the
preservice time in future rulemaking.
Response: We appreciate the feedback on our proposed direct PE
refinements from the commenters.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for CPT code 33440 as proposed.
(13) Hemi-Aortic Arch Replacement (CPT Code 33866)
At the September 2017 CPT Editorial Panel meeting, the Panel
created one new add-on code to report hemi-aortic arch graft
replacement. For CY 2019, we proposed the RUC-recommended work RVU of
19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and
control of the arch vessels, beveled open distal aortic anastomosis
extending under one or more of the arch vessels, and total circulatory
arrest or isolated cerebral perfusion). CPT code 33866 is a facility-
only procedure with no recommended direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving CPT code 33866.
Comment: We received several comments, including comments from the
RUC. The RUC noted in its comment letter that at the April 2018 RUC
meeting, the specialty societies determined that the family of services
encompassing CPT code 33866 should be submitted to the CPT Editorial
Panel for the following revisions: (1) To develop distinct codes for
ascending aortic report for dissection and ascending aortic repair for
other ascending aortic disease such as aneurysms and congenital
anomalies. The specialties noted that there is a difference in the work
associated with these procedures and now there is sufficient volume to
allow for more accurate capture of the work and outcomes data for these
distinct patient populations, which was not the case when the code was
first developed, (2) Revise the descriptor for transverse arch code,
CPT code 33870, to further clarify the difference in work between the
new add on code, CPT code 33866, and (3) Revise the guidelines to
provide additional instructions on the appropriate use of these codes.
The RUC further noted that the specialty societies had already
submitted a new coding proposal for consideration at the May 2018 CPT
Editorial Panel for CPT 2020, which the RUC supported. Following the
April 2018 RUC meeting, the RUC rescinded its interim value
recommendation (work RVU of 19.74) to us for CPT code 33866 for CY
2019. One commenter noted, that although the RUC rescinded the interim
work RVU of 19.74 due to a specialty societies' recommendation to
submit the family of services to the CPT Editorial Panel, they
encouraged CMS to consider using the work RVU of 19.74 as an interim
value until the code can be re-surveyed and reviewed by the RUC. The
commenter further noted that using the RUC-recommended value would
allow physicians to be paid for the service in CY 2019, decreasing the
burden of reporting a carrier-priced service to both the carriers and
providers.
Response: While we recognize that the RUC rescinded its work RVU
recommendation, we note that we proposed the RUC-recommended work RVU
for valuation in CY 2019. We also want to remind commenters that we no
longer establish interim valuations on a routine basis, and we are not
convinced that establishing an interim valuation for CPT code 33866 is
necessary. We will review any new coding that the CPT Editorial Panel
provides for 2020, and will review any recommendations we receive
timely from the RUC or other stakeholders for valuation through CY 2020
rulemaking.
After consideration of the public comments received, we are
finalizing the RUC-recommended work RVUs for CPT code 33866 as
proposed.
(14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)
At the September 2017 CPT Editorial Panel meeting, the Panel
replaced the five leadless pacemaker services, Category III codes, with
the addition of two new CPT codes to report transcatheter leadless
pacemaker procedures and revised five codes to include evaluation and
interrogation services of leadless pacemaker systems.
For CPT code 33274 (Transcatheter insertion or replacement of
permanent leadless pacemaker, right ventricular, including imaging
guidance (e.g., fluoroscopy, venous ultrasound, ventriculography,
femoral venography) and device evaluation (e.g., interrogation or
programming), when performed), we disagreed with the recommended work
RVU of 8.77 and we proposed a work RVU of 7.80 based on a direct
crosswalk to one of the top reference codes selected by the RUC survey
participants, CPT code 33207 (Insertion of new or replacement of
permanent pacemaker with transvenous electrode(s); ventricular). This
code has the same 60 minutes of intraservice time as CPT code 33274 and
an additional 61 minutes of total time at a work RVU of 7.80. In our
review of CPT code 33274, we noted that this reference code had an
additional inpatient hospital visit of CPT code 99232 (Subsequent
hospital care, per day, for the evaluation and management of a patient,
which requires at least 2 of 3 key components) and a full instead of a
half discharge visit of CPT code 99238 (Hospital discharge day
management; 30 minutes or less) included in its 90-day global period.
The combined work RVU of these two visits would be equal to 2.03.
However, the recommended work RVU for CPT code 33274 was 0.97 work RVUs
higher than CPT code 33207, despite having fewer of these visits and
significantly less surveyed total time. While we acknowledge that CPT
code 33274 is a more intense procedure than CPT code 33207, we do not
believe that it should be valued almost a full RVU higher than the
reference code given the fewer visits in the global period and the
lower surveyed work time.
Therefore, we proposed to crosswalk CPT code 33274 to CPT code
33207 at the same work RVU of 7.80. The proposed work RVU was also
supported through a reference crosswalk to CPT code 38542 (Dissection,
deep jugular node(s)), which has 60 minutes of intraservice time, 198
minutes of total time, and a work RVU of 7.95. We believe that our
proposed work RVU of
[[Page 59529]]
7.80 is a more accurate valuation for CPT code 33274, while still
recognizing the greater intensity of this procedure in comparison to
its reference code.
For CPT code 33275 (Transcatheter removal of permanent leadless
pacemaker, right ventricular), we disagreed with the RUC-recommended
work RVU of 9.56 and we proposed a work RVU of 8.59. Although we
disagreed with the RUC-recommended work RVU, we concurred that the
relative difference in work between CPT codes 33274 and 33275 is
equivalent to the recommended interval of 0.79 RVUs. Therefore, we
proposed a work RVU of 8.59 for CPT code 33275, based on the
recommended interval of 0.79 additional RVUs above our proposed work
RVU of 7.80 for CPT code 33274. We also noted that our proposed work
RVU for CPT code 33275 situates it approximately halfway between the
two reference codes from the survey, with CPT code 33270 (Insertion or
replacement of permanent subcutaneous implantable defibrillator system,
with subcutaneous electrode, including defibrillation threshold
evaluation, induction of arrhythmia, evaluation of sensing for
arrhythmia termination, and programming or reprogramming of sensing or
therapeutic parameters, when performed) having an intraservice time of
90 minutes and a work RVU of 9.10, and CPT code 33207 having an
intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275
has a surveyed intraservice time of 75 minutes and nearly splits the
difference between them at our proposed work RVU of 8.59.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Leadless Pacemaker Procedures family of
codes.
Comment: One commenter recommended that CMS adopt the RUC-
recommended RVUs for both codes due to the newness of the procedures.
The commenter stated that there might not be sufficient evidence or
rationale for CMS to disagree with the RUC-recommended values, and
again cited the newness of these procedures.
Response: We disagree with the commenter that the newness of a
procedure would provide a sufficient rationale for finalizing the RUC-
recommended work RVU for a new CPT code without any further
consideration. Establishing valuations for newly created CPT codes is a
routine part of maintaining the PFS, and we have historically valued
new services since the inception of the resource-based relative value
system. We also believe that RUC surveys are less likely to be
representative of practitioners when evaluating new services, due to
the fact that practitioners are not yet sufficiently experienced with
the services to provide accurate evaluations, which is why we have been
supportive of the RUC's policy to resurvey new services a few years
after their creation when typical practice patterns have been more
firmly established.
Comment: Many commenters disagreed with the proposed work RVUs for
CPT codes 33274 and 33275 and stated that CMS should instead finalize
the RUC-recommended work RVUs for these services. Commenters stated
that CMS provided no qualitative or quantitative rationale to support
their assumption that the difference in time between CPT codes 33274
and the top key reference from the survey (CPT code 33207) completely
reflects the difference in intensity. Commenters stated that patients
receiving leadless pacemakers are more complex and have more
comorbidities and contraindications than transvenous patients, with
more significant groin complications and more commonly present
tamponade. Commenters stated that there were other issues that make CPT
code 33274 more challenging, including: (1) Capture thresholds tend to
change more than with transvenous devices; (2) There is a higher risk
for complications including embolization and groin complications, which
are not associated with tranvenous implants; and (3) Patients
undergoing leadless pacemaker procedures are more likely to have
chronic atrial fibrillation and poor venous access. Commenters
emphasized that they believed the leadless pacemaker procedure
described by CPT code 33274 was more intensive than the CMS crosswalk
to CPT code 33207.
Response: We disagree with the commenters' assertion that we
provided no qualitative or quantitative rationale to support our choice
of a crosswalk to CPT code 33207. We stated in the proposed rule that
in our review of CPT code 33274, we noted that this reference code had
an additional inpatient hospital visit of CPT code 99232 and a full,
instead of a half, discharge visit of CPT code 99238 included in its
90-day global period. We acknowledged that CPT code 33274 is a more
intense procedure than CPT code 33207; however, we did not believe that
it should be valued almost a full RVU higher than the reference code.
We also supported the proposed work RVU through the use of a reference
code, CPT code 38542, which was not addressed by the commenters.
We also disagree with the commenters that CPT code 33274 has so
much additional intensity and complexity as compared to key reference
CPT code 33207 that they should be valued at the same work RVU of 8.77.
We note that the RUC's research panel selected preservice package 3,
``a straightforward patient and a difficult procedure'' for CPT code
33274. We believe this indicates that the patient population for CPT
code 33274 would not be unusually difficult or complex as suggested by
the commenters. We further note that the summary of recommendations for
CPT code 33274 states that these patients are typically sent home from
the facility the next day. In contrast, reference CPT code 33207
includes a full hospital inpatient day of post procedure care
associated with CPT code 99322, as well as a full discharge visit
instead of half of a discharge visit. We believe that this further
suggests that the patient population for CPT code 33274 would not be
more difficult or complex than the patient population for CPT code
33207. As we stated in the proposed rule, we continue to acknowledge
that CPT code 33274 is a more intense procedure than CPT code 33207,
but we do not believe that it should be valued almost a full RVU higher
than the reference code given the fewer visits in the global period and
the lower surveyed work time.
Comment: Commenters stated that CMS should use valid methods of
evaluating services, such as survey data and magnitude estimation,
instead of relying on an incremental difference in work RVUs between
CPT codes 33274 and 33275.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 33275,
supporting our proposed valuation by noting that the CMS work RVU of
8.59 situated the code approximately halfway between the two reference
codes from the survey, with CPT code 33270 having an intraservice time
of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an
intraservice
[[Page 59530]]
time of 60 minutes and a work RVU of 7.80.
Comment: Several commenters stated that while these procedures
described in CPT code 33275 will be rare, these patients will still
have the elevated risk factors mentioned in discussion of CPT code
33274 and warranted the additional work indicated by survey respondents
at the 25th percentile of the survey.
Response: We continue to believe that the patients in CPT code
33274 would not be more difficult or complex than the patients in CPT
code 33207 for the reasons detailed above. We continue to believe that
the relative difference in work between CPT codes 33274 and 33275 is
equivalent to the recommended interval of 0.79 RVUs.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Leadless Pacemaker
Procedures family as proposed.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, and
36584)
In CY 2016, CPT code 36569 (Insertion of peripherally inserted
central venous catheter (PICC), without subcutaneous port or pump,
without imaging guidance; age 5 years or older) was identified as
potentially misvalued using a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. CPT
code 36569 is typically reported with CPT codes 76937 (Ultrasound
guidance for vascular access requiring ultrasound evaluation of
potential access sites, documentation of selected vessel patency,
concurrent real-time ultrasound visualization of vascular needle entry,
with permanent recording and reporting) and 77001 (Fluoroscopic
guidance for central venous access device placement, replacement
(catheter only or complete), or removal) and was referred to the CPT
Editorial Panel to have the two common imaging codes bundled into the
code. In September 2017, the CPT Editorial Panel revised CPT codes
36568 (Insertion of peripherally inserted central venous catheter
(PICC), without subcutaneous port or pump; younger than 5 years of
age), 36569 and 36584 (Replacement, complete, of a peripherally
inserted central venous catheter (PICC), without subcutaneous port or
pump, through same venous access, including all imaging guidance, image
documentation, and all associated radiological supervision and
interpretation required to perform the replacement) and created two new
CPT codes to specify the insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion.
For CY 2019, we proposed the RUC-recommended work RVU for two of
the CPT codes in the family. We proposed the RUC-recommended work RVU
of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for
CPT code 36569.
For CPT code 36572 (Insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion; younger than 5 years of age), we disagreed with the RUC-
recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a
direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy)
and all associated radiological supervision and interpretation). CPT
code 50435 is a recently reviewed code that also includes radiological
supervision and interpretation with similar intraservice and total time
values. In our review of CPT code 36572, we were concerned about the
possibility that the recommended work RVU of 2.00 could create a rank
order anomaly in terms of intensity with the other codes in the family.
We noted that the recommended intraservice time for CPT code 36572 as
compared to CPT code 36568, the most similar code in the family, is
decreasing from 38 minutes to 22 minutes (42 percent), and the
recommended total time is decreasing from 71 minutes to 51 minutes (38
percent); however, the recommended work RVU is only decreasing from
2.11 to 2.00, which is a reduction of just over 5 percent. We also
noted that CPT code 36572 has a lower recommended intraservice time and
total time as compared to CPT code 36569, yet has a higher recommended
work RVU. Although we did not imply that the decreases in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs.
In the case of CPT code 36572, we believed that it would be more
accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code
50435 to better fit with the recommended work RVUs for CPT codes 36568
and 36569. The proposed work valuation was also based on the use of
three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle
or catheter, aspiration of the pleural space; without imaging
guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with
biopsy, single or multiple), and CPT code 64644 (Chemodenervation of
one extremity; 5 or more muscles). All of these codes were recently
reviewed with similar intensity, intraservice time, and total time
values, and all three of them share a work RVU of 1.82.
For CPT code 36573 (Insertion of peripherally inserted central
venous catheter (PICC), without subcutaneous port or pump, including
all imaging guidance, image documentation, and all associated
radiological supervision and interpretation required to perform the
insertion; age 5 years or older), we disagreed with the RUC-recommended
work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining
the current work RVU of CPT code 36569. In our review of CPT code
36573, we were again concerned about the possibility that the
recommended work RVU of 1.90 could create a rank order anomaly in terms
of intensity with the other codes in the family. We noted that the
recommended intraservice time for CPT code 36573 as compared to CPT
code 36569, the most similar code in the family, was decreasing from 27
minutes to 15 minutes (45 percent), and the recommended total time was
decreasing from 60 minutes to 40 minutes (33 percent); however, the
RUC-recommended work RVU was exactly the same for these two codes at
1.90. Although we did not imply that the decreases in time as reflected
in survey values must equate to a one-to-one or linear decrease in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs.
In the case of CPT code 36573, we believed that it would be more
accurate to propose a work RVU of 1.70 based on maintaining the current
work RVU of CPT code 36569. These two CPT codes describe the same
procedure done with (CPT code 36573) and without (CPT code 35659)
imaging guidance and radiological supervision and interpretation.
Because the inclusion of the imaging described by CPT code 36573 has
now become the typical case for this service, we believe that it is
more accurate to maintain the current work RVU of 1.70 as opposed to
[[Page 59531]]
increasing the work RVU to 1.90, especially considering that the new
surveyed work time for CPT code 36573 is lower than the current work
time for CPT code 36569. The proposed work RVU of 1.70 was also based
on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally
inserted central venous catheter; age 5 years or older). This is a
recently reviewed code with the same 15 minutes of intraservice time
and the same 40 minutes of total time with a work RVU of 1.75.
For CPT code 36584, we disagreed with the RUC-recommended work RVU
of 1.47 and proposed a work RVU of 1.20 based on maintaining the
current work RVU. We noted that the recommended intraservice time for
CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent
reduction), and the recommended total time was decreasing from 45
minutes to 34 minutes (25 percent reduction); however, the recommended
work RVU was increasing from 1.20 to 1.47, an increase of approximately
23 percent. Although we did not imply that the decreases in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believed that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs. We were especially
concerned when the recommended work RVU is increasing despite survey
results indicating that the work time is decreasing due to a
combination of improving technology and greater efficiencies in
practice patterns.
In the case of CPT code 36584, we believed that it would be more
accurate to propose a work RVU of 1.20 based on maintaining the current
work RVU for the code. Because the inclusion of the imaging has now
become the typical case for this service, we believed that it was more
accurate to maintain the current work RVU of 1.20 as opposed to
increasing the work RVU to 1.47, especially considering that the new
surveyed work time for CPT code 36584 was decreasing from the current
work time. The proposed work RVU of 1.20 was also based on a crosswalk
to CPT code 40490 (Biopsy of lip), which has the same total time of 34
minutes and slightly higher intraservice time at a work RVU of 1.22.
We noted that the RUC-recommended work pool was increasing by
approximately 68 percent for the PICC Line Procedures family as a
whole, while the RUC-recommended work time pool for the same codes was
only increasing by about 22 percent. Since time is defined as one of
the two components of work, we believe that this indicated a
discrepancy in the recommended work values. We do not believe that the
recoding of the services in this family has resulted in an increase in
their intensity, only a change in the way in which they will be
reported, and therefore, we did not believe that it would serve the
interests of relativity to propose the RUC-recommended work values for
all of the codes in this family. We believe that, generally speaking,
the recoding of a family of services should maintain the same total
work pool, as the services themselves are not changing, only the coding
structure under which they are being reported. We also noted that,
through the bundling of some of these frequently reported services, it
is reasonable to expect that the new coding system will achieve savings
via elimination of duplicative assumptions of the resources involved in
furnishing particular servicers. For example, a practitioner would not
be carrying out the full preservice work three times for CPT codes
36568, 76937, and 77001, but preservice times were assigned to all of
the codes under the old coding. We believed the new coding assigns more
accurate work times and thus reflects efficiencies in resource costs
that existed but were not reflected in the services as they were
previously reported.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare, set-up and start IV, initial positioning and
monitoring of patient'' (CA016) activity from 4 minutes to 2 minutes
for CPT codes 36572 and 36573. We noted that the two reference codes
for the two new codes, CPT codes 36568 and 36569, currently have 2
minutes assigned for this activity, and CPT code 36584 also has a
recommended 2 minutes assigned to this same activity. We did not agree
that the patient positioning would take twice as long for CPT codes
36572 and 36573 as compared to the rest of the family, and therefore
proposed to refine both of them to the same 2 minutes of clinical labor
time. We also proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the PICC Line Procedures family of codes.
Comment: One commenter stated that CMS believes it is not accurate
to ``increase'' work RVUs when survey results indicate that work time
is ``decreasing'' due to improving technology and greater efficiencies
in practice patterns. The commenter disagreed that the difference
between the current codes (without imaging guidance) and the new
bundled codes (with imaging guidance) could be characterized as an
``increase'' or a ``decrease,'' as it was inappropriate simply to
compare the RVUs of the bundled codes to the existing codes, because
the bundled codes include imaging services that involve significantly
more intense physician work than PICC line insertion without imaging
guidance.
Response: We disagree with the commenter that it is
methodologically inappropriate to characterize changes in surveyed work
time as ``increases'' or ``decreases''. As we stated in the proposed
rule, we do not believe that the revised coding of the services in this
family has changed the services themselves or resulted in an increase
in their intensity, only changed in the way in which they will be
reported under the new coding. CPT code 36572 is a new code resulting
from the bundling together of CPT code 36568 with imaging guidance. The
same services that were previously reported through a combination of
CPT codes 36568 and 76397 will now be reported under CPT code 36572. We
believe that it is highly relevant to note how the recommended work
times for CPT code 36572 compare to the recommended work times for CPT
code 36568, which includes noting that the intraservice time is
decreasing from 38 minutes to 22 minutes (42 percent), and the
recommended total time is decreasing from 71 minutes to 51 minutes (38
percent). We also do not agree that it is inappropriate to compare the
RVUs of the bundled codes to the existing codes, as all of these
procedures describe clinically similar procedures that together
comprise a family of codes. In more general terms, we continue to
believe that the nature of the PFS relative value system is such that
all services are appropriately subject to comparisons to one another.
Although codes with clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must both include imaging
guidance or not include imaging guidance to be used as a crosswalk.
Comment: Several commenters disagreed that the recoding of the
services in the PICC line code family had only resulted in a change in
the way that services will be reported, and stated that that the
imaging-related services now bundled into CPT codes 36572, 36573, and
36584 are significantly more intense than PICC line insertion standing
alone. One commenter stated that valuing a code using imaging guidance
the same or less than the same code without imaging guidance is
[[Page 59532]]
specious and treats the use of imaging guidance as a negative work
component when in fact there is additional work required in using
imaging guidance. Commenters stated that the RUC-recommended values
already reflect efficiencies in radiology work, and that the efficiency
of radiologists should not diminish the RUC's recognition that their
work is significantly more intense in these procedures.
Response: We disagree with the commenters that the addition of
imaging guidance has made CPT codes 36572, 36573, and 36584
significantly more intense than the non-imaging guidance version of
these procedures. While the incorporation of new technology can
sometimes make services more complex and difficult to perform, it can
also have the opposite effect by making services less reliant on manual
skill and technique. We believe that if these procedures were
significantly more intensive to perform, this would be reflected in the
surveyed work times associated with these codes. However, the surveyed
work times are instead decreasing in all three cases in comparison to
the current non-imaging guidance version of the same services. As we
stated in the proposed rule, we believe that the work times for these
services are decreasing due to a combination of improving technology
and greater efficiencies in practice patterns. Based on the RUC-
recommended utilization crosswalk for these services, which has 90 to
95 percent of the utilization expected to be reported under the new
codes that include imaging guidance, we believe that the use of imaging
guidance has become typical for these services and does not represent a
dramatic increase in intensity.
Comment: Many commenters disagreed with the proposed work RVU of
1.82 for CPT code 36572 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that the CMS use of a
crosswalk to CPT code 50435 was unsupported on a clinical basis, with
significant differences in work intensity and patient population.
Commenters stated that CPT code 36572 involves establishing new deep
venous access on a pediatric patient while ensuring maximum sterile
barrier technique so as to prevent a hospital acquired infection,
whereas CPT code 50435 involves the exchange of an existing catheter in
an adult who understands the procedure involved and has had previous
catheter exchanges to maintain patency. One commenter stated that the
RUC crosswalk to CPT code 19283 (Placement of breast localization
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive
seeds)) was a more accurate choice because this service also uses
imaging guidance to obtain de novo percutaneous access to a target and
perform an intervention. Commenters stated that the crosswalk code
would frequently be less intense than CPT code 36572.
Response: We disagree with the commenters that the work involved in
CPT code 50435 would be less clinically intense than the work in CPT
code 36572. We believe that the exchange of a nephrostomy catheter
taking place in CPT code 50435 is more difficult than the placement of
a breast localization device as in the RUC crosswalk to CPT code 19283,
percutaneous; first lesion, including stereotactic guidance). We also
disagree with the commenters that the crosswalk we identified lacks
clinical similarity to CPT code 36572. Both the reviewed code and the
crosswalk to CPT code 50435 involve the percutaneous placement of a
catheter in a deep structure; we believe that this crosswalk code is
more clinically similar than the RUC's choice of a crosswalk to CPT
code 19283, which does not involve catheter placement at all.
Commenter: Several commenters disagreed that the RUC-recommended
work RVU of 2.00 for CPT code 36572 would create a rank order anomaly
within the family of codes. Commenters stated that since CPT code 36568
requires more physician time to complete than CPT code 36572 (38 versus
22 minutes intra-service time), the recommended work RVU of 2.00 for
CPT code 36572 maintains the proper rank order within this family of
services considering differences in patient population and differences
in clinical intensity of work.
Response: The commenters did not address the concerns we expressed
regarding a potential rank order anomaly within the family. We noted in
the proposed rule that CPT code 36572 had a lower recommended
intraservice time and total time as compared to CPT code 36569 (not CPT
code 36568), yet had a higher recommended work RVU. We continue to
believe that this creates the potential for a rank order anomaly within
the family, and we do not believe that this discrepancy can be
justified by differences in patient population and differences in
clinical intensity of work.
Comment: Several commenters disagreed with the CMS statement that
the reduced intraservice and total times in CPT code 36572 as compared
to CPT code 36568 should result in a lower work value. Commenters
stated that this was a simplistic comparison based on time, and that
these were two technically different procedures, involving different
patient populations and different service intensity. Commenters stated
that each step in the non-image guided CPT code 36568 takes longer,
though involves more periods of low intensity intraservice work as
compared to CPT code 36572, where each procedural step is performed
sequentially without the less intense intraservice work of the non-
image guided CPT code 36568.
Response: We disagree with the commenters that the reductions in
intraservice and total work time in CPT code 36572 as compared to CPT
code 36568 should not result in a lower work value. Although we do not
imply that the decreases in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we continue to believe that, since the two components of work are
time and intensity, significant decreases in time should typically be
reflected in decreases to work RVUs. We disagree that this is a
simplistic comparison, and chose a crosswalk to CPT code 50435 to
better fit with the recommended work RVUs for CPT codes 36568 and
36569.
We also do not agree that CPT codes 36568 and 36572 have
significantly different patient populations and different service
intensity. As we stated in the proposed rule, we do not believe that
the revised coding of the services in this family has changed the
services themselves or resulted in an increase in their intensity, only
changed in the way in which they will be reported under the new coding.
CPT code 36572 is a new code resulting from the bundling together of
CPT code 36568 with imaging guidance. The same services that were
previously reported through a combination of CPT codes 36568 and 76397
will now be reported under CPT code 36572. Given that 90 percent of the
services that were formerly reported using CPT code 36568 will now be
reported using CPT code 36572, we do not agree that these codes
represent significantly different patient populations.
Comment: Many commenters disagreed with the proposed work RVU of
1.70 for CPT code 36573 and stated that CMS should finalize the RUC-
recommended work RVU of 1.90. Commenters stated that CMS should not use
a code value that is no longer in existence as the service (CPT code
36569) itself has been revised and is currently under review in this
family. Commenters stated that the reference was therefore not valid to
the old work RVU.
[[Page 59533]]
Response: We disagree with the commenters that it is somehow
invalid to use a crosswalk to the current work RVU for CPT code 36569.
It is not accurate to state that this code is no longer in existence,
as it is being revised for CY 2019, not deleted. The RUC frequently
recommends maintaining the current work RVU for reviewed codes rather
than using a new work RVU from survey results when it believes that
there is appropriate rationale to do so. Given that CPT code 36573 is a
new code resulting from the bundling together of CPT code 36569 with
imaging guidance, and that the use of imaging guidance has become
typical in the performance of this service, we believe that it is
appropriate to maintain the same work RVU for these services when they
are reported under the new coding, especially in light of the fact that
the surveyed intraservice work time for CPT code 36573 remains the same
15 minutes as the current intraservice work time for CPT code 36569.
Comment: Several commenters stated that CPT code 36573 involves a
different patient population than CPT code 36569, as the patient
population for CPT code 36573 does not have peripheral venous access
present that can be used to obtain central venous access. Commenters
stated that there is no evidence for a rank order anomaly within the
codes in the family considering the differences in intensity and
patient population.
Response: As we stated previously with regard to CPT codes 36568
and 36572, we also do not agree that CPT codes 36569 and 36573 have
significantly different patient populations and different service
intensity. As we stated in the proposed rule, we do not believe that
the revised coding of the services in this family has changed the
services themselves or resulted in an increase in their intensity, only
changed in the way in which they will be reported under the new coding.
CPT code 36573 is a new code resulting from the bundling together of
CPT code 36569 with imaging guidance. The same services that were
previously reported through a combination of CPT codes 36569 and 76397
will now be reported under CPT code 36573. Given that 95 percent of the
services that were formerly reported using CPT code 36569 are expected
to be reported using CPT code 36573, we do not agree that these codes
represent noticeably different patient populations.
Comment: Several commenters disagreed with our use of CPT code
36556 as a reference code. Commenters stated that CPT code 36556
describes line placement in a larger and more central vein such as the
internal jugular vein with known anatomical landmarks and a shorter
distance between access and where the tip terminates centrally while
CPT code 36573 describes access into a smaller vein without anatomic
landmarks. Commenters stated that although imaging is inherent to CPT
code 36573, the catheter is longer and there is a need to navigate the
catheter through these peripheral and central veins for adequate
placement, all of which would require more work.
Response: We disagree with the commenters that CPT code 36556 would
not be an accurate reference code for CPT code 36573. CPT code 36556
describes the insertion of non-tunneled centrally inserted central
venous catheter whereas CPT code 36573 describes the insertion of a
peripherally inserted central venous catheter (PICC). We believe that
these two codes, which both describe the insertion of central venous
catheters, are highly similar to one another on a clinical basis and
also from the perspective of work time, as they share the identical
intraservice work time and total work time. Moreover, after further
consideration, we are not able to identify any other more appropriate
reference code for CPT code 36573 than CPT code 36556.
Comment: Many commenters disagreed with the proposed work RVU of
1.20 for CPT code 36584 and stated that CMS should finalize the RUC-
recommended work RVU of 1.47. Commenters stated that CMS was completely
dismissing the additional work that was bundled in with CPT code 36584
as part of the imaging guidance. Commenters stated that the RUC agreed
that the recommended work RVU of 1.47 involves less time but involves a
significant increase in intensity, and that the work RVU should not
remain at the current work RVU of 1.20 as CPT code 36584 is now a
bundled service.
Response: We disagree with the commenters that the bundling of a
service or the addition of imaging guidance must necessarily increase
the intensity of the service or the work RVU. As we stated above, while
the incorporation of new technology can sometimes make services more
complex and difficult to perform, it can also have the opposite effect
by making services less reliant on manual skill and technique. We
believe that if CPT code 36584 had become significantly more intensive
to perform, this would be reflected in the surveyed work times
associated with the code. However, the surveyed intraservice work time
and total work time for CPT code 36584 are both decreasing from their
current values. As we stated in the proposed rule, we believe that
these work times are decreasing due to a combination of improving
technology and greater efficiencies in practice patterns, and we
believe that the use of imaging guidance has become now typical for CPT
code 36584 and does not represent a dramatic increase in intensity.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Prepare, set-up and start IV, initial
positioning and monitoring of patient'' (CA016) activity from 4 minutes
to 2 minutes for CPT codes 36572 and 36573. Commenters stated that this
additional clinical labor time would be typical since it included
positioning of the patient as well as positioning the two forms of
imaging equipment which are being bundled into the code (fluoroscopy
and ultrasound). Commenters stated that the equipment needs to be
positioned in a manner that is specific to the procedure and the chosen
extremity, and that it takes approximately 2 additional minutes to
position the patient and the equipment for those codes which are
imaging-guided as opposed to those procedures which are not. Commenters
stated that this difference applies to the two new placement codes (CPT
code 36572 and 36573) but not to the replacement code (CPT code 36584)
as the equipment is limited to fluoroscopy and the positioning is
slightly simpler as the site already contains a PICC line.
Response: After consideration of the new information provided by
the commenters regarding the need for additional positioning time, we
are not finalizing our proposed refinement to the CA016 clinical labor
time. Due to this change in clinical labor time, we are also not
finalizing any changes to the RUC-recommended equipment times.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the PICC Line Procedures family as proposed.
After considering public comments, we are not finalizing our proposed
direct PE refinements, and we are instead finalizing the RUC-
recommended direct PE inputs for all five codes.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)
In September 2017, the CPT Editorial Panel created a new code to
describe biopsy or excision of inguinofemoral node(s). A parenthetical
was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633
(Vulvectomy, radical, complete) to instruct separate reporting of CPT
code 38531 with radical
[[Page 59534]]
vulvectomy. This service was previously reported with unlisted codes.
CPT code 38531 (Biopsy or excision of lymph node(s); open,
inguinofemoral node(s)) is a new CPT code describing a lymph node
biopsy without complete lymphadenectomy. The RUC recommended a work RVU
of 6.74 for CPT code 38531, with 223 minutes of total time and 65
minutes of intraservice time. We proposed the RUC-recommended work RVU
of 6.74 for CPT code 38531. However, we were concerned that this CPT
code is described as having a 10-day global period. The two CPT codes
that are often reported together with this code, CPT codes 56630 and
56633, are both 90-day global codes. In addition, CPT code 38531 has a
discharge visit and two follow up visits in the global period. This is
consistent with the number of postoperative visits typically associated
with 90-day global codes. Therefore, we proposed to assign a 90-day
global indicator for CPT code 38531 rather than the 10-day global time
period reflected in the RUC recommendation.
We did not propose any direct PE refinements for this code family.
Comment: Several commenters thanked us for proposing the RUC-
recommended work RVU of 6.74 for CPT code 38531.
Response: We appreciate the support from commenters.
Comment: Several stakeholders disagreed with CMS's proposal to
change the global status of this code from a 10-day global code to a
90-day global code. They maintained that there are no claims data
available to assess how often CPT code 38531 will be billed together
with CPT codes 56630 or 56633. Commenters also noted that there is no
necessary direct correlation between the two codes (CPT code 56630 and
CPT code 56633) having a 90-day global period and the new code having a
90-day global period.
Response: We agree with commenters that when two or more closely
related CPT codes are billed together, there is no requirement for them
to share the same global period. However, the amount of post service
time and the number of visits in CPT code 38531 are consistent with
other 90-day global codes. We continue to believe that CPT code 38531
should have a 90-day global period and we are finalizing that change as
proposed.
Comment: A few commenters pointed out that CMS has the opportunity
to review the global periods for new codes directly after CPT Editorial
Panel meetings, and that CMS should have provided input regarding the
code's global period at that time.
Response: While some of our staff have the opportunity to review
global periods for new or modified CPT codes immediately after the CPT
Editorial Panel meeting, the Agency does not systematically review or
provide feedback on components of a CPT code, including global period,
until we fully consider and address the code as part of the annual PFS
notice-and-comment rulemaking process.
After consideration of the public comments, we are finalizing a
work RVU of 6.74 for CPT code 38531 as proposed.
(17) Radioactive Tracer (CPT Code 38792)
CPT code 38792 (Injection procedure; radioactive tracer for
identification of sentinel node) was identified as potentially
misvalued on a screen of codes with a negative intraservice work per
unit of time (IWPUT), with 2016 estimated Medicare utilization over
10,000 for RUC reviewed codes and over 1,000 for Harvard valued and
CMS/Other source codes. For CY 2019, we proposed the RUC-recommended
work RVU of 0.65 for CPT code 38792.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 38792,
as well as its alternate reference code, CPT code 78300 (Bone and/or
joint imaging; limited area), did not previously have clinical labor
time assigned for the ``Confirm order, protocol exam'' clinical labor
task, and we do not have any reason to believe that the services being
furnished by the clinical staff have changed, only the way in which
this clinical labor time has been presented on the PE worksheets. We
also note that there is no effect on the total clinical labor direct
costs in these situations, since the same 3 minutes of clinical labor
time is still being furnished. We also proposed to refine the equipment
times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 38792.
Comment: A commenter stated that they appreciated and supported our
proposal to adopt the RUC-recommended work RVU of 0.65. The commenter
also stated that they agreed with and supported the changes CMS
proposed in clinical labor time and the standardized equipment time
formulas.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 38792 as proposed.
(18) Percutaneous Change of G-Tube (CPT Code 43760)
CPT code 43760 (Change of gastrostomy tube, percutaneous, without
imaging or endoscopic guidance) was identified as potentially misvalued
on a screen of 0-day global services reported with an E/M visit 50
percent of the time or more, on the same day of service by the same
patient and the same practitioner, that have not been reviewed in the
last 5 years with Medicare utilization greater than 20,000. It was
surveyed for the April 2017 RUC meeting and recommendations for work
and direct PE inputs were submitted to CMS. However, the RUC also noted
that because the data for CPT code 43760 were bimodal, it might be
appropriate to consider changes in the CPT descriptors to better
differentiate physician work. In September 2017, the CPT Editorial
Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes
43762 and 43763, which describe replacement of gastrostomy tube, with
and without revision of gastrostomy tract, respectively. (See
discussion of these codes below.) Therefore, we did not propose work or
direct PE values for CPT code 43760.
Due to the impending deletion of CPT code 43760, we received no
comments on this code.
(19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)
In September 2017, the CPT Editorial Panel created two new codes
that describe replacement of gastrostomy tube, with and without
revision of gastrostomy tract, respectively. These two new codes were
surveyed for the January 2018 RUC meeting and recommendations for work
and direct PE inputs were submitted to CMS.
We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of
gastrostomy tube, percutaneous, includes removal, when performed,
without imaging or endoscopic guidance; not requiring revision of
gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763
(Replacement of gastrostomy tube, percutaneous, includes removal, when
performed, without imaging or endoscopic guidance; requiring revision
of gastrostomy tract.), consistent with the RUC's recommendations for
these new CPT codes.
[[Page 59535]]
For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the codes in the Gastrostomy Tube Replacement
code family.
Comment: Several commenters stated that they appreciated CMS
proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was added to the calculation of the equipment
time, and that this made it difficult to determine the accuracy of the
refinements. The commenter requested more information about this
change.
Response: For the four equipment items where we made time
refinements, we added the clinical labor for the CA029 clinical labor
activity in accordance with our standard equipment time formula for
non-highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for the codes in the as Gastrostomy Tube
Replacement code family as proposed.
(20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)
CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or
without collection of specimen(s) by brushing or washing (separate
procedure)) was identified as potentially misvalued on a screen of 0-
day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years, with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.80 for CPT code 45300.
For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 45300.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the four equipment items where we made time
refinements, we removed the clinical labor for the CA035 clinical labor
activity in accordance with our standard equipment time formula for
non-highly technical equipment.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 45300 as proposed.
(21) Hemorrhoid Injection (CPT Code 46500)
CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was
identified as potentially misvalued on a screen of codes with a
negative intraservice work per unit of time (IWPUT), with 2016
estimated Medicare utilization over 10,000 for RUC reviewed codes and
over 1,000 for Harvard valued and CMS/Other source codes.
For CPT code 46500, we disagreed with the RUC-recommended work RVU
of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk
to CPT code 68811 (Probing of nasolacrimal duct, with or without
irrigation; requiring general anesthesia). This crosswalk code is
another recently-reviewed 10-day global code with the same 10 minutes
of intraservice time and slightly higher total time. When CPT code
46500 was previously reviewed as described in the CY 2016 PFS final
rule with comment period (80 FR 70963), we finalized a proposal to
reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by
the same ratio as the reduction in the total work time. In light of the
additional evidence provided by this new survey, we agree that the work
RVU should be increased from the current value of 1.42. However, we
believe that our proposed work RVU of 1.74 based on a crosswalk to CPT
code 68811 is more accurate than the RUC-recommended work RVU of 2.00.
In the most recent survey of CPT code 46500, the intraservice work
time remained unchanged at 10 minutes while the total time increased by
only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent).
However, the RUC-recommended work RVU is increasing from 1.42 to 2.00,
an increase of 41 percent, and also an increase of 19 percent over the
historic value of 1.69 for CPT code 46500. Although we did not imply
that the increase in time as reflected in survey values must equate to
a one-to-one or linear increase in the valuation of work RVUs, we
believe that since the two components of work are time and intensity,
minimal increases in surveyed work time typically should not be
reflected in disproportionately large increases to work RVUs. In the
case of CPT code 46500, we believe that our crosswalk to CPT code 68811
at a work RVU of 1.74 more accurately maintains relativity with other
10-day global codes on the PFS. We also noted that the 3 percent
increase in surveyed work time for CPT code 46500 matches a 3 percent
increase in the historic work RVU of the code, from 1.69 to 1.74.
Therefore, we proposed a work RVU of 1.74 for CPT code 46500 based on
the aforementioned crosswalk.
For the direct PE inputs, we proposed to remove 10 minutes of
clinical labor time for the ``Assist physician or other qualified
healthcare professional--directly related to physician work time
(100%)'' (CA018) activity. This clinical labor time is listed twice in
the recommendations along with a statement that although the clinical
labor has not changed from prior reviews, time for both clinical staff
members was inadvertently not included in the previous spreadsheets. We
appreciated this notification in the recommendations, and therefore, we
requested more information about why the clinical labor associated with
this additional staff member was left out for previous reviews. We were
particularly interested in knowing what activities the additional staff
member would be undertaking during the procedure. We proposed to remove
the clinical labor associated with this additional clinical staff
member pending the receipt of additional information. We also proposed
to remove 1 impervious staff gown (SB027), 1 surgical mask with face
shield (SB034), and 1 pair of shoe covers (SB039) pending more
information about the additional clinical staff member.
We proposed to remove the clinical labor time for the ``Review home
care instructions, coordinate visits/prescriptions'' (CA035) activity.
CPT code 46500 is typically billed with a same day E/M service, and we
believe that it would be duplicative to assign clinical labor time for
reviewing home care instructions given that this task would typically
be done during the same day E/M service. We also proposed to refine the
equipment times in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 46500.
Comment: Many commenters disagreed with the proposed work RVU
[[Page 59536]]
of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that they disagreed
with CMS calculating intraservice time ratios to account for changes in
work time, and that CPT code 46500 possesses a negative IWPUT, which
makes the use of time ratios particularly inappropriate.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several reasonable methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values do not account for information
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology, we direct readers to the CY
2017 PFS final rule (81 FR 80272 through 80277). We also note that in
the case of CPT code 46500, we derived our proposed work RVU of 1.74 by
using a direct crosswalk to CPT code 68811 and not a time ratio.
Comment: Several commenters stated that the RUC compared CPT code
46500 to the two key reference services: CPT code 46221
(Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code
46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g.,
infrared coagulation, cautery, radiofrequency)). Commenters stated that
the RUC-recommended work RVU of 2.00 places the value correctly between
the key reference services and results in similar procedure intensity,
whereas the CMS crosswalk to CPT code 68811 was not well aligned with
the top two key reference services due to having a lower intensity.
Response: We disagree with the commenters that our crosswalk to CPT
code 68811 would be less accurate for work valuation than the two key
references chosen by the survey respondents. We note, for example, that
CPT code 46221 has 50 percent more intraservice time than CPT code
46500, and CPT code 46930 has 50 percent less intraservice time than
CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the
same 10 minutes of intraservice time as CPT code 46500. We believe that
this closer match in the work time values makes CPT code 68811 a more
appropriate choice for a crosswalk code. We also note that at the RUC
meeting when CPT code 46500 was under review, the specialty presenters
stated that the work RVU had not changed from the historical value of
1.69 before the recommendation was changed to the final value of 2.00.
As we stated in the proposed rule, the 3 percent increase in surveyed
work time for CPT code 46500 matches a 3 percent increase in the
historic work RVU of the code, from 1.69 to 1.74. We continue to
believe that this is the most accurate value to finalize for CPT code
46500.
Comment: Several commenters compared CPT code 46500 to CPT code
68810 (Probing of nasolacrimal duct, with or without irrigation) and
noted that these codes have the same intraservice work time but the
comparison code includes a lower level follow-up visit and therefore
correctly has a lower work RVU. Commenters stated that CPT code 46500
includes a follow-up office visit with an anoscopy to determine the
effectiveness of the treatment and to monitor for infection or sepsis
which adds work to the visit. Commenters stated that the proposed CMS
crosswalk to CPT code 68811 includes an even lower level office visit
(CPT code 99211) than the office visit in CPT code 68810, which
indicated that it was an inappropriate choice for a crosswalk.
Response: We continue to disagree with the commenters that the CMS
crosswalk to CPT code 68811 would provide an inappropriate work
valuation for CPT code 46500 based on the differences in postoperative
work and work time. We would like to clarify again that we used CPT
code 68811 as our crosswalk, not CPT code 68810, and we do not
understand the comparisons to CPT code 68810 suggested by the
commenters. Regarding our crosswalk code, while it is true that CPT
code 68811 does not contain a level three (CPT code 99213) office visit
in its global period like CPT code 46500, the code does include half of
a discharge visit (CPT code 99238) in its global period, which is
missing from the reviewed code. Under the building block methodology,
the combined work RVU and the work time of a half discharge visit (CPT
code 99238) and a level 1 office visit (CPT code 99211) would equal
0.82 RVUs and 26 minutes. This is approximately equal to the level 3
office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work
time) in the global period of CPT code 46500. As a result, we do not
agree with the commenters that CPT code 46500 has a significantly
greater amount of postservice work and postservice work time than our
crosswalk code.
Comment: Several commenters responded to our request for more
information about why the clinical labor associated with the additional
staff member was left out of previous reviews and what activities the
additional staff member would be undertaking during the procedure.
Commenters stated that two clinical staff are needed to assist the
physician during the intraservice portion of the service: one staff
person is handling suction and holding the retractor while the surgeon
identifies and injects anesthetic and sclerosant into the poles of the
hemorrhoids, and the second staff person is handing supplies (syringes,
gauze) and taking soiled supplies away. The commenters stated that one
staff person will assist with tasks such as irrigation, suction, etc.
and one circulating staff person will hand syringes, sponges, etc. to
the physician.
Response: We appreciate the additional feedback from the commenters
regarding what activities the additional staff member would be
undertaking during the procedure, although we note that we did not
receive a response regarding why the clinical labor associated with
this additional staff member was left out of previous reviews. After
reviewing the
[[Page 59537]]
additional information supplied by the commenters, we are not
finalizing our proposal to remove the clinical labor time for the
``Assist physician or other qualified healthcare professional'' (CA018)
activity or the proposal to remove 1 impervious staff gown (SB027), 1
surgical mask with face shield (SB034), and 1 pair of shoe covers
(SB039). We are finalizing the RUC-recommended values for these direct
PE inputs.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Review home care instructions,
coordinate visits/prescriptions'' (CA035) activity. Commenters stated
that this clinical activity was not duplicative with the same day E/M
office visit, as the home care instructions directly pertain to the
procedure and would not be provided during an evaluation of the
patient.
Response: We disagree with the commenters that home care
instructions would not be provided during the same day E/M visit. The
commenters did not provide a rationale to explain why home care
instructions would not be provided during the same day E/M visit, which
also directly pertains to the procedure. We continue to believe that it
would be duplicative to assign clinical labor time for this task, as we
believe that the home care instructions would be furnished during the
same day E/M visit.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the anoscope with light source (ES002) equipment, we
removed the clinical labor for the CA029 and CA035 clinical labor
activities in accordance with our standard equipment time formula for
scopes.
After consideration of the public comments, we are finalizing the
work RVU for CPT code 46500 as proposed. We are finalizing the RUC-
recommended direct PE inputs for this code, with the exception of our
refinement to the CA035 clinical labor activity and standard equipment
time refinements as detailed above.
(22) Removal of Intraperitoneal Catheter (CPT Code 49422)
In October 2016, CPT code 49422 (Removal of tunneled
intraperitoneal catheter) was identified as a site of service anomaly
because Medicare data from 2012-2014 indicated that it was performed
less than 50 percent of the time in the inpatient setting, yet it
included inpatient hospital E/M services within the 10-day global
period. The code was resurveyed using a 0-day global period for the
April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended
work RVU of 4.00 for CPT code 49422.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 49422.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs. Commenters also supported the change in global
period to a 0-day global.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU and direct PE inputs for CPT code 49422 as
proposed.
(23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and
74485)
In October 2014, the CPT Editorial Panel deleted 6 codes and
created 12 new codes to describe genitourinary catheter procedures and
bundle inherent imaging services. In January 2015, the specialty
societies indicated that CPT code 50395 (Introduction of guide into
renal pelvis and/or ureter with dilation to establish nephrostomy
tract, percutaneous), which was identified as part of the family, would
be referred to the CPT Editorial Panel to clear up any confusion with
overlap in physician work with CPT code 50432 (Placement of nephrostomy
catheter, percutaneous, including diagnostic nephrostogram and/or
ureterogram when performed, imaging guidance (e.g., ultrasound and/or
fluoroscopy) and all associated radiological supervision and
interpretation). In September 2017, the CPT Editorial Panel deleted CPT
code 50395 and created 2 new codes to report dilation of existing
tract, and establishment of new access to the collecting system,
including percutaneous, for an endourologic procedure including imaging
guidance (e.g., ultrasound and/or fluoroscopy), all associated
radiological supervision and interpretation, as well as post procedure
tube placement when performed.
The specialty society surveyed the new CPT code 50436 (Dilation of
existing tract, percutaneous, for an endourologic procedure including
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all
associated radiological supervision and interpretation, as well as post
procedure tube placement, when performed), and the RUC recommended a
total time of 70 minutes, intraservice time of 30 minutes, and a work
RVU of 3.37. The RUC indicated that its recommended work RVU for this
CPT code is identical to the work RVU of the CPT code being deleted,
even though imaging guidance CPT code 74485 has now been bundled into
the valuation of the CPT code. The RUC provided two key reference CPT
codes to support its recommendation: CPT code 50694 (Placement of
ureteral stent, percutaneous, including diagnostic nephrostogram and/or
ureterogram when performed, imaging guidance (e.g., ultrasound and/or
fluoroscopy), and all associated radiological supervision and
interpretation; new access, without separate nephrostomy catheter) with
total time of 111 minutes, intraservice time of 62 minutes, and a work
RVU of 5.25; and CPT code 50695 (Placement of ureteral stent,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; new
access, with separate nephrostomy catheter), with total time of 124
minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To
further support its recommendation, the RUC also referenced CPT code
52287 (Cystourethroscopy, with injection(s) for chemodenervation of the
bladder) with total time of 58 minutes, intraservice time of 21
minutes, and a work RVU of 3.37.
We disagreed with the RUC that the work RVU for this CPT code
should be the same as the CPT code being deleted. Survey respondents
indicated that the total time for completing the service described by
the new CPT code is nearly 30 minutes less than the existing CPT code,
even though imaging guidance was described as part of the procedure. We
also noted that the reference CPT codes both have substantially higher
total and intraservice times than CPT code 50436. We considered a
number of parameters to arrive at our proposed work RVU of 2.78,
supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
therapeutic aspiration of tracheobronchial tree, subsequent, same
hospital stay). We examined the intraservice time ratio for the new CPT
code in relation to the combination of CPT codes that the service
represents and found that this would support a work RVU of 2.55. We
also calculated the intraservice time ratio for the new CPT code in
relation to each of the two
[[Page 59538]]
reference CPT codes. For the comparison with CPT code 50694, the
intraservice time ratio is 2.54, while the comparison with the second
reference CPT code 50695 yields an intraservice time ratio of 2.72. We
took the highest of these three values, 2.72, and found a corresponding
crosswalk that we believe appropriately values the service described by
the new CPT code. Therefore, we proposed a work RVU of 2.78 for CPT
code 50436.
The specialty society also surveyed the new CPT code 50437
(Dilation of existing tract, percutaneous, for an endourologic
procedure including imaging guidance (e.g., ultrasound and/or
fluoroscopy) and all associated radiological supervision and
interpretation, as well as post procedure tube placement, when
performed; including new access into the renal collecting system) and
the RUC recommended a total time of 100 minutes, an intraservice time
of 60 minutes, and a work RVU of 5.44. The recommended intraservice
time of 60 minutes reflects the 75th percentile of survey results,
rather than the median survey time, which is typically used for
determining the intraservice time for new CPT codes. The RUC justified
the use of the higher intraservice time because they believe the time
better represents the additional time needed to introduce the guidewire
into the renal pelvis and/or ureter, above and beyond the work involved
in performing CPT code 50436. The RUC compared this CPT code to CPT
code 52235 (Cystourethroscopy, with fulguration (including cryosurgery
or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to
5.0 cm)), with total time of 94 minutes, intraservice time of 45
minutes, and a work RVU of 5.44. The RUC also cited as support the
second key reference CPT code 50694 (Placement of ureteral stent,
percutaneous, including diagnostic nephrostogram and/or ureterogram
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy),
and all associated radiological supervision and interpretation; new
access, without separate nephrostomy catheter) with total time 111
minutes, intraservice time 62 minutes, and a work RVU of 5.25.
We did not agree with the RUC's recommended work RVU because we
believed that the intraservice time for this CPT code should reflect
the survey median rather than the 75th percentile. There is no
indication that the additional work of imaging guidance was
systematically excluded by survey respondents when estimating the time
needed to furnish the service. Therefore, we proposed to reduce the
intraservice time for CPT code 50437 from the RUC- recommended 60
minutes to the survey median time of 45 minutes. We noted that this is
still 15 minutes more than the intraservice time for CPT code 50436,
primarily for the provider to introduce the guidewire into the renal
pelvis and/or ureter. We welcomed comments about the amount of time
needed to furnish this procedure.
With the revised intraservice time of 45 minutes and a total time
of 85 minutes, we believed that the RUC-recommended work RVU for this
CPT code is overstated. When we applied the increment between the RUC-
recommended values for between CPT codes 50436 and 50437 (2.07 work
RVUs) in addition to our proposed work RVU for CPT code 50436, we
estimated that this CPT code was more accurately represented by a work
RVU of 4.83. This value is supported by a crosswalk to CPT code 36902
(Introduction of needle(s) and/or catheter(s), dialysis circuit, with
diagnostic angiography of the dialysis circuit, including all direct
puncture(s) and catheter placement(s), injection(s) of contrast, all
necessary imaging from the arterial anastomosis and adjacent artery
through entire venous outflow including the inferior or superior vena
cava, fluoroscopic guidance, radiological supervision and
interpretation and image documentation and report; with transluminal
balloon angioplasty, peripheral dialysis segment, including all imaging
and radiological supervision and interpretation necessary to perform
the angioplasty), which has an intraservice time of 40 minutes and a
total time of 86 minutes. We believed that CPT code 36902 describes a
service that is similar to the new CPT code 50437) and therefore
provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT
code 50437.
We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334
(Cystourethroscopy with insertion of ureteral guide wire through kidney
to establish a percutaneous nephrostomy, retrograde) and the RUC-
recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s)
or urethra, radiological supervision and interpretation).
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Confirm availability of prior images/studies'' (CA006)
activity for CPT code 52334. This code does not currently include this
clinical labor time, and unlike the two new codes in the family (CPT
codes 50436 and 50437), CPT code 52334 does not include imaging
guidance in its code descriptor. When CPT code 52334 is performed with
imaging guidance, it would be billed together with a separate imaging
code that already includes clinical labor time for confirming the
availability of prior images. As a result, we believed that it would be
duplicative to include this clinical labor time in CPT code 52334.
The following is a summary of the public comments we received on
our proposals involving the Dilation of Urinary Tract family of codes.
Comment: Several commenters responded to our proposals regarding
work RVUs for this family of codes. In general, commenters expressed
support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83
for CPT code 74485.
Response: We are finalizing the work RVUs for each of these codes
as proposed.
Comment: Several commenters did not support our proposals regarding
the work RVU for CPT codes 50436 and 50437. The RUC and other
commenters stated that CMS misunderstood the RUC's summary of results
(SOR) and the purpose of the reference codes and the code comparisons
as part of their review process. They suggested that our rejection of
the RUC recommendation for CPT code 50436 was based on a mistake about
the codes that the RUC cited as reference codes.
Response: We consider a variety of documents and data during our
review of the RUC's recommended work RVU for a code. The two reference
codes cited in the excel summary work RVU spreadsheet for CPT code
50436 were CPT codes 50694 and 50695, while the two reference codes
cited in the SOR were CPT codes 52287 52214. In other words, there was
an inconsistency in the documentation. We believe that any of the four
reference codes cited in the documentation and/or data are valid points
of comparison for evaluating whether the RUC's recommended work RVUs
are appropriate.
Comment: Some commenters did not agree with CMS's use of
intraservice time ratios as a factor in determining whether a CPT code
is appropriately valued. The commenters maintained that CMS's use of
these parameters is inappropriate and demonstrates our prioritization
of time-related factors above the intensity and complexity of the
service.
Response: We routinely use intraservice time ratios to determine
whether a recommended work RVU for a new CPT code adequately reflects
efficiencies gained when codes are bundled and/or providers become more
efficient at furnishing services and we disagree with commenters that
time
[[Page 59539]]
ratios are an inappropriate metric. We identify a crosswalk for the
purpose of establishing the work RVU by comparing the survey code to
other codes in the PFS with similar intraservice and total times and
also by considering the intensity among codes with similar times. We
disagree that this means we are prioritizing time parameters over other
factors that are relevant in considering a code's value.
Comment: Commenters disagreed with CMS's proposed work RVU of 2.78
for CPT code 50436, citing CMS's inappropriate use of time parameters
in comparing this code with the deleted CPT code 50395.
Response: Even after taking into consideration the bundling of the
deleted code, CPT 50395, with CPT code 74485, we believe that there are
efficiencies in the work that are not adequately reflected in the RUC-
recommended work RVU for this new code, CPT 50436. We examined a number
of parameters in seeking an appropriate crosswalk code for CPT 50436,
including the intraservice time ratio for this new code in relation to
the combination of CPT codes that the service represents and the
intraservice time ratio for the new code in relation to each of the
RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the
work RVU (2.78) corresponding to the most appropriate, and the highest,
work RVU (2.72) associated with these calculations. Our identification
of a crosswalk code is not dictated by the time parameter calculations
alone, but rather is based on a combination of the time parameters and
our understanding of the intensity involved in furnishing the service.
If we had been looking only at time parameters, we might have chosen a
CPT code with a work RVU closest to the lowest of the time parameter
calculations (2.54). We continue to believe that the most appropriate
crosswalk is CPT code 31646, and we are finalizing our proposed work
RVU of 2.78 for CPT code 50436.
Comment: As with CPT code 50436, commenters suggested that CMS
mistook the codes included in the SOR as the codes that the RUC cited
as reference codes.
Response: As we indicated in our response to this comment for CPT
code 50436, we consider all documentation and data provided by the RUC
in our assessment of the work RVU for a code. The reference and
comparison CPT codes cited in the SOR did not match those in the
summary work RVU spreadsheet.
Comment: Several commenters disagreed with our method of proposing
a work RVU based on the incremental differences in the RUC-recommended
work RVU between codes. Commenters stated that this erroneously
considers all time components as having equal intensity.
Response: We generally apply this methodology where we agree with,
and seek to maintain the relativity between two codes reflected in the
RUC recommendations, but we disagree with the RUC-recommended work RVU
for one or both of the codes. We also considered, as an alternative,
whether it would be more appropriate to use proportional increments
rather than absolute differences between two RUC-recommended work RVUs.
Under that scenario, we would have proposed a work RVU of 4.49 for CPT
code 50437 [(2.78 * 5.44)/3.37 = 4.49]. However, since our general
approach involves applying the absolute difference in work RVUs, our
proposed value for CPT code 50437 was 4.83 work RVUs. We thank the
commenter for pointing out our calculation error, due to which our
proposed work RVU should have been 4.85 instead of 4.83. We continue to
believe that relative difference in the RUC's recommendations for work
RVUs between codes is a useful and appropriate tool for determining
work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for
CPT code 50437 based on a comparison with CPT code 36902, which has a
work RVU of 4.83.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Confirm availability of prior images/
studies'' (CA006) activity for CPT code 52334. Commenters stated that
the equivalent of the CA006 clinical labor activity did not exist when
this service was last reviewed by the Practice Expense subcommittee in
2002, and that many surgical procedures and other types of services
that do not have imaging bundled involve the physician reviewing images
and studies before performing the service. Commenters stated that this
review is not duplicative with image-guidance codes as it instead
involves reviewing distinct previous studies.
Response: We continue to believe that this clinical labor time
should be removed because it is duplicative, as CPT code 52334 would be
billed together with a separate imaging code that already includes
clinical labor time for confirming the availability of prior images
when it is performed with imaging guidance. We believe that the
commenters may be conflating the absence of the CA006 clinical labor
activity when CPT code 52334 was previously reviewed with the lack of
any clinical labor for reviewing images that did not exist previously
in this specific code. There were hundreds of procedures that included
clinical labor for reviewing images prior to the creation of the CA006
clinical labor code, and CPT code 52334 was not one of them. Similarly,
while we agree that there are many services that do not have bundled
imaging and nonetheless include the physician reviewing images and
studies before performing the service, this does not explain why CPT
code 52334 would require clinical labor time for confirming the
availability of prior images and studies when the service did not
include this clinical labor time previously. We continue to believe
that the inclusion of this clinical labor time would be duplicative for
this service.
Comment: One commenter requested that CPT code 52334 be added to
the phase-in list for codes with significant PE RVU reductions.
Response: Section 1848(c)(7) of the Act, as added by section 220(e)
of the PAMA, specifies that for services that are not new or revised
codes, if the total RVUs for a service for a year would otherwise be
decreased by an estimated 20 percent or more as compared to the total
RVUs for the previous year, the applicable adjustments in work, PE, and
MP RVUs shall be phased-in over a 2-year period. We proposed to exempt
CPT code 52334 from the phase-in due to the fact that it is part of the
same family of codes that included new CPT codes 50436 and 50437. We
have previously finalized this policy through rulemaking, stating that
significant coding revisions within a family of codes can change the
relationships among codes to the extent that it changes the way that
all services in the group are reported, even if some individual codes
retain the same number or, in some cases, the same descriptor.
Excluding codes from the phase-in when there are significant revisions
to the code family also helps to maintain the appropriate rank order
among codes in the family, avoiding years for which RVU changes for
some codes in a family are in transition while others were fully
implemented. For additional information regarding the phase-in of
significant RVU reductions, we direct readers to the CY 2016 PFS final
rule with comment period (80 FR 70927 through 70929).
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850,
53852, and 53854)
In September 2017, the CPT Editorial Panel created a new code (CPT
code
[[Page 59540]]
53854) to report transurethral destruction of prostate tissue by
radiofrequency-generated water vapor thermotherapy. CPT codes 53850
(Transurethral destruction of prostate tissue; by microwave
thermotherapy) and 53852 (Transurethral destruction of prostate tissue;
by radiofrequency thermotherapy) were also included for review as part
of the same family of codes.
For CPT code 53850 (Transurethral destruction of prostate tissue;
by microwave thermotherapy), the RUC recommended a work RVU of 5.42,
supported by a direct crosswalk to CPT code 33272 (Removal of
subcutaneous implantable defibrillator electrode) with a total time of
151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42.
The RUC indicated that a work RVU of 5.42 accurately reflects the
lowest value of the three CPT codes in this family. We proposed the
work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
The RUC recommended a work RVU of 5.93 for CPT code 53852
(Transurethral destruction of prostate tissue; by radiofrequency
thermotherapy) and for CPT code 53854 (Transurethral destruction of
prostate tissue; by radiofrequency generated water vapor
thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for
CPT code 53852.
CPT code 53854 is a service reflecting the use of a new technology,
``radiofrequency generated water vapor thermotherapy,'' as distinct
from CPT code 53852, which describes destruction of tissue by
``radiofrequency thermotherapy.'' The RUC indicated that this CPT code
is the most intense of the three CPT codes in this family, thereby
justifying a work RVU identical to that of CPT code 53852, despite
lower intraservice and total times. The RUC stated that 15 minutes of
post service time is appropriate due to greater occurrence of post-
procedure hematuria necessitating a longer monitoring time. However,
the post-service monitoring time for this CPT code, 15 minutes, is
identical to that for CPT code 53852. We did not agree with the
explanation provided by the RUC for recommending a work RVU identical
to that of CPT code 53852, given that the total time is 5 minutes
lower, and the post service times are identical. Both the intraservice
time ratio between this new CPT code and CPT code 53852 (4.94) and the
total time ratio between the two CPT codes (5.72) suggest that the RUC-
recommended work RVU of 5.93 overestimates the work involved in
furnishing this service. We reviewed other 90-day global CPT codes with
similar times and identified CPT code 24071 (Excision, tumor, soft
tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with
a total time of 183 minutes, intraservice time of 45 minutes, and a
work RVU of 5.70 as an appropriate crosswalk. We believed that this
would be a better reflection of the work involved in furnishing CPT
code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT
code. We welcomed comments about the time and intensity required to
furnish this new service. Since this CPT code reflects the use of a new
technology, it will be reviewed again in 3 years.
For the direct PE inputs, we proposed to add a new supply (SA128:
``kit, Rezum delivery device''), a new equipment item (EQ389:
``generator, water thermotherapy procedure''), and proposed to update
the price of two supplies (SA036: ``kit, transurethral microwave
thermotherapy'' and SA037: ``kit, transurethral needle ablation
(TUNA)'') after reviewing invoices that we received. We noted that
these invoices were submitted along with additional information listing
the vendor discount for these supplies and equipment. We appreciated
the inclusion of the discounted prices on these invoices, and we
encouraged other invoice submissions to provide the discounted price as
well, where available. Based on market research on supply and equipment
pricing carried out by our contractors, we believe that a vendor
discount of 10-15 percent is common on many supplies and equipment.
Since we are obligated by statute to establish RVUs for each service as
required based on the resource inputs required to furnish the typical
case of a service, we have concerns that relying on invoices for supply
and equipment pricing absent these vendor discounts may overestimate
the resource cost of some services. We encouraged the submission of
additional invoices that include the discounted price of supplies and
equipment to more accurately assess the market cost of these resources.
The following is a summary of the public comments we received on
our proposals involving the Transurethral Destruction of Prostate
Tissue family of codes.
Comment: Several commenters expressed support for our proposed work
RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which
reflect the RUC's recommendations for these two codes.
Response: We appreciate the commenters' support and we are
finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93
for CPT code 53852.
Comment: A commenter pointed out that there is an error in our
description of the RUC's time components for this code. We stated that
there was less post service time for CPT code 53854 than for CPT code
53852 when, in fact, both codes have a post service time of 15 minutes.
The intraservice time between the two codes differs by 5 minutes, with
CPT code 53854 having 5 fewer minutes than CPT code 53852.
Response: We thank the commenter for informing us of the error. We
note, however, that this does not affect our proposal which is based on
a comparison of both intraservice and total time ratios.
Comment: Several commenters, ranging from device manufacturers and
professional associations, disagreed with our proposed value of 5.70
for CPT code 53854 instead of the RUC-recommended work RVU of 5.93.
Commenters stated that the work involved in furnishing the service
described by CPT code 53854 is the most intense of the three CPT codes
in this family because of the added risk of bleeding, urinary retention
and damage to the external urinary sphincter with resultant
incontinence of urine if not performed properly. Commenters also urged
CMS to approach the time results from the survey for this code with
caution, as few practitioners are likely to have had much experience
with the new technology described by this service.
Response: In our proposal, we requested additional information from
stakeholders about the time and intensity required to furnish this
service because we were not convinced that the work involved in
furnishing the service described by CPT code 53854 is more intense than
the work involved in furnishing CPT code 53852, which the RUC used as a
reference code in developing their recommendation. We were convinced by
commenters, however, that the additional risk in furnishing this
service supports a higher work RVU than what we proposed. Therefore, we
are finalizing a work RVU of 5.93 for this CPT code, as recommended by
the RUC.
Comment: One commenter stated that both CPT codes should be subject
to the phase-in for CY 2019 because they will decrease more than 20
percent and are not new or revised codes. The commenter urged CMS to
add CPT codes 52380 and 52382 to the list of codes subject to the
phase-in.
Response: Section 1848(c)(7) of the Act, as added by section 220(e)
of the PAMA, specifies that for services that
[[Page 59541]]
are not new or revised codes, if the total RVUs for a service for a
year would otherwise be decreased by an estimated 20 percent or more as
compared to the total RVUs for the previous year, the applicable
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year
period. We proposed to exempt CPT codes 52380 and 52382 from the phase-
in of significant RVU reductions required by section 1848(b)(11) of the
Act because these codes are part of the same family of codes that
included new CPT code 53854. We have previously finalized this policy
through rulemaking, stating that significant coding revisions within a
family of codes can change the relationships among codes to the extent
that it changes the way that all services in the group are reported,
even if some individual codes retain the same number or, in some cases,
the same descriptor. Excluding codes from the phase-in when there are
significant revisions to the code family also helps to maintain the
appropriate rank order among codes in the family, avoiding years for
which RVU changes for some codes in a family are in transition while
others were fully implemented. For additional information regarding the
phase-in of significant RVU reductions, we direct readers to the CY
2016 PFS final rule with comment period (80 FR 70927 through 70929).
Comment: One commenter stated that they were concerned about
substantial reductions in billable staff time and supply costs
associated with CPT codes 53850 and 53852. The commenter stated that
reductions in billable staff time will require treating physicians to
minimize non-procedural time which may include: Comfort control
protocols; patient expectation management; patient post-procedure
instructions; and recommended best practices for follow-up care. The
commenter stated that they were concerned that the proposed supply
costs are not in line with actual pricing or with actual cost increases
for manufacturing of the product, and indicated that significant
reductions in reimbursement will limit patient access to a therapy with
demonstrated safety, effectiveness, and cost efficacy.
Response: We appreciate the feedback from the commenter, and we are
sensitive to the need for accurate payment under the PFS to ensure that
beneficiaries maintain access to care. However, we note that we
proposed the RUC-recommended direct PE inputs for this family of codes
without refinement, and the decreases in clinical staff time for these
procedures were almost entirely due to shorter surveyed intraservice
work times and the removal of office visits in the postoperative
portion of the global period as identified by the RUC. We agree with
the RUC that fewer follow-up office visits and shorter intraservice
times are now typical for these procedures, and we do not believe that
the resulting decreases in clinical labor time will create barriers to
accessing care. With regard to changes in the proposed supply costs, we
direct readers to our discussion of the market-based supply and
equipment pricing update in section II.B. of this final rule. We
encourage stakeholders to continue to provide feedback concerning
accurate supply and equipment pricing.
After consideration of the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for the three codes in the
Transurethral Destruction of Prostate Tissue family of codes.
(25) Vaginal Treatments (CPT Codes 57150 and 57160)
CPT codes 57150 (Irrigation of vagina and/or application of
medicament for treatment of bacterial, parasitic, or fungoid disease)
and 57160 (Fitting and insertion of pessary or other intravaginal
support device) were identified as potentially misvalued on a screen of
0-day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-
recommended work RVU of 0.89 for CPT code 57160.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Vaginal Treatments family of codes.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and
57160 as proposed.
(26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)
CPT code 58100 (Endometrial sampling (biopsy) with or without
endocervical sampling (biopsy), without cervical dilation, any method)
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. CPT code 58110 (Endometrial sampling
(biopsy) performed in conjunction with colposcopy) was also included
for review as part of the same family of codes. For CY 2019, we
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and
the RUC-recommended work RVU of 0.77 for CPT code 58110.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Review/read post-procedure x-ray, lab and pathology
reports'' (CA028) activity for CPT code 58100. This code is typically
billed with a same day E/M service, and we believe that it would be
duplicative to assign clinical labor time for reviewing reports given
that this task would typically be done during the same day E/M service.
We also proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Biopsy of Uterus Lining family of codes.
Comment: Several commenters stated that they appreciated that CMS
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and
the RUC-recommended work RVU of 0.77 for CPT code 58110.
Response: We appreciate the support for our proposals from the
commenters.
Comment: Several commenters disagreed with the CMS proposal to
remove the clinical labor time for the ``Review/read post-procedure x-
ray, lab and pathology reports'' (CA028) activity for CPT code 58100.
Commenters stated that this clinical labor activity was not
duplicative, as CA028 is designed specifically for post-procedure
activity during the postservice of the service period which would not
overlap with activities in the E/M office visit, which typically occur
prior to the procedure and are listed as a preservice clinical labor
activity. Commenters stated that the clinical description of the
service for CPT code 58100 clearly notes that the E/M service is done
the day before the service and that the patient returns for the biopsy.
Response: We disagree with the commenters' statements about the
timing of the E/M office visit. The same day billing data indicates
that CPT code 58100 is typically billed with an E/M office visit on the
same day (59 percent of the time), and it therefore seems clear that
the E/M office visit typically takes place during the day of the
procedure,
[[Page 59542]]
not the day before. We do not understand how the claims analysis fits
with the statement from the commenters that the E/M service happens the
day before the procedure, especially since CPT code 58100 has a 0-day
global period that does not include preoperative care that takes place
the day before the procedure. We continue to believe that it would be
duplicative to assign clinical labor time for reviewing reports given
that this task would typically be done during the same day E/M service.
We believe that this clinical labor would be carried out during the
same day E/M visit.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Biopsy of
Uterus Lining family of codes as proposed.
(27) Injection Greater Occipital Nerve (CPT Code 64405)
CPT code 64405 (Injection, anesthetic agent; greater occipital
nerve) was identified as potentially misvalued on a screen of 0-day
global services reported with an E/M visit 50 percent of the time or
more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. For CY 2019, we proposed the
RUC-recommended work RVU of 0.94 for CPT code 64405.
For the direct PE inputs, we proposed to refine the equipment time
for the exam table (EF023) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 64405.
Comment: Some commenters expressed support for our proposal to
accept the RUC-recommended work RVU for this code.
Response: We appreciate the support from the commenters for our
proposals.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 64405 as proposed.
(28) Injection Digital Nerves (CPT Code 64455)
CPT code 64455 (Injection(s), anesthetic agent and/or steroid,
plantar common digital nerve(s) (e.g., Morton's neuroma)) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 64455.
For the direct PE inputs, we proposed to refine the equipment time
for the exam table (EF023) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 64455.
Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 0.75.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 64455 as proposed.
(29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)
CPT codes 65205 (Removal of foreign body, external eye;
conjunctival superficial) and 65210 (Removal of foreign body, external
eye; conjunctival embedded (includes concretions), subconjunctival, or
scleral nonperforating) were identified as potentially misvalued on a
screen of 0-day global services reported with an E/M visit 50 percent
of the time or more, on the same day of service by the same patient and
the same practitioner, that have not been reviewed in the last 5 years
with Medicare utilization greater than 20,000.
For CY 2019, we proposed the RUC-recommended work RVU of 0.49 for
CPT code 65205. We noted that the recommendations for this code
included a statement that the work required to perform CPT code 65205
and the procedure itself had not fundamentally changed since the time
of the last review. However, due to the fact that the surveyed
intraservice time had decreased from 5 minutes to 3 minutes, the work
RVU was lowered from the current value of 0.71 to the recommended work
RVU of 0.49, based on a direct crosswalk to CPT code 68200
(Subconjunctival injection). We noted that this recommendation appears
to have been developed under a methodology similar to our ongoing use
of time ratios as one of several methods used to evaluate work. We used
time ratios to identify potential work RVUs and considered these work
RVUs as potential options relative to the values developed through
other options. As we have stated in past rulemaking (such as 82 FR
53032-53033), we did not imply that the decrease in time as reflected
in survey values must equate to a one-to-one or linear decrease in
newly valued work RVUs, as indeed it does not in the case of CPT code
65205 here. Instead, we believed that, since the two components of work
are time and intensity, significant decreases in time should be
reflected in decreases to work RVUs. We appreciate that the RUC-
recommended work RVU for CPT code 65205 has taken these changes in work
time into account, and we support the use of similar methodologies,
where appropriate, in future work valuations.
For CPT code 65210, we disagreed with the RUC-recommended work RVU
of 0.75 and we proposed a work RVU of 0.61 based on a direct crosswalk
to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk
code has the same intraservice time of 5 minutes and 4 additional
minutes of total time as compared to CPT code 65210. We noted that the
recommended intraservice time for CPT code 65210 is decreasing from 13
minutes to 5 minutes (62 percent reduction), and the recommended total
time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48
percent reduction); however, the RUC-recommended work RVU is only
decreasing from 0.84 to 0.75, which is a reduction of about 11 percent.
As we noted earlier, we do not believe that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, and we did not propose a linear
decrease in the work valuation based on these time ratios. However, we
believe that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs, and we do not believe that the recommended work RVU of 0.75
appropriately reflects these decreases in surveyed work time.
Our proposed work RVU of 0.61 is also based on a crosswalk to CPT
code 51700 (Bladder irrigation, simple, lavage and/or instillation),
another recently reviewed code with higher time values and a work RVU
of 0.60. We also noted that two injection codes (CPT codes 20551 and
64455) were reviewed at the same RUC meeting as CPT code 65210, each of
which shared the same intraservice time of 5 minutes and had a higher
total time of 21 minutes. Both of these codes had a RUC-recommended
work RVU of 0.75, which we proposed without refinement for CY 2019. Due
to the fact that CPT code 65210 has a lower total time and a lower
intensity than both of these injection procedures, we did not agree
that CPT code 65210 should be valued at the same work RVU of 0.75. We
believe that our proposed work RVU of 0.61 based on a crosswalk to CPT
code 92511 is a more accurate value for this code.
For the direct PE inputs, we noted that the RUC-recommended
equipment time for the screening lane (EL006)
[[Page 59543]]
equipment in CPT codes 65205 and 65210 was equal to the total work time
in addition to the clinical labor time needed to set up and clean the
equipment. We disagreed that the screening lane would typically be in
use for the total work time, given that this includes the preservice
evaluation time and the immediate postservice time. Although we did not
currently propose to refine the equipment time for the screening lane
in these two codes, we solicited comments on whether the use of the
intraservice work time would be more typical than the total work time
for CPT codes 65205 and 65210.
The following is a summary of the public comments we received on
our proposals involving the Removal of Foreign Body--Eye family of
codes.
Comment: Commenters agreed with the CMS proposal of the RUC-
recommended work RVU for CPT code 65205.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with our statement that the
RUC-recommended work RVU for CPT code 65205 appeared to have been
developed under a methodology similar to the use of time ratios.
Commenters stated that time ratios were not used in arriving at the
value of 0.49 for CPT code 65205, and that the recommended work RVU was
based instead on a crosswalk to the second key reference code from the
survey, CPT code 68200, which requires the same total time to perform
and shares identical intensity and complexity.
Response: We appreciate the additional information provided by the
commenters regarding the methodology behind the recommended work RVU
for CPT code 65205. As we noted in the proposed rule, this
recommendation appeared to have been developed under a methodology
similar to our ongoing use of time ratios; we did not state that the
recommendation was explicitly based on the use of a time ratio.
Comment: Many commenters disagreed with the proposed work RVU of
0.61 for CPT code 65210 and stated that CMS should finalize the RUC-
recommended work RVU of 0.75. Commenters stated that CMS should not use
intraservice time ratios for work valuation as this methodology ignored
the work estimates present in the survey data and the RUC review of
those work estimates. Commenters stated that the RUC-recommended work
values consider intensity and complexity of the work, while CMS
substituted an arbitrary determination of work values based on time and
a subjective estimate of intensity and complexity based on an unknown
and clinically uninformed opinion.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion in the CY 2017 PFS final rule (81 FR
80272 through 80277). We also note that in the case of CPT code 65210,
we derived our proposed work RVU of 0.61 by using a direct crosswalk to
CPT code 92511 and not a time ratio.
Comment: Several commenters noted that CPT code 65210 had never
been surveyed and was based on Harvard time which contributed to the
median survey intraservice time of 5 minutes being less than half of
the current value of 13 minutes. Commenters stated that Harvard times
should be not be used for any sort of time comparison, especially when
the code was not originally surveyed by Harvard, and any comparisons
with these work times were inappropriate.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of
current work time values in our methodology, we refer readers to our
discussion of the subject in the CY 2017 final rule (81 FR 80273
through 80274).
Comment: Several commenters stated that the procedure described by
CPT code 65210 has not fundamentally changed, and therefore the RUC had
recommended a work RVU at the 25th percentile in accordance with the
recent survey. One commenter stated that the
[[Page 59544]]
intensity of the procedure was also unchanged. Commenters stated that
the crosswalk and reference codes chosen by CMS were clearly not as
intense as the removal of an embedded foreign body described by CPT
code 65210, in which an incision into ocular tissue is required.
Response: We disagree with the commenters that CPT code 65210 has
not fundamentally changed. We note for example that the surveyed work
times have decreased drastically from the prior valuation, and
similarly, the intensity of the service as measured by the survey more
than doubled. These factors do not comport with the statement from the
commenters that intensity of this service is unchanged. We also note
that the RUC-recommended work RVU of 0.75 was a decrease from the
current work RVU of 0.84, which also does not appear to reflect the
idea that the intensity of the service has not changed. We similarly
disagree with the commenters that our crosswalk and reference codes are
not as intense as CPT code 65210. CPT code 92511 in particular
describes a nasopharyngoscopy with endoscope that requires removing
secretions and dried mucus blocking passage to the nasopharynx with
suction and/or forceps. We disagree with the commenters that this
procedure would be less intensive than the removal of a foreign body as
described in CPT code 65210.
Comment: Several commenters disagreed with the CMS comparison of
CPT code 65210 to two injection codes (CPT codes 20551 and 64455) which
were reviewed at the same RUC meeting as CPT code 65210. Commenters
stated that the two referenced codes both have a lower intensity than
CPT code 65210 and therefore they were not appropriate references for
work valuation. Commenters stated that CPT code 65210 has a lower total
time and a higher intensity than both of these injection procedures,
justifying the recommended work RVU of 0.75.
Response: We disagree with the commenters that CPT code 65210 would
typically have a higher intensity than CPT codes 20551 and 64455. These
codes both describe injection procedures, with CPT code 20551
describing an injection into the tendon and CPT code 64455 describing
an injection into the plantar common digital nerve. We do not agree
that the removal of a foreign body from the eye as described in CPT
code 65210 would have such greater intensity that it warrants a work
RVU of 0.75 (to match CPT codes 20551 and 64455) despite having
approximately 40 percent less total work time.
Comment: Several commenters stated in response to the CMS comment
solicitation that the screening lane (EL006) equipment would typically
be in use for the total work time of CPT codes 65205 and 65210.
Commenters stated that the screening lane is the ophthalmic equivalent
of an exam room in the non-facility setting which would be needed for
the total time of the procedure. Commenters stated that this equipment
time represented the total time taken by the physician to perform the
service in the screening lane (which would be not be available for use
by another patient during the time of the procedure), plus the time
inputs for the technician work as listed above.
Response: We appreciate the additional information provided by the
commenters regarding the use of the screening lane (EL006) equipment.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Removal of
Foreign Body--Eye family of codes as proposed.
(30) Injection--Eye (CPT Codes 67500, 67505, and 67515)
CPT code 67515 (Injection of medication or other substance into
Tenon's capsule) was identified as potentially misvalued on a screen of
0-day global services reported with an E/M visit 50 percent of the time
or more, on the same day of service by the same patient and the same
practitioner, that have not been reviewed in the last 5 years with
Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar
injection; medication (separate procedure, does not include supply of
medication)) and 67505 (Retrobulbar injection; alcohol) were also
included for review as part of the same family of codes. For CY 2019,
we proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.
For CPT code 67505, we disagreed with the RUC-recommended work RVU
of 1.18 and we proposed a work RVU of 0.94 based on a direct crosswalk
to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a
recently reviewed code with the same intraservice time of 5 minutes and
2 fewer minutes of total time as compared to CPT code 67505. We
disagreed with the recommendation to propose the same work RVU of 1.18
for both CPT code 67500 and 67505 for several reasons. We noted that
the current work RVU of 1.44 for CPT code 67500 is higher than the
current work RVU of 1.27 for CPT code 67505, while the current work
time of CPT code 67500 is less than the current work time for CPT code
67505. This supported the view that CPT code 67500 should be valued
higher than CPT code 67505 due to its greater intensity, which we also
found to be supportable on clinical grounds. The typical patient for
CPT code 67505 has already lost their sight, and there is less of a
concern about accidental blindness as compared to CPT code 67500. At
the recommended identical work RVUs, CPT code 67500 has almost triple
the intensity of CPT code 67505. Similarly, the intensity does not
match our clinical understanding of the complexity and difficulty of
the two procedures.
We also noted that the surveyed total time for CPT code 67505 was 7
minutes less than the surveyed time for CPT code 67500, approximately
21 percent lower. If we were to take the total time ratio between the
two codes, it would produce a suggested work RVU of 0.93 (26 minutes
divided by 33 minutes times a work RVU of 1.18). This time ratio
suggested a work RVU almost identical to the 0.94 value that we
determined via a crosswalk to CPT code 31575. Based on the preceding
rationale, we proposed a work RVU of 0.94 for CPT code 67505.
For CPT code 67515, we disagreed with the RUC-recommended work RVU
of 0.84 and we proposed a work RVU of 0.75 based on a crosswalk to CPT
code 64450 (Injection, anesthetic agent; other peripheral nerve or
branch). The recommended work RVU is based on a direct crosswalk to CPT
code 65222 (Removal of foreign body, external eye; corneal, with slit
lamp) at a work RVU of 0.84. However, the recommended crosswalk code
has more than double the intraservice time of CPT code 67515 at 7
minutes, and we believe that it would be more accurate to use a
crosswalk to a code with a more similar intraservice time such as CPT
code 64450, which is another type of injection procedure. The proposed
work RVU of 0.75 is also based on the use of the intraservice time
ratio with the first code in the family, CPT code 67500. The
intraservice time ratio between these codes is 0.60 (3 minutes divided
by 5 minutes), which yields a suggested work RVU of 0.71 when
multiplied by the recommended work RVU of 1.18 for CPT code 67500. We
believe that this provides further rationale for our proposed work RVU
of 0.75 for CPT code 67515.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Injection--Eye family of codes.
[[Page 59545]]
Comment: Commenters were supportive of the CMS proposal of the RUC-
recommended work RVU of 1.18 for CPT code 67500.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Many commenters disagreed with the proposed work RVU of
0.94 for CPT code 67505 and stated that CMS should finalize the RUC-
recommended work RVU of 1.18. Commenters were confused by the CMS
statement that, at the recommended identical work RVUs, CPT code 67500
has almost triple the intensity of CPT code 67505. Commenters stated
that the RUC recommendation for CPT code 67505 has less total time and
slightly higher intensity than CPT code 67500.
Response: We agree with the commenters that this was an inaccurate
statement; we intended to state that the current intensity of CPT code
67500 prior to review is almost triple the current intensity of CPT
code 67505. We regret any resulting confusion on this subject.
Comment: Several commenters disagreed with the use of a time ratio
analysis to support the CMS proposed work value. Commenters stated that
time ratios do not adequately account for intensity and complexity of
work, which can only be addressed through the survey and the RUC
process.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277). We also note that in the case of CPT code 65210, we
derived our proposed work RVU of 0.61 by using a direct crosswalk to
CPT code 31575 and not a time ratio.
Comment: Several commenters stated that while it was true that the
current work value for CPT code 67500 is higher than that of CPT code
67505, the survey 25th percentiles indicated that the physician work of
CPT code 67505 (work RVU = 1.30) is higher than that of CPT code 67500
(work RVU = 1.18). Commenters stated that the reason for performing
surveys is to adjust for changes in physician work that have occurred
since the prior survey, and that it was inappropriate to put more
weight on old data than on the most recent data. Commenters also
disagreed with the proposed work RVU on clinical grounds, stating that
CPT code 67505 has a higher intensity than CPT code 67500, not because
of potential vision loss, but because of the risk of death if the
absolute alcohol is injected accidentally into the optic nerve sheath.
Commenters stated that the alcohol injection involved in CPT code 67505
is typically very painful, even after a local anesthetic injection, and
carries with it the risk of death which therefore makes it a high-
intensity procedure for both patient and physician.
Response: We appreciate the additional clinical details involving
CPT code 67505 from the commenters. After reviewing the information
provided by the commenters, we are not finalizing our proposed work RVU
of 0.94 for CPT code 67505, and we are finalizing the RUC-recommended
work RVU of 1.18 instead due to the additional risks carried by the
procedure.
Comment: Many commenters disagreed with the proposed work RVU of
0.75 for CPT code 67515 and stated that CMS should finalize the RUC-
recommended work RVU of 0.84. Commenters disagreed with the CMS
crosswalk to CPT code 64450 and stated that the intensity of an
injection adjacent to the eye in which the physician is unable to see
the needle tip is clearly greater than that of an injection into a
peripheral nerve as in the code for the CMS proposed crosswalk.
Commenters stated that the use of a time ratio methodology for CPT code
67515 was particularly inappropriate due to changes in the RUC survey
methodology since the last survey for this service was performed, and
that increases in the intensity of CPT code 67515 should not be of
concern due to the 0-day global period and short intraservice work
time.
Response: We continue to believe that the use of time ratios is one
of several appropriate methods for identifying potential work RVUs, as
described in more detail in our response to the comments for CPT code
67505 above. We also disagree with the commenters on their objections
on clinical grounds concerning our crosswalk to CPT code 64450. CPT
code 64450 describes the injection of an anesthetic agent into a
peripheral nerve or branch, and the practitioner performing this
service also cannot see a needle tip when injecting into a peripheral
nerve. In other words, this is the same situation as that described in
CPT code 67515: The practitioner performing the service is unable to
see the needle tip in both cases. We continue to note that the RUC-
recommended crosswalk code (CPT code 65222) has more than double the
intraservice time of CPT code 67515 at 7 minutes, and we continue to
believe that it would be more accurate to use a crosswalk to a code
with a similar intraservice time such as CPT code 64450.
After consideration of the public comments, we are finalizing the
work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing
the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also
finalizing the direct PE inputs for all three codes as proposed.
(31) X-Ray Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 72072,
72074, 72080, 72100, 72110, 72114, and 72120)
CPT codes 72020 (Radiologic examination, spine, single view,
specify level) and 72072 (Radiologic examination, spine; thoracic, 3
views) were identified on a screen of CMS or
[[Page 59546]]
Other source codes with Medicare utilization greater than 100,000
services annually. The code family was expanded to include ten
additional CPT codes to be reviewed together as a group: CPT codes
72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050
(Radiologic examination, spine, cervical; 4 or 5 views), 72052
(Radiologic examination, spine, cervical; 6 or more views), 72070
(Radiologic examination, spine; thoracic, 2 views), 72074 (Radiologic
examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic
examination, spine; thoracolumbar junction, minimum of 2 views), 72100
(Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110
(Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114
(Radiologic examination, spine, lumbosacral; complete, including
bending views, minimum of 6 views), and 72120 (Radiologic examination,
spine, lumbosacral; bending views only, 2 or 3 views).
The radiologic examination procedures described by CPT codes 72020
(Radiologic examination, spine, single view, specify level), 72040
(Radiologic examination, spine, cervical; 2 or 3 views), 72050
(Radiologic examination, spine, cervical; 4 or 5 views), 72052
(Radiologic examination, spine, cervical; 6 or more views), 72070
(Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic
examination, spine; thoracic, 3 views), 72074 (Radiologic examination,
spine; thoracic, minimum of 4 views), 72080 (Radiologic examination,
spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic
examination, spine, lumbosacral; complete, including bending views,
minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral;
bending views only, 2 or 3 views), 72200 (Radiologic examination,
sacroiliac joints; less than 3 views), 72202 (Radiologic examination,
sacroiliac joints; 3 or more views), 72220 (Radiologic examination,
sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination,
elbow; 2 views), 73080 (Radiologic examination, elbow; complete,
minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views),
73650 (Radiologic examination; calcaneus, minimum of 2 views), and
73660 (Radiologic examination; toe(s), minimum of 2 views) were all
identified as potentially misvalued through a screen for CPT codes with
high utilization.
With approval from the RUC Research Subcommittee, the specialty
societies responsible for reviewing these CPT codes did not conduct
surveys, but instead employed a ``crosswalk methodology,'' in which
they derived physician work and time components for CPT codes by
comparing them to similar CPT codes. We recognize that a substantial
amount of time and effort is involved in conducting surveys of
potentially misvalued CPT codes; however, we had concerns about the
quality of the underlying data used to value these CPT codes. The
descriptors and other information on which the recommendations are
based have themselves not been surveyed, in several instances, since
1995. Without the benefit of a survey or other external source of data
about these CPT codes, there is no information that would allow us to
detect any potential improvements in efficiency of furnishing the
service or evaluate whether changes in practice patterns have affected
time and intensity. We are not categorically opposed to changes in the
RUC process or methodology that might reduce the burden of conducting
surveys, but without the benefit of any additional data, through
surveys or otherwise, we were not convinced that there was a basis for
evaluating the RUC's recommendations for work RVUs for each of these
CPT codes.
Since all 20 of the CPT codes in this group have very similar
intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes)
times, we proposed to use an alternative approach to the valuation of
work RVUs for these CPT codes. We calculated the utilization-weighted
average RUC-recommended work RVU for the 20 CPT codes. The result of
this calculation was a work RVU of 0.23, which we proposed to apply
uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072,
72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070,
73080, 73090, 73650, and 73660. We recognized that the proposed work
RVU for some of these CPT codes might be somewhat lower at the code
level than the RUC's recommendation, while the proposed work RVU for
other CPT codes might be slightly higher than the RUC's recommended
value. We nevertheless believe that the alternative, accepting the
RUC's recommendation for each separate CPT code implied a level of
precision about the time and intensity of the CPT codes that we had no
way to validate.
For the direct PE inputs, we proposed to add a patient gown (SB026)
supply to CPT code 72120. We noted that all of the other codes in the
family that included clinical labor time for the ``Greet patient,
provide gowning, ensure appropriate medical records are available''
(CA009) task included a patient gown, and we proposed to add the
patient gown to match the other codes in the family. We believed that
the exclusion of the patient gown for CPT code 72120 was most likely
due to a clerical error in the recommendations. We also proposed to
refine the equipment time for the basic radiology room (EL012) in
accordance with our standard equipment time formulas.
In our review of the clinical labor time recommended for the
``Perform procedure/service--NOT directly related to physician work
time'' (CA021) task, we noted that the standard convention for this
family of codes seemed to be 3 minutes of clinical labor time per view
being conducted. For example, CPT code 72020 with a single view had 3
minutes of recommended clinical labor time for this activity, while CPT
code 72070 with two views had 6 minutes. However, we also noted that
for the codes with 2-3 views such as CPT codes 72040 and 72100, the
recommended clinical labor time of 9 minutes appears to assume that 3
views would always be typical for the procedure. The same pattern
occurred for codes with 4-5 views, which have a recommended clinical
labor time of 15 minutes (assuming 5 views is typical), and for codes
with 6 or more views, which have a recommended clinical labor time of
21 minutes (assuming 7 views is typical).
We did not propose to refine the clinical labor times for this task
as we did not have data available to know how many views would be
typical for these CPT codes. However, we noted that the intraservice
clinical labor time has not changed in roughly 2 decades for these X-
ray services, including during this most recent review, and we believed
that improving technology during this span of time may have resulted in
greater efficiencies in the procedures. We continue to be interested in
data sources regarding the intraservice clinical labor times for
services such as these that do not match the physician intraservice
time, and we welcomed any comments that may be able to provide
additional details for the 12 codes under review in this family.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Spine family of codes.
[[Page 59547]]
Comment: A number of commenters disagreed with our proposal to
apply an identical work RVU, calculated as the utilization-weighted
average RUC-recommended work RVU for each of the 20 CPT codes, to each
of the CPT codes in this group. Commenters defended the crosswalk
methodology, stating that it is the best approach for valuing work RVUs
for codes in which the service times are very low and therefore
difficult to survey. The commenters noted that the specialty societies
have tried to survey codes such as this in the past with results that
yielded substantial inconsistencies.
Response: We share the commenters' concerns about the validity of
surveying services with very low intraservice and total time, but we
have even more substantial concerns about a methodology that introduces
no new information about the work involved in furnishing these CPT
codes and then states their accuracy to the hundredth of a work RVU.
Survey data from the specialty societies is often the only data source
available to us that reflects the experiences of a cross-section of
providers. We remind stakeholders that we welcome additional
information or data from all sources to assist us in making proposals
and finalizing values.
Comment: In response to our proposal, the RUC offered to survey
each code in the expanded family of X-ray codes to which CMS applied
the weighted average methodology and provide survey based
recommendations for CY 2020.
Response: We appreciate the recognition on the part of the RUC of
our serious concerns about the crosswalk methodology and the integrity
of the resulting RUC recommended work RVUs. We welcome the submission
of any additional data or information that would allow us to consider
these codes for review at a future time. Commenters raised concerns
that assigning a single weighted average work RVU across this broad
family of x-ray codes inadequately reflects meaningful differences
among the codes, including the number of views and the complexity of
positioning for some x-ray services. In response to commenters'
concerns, we are instead maintaining the CY 2018 work RVUs for each CPT
code as follows: Work RVU of 0.15 for CPT code 72020, 0.22 for CPT
72040, 0.31 for CPT code 72050, 0.36 for CPT code 72052, 0.22 for CPT
code 72070, 0.22 for CPT code 72072, 0.22 for CPT code 72074, 0.22 for
CPT code 72080, 0.22 for CPT code 72100, 0.31 for CPT code 72110, 0.32
for CPT code 72114, and 0.22 for CPT code 72120.
Comment: Several commenters indicated that it was inappropriate for
CMS to value the practice expense portion of the 20 CPT codes
identically because the resources required to furnish each of the
services differ in accordance with the number of X-rays or views and
other factors.
Response: We did not propose to value the practice expense portion
of these codes identically. The proposal regarding the weighted average
for these codes refers to the work component of RVUs only.
Comment: One commenter stated that they appreciated and agreed with
adding a patient gown (SB026) supply to CPT code 72120.
Response: We appreciate the support for our proposal from the
commenter.
Comment: Several commenters stated that they would like to provide
clarity on the typical number of films obtained for the X-ray spine
codes and the rationale for the number of minutes and assumed number of
views that would be typical. Commenters stated that a minimum of 3
views would be needed in order to adequately assess the cervical spine
as described by CPT code 72040. Commenters stated that the open mouth
odontoid view helps in the assessment of the atlanto-occipital joint,
and that the AP and lateral views of the vertebral bodies are required
to assess the alignment of the vertebral bodies in two planes, the disc
spaces, the spinal canal, fractures, and widening of different joints.
Commenters provided a similar level of clinical detail regarding the
typical number of views required for CPT codes 72050 and 72052.
Response: We appreciate the detailed information provided by the
commenters in response to our request for data sources regarding the
intraservice clinical labor times in those services that do not match
the physician intraservice time.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(32) X-Ray Sacrum (CPT Codes 72200, 72202, and 72220)
CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum
of 2 views) was identified on a screen of CMS or Other source codes
with Medicare utilization greater than 100,000 services annually. CPT
codes 72200 (Radiologic examination, sacroiliac joints; less than 3
views) and 72202 (Radiologic examination, sacroiliac joints; 3 or more
views) were also included for review as part of the same family of
codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052,
72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a
discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to refine the equipment time
for the basic radiology room (EL012) in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Sacrum family of codes.
Comment: Comments regarding our proposed work RVU for this family
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVUs for each code in this family as follows: Work RVU of 0.17 for CPT
code 72200, 0.19 for CPT Code 72202, and 0.17 for CPT code 72220.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(33) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090
(Radiologic examination; forearm, 2 views) were identified on a screen
of CMS or Other source codes with Medicare utilization greater than
100,000 services annually. CPT code 73080 (Radiologic examination,
elbow; complete, minimum of 3 views) was also included for review as
part of the same family of codes. See (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120) above for a discussion of proposed work RVUs for
these codes.
For the direct PE inputs, we proposed to refine the equipment time
for the
[[Page 59548]]
basic radiology room (EL012) in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving the X-Ray Elbow-Forearm family of codes.
Comment: Comments regarding our proposed work RVU for this family
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110,
72114, and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVUs for each code in this family as follows: Work RVU of 0.15 for CPT
code 73070, 0.17 for CPT code 73080, 0.17 for CPT code 73090.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of
codes. We are finalizing the direct PE inputs for these codes as
proposed.
(34) X-Ray Heel (CPT Code 73650)
CPT code 73650 (Radiologic examination; calcaneus, minimum of 2
views) was identified on a screen of CMS or Other source codes with
Medicare utilization greater than 100,000 services annually. See (31)
X-Ray Spine above for a discussion of proposed work RVUs for these
codes.
For the direct PE inputs, we proposed to refine the equipment time
for the basic radiology room (EL012) in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 73650.
Comment: Comments regarding our proposed work RVU for this code
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020,
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114,
and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVU of 0.16 for CPT code 73650.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We
are finalizing the direct PE inputs for these codes as proposed.
(35) X-Ray Toe (CPT Code 73660)
CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views)
was identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. See (31) X-Ray
Spine above for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to add a patient gown (SB026)
supply to CPT code 73660. We noted that the other codes in related X-
ray code families that included clinical labor time for the ``Greet
patient, provide gowning, ensure appropriate medical records are
available'' (CA009) task included a patient gown, and we proposed to
add the patient gown to match the other codes in these families. We
also proposed to refine the equipment time for the basic radiology room
(EL012) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 73660.
Comment: Comments regarding our proposed work RVU for this code
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020,
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114,
and 72120).
Response: As discussed above, we are maintaining the CY 2018 work
RVU of 0.13 for CPT code 73660.
Comment: Several commenters stated that the typical patient for
this service would not require a patient gown. Commenters stated that
this was different than other codes in the family where the patient may
need to be rotated lateral and prone for different views.
Response: We appreciate the feedback from the commenters. In light
of the information supplied by commenters, we will not finalize our
proposal to add a patient gown (SB026) supply to CPT code 73660.
Comment: One commenter stated that CMS did not indicate what amount
of service period time was removed from the calculation of the
equipment time, and that this made it difficult to determine the
accuracy of the refinements. The commenter requested more information
about this change.
Response: For the basic radiology room (EQ137) equipment, we
removed the clinical labor for the CA030 clinical labor activity in
accordance with our standard equipment time formula for highly
technical equipment.
After consideration of the public comments, we are maintaining the
CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We
are finalizing the direct PE inputs as proposed with the exception of
the patient gown (SB026) supply as detailed above.
(36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)
CPT code 74220 (Radiologic examination; esophagus) was identified
on a screen of CMS or Other source codes with Medicare utilization
greater than 100,000 services annually. CPT codes 74210 (Radiologic
examination; pharynx and/or cervical esophagus) and 74230 (Swallowing
function, with cineradiography/videoradiography) were also included for
review as part of the same family of codes.
We proposed the work RVUs recommended by the RUC for the CPT codes
in this family as follows: A work RVU 0.59 for CPT code 74210
(Radiologic examination; pharynx and/or cervical esophagus), a work RVU
of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a
work RVU of 0.53 for CPT code 74230 (Swallowing function, with
cineradiography/videoradiography).
For the direct PE inputs, we noted that the recommended quantity of
the Polibar barium suspension (SH016) supply is increasing from 1 ml to
150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220,
which did not previously include this supply. The RUC recommendation
states that this supply quantity increase is due to clinical necessity,
but does not go into further details about the typical use of the
supply. Although we did not propose to refine the quantity of the
Polibar barium suspension at this time, we solicited additional comment
about the typical use of the supply in these procedures. We also
proposed to refine the equipment times for all three codes in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our
[[Page 59549]]
proposals involving the X-Ray Esophagus family of codes.
Comment: We received no specific comments regarding our proposals
for work RVUs in this family.
Response: As a result, we are finalizing a work RVU of 0.59 for CPT
code 74210, a work RVU of 0.67 for CPT code 74220, and a work RVU of
0.53 for CPT code 74230 as proposed.
Comment: Several commenters responded to the comment solicitation
about the typical use of the Polibar barium suspension (SH016) supply
in these procedures. Commenters stated that the barium suspension
quantity listed for CPT code 74210 prior to review was only 1 ml which
appeared to be a technical error in mistaking number of milliliters for
number of items, as this was an insufficient quantity of barium for the
procedure. Commenters stated that CPT code 74220 did not have barium
suspension listed as a supply item, which appeared to be an oversight.
The commenters described how the patient swallows a small quantity of
high density barium to outline the esophagus, followed by multiple
subsequent swallows of normal density barium that are assessed under
fluoroscopy from different angles to evaluate the esophageal anatomy
and mucosa.
Response: We appreciate the additional details provided by the
commenters regarding the use of the Polibar barium suspension (SH016)
supply, and the clarification that the previous supply quantities in
these procedures appear to have been in error.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for the codes in the X-Ray Esophagus
family of codes as proposed.
(37) X-Ray Urinary Tract (CPT Code 74420)
CPT code 74420 (Urography, retrograde, with or without KUB) was
identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. We proposed the
RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography,
retrograde, with or without KUB).
For the direct PE inputs, we proposed to remove the 1 minute of
clinical labor time for the ``Confirm order, protocol exam'' (CA014)
activity. The clinical labor time recommended for this activity is not
included in the reference code, nor is it included in any of the two
dozen other X-ray codes that were reviewed at the same RUC meeting.
There is also no explanation in the recommended materials as to why
this clinical labor time would need to be added. We do not believe that
this clinical labor would be typical for CPT code 74420, and we
proposed to remove it to match the rest of the X-ray codes. We also
proposed to refine the equipment times in accordance with our standard
equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 74420.
Comment: We received no specific comments regarding our proposal
for the work RVU for CPT code 74420.
Response: We are finalizing a work RVU of 0.52 for CPT code 74420.
Comment: Several commenters disagreed with the proposal to remove
the 1 minute of clinical labor time for the ``Confirm order, protocol
exam'' (CA014) activity. The commenters stated that this service was
distinct from the other X-ray services reviewed during this cycle and
encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
74420, we are finalizing these clinical labor refinements as proposed
as there is no clinical labor assigned to the ``Review patient clinical
extant information and questionnaire'' (CA007) activity. We also note
that commenters did not provide a rationale as to what made CPT code
74420 distinct from the other X-ray services reviewed during this cycle
and would justify this additional clinical labor time.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 74420 as proposed.
(38) Fluoroscopy (CPT Code 76000)
CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour
physician or other qualified health care professional time) was
identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. CPT code 76001
(Fluoroscopy, physician or other qualified health care professional
time more than 1 hour, assisting a nonradiologic physician or other
qualified health care professional) was also included for review as
part of the same family of codes. However, due to the fact that
supervision and interpretation services have been increasingly bundled
into the underlying procedure codes, the RUC concluded that this
practice is rare, if not obsolete, and CPT code 76001 was recommended
for deletion by the CPT Editorial Panel for CY 2019.
We proposed the RUC-recommended work RVU of 0.30 for CPT code 76000
(Fluoroscopy (separate procedure), up to 1 hour physician or other
qualified health care professional time, other than 71023 or 71034
(e.g., cardiac fluoroscopy)). For the direct PE inputs, we proposed to
refine the equipment times in accordance with our standard equipment
time formulas.
We did not receive specific comments regarding our proposals for
CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE
inputs for CPT code 76000 as proposed.
(39) Echo Exam of Eye Thickness (CPT Code 76514)
CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal
pachymetry, unilateral or bilateral (determination of corneal
thickness)) was identified as potentially misvalued on a screen of
codes with a negative intraservice work per unit of time (IWPUT), with
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes
and over 1,000 for Harvard-valued and CMS/Other source codes.
For CPT code 76514, we disagreed with the RUC-recommended work RVU
of 0.17 and we proposed a work RVU of 0.14. We noted that the
recommended intraservice time for CPT code 76514 is decreasing from 5
minutes to 3 minutes (40 percent reduction), and the recommended total
time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67
percent reduction); however, the RUC-recommended work RVU is not
decreasing at all and remains at 0.17. Although we did not imply that
the decrease in time as reflected in survey values must equate to a
one-to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs.
We also noted that the RUC recommendations for CPT code 76514
stated that, although the steps in the procedure are unchanged since it
was first valued, the workflow has changed. With the advent of smaller
and easier to use pachymeters, the technician now typically takes the
measurements that used to be taken by the practitioner for CPT code
76514, and the intraservice time was reduced by two minutes to account
for the technician performing this service. We believe that this change
in workflow indicates that the work RVU for the code should be reduced
in some fashion, since some of the work
[[Page 59550]]
that was previously done by the practitioner is now typically performed
by the technician. We have no reason to believe that there is more
intensive cognitive work being performed by the practitioner after
these measurements are taken since the recommendations indicated that
the steps in the procedure are unchanged since this code was first
valued.
Therefore, we proposed a work RVU of 0.14 for CPT code 76514, which
is based on taking half of the intraservice time ratio. We considered
applying the intraservice time ratio to CPT code 76514, which would
reduce the work RVU to 0.10 based on taking the change in intraservice
time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60
times the current work RVU of 0.17. However, we recognized that the
minutes shifted to the clinical staff were less intense than the
minutes that remained in CPT code 76514, and therefore, we applied half
of the intraservice time ratio for a reduction of 0.03 RVUs to arrive
at a proposed work RVU of 0.14. We believe that this proposed value
more accurately takes into account the changes in workflow that have
caused substantial reductions in the surveyed work time for the
procedure.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 76514.
Comment: Many commenters disagreed with the proposed work RVU of
0.14 for CPT code 76514 and stated that CMS should finalize the RUC-
recommended work RVU of 0.17. Commenters stated that using an approach
that takes a fraction of the intraservice time ratio in lieu of strong
crosswalks and input from the RUC and physicians providing these
services is unfounded. Commenters restated the key reference codes
chosen by the survey participants and urged CMS to use survey data and
supportive relative reference services when valuing services.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case, as indicated by the many
services that share the same time values but have different work RVUs.
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all
share identical CY 2019 work times with 15 minutes of preservice time,
30 minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277). We also note that in the case of CPT code 76514, we
recognized that the minutes shifted to the clinical staff were less
intense than the minutes that remained in CPT code 76514, and
therefore, we applied only half of the intraservice time ratio instead
of the full ratio.
Comment: Several commenters stated that while it is true that
changes in workflow as a result of smaller, portable, easier to use
pachymeters now mean that the technician typically takes the
measurements that used to be taken by the physician, the remaining 3
minutes of intraservice work time reflect the more intense cognitive
work performed by the physician after the measurements are taken.
Commenters agreed that the procedure has not fundamentally changed and
that maintaining a work RVU of 0.17 was warranted.
Response: We disagree with the commenters and continue to believe
that CPT code 76514 does not require more intensive cognitive work
being performed by the practitioner after these measurements are taken,
since the recommendations indicated that the steps in the procedure are
unchanged since this code was first valued. While the incorporation of
new technology can sometimes make services more complex and difficult
to perform, it can also have the opposite effect by making services
less reliant on manual skill and technique, and we believe that for CPT
code 76514 the latter case is true since the same work previously
carried out by the practitioner is now being carried out by the
technician.
After consideration of the public comments, we are finalizing the
work RVU and the direct PE inputs for CPT code 76514 as proposed.
(40) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)
In September 2017, the CPT Editorial Panel created three new codes
describing the use of ultrasound elastography to assess organ
parenchyma and focal lesions: CPT codes 76981 (Ultrasound,
elastography; parenchyma), 76982 (Ultrasound, elastography; first
target lesion) and 76983 (Ultrasound, elastography; each additional
target lesion). The most common use of this code set will be for
preparing patients with disease of solid organs, like the liver, or
lesions within solid organs.
The RUC recommended a work RVU of 0.59 for CPT code 76981
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of
0.59 for CPT code 76982 (Ultrasound, elastography; first target
lesion), and a work RVU of 0.50 for add-on CPT code 76983 (Ultrasound,
elastography; each additional target lesion). We are proposing the RUC-
recommended work RVUs for each of these new CPT codes.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT codes
76981 and 76982. CPT code 76700 (Ultrasound, abdominal, real time with
image documentation; complete), the reference code for these two new
codes, did not previously have clinical labor time assigned for the
``Confirm order, protocol exam'' clinical labor task, and we do not
have any reason to believe that these particular services being
furnished by the clinical staff have changed in the new codes, only the
way in which this clinical labor time has been presented on the PE
[[Page 59551]]
worksheets. We also noted that there is no effect on the total clinical
labor direct costs in these situations, since the same 3 minutes of
clinical labor time is still being furnished in CPT codes 76981 and
76982. We also proposed to refine the equipment times in accordance
with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Ultrasound Elastography family of codes.
Comment: Several commenters expressed support for our proposed work
RVUs for each of the three CPT codes in this family.
Response: We appreciate the support of commenters.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT codes 76981 and 76982, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
76981 and 76982, we are not finalizing these clinical labor refinements
as proposed, as these codes have the ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' task in predecessor CPT code 76700
on the old PE worksheet as well as 1 minutes of CA007 clinical labor
time. We are instead finalizing the RUC-recommended clinical labor
times for CA013 and CA014 for CPT codes 76981 and 76982. We are also
not finalizing our refinements to the corresponding equipment times as
a result.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Ultrasound Elastography family of codes
as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT
code 76982, and 0.50 work RVUs for CPT code 76983. We are not
finalizing our proposed direct PE inputs and are instead finalizing the
RUC-recommended direct PE inputs for these three codes.
(41) Ultrasound Exam--Scrotum (CPT Code 76870)
CPT code 76870 (Ultrasound, scrotum and contents) was identified on
a screen of CMS or Other source codes with Medicare utilization greater
than 100,000 services annually. We proposed a work RVU of 0.64 for CPT
code 76870 (Ultrasound, scrotum and contents), as recommended by the
RUC.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 76870
did not previously have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we did not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets. We also noted that there was no
effect on the total clinical labor direct costs in these situations
since the same 3 minutes of clinical labor time is still being
furnished under the CA013 room preparation activity. We also proposed
to refine the equipment times in accordance with our standard equipment
time formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 76870.
Comment: We received general support from commenters for our
proposed work RVU of 0.64 for CPT code 76870, as recommended by the
RUC.
Response: We thank commenters for their support.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 76870, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
76870, we are finalizing these clinical labor refinements as proposed.
After consideration of the public comments, we are finalizing the
work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76978 and 76979)
In September 2017, the CPT Editorial Panel created two new CPT
codes describing the use of intravenous microbubble agents to evaluate
suspicious lesions by ultrasound. CPT code 76978 (Ultrasound, targeted
dynamic microbubble sonographic contrast characterization (non-
cardiac); initial lesion) is a stand-alone procedure for the evaluation
of a single target lesion. CPT code 76979 (Ultrasound, targeted dynamic
microbubble sonographic contrast characterization (non-cardiac); each
additional lesion with separate injection) is an add-on code for the
evaluation of each additional lesion.
The two new CPT codes in this family represent a new technology
that involves the use of intravenous microbubble agents to evaluate
suspicious lesions by ultrasound. The first new CPT code 76978
(Ultrasound, targeted dynamic microbubble sonographic contrast
characterization (non-cardiac); initial lesion), is the base code for
the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble
sonographic contrast characterization (non-cardiac); each additional
lesion with separate injection). The RUC reviewed the survey results
for CPT code 76978 and recommended total time of 30 minutes and
intraservice time of 20 minutes. Their recommendation for a work RVU of
1.62 is based neither on the median of the survey results (1.82) nor
the 25th percentile of the survey results (1.27). Instead, the RUC-
recommended work RVU is based on a crosswalk to CPT code 73719
(Magnetic resonance (e.g., proton) imaging, lower extremity other than
joint; with contrast material(s)), which has identical intraservice and
total times as the survey CPT code. The RUC also identified a
comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton)
imaging, any joint of upper extremity; with contrast material(s)) with
work RVU 1.62 and similar times. For add-on CPT code 76979, the RUC
recommended a work RVU of 0.85, which is the 25th percentile of survey
results, with total and intraservice times of 15 minutes.
Although we generally agree that, particularly in instances where a
CPT code represents a new technology or procedure, there may be reason
to deviate from survey metrics, we are confused by the logic behind the
RUC's recommendation of a work RVU of 1.62 for CPT code 76978. When we
considered the range of existing CPT codes with 30 minutes total time
and 20 minutes intraservice time, we noted that a work RVU of 1.62 is
among the highest potential crosswalks. We also noted that the RUC
agreed with the 25th percentile of survey results for the new add-on
CPT code, 76979, and we did not see
[[Page 59552]]
why the 25th percentile would not also be appropriate for the base CPT
code, 76978. Therefore, we proposed a work RVU of 1.27 for CPT code
76978. We identified two CPT codes with total time of 30 minutes and
intraservice time of 20 minutes that bracket the proposed work RVU of
1.27: CPT code 93975 (Duplex scan of arterial inflow and venous outflow
of abdominal, pelvic, scrotal contents and/or retroperitoneal organs;
complete study) has a work RVU of 1.16, and CPT code 72270
(Myelography, 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical), radiological
supervision and interpretation) has a work RVU of 1.33. We proposed the
RUC-recommended work RVU of 0.85 for add-on CPT code 76979.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes for CPT code
76978. CPT codes 76700 (Ultrasound, abdominal, real time with image
documentation; complete) and 76705 (Ultrasound, abdominal, real time
with image documentation; limited), the reference codes for this new
code, did not previously have clinical labor time assigned for the
``Confirm order, protocol exam'' clinical labor task, and we did not
have any reason to believe that these particular services being
furnished by the clinical staff have changed in the new code, only the
way in which this clinical labor time has been presented on the PE
worksheets. We also noted that there is no effect on the total clinical
labor direct costs in these situations, since the same 3 minutes of
clinical labor time is still being furnished in CPT code 76978.
We proposed to remove the 50 ml of the phosphate buffered saline
(SL180) for CPT codes 76978 and 76979. When these codes were reviewed
by the RUC, the conclusion that was reached was to remove this supply
and replace it with normal saline. Since the phosphate buffered saline
remained in the recommended direct PE inputs, we believe its inclusion
may have been a clerical error. We proposed to remove the supply and
solicited comments on the phosphate buffered saline or a replacement
saline solution. We also proposed to refine the equipment times in
accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Contrast-Enhanced Ultrasound family of
codes.
Comment: Commenters were supportive of our proposed work RVU of
0.85 for CPT code 76979, as recommended by the RUC.
Response: We thank the commenters for their support of our proposal
regarding the work RVU for this CPT code.
Comment: A few commenters expressed opposition to our proposed work
RVU of 1.27 for new CPT code 76978. Commenters acknowledged that the
code is valued at the high end of the range of values for a given
intraservice time. However, they stated, being on the high end of a
range of comparison codes is not necessarily in itself a reason to
reduce the work RVU. They cite this as an illustration of CMS's
discounting the importance of intensity in valuing physician services
in favor of considering only time. The same commenters also noted that
the new technology used in furnishing the service, Contrast Enhanced
Ultrasound (CEUS), requires more technical skill and time than other
established ultrasound services.
Response: Our observation that a survey code is on the high end of
codes on the PFS with similar intraservice and total times is only one
among several factors we consider when we perceive that the code is not
properly valued in relation to other similar codes. We agree that there
are instances in which valuing a code at the high range of work RVUs
for codes with similar times is appropriate. However, on the whole, if
a recommended work RVU places the code on the very high end of work
RVUs with similar time parameters, we expect that the code would be of
notably higher intensity than most other codes with those time
parameters. We were not convinced that this was the case with CPT code
76978.
We were, however, persuaded by commenters that the higher technical
skill and time involved in using the new technology, CEUS, compared
with other established ultrasound services, is better reflected by the
RUC's recommended work RVU than our proposed value. Consequently we are
finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 76978, CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
76978, we are not finalizing these clinical labor refinements as
proposed, as this code has the ``Patient clinical information and
questionnaire reviewed by technologist, order from physician confirmed
and exam protocoled by radiologist'' task in predecessor CPT code 76700
on the old PE worksheet as well as 1 minutes of CA007 clinical labor
time. We are therefore finalizing the RUC-recommended clinical labor
times for CA013 and CA014 for CPT code 76978. We are also not
finalizing our refinements to the corresponding equipment times as a
result.
Comment: Several commenters disagreed with the proposal to remove
the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978
and 76979. Commenters stated that the SL180 supply can be replaced with
``normal saline'', however the change was not made because an
appropriate replacement could not be identified. Commenters stated that
the SL180 phosphate buffered saline (PBS) had been removed but ``normal
saline'' has not replaced it. Commenters agreed that this change was
appropriate and urged CMS to add the correct supply item for the
appropriate type of saline.
Response: We disagree with the commenters that the ``normal
saline'' was not added to these procedures. Both of these CPT codes
include the ``sodium chloride 0.9% inj bacteriostatic (30ml uou)''
(SH068) supply which would function as a form of normal saline. We do
not believe that it would be typical for these procedures to contain 50
ml of the phosphate buffered saline (SL180) in addition to the ``normal
saline'' described by the SH068 supply.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for both codes in this family as follows:
Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code
76978. We are also finalizing the RUC-recommended direct PE inputs for
these codes, with the exception of the refinement to the phosphate
buffered saline (SL180) supply as detailed above.
(43) Magnetic Resonance Elastography (CPT Code 76391)
The CPT Editorial Panel created new stand-alone CPT code 76391
describing the use of magnetic resonance elastography for the
evaluation of organ parenchymal pathology. This code will most often be
used to evaluate patients
[[Page 59553]]
with disease of solid organs (for example, cirrhosis of the liver) or
pathology within solid organs that manifest with increasing fibrosis or
scarring. The goal with magnetic resonance elastography is to evaluate
the degree of fibrosis/scarring (that is, stiffness) without having to
perform more invasive procedures (for example, biopsy). This technique
can be used to characterize the severity of parenchymal disease, follow
disease progression, or response to therapy.
The RUC recommended a work RVU for new CPT code 76391 (Magnetic
resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of
intraservice time and 25 minutes of total time. The recommendation is
based on a comparison with two reference CPT codes, CPT code 74183
(Magnetic resonance (e.g., proton) imaging, abdomen; without contrast
material(s), followed by with contrast material(s) and further
sequences) with total time of 40 minutes, intraservice time of 30
minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance
(e.g., proton) imaging, abdomen; without contrast material(s)), which
has a total time of 30 minutes, intraservice time of 20 minutes, and a
work RVU of 1.46. The RUC stated that both reference CPT codes have
higher work values than the new CPT code, which is justified in both
cases by higher intra-service times. They noted that, despite shorter
intraservice and total time, CPT code 76391 is slightly more intense to
perform due to the evaluation of wave propagation images and
quantitative stiffness measures. We did not agree with the RUC's
recommended work RVU for this CPT code. Using the RUC's two top
reference CPT codes as a point of comparison, the intraservice time
ratio in both instances suggests that a work RVU closer to 1.10 would
be more appropriate. We recognize that the RUC believes the new CPT
code is slightly more intense to furnish, but we are concerned about
the relativity of this code in comparison with other imaging procedures
that have similar intraservice and total times. Instead of the RUC-
recommended work RVU of 1.29 for CPT code 76391, we proposed a work RVU
of 1.10, which is based on a direct crosswalk to CPT code 71250
(Computed tomography, thorax; without contrast material). CPT code
71250 has identical intraservice time (15 minutes) and total time (25
minutes) compared to CPT code 76391, and we believe that the work
involved in furnishing both services is similar. We note that CPT code
76391 describes a new technology and will be reviewed again by the RUC
in 3 years.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
from 6 minutes to 5 minutes, and for the ``Prepare, set-up and start
IV, initial positioning and monitoring of patient'' (CA016) activity
from 4 minutes to 3 minutes. We disagreed that this additional clinical
labor time would be typical for these activities, which are already
above the standard times for these tasks. In both cases, we proposed to
maintain the current time from the reference CPT code 72195 (Magnetic
resonance (e.g., proton) imaging, pelvis; without contrast material(s))
for these clinical labor activities. We also proposed to refine the
equipment times in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 76391.
Comment: A commenter stated that CMS misunderstood the role of
reference CPT codes in the RUC's valuation process, and therefore our
proposed work RVU for CPT code 76391 is premised on a false time
comparison and a methodology that is invalid.
Response: In the materials provided to us, the RUC explicitly
compared the two key reference services to CPT 76391 and stated that
the higher work values for these codes are justified by higher
intraservice times. The RUC did not provide a crosswalk code for CPT
76391. Because of the RUC's justification of the higher work RVUs in
the reference services in relation to the higher intraservice times for
these codes, and because the RUC did not provide a crosswalk CPT code
for us to review, we believe it is an entirely appropriate methodology
to calculate the intraservice time ratios using those reference codes.
We acknowledged that the survey code is slightly more intense to
perform than the reference codes, according to the RUC's SOR, which is
why our calculation of intraservice time ratios is only a starting
point in our review of the code's recommended work RVU. We considered
the intraservice time ratios for both reference codes, which were not
identical, and compared these values to other CPT codes in the PFS with
similar intraservice and total times. For this particular CPT code
76391, we identified a crosswalk to CPT code 71250, which, as we
stated, achieved an overall balance of similar times and similar
intensity as the survey code and has a work RVU of 1.10.
Comment: Some commenters stated that our proposed value of 1.10
work RVUs for CPT code 76391 creates a rank order anomaly between an
MRI code and CPT code, CPT code 74160.
Response: We do not agree that our proposed work RVU of 1.10 for
this code creates a rank order anomaly between an MRI code and CT code
because this service is described as being unlike a routine magnetic
resonance imaging. This service also involves use of a new technology,
which makes it difficult to compare directly to services involving
magnetic resonance imaging. We are finalizing a work RVU of 1.10 for
CPT code 76391.
Comment: One commenter agreed with the refinements to the direct PE
inputs.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing the
work RVU of 1.10 and the direct PE inputs for CPT code 76391 as
proposed.
(44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)
CPT code 77012 (Computed tomography guidance for needle placement
(e.g., biopsy, aspiration, injection, localization device),
radiological supervision and interpretation) was identified on a screen
of CMS or Other source codes with Medicare utilization greater than
100,000 services annually.
We proposed the RUC-recommended work RVU of 1.50 for CPT code 77012
(Computed tomography guidance for needle placement (e.g., biopsy,
aspiration, injection, localization device), radiological supervision
and interpretation).
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare room, equipment and supplies'' (CA013) activity
to 3 minutes and to refine the clinical labor time for the ``Confirm
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 77012
did not previously have clinical labor time assigned for the ``Confirm
order, protocol exam'' clinical labor task, and we did not have any
reason to believe that the services being furnished by the clinical
staff have changed, only the way in which this clinical labor time has
been presented on the PE worksheets. We also noted that there is no
effect on the total clinical labor direct costs in these situations
since the same 3 minutes of clinical labor time is still being
furnished under the CA013 room preparation activity.
We proposed to refine the equipment time for the CT room (EL007) to
maintain the current time of 9 minutes. CPT code 77012 is a
radiological supervision and interpretation
[[Page 59554]]
procedure and there has been a longstanding convention in the direct PE
inputs, shared by 38 other codes, to assign an equipment time of 9
minutes for the equipment room in these procedures. We do not believe
that it would serve the interests of relativity to increase the
equipment time for the CT room in CPT code 77012 without also
addressing the equipment room time for the other radiological
supervision and interpretation procedures. Therefore, we proposed to
maintain the current equipment room time of 9 minutes until this group
of procedures can be subject to a more comprehensive review. We also
proposed to refine the equipment time for the Technologist PACS
workstation (ED050) in accordance with our standard equipment time
formulas.
The following is a summary of the public comments we received on
our proposals involving CPT code 77012.
Comment: We received support from a few commenters for our proposed
work RVU for CPT code 77012, as recommended by the RUC.
Response: We appreciate commenters' support. We are finalizing a
work RVU of 1.50 for CPT code 77012.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for CPT code 77012 CMS proposed to remove 1 minute
from the CA014 activity code and proposed to add 1 minute to the CA013
activity code. The commenter stated that this refinement was inaccurate
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT code
77012, we are finalizing these clinical labor refinements as proposed.
Comment: Several commenters disagreed with the proposal to refine
the equipment time for the CT room (EL007) to maintain the current time
of 9 minutes. Commenters stated that the room time is included in CT
guidance, as it is in US guidance (such as in CPT code 76942) because
that is the room the procedure is performed in. Commenters stated that
they agreed with CMS that other RS&I codes use the 9 minutes for room
time as a precedent, but this was specific to angiographic rooms and
referred to language from 2013 regarding angiographic rooms.
Response: We disagree with the commenters regarding the equipment
time for the CT room (EL007) due to the longstanding convention in the
direct PE inputs, shared by 38 other codes, to assign an equipment time
of 9 minutes for the equipment room in radiological supervision and
interpretation procedure. We agree with the commenters that at least
some portion of the procedure is performed in the CT room, but we
continue to believe that it would not serve the interests of relativity
to increase the equipment time for the CT room in CPT code 77012
without also addressing the equipment room time for the other
radiological supervision and interpretation procedures in a more
comprehensive fashion. We also disagree with the commenters that this
policy is specific to angiography rooms, as CPT codes 75989 and 77012
both employ CT rooms and currently utilize the standardized 9 minutes
of equipment time for radiological supervision and interpretation
procedures.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 77012 as proposed.
(45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)
CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone
density study, 1 or more sites; appendicular skeleton (peripheral)
(e.g., radius, wrist, heel)) was identified as potentially misvalued on
a screen of codes with a negative intraservice work per unit of time
(IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC
reviewed codes and over 1,000 for Harvard valued and CMS/Other source
codes. For CY 2019, we proposed the RUC-recommended work RVU of 0.20
for CPT code 77081.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 77081.
Comment: Commenters were supportive of our proposal regarding the
work RVU for CPT code 77081.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77046, 77047,
77048, and 77049)
CPT codes 77058 (Magnetic resonance imaging, breast, without and/or
with contrast material(s); unilateral) and 77059 (Magnetic resonance
imaging, breast, without and/or with contrast material(s); bilateral)
were identified in 2016 on a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. When
preparing to survey these codes, the specialties noted that the
clinical indications had changed for these exams. The technology had
advanced to make computer-aided detection (CAD) typical and these codes
did not parallel the structure of other magnetic resonance imaging
(MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes
0159T, 77058, and 77059 and created four new CPT codes to report breast
MRI with and without contrast (including computer-aided detection).
The RUC recommended a work RVU of 1.45 for CPT code 77046 (Magnetic
resonance imaging, breast, without contrast material; unilateral). This
recommendation was based on a comparison with CPT codes 74176 (Computed
tomography, abdomen and pelvis; without contrast material) and 74177
(Computed tomography, abdomen and pelvis; with contrast material(s)),
which both have similar intraservice and total times in relation to CPT
code 77046. We disagreed with the RUC's recommended work RVU because we
did not believe that the reduction in total time of 15 minutes between
the new CPT code 77046 and the deleted CPT code 77058 was adequately
reflected in its recommendation. Although total time has decreased by
15 minutes, the only other difference between the two CPT codes is the
change in the descriptor from the phrase `without and/or with contrast
material(s)' to `without contrast material,' suggesting that there is
less work involved in the new CPT code than in the deleted CPT code.
Instead, we proposed a work RVU of 1.15 for CPT code 77046, which is
similar to the total time ratio between the new CPT code and the
deleted CPT code. It is also supported by a crosswalk to CPT code 77334
(Treatment devices, design and construction; complex (irregular blocks,
special shields, compensators, wedges, molds or casts)). CPT code 77334
has total time of 35 minutes, intraservice time of 30 minutes, and a
work RVU of 1.15.
CPT code 77047 (Magnetic resonance imaging, breast, without
contrast material; bilateral) describes the same work as CPT code
77046, but reflects a bilateral rather than the unilateral procedure.
The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we
proposed a different work RVU for the unilateral procedure than the
value proposed by the RUC, we believe it is appropriate to recalibrate
the work RVU for CPT code 77047 relative to the RUC's recommended
difference in work between the two CPT codes. The RUC's recommendation
for
[[Page 59555]]
the bilateral procedure is 0.15 work RVUs larger than for the
unilateral procedure. Therefore, we proposed a work RVU of 1.30 for CPT
code 77047.
The RUC recommended a work RVU of 2.10 for CPT code 77048 (Magnetic
resonance imaging, breast, without and with contrast material(s),
including computer-aided detection (CAD-real time lesion detection,
characterization and pharmacokinetic analysis) when performed;
unilateral). CPT code 77048 is a new CPT code that bundles the deleted
CPT code for unilateral breast MRI without and/or with contrast
material(s) with CAD, which was previously reported, in addition to the
primary procedure CPT code, as CPT code 0159T (computer aided
detection, including computer algorithm analysis of MRI image data for
lesion detection/characterization, pharmacokinetic analysis, with
further physician review for interpretation, breast MRI). Consistent
with our belief that the proposed value for the base CPT code in this
series of new CPT codes (CPT code 77046) should be a work RVU of 1.15,
we are proposing a work RVU for CPT code 77048 that adds the RUC-
recommended difference in RUC-recommended work RVUs between CPT codes
77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code
77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.
The last new CPT code in this series, CPT code 77049 (Magnetic
resonance imaging, breast, without and with contrast material(s),
including computer-aided detection (CAD-real time lesion detection,
characterization and pharmoacokinetic analysis) when performed;
bilateral) describes the same work as CPT code 77048, but reflects a
bilateral rather than a unilateral procedure. The RUC recommended a
work RVU of 2.30 for this CPT code. Similar to the process for valuing
work RVUs for CPT code 77047 and CPT code 77048, we believe that a more
appropriate work RVU is calculated by adding the difference in the RUC
recommended work RVU for CPT codes 77046 and 77049, to the proposed
value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for
CPT code 77049.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Prepare, set-up and start IV, initial positioning and
monitoring of patient'' (CA016) activity from 7 minutes to 3 minutes
for CPT codes 77046 and 77047, and from 9 minutes to 5 minutes for CPT
codes 77048 and 77049. We noted that when the MRI of Lower Extremity
codes were reviewed during the previous rule cycle (CPT codes 73718-
73720), these codes contained either 3 minutes or 5 minutes of
recommended time for this same clinical labor activity. We also noted
that the current Breast MRI codes that are being deleted and replaced
with these four new codes, CPT codes 77058 and 77059, contain 5 minutes
of clinical labor time for this same activity. We had no reason to
believe that the new codes would require additional clinical labor time
for patient positioning, especially given that the recommended clinical
labor times are decreasing in comparison to the reference codes for
obtaining patient consent (CA011) and preparing the room (CA013).
Therefore, we refined the clinical labor time for the CA016 activity as
detailed earlier to maintain relativity with the current clinical labor
times in the reference codes, as well as with other recently reviewed
MRI procedures.
Included in the recommendations for this code family were five new
equipment items: CAD Server (ED057), CAD Software (ED058), CAD
Software--Additional User License (ED059), Breast coil (EQ388), and CAD
Workstation (CPU + Color Monitor) (ED056). We did not receive any
invoices for these five equipment items, and as such we do not have any
direct pricing information to use in their valuation. We proposed to
use crosswalks to similar equipment items as proxies for three of these
new types of equipment until we do have pricing information:
CAD software (ED058) is crosswalked to flow cytometry
analytics software (EQ380).
Breast coil (EQ388) is crosswalked to Breast biopsy device
(coil) (EQ371).
CAD Workstation (CPU + Color Monitor) (ED056) is
crosswalked to Professional PACS workstation (ED053).
We welcomed the submission of invoices with pricing information for
these three new equipment items for our consideration to replace the
use of these proxies. For the other two equipment items (CAD Server
(ED057) and CAD Software--Additional User License (ED059)), we did not
propose to establish a price at this time as we believe both of them
would constitute forms of indirect PE under our methodology. We do not
believe that the CAD Server or Additional User License would be
allocated to the use of an individual patient for an individual
service, and can be better understood as forms of indirect costs
similar to office rent or administrative expenses. We understand that
as the PE data age, these issues involving the use of software and
other forms of digital tools become more complex. However, the use of
new technology does not change the statutory requirement under which
indirect PE is assigned on the basis of direct costs that must be
individually allocable to a particular patient for a particular
service. We look forward to continuing to seek out new data sources to
help in updating the PE methodology.
We also proposed to refine the equipment times in accordance with
our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving the Breast MRI with Computer-Aided Detection
(CAD) family of codes.
Comment: A commenter disagreed with our use of deleted CPT code
77058 as a point of reference for considering whether the reduction in
work RVU in the new code, CPT code 77046, is commensurate with the
reduction in work time between the two codes. The commenter stated that
CMS should not compare these new services with the old deleted
services, as indicated by the specialty society having demonstrated
compelling evidence that the work involved in the breast MRI code
family has fundamentally changed.
Response: We disagree that it is inappropriate to use time
comparisons with a code that is being deleted as a guide for assessing
whether the reduction in work RVU recommended by the RUC is
commensurate with the reduction in time based on survey results. The
description of the work involved in furnishing CPT code 77046 has not
changed substantively from the code being deleted. The compelling
evidence that the commenter cites is related to the two new codes, CPT
code 77048 and 77049, which are newly bundled with CAD. The main
distinction in the description of physician work for this CPT code is
that the new code specifies `without contrast', while the deleted code
described the service `without and/or with contrast.' The change in
patient population, also cited by the commenter, actually suggests that
the more complex patients will be screened using the advanced
technologies, such as is described by CPT code 77048. We recognize that
changes in technology and work flow for the work described by CPT code
77046 have affected the work involved in furnishing these services.
This is why we use the time ratios as a starting point for code
comparisons rather than the end point.
Comment: One commenter stated that our proposed crosswalk code for
CPT 77046, CPT code 77334, is inappropriate because of different
preservice and intraservice times between the two codes, and because
there is more low-
[[Page 59556]]
intensity time in CPT code 77334 compared with CPT code 77046. The
commenter also indicated that our proposed work RVU for CPT code 77046
would create a rank order anomaly with other MRI codes.
Response: As a matter of principle, we do not agree that a chosen
crosswalk for a CPT code is required to be clinically similar or to
have identical intraservice and/or total time as the code being valued.
However, in this instance, after further consideration, we agree with
the commenter that our crosswalk code, CPT 77334, is not a particularly
good comparison, in terms of intensity, to CPT 77046. We also agree
with the commenter that our proposed work RVU for CPT code 77046 would
create an anomaly among other CPT codes involving MRI. We are
finalizing a work RVU for CPT code 77046 of 1.45, as recommended by the
RUC.
Comment: A commenter disagreed with our use of increments in
recalibrating work RVUs for codes that precede or follow a new or
revalued CPT code, as was the process underlying our proposed work RVUs
for CPT codes 77047, 77048, and 77049.
Response: The recalibration of CPT codes based on incremental
difference in the work RVUs recommended by the RUC is an established
methodology used by CMS to value the work involved in furnishing a
service. There are certain types of code groups, particularly those
with clear stepwise changes in intensity, as described by the RUC, for
which we believe this is entirely appropriate. We continue to believe
that this is an appropriate approach. However, having agreed with the
commenter that our proposed work RVU for CPT code 77046 should be
finalized at the RUC recommended work RVU of 1.45, we also believe that
it is unnecessary to recalibrate the RUC's recommended work RVUs for
the remainder of the three codes in the series. Therefore, we are
finalizing a work RVU of 1.60 for CPT code 77047, 2.10 for CPT code
77048, and 2.30 for CPT code 77049.
Comment: Several commenters disagreed with the CMS proposal to
refine the clinical labor time for the ``Prepare, set-up and start IV,
initial positioning and monitoring of patient'' (CA016) activity from 7
minutes to 3 minutes for CPT codes 77046 and 77047, and from 9 minutes
to 5 minutes for CPT codes 77048 and 77049. Commenters stated that the
rationale for this change was likely derived from reference to the
lower clinical labor times for this activity associated with lower
extremity MRI codes, and that it was an error to treat the clinical
labor time for this activity as akin to that for lower extremity MRI.
Commenters requested that CMS consider the experience of an 80-year-old
patient who needs assistance on and off the table, along with
reassurance, added explanation, IV insertion into delicate skin, and
other anxiety needs. Commenters stated that another major distinction
between breast MRI and extremity MRI is that the patient lies prone on
the coil, which requires an awkward process of positioning and causes
the need for additional clinical labor time.
Response: We continue to disagree with the commenters that the RUC-
recommended clinical labor time would be typical for these procedures.
As part of our review, we compared the clinical labor times for the
CA016 activity not only to the codes in the MRI of Lower Extremity
family, but also to the current Breast MRI codes that are being deleted
and replaced with these four new codes. CPT codes 77058 and 77059
contain 5 minutes of clinical labor time for this same activity, and we
do not agree that the clinical labor times would be increasing to 7 and
9 minutes in the newly created CPT codes, especially given that
commenters did not provide a rationale as to why time would be
increasing. We also note that while some patients will have conditions
that are more difficult than the typical case, such as the 80-year-old
patient described by the commenters, other patients would have
conditions that are less difficult than the typical case. We remind the
reader that valuation of services under the PFS is based on the typical
case and not the most difficult cases that may arise. We further note
that the clinical vignette for CPT code 77047 describes a 53-year old
female patient, not an 80-year old patient, and was stated to be
typical by 96 percent of the survey respondents.
Comment: A commenter stated that in the CMS refinements to the
direct PE inputs for these four CPT codes, CMS proposed to remove 1
minute from the CA014 activity code and proposed to add 1 minute to the
CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor.
Response: We believe that the commenter may have been confused with
several of the other code families that included these clinical labor
refinements, which we described in the PE section of this final rule
under the Changes to Direct PE Inputs for Specific Services heading
(section II.B.3. of this final rule). We did not propose any
refinements to the CA014 clinical labor for the codes in this family.
Comment: Several commenters requested that CMS add 5 minutes to CPT
codes 77048 and 77049 to account for the time required to obtain vital
signs. Commenters stated that to maintain consistency within the codes
for MRI with contrast, they requested that new codes for breast MRI
with contrast receive an additional two minutes of time for MRI
technologist (L047A) bringing the total time for obtain vital signs to
5 minutes.
Response: We proposed in CY 2018 to assign 5 minutes of clinical
labor time for all codes that include the ``Obtain vital signs'' task,
that included at least 1 minute previously assigned to this task
regardless of the date of last review. After considering the comments,
we did not finalize our proposal to establish 5 minutes as the new
standard for the ``Obtain vital signs'' clinical labor task. As a
result, we do not agree with the commenters that the clinical labor
time for the CA010 activity should be increased to 5 minutes for CPT
codes 77048 and 77049, especially given that we did not make a proposal
to do so. We refer readers to the CY 2018 PFS final rule (82 FR 52990-
52991) for additional details about last year's proposal on this issue.
Comment: One commenter requested that CMS assign additional
clinical labor time for MRI procedures with contrast in order to
account for time spent counseling patients. Commenters stated that
because of the increased public awareness of the risk relating to
gadolinium, additional time is required to explain the benefits and
risks of the procedure.
Response: We note that the MRI procedures in this family that are
done with contrast (CPT codes 77048 and 77049) already contain more
clinical labor than the MRI procedures that are done without contrast
(CPT codes 77046 and 77047). Specifically, these procedures already
contain two additional minutes for ``Provide education/obtain consent''
(CA011) clinical labor than the non-contrast versions of the
procedures, which we believe indicates that the concerns of the
commenters have been taken into account.
Comment: Several commenters stated that the lack of invoices for
the new equipment items may have been an oversight and enclosed new
invoices with their comment letter. Commenters also stated that the CAD
Software equipment (ED058) is actually synonymous with the ``breast
biopsy software'' (EQ370) equipment, and recognized that in hindsight
they should
[[Page 59557]]
have been consistent in identifying the equipment item between the
breast biopsy codes and the MR breast codes. One commenter disagreed
that the CAD Server or Additional User License equipment constituted
forms of direct PE, and requested that CMS consider the cost of CAD
service contracts and ``C-view'' costs in order to accurately access
the calculation of indirect practice expenses.
Response: We appreciate the submission of additional invoices from
the commenters to assist in pricing these new equipment items. As we
detailed in the Practice Expense portion of this final rule (section
II.B. of this final rule), we are finalizing an update in the price of
the CAD Software (ED058) equipment to $43,308.12 based on the new
invoice submission and additional review by the StrategyGen contractor.
We are also finalizing a price of $83,200 for the Breast coil (EQ388)
equipment and a price of $12,031.52 for the CAD Workstation (CPU +
Color Monitor) (ED056) based on the invoices submitted by the
commenters. For the other two equipment items (CAD Server (ED057) and
CAD Software--Additional User License (ED059)), we continue to believe
that both of them would constitute forms of indirect PE under our
methodology. The submitted invoices indicated that the CAD Server was a
server type used in a data center while the user license was for a
third license above and beyond the two licenses included in the price
of the CAD software. As we stated in the proposed rule, we do not
believe that these types of equipment would be allocated to the use of
an individual patient for an individual service, and can be better
understood as forms of indirect costs similar to office rent or
administrative expenses.
Comment: Several commenters stated that CMS had overstated the
useful life of a breast coil. The commenters stated that a coil will
start to display signs of wear, such as cracking of its case, flex
spots, exposed wiring, or a degradation of its attenuated field causing
a loss in image quality after about three to four years. Commenters
stated that a useful life of 5 years would be more appropriate and
consistent with the experience of their members.
Response: We appreciate the additional information regarding the
useful life of the breast coil equipment from the commenters. Our
proposal to use 10 years as the useful life for this new equipment was
based on our use of the breast biopsy device (EQ371) equipment as a
proxy. We agree with the commenters that it would be more accurate to
update the useful life to 5 years in light of this new information.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs for the codes in the Breast MRI with
Computer-Aided Detection family of codes. We are finalizing the direct
PE inputs as proposed, with the updates to the pricing of the new
equipment as detailed above.
(47) Blood Smear Interpretation (CPT Code 85060)
CPT code 85060 (Blood smear, peripheral, interpretation by
physician with written report) was identified on a screen of CMS or
Other source codes with Medicare utilization greater than 100,000
services annually. For CY 2019, the RUC recommended a work RVU of 0.45
based on maintaining the current work RVU.
We disagreed with the recommended value and proposed a work RVU of
0.36 for CPT code 85060 based on the total time ratio between the
current time of 15 minutes and the recommended time established by the
survey of 12 minutes. This ratio equals 80 percent, and 80 percent of
the current work RVU of 0.45 equals a work RVU of 0.36. When we
reviewed CPT code 85060, we found that the recommended work RVU was
higher than nearly all of the other global XXX codes with similar time
values, and we do not believe that this blood smear interpretation
procedure would have an anomalously high intensity. Although we did not
imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be reflected in
decreases to work RVUs. In the case of CPT code 85060, we believe that
it would be more accurate to propose the total time ratio at a work RVU
of 0.36 to account for these decreases in the surveyed work time.
The proposed work RVU was also based on the use of three crosswalk
codes. We directly supported the proposed valuation through a crosswalk
to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash
testing, central nervous system except glaucoma, with interpretation
and report), which has a work RVU of 0.35 along with 10 minutes of
intraservice time and 14 minutes of total time. We also explained the
proposed valuation by bracketing it between two other crosswalks, with
CPT code 99152 (Moderate sedation services provided by the same
physician or other qualified health care professional performing the
diagnostic or therapeutic service that the sedation supports; initial
15 minutes of intraservice time, patient age 5 years or older) on the
lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral
noninvasive physiologic studies of upper or lower extremity arteries, 3
or more levels, or single level study with provocative functional
maneuvers) on the higher end at a work RVU of 0.45.
The RUC recommended no direct PE inputs for CPT code 85060 and we
proposed none.
The following is a summary of the public comments we received on
our proposals involving CPT code 85060.
Comment: Many commenters disagreed with the proposed work RVU of
0.36 for CPT code 85060 and stated that CMS should finalize the RUC-
recommended work RVU of 0.45. Commenters stated that a time ratio
should not be used because any decrease will result in a large ratio
and a corresponding but inappropriate decrease to the physician work
RVU. Commenters stated that rather than using time ratios CMS should
examine the magnitude estimation between the physician work, time, and
intensity. Commenters also stated that the current time was not based
on a survey and it was unclear how the time was determined.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values recommended by the RUC and
other commenters do not account for information provided by surveys
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values reveals that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual
[[Page 59558]]
procedures. Were we to disregard intensity altogether, the work RVUs
for all services would be developed based solely on time values and
that is definitively not the case, as indicated by the many services
that share the same time values but have different work RVUs. (As an
example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share
identical CY 2019 work times with 15 minutes of preservice time, 30
minutes of intraservice time, and 15 minutes of postservice time;
however these codes have respective CY 2019 work RVUs of 1.44, 2.04,
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
through 80277).
Comment: Several commenters disagreed with our statement that the
recommended work value of 0.45 is higher than nearly all of the other
global XXX codes with similar time values. Commenters stated that a
search of the RUC database contradicted this finding, showing that
eleven XXX codes with 12 minutes of intraservice time have values lower
than 0.45 and thirteen XXX codes with 12 minutes of intraservice time
have values the same or higher than 0.45 RVUs. Commenters stated that
none of these services are pathology services and were not comparable,
except for CPT code 88388 (Macroscopic examination, dissection, and
preparation of tissue for non-microscopic analytical studies (e.g.,
nucleic acid-based molecular studies)) which has identical work value
and intra-service time and was the reference code cited in the RUC
recommendation. Commenters also disagreed with the CMS crosswalk to CPT
code 95930 due to the fact that it is not a pathology service.
Response: We disagree with the commenters' statement that pathology
services are only comparable to other pathology services. Although we
agree that the unique nature of pathology and laboratory services can
make comparisons across codes more difficult than in other services, we
believe the comparison of codes with similar work RVUs across different
specialties is important to maintaining the relativity of the PFS. We
disagree with the commenters that the crosswalk to CPT code 95930 would
be methodologically inappropriate solely on the grounds that it is not
a pathology service.
Comment: Several commenters stated that there are a number of
variables that must be considered in the evaluation of a blood smear
when compared to others, including red blood cell count, size and
morphology, platelet morphology and number, white blood cell morphology
and the presence of white blood cell precursors. Commenters stated that
other services with identical physician work include CPT code 88314
(Special stain including interpretation and report; histochemical stain
on frozen tissue block) and CPT code 93923 (Complete bilateral
noninvasive physiologic studies of upper or lower extremity arteries, 3
or more levels). Commenters stated the proposed work value would create
significant rank order anomalies within the array of pathology
services, as CPT code 85060 has nearly identical work time to CPT code
88314 but would be valued lower at the proposed work RVU.
Response: We appreciate the detailed information about CPT code
85060 provided by the commenters regarding the clinical comparisons to
CPT codes 88314 and 93923.
After consideration of the public comments, we are not finalizing
our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the
RUC-recommended work RVU of 0.45 instead.
(48) Bone Marrow Interpretation (CPT Code 85097)
CPT code 85097 (Bone marrow, smear interpretation) was identified
on a screen of CMS or Other source codes with Medicare utilization
greater than 100,000 services annually. For CY 2019, the RUC
recommended a work RVU of 1.00 based on a direct crosswalk to CPT code
88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract
specimen with morphometric analysis, 3-5 molecular probes, each
specimen; using computer-assisted technology).
We disagreed with the RUC-recommended value and we proposed a work
RVU of 0.94 for CPT code 85097 based on maintaining the current work
valuation. We noted that the survey indicated that CPT code 85097
typically takes 25 minutes of work time to perform, down from a
previous work time of 30 minutes, and, generally speaking, since the
two components of work are time and intensity, we believe that
significant decreases in time should be reflected in decreases to work
RVUs. For the specific case of CPT code 85097, we supported our
proposed work RVU of 0.94 through a crosswalk to CPT code 88361
(Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu,
estrogen receptor/progesterone receptor), quantitative or
semiquantitative, per specimen, each single antibody stain procedure;
using computer-assisted technology), a recently reviewed code from CY
2018 with the identical time values and a work RVU of 0.95.
We also considered a work RVU of 0.90 based on double the
recommended work RVU of 0.45 for CPT code 85060 (Blood smear,
peripheral, interpretation by physician with written report). When both
of these CPT codes were under review, the explanation was offered that
in a peripheral blood smear, typically, the practitioner does not have
the approximately 12 precursor cells to review, whereas in an aspirate
from the bone marrow, the practitioner is examining all the precursor
cells. Additionally, for CPT code 85097, there are more cell types to
look at as well as more slides, usually four, whereas with CPT code
85060 the practitioner would typically only look at one slide. Although
we did not propose to value CPT code 85097 at twice the work RVU of CPT
code 85060, we believe this analysis also supports maintaining the
current work RVU of 0.94 as opposed to raising it to 1.00.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Accession and enter information'' (PA001) and ``File
specimen, supplies, and other materials'' (PA008) activities. As we
stated previously, information entry and specimen filing tasks are not
individually allocable to a particular patient for a particular service
and are considered to be forms of indirect PE. Although we agree that
these are necessary tasks, under our established methodology we believe
that they are more appropriately classified as indirect PE.
The following is a summary of the public comments we received on
our proposals involving CPT code 85097.
Comment: Many commenters disagreed with the proposed work RVU of
0.94 for CPT code 85097 and stated that CMS should finalize the RUC-
recommended work RVU of 1.00. Commenters stated that the CMS rationale
about changes in work time was out of place in this context because the
survey respondents indicate that the service requires 25 minutes to
perform rather than the current time of 30 minutes, yet CMS proposed to
maintain the current work value. The commenters suggested that
maintaining the current work RVU of 0.94 was therefore inappropriate.
Commenters also stated that the current work time for CPT code 85097
was not based on a survey and that it was unknown how this time was
[[Page 59559]]
determined and what it actually represents.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important role in
PFS ratesetting, both as points of comparison in establishing work RVUs
and in the allocation of indirect PE RVUs by specialty. If we were to
operate under the assumption that previously recommended work times had
routinely been overestimated, this would undermine the relativity of
the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times, and
it also would undermine the validity of the allocation of indirect PE
RVUs to physician specialties across the PFS. Instead, we believe that
it is crucial that the code valuation process take place with the
understanding that the existing work times used in the PFS ratesetting
processes are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of old
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
With regard to the specific case of CPT code 85097, we proposed to
maintain the current work RVU rather than decreasing the work RVU due
to some of the same concerns about the historical work times for this
code raised by the commenters. We believe that the logic provided by
the commenters suggests that the decreases in the work time of CPT code
85097 should have been reflected in decreases to the work RVU (as
opposed to maintaining the current value), which we do not believe was
their intention.
Comment: Several commenters stated that given the total work, time,
intensity, and complexity of the patient case, the current work RVU of
0.94 was too low for CPT code 85097. Commenters stated that the RUC
chose a crosswalk to CPT code 88121 (Cytopathology, in situ
hybridization (e.g., FISH), urinary tract specimen with morphometric
analysis, 3-5 molecular probes, each specimen; using computer-assisted
technology) specifically because it is a similar pathology code with a
value between the current work value of 0.94 and the survey 25th
percentile of 1.15. Commenters stated that the CMS reference code (CPT
code 88361) was less intense and complex to perform as it involves
evaluating a single antibody and determining the percentage of tumor
cells that are positive for that antibody, as opposed to the work of
CPT code 85097 which involves evaluating all blood cell precursors for
quantitative and morphologic abnormalities, as well as evaluating for
metastatic tumor cells, evidence of infection, or evidence of lymphoid
neoplasms.
Response: We disagree with the commenters that the current work RVU
of 0.94 or the work RVU of our reference code of 88361 are too low in
comparison to CPT code 85097. All three of the codes under discussion
(CPT codes 85097, 88121, and 88361) are clinically similar procedures
that involve the practitioner using their eyes to look at staining
patterns. We do not agree with the commenters that the RUC's use of CPT
code 88121 as a crosswalk would be any more accurate on clinical
grounds that the reference code of 88361 that we chose in the proposed
rule. Overall, we do not believe that there is a significant difference
between these three procedures given their nearly identical work RVUs,
intensities, and work times. However, given the decrease in surveyed
work time, we continue to believe that it is more appropriate to
maintain the current work RVU of 0.94 than to increase it to 1.00 due
to our longstanding belief that decreases in work time should typically
be not be reflected in increases to the work RVU. We note that we are
not proposing to decrease the work RVU for CPT code 85097 despite this
decrease in the surveyed work time, only to maintain the current
valuation.
Comment: Several commenters responded to the CMS consideration of a
work RVU of 0.90 based on double the recommended work RVU of 0.45 for
CPT code 85060. Commenters stated that they wished to clarify that this
explanation was put forward to a RUC member whom was simply questioning
why this service requires twice the time of CPT code 85060. Commenters
stated that simply doubling the RUC-recommended work RVU of 0.45 for
CPT code 85060 based on the amount of time does not account for the
considerably greater intensity and complexity of CPT code 85097 over
CPT code 85060 as described elsewhere in their comments.
Response: We appreciate the clarification on this issue from the
commenters.
Comment: Several commenters disagreed with the CMS proposal remove
the clinical labor time for the ``Accession and enter information''
(PA001) and ``File specimen, supplies, and other materials'' (PA008)
activities. Commenters stated that although the descriptions for the
PA001 and PA008 clinical labor activities appeared to describe data
entry and filing activities, these tasks are very different in the
pathology lab. Commenters stated that it is crucial for the performance
of these tasks be executed accurately according to rigid patient
laboratory protocols, standards, and legal processes associated with
specimen/patient care and they should not be considered a form of
indirect expense.
Response: Although we agree that the unique nature of pathology and
laboratory services can make comparisons across codes more difficult
than for other services, we believe the comparison of similar clinical
labor activities across different services is important to maintaining
the relativity of the direct PE inputs. As we stated in the CY 2017 PFS
final rule (81 FR 80324), we agree with the commenters that entering
patient data into information systems and filing specimens are
important tasks, and we agree that these would take more than zero
minutes to perform. However, we continue to believe that these
activities are correctly categorized as indirect PE as administrative
functions, and therefore, we do not recognize the entry of patient data
or the filing of specimens as direct PE inputs, and we do not consider
this task as typically performed by clinical labor on a per-service
basis.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for CPT code 85097 as proposed.
(49) Fibrinolysins Screen (CPT Code 85390)
CPT code 85390 (Fibrinolysins or coagulopathy screen,
interpretation and report) was identified as potentially misvalued on a
screen of codes with a negative IWPUT, with 2016 estimated Medicare
utilization over 10,000 for
[[Page 59560]]
RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other
source codes. For CY 2019, we are proposing the RUC-recommended work
RVU of 0.75 for CPT code 85390. Because this is a work only code, the
RUC did not recommend, and we did not propose any direct PE inputs for
CPT code 85390.
The following is a summary of the public comments we received on
our proposals involving CPT code 85390.
Comment: A commenter expressed support for our proposal to accept
the RUC-recommended work RVU for this code.
Response: We appreciate the support for our proposals from the
commenter.
After consideration of the public comments, we are finalizing our
proposal to accept the RUC-recommended work RVU for this code.
(50) Electroretinography (CPT Codes 92273, 92274, and 0509T)
CPT code 92275 (Electroretinography with interpretation and report)
was identified in 2016 on a high expenditure services screen across
specialties with Medicare allowed charges of $10 million or more. In
January 2016, the specialty society noted that they became aware of
inappropriate use of CPT code 92275 for a less intensive version of
this test for diagnosis and indications that are not clinically proven
and for which less expensive and less intensive tests already exist.
CPT changes were necessary to ensure that the service for which CPT
code 92275 was intended was clearly described, as well as an accurate
vignette and work descriptor were developed. In September 2017, the CPT
Editorial Panel deleted CPT code 92275 and replaced it with two new
codes to describe electroretinography full field and multi focal. A
category III code was retained for pattern electroretinography.
For CPT code 92273 (Electroretinography (ERG) with interpretation
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we
disagreed with the recommended work RVU of 0.80 and we instead proposed
a work RVU of 0.69 based on a direct crosswalk to CPT code 88172
(Cytopathology, evaluation of fine needle aspirate; immediate
cytohistologic study to determine adequacy for diagnosis, first
evaluation episode, each site). CPT code 88172 is another
interpretation procedure with the same 20 minutes of intraservice time,
which we believe is a more accurate comparison for CPT code 92273 than
the two reference codes chosen by the survey participants due to their
significantly higher and lower intraservice times. We noted that the
recommended intraservice time for CPT code 92273 as compared to its
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes
(56 percent reduction), and the recommended total time is decreasing
from 71 minutes to 22 minutes (69 percent reduction); however, the work
RVU is only decreasing from 1.01 to 0.80, which is a reduction of just
over 20 percent. Although we did not imply that the decreases in time
as reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in
time should be reflected in decreases to work RVUs. In the case of CPT
code 92273, we have reason to believe that the significant drops in
surveyed work time as compared to CPT code 92275 are a result of
improvements in technology since the predecessor code was reviewed. The
older machines used for electroretinography were slower and more
cumbersome, and now the same work for the service can be performed in
significantly less time. Therefore, we proposed a work RVU of 0.69
based on the direct crosswalk to CPT code 88172, which we believe more
accurately accounts for these decreases in surveyed work time.
For CPT code 92274 (Electroretinography (ERG) with interpretation
and report; multifocal (mfERG)), we disagreed with the RUC-recommended
work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the
relative difference in work between CPT code 92273 and 92274 is
equivalent to the recommended interval of 0.08 RVUs. Therefore, we
proposed a work RVU of 0.61 for CPT code 92274, based on the
recommended interval of 0.08 fewer RVUs below our proposed work RVU of
0.69 for CPT code 92273. The proposed work RVU is also based on the use
of two crosswalk codes: CPT code 88387 (Macroscopic examination,
dissection, and preparation of tissue for non-microscopic analytical
studies; each tissue preparation); and CPT code 92100 (Serial tonometry
(separate procedure) with multiple measurements of intraocular pressure
over an extended time period with interpretation and report, same day).
Both codes share the same 20 minutes of intraservice and 20 minutes of
total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU
of 0.61 for CPT code 92100.
The recommendations for this code family also include CPT Category
III code 0509T (Electroretinography (ERG) with interpretation and
report, pattern (PERG)). We typically assign contractor pricing for
Category III codes since they are temporary codes assigned to emerging
technology and services. However, in cases where there is an unusually
high volume of services that will be performed under a Category III
code, we have sometimes assigned an active status to the procedure and
developed RVUs before a formal CPT code is created. In the case of CPT
code 0509T, the recommendations indicate that approximately 80 percent
of the services currently reported under CPT code 92275 will be
reported under the new Category III code. Since this will involve an
estimated 100,000 services for CY 2019, we believe that the interests
of relativity would be better served by assigning an active status to
CPT code 0509T and creating RVUs through the use of a proxy crosswalk
to a similar existing service. Therefore, we proposed to assign an
active status to CPT Category III code 0509T for CY 2019, with a work
RVU and work time values crosswalked from CPT code 92250 (Fundus
photography with interpretation and report). CPT code 92250 is a
clinically similar procedure that was recently reviewed during the CY
2017 rule cycle. We proposed a work RVU of 0.40 and work times of 10
minutes of intraservice and 12 minutes of total time for CPT code 0509T
based on this crosswalk to CPT code 92250.
For the direct PE inputs, we proposed to remove the preservice
clinical labor in the facility setting for CPT codes 92273 and 92274.
Both of these codes are diagnostic tests under which the professional
(26 modifier) and technical (TC modifier) components will be separately
billable, and codes that have these professional and technical
components typically will not have direct PE inputs in the facility
setting since the technical component is only valued in the nonfacility
setting. We also noted on this subject that the predecessor code, CPT
code 92275, does not currently include any preservice clinical labor,
nor any facility direct PE inputs.
We proposed to remove the clinical labor time for the ``Greet
patient, provide gowning, ensure appropriate medical records are
available'' (CA009) and the ``Provide education/obtain consent''
(CA011) activities for CPT codes 92273 and 92274. Both of these CPT
codes will typically be reported with a same day E/M service, and we
believe that these clinical labor tasks will be carried out during the
E/M service. We believe that their inclusion in CPT codes 92273 and
92274 would be duplicative. We also proposed to refine the clinical
labor time for the
[[Page 59561]]
``Prepare room, equipment and supplies'' (CA013) activity to 3 minutes
and to refine the clinical labor time for the ``Confirm order, protocol
exam'' (CA014) activity to 0 minutes for both codes. The predecessor
CPT code 92275 did not previously have clinical labor time assigned for
the ``Confirm order, protocol exam'' clinical labor task, and we did
not have any reason to believe that the services being furnished by the
clinical staff had changed in the new codes, only the way in which this
clinical labor time has been presented on the PE worksheets. We also
noted that there is no effect on the total clinical labor direct costs
in these situations since the same 3 minutes of clinical labor time is
still being furnished.
We proposed to refine the clinical labor time for the ``Clean room/
equipment by clinical staff'' (CA024) activity from 12 minutes to 8
minutes for CPT codes 92273 and 92274. The recommendations for these
codes stated that cleaning is carried out in several steps: The patient
is first cleaned for 2 minutes, followed by wires and electrodes being
scrubbed carefully with detergent, soaked, and then rinsed with sterile
water. We agree with the need for 2 minutes of patient cleaning time
and for the cleaning of the wires and electrodes to take place in two
different steps. However, our standard clinical labor time for room/
equipment cleaning is 3 minutes, and therefore, we proposed a total
time of 8 minutes for these codes, based on 2 minutes for patient
cleaning and then 3 minutes for each of the two steps of wire and
electrode cleaning.
We proposed to refine the clinical labor time for the
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT
codes 92273 and 92274. We finalized in the CY 2017 PFS final rule (81
FR 80184-80186) a range of appropriate standard minutes for this
clinical labor activity, ranging from 2 minutes for simple services up
to 5 minutes for highly complex services. We believe that the
complexity of the imaging in CPT codes 92273 and 92274 is comparable to
the CT and magnetic resonance (MR) codes that have been recently
reviewed, such as CPT code 76391 (Magnetic resonance (e.g., vibration)
elastography). Therefore, in order to maintain relativity, we proposed
the same clinical labor time of 3 minutes for CPT codes 92273 and 92274
that has been recommended for these CT and MR codes. We also proposed
to refine the clinical labor time for the ``Review examination with
interpreting MD/DO'' (CA031) activity from 5 minutes to 2 minutes for
CPT codes 92273 and 92274. We also finalized in the CY 2017 PFS final
rule a standard time of 2 minutes for reviewing examinations with the
interpreting MD, and we have no reason to believe that these codes
would typically require additional clinical labor at more than double
the standard time.
We noted that the new equipment item ``Contact lens electrode for
mfERG and ffERG'' (EQ391) was listed twice for CPT code 92273 but only
a single time for CPT code 92274. We solicited additional information
about whether the recommendations intended this equipment item to be
listed twice, with one contact intended for each eye, or whether this
was a clerical mistake. We are also interested in additional
information as to why the contact lens electrode was listed twice for
CPT code 92273 but only a single time for CPT code 92274. Finally, we
also proposed to refine the equipment times in accordance with our
standard equipment time formulas.
We proposed to use the direct PE inputs for CPT code 92274,
including the refinements detailed above, as a proxy for CPT Category
III code 0509T until it can be separately reviewed by the RUC.
The following is a summary of the public comments we received on
our proposals involving the Electroretinography family of codes.
Comment: Many commenters disagreed with the proposed work RVU of
0.69 for CPT code 92273 and stated that CMS should finalize the RUC-
recommended work RVU of 0.80. Commenters stated that the RUC-
recommended work RVU was based on the survey 25th percentile and CMS
should use survey data in establishing the work RVU. Commenters stated
that the decrease in intraservice work time of deleted CPT code 92275
from when it was last surveyed in 1995 was due to the fact that the
physician no longer participates in the acquisition of the data or
performing the test on the patient, which has become the technician's
work. Commenters stated that the RUC determined that the physician work
is not the same as it was with CPT code 92275 and the recommended
decrease in work RVUs appropriately addresses the decrease in physician
time to perform this service.
Response: We disagree with the commenters that the RUC-recommended
decrease in work RVUs appropriately addresses the decrease in physician
time to perform this service. As we stated in the proposed rule, the
recommended intraservice time for CPT code 92273 as compared to its
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes
(56 percent reduction), and the recommended total time is decreasing
from 71 minutes to 22 minutes (69 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.01 to 0.80, which is a
reduction of just over 20 percent. Although we did not imply that the
decreases in time as reflected in survey values must equate to a one-
to-one or linear decrease in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant decreases in time should be reflected in decreases to work
RVUs. As a result, we believe that our proposed work RVU of 0.69 more
accurately captures the changes in work that have taken place since the
previous survey.
Comment: Several commenters stated that while the time required for
CPT code 92273 is less than the time required for CPT code 92275, the
code it replaced, the intensity and complexity of the work involved in
interpreting the test has increased significantly. Commenters stated
that the newer machines are easily programmed to produce more images
and numbers for interpretation (double or more) than the machines in
use in 1995 when the procedure was last valued and that advances in
medical knowledge have identified more specific retinal dystrophy
diagnoses with specific genotypes that the clinician must consider when
interpreting the test. Commenters emphasized that while the machine may
be more efficient as stated by CMS, the cognitive work required by the
physician interpreting the test has increased significantly.
Response: We disagree with the commenters that all of the
efficiencies gained in work time via improved technology would be
offset via higher intensity (that is, greater cognitive work on the
part of the practitioner). While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. At the RUC-recommended work RVU of 0.80,
the intensity of CPT code 92273 would increase by nearly 300 percent,
and we do not agree that the cognitive intensity of the procedure would
have increased by this amount. We continue to believe that our proposed
work RVU of 0.69 more accurately captures the changes in work taking
place as a result of greater technological efficiencies in the service.
[[Page 59562]]
Comment: Many commenters disagreed with the proposed work RVU of
0.61 for CPT code 92274 and stated that CMS should finalize the RUC-
recommended work RVU of 0.72. Commenters stated that CMS should use
valid methods of evaluating services, such as survey data and magnitude
estimation, instead of relying on an incremental difference in work
RVUs between codes 92273 and 92274.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We further note that we did not rely solely
on an increment for our proposed work RVU for CPT code 92274, as the
proposed work RVU was also based on the use of a reference code (CPT
code 88387) and a crosswalk code (CPT code 92100). Both codes share the
same 20 minutes of intraservice and 20 minutes of total time, with a
work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code
92100.
Comment: Several commenters stated that while there was no
predecessor code for direct comparison, the intensity and complexity of
the work involved in interpreting the test has increased significantly
compared to 1995, when CPT code 92275 was last valued. Commenters
restated the same arguments they expressed for CPT code 92273: The new
machines used in CPT code 92274 have become more efficient but the
cognitive work required by the physician interpreting the test has
increased significantly.
Response: As we stated with regard to CPT code 92273, we continue
to disagree with the commenters that all of the efficiencies gained in
work time via improved technology would be offset via higher intensity
(that is, greater cognitive work on the part of the practitioner). At
the RUC-recommended work RVU of 0.72, the intensity of CPT code 92274
would also increase by nearly 300 percent, and we do not agree that the
cognitive intensity of the procedure would have increased by this
amount. We continue to believe that our proposed work RVU of 0.61 more
accurately captures the changes in work taking place as a result of
greater technological efficiencies in the service.
Comment: Several commenters stated that CPT code 92274 requires
more physician work than the crosswalks we identified. Commenters
stated that CPT code 88387 is a straightforward manual dissection that
does not require interpretation of multiple images and numeric values
to arrive at a diagnosis. Commenters stated that CPT code 92100 also
requires less physician work, as CPT code 92274 requires interpretation
of significantly more data and consideration of many more diagnostic
possibilities.
Response: We disagree with the commenters that our reference and
crosswalk codes require less work than CPT code 92274. While it is true
that CPT code 88387 does not require interpretation of multiple images
and numeric values, this is because it is not an imaging service, and
it is inappropriate to state that the work of CPT code 88387 is lower
than CPT code 92274 based on this criteria. We do not agree that the
macroscopic examination, dissection, and preparation of tissue taking
place in CPT code 88387 would inherently constitute less work than CPT
code 92274. Similarly, we do not agree that the serial tonometry with
multiple measurements of intraocular pressure taking place in CPT code
92100 would involve less work than CPT code 92274, especially due to
the nearly identical intraservice and total work times shared by these
procedures.
Comment: One commenter disagreed with our proposal to assign active
pricing to Category III code 0509T. The commenter stated that this code
should go through the regular vetting process that other new technology
typically follows, including development of appropriate clinical
literature that would qualify it for elevation to a full Category I CPT
code, and then a RUC survey in order to develop accurate valuation for
work and practice expense. The commenter was concerned that CMS would
single out and put forward a value for a technology that has not gone
through the same scrutiny as other new technologies.
Response: We understand the concerns expressed by the commenter. As
we stated in the proposed rule, we typically assign contractor pricing
for Category III codes since they are temporary codes assigned to
emerging technology and services. However, in cases where there is an
unusually high volume of services that will be performed under a
Category III code, we have sometimes assigned an active status to the
procedure, and in the case of Category III code 0509T the
recommendations indicated that approximately 80 percent of the services
currently reported under CPT code 92275 will be reported under the new
Category III code. Since this will involve an estimated 100,000
services for CY 2019, we continue to believe that the interests of
relativity would be better served by assigning an active status to
Category III code 0509T and creating RVUs through the use of a proxy
crosswalk to a similar existing service. We agree with the commenter
that this code should still go through the regular vetting process that
other new technology typically follows, and we look forward to
receiving recommendations for work and practice expense inputs in the
future.
Comment: One commenter stated that many of the proposed changes to
the direct PE inputs were made with the intent to standardize inputs.
The commenter stated that although the RUC has created many standards,
they have always acknowledged that there are and will be exceptions to
those standards. The commenter stated that these important diagnostic
tests are unusual services that require significant amounts of
preservice clinical labor time in whichever setting they are performed,
and that the recommended direct PE inputs were carefully prepared based
upon documented personal observation and time motion studies. The
commenter stated that the predecessor CPT code 92275 had an over-
simplified PE spreadsheet with very few data inputs, each comprising
substantial amounts of time that are now broken out into separate
inputs, and as a result the work required had not changed substantially
but there had been additional granularity in the direct PE inputs.
Response: As we noted in the CY 2015 PFS final rule with comment
period (79 FR 67640 through 67641), we continue to make improvements to
the direct PE input database to provide the number of clinical labor
minutes assigned for each task for every code in the database instead
of only including the number of clinical labor minutes for the
preservice, service, and postservice periods for each code. We have
stated that we believe this additional level of detail helps to
facilitate transparency, allows us to more easily compare clinical
labor times across the PFS to maintain relativity, and helps in
maintaining standard times for particular clinical labor tasks that can
be applied consistently to many codes as they are valued over several
years. However, we have always recognized that standards for clinical
labor cannot be applied universally due to the differences between
individual services, and we have frequently finalized
[[Page 59563]]
clinical labor times above the standard values where we believed that
there was sufficient reason to establish these values as the typical
case. In the case of CPT code 92273 and 92274, we detailed our
rationale in the proposed rule for why we believed that some of the
RUC-recommended direct PE inputs should be refined to a standard
clinical labor time. We also note that we did not propose the standard
clinical labor time for all activities, such as the ``Clean room/
equipment by clinical staff'' (CA024) activity.
Comment: Several commenters disagreed with the proposal to remove
the preservice clinical labor in the facility setting for CPT codes
92273 and 92274. Commenters stated that these procedures, when done in
a facility, must be scheduled in the operating room. Commenters stated
that these procedures would typically be done in the facility only when
it is not clinically appropriate for them to be performed in the
clinic, such as for children or the cognitively impaired; and it takes
substantial amounts of time for the staff to accomplish this
coordination of care for these higher-needs patients.
Response: We recognize that these procedures are rarely performed
in the facility setting, with approximately 1 percent of the
utilization of predecessor CPT code 92275 taking place in this setting.
However, we disagree that these procedures would typically be performed
in the operating room when furnished in the facility, and therefore, we
do not agree that these procedures would typically require preservice
clinical labor for coordination of care. We also noted on this subject
that the predecessor code, CPT code 92275, does not currently include
any preservice clinical labor, nor any facility direct PE inputs, and
we did not receive an explanation from the commenters as to why this
was the case. Furthermore, both of these codes are diagnostic tests
under which the professional (26 modifier) and technical (TC modifier)
components will be separately billable, and codes that have these
professional and technical components typically will not have direct PE
inputs in the facility setting since the technical component is only
valued in the nonfacility setting.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Greet patient, provide gowning,
ensure appropriate medical records are available'' (CA009) and the
``Provide education/obtain consent'' (CA011) activities for CPT codes
92273 and 92274. Commenters stated that although slightly more than 50
percent of these services are done on the same day as an office visit,
the clinical staff time involved is completely divorced from the office
visit and the staff performing the test are different from the staff
assisting in the office visit. Commenters stated that the machine used
for these procedures is housed in a different room, the patient needs
to be transported from the ophthalmic exam lane to the ERG room and
back, additional instructions are required that are never done during a
typical office visit, and the nature of this test requires extra
supplies and work in addition to those used for the office visit.
Commenters emphasized that these clinical tasks are not duplicative
with an E/M, as they represent separate actions by a different
technician in a different room.
Response: We disagree with the commenters and continue to believe
that this clinical labor would be duplicative with the same day E/M
office visit. While it is true that there is a different clinical labor
staff type used by CPT codes 92273 and 92274, we are not suggesting
that all clinical labor is duplicative with the same day E/M visit,
only that clinical labor activities such as greeting and gowning the
patient would only be done a single time. We also note that we do not
include patient transportation as a form of direct PE, as it is not
individually allocable to a single service and would instead be
classified as an administrative task under indirect PE. However, we do
agree with the commenters that additional instructions would be
required for these electroretinography services, and as a result we
will restore the 1 minute of clinical labor time for the ``Provide
education/obtain consent'' (CA011) activity. We agree that this would
not be duplicative with the same day E/M office visit.
Comment: Several commenters stated that in our refinements to the
direct PE inputs for CPT codes 92273 and 92274, CMS proposed to remove
1 minute from the CA014 activity code and proposed to add 1 minute to
the CA013 activity code. The commenter stated that this refinement was
inaccurate and encouraged CMS to modify this proposal by finalizing the
RUC-recommended direct PE inputs for clinical labor. One commenter
stated that this work is done by a different technician in a different
room typically in a busy clinical setting and this work was separate
from that being done during the office visit.
Response: We addressed this subject in detail in the PE section of
this final rule under the Changes to Direct PE Inputs for Specific
Services heading (section II.B.3. of this final rule). For CPT codes
92273 and 92274, we are finalizing these clinical labor refinements as
proposed. We also note in response to the one commenter that our
refinements to the CA013 and CA014 clinical labor activities were not
based on the premise on being duplicative with the same day E/M visit.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Clean room/equipment by clinical
staff'' (CA024) activity from 12 minutes to 8 minutes for CPT codes
92273 and 92274. Commenters stated that this was the time that the
specialty society found when directly shadowing the process to clean
the patient and the equipment. Commenters stated that the technician
needs to clean the patient's skin, rinse their eyes, and clean around
the patient and escort them out. Commenters stated that the expensive
and delicate eye electrodes require a significant amount of time to
remove and clean the conductive paste and Goniosol without damaging the
electrodes, which needs to be performed after each procedure so that
the electrodes can be re-used for the next procedure. Commenters
emphasized that the equipment cleaning process requires meticulous care
and a significant amount of technician time.
Response: We agree with the commenters that these procedures
require more time for cleaning the room and equipment than the standard
for the CA024 activity. This is the reason we proposed 8 minutes of
clinical labor time instead of 3 minutes, almost triple the standard
value for this activity code. As we stated in the proposed rule, we
agreed with the need for 2 minutes of patient cleaning time and for the
cleaning of the wires and electrodes to take place in two different
steps. Since our standard clinical labor time for room/equipment
cleaning is 3 minutes, we therefore proposed a total time of 8 minutes
for these codes, based on 2 minutes for patient cleaning and then 3
minutes for each of the two steps of wire and electrode cleaning. We
continue to believe that 8 minutes would be the typical amount of
clinical labor used for these procedures.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Technologist QC's images in PACS,
checking for all images, reformats, and dose page'' (CA030) activity
from 10 minutes to 3 minutes for CPT codes 92273 and 92274. Commenters
stated that the machine used for the ERG codes is not typically
integrated into the clinic's electronic medical record. Commenters
stated that this machine requires printing all images created by the
testing
[[Page 59564]]
machine and uploading them into the EMR for subsequent review by the
physician and that it is not unusual for re-printing using a different
scale or limits to be necessary. Commenters stated that this clinical
labor differed from a typical radiology scenario because the procedure
is in fact different from a typical imaging study.
Response: We disagree with the commenters that the full recommended
time of 10 minutes would be typical for this clinical labor activity.
We do not agree that it would be typical to physically print out all of
the images produced by the machine, and note that we do not include
additional direct PE inputs for inefficiencies in practice operations.
We continue to believe that the complexity of the imaging in CPT codes
92273 and 92274 is comparable to the CT and magnetic resonance (MR)
codes, and that in order to maintain relativity, we proposed the same
clinical labor time of 3 minutes.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Review examination with interpreting
MD/DO'' (CA031) activity from 5 minutes to 2 minutes for CPT codes
92273 and 92274. Commenters stated that this input was calculated by
direct observation of typical procedures with a stopwatch. Commenters
stated that this test is performed in a different room than the office
visit, and the technician needs to take time to find the ordering/
interpreting physician and review the quality of the gain and results.
Response: We disagree with the commenters that the full recommended
time of 5 minutes would be typical for this clinical labor activity. We
note again that we do not include additional direct PE inputs for
inefficiencies in practice operations, and that we would not increase
the clinical labor to include time that the technician needs to find
the ordering/interpreting physician. We finalized in the CY 2017 PFS
final rule a standard time of 2 minutes for reviewing examinations with
the interpreting MD, and we have no reason to believe that these codes
would typically require additional clinical labor at more than double
the standard time.
Comment: Several commenters responded to the comment solicitation
regarding additional information about whether the recommendations for
the ``Contact lens electrode for mfERG and ffERG'' (EQ391) equipment
intended this equipment item to be listed twice, with one contact
intended for each eye, or whether this was a clerical mistake.
Commenters stated that this was not an error but was intentional and
reflects typical practice. Commenters stated that the test carried out
in CPT code 92273 is performed with two contact lenses in place (one in
each eye at the same time) in a simultaneous testing fashion.
Commenters stated that the test carried out in CPT code 92274 is
typically performed sequentially one eye at a time, re-using the same
contact lens for each eye. Commenters stated that this discrepancy is
primarily due to the dark and light-adaptation needs for the ffERG,
which if done sequentially would double the amount of clinical time.
Response: We appreciate the additional information supplied by the
commenters in response to our comment solicitation.
Comment: One commenter stated that the highly technical equipment
formula should be used for the mfERG and ffERG electrodiagnostic unit
(EQ390) equipment item.
Response: We did not propose to classify the EQ390 equipment as
highly technical. We note that if we were to use the highly technical
equipment formula for the EQ390 equipment, the total equipment time for
this item would decrease, and we do not believe that this was what the
commenter intended.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Electroretinography family of codes as
proposed. We are also finalizing the direct PE inputs as proposed, with
the exception of the CA011 clinical labor activity as described above.
(51) Cardiac Output Measurement (CPT Codes 93561 and 93562)
CPT codes 93561 (Indicator dilution studies such as dye or
thermodilution, including arterial and/or venous catheterization; with
cardiac output measurement) and 93562 (Indicator dilution studies such
as dye or thermodilution, including arterial and/or venous
catheterization; subsequent measurement of cardiac output) were
identified as potentially misvalued on a screen of codes with a
negative IWPUT, with 2016 estimated Medicare utilization over 10,000
for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other
source codes. The specialty societies noted that CPT codes 93561 and
93562 are primarily performed in the pediatric population, thus the
Medicare utilization for these Harvard-source services is not over
1,000. However, the specialty societies requested and the RUC agreed
that these services should be reviewed under this negative IWPUT
screen.
For CPT code 93561, we disagreed with the RUC-recommended work RVU
of 0.95 and we proposed a work RVU of 0.60 based on a crosswalk to CPT
code 77003 (Fluoroscopic guidance and localization of needle or
catheter tip for spine or paraspinous diagnostic or therapeutic
injection procedures (epidural or subarachnoid)). CPT Code 77003 is
another recently-reviewed add-on global code with the same 15 minutes
of intraservice time and 2 additional minutes of preservice evaluation
time. In our review of CPT code 93561, we found that there was a
particularly unusual relationship between the surveyed work times and
the RUC-recommended work RVU. We noted that the recommended
intraservice time for CPT code 93561 was decreasing from 29 minutes to
15 minutes (48 percent reduction), and the recommended total time for
CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent
reduction); however, the recommended work RVU was instead increasing
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although
we did not imply that the decrease in time as reflected in survey
values must equate to a one-to-one or linear decrease in the valuation
of work RVUs, we believe that since the two components of work are time
and intensity, significant decreases in time should typically be
reflected in decreases to work RVUs, not increases in valuation. We
recognized that CPT code 93561 is an unusual case, as it is shifting
from 0-day global status to add-on code status. However, when the work
time for a code is going down and the unit of service is being reduced,
we would not expect to see an increased work RVU under these
circumstances, and especially not such a large work RVU increase.
Therefore, we proposed instead to crosswalk CPT code 93561 to CPT code
77003 at a work RVU of 0.60, which we believe is a more accurate
valuation in relation to other recently-reviewed add-on codes on the
PFS. We believe that this proposed work RVU of 0.60 better preserves
relativity with other clinically similar codes with similar surveyed
work times.
For CPT code 93562, we disagreed with the recommended work RVU of
0.77 and proposed a work RVU of 0.48 based on the intraservice time
ratio with CPT code 93561. We observed a similar pattern taking place
with CPT code 93562 as with the first code in the family, noting that
the recommended intraservice time was decreasing from 16 minutes to 12
minutes (25 percent reduction), and the recommended total time was
decreasing from 44 minutes to
[[Page 59565]]
12 minutes (73 percent reduction); however, the RUC-recommended work
RVU was instead increasing from 0.01 to 0.77. We recognized that CPT
code 93562 is another unusual case, as it is also shifting from 0-day
global status to add-on code status, and the current work RVU of 0.01
is a decrease from the code's former valuation of 0.16 following the
removal of moderate sedation in the CY 2017 rule cycle. However, when
the work time for a code is going down and the unit of service is being
reduced, we typically would not expect to see a work RVU increase under
these circumstances, and especially not such a large work RVU increase.
Therefore, we proposed instead to apply the intraservice time ratio
from CPT code 93561, for a ratio of 0.80 (12 minutes divided by 15
minutes) multiplied by the proposed work RVU of 0.60 for CPT code
93561, which results in the proposed work RVU of 0.48 for CPT code
93562. We noted that the RUC-recommended work values also line up
according to the same intraservice time ratio, with the recommended
work RVU of 0.77 for CPT code 93562 existing in a ratio of 0.81 with
the recommended work RVU of 0.95 for CPT code 93561. We believe that
this provides further rationale for our proposal to value the work RVU
of CPT code 93562 at 80 percent of the work RVU of CPT code 93561.
There are no recommended direct PE inputs for the codes in this
family and we did not propose any direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving the Cardiac Output Measurement family of codes.
Comment: Commenters stated that there were three intertwined flawed
assumptions that CMS considered when proposing values for CPT codes
93561 and 93562, which if finalized would lead to continued
misvaluation of these services. Commenters stated that the first of
these flawed assumptions was a comparison of the survey data to Harvard
data: The current time data for these codes came from the Harvard
studies, has zero validity and should not be used to compare to current
valid survey data. Commenters stated that the second of these flawed
assumptions was a comparison of the recommended physician work RVUs to
old work RVUs: The negative intensity of these codes confirmed that
this previous methodology in which the current work RVU was derived
from is flawed. Commenters stated that the third of these flawed
assumptions was the use of an intraservice time ratio: This
inaccurately treated all components of the physician time as having
identical intensity and is incorrect. Other commenters identified
changes in the global period from 0-day to add-on status and changes in
the patient population from adult patients to pediatric patients as a
rationale for why the increases in valuation were appropriate.
Many commenters disagreed with the proposed work RVU of 0.60 for
CPT code 93561 and stated that CMS should finalize the RUC-recommended
work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT
code 77003, stating that it was not a good crosswalk despite having the
same intraservice work time. Commenters stated that CPT code 77003 is
the imaging guidance code for needle placement for the epidural
injection, and that placing a catheter in the heart and lungs of a
child is not merely an imaging procedure. Commenters stated that a more
appropriate injection procedure comparison would be the actual epidural
injection procedure code, CPT code 62320 (Injection(s), of diagnostic
or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid,
steroid, other solution), not including neurolytic substances,
including needle or catheter placement, interlaminar epidural or
subarachnoid, cervical or thoracic; without imaging guidance) at a work
RVU of 1.80 or to the top key reference CPT code 93567 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for supravalvular aortography) at a work
RVU of 0.97.
Many commenters also disagreed with the proposed work RVU of 0.48
for CPT code 93562 and stated that CMS should finalize the RUC-
recommended work RVU of 0.77. Commenters stated that using an
incremental approach in lieu of strong crosswalks and input from the
RUC and physicians providing these services was an unfounded
methodology. Commenters stated that CMS should rely on the survey data
instead of the use of an increment, and commenters listed the reference
codes chosen by the RUC which they stated were more appropriate for
valuation.
Response: We appreciate the detailed feedback from the commenters
regarding CPT Codes 93561 and 93562. We agree with the commenters that
the proposed crosswalk to CPT code 77003 would result in an
inappropriately low intensity for CPT code 93561.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-
recommended work RVU of 0.77 for CPT code 93562. We are also finalizing
our proposal to have no direct PE inputs for these codes.
(52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)
CPT code 93571 (Intravascular Doppler velocity and/or pressure
derived coronary flow reserve measurement (coronary vessel or graft)
during coronary angiography including pharmacologically induced stress;
initial vessel) was identified on a list of all services with total
Medicare utilization of 10,000 or more that have increased by at least
100 percent from 2009 through 2014. CPT code 93572 (Intravascular
Doppler velocity and/or pressure derived coronary flow reserve
measurement (coronary vessel or graft) during coronary angiography
including pharmacologically induced stress; each additional vessel) was
also included for review as part of the same family of CPT codes. The
RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower
than the current work RVU of 1.80. The total time for this service
decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's
recommendation is based on a crosswalk to CPT code 15136 (Dermal
autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits; each additional 100 sq cm, or each
additional 1% of body area of infants and children, or part thereof),
which has an identical intraservice and total time as CPT code 93571 of
15 minutes.
We disagreed with the recommended work RVU of 1.50 for this CPT
code because we did not believe that a reduction in work RVU from 1.80
to 1.50 was commensurate with the reduction in time for this service of
5 minutes. Using the building block methodology, we believed the work
RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to
CPT code 61517 (Implantation of brain intracavitary chemotherapy agent
(List separately in addition to CPT code for primary procedure)) with a
work RVU of 1.38 was more appropriate because it has an identical
intraservice and total time (15 minutes) as CPT code 93571, described
work that is similar, and was closer to the calculations for
intraservice time ratio, total time ratio, and the building block
method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.
We proposed the RUC-recommended work RVU for CPT code 93572
(Intravascular Doppler velocity and/or pressure derived coronary flow
reserve measurement (coronary vessel or graft)
[[Page 59566]]
during coronary angiography including pharmacologically induced stress;
each additional vessel) of 1.00.
Both of these codes are facility-only procedures with no
recommended direct PE inputs.
The following is a summary of the public comments we received on
our proposals involving the Coronary Flow Reserve Measurement family of
codes.
Comment: We received several comments regarding our proposed work
RVU of 1.38 for CPT 93571. Commenters generally did not agree with the
use of time based metrics in our assessment of the work RVU for this
code. In particular, they opposed CMS's reduction of work RVUs in
proportion to the total reduction in time for furnishing this service.
This methodology, they maintain, ignores the fact that the time
reduction of 5 minutes in furnishing this service is associated with
the low intensity portion of the work.
Response: We do not agree that a reduction in work RVU proportional
to the total time decrease for this code, which has essentially only
one time parameter since the intraservice time and total time are the
same, is not appropriate. We continue to believe that this calculated
value of 1.35 (a 75 percent reduction in both time and work RVU)
accounts more appropriately for the reduction in time for a service in
which the work to perform the service has not changed. We therefore
continue to believe that our crosswalk to CPT code 61517 is similar in
both work and time to CPT code 93571, and we are finalizing our
proposed work RVU for CPT code 93571 of 1.38.
Comment: We received support from commenters regarding our proposed
work RVU of 1.00 for CPT code 93572.
Response: We appreciate the support and are finalizing a work RVU
of 1.00 for CPT code 93572 as proposed.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Coronary Flow Reserve Measurement family
of codes as proposed.
(53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
During 2017, we issued a national coverage determination (NCD) for
Medicare coverage of supervised exercise therapy (SET) for the
treatment of peripheral artery disease (PAD). Previously, the service
had been assigned noncovered status under the PFS. CPT code 93668
(Peripheral arterial disease (PAD) rehabilitation, per session) was
payable before the end of CY 2017, retroactive to the effective date of
the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-
covered SET for the treatment of PAD, consistent with the NCD, reported
with CPT code 93668. We used the most recent RUC-recommended work and
direct PE inputs and requested that the RUC review the service, which
had not been reviewed since 2001, for direct PE inputs. The RUC did not
recommend a work RVU for CPT code 93668 due to the belief that there is
no physician work involved in this service. After reviewing this code,
we proposed a work RVU of 0.00 for CPT code 93668 and proposed to
continue valuing the code for PE only.
The following is a summary of the public comments we received on
our proposals involving CPT code 93688.
Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs and PE inputs.
Response: We thank commenters for their support.
Comment: Several commenters noted that the proposed reductions in
payment would impact their ability to perform the service in an office
setting and that this would force them to perform the service in a
hospital setting. They further noted that this would ultimately
increase costs and impact patient satisfaction as well as impact their
ability to provide the service to rural and under insured patients.
Response: We appreciate the feedback these commenters provided. We
note that we accepted the RUC-recommended work RVU of 0.00 and the RUC-
recommended direct PE inputs without refinements for CPT code 93668. We
further note that the RUC has generally provided recommendations on
work, work time, and direct PE inputs. We do not believe that the work
or direct PE inputs assigned to these services are inaccurate. We
further note that if commenters believe an additional RUC review would
serve to address the issues they identified in our proposal, we would
consider this information or recommendations from other interested
stakeholders for future rulemaking.
After consideration of the public comments received, we are
finalizing the RUC-recommended work RVUs and direct PE inputs for CPT
code 93668 as proposed.
(54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)
CPT codes 95800 (Sleep study, unattended, simultaneous recording;
heart rate, oxygen saturation, respiratory analysis (e.g., by airflow
or peripheral arterial tone), and sleep time), 95801 (Sleep study,
unattended, simultaneous recording; minimum of heart rate, oxygen
saturation, and respiratory analysis (e.g., by airflow or peripheral
arterial tone)), and 95806 (Sleep study, unattended, simultaneous
recording of, heart rate, oxygen saturation, respiratory airflow, and
respiratory effort (e.g., thoracoabdominal movement)) were flagged by
the CPT Editorial Panel and reviewed at the October 2014 Relativity
Assessment Workgroup meeting. Due to rapid growth in service volume,
the RUC recommended that these services be reviewed after 2 more years
of Medicare utilization data (2014 and 2015 data). These three codes
were surveyed for the April 2017 RUC meeting and new recommendations
for work and direct PE inputs were submitted to CMS.
For CPT code 95800, the RUC recommended a work RVU of 1.00 based on
the survey 25th percentile value. We disagreed with the recommended
value and proposed a work RVU of 0.85 based on a pair of crosswalk
codes: CPT code 93281 (Programming device evaluation (in person) with
iterative adjustment of the implantable device to test the function of
the device and select optimal permanent programmed values with
analysis, review and report by a physician or other qualified health
care professional; multiple lead pacemaker system) and CPT code 93260
(Programming device evaluation (in person) with iterative adjustment of
the implantable device to test the function of the device and select
optimal permanent programmed values with analysis, review and report by
a physician or other qualified health care professional; implantable
subcutaneous lead defibrillator system). Both of these codes have a
work RVU of 0.85, as well as having the same intraservice time of 15
minutes, similar total times to CPT code 95800, and recent review dates
within the last few years.
In reviewing CPT code 95800, we noted that the recommended
intraservice time is decreasing from 20 minutes to 15 minutes (25
percent reduction), and the recommended total time is decreasing from
50 minutes to 31 minutes (38 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.05 to 1.00, which is a
reduction of less than 5 percent. Although we did not imply that the
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that
since the two components of work are time and intensity, significant
decreases in time should be reflected in decreases to work RVUs. In the
case of CPT code 95800, we believe that it would be more accurate to
propose a work RVU of 0.85
[[Page 59567]]
based on the aforementioned crosswalk codes to account for these
decreases in the surveyed work time. We also noted that in this case
where the surveyed times are decreasing and the utilization of CPT code
95800 is increasingly significantly (quadrupling in the last 5 years),
we had reason to believe that practitioners are becoming more efficient
at performing the procedure, which, under the resource-based nature of
the RVU system, lends further support for a reduction in the work RVU.
For CPT code 95801, the RUC proposed a work RVU of 1.00 again based
on the survey 25th percentile. We disagreed with the recommended value
and we proposed a work RVU of 0.85 based on the same pair of crosswalk
codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and
95801 had identical recommended work RVUs and identical recommended
survey work times. Given that these two codes also have extremely
similar work descriptors, we interpreted this to mean that the two
codes could have the same work RVU, and therefore, we proposed the same
work RVU of 0.85 for both codes.
For CPT code 95806, the RUC recommended a work RVU of 1.08 based on
a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including
recording awake and asleep). Although we disagreed with the RUC-
recommended work RVU of 1.08, we concurred that the relative difference
in work between CPT codes 95800 and 95801 and CPT code 95806 was
equivalent to the recommended interval of 0.08 RVUs. Therefore, we
proposed a work RVU of 0.93 for CPT code 95806, based on the
recommended interval of 0.08 additional RVUs above our proposed work
RVU of 0.85 for CPT codes 95800 and 95801. We also noted that CPT code
95806 is experiencing a similar change in the recommended work and time
values comparable to CPT code 95800. The recommended intraservice time
for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40
percent), and the recommended total time is decreasing from 50 minutes
to 31 minutes (38 percent); however, the recommended work RVU is only
decreasing from 1.25 to 1.08, which is a reduction of only 14 percent.
As we stated for CPT code 95800, we do not believe that decreases in
work time must equate to a one-to-one or linear decrease in the
valuation of work RVUs, but we do believe that these changes in
surveyed work time suggest that practitioners are becoming more
efficient at performing the procedure, and that it would be more
accurate to maintain the recommended work interval with CPT codes 95800
and 95801 by proposing a work RVU of 0.93 for CPT code 95806.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Home Sleep Apnea Testing family of codes.
Comment: One commenter stated that the obesity epidemic has
contributed to the rising prevalence of obstructive sleep apnea, and
sleep centers have already worked to reduce costs in diagnosis of
obstructive sleep apnea by utilizing out-of-center, or home, sleep
apnea testing. The commenter stated that further reduction in work
RVUs, and hence payments for home sleep apnea testing services, may
endanger the sustainability of sleep centers to provide this service to
Medicare beneficiaries and may thus deny beneficiaries access to
testing for obstructive sleep apnea. A different commenter stated that
a reduction in work RVUs for home sleep apnea testing services will
discourage vendors from producing technically better home sleep apnea
testing devices and software.
Response: We agree with the commenter regarding the importance of
sleep centers in helping to diagnose and treat the occurrence of
obstructive sleep apnea. However, we remind the commenter that we are
obligated under the statute to consider both time and intensity in
establishing work RVUs for PFS services. As explained in the CY 2017
PFS final rule (81 FR 80272 through 80277), we recognize that adjusting
work RVUs for changes in time is not always a straightforward process,
so we have applied various methodologies to identify several potential
work values for individual codes. When the recommended work RVUs do not
appear to account for significant changes in time, we have employed the
different approaches to identify potential values that reconcile the
recommended work RVUs with the recommended time values. For the codes
in the Home Sleep Apnea Testing family, we believe that the decreases
in the surveyed work times should be reflected in decreases to the work
RVUs.
Comment: Many commenters disagreed with the proposed work RVU of
0.85 for CPT codes 95800 and 95801, and stated that CMS should finalize
the RUC-recommended work RVU of 1.00 for these services. Commenters
stated that it was unclear why CMS chose to employ the crosswalk to CPT
codes 93281 and 93260, which the commenters stated were not at all
similar to the home sleep apnea test codes and are cardiovascular
implantable recording device codes, not diagnostic studies.
Response: We continue to believe that the nature of the PFS
relative value system is such that all services are appropriately
subject to comparisons to one another. Although codes with clinically
similar services are sometimes stronger comparator codes, we do not
agree that codes must both constitute diagnostic studies to be used as
a crosswalk. In the case of our specific crosswalk to CPT codes 93281
and 93260, we noted in the proposed rule that both of these codes have
a work RVU of 0.85, as well as having the same intraservice time of 15
minutes and similar total times to CPT codes 95800 and 95801, and
recent review dates within the last few years.
Comment: Several commenters stated that the existing times for CPT
codes 95800 and 95801 were likely an overestimate due to the lack of
experience providing these services when they were first valued as new
codes in April 2010. Commenters stated that physicians are now more
familiar with home sleep apnea testing and the new survey times were
more reflective of this family of services.
Response: This information from the commenters appears to suggest
that the current work RVUs for CPT codes 95800 and 95801 are also
overestimates. If practitioners have become more familiar and efficient
in the practice of home sleep apnea testing, we believe that the work
RVUs should also be decreased to reflect the fact that the procedures
can now be performed faster. We remind the commenters that we are
obligated under the statute to consider both time and intensity in
establishing work RVUs for PFS services, and we have no reason to
believe that the intensity of these procedures has increased to the
point of offsetting these gains in time efficiency.
Comment: Several commenters stated that, despite the fact that we
indicated we did not intend to imply that the decrease in time should
equate to a linear decrease in the valuation of work RVUs, this seems
to be the approach taken in the proposed rule. Commenters stated that
modifications to work RVUs should be based on empirical evidence,
gathered through the survey process, which takes into consideration the
amount of time required to provide a service as well as the complexity
and intensity of each service.
Response: We disagree with the commenters, and we note that the
proposed work RVUs for both CPT codes 95800 and 95801 were not based on
pure time ratios on a one-to-one or linear basis. For CPT code 95800,
use of
[[Page 59568]]
the intraservice time ratio alone would have yielded a work RVU of 0.79
and the total time ratio would have yielded a work RVU of 0.65. For CPT
code 95801, use of the intraservice time ratio would have yielded a
work RVU of 1.00 and the total time ratio would have yielded a work RVU
of 0.78. We did not propose these values and instead proposed a work
RVU of 0.85 for both codes specifically because the consideration of
time ratios is only one component of our review process. We believe
that our proposed work RVU of 0.85 for these services based on a pair
of crosswalk codes, CPT codes 93281 and 93260 is appropriate, and note
that we recognized that the use of pure time ratios at a one-to-one or
linear basis would not accurately capture the changes in work taking
place in these codes since their last valuation.
Comment: Many commenters disagreed with the proposed work RVU of
0.93 for CPT code 95806, and stated that CMS should finalize the RUC-
recommended work RVU of 1.08. Commenters stated that the survey process
values a service compared to other similar services, and that using an
incremental approach in lieu of strong crosswalks and input from the
RUC and physicians providing these services was unfounded.
Response: We believe the use of an incremental difference between
codes is a valid methodology for setting values, especially in valuing
services within a family of revised codes where it is important to
maintain appropriate intra-family relativity. Historically, we have
frequently utilized an incremental methodology in which we value a code
based upon its incremental difference between another code or another
family of codes. We note that the RUC has also used the same
incremental methodology on occasion when it was unable to produce valid
survey data for a service. We continue to believe that the proposed
work RVU of 0.93 would be the most accurate valuation for CPT code
95806.
Comment: Several commenters stated that CPT code 95806 has become a
more complex study and requires more time as well as greater levels of
skill and training to perform the interpretation for this study.
Commenters stated that more complex patients with a wider variety of
sleep problems and more severe conditions are being studied with this
modality, which means that the skills and continuing updates to
education required to interpret these studies have dramatically
increased.
Response: We agree with the commenters that due to the decreasing
surveyed work times and rapidly increasing utilization for these codes,
we had reason to believe that practitioners are becoming more efficient
at performing the procedure. While the incorporation of new technology
can sometimes make services more complex and difficult to perform, it
can also have the opposite effect by making services less reliant on
manual skill and technique. We do not agree with the commenter that the
need for additional training to use the equipment would necessarily be
grounds for an increase in the work RVU, as improvements in technology
are commonplace across many different services and are not specific to
this procedure. As detailed above, we also have reason to believe that
the improved technology has led to greater efficiencies in the
procedure which, under the resource-based nature of the RVU system,
lends further support for a reduction in the work RVU.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Home Sleep
Apnea Testing family of codes as proposed.
(55) Neurostimulator Services (CPT Codes 95970, 95976, 95977, 95983,
and 95984)
In October 2013, CPT code 95971 (Electronic analysis of implanted
neurostimulator pulse generator system; simple spinal cord, or
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular)
neurostimulator pulse generator/transmitter, with intraoperative or
subsequent programming) was identified in the second iteration of the
High Volume Growth screen. In January 2014, the RUC recommended that
CPT codes 95971, 95972 (Electronic analysis of implanted
neurostimulator pulse generator system; complex spinal cord, or
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular)
(except cranial nerve) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming) and 95974 (Electronic
analysis of implanted neurostimulator pulse generator system; complex
cranial nerve neurostimulator pulse generator/transmitter, with
intraoperative or subsequent programming, with or without nerve
interface testing, first hour) be referred to the CPT Editorial Panel
to address the entire family regarding the time referenced in the CPT
code descriptors. In June 2017, the CPT Editorial Panel revised CPT
codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975
(Electronic analysis of implanted neurostimulator pulse generator
system; complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each
additional 30 minutes after first hour), 95978 (Electronic analysis of
implanted neurostimulator pulse generator system, complex deep brain
neurostimulator pulse generator/transmitter, with initial or subsequent
programming; first hour), and 95979 (Electronic analysis of implanted
neurostimulator pulse generator system, complex deep brain
neurostimulator pulse generator/transmitter, with initial or subsequent
programming; each additional 30 minutes after first hour) and created
four new CPT codes for analysis and programming of implanted cranial
nerve neurostimulator pulse generator, analysis, and programming of
brain neurostimulator pulse generator systems and analysis of stored
neurophysiology recording data.
The RUC recommended a work RVU of 0.45 for CPT code 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group(s),interleaving, amplitude, pulse
width, frequency (Hz), on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters by
physician or other qualified health care professional; with brain,
cranial nerve, spinal cord, peripheral nerve, or sacral nerve
neurostimulator pulse generator/transmitter, without programming)),
which is identical to the current work RVU for this CPT code. The
descriptor for this CPT code has been modified slightly, but the
specialty societies affirmed that the work itself has not changed. To
justify its recommendation, the RUC provided two references: CPT code
62368 (Electronic analysis of programmable, implanted pump for
intrathecal or epidural drug infusion (includes evaluation of reservoir
status, alarm status, drug prescription status); with reprogramming),
with intraservice time of 15 minutes, total time of 27 minutes, and a
work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit
for the evaluation and management of an established patient, which
requires at least 2 of these 3 key components: An expanded problem
focused history; An expanded problem focused examination; or Medical
decision making of low complexity. Counseling and coordination of care
with other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the
[[Page 59569]]
presenting problem(s) are of low to moderate severity. Typically, 15
minutes are spent face-to-face with the patient and/or family), with
intraservice time of 15 minutes, total time of 23 minutes, and a work
RVU of 0.97.
We disagreed with the RUC's recommendation because we did not
believe that maintaining the work RVU, given a decrease of four minutes
in total time, was appropriate. In addition, we noted that the
reference CPT codes chosen have much higher intraservice and total
times than CPT code 95970, and also have higher work RVUs, making them
poor comparisons. Instead, we identified a crosswalk to CPT code 95930
(Visual evoked potential (VEP) checkerboard or flash testing, central
nervous system except glaucoma, with interpretation and report) with 10
minutes intraservice time, 14 minutes total time, and a work RVU of
0.35. Therefore, we proposed a work RVU of 0.35 for CPT code 95970.
CPT code 95976 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group(s), interleaving,
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with simple cranial nerve neurostimulator pulse
generator/transmitter programming by physician or other qualified
health care professional) is a new CPT code replacing CPT code 95974
(Electronic analysis of implanted neurostimulator pulse generator
system (e.g., rate, pulse amplitude, pulse duration, configuration of
wave form, battery status, electrode selectability, output modulation,
cycling, impedance and patient compliance measurements); complex
cranial nerve neurostimulator pulse generator/transmitter, with
intraoperative or subsequent programming, with or without nerve
interface testing, first hour). The description of the work involved in
furnishing CPT code 95976 differs from that of the deleted CPT code in
a few important ways, notably that the time parameter has been removed
so that the CPT code no longer describes the first hour of programming.
In addition, the new CPT code refers to simple rather than complex
programming. Accordingly, the intraservice and total times for this CPT
code are substantively different from those of the deleted CPT code.
CPT code 95976 has an intraservice time of 11 minutes and a total time
of 24 minutes, while CPT code 95974 has an intraservice time of 60
minutes and a total time of 110 minutes. The RUC recommended a work RVU
of 0.95 for CPT code 95976. The RUC's top reference CPT code as chosen
by the RUC survey participants was CPT code 95816 (Electroencephalogram
(EEG); including recording awake and drowsy), with an intraservice time
of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC
indicated that the service is similar, but somewhat more complex than
CPT code 95976.
We disagreed with the RUC's recommended work RVU for this CPT code
because we did not believe that the large difference in time between
the new CPT code and CPT code 95974 was reflected in the slightly
smaller proportional decrease in work RVUs. The reduction in total
time, from 110 minutes to 24 minutes is nearly 80 percent. However, the
RUC's recommended work RVU reflects a reduction of just under 70
percent. We believe that a more appropriate crosswalk would be CPT code
76641 (Ultrasound, breast, unilateral, real time with image
documentation, including axilla when performed; complete) with
intraservice time of 12 minutes, total time of 22 minutes, and a work
RVU of 0.73. Therefore, we proposed a work RVU of 0.73 for CPT code
95976.
CPT code 95977 describes the same work as CPT code 95976, but with
complex rather than simple programming. The CPT Editorial Panel refers
to simple programming of a neurostimulator pulse generator/transmitter
as the adjustment of one to three parameter(s), while complex
programming includes adjustment of more than three parameters. For
purposes of applying the building block methodology and calculating
intraservice and total time ratios, the RUC compared CPT code 94X84
with CPT code 95975 (Electronic analysis of implanted neurostimulator
pulse generator system (e.g., rate, pulse amplitude, pulse duration,
configuration of wave form, battery status, electrode selectability,
output modulation, cycling, impedance and patient compliance
measurements); complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each
additional 30 minutes after first hour), which is being deleted by the
CPT Editorial Panel. We believe that this was an inappropriate
comparison since it is time based (first hour of programming) and is an
add-on code. Instead we believe that the RUC intended to compare CPT
code 95977 with CPT code 95974 (Electronic analysis of implanted
neurostimulator pulse generator system (e.g., rate, pulse amplitude,
pulse duration, configuration of wave form, battery status, electrode
selectability, output modulation, cycling, impedance and patient
compliance measurements); complex cranial nerve neurostimulator pulse
generator/transmitter, with intraoperative or subsequent programming,
with or without nerve interface testing, first hour), which has been
recommended for deletion by the CPT Editorial Panel and is also the
comparison for CPT code 95976. The RUC recommended a work RVU of 1.19
for CPT code 95977. The RUC disagreed with the two top reference
services CPT code 99215 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires at
least 2 of these 3 key components: A comprehensive history; A
comprehensive examination; or Medical decision making of high
complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the presenting problem(s) are of
moderate to high severity. Typically, 40 minutes are spent face-to-face
with the patient and/or family) and CPT code 99202 (Office or other
outpatient visit for the evaluation and management of a new patient,
which requires these 3 key components: An expanded problem focused
history; an expanded problem focused examination; or straightforward
medical decision making. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the presenting problem(s)
are of low to moderate severity. Typically, 20 minutes are spent face-
to-face with the patient and/or family) and instead compared CPT code
95977 to CPT code 99308 (Subsequent nursing facility care, per day, for
the evaluation and management of a patient, which requires at least 2
of these 3 key components: An expanded problem focused interval
history; An expanded problem focused examination; or Medical decision
making of low complexity. Counseling and/or coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and/or family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
[[Page 59570]]
Typically, 15 minutes are spent at the bedside and on the patient's
facility floor or unit.) with total time of 31 minutes, intraservice
time of 15 minutes, and a work RVU of 1.16; and CPT code 12013 (Simple
repair of superficial wounds of face, ears, eyelids, nose, lips and/or
mucous membranes; 2.6 cm to 5.0 cm), with total time of 27 minutes,
intraservice time of 15 minutes, and a work RVU of 1.22.
We disagreed with the RUC's recommended work RVU of 1.19 for CPT
code 95977. Once the comparison CPT code is corrected to CPT code
95974, the reverse building block calculation indicates that a lower
work RVU (close to 0.82) would be a better reflection of the work
involved in furnishing this service. As an alternative to the RUC's
recommendation, we added the difference in RUC-recommended work RVUs
between CPT codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU
of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97
for CPT code 95977.
CPT code 95983 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group(s), interleaving,
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet
mode, doe lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain neurostimulator pulse generator/transmitter
programming, first 15 minutes face-to-face time with physician or other
qualified health care professional) is the base code for add-on CPT
code 95984 (Electronic analysis of implanted neurostimulator pulse
generator/transmitter (e.g., contact group(s), interleaving, amplitude,
pulse width, frequency (Hz), on/off cycling, burst, magnet mode, doe
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, each
additional 15 minutes face-to-face time with physician or other
qualified health care professional), which is an add-on CPT code and
can only be billed with CPT code 95983. The RUC compared CPT code 95983
with CPT code 95978 (Electronic analysis of implanted neurostimulator
pulse generator system (e.g., rate, pulse amplitude and duration,
battery status, electrode selectability and polarity, impedance and
patient compliance measurements), complex deep brain neurostimulator
pulse generator/transmitter, with initial or subsequent programming;
first hour), which the CPT Editorial Panel is recommending for
deletion. The primary distinction between the new and old CPT codes is
that the new CPT code describes the first 15 minutes of programming
while the deleted CPT code describes up to one hour of programming. The
RUC recommended a work RVU of 1.25 for CPT code 95983 and a work RVU of
1.00 for CPT code 95984. For CPT code 95983, the RUC's recommendation
is based on reference CPT codes 12013 (Simple repair of superficial
wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6
cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15
minutes, and a work RVU of 1.22; and CPT code 70470 (Computed
tomography, head or brain; without contrast material, followed by
contrast material(s) and further sections) with 25 minutes of total
time, 15 minutes of intraservice time, and a work RVU of 1.27.
We disagreed with the RUC's recommended work RVU for CPT code 95983
because we did not believe that the reduction in work RVU reflected the
change in time described by the CPT code. Using the reverse building
block methodology, we estimated that a work RVU of nearer to 1.11 would
be more appropriate. In addition, if we were to sum the RUC-recommended
RVUs for a single hour of programming using one of the base CPT codes
and three of the 15 minute follow-on CPT codes, 1 hour of programming
would be valued at 4.25 work RVUs. This contrasts sharply from the work
RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978.
We believe that a more appropriate valuation of the work involved in
furnishing this service is reflected by a crosswalk to CPT code 93886
(Transcranial Doppler study of the intracranial arteries; complete
study), with total time 27 minutes, intraservice time of 17 minutes,
and a work RVU of 0.91. Therefore, we proposed a work RVU of 0.91 for
CPT code 95983.
The RUC's recommended work RVU of 1.00 for CPT code 95984 is based
on the key reference service CPT code 64645 (Chemodenervation of one
extremity; each additional extremity, 5 or more muscles), which has
total time of 26 minutes, intraservice time of 25 minutes, and a work
RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic
analysis of implanted neurostimulator pulse generator system (e.g.,
rate, pulse amplitude and duration, battery status, electrode
selectability and polarity, impedance and patient compliance
measurements), complex deep brain neurostimulator pulse generator/
transmitter, with initial or subsequent programming; first hour), which
is being deleted by the CPT Editorial Panel. If we were to add the
incremental difference between CPT codes 95983 and 95984 to the
proposed value for the base CPT code (95983, work RVU = 0.91), we
estimated that this add-on CPT code would have a work RVU of 0.75. The
building block methodology results in a recommendation of a slightly
higher work RVU of 0.82. We proposed a work RVU of 0.80 for CPT code
95984, which falls between the calculated value using incremental
differences and the calculation from the reverse building block, and is
supported by a crosswalk to CPT code 51797 (Voiding pressure studies,
intra-abdominal (ie, rectal, gastric, intraperitoneal)), which is an
add-on CPT code with identical total and intraservice times (15
minutes) as CPT code 95984.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving the Neurostimulator Services family of codes.
Comment: We received a number of comments regarding our proposed
work RVUs for CPT codes 95970, 95976, 95977, 95983, and 95984.
Commenters suggested that CMS misunderstood the role of reference codes
in the RUC's process, and that CMS should not be comparing the times
for the surveyed code to the reference codes because they are not
specifically intended to match in time.
Response: We appreciate the opportunity to clarify that we do not
believe the reference codes provided by the RUC in the summary
documents are being provided as a crosswalk. We did not state that we
thought the two top reference codes, CPT code 62368 (total time of 27
minutes) and CPT code 99213 (total time of 23 minutes) were being used
by the RUC as crosswalk codes (as that term is used in the RUC
process). Instead, we pointed out that the two reference codes are
generally not a particularly good comparison for a survey code with 15
minutes of total time. We understand that survey respondents, not the
RUC, chose the reference codes, and that survey respondents do not have
the physician times readily available when choosing from among services
that they are familiar with. Nonetheless, we expect reference codes to
generally have physician work times that are more similar to the survey
code than an 80 percent difference (in the case of CPT
[[Page 59571]]
code 62368). When we make such an observation with regard to the times
for reference codes in relation to a survey code, we are not
disregarding parameters other than time. We also note that the RUC
compares reference codes in terms of time or intensity relative to the
survey code as a matter of common practice. We understand those
comparisons to be intended by the RUC as one of several dimensions of a
code's work RVU valuation.
As we have stated in the past, we believe that practitioners become
more efficient at furnishing some services over time, shortening the
amount of clinical time required. We still believe this is the case
with regard to CPT code 95970, which has decreased in time without a
significant change in intensity. We maintain that our crosswalk to CPT
code 95930 with a work RVU of 0.35 for this CPT code is appropriate.
Comment: A commenter stated that, since CMS acknowledges that CPT
code 95976 is different from CPT code 95974, which is being deleted,
CMS should not compare the two codes for purpose of evaluating whether
the decreased work time in the new code is appropriate in relation to
the work involved in furnishing CPT code 95930. The commenter urged CMS
to finalize the work RVU proposed by the RUC, which is 0.95.
Response: The major difference in the description of work involved
in furnishing CPT code 95974 and CPT code 95976 involves a change from
`complex' to `simple' programming. We do not believe that this change,
which indicates a lower level of intensity for new CPT code 95976 than
for deleted CPT code 95974, precludes us from using the deleted CPT
code as the basis for evaluating whether the comparatively lower time
involved in furnishing CPT code 95976 is adequately reflected by the
RUC-recommended work RVU for this new CPT code. We continue to believe
that the lower time in furnishing the work described by CPT code 95976,
compared with the time in furnishing the service described by deleted
CPT code 95974, should result in a lower work RVU than the value
recommended by the RUC. Therefore, we are finalizing the work RVU for
CPT code 95976 of 0.73 based on a crosswalk to CPT code 76641.
Comment: A commenter clarified that we incorrectly stated that the
RUC compared the new CPT code 95977 with deleted CPT code 95975, which
is an add-on code and would therefore not be an acceptable point of
comparison.
Response: We appreciate the commenter informing us of the error and
we agree that the RUC did not compare CPT code 95977 with the deleted
code, CPT code 95975. Instead, the RUC compared the new code with
several other codes: CPT code 99308 (Subsequent nursing facility care,
per day, for the evaluation and management of a patient) with a work
RVU of 1.16, 15 minutes of intra-service time and 31 minutes total time
and CPT code 12013 (Simple repair of superficial wounds of face, ears,
eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm) with a
work RVU of 1.22, 15 minutes of intra-service time and 27 minutes total
time. The RUC also cited the following two CPT codes for support: CPT
code 93975 (Duplex scan of arterial inflow and venous outflow of
abdominal, pelvic, scrotal contents and/or retroperitoneal organs;
complete study) with a work RVU of 1.16, 20 minutes of intra-service
time and 30 minutes total time, and 67810 (Incisional biopsy of eyelid
skin including lid margin), with a work RVU of 1.18, 13 minutes of
intra-service time and 27 minutes total time. Despite having cited
these numerous CPT codes as support for their recommended work RVU for
CPT code 95977, we do not see why CPT code 95974 is not an entirely
appropriate point of comparison for CPT code 95977 as we explained in
making our proposal. The only difference between new CPT code 95977 and
new CPT code 95976 is complex vs. simple programming and, since as we
explained in response to comments above, we believe it is appropriate
to use the deleted CPT code 95974 for a time comparison with CPT code
95976, we believe that code is equally valid as the basis for
comparison to CPT code 95977. The building block methodology between
CPT code 95977 and CPT code 95974 suggests that a work RVU in the area
of 0.82 would better reflect both the time and intensity of furnishing
this service. In identifying a more appropriate work RVU, we looked at
the difference in the RUC-recommended work RVU between CPT codes 95976
and 95977, which differ by simple vs. complex programming, and added
the increment to our proposed value for CPT code 95976. We continue to
believe the use of an incremental difference between codes is a valid
methodology for setting values, especially in valuing services within a
family of revised codes where it is important to maintain appropriate
intra-family relativity. Given that we are finalizing our proposed work
RVU for CPT code 95976 of 0.73, we believe a work RVU of 0.97 for CPT
code 95977 is appropriate. We are finalizing a work RVU of 0.97 for CPT
code 95977 as proposed.
Comment: A commenter expressed opposition to our use of the reverse
building block methodology to evaluate the RUC-recommended work RVU for
CPT code 95983 and to identify possible alternative crosswalk CPT
codes. Consequently, the commenter stated that our crosswalk of CPT
code 93886 is based on invalid reasoning about how the time parameter
factors into the code valuation. The work involved in furnishing the
service described by the crosswalk code, according to the commenter, is
less intense than the work described by the survey code.
Response: We disagree with the commenter that the reverse building
block methodology not an appropriate approach to assessing whether the
RUC-recommended work RVU for a code is appropriate. We employed a
reverse building block methodology to assess the reasonableness of the
RUC's recommendation, not to value the code in the first instance. As
the commenter noted, the work described by new CPT code 95983 is
difficult to value in relation to both the deleted code and other codes
on the fee schedule because of the 15 minute time parameter. However,
having looked carefully at the work involved in furnishing the service
described by our crosswalk code, CPT code 93886, we do not believe it
is less intense than the survey code. The service described by CPT code
93886 is performed on patients with recent brain hemorrhage, which we
believe is as complex to study as the work involved in programming
adjustments to multiple parameters in real time. We continue to believe
that CPT code 93886 is an appropriate crosswalk for CPT code 95983, and
we are finalizing a work RVU for this code of 0.91.
Comment: A commenter stated that our approach for valuing CPT code
95984 ignored physician work intensity and complexity in favor of a
random calculation involving code increments, which is a flawed
methodology. CMS's choice of crosswalk code, according to the
commenter, is invalid because it is based on this incorrect approach.
Response: We disagree that the use of incremental differences in
work RVU between codes that have an established pattern of intensity or
time, is inappropriate. We remind the commenter that our calculation of
increments is based on the RUC's recommended work RVUs for the relevant
CPT codes. We continue to believe that this approach is necessary to
maintain intra-family relativity of the PFS, and we maintain that CPT
code 51797 is an appropriate crosswalk to the
[[Page 59572]]
add-on CPT code 95984. We are finalizing a work RVU for CPT 95984 of
0.80.
Comment: One commenter stated that CMS reduced the nonfacility
service cost for clinical labor for CPT code 95970 to zero. The
commenter stated that this may be a potential oversight, given that the
RUC recommended nonfacility clinical labor time be reduced from 44 to
15 minutes. The commenter stated that it was not consistent for CMS to
recommend a nonfacility service cost of zero in light of the
nonfacility exam table (EF023) equipment time of 15 minutes, and that
this clinical labor should still be reflected in this service.
Response: We disagree with the commenter and note that the RUC did
not recommend any clinical labor time for CPT code 95970, as we
proposed the RUC-recommended direct PE inputs without refinement. We
believe that the equipment time assigned for the exam table (EF023) and
the neurostimulator programmer (EQ209) indicate that these equipment
items are in use by the practitioner and not the clinical staff.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the codes in the Neurostimulator
Services family of codes as proposed.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105,
96110, 96116, 96125, 96127, 96112, 96113, 96121, 96130, 96131, 96132,
96133, 96136, 96137, 9613896138, 96139, 96X11, and 96146)
In CY 2016, the Psychological and Neuropsychological Testing family
of codes were identified as potentially misvalued using a high
expenditure services screen across specialties with Medicare allowed
charges of $10 million or more. The entire family of codes was referred
to the CPT Editorial Panel to be revised, as the testing practices had
been significantly altered by the growth and availability of
technology, leading to confusion about how to report the codes. In June
2017, the CPT Editorial Panel revised five existing codes, added 13
codes to provide better description of psychological and
neuropsychological testing, and deleted CPT codes 96101, 96102, 96103,
96111, 96118, 96119, and 96120. The RUC and HCPAC submitted
recommendations for the 13 new codes and for the existing CPT codes
96105, 96110, 96116, 96125, and 96127.
We proposed the RUC- and HCPAC-recommend work RVUs for several of
the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a
work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code
96125; a work RVU of 1.71 for CPT code 96121; a work RVU of 0.55 for
CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and
96146 were valued by the RUC for PE only.
This code family contains a subset of codes that describe
psychological and neuropsychological testing administration and
evaluation, not including assessment of aphasia, developmental
screening, or developmental testing. The CPT Editorial Panel's
recommended coding for this subset of services consists of seven new
codes: Two that describe either psychological or neuropsychological
testing when administered by physicians or other qualified health
professionals (CPT codes 96136 and 96137), and two for either type of
testing when administered by technicians (CPT codes 96138 and 96139);
and four new codes that describe testing evaluation by physicians or
other qualified health care professionals (CPT codes 96130 through
96133). This new coding effectively unbundles codes that currently
report the full course of testing into separate codes for testing
administration (CPT codes 96136, 96137, 96138, and 96139) and
evaluation (CPT codes 96130, 96131, and 96132). According to a
stakeholder that represents the psychologist and neuropsychologist
community, this new coding will result in significant reductions in
payment for these services due to the unbundling of the testing codes
into codes for physician-administered tests and technician-administered
tests. The stakeholder noted that because the new coding includes
testing codes with zero work RVUs for the technician administered tests
and the work RVUs are lower than they believe to be accurate, this new
valuation would ignore the clinical evaluation and decision making
performed by the physician or other qualified health professional
during the course of testing administration and evaluation.
Furthermore, the net result of the code valuations for these new codes
is a reduction in the overall work RVUs for this family of codes. In
other words, the stakeholder's analysis found that the RUC
recommendations result in a reduction in total work RVUs, even though
the actual physician work of a testing battery has not changed.
In the interest of payment stability for these high-volume
services, we proposed to implement work RVUs for this code family,
which would eliminate the approximately 2 percent reduction in work
spending. We proposed to achieve work neutrality for this code family
by scaling the work RVUs upward from the RUC-recommended values so that
the size of the pool of work RVUs would be essentially unchanged for
this family of services. Therefore, we proposed: A work RVU of 2.56 for
CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a
work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended
work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than
the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code
96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of
2.56 for CPT code 96132, rather than the RUC-recommended work RVU of
2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-
recommended work RVU of 1.90. We saw no evidence that the typical
practice for these services has changed to merit a reduction in
valuation of professional services.
The RUC made several revisions to the recommended direct PE inputs
for the administration codes from their respective predecessor codes,
including revisions to quantities of testing forms. For the supply
item, ``psych testing forms, average'' there is a quantity of 0.10 in
the predecessor CPT code 96101, and a quantity of 0.33 in the
predecessor CPT code 96102. For the supply item ``neurobehavioral
status forms, average,'' there is a quantity of 1.0 in the predecessor
CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119,
and for the supply item ``aphasia assessment forms, average,'' there is
a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of
0.30 in predecessor CPT code 96119. The RUC recommendation does not
include any forms for CPT codes 96132 and 96133. The RUC has replaced
the corresponding predecessor supply items with new items ``WAIS-IV
Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response
Booklet #2,'' and assigned quantities of 0.165 for each of these new
supply items for CPT codes 96136 through 96139. In our analysis, we
found that the RUC-recommended direct PE refinements contributed
significantly to the reduction in the overall payment for this code
family. We saw no compelling evidence that the quantities of testing
forms used in a typical course of testing would have been reduced
dramatically and, in the interest of payment stability, we proposed to
refine the direct PE inputs for CPT codes 96132 through 96139 by
including 1.0 quantity each of the supply items ``WAIS-IV Record
[[Page 59573]]
Form,'' ``WAIS-IV Response Booklet #1'', and ``WAIS-IV Response Booklet
#2.'' We believe that a typical course of testing would involve use of
one booklet for each of the relevant codes. In addition, these proposed
refinements would largely mitigate potentially destabilizing payment
reductions for these services. We solicited comments on our proposed
work RVUs and proposed PE refinements for this family of services.
We also proposed to remove the equipment time for the CANTAB Mobile
(ED055) equipment item from CPT code 96146. This item was listed at
different points in the recommendations as a supply item with a cost of
$28 per assessment and as an equipment item for a software license with
a cost of $2,800 that could be used for up to 100 assessments. We were
unclear as to how the CANTAB Mobile would typically be used in this
procedure, and we proposed to remove the equipment time pending the
submission of more data about the item. We solicited additional
information about the use of this item and how it should best be
included into the PE methodology. We were also interested in
information as to whether the submitted invoice refers to the cost of
the mobile device itself, or the cost of user licenses for the mobile
device, which was unclear from the information submitted with the
recommendations.
The following is a summary of the comments we received regarding
our proposed work RVUs and proposed direct PE refinements for this
family of services.
Comment: Many commenters supported our proposal to increase payment
from the RUC recommendations in the interest of payment stability.
These commenters stated this proposal will help mitigate reductions in
reimbursement rates for psychologists.
According to some commenters, some psychologists will see slight
decreases for neuropsychological testing services due to the new coding
structure, which they say aligns psychological and neuropsychological
testing services with other testing services in the program. Some
commenters said that, due to the new coding structure, reimbursement
will be lower for neuropsychological evaluation services that are
provided by physicians than those provided by technicians. These
commenters stated that physicians should not be reimbursed at a lesser
rate than EEG or MRI technicians or other physician extenders.
Response: We note that our proposed values for the evaluation CPT
codes 96130 through 96133 and the administration and scoring CPT codes
96136 through 96139 are generally higher for the physician-administered
codes than for the analogous technician-administered codes. According
to our proposed rates, however, the valuation of the add-on code for
each additional 30 minutes of administration and scoring when performed
by a technician reported with CPT code 96139 is, however, slightly
higher than the valuation of the add-on code for each additional 30
minutes of administration and scoring when performed by a physician or
other qualified health care professional, reported with CPT code 96137.
We thank commenters for bringing this potential rank-order anomaly to
our attention. We believe that clinical staff will typically be
providing some support when the physician or other qualified health
care professional is performing testing administration as described by
CPT codes 96136 and 96137. We are therefore refining the direct PE
inputs for these services by adding 10 minutes of clinical labor time
for the CA021 clinical labor activity, ``Perform procedure/service--NOT
directly related to physician work time'' for these codes. We believe
this will more accurately reflect the clinical staff support that is
typical when a physician is performing test administration, and it will
preserve appropriate rank-order among this subset of services, while
mitigating reductions to payment rates for testing administration
services.
Comment: The RUC noted that in the February 5, 2018 RUC submission
to CMS, the RUC rescinded its interim recommendation from October 2017,
and stated that CPT code 96X11 is deleted and will not be a CPT code
for CPT 2019. The RUC recommended that CMS delete this service and work
RVU recommendation for the 2019 PFS.
Response: As CPT code 96X11 will not be a CPT code for CY 2019, we
are deleting this code. Based on the RUC-recommended utilization
crosswalk, our proposed rates included utilization assumptions that for
all services currently reported with CPT codes 96103 and 96120, half of
these services will be reported with the new CPT code 96X11 and half
will be reported with CPT code 96146. As we are not finalizing 96X11,
for the purposes of ratesetting, our utilization for these service will
include the assumption that half of the services currently reported
with 96103 and 96120 will be reported with CPT code 96136 and half with
CPT code 96146.
Comment: A commenter requested clarification on how much time is
considered typical for the neuropsychologist to perform record review
and test selection in newly created CPT codes 96132 and 96133.
Response: For CPT code 96132, we proposed the RUC-recommended 5
minutes of pre-service work time which reflects activities such as
preliminary selection of tests and record review. As CPT code 96133 is
an add-on code for reporting each additional hour, it does not include
additional pre-service work time, as the latter would be considered to
be included in the corresponding base code.
Comment: Several commenters disagreed with the proposal to remove
the equipment time for the CANTAB Mobile (ED055) equipment item from
CPT code 96146. Commenters stated that the PE Subcommittee determined
that this was a software license and it would be more appropriately
classified as equipment than as a supply. Commenters stated that they
had submitted paid invoices for two additional software license-based
automated instruments typically used when furnishing CPT code 96146,
and that they were resubmitting these same invoices with their comment
letter.
Response: We appreciate the feedback from the commenter that the
CANTAB Mobile (ED055) equipment item referred to a software license. We
continue to believe that software licenses would typically be
classified as a form of indirect PE under our methodology, and as a
result we are finalizing our proposal to remove this equipment time
from CPT code 96146.
Comment: A commenter requested clarification on why new CPT codes
96138, 96139, and 96146 do not include a facility fee, despite the fact
that their respective source CPT codes 96102, 96119, 96103, and 96120
do have RVUs in the facility setting.
Response: The source codes mentioned by the commenter have
associated work RVUs, while the new CPT codes do not, and they do not
include physician work time. The new CPT coding effectively unbundles
professional and technical services for some of these codes. Codes that
do not have a physician work component would typically not be valued in
the facility setting.
After consideration of the public comments, we are finalizing the
work RVUs for the codes in the Psychological and Neuropsychological
Testing family of codes as proposed. We are also finalizing the direct
PE inputs as proposed, with the exception of the refinement to the
CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.
[[Page 59574]]
(57) Electrocorticography (CPT Code 95836)
CPT Code 95829 is used for Electrocorticogram performed at the time
of surgery; however, a new code was needed to account for this non-
face-to-face service for the review of a month's worth or more of
stored data. CPT code 95836 (Electrocorticogram from an implanted brain
neurostimulator pulse generator/transmitter, including recording, with
interpretation and written report, up to 30 days) is a new code
approved at the September 2017 CPT Editorial Panel Meeting to describe
this service.
We disagreed with the RUC-recommended work RVU of 2.30 for CPT code
95836 and proposed a work RVU of 1.98 based on a direct crosswalk to
the top reference, CPT code 95957 (Digital analysis of
electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This
is a recently-reviewed code with the same intraservice time of 30
minutes and a total time only 2 minutes lower than CPT code 95836. We
agreed with the survey respondents that CPT code 95957 was an accurate
valuation for this new code, and due to the clinically similar nature
of the two procedures and their near-identical time values, we proposed
to value both of them at the same work RVU of 1.98.
The RUC did not recommend, and we did not propose, any direct PE
inputs for CPT code 95836.
The following is a summary of the public comments we received on
our proposals involving CPT code 95836.
Comment: Many commenters disagreed with the proposed work RVU of
1.98 for CPT code 95836 and stated that CMS should finalize the RUC-
recommended work RVU of 2.30. Commenters stated that the survey
respondents chose CPT code 95957 as a reference service and not as a
direct crosswalk. Commenters stated that the survey respondents pick
from a list of 10-20 services to use as a comparison and then recommend
a work RVU based on the intensity, complexity and physician time
required to perform the surveyed code. Commenters stated that the
median survey work RVU was actually 2.97, much higher than the key
reference service, and that the respondents specifically indicated that
CPT code 95836 is more intense and complex than CPT code 95957 on all
measures.
Response: We disagree with the commenters that the key reference
service of CPT code 95957 would be an inappropriate choice for a direct
crosswalk, not least because the RUC commonly uses one of the key
reference services in exactly this fashion. While it is true that the
median survey work RVU was 2.97, we note that the RUC did not recommend
this work valuation either, instead choosing to recommend a work RVU of
2.30 in recognition that the survey median would be a value that is too
high to maintain relativity. Similarly, while the survey respondents
specifically indicated that CPT code 95836 is more intense and complex
than CPT code 95957 on all measures, we note that the survey
respondents also indicated that CPT code 95836 is more intense and
complex than the second key reference code, CPT code 95810
(Polysomnography; age 6 years or older, sleep staging with 4 or more
additional parameters of sleep, attended by a technologist) which has a
work RVU of 2.50. We proposed to use a crosswalk to CPT code 95957 not
only because it was selected by the survey participants as the top key
reference, but also because it is a recently-reviewed code with the
same intraservice time of 30 minutes and a total time only 2 minutes
lower than CPT code 95836. We continue to believe that this is the most
accurate choice for work valuation.
Comment: Several commenters stated that although the specialty
society did not submit any direct PE inputs, it is not a facility only
code. Commenters stated that CPT code 95836 can be performed in both
the nonfacility and the facility setting, and that the nonfacility is
actually the typical setting for this service. Commenters stated that
they understood that there would be no direct staffing, equipment or
supply costs associated with this service and that indirect costs would
be similar regardless of the setting in which the service is performed,
but there would still be indirect practice expense associated with
providing the service in the nonfacility. Commenters apologized for the
misunderstanding and requested that CPT code 95836 should be valued in
the nonfacility setting.
Response: We appreciate the additional information supplied by the
commenters on this issue. We will remove the ``NA'' designation from
the nonfacility setting for CPT code 95836. Due to the fact that there
are no direct PE inputs for CPT code 95836, the PE RVU will be the same
in both the nonfacility and facility settings because it is based
solely on the indirect PE methodology.
After consideration of the public comments, we are finalizing the
work RVU for CPT code 95836 as proposed. We are not finalizing any
direct PE inputs for this code, but we will value it in both the
facility and nonfacility settings as noted above.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453,
99454, and 99457)
In the CY 2018 PFS final rule, we finalized separate payment for
CPT code 99091 (Collection and interpretation of physiologic data
(e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or
transmitted by the patient and/or caregiver to the physician or other
qualified health care professional, qualified by education, training,
licensure/regulation (when applicable) requiring a minimum of 30
minutes of time) (82 FR 53014). In that rule, we indicated that there
would be new coding describing remote monitoring forthcoming from the
CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the
CPT Editorial Panel revised one code and created three new codes to
describe remote physiologic monitoring and management, and the RUC
provided valuation recommendations through our standard rulemaking
process.
CPT codes 99453 (Remote monitoring of physiologic parameter(s)
(e.g., weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; set-up and patient education on use of equipment) and 99454
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood
pressure, pulse oximetry, respiratory flow rate), initial; device(s)
supply with daily recording(s) or programmed alert(s) transmission,
each 30 days) are both PE-only codes. We proposed the RUC-recommended
work RVU of 0.61 for CPT code 99457 (Remote physiologic monitoring
treatment management services, 20 minutes or more of clinical staff/
physician/other qualified healthcare professional time in a calendar
month requiring interactive communication with the patient/caregiver
during the month).
For the direct PE inputs, we proposed to accept the RUC-recommended
direct PE inputs for CPT code 99453 and to remove the ``Monthly
cellular and licensing service fee'' supply from CPT code 99454. We do
not believe that these licensing fees will be allocated to the use of
an individual patient for an individual service, and instead believe
they can be better understood as forms of indirect costs similar to
office rent or administrative expenses. Therefore, we proposed to
remove this supply input as a form of indirect PE. We proposed the
direct PE inputs for CPT code 99457 without refinement.
The following is a summary of the public comments we received on
our
[[Page 59575]]
proposals involving the Chronic Care Remote Physiologic Monitoring
family of codes.
Comment: Commenters were very supportive of CMS making separate
payment for these services. Several commenters supported the proposal
of the RUC-recommended work RVU of 0.61 for CPT code 99457. A few
commenters stated that the proposed rates for these services were too
low, and that given industry standards, reimbursement should be
increased.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters disagreed with the proposal to remove
the ``Monthly cellular and licensing service fee'' supply from CPT code
99454. Commenters stated that the monthly cellular and licensing
service fee was a direct practice expense input as it is allocable to
the patient for this service. Commenters stated that this fee is not a
license for the entire practice; rather it is an individually allocable
fee for the period that the patients is monitored and the physician
would not incur such fees if the patient did have the wireless monitor.
Commenters clarified that the fee is comprised of the monthly cost
associated with encryption of data for safe HIPAA compliant transfer,
programmed alerts, and the monthly cost of pre-loaded connectivity used
to transmit patient generated physiological data from a specific
patient to the provider's software. Commenters stated that reliance
upon a patient's cellular connectivity or WIFI, which may or may not be
operating based on patient technology capabilities, was not reliable
for medical delivery purposes.
Response: We disagree with the commenters and we continue to
believe that the monthly cellular and licensing service fee constitutes
a form of indirect PE. We believe that licensing and data costs are
administrative costs that are not unique to individual procedures, in
the same fashion that we do not assign separate direct PE for higher
electricity costs to diagnostic imaging procedures as compared to
cognitive evaluation procedures. We continue to believe that these data
costs are appropriately captured via the indirect PE methodology as
opposed to being included as a separate direct PE input. We also note
that other services that require around-the-clock monitoring, such as
the home PT/INR monitoring described in HCPCS code G0249 (Provision of
test materials and equipment for home inr monitoring of patient with
either mechanical heart valve(s), chronic atrial fibrillation, or
venous thromboembolism who meets Medicare coverage criteria; includes:
Provision of materials for use in the home and reporting of test
results to physician; testing not occurring more frequently than once a
week; testing materials, billing units of service include 4 tests), do
not include additional direct PE inputs for data costs, and we do not
believe it would be appropriate to include them for CPT code 99454.
Comment: One commenter stated that CMS should add the cost of
equipment sanitation and reprocessing as a one-time cost that is
directly attributable to a patient. The commenter stated that FDA
device guidelines require that a reusable medical device be
reprocessed, which includes sanitation or sterilization and ensuring
that all personal data is `wiped' or removed from the device. The
commenter stated that this cost was not considered by the RUC, however,
it is routinely part of the `set up' costs that are onetime costs
directly attributable to a patient.
Response: We disagree with the commenter that these expenses would
constitute a separate form of direct PE. We agree with the RUC, which
discussed the specialty society's recommended supply items, shipping
costs and a device reprocessing fee, and determined that these expenses
are not specifically allocable to the patient for this service, and
would be considered indirect practice expenses.
Comment: One commenter stated that there was direct time spent by
pharmacists for each patient, and the commenter requested that CMS
factor pharmacist time into the PE valuation for CPT codes 99453,
99454, 99091, and 99457.
Response: We typically do not consider time spent by a pharmacist
to be a part of the clinical labor time for purposes of direct PE. For
additional information, we direct readers to the Practice Expense
portion of this final rule (section II.B. of this final rule).
Comment: Many commenters pointed out that beneficiary cost sharing
is a significant barrier to the use of non-face-to-face services, like
remote patient monitoring. Commenters requested that CMS waive the cost
sharing requirements for these codes.
Response: We do not have the authority to make changes to the
applicable beneficiary cost sharing for most physicians' services,
including these.
Comment: Many commenters requested that CMS clarify the kinds of
technology covered under CPT codes 99453, 99454, and 99457. Commenters
provided examples of the kinds of technology these codes should cover
including software applications that could be integrated into a
beneficiary's smart phone, Holter-Monitors, Fit-Bits, or artificial
intelligence messaging. One commenter suggested that behavioral health
data and data from wellness applications be included as well. Another
commenter stated that the descriptor should include results of
patients' self-care tasks. Many commenters stated that CMS should
clarify certain elements in the scope of service and code descriptors
and issue appropriate sub-regulatory guidance. Commenters inquired as
to whether CPT code 99453 can be furnished via telecommunication
technology, if it can be billed again if the number of parameters
changed in the future. Commenters requested that CMS clarify the
meaning of ``programmed alerts transmission'' in the descriptor for CPT
code 99454, and whether it included transmissions that occurred other
than daily. Commenters also encouraged CMS to allow flexibility in the
time frame covered by these services.
Response: We plan to issue guidance to help inform practitioners
and stakeholders on these issues.
Comment: Commenters requested that CMS clarify whether CPT code
99457 can be billed incident to a practitioner's professional services
and asked that CMS make an exception to the direct supervision
requirements, stating that general supervision is sufficient for these
services.
Response: We note that CPT code 99457 describes professional time
and therefore cannot be furnished by auxiliary personnel incident to a
practitioner's professional services.
Comment: A few commenters suggested that additional medical
professionals, including pharmacists, paramedics, chiropractors,
physical therapists, occupational therapists and dentists should be
allowed to bill Medicare for these services. Other commenters requested
that CMS clarify the practitioners referred to as ``other qualified
healthcare professionals'' in the code descriptor.
Response: We note that all practitioners must practice in
accordance with applicable state law and scope of practice laws, and
that some of the practitioners identified by the commenters are not
authorized to bill Medicare independently for their services. We note
that the term, ``other qualified healthcare professionals,'' used in
the code descriptor is a defined by CPT, and that definition can be
found in the CPT Codebook.
Comment: A few commenters provided specific suggestions for
revising the code descriptors, including
[[Page 59576]]
the addition of secure messaging platforms, revision of the time
thresholds, specifying that the follow-up should be written in all
instances, including ``for medical consultative discussion and review''
in the descriptor for CPT codes 99446 through 99449, and striking
``referral services'' and rather, including language similar to the
other codes regarding ``assessment and management'' services. Other
commenters requested CMS clarify the definition of ``health record
assessment'' in the descriptors for CPT codes 99451 and 99452. One
commenter suggested that CMS add language about use of EHR to the
existing CPT codes, rather than finalize separate payment for CPT codes
99451 and 99452.
Response: While we appreciate all of the specific suggestions
regarding the code descriptions, we defer to the CPT to maintain code
descriptors for CPT codes. Where additional clarification is needed, we
may provide guidance in the future.
Comment: A few commenters urged CMS not to be prescriptive
regarding the technology that could be used to perform consultations,
including real-time video, a store-and-forward visit, or simply a
patient-provider message via a patient portal.
Response: While we are sympathetic to the commenters' desire not to
be overly prescriptive about the technology used to furnish these
services, especially given the speed at which technology evolves, we
note that we refer to the CPT code descriptors and guidance to
ascertain the scope of technology that is used to furnish these
services.
Comment: One commenter asked whether there were geographic
restrictions on these services.
Response: There are no geographic restrictions, as these services
are not Medicare telehealth services.
After considering the public comments, we are finalizing the RUC-
recommended work RVU of 0.61 for CPT code 99457 and the direct PE
inputs for all three codes as proposed.
(59) Interprofessional Internet Consultation (CPT Codes 99451, 99452,
99446, 99447, 99448, and 99449)
In September 2017, the CPT Editorial Panel revised four codes and
created two codes to describe interprofessional telephone/internet/
electronic medical record consultation services. CPT codes 99446
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 5-10 minutes of medical
consultative discussion and review), 99447 (Interprofessional
telephone/internet assessment and management service provided by a
consultative physician including a verbal and written report to the
patient's treating/requesting physician or other qualified health care
professional; 11-20 minutes of medical consultative discussion and
review), 99448 (Interprofessional telephone/internet assessment and
management service provided by a consultative physician including a
verbal and written report to the patient's treating/requesting
physician or other qualified health care professional; 21-30 minutes of
medical consultative discussion and review), and 99449
(Interprofessional telephone/internet assessment and management service
provided by a consultative physician including a verbal and written
report to the patient's treating/requesting physician or other
qualified health care professional; 31 minutes or more of medical
consultative discussion and review) describe assessment and management
services in which a patient's treating physician or other qualified
healthcare professional requests the opinion and/or treatment advice of
a physician with specific specialty expertise to assist with the
diagnosis and/or management of the patient's problem without the need
for the face-to-face interaction between the patient and the
consultant. These CPT codes are currently assigned a procedure status
of B (bundled) and are not separately payable under Medicare. The CPT
Editorial Panel revised these codes to include electronic health record
consultations, and the RUC reaffirmed the work RVUs it had previously
submitted for these codes. We reevaluated the submitted recommendations
and, in light of changes in medical practice and technology, we
proposed to change the procedure status for CPT codes 99446, 99447,
99448, and 99449 from B (bundled) to A (active). We also proposed the
RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code
99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.
The CPT Editorial Panel also created two new codes, CPT code 99452
(Interprofessional telephone/internet/electronic health record referral
service(s) provided by a treating/requesting physician or qualified
health care professional, 30 minutes) and CPT code 99451
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician
including a written report to the patient's treating/requesting
physician or other qualified health care professional, 5 or more
minutes of medical consultative time). The RUC-recommended work RVUs
are 0.50 for CPT code 99452 and 0.70 for 99451. Since the CPT code for
the treating/requesting physician or qualified healthcare professional
and the CPT code for the consultative physician have similar
intraservice times, we believe that these CPT codes should have equal
values for work. Therefore, we proposed a work RVU of 0.50 for both CPT
codes 99452 and 99451.
We welcomed comments on this proposal. We also direct readers to
section II.D. of this final rule, Modernizing Medicare Physician
Payment by Recognizing Communication Technology-Based Services, which
includes additional detail regarding our policies for modernizing
Medicare physician payment by recognizing communication technology-
based services.
There are no recommended direct PE inputs for the codes in this
family.
The following is a summary of the public comments we received on
our proposals involving the Interprofessional Internet Consultation
family of codes.
Comment: Almost all commenters were supportive of CMS' proposal to
unbundle CPT codes 99446 through 99449 and make separate payment for
CPT codes 99452 and 99451. Almost all commenters did not support
lowering the RVU of CPT code 99451 to 0.50 as the work of the
consulting physician in CPT code 99451 is more intense than the work of
the treating physician in CPT code 99452. Commenters stated that the
consulting practitioner exercises greater effort, both in judgment and
technical skill to make a recommendation for the treatment of a
previously unknown patient than the treating physician does in
conveying the relevant information. A few commenters expressed concern
that the proposed work RVU for CPT code 99452 is too low, and does not
accurately reflect the resources associated with the work of the
treating physician.
Response: We agree with commenters that the work of the consulting
physician is significant, and we are persuaded by the additional
descriptions of that work provided by commenters. We also agree with
the commenters who suggested that the proposed work RVU of 0.50 for CPT
code 99452 undervalues the work associated with aggregating patient
information, communicating with the consulting practitioner, and
[[Page 59577]]
implementing the results of the consultation. We continue, however, to
have concerns regarding the valuation of these services. We note that
there are instances where the patient would not be new to the
consulting practitioner, and therefore the intensity of the work would
be reduced. We are also concerned that, given the similarity of
intraservice times, CPT code 99452 is undervalued relative to CPT code
99451, especially since the code descriptor for CPT code 99452
specifies that the consulting practitioner can spend a minimum of 5
minutes providing the consultation. We believe that a work RVU of 0.50
more accurately describes the work associated with both services. Given
the similarity of intraservice times and the information indicating
that both codes may be undervalued at 0.50 RVUs, we are finalizing a
work RVU of 0.70 for CPT codes 99451 and 99452.
Comment: A few commenters expressed concern that these codes were
only payable in the facility setting.
Response: These codes are payable in both facility and non-facility
settings.
Comment: One commenter requested that CMS include pharmacists as
clinical staff in the direct PE.
Response: We direct readers to the discussion of this issue in the
PE section of the rule (Section II.B. of this final rule). We also note
that these codes do not have direct PE inputs.
(60) Chronic Care Management Services (CPT Code 99491)
In February 2017, the CPT Editorial Panel created a new code to
describe at least 30 minutes of chronic care management services
performed personally by the physician or qualified health care
professional over one calendar month. CMS began making separate payment
for CPT code 99490 (Chronic care management services, at least 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month, with the
following required elements: Multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient;
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline; comprehensive
care plan established, implemented, revised, or monitored) in CY 2015
(79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff
time spent on care management services for patients with 2 or more
chronic conditions. CPT code 99490 also includes 15 minutes of
physician time for supervision of clinical staff. For CY 2019, the CPT
Editorial Panel created CPT code 99491 (Chronic care management
services, provided personally by a physician or other qualified health
care professional, at least 30 minutes of physician or other qualified
health care professional time, per calendar month, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient, chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; comprehensive care
plan established, implemented, revised, or monitored) to describe
situations when the billing practitioner is doing the care coordination
work that is attributed to clinical staff in CPT code 99490. For CPT
code 99491, the RUC recommended a work RVU of 1.45 for 30 minutes of
physician time.
We believe this work RVU overvalues the resource costs associated
with the physician performing the same care coordination activities
that are performed by clinical staff in the service described by CPT
code 99490. Additionally, this valuation of the work is higher than
that of CPT code 99487 (Complex chronic care management services, with
the following required elements: Multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline,
establishment or substantial revision of a comprehensive care plan,
moderate or high complexity medical decision making; 60 minutes of
clinical staff time directed by a physician or other qualified health
care professional, per calendar month), which includes 60 minutes of
clinical staff time, creating a rank order anomaly within the family of
codes if we were to accept the RUC-recommended value.
CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician
time. Therefore, as CPT code 99491 describes 30 minutes of physician
time, we proposed a work RVU of 1.22, which is double the work RVU of
CPT code 99490.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on
our proposals involving CPT code 99491.
Comment: Almost all commenters recommended that CMS finalize the
RUC-recommended work value of 1.45 for 99491. The RUC stated that CPT
code 99491 is different from the existing chronic care management (CCM)
services codes because those codes are performed by clinical staff
under the supervision of a physician, while CPT code 99491 is performed
by the physicians themselves. Commenters also stated that the typical
patient requiring that the physician personally perform the care
management services is of greater acuity than the typical patient for
whom CCM may be performed by clinical staff. Additionally, CPT code
99491 cannot be reported with CPT code 99490 or CPT code 99487, and
must therefore account for all of the care management work in the
month. Commenters also pointed out that there are multiple examples of
CMS valuing the work of a physician more highly than clinical staff
when they perform the same services, for example CPT codes 96101
(Psychological testing (includes psychodiagnostic assessment of
emotionality, intellectual abilities, personality and psychopathology,
e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or
physician's time, both face-to-face time administering tests to the
patient and time interpreting these test results and preparing the
report) and 96102 (Psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI and WAIS), with qualified health care
professional interpretation and report, administered by technician, per
hour of technician time, face-to-face.)
Response: We agree with commenters that a work RVU of 1.45
accurately captures the resources associated when a physician furnishes
CCM. We agree that in most cases, the physician would perform CCM on
patients with higher acuity and therefore the care planning and medical
decision making would be of greater intensity. We also agree with
commenters that the work associated with personally performing CCM as
opposed to supervising clinical staff is also of greater intensity.
Therefore, we are finalizing that value based on our review of comments
received.
Comment: A few commenters requested that CMS clarify that CPT code
99491 can be performed incident to a practitioner's professional
services.
Response: CPT code 99491 is specifically for use when the billing
practitioner personally performs care management services, so this code
cannot be furnished incident to a practitioner's professional services.
(61) Diabetes Management Training (HCPCS Codes G0108 and G0109)
HCPCS codes G0108 (Diabetes outpatient self-management training
services, individual, per 30 minutes) and G0109 (Diabetes outpatient
self-
[[Page 59578]]
management training services, group session (2 or more), per 30
minutes) were identified on a screen of CMS or Other source codes with
Medicare utilization greater than 100,000 services annually. For CY
2019, we proposed the HCPAC-recommended work RVU of 0.90 for HCPCS code
G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109.
For the direct PE inputs, we noted that there was a significant
disparity between the specialty recommendation and the final
recommendation submitted by the HCPAC. We were concerned about the
significant decreases in direct PE inputs in the final recommendation
when compared to the current makeup of the two codes. The final HCPAC
recommendation removed a series of different syringes and the patient
education booklet that currently accompanies the procedure. We believe
that injection training is part of these services and that the supplies
associated with that training would typically be included in the
procedures. Due to these concerns, we proposed to maintain the current
direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we
proposed not to add the new supply item ``20x30 inch self-stick easel
pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109 that was
included in the final HCPAC recommendation, as it was not a current
supply for HCPCS code G0109; however, we proposed to accept the
submitted invoice price and to add the supply to our direct PE
database.
The following is a summary of the public comments we received on
our proposals involving the Diabetes Management Training family of
codes.
Comment: Several commenters supported the proposal of the HCPAC-
recommended work RVUs. Commenters also stated that they applauded CMS
for recognizing and addressing the significant disparity in direct PE
inputs between the specialty recommendations and the final
recommendations submitted to CMS by the HCPAC.
Response: We appreciate the support for our proposals from the
commenters.
Comment: One commenter expressed disappointment that CMS did not
address barriers in Medicare that impact beneficiary utilization of the
diabetes self-management training (DSMT) benefit. The commenter stated
that CMS solicited comments from stakeholders in the CY 2017 PFS
proposed rule on this subject, and the commenter has been part of
ongoing conversations with CMS about this issue, through in-person
meetings and written communications, over the past two years. The
commenter stated that they were hopeful CMS would use this opportunity
to address barriers to DSMT given that utilization of the DSMT benefit
stands at only 5 percent of eligible Medicare beneficiaries.
Response: We appreciate the feedback from the commenter, and we
will consider these issues for future rulemaking. However, we note that
we did not specifically make any proposals associated with these
subjects in the CY 2019 proposed rule.
Comment: One commenter stated that the final HCPAC recommendations
removed a series of different syringes and the patient education
booklet that currently accompany these procedures. The commenter stated
that several anti-glycemic medications other than insulin require
injection with a syringe and a significant number of persons with both
type 1 and type 2 diabetes are prescribed these medications, however
the list of supplies in the current direct PE inputs does not include
syringes. The commenter therefore recommended that CMS add a series of
different syringes to the direct PE inputs for HCPCS codes G0108 and
G0109.
Response: We proposed to maintain the current direct PE inputs for
HCPCS codes G0108 and G0109, which do not currently include the syringe
supplies described by the commenter (supply codes SC051, SC052, and
SC055). Although we are sensitive to the concerns raised by the
commenter, we do not believe that adding these syringe supplies to the
procedures would be consistent with our policy of maintaining the
current direct PE inputs.
After consideration of the public comments, we are finalizing the
work RVUs and the direct PE inputs for the codes in the Diabetes
Management Training family of codes as proposed.
(62) External Counterpulsation (HCPCS Code G0166)
HCPCS code G0166 (External counterpulsation, per treatment session)
was identified on a screen of CMS or Other source codes with Medicare
utilization greater than 100,000 services annually. The RUC is not
recommending a work RVU for HCPCS code G0166 because they found that
there is no physician work involved in this service. After reviewing
this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and
proposed to make the code valued for PE only. For the direct PE inputs,
we proposed to refine the equipment times in accordance with our
standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0166.
Comment: A commenter agreed with the proposal that an individual
treatment session would have no physician work and supported the
proposed direct PE inputs. However, the commenter stated that future
coding solutions may be necessary to recognize management of these
services that is additional to that captured by E/M coding.
Response: We appreciate the feedback from the commenter, and we
will consider this information for future rulemaking.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0166 as proposed.
(63) Wound Closure by Adhesive (HCPCS Code G0168)
HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only)
was identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, the RUC recommended a
work RVU of 0.45 based on maintaining the current work RVU.
We disagreed with the recommended value and we proposed a work RVU
of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code
93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single,
dual, or multiple lead pacemaker system, includes recording with and
without magnet application with analysis, review and report(s) by a
physician or other qualified health care professional, up to 90 days).
CPT code 93293 is a recently-reviewed code with the same 5 minutes of
intraservice time and 1 fewer minute of total time. In reviewing HCPCS
code G0168, the recommendations stated that the work involved in the
service had not changed even though the surveyed intraservice time was
decreasing by 50 percent, from 10 minutes to 5 minutes. Although we did
not imply that the decrease in time as reflected in survey values must
equate to a one-to-one or linear decrease in the valuation of work
RVUs, we believe that since the two components of work are time and
intensity, significant decreases in time should be reflected in
decreases to work RVUs. In the case of HCPCS code G0168, we believe
that it would be more accurate to propose a work RVU of 0.31 based on
[[Page 59579]]
the aforementioned crosswalk to CPT code 93293 to account for these
decreases in the surveyed work time. Maintaining the current work RVU
of 0.45 despite a 50 percent decrease in the surveyed intraservice time
would result in a significant increase in the intensity of HCPCS code
G0168, and we have no reason to believe that the procedure has
increased in intensity since the last time that it was valued.
For the direct PE inputs, we proposed to refine the equipment times
in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0168.
Comment: Many commenters disagreed with the proposed work RVU of
0.31 for HCPCS code G0168 and stated that CMS should finalize the
HCPAC-recommended work RVU of 0.45. Commenters stated that CMS should
not compare the valid survey time to the current work time because the
initial CMS/Other source data is flawed and maintains zero validity for
comparison. Commenters stated that surveyed time was never obtained
from physicians who perform this service and should not be used as a
comparison.
Response: We agree that it is important to use the most recent data
available regarding time, and we note that when many years have passed
between when time is measured, significant discrepancies can occur.
However, we also believe that our operating assumption regarding the
validity of the existing values as a point of comparison is critical to
the integrity of the relative value system as currently constructed.
The times currently associated with codes play a very important element
in PFS ratesetting, both as points of comparison in establishing work
RVUs and in the allocation of indirect PE RVUs by specialty. If we were
to operate under the assumption that previously recommended work times
had routinely been overestimated, this would undermine the relativity
of the work RVUs on the PFS in general, given the process under which
codes are often valued by comparisons to codes with similar times and
it undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS. Instead, we believe that it is
crucial that the code valuation process take place with the
understanding that the existing work times, used in the PFS ratesetting
processes, are accurate. We recognize that adjusting work RVUs for
changes in time is not always a straightforward process and that the
intensity associated with changes in time is not necessarily always
linear, which is why we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we believe it would be irresponsible to ignore changes
in time based on the best data available and that we are statutorily
obligated to consider both time and intensity in establishing work RVUs
for PFS services. For additional information regarding the use of old
work time values in our methodology, we refer readers to our discussion
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
Comment: Several commenters stated that HCPCS code G0168 should not
be crosswalked to CPT code 93293, as this is an evaluation of pacemaker
strips over a 90 day period. Commenters stated that the skill of
closing a facial laceration, typically near the eye, using a surgical
tissue adhesive for HCPCS code G0168 is more intense and complex to
perform than CPT code 93293 and thus should be valued higher.
Commenters stated that CPT code 51702 (Insertion of temporary
indwelling bladder catheter; simple (e.g., Foley)) would be a better
reference service.
Response: We disagree with the commenters that CPT code 93293 would
be an inappropriate choice for a crosswalk. CPT code 93293 describes a
transtelephonic rhythm strip pacemaker evaluation(s) for a single,
dual, or multiple lead pacemaker system. We do not agree that this
crosswalk code has lower intensity or complexity due to the cognitive
work involved in evaluating the patient correctly. Both CPT code 93293
and HCPCS code G0168 require skill on the part of the practitioner,
only of different types. We also believe that our crosswalk to CPT code
92393 is a more accurate choice because it has the same intraservice
work time (5 minutes) closely matches the total work time (13 minutes
as opposed to 14 minutes) of HCPCS code G0168. By contrast, CPT code
51702 has nearly double the total work time at 25 minutes, which
accounts for its higher work RVU of 0.50.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0168 as proposed.
(64) Removal of Impacted Cerumen (HCPCS Code G0268)
HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by
physician on same date of service as audiologic function testing) was
identified as potentially misvalued on a screen of 0-day global
services reported with an E/M visit 50 percent of the time or more, on
the same day of service by the same patient and the same practitioner,
that have not been reviewed in the last 5 years with Medicare
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
For the direct PE inputs, we proposed to remove the clinical labor
time for the ``Clean surgical instrument package'' (CA026) activity.
There is no surgical instrument pack included in the recommended
equipment for HCPCS code G0268, and this code already includes the
standard 3 minutes allocated for cleaning the room and equipment. In
addition, all of the instruments used in the procedure appear to be
disposable supplies that would not require cleaning since they would
only be used a single time.
The following is a summary of the public comments we received on
our proposals involving HCPCS code G0268.
Comment: Several commenters supported our proposal of the HCPAC-
recommended work RVU as well as the refinement to the direct PE inputs.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G0268 as proposed.
(65) Structured Assessment, Brief Intervention, and Referral to
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and
G2011)
In response to the Request for Information in the CY 2018 PFS
proposed rule (82 FR 34172), commenters requested that CMS pay
separately for assessment and referral related to substance use
disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two
G-codes to allow for appropriate Medicare reporting and payment for
alcohol and substance abuse assessment and intervention services that
are not provided as screening services, but that are performed in the
context of the diagnosis or treatment of illness or injury. The codes
are HCPCS code G0396 (Alcohol and/or substance (other than tobacco)
abuse structured assessment (e.g., AUDIT, DAST) and brief intervention,
15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance
(other than tobacco) abuse structured assessment (e.g., AUDIT, DAST)
and intervention greater than 30 minutes)). In 2008, we instructed
Medicare contractors to pay for these codes only when the services were
considered reasonable and necessary.
[[Page 59580]]
Given the ongoing opioid epidemic and the current needs of the
Medicare population, we expect that these services would often be
reasonable and necessary. However, the utilization for these services
is relatively low, which we believe is in part due to the service-
specific documentation requirements for these codes (the current
requirements are available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional
documentation requirements will also ease the administrative burden on
providers. Therefore, for CY 2019, we proposed to eliminate the
service-specific documentation requirements for HCPCS codes G0397 and
G0398. We welcomed comments on our proposal to change the documentation
requirements for these codes.
The following is a summary of the comments we received regarding
our proposal to change the documentation requirements for these codes.
Comment: The majority of commenters were supportive of this
proposal, some noting that this will ease administrative burden and
some noting that this will incentivize providers to deliver SBIRT
services, thereby increasing access to this service. One commenter
stated they believe that practitioners are not utilizing SBIRT for
illicit drug use due to the absence of conclusive evidence to support
use of this service for illicit drug use and therefore, support
removing the service documentation requirements for SBIRT when used to
screen for unhealthy alcohol use, but not when used to screen for
illicit drug use.
Response: We thank the commenters for their feedback. We note that
the services described by HCPCS codes G0397 and G0398 describe services
for alcohol and/or substance abuse; we believe it would be
administratively burdensome for practitioners were we to create varying
rules for different diagnoses. Additionally, it is our intention to
increase access to care for services that may be of use in addressing
all substance use disorders, especially in light of the ongoing opioid
epidemic. Therefore, we are finalizing our proposal to eliminate the
service-specific documentation requirements for HCPCS codes G0397 and
G0398.
Additionally, we proposed to create a third HCPCS code G2011with a
lower time threshold in order to accurately account for the resource
costs when practitioners furnish these services, but do not meet the
minimum time requirements of the existing codes. We note that in the
proposed rule we referred to this service as HCPCS code GSBR1, which
was a placeholder code. The code will be described as G2011: Alcohol
and/or substance (other than tobacco) abuse structured assessment
(e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We proposed
a work RVU of 0.33, based on the intraservice time ratio between HCPCS
codes G0396 and G0397. We welcomed comments on this code descriptor and
proposed valuation for HCPCS code G2011.
The following is a summary of the comments we received on this code
descriptor and proposed valuation for HCPCS code G2011.
Comment: Commenters were supportive of creating this code and the
valuation proposed, and noted the lower time threshold will allow
physicians the opportunity to provide brief counseling rather than 15
or more minutes of discussion, which requires extended interest from a
patient who may not yet be ready for prolonged discussion and/or is
receptive to being referred to another health care provider for
treatment. One commenter recommended finalizing guidance that allows
the newly proposed SBIRT HCPCS code to be used for alcohol, but not
illicit drug use.
Response: We thank the commenters for their feedback. After
considering these comments, we are finalizing the code descriptor and
valuation for HCPCS code G2011 as proposed. We believe the code
descriptor and guidance for this new SBIRT HCPCS code should be
consistent with the existing SBIRT HCPCS codes. For future rulemaking
we would consider recommendations on how to refine this family of codes
under our standard process of reviewing codes.
(66) Prolonged Services (HCPCS Code GPRO1)
CPT codes 99354 (Prolonged evaluation and management or
psychotherapy service(s) (beyond the typical service time of the
primary procedure) in the office or other outpatient setting requiring
direct patient contact beyond the usual service; first hour (List
separately in addition to code for office or other outpatient
Evaluation and Management or psychotherapy service)) and 99355
(Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; each additional 30 minutes (List separately
in addition to code for prolonged service)) describe additional time
spent face-to-face with a patient. Stakeholders have shared with us
that the threshold of 60 minutes for CPT code 99354 is difficult to
meet and is an impediment to billing these codes. In response to
stakeholder feedback and as part of our proposal as discussed in
section II.I. of this final rule, Evaluation and Management Services,
to implement a single PFS rate for E/M visit levels 2-5 while
maintaining payment stability across the specialties, we proposed HCPCS
code GPRO1 (Prolonged evaluation and management or psychotherapy
service(s) (beyond the typical service time of the primary procedure)
in the office or other outpatient setting requiring direct patient
contact beyond the usual service; 30 minutes (List separately in
addition to code for office or other outpatient Evaluation and
Management or psychotherapy service)), which could be billed with any
level of E/M code. We noted that we did not propose to make any changes
to CPT codes 99354 and 99355, which can still be billed, as needed,
when their time thresholds and all other requirements are met. We
proposed a work RVU of 1.17, which is equal to half of the work RVU
assigned to CPT code 99354. Additionally, we proposed direct PE inputs
for HCPCS code GPRO1 that are equal to one half of the values assigned
to CPT code 99354, which can be found in the Direct PE Inputs public
use file for this final rule.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals, we did not receive many comments with
specific suggestions on valuation for HCPCS code GPRO1. Of the
commenters that supported creation of the code, most supported the
proposed valuation while others, while supporting the creation of a 30-
minute prolonged services code in principle, encouraged CMS to wait for
recommendations from the CPT Editorial Panel and the RUC.
Response: For CY 2021, we are finalizing the proposed add-on code
for HCPCS code GPRO1 using the input values, as proposed. We note that
prior to implementation for 2021, we could consider, through
rulemaking, the code and its valuation in the context of any potential
changes to CPT codes and/or recommendations offered by stakeholders,
including the RUC, as part of our annual process for valuing PFS
services. See section II.I. of this final rule for further discussion
of the E/M policy.
[[Page 59581]]
(67) Remote Pre-Recorded Services (HCPCS Code G2010)
For CY 2019, we proposed to make separate payment for remote
evaluation services when a physician uses pre-recorded video and/or
images submitted by a patient in order to evaluate a patient's
condition through new HCPCS G-code G2010 (Remote evaluation of recorded
video and/or images submitted by the patient (e.g., store and forward),
including interpretation with verbal follow-up with the patient within
24 business hours, not originating from a related E/M service provided
within the previous 7 days nor leading to an E/M service or procedure
within the next 24 hours or soonest available appointment). We proposed
to value this service by a direct crosswalk to CPT code 93793
(Anticoagulant management for a patient taking warfarin, must include
review and interpretation of a new home, office, or lab international
normalized ratio (INR) test result, patient instructions, dosage
adjustment (as needed), and scheduling of additional test(s), when
performed), as we believe the work described is similar in kind and
intensity to the work performed as part of HCPCS code G2010. Therefore,
we proposed a work RVU of 0.18, preservice time of 3 minutes,
intraservice time of 4 minutes, and post service time of 2 minutes. We
also proposed to add 6 minutes of clinical labor (L037D) in the service
period. We solicited comment on the code descriptor and valuation for
HCPCS code G2010. We direct readers to section II.D. of this final
rule, which includes additional detail regarding our proposed policies
for modernizing Medicare physician payment by recognizing communication
technology-based services.
The following is a summary of the comments we received on the code
descriptor and valuation for HCPCS code G2010.
Comment: Several commenters stated that the proposed payment rate
is too low, citing that it is below market compared to the rate many
asynchronous telemedicine companies pay their contracted/employed
physician staff, and noted that new patients in particular require more
resources, whereas others stated that the proposed valuation was
appropriate.
Response: We believe that the proposed valuation accurately
reflects the resources involved in furnishing this service and note
that we are finalizing limiting this service to established patients.
We also note that we plan to monitor the utilization of this code and
routinely address recommended changes in values for codes paid under
the PFS.
After considering the public comments, we are finalizing the work
RVU and direct PE inputs for HCPCS code G2010 as proposed.
(68) Brief Communication Technology-Based Service, e.g. Virtual Check-
In (HCPCS Code G2012)
We proposed to create a G-code, HCPCS code G2012 (Brief
communication technology based service, e.g. virtual check-in, by a
physician or other qualified health care professional who may report
evaluation and management services provided to an established patient,
not originating from a related E/M service provided within the previous
7 days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion) to facilitate payment for these brief communication
technology-based services. We proposed to base the code descriptor and
valuation for HCPCS code G2012 on existing CPT code 99441 (Telephone
evaluation and management service by a physician or other qualified
health care professional who may report evaluation and management
services provided to an established patient, parent, or guardian not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion), which is currently not separately payable under the PFS.
As CPT code 99441 only describes telephone calls, we are proposing to
create a new HCPCS code G2012 to encompass a broader array of
communication modalities. We do, however, believe that the resource
assumptions for CPT code 99441 would accurately account for the costs
associated with providing the proposed virtual check-in service,
regardless of the technology. We proposed a work RVU of 0.25, based on
a direct crosswalk to CPT code 99441. For the direct PE inputs for
HCPCS code G2012, we also proposed the direct PE inputs assigned to CPT
code 99441. Given the breadth of technologies that could be described
as telecommunications, we anticipated receiving public comments and
working with the CPT Editorial Panel and the RUC to evaluate whether
separate coding and payment is needed to account for differentiation
between communication modalities. We solicited comment on the code
descriptor, as well as the proposed valuation for HCPCS code G2012. We
direct readers to section II.D. of this final rule, which includes
additional detail regarding our proposed policies for modernizing
Medicare physician payment by recognizing communication technology-
based services.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code G2012.
Comment: Several commenters stated that the proposed payment rate
would be inadequate for modalities that are both audio and visual
capable, whereas other commenters stated that the proposed valuation
was appropriate.
Response: We appreciate the input provided by the commenters. As
noted in section II.D. of this final rule, we are finalizing the
valuation for this service as proposed. We note that we are finalizing
allowing audio-only real-time telephone interactions in addition to
synchronous, two-way audio interactions that are enhanced with video or
other kinds of data transmission. We believe the proposed valuation
reflects the low work time and intensity and accounts for the resource
costs and efficiencies associated with the use of communication
technology. We recognize that the valuation of this service is
relatively modest, especially compared to in-person services, however,
we believe that the proposed valuation accurately reflects the
resources involved in furnishing this service.
We plan to monitor the utilization of this code and note that we
routinely address recommended changes in values for codes paid under
the PFS and would expect to do this in future rulemaking.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HCPCS code G2012 as proposed.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code
GCG0X)
We proposed to create a HCPCS G-code to be reported with an E/M
service to describe the additional resource costs for specialties for
whom E/M visit codes make up a large percentage of their total allowed
charges and who we believe primarily bill level 4 and level 5 visits.
The treatment approaches for these specialties generally do not have
separate coding and are generally reported using the E/M visit codes.
We proposed to create HCPCS code, GCG0X (Visit complexity inherent to
evaluation and management associated with endocrinology, rheumatology,
hematology/oncology, urology, neurology, obstetrics/gynecology,
allergy/immunology, otolaryngology, or
[[Page 59582]]
interventional pain management-centered care (Add-on code, list
separately in addition to an evaluation and management visit)). We
proposed a valuation for HCPCS code GCG0X based on a crosswalk to 75
percent of the work RVU and time of CPT code 90785 (Interactive
complexity), which would result in a proposed work RVU of 0.25 and a
physician time of 8.25 minutes for HCPCS code GCG0X. CPT code 90785 has
no direct PE inputs. Interactive complexity is an add-on code that may
be billed when a psychotherapy or psychiatric service requires more
work due to the complexity of the patient. We believe that this work
RVU and physician time would be an accurate representation of the
additional work associated with the higher level complex visits. For
further discussion of proposals relating to this code, see section
II.I. of this final rule. We solicited comment on the code descriptor,
as well as the proposed valuation for HCPCS code GCG0X.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code GCG0X.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals, we did not receive comments with specific
suggestions on valuation for HCPCS code GCG0X.
Response: For CY 2021, we are finalizing the proposed add-on code
for visit complexity inherent to non-procedural specialty care using
the input values, as proposed. We note that prior to implementation for
CY 2021, we could consider, through rulemaking, the code and its
valuation in the context of any potential changes to CPT codes and/or
recommendations offered by stakeholders, including the RUC, as part of
our annual process for valuing PFS services. See section II.I. of this
final rule for further discussion of the E/M policy.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code
GPC1X)
We proposed to create a HCPCS G-code for primary care services,
GPC1X (Visit complexity inherent to evaluation and management
associated with primary medical care services that serve as the
continuing focal point for all needed health care services (Add-on
code, list separately in addition to an evaluation and management
visit)). This code describes furnishing a visit to a new or existing
patient, and can include aspects of care management, counseling, or
treatment of acute or chronic conditions not accounted for by other
coding. HCPCS code GPC1X would be billed in addition to the E/M visit
code when the visit involved primary care-focused services. We proposed
a work RVU of 0.07, physician time of 1.75 minutes. This proposed
valuation accounts for the additional work resource costs associated
with furnishing primary care that distinguishes E/M primary care visits
from other types of E/M visits and maintains work budget neutrality
across the office/outpatient E/M code set. For further discussion of
proposals relating to this code, see section II.I. of this final rule.
We solicited comment on the code descriptor, as well as the proposed
valuation for HCPCS code GPC1X.
The following is a summary of the comments we received on the code
descriptor, as well as the proposed valuation for HCPCS code GPC1X.
Comment: We received a few comments suggesting that the primary
care add-on was undervalued, particularly in comparison to the add-on
code for specialty visit complexity. A few commenters suggested that,
at the very least, we should equalize the value for these codes.
Response: We agree that the proposed inputs do not reflect the
resources associated with furnishing primary care visits. For CY 2021,
we are finalizing the proposed add-on code for visit complexity
inherent to primary care using the inputs associated with HCPCS code
GCG1X: A work RVU of 0.25 and a physician time of 8.25 minutes. We note
that prior to implementation for 2021, we could consider, through
rulemaking, the code and its valuation in the context of any potential
changes to CPT codes and/or recommendations offered by stakeholders,
including the RUC, as part of our annual process for valuing PFS
services. See section II.I. of this final rule for further discussion
of the E/M policy.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X
and GPD1X)
We proposed to create two HCPCS G-codes, HCPCS codes GPD0X
(Podiatry services, medical examination and evaluation with initiation
of diagnostic and treatment program, new patient) and GPD1X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, established patient), to describe
podiatric evaluation and management services. We proposed a work RVU of
1.36, a physician time of 28.19 minutes, and direct costs summing to
$21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of
21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X.
These values are based on the average rate for CPT codes 99201-99203
and CPT codes 99211-99212 respectively, weighted by podiatric volume.
For further discussion of proposals relating to these codes, see
section II.I. of this final rule.
Comment: As almost all commenters did not support the overall E/M
coding and payment proposals and these codes specifically, we did not
receive comments with specific suggestions on valuation.
Response: In response to comments, we are not finalizing HCPCS
codes GPD0X and GPD1X for CY 2019. See section X of this final rule for
further discussion of the E/M policy.
(72) Comment Solicitation on Superficial Radiation Treatment Planning
and Management
In the CY 2015 PFS final rule with comment period (79 FR 67666
through 67667), we noted that changes to the CPT prefatory language
limited the codes that could be reported when describing services
associated with superficial radiation treatment (SRT) delivery,
described by CPT code 77401 (radiation treatment delivery, superficial
and/or ortho voltage, per day). The changes effectively meant that many
other related services were bundled with CPT code 77401, instead of
being separately reported. For example, CPT guidance clarified that
certain codes used to describe clinical treatment planning, treatment
devices, isodose planning, physics consultation, and radiation
treatment management cannot be reported when furnished in association
with SRT. Stakeholders informed us that these changes to the CPT
prefatory language prevented them from billing Medicare for codes that
were previously frequently billed with CPT code 77401. We solicited
comments as to whether the revised bundled coding for SRT allowed for
accurate reporting of the associated services. In the CY 2016 PFS final
rule with comment period (80 FR 70955), we noted that the RUC did not
review the inputs for SRT procedures, and therefore, did not assess
whether changes in valuation were appropriate in light of the bundling
of associated services. In addition, we solicited recommendations from
stakeholders regarding whether it would be appropriate to add physician
work for this service, even though physician work is not included in
other radiation treatment services. In the CY 2018 PFS proposed rule
(82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted
that the 2016 National Correct
[[Page 59583]]
Coding Initiative (NCCI) Policy Manual for Medicare Services states
that radiation oncology services may not be separately reported with E/
M codes. While this NCCI edit is no longer active stakeholders have
stated that MACs have denied claims for E/M services associated with
SRT based on the NCCI policy manual language. According to
stakeholders, the bundling of SRT with associated services, as well as
coding confusion regarding the appropriate use of E/M coding to report
associated physician work, meant that practitioners were not being paid
appropriately for planning and treatment management associated with
furnishing SRT. Due to these concerns regarding reporting of services
associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012
through 34013), we proposed to make separate payment for the
professional planning and management associated with SRT using HCPCS
code GRRR1 (Superficial radiation treatment planning and management
related services, including but not limited to, when performed,
clinical treatment planning (for example, 77261, 77262, 77263),
therapeutic radiology simulation-aided field setting (for example,
77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for
example, 77300), treatment devices (for example, 77332, 77333, 77334),
isodose planning (for example, 77306, 77307, 77316, 77317, 77318),
radiation treatment management (for example, 77427, 77431, 77432,
77435, 77469, 77470, 77499), and associated E/M per course of
treatment). We proposed that this code would describe the range of
professional services associated with a course of SRT, including
services similar to those not otherwise separately reportable under CPT
guidance. Furthermore, we proposed that this code would have included
several inputs associated with related professional services such as
treatment planning, treatment devices, and treatment management. Many
commenters did not support our proposal to make separate payment for
HCPCS code GRRR1 for CY 2018, stating that our proposed valuation of
HCPCS code GRRR1 would represent a significant payment reduction for
the associated services as compared with the list of services that they
could previously bill in association with SRT. Commenters voiced
concern that the proposed coding would inhibit access to care and
discourage the use of SRT as a non-surgical alternative to Mohs
surgery. We received comments recommending a variety of potential
coding solutions but without a consistent preferred alternative. In the
CY 2018 PFS final rule (82 FR 53081-53083), we solicited further
comment, and stated that we would continue our dialogue with
stakeholders to address appropriate coding and payment for professional
services associated with SRT.
Given stakeholder feedback that we have continued to receive
following the publication of the CY 2018 PFS final rule, we continue to
believe that there are potential coding gaps for SRT-related
professional services. We generally rely on the CPT process to
determine coding specificity, and we believe that deferring to this
process in addressing potential coding gaps is generally preferable. As
our previous attempt at designing a coding solution in the CY 2018 PFS
proposed rule did not gain stakeholder consensus, and given that there
were various, in some cases diverging, suggestions on a coding solution
from stakeholders, we did not propose changes relating to SRT coding,
SRT-related professional codes, or payment policies for CY 2019.
However, we solicited comment on the possibility of creating multiple
G-codes specific to services associated with SRT, as was suggested by
one stakeholder following the CY 2018 PFS final rule. These codes would
be used separately to report services including SRT planning, initial
patient simulation visit, treatment device design and construction
associated with SRT, SRT management, and medical physics consultation.
We solicited comment on whether we should create such G-codes to
separately report each of the services described previously, mirroring
the coding of other types of radiation treatment delivery. For
instance, HCPCS code G6003 (Radiation treatment delivery, single
treatment area, single port or parallel opposed ports, simple blocks or
no blocks: Up to 5 mev) is used to report radiation treatment delivery,
while associated professional services are billed with codes such as
CPT codes 77427 (Radiation treatment management, 5 treatments), 77261
(Therapeutic radiology treatment planning; simple), 77332 (Treatment
devices, design and construction; simple (simple block, simple bolus),
and 77300 (Basic radiation dosimetry calculation, central axis depth
dose calculation, TDF, NSD, gap calculation, off axis factor, tissue
inhomogeneity factors, calculation of non-ionizing radiation surface
and depth dose, as required during course of treatment, only when
prescribed by the treating physician).
We stated that we consider contractor pricing such codes for CY
2019 because we believe that the preferable method to develop new
coding is with multi-specialty input through the CPT and RUC process,
and we prefer to defer nationally pricing such codes pending input from
the CPT Editorial Panel and the RUC process to assist in determining
the appropriate level of coding specificity for SRT-related
professional services. Based on stakeholder feedback, we continue to
believe there may be a coding gap for these services, and therefore, we
solicited comment on whether we should create these G-codes and allow
them to be contractor priced for CY 2019. This would be an interim
approach for addressing the potential coding gap until the CPT
Editorial Panel and the RUC can address coding for SRT and SRT-related
professional services, giving the CPT Editorial Panel and the RUC an
opportunity to develop a coding solution that could be addressed in
future rulemaking.
The following is a summary of the comments we received on the
possibility of creating multiple G-codes specific to services
associated with SRT, which could be used separately to report services
including SRT planning, initial patient simulation visit, treatment
device design and construction associated with SRT, SRT management, and
medical physics consultation, which would be contractor priced for CY
2019.
Comment: Many commenters urged CMS to make appropriate payment for
SRT-related services, stating that it is a vital non-surgical
alternative treatment for skin cancer. Many commenters also said that
coding should recognize newer generation, Image Guided Superficial
Radiation (IGSRT), stating that IGSRT is the most advanced form of this
technology, and has far better outcomes compared to those achieved with
SRT.
Some commenters recommended implementation of G-codes for SRT-
related professional services, and they submitted alternative G-code
scenarios that they believe would be preferable to adopting contractor-
priced G-codes. These scenarios include one in which there would be one
code for SRT-related treatment planning, with a value based on a
crosswalk to CPT code 77261 (Therapeutic radiology treatment planning;
simple), a code for SRT treatment device construction, with a value
based on a crosswalk to CPT code 77332 (Treatment devices, design and
construction; simple (simple block, simple bolus), and a code for SRT
treatment management billed once per treatment, valued with a crosswalk
to CPT code 99213 (Office or other outpatient visit for the evaluation
and management of an established patient,
[[Page 59584]]
which requires at least 2 of these 3 key components: An expanded
problem focused history; An expanded problem focused examination;
Medical decision making of low complexity. Counseling and coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of low to moderate severity. Typically, 15
minutes are spent face-to-face with the patient and/or family.).
According to this commenter, image guidance and tracking should not be
billed with superficial treatments. Another commenter suggested a
single code bundling SRT-related treatment management with SRT-related
device construction as well as a code for SRT-related radiation
treatment management, and a code representing treatment for multiple
lesions. This commenter also urged us to either revalue CPT code 77401
or to create an additional G-code billable with CPT code 77401 to
represent professional services associated with SRT. Another commenter
suggested a code for SRT-related radiology treatment planning, and an
SRT management code including five treatments. A commenter suggested a
coding structure that recognizes Image-Guided Superficial Radiation
Therapy as a newer generation of SRT, and would consist of CPT code
77401 for practitioners that utilize the SRT technologies; relying on
human visualization for lesion(s) simulation, treatment and tracking,
and a new G-code for providers who provide the newer generation
technology relying on image-guided lesion simulation, treatment and
tracking per fraction with Record and Verify precision tracking of
treatment progress.
A commenter stated that any codes utilized as part of superficial
radiation treatment delivery that include medical physics time should
require that a qualified medical physicist perform the physics work.
A commenter stated that adopting contractor-priced G codes would be
appropriate. Some other commenters, however, did not support our
suggested adoption of contractor-priced codes. According to these
commenters, we are correct in our belief that there are coding gaps in
the current reimbursement structure, however a fuller evaluation that
does not defer to Medicare contractors in determining reimbursement
rates is appropriate. According to a commenter, contractor pricing
creates unnecessary work for the Medicare Administrative Contractors
and can also lead to wide variances in the valuing of codes across
jurisdictions. Commenters expressed preference that coding for these
services be developed through the CPT and RUC processes. Many
commenters urged us not to change coding for CY 2019 for these
services.
Response: We expect to take these comments into consideration for
future rulemaking and we hope to continue a dialogue with stakeholders
on these important services. We reiterate that we believe multi-
specialty input through the CPT and RUC processes is the ideal way to
develop coding specificity and evaluation, and we are not making any
changes to payment policy based on this comment solicitation. In the
interim, we refer readers to CPT guidance that states that CPT code
77401, when performed, may be reported with appropriate E/M codes, and
this is the appropriate way to currently report professional work
associated with SRT. Going forward, we will attempt to determine
whether MACs are inappropriately denying billing of E/M codes with CPT
code 77401, and we will instruct MACs accordingly.
(73) Adaptive Behavior Analysis Services
We note that we intended to assign a contractor price status in the
Addendum B file of the proposed rule for the following CPT codes that
describe adaptive behavior analysis services: CPT codes 97151, 97152,
97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly
contractor priced Category III CPT codes that were converted to
Category I for CY 2019. We inadvertently excluded these codes in the
Addendum B file of the proposed rule, and have updated the Addendum B
file for this final rule.
BILLING CODE 4120-01-P
[[Page 59585]]
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[[Page 59586]]
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[[Page 59593]]
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[[Page 59594]]
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[[Page 59599]]
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[[Page 59601]]
[GRAPHIC] [TIFF OMITTED] TR23NO18.016
[[Page 59602]]
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[[Page 59603]]
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[[Page 59622]]
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[[Page 59623]]
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[[Page 59624]]
Table 15--CY 2019 Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
non-
facility
Current Updated Percent Number of allowed
CPT/HCPCS codes Item name CMS code price price change invoices services
for HCPCS
codes using
this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
53850..................................... kit, transurethral SA036 1,149.00 1,000.00 -13 1 5,608
microwave thermotherapy.
53852..................................... kit, transurethral needle SA037 1,050.00 900.00 -14 2 2,476
ablation (TUNA).
85097..................................... stain, Wright's Pack (per SL140 0.05 0.16 235 1 43,183
slide).
96116, 96118, 96119, 96125................ neurobehavioral status SK050 5.77 4.00 -31 3 414,139
forms, average.
258 codes................................. scope video system ES031 33,391.00 36,306.00 9 ......... 2,480,515
(monitor, processor,
digital capture, cart,
printer, LED light).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 16--CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of NF Allowed
CPT/HCPCS codes Item name CMS code Average price invoices services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10011, 10012............................. MREYE Chiba Biopsy Needle... SC106 37.00 1 0
33285.................................... subcutaneous cardiac rhythm SA127 5,032.50 4 280
monitor system.
36572, 36573, 36584...................... Turbo-Ject PICC Line........ SD331 170.00 1 24,402
53854.................................... kit, Rezum delivery device.. SA128 1,150.00 1 121
53854.................................... generator, water EQ389 27,538.00 10 121
thermotherapy procedure.
58100.................................... Uterine Sound............... SD329 3.17 1 59,152
58100.................................... Tenaculum................... SD330 3.77 1 59,152
76391.................................... MR Elastography Package..... EL050 200,684.50 1 350
76978, 76979............................. bubble contrast............. SD332 126.59 1 89
76978, 76979............................. Ultrasound Contrast Imaging ER108 5,760.00 1 89
Package.
76981, 76982, 76983...................... sheer wave elastography ED060 9,600.00 1 493
software.
77048, 77049............................. CAD Software................ ED058 43,308.12 1 36,675
77046, 77047, 77048, 77049............... Breast coil................. EQ388 83,200.00 1 39,785
77048, 77049............................. CAD Workstation (CPU + Color ED056 12,031.52 1 36,675
Monitor).
85097.................................... slide stainer, automated, EP121 8,649.43 1 34,559
hematology.
92273.................................... Sleep mask.................. SK133 9.95 1 10,266
92273, 92274............................. mfERG and ffERG EQ390 102,400.00 1 25,602
electrodiagnostic unit.
92273, 92274............................. Contact lens electrode for EQ391 1,440.00 1 25,602
mfERG and ffERG.
96136, 96137, 96138, 96139............... WAIS-IV Record Form......... SK130 5.25 1 301,452
96136, 96137, 96138, 96139............... WAIS-IV Response Booklet #1. SK131 3.30 1 301,452
96136, 96137, 96138, 96139............... WMS-IV Response Booklet #2.. SK132 2.00 1 301,452
96136, 96137, 96138, 96139............... Wechsler Adult Intelligence EQ387 971.30 1 301,452
Scale--Fourth Edition (WAIS-
IV) Kit (less forms).
99454.................................... heart failure patient EQ392 1,000.00 1 58
physiologic monitoring
equipment package.
G0109.................................... 20x30 inch self-stick easel SK129 0.00 0 93,576
pad, white, 30 sheets/pad.
none..................................... needle holder, Mayo Hegar, SC105 3.03 1 0
6''.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 17--CY 2019 No PE Refinements
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
10004............................. Fna bx w/o img gdn ea addl.
10006............................. Fna bx w/us gdn ea addl.
10008............................. Fna bx w/fluor gdn ea addl.
10010............................. Fna bx w/ct gdn ea addl.
10011............................. Fna bx w/mr gdn 1st les.
10012............................. Fna bx w/mr gdn ea addl.
11103............................. Tangntl bx skin ea sep/addl.
11105............................. Punch bx skin ea sep/addl.
11107............................. Incal bx skn ea sep/addl.
33274............................. Tcat insj/rpl perm ldls pm.
33275............................. Tcat rmvl perm ldls pm.
33285............................. Insj subq car rhythm mntr.
33286............................. Rmvl subq car rhythm mntr.
33289............................. Tcat impl wrls p-art prs snr.
36568............................. Insj picc <5 yr w/o imaging.
36569............................. Insj picc 5 yr+ w/o imaging.
36572............................. Insj picc rs&i <5 yr.
36573............................. Insj picc rs&i 5 yr+.
36584............................. Compl rplcmt picc rs&i.
38531............................. Open bx/exc inguinofem nodes.
49422............................. Remove tunneled ip cath.
50436............................. Dilat xst trc ndurlgc px.
50437............................. Dilat xst trc new access rcs.
53850............................. Prostatic microwave thermotx.
53852............................. Prostatic rf thermotx.
53854............................. Trurl dstrj prst8 tiss rf wv.
57150............................. Treat vagina infection.
57160............................. Insert pessary/other device.
58110............................. Bx done w/colposcopy add-on.
65205............................. Remove foreign body from eye.
65210............................. Remove foreign body from eye.
67500............................. Inject/treat eye socket
67505............................. Inject/treat eye socket.
67515............................. Inject/treat eye socket.
74485............................. Dilation urtr/urt rs&i.
76514............................. Echo exam of eye thickness.
[[Page 59625]]
76942............................. Echo guide for biopsy.
76981............................. Use parenchyma.
76982............................. Use 1st target lesion.
76983............................. Use ea addl. target lesion.
77081............................. Dxa bone density/peripheral.
93264............................. Rem mntr wrls p-art prs snr.
93668............................. Peripheral vascular rehab.
95800............................. Slp stdy unattended.
95801............................. Slp stdy unatnd w/anal.
95806............................. Sleep study unatt&resp efft.
95836............................. Ecog impltd brn npgt <30 d.
95970............................. Alys npgt w/o prgrmg.
95976............................. Alys smpl cn npgt prgrmg.
95977............................. Alys cplx cn npgt prgrmg.
95983............................. Alys brn npgt prgrmg 15 min.
95984............................. Alys brn npgt prgrmg addl 15.
96105............................. Assessment of aphasia.
96110............................. Developmental screen w/score.
96112............................. Devel tst phys/qhp 1st hr.
96113............................. Devel tst phys/qhp ea addl.
96116............................. Neurobehavioral status exam.
96121............................. Nubhvl xm phy/qhp ea addl hr.
96125............................. Cognitive test by hc pro.
96127............................. Brief emotional/behav assmt.
96130............................. Psycl tst eval phys/qhp 1st.
96131............................. Psycl tst eval phys/qhp ea.
99453............................. Rem mntr physiol param setup.
99457............................. Rem physiol mntr 20 min mo.
99491............................. Chrnc care mgmt svc 30 min.
G0166............................. Extrnl counterpulse, per tx.
------------------------------------------------------------------------
I. Evaluation & Management (E/M) Visits
1. Background
a. E/M Visits Coding Structure
Physicians and other practitioners paid under the PFS bill for
common office visits for evaluation and management (E/M) services under
a relatively generic set of CPT codes (Level I HCPCS codes) that
distinguish visits based on the level of complexity, site of service,
and whether the patient is new or established. The CPT codes have three
key components:
History of Present Illness (History),
Physical Examination (Exam) and
Medical Decision Making (MDM).
These codes are broadly referred to as E/M visit codes. There are
three to five E/M visit code levels, depending on site of service and
the extent of the three components of history, exam and MDM. For
example, there are three to four levels of E/M visit codes in the
inpatient hospital and nursing facility settings, based on a relatively
narrow degree of complexity in those settings. In contrast, there are
five levels of E/M visit codes in the office or other outpatient
setting based on a broader range of complexity in those settings.
Current PFS payment rates for E/M visit codes increase with the
level of visit billed. As for all services under the PFS, the rates are
based on the resources in terms of work (time and intensity), PE and
malpractice expense required to furnish the typical case of the
service. The current payment rates reflect typical service times for
each code that are based on RUC recommendations.
In total, E/M visits comprise approximately 40 percent of allowed
charges for PFS services, and office/outpatient E/M visits comprise
approximately 20 percent of allowed charges for PFS services. Within
these percentages, there is significant variation among specialties.
According to Medicare claims data, E/M visits are furnished by nearly
all specialties, but represent a greater share of total allowed
services for physicians and other practitioners who do not routinely
furnish procedural interventions or diagnostic tests. Generally, these
practitioners include both primary care practitioners and specialists
such as neurologists, endocrinologists and rheumatologists. Certain
specialties, such as podiatry, tend to furnish lower level E/M visits
more often than higher level E/M visits. Some specialties, such as
dermatology and otolaryngology, tend to bill more E/M visits on the
same day as they bill minor procedures.
Potential misvaluation of E/M codes is an issue that we have been
carefully considering for several years. We have discussed at length in
our recent PFS proposed and final rules that the E/M visit code set is
outdated and needs to be revised and revalued (for example: 81 FR 46200
and 76 FR 42793). We have noted that this code set represents a high
proportion of PFS expenditures, but has not been recently revalued to
account for significant changes in the disease burden of the Medicare
patient population and changes in health care practice that are
underway to meet the Medicare population's health care needs (81 FR
46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M
codes to the RUC for review as potentially misvalued (76 FR 42793).
Many commenters to that rule were concerned about the possible
inadequacies of the current E/M coding and documentation structure to
address evolving chronic care management and to support primary care
(76 FR 73060 through 73064). We did not finalize our proposal to refer
the E/M codes for RUC review at that time. Instead, we stated that we
would allow time for consideration of the findings of certain
demonstrations and other initiatives to provide improved information
for the valuation of chronic care management, primary care, and care
transitions. We stated that we would also continue to consider the
numerous policy alternatives that commenters offered, such as separate
E/M codes for established visits for patients with chronic disease
versus a post-surgical follow-up office visit.
Many stakeholders continue to similarly express to us through
letters, meetings, public comments in past rulemaking cycles, and other
avenues, that the E/M code set is outdated and needs to be revised. For
example, some stakeholders recommend an extensive research effort to
revise and revalue E/M services, especially physician work inputs (CY
2017 PFS final rule, 81 FR 80227-80228). In recent years, we have
continued to consider the best ways to recognize the significant
changes in health care practice, especially innovations in the active
management and ongoing care of chronically ill patients, under the PFS.
We have been engaged in an ongoing, incremental effort to identify gaps
in appropriate coding and payment.
b. E/M Documentation Guidelines
For coding and billing E/M visits to Medicare, practitioners may
use one of two versions of the E/M Documentation Guidelines for a
patient encounter, commonly referenced based on the year of their
release: the ``1995'' or ``1997'' E/M Documentation Guidelines. These
guidelines are available on the CMS website.\3\ They specify the
medical record information within each of the three key components
(such as number of body systems reviewed) that serves as support for
billing a given level of E/M visit. The 1995 and 1997 guidelines are
very similar to the guidelines that reside within the AMA's CPT
codebook for E/M visits. For example, the core structure of what
comprises or defines the different levels of history, exam, and medical
decision-making are the same. However, the 1995 and 1997 guidelines
include extensive examples of clinical work that comprise different
levels of medical decision-making and do not appear in the AMA's CPT
codebook. Also, the 1995 and 1997 guidelines do not contain references
to preventive care that appear in the AMA's CPT codebook. We provide an
example of how the 1995 and 1997 guidelines distinguish between level 2
and level 3 E/M visits in Table 18.
---------------------------------------------------------------------------
\3\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf;
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
---------------------------------------------------------------------------
BILLING CODE 4120-01-P
[[Page 59626]]
[GRAPHIC] [TIFF OMITTED] TR23NO18.287
BILLING CODE 4120-01-C
According to both Medicare claims processing manual instructions
and CPT coding rules, when counseling and/or coordination of care
accounts for more than 50 percent of the face-to-face physician/patient
encounter (or, in the case of inpatient E/M services, the floor time)
the duration of the visit can be used as an alternative basis to select
the appropriate E/M visit level (Pub. L. 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management
Services Guidelines, page 10). Public Law 100-04, Medicare Claims
Processing Manual, Chapter 12, Section 30.6.1.B states, ``Instruct
physicians to select the code for the service based upon the content of
the service. The duration of the visit is an ancillary factor and does
not control the level of the service to be billed unless more than 50
percent of the face-to-face time (for non-inpatient services) or more
than 50 percent of the floor time (for inpatient services) is spent
providing counseling or coordination of care as described in subsection
C.'' Subsection C states that ``the physician may document time spent
with the patient in conjunction with the medical decision-making
involved and a description of the coordination of care or counseling
provided. Documentation must be in sufficient detail to support the
claim.'' The example included in subsection C further states, ``The
code selection is based on the total time of the face-to-face encounter
or floor time, not just the counseling time. The medical record must be
documented in sufficient detail
[[Page 59627]]
to justify the selection of the specific code if time is the basis for
selection of the code.''
Both the 1995 and 1997 E/M guidelines contain guidelines that
address time, which state that ``In the case where counseling and/or
coordination of care dominates (more than 50 percent of) the physician/
patient and/or family encounter (face-to-face time in the office or
other outpatient setting or floor/unit time in the hospital or nursing
facility), time is considered the key or controlling factor to qualify
for a particular level of E/M services.'' The guidelines go on to state
that ``If the physician elects to report the level of service based on
counseling and/or coordination of care, the total length of time of the
encounter (face-to-face or floor time, as appropriate) should be
documented and the record should describe the counseling and/or
activities to coordinate care.'' \4\
---------------------------------------------------------------------------
\4\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997
guidelines.
---------------------------------------------------------------------------
We note that other manual provisions regarding E/M visits that are
cited in this final rule are housed separately within Medicare's
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.
In accordance with section 1862(a)(1)(A) of the Act, which requires
services paid under Medicare Part B to be reasonable and necessary for
the diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member, medical necessity is a
prerequisite to Medicare payment for E/M visits. The Medicare Claims
Processing Manual states, ``Medical necessity of a service is the
overarching criterion for payment in addition to the individual
requirements of a CPT code. It would not be medically necessary or
appropriate to bill a higher level of evaluation and management service
when a lower level of service is warranted. The volume of documentation
should not be the primary influence upon which a specific level of
service is billed. Documentation should support the level of service
reported'' (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter
12, Section 30.6.1.A., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
Stakeholders have long maintained that all of the E/M documentation
guidelines are administratively burdensome and outdated with respect to
the practice of medicine. Stakeholders have provided CMS with examples
of such outdated material (on history, exam and MDM) that can be found
within all versions of the E/M guidelines (the AMA's CPT codebook, the
1995 guidelines and the 1997 guidelines). Stakeholders have told CMS
that they believe the guidelines are too complex, ambiguous, fail to
meaningfully distinguish differences among code levels, and are not
updated for changes in technology, especially electronic health record
(EHR) use. Prior attempts to revise the E/M guidelines were
unsuccessful or resulted in additional complexity due to lack of
stakeholder consensus (with widely varying views among specialties),
and differing perspectives on whether code revaluation would be
necessary under the PFS as a result of revising the guidelines, which
contributed another layer of complexity to the considerations. For
example, an early attempt to revise the guidelines resulted in an
additional version designed for use by certain specialties (the 1997
version), and in CMS allowing the use of either the 1995 or 1997
versions for purposes of documentation and billing to Medicare. Another
complication in revising the guidelines is that they are also used by
many other payers, which have their own payment rules and audit
protocols. Moreover, stakeholders have suggested that there is
sometimes variation in how Medicare's own contractors (Medicare
Administrative Contractors (MACs)) interpret and apply the guidelines
as part of their audit processes.
As previously mentioned, in recent years, some clinicians and other
stakeholders have requested a major CMS research initiative to overhaul
not only the E/M documentation guidelines, but also the underlying
coding structure and valuation. Stakeholders have reported to CMS that
they believe the E/M visit codes themselves need substantial updating
and revaluation to reflect changes in the practice of medicine, and
that revising the documentation guidelines without addressing the codes
themselves simply preserves an antiquated framework for payment of E/M
services.
Last year, CMS sought public comment on potential changes to the E/
M documentation rules, deferring making any changes to E/M coding
itself in order to immediately focus on revision of the E/M guidelines
to reduce unnecessary administrative burden (82 FR 34078 through
34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we
summarized the public comments we received and stated that we would
take that feedback into consideration for future rulemaking. In
response to commenters' request that we provide additional venues for
stakeholder input, we held a listening session this year on March 18,
2018 (transcript and materials are available on the CMS website at
https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-and-Burden-Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We
also sought input by participating in several listening sessions
recently hosted by the Office of the National Coordinator for Health
Information Technology (ONC) in the course of implementing section
4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision
requires the Department of Health and Human Services to establish a
goal, develop a strategy, and make recommendations to reduce regulatory
or administrative burdens relating to the use of EHRs. The ONC
listening sessions sought public input on the E/M guidelines as one
part of broader, related and unrelated burdens associated with EHRs.
Several themes emerged from this recent stakeholder input.
Stakeholders commended CMS for undertaking efforts to revise the E/M
guidelines and recommended a multi-year process. Many commenters
advised CMS to obtain further input across specialties. They
recommended town halls, open door forums or a task force that would
come up with replacement guidelines that would work for all specialties
over the course of several years. They urged CMS to proceed cautiously
given the magnitude of the undertaking; past failed reform attempts by
the AMA, CMS, and other payers; and the wide-ranging impact of any
changes (for example, how other payers approach the issue).
We received substantially different recommendations by specialty.
Based on this feedback, it is clear that any changes would have
meaningful specialty-specific impacts, both clinical and financial.
Based on this feedback, it also seems that the history and exam
portions of the guidelines are most significantly outdated with respect
to current clinical practice.
A few stakeholders seemed to indicate that the documentation
guidelines on history and exam should be kept in their current form.
Many stakeholders believed they should be simplified or reduced, but
not eliminated. Some stakeholders indicated that the documentation
guidelines on history and exam could be eliminated altogether, and/or
that documentation of these parts of an E/M visit could be left
[[Page 59628]]
to practitioner discretion. We also heard from stakeholders that the
degree to which an extended history and exam enables a given
practitioner to reach a certain level of coding (and payment) varies
according to their specialty. Many commenters advised CMS to increase
reliance on medical decision-making (MDM) and time in determining the
appropriate level of E/M visit, or to use MDM by itself, but many of
these commenters noted that the MDM portions of the guidelines would
need to be altered before being used alone. Commenters were divided on
the role of time in distinguishing among E/M visit levels, and
expressed some concern about potential abuse or inequities among more-
or less-efficient practitioners. Some commenters expressed support for
simplifying E/M coding generally into three levels such as low, medium
and high, and potentially distinguishing those levels on the basis of
time.
2. CY 2019 Final Policies
a. Overview
Having considered the public feedback to the CY 2018 PFS proposed
rule (82 FR 53163 through 53166) and our other outreach efforts
described above, in our CY 2019 proposed rule, we proposed several
changes to E/M visit documentation and payment. We proposed that the
changes would only apply to office/outpatient visit codes (CPT codes
99201 through 99215), except where we specify otherwise. We agreed with
commenters that we should take a step-wise approach to these issues,
and therefore, we limited proposed changes to the office/outpatient E/M
code set. We understood from commenters that there are more unique
issues to consider for the E/M code sets used in other settings such as
inpatient hospital or emergency department care, such as unique
clinical and legal issues and the potential intersection with hospital
Conditions of Participation (CoPs). We may consider expanding our
efforts more broadly to address sections of the E/M code set beyond the
office/outpatient codes in future years.
We emphasized that, this year, we included our proposed E/M
documentation changes in a proposed rule due to the longstanding nature
of our instruction that practitioners may use either the 1995 or 1997
versions of the E/M guidelines to document E/M visits billed to
Medicare, the magnitude of the proposed changes, and the associated
payment policy proposals that require notice and comment rulemaking. We
believed our proposed documentation changes for E/M visits were
intrinsically related to our proposal to alter PFS payment for E/M
visits, and the PFS payment proposal for E/M visits required notice and
comment rulemaking. We noted that we were proposing a relatively broad
outline of changes, and anticipated that many details related to
program integrity and ongoing refinement would need to be developed
over time through subregulatory guidance. This would afford flexibility
and enable us to more nimbly and quickly make ongoing clarifications,
changes and refinements in response to continued practitioner
experience moving forward.
We put forth a key proposal that, at its core, strived to reduce
the significant burden associated with documentation for payment
purposes by eliminating the payment rules associated with the current
primary means of varying payment among office/outpatient visits.
Specifically, we proposed to develop single payment rates for the
office/outpatient E/M visit levels 2 through 5 (one rate for
established patients, and one rate for new patients), in order to
mitigate the need for physicians and other practitioners to adhere to
complex payment-specific documentation rules for each and every visit
furnished to a Medicare beneficiary. If there were minimal payment
variation based on the level of visit billed, then there would be
minimal need to engage with the burdensome and outdated documentation
guidelines and E/M visit coding to justify that the appropriate level
visit was reported. Though we acknowledged a continued need to document
information in the medical record for clinical and other purposes, our
understanding based on extensive feedback from medical professionals
was that the documentation specific to justifying the visit level
reported to payers, including Medicare, was unduly and
disproportionately burdensome among the many administrative burdens in
current medical practice. To avoid the administrative burden and
disruption of establishing a new G code to describe the level 2 through
5 combined visit, under our proposal practitioners would continue to
report on the claim the CPT code associated with the level of visit the
practitioner believed they furnished.
Along with eliminating payment variation for office/outpatient E/M
visit levels 2 through 5, we proposed a series of corollary policies
intended to vary payment for these visits based on a more meaningful
set of attributes for visits. Our goal was that these payment
variations, accomplished through new add-on and other coding changes,
and multiple procedure payment reductions, would reflect the relative
resource costs of furnishing E/M visits without requiring detailed
documentation for purposes of justifying particular payment rates. We
also expected these adjustments to offset some of the more significant
potentially redistributive impacts of this proposal, especially among
physicians and practitioners of different specialties. The potential
redistributive impacts helped us to determine potential, initial values
for the proposed add-on codes providing for the adjustments. Again,
these proposals were intended to provide a more meaningful avenue for
payment variation that would ease the documentation burdens currently
faced by clinicians to justify the visit level that is reported for
each and every visit with a beneficiary. These proposals reflected our
longstanding beliefs that: There are certain complexities inherent in
furnishing some kinds of E/M visits that are not currently accounted
for in valuations for the current E/M code set, there are unaccounted-
for efficiencies when E/M visits are billed on the same day as global
procedure codes that are already valued to include resources associated
with E/M services, and the current E/M coding system does not fully
account for the variety of legitimate circumstances when the needs of
individual patients require more time with their physicians. We also
proposed to establish unique E/M visit codes for podiatric care and
make changes to the PE methodology in order to standardize the amount
of PE RVUs allocated for this series of codes, regardless of which
specialties were assumed to bill them.
In conjunction with our proposal to effectively eliminate the
variation in payment of choosing from among E/M visit levels 2 through
5 for office/outpatient visits, we proposed a minimum level of
associated documentation that would apply for payment purposes across
all level 2 through 5 office/outpatient E/M visits. We also proposed to
allow practitioners a choice regarding the basis for their
documentation for these visits: Current documentation guidelines
(history, exam and MDM); MDM alone; or time alone. We proposed that,
when using current documentation guidelines or MDM, the current
guidelines for level 2 visits would apply. When using time to document
a visit, the practitioner would be required to demonstrate the medical
necessity of the visit and report the total amount of face-to-face time
they spent with the beneficiary. We solicited public comment on what
the total time
[[Page 59629]]
requirement should be when using time to document a level 2 through 5
visit. We presented several alternatives for determining the amount of
time associated with each visit level: The new intra-service times
associated with setting the payment rate for the visit codes, the
midpoint of these new times, or the typical time for the CPT code
reported on the claim (the time listed in the AMA/CPT codebook for that
code) (83 FR 35837).
We sought feedback in particular on the option to document using
time when prolonged E/M services are billed. We proposed that when a
practitioner uses time to document the visit and also reports prolonged
E/M services, we would require the practitioner to document that the
typical time required for the base or ``companion'' visit is exceeded
by the amount required to report prolonged services (83 FR 35837). We
did not propose any changes to CPT codes 99354 and 99355, and under our
proposal these codes could still be billed, as needed, when their time
thresholds and all other requirements are met (83 FR 35774).
Since we proposed to create a single payment rate under the PFS
that would be paid for services billed using the current CPT codes for
level 2 through 5 visits, it would not be material to Medicare's
payment decision which CPT code (of levels 2 through 5) would be
reported on the claim, except to justify billing a level 2 or higher
visit in comparison to a level 1 visit (providing the visit itself was
reasonable and necessary) and when using certain potential approaches
to documenting the visit using time (83 FR 35836 through 35837).
However, we expected that for record keeping purposes or to meet
requirements of other payers, practitioners would continue to choose
and report the level of E/M visit they believed to be appropriate under
the current CPT coding structure.
We also proposed to remove an existing manual provision for home
visits requiring documentation in the patient's medical record of the
medical necessity of furnishing the visit in the home. For all office/
outpatient E/M visits, we also proposed several simplifications
centered on reducing the need for duplicative, redundant data entry in
the medical record.
Several thousand commenters responded to this series of proposals.
Generally, the commenters stated appreciation for CMS' goal of reducing
administrative burden and reforming E/M coding and payment, but
expressed concern about many impacts of the proposals. Commenters
largely objected to our proposal to eliminate payment differences for
office/outpatient E/M visit levels 2 through 5 based on the level of
visit complexity. Many commenters stated that they would experience
payment cuts relative to the current payment structure. Commenters
generally stated that the implementation timeframe for the changes as
proposed was too aggressive, especially since stakeholders were
uncertain as to whether other payers would follow Medicare's proposed
policies. Many commenters suggested that CMS could implement the
proposed documentation reduction without the coding/payment policies,
or that these policies could be adopted on separate timeframes.
Many commenters suggested that the proposals did not specify the
circumstances in which the proposed add-on codes for office/outpatient
E/M visits could be used, and what documentation requirements might be
adopted for them. Many commenters stated that it would be better if the
physician community could consider a range of alternative coding and
payment options to be modeled and thoroughly evaluated over several
years instead of a single alternative during a 60-day public comment
period.
Many commenters opposed our proposal to establish that clinicians
billing an office/outpatient E/M visit level 2 through 5 need only
document medical necessity as specified for a level 2 visit (unless
time is used as the basis for the visit level). Some commenters
supported allowing a choice of documentation methodologies, while
others opposed it. The vast majority of commenters did not support
having only a single payment level to distinguish visit complexity
(other than level 1), despite the associated minimum documentation that
we proposed for these codes. Most commenters noted that CMS did not
provide enough specificity in its proposals for how clinicians would
document using time, and that because the definitions and billing rules
regarding the add-on codes were ambiguous, they questioned whether the
codes would have clinical validity. Regarding the valuation of these
services, some commenters stated that the proposal did not follow the
statutory requirement regarding using relative resources to set PFS
rates. Others perceived that some of the newly proposed codes would be
required or restricted based on physician specialty, and that such
limitations would violate statutory provisions prohibiting varying
payment for the same physicians' service by physician specialty.
Many commenters recommended that CMS finalize the documentation
proposals regarding home visits and redundant data recording for 2019,
but defer other documentation reforms to future years after
stakeholders provide additional input. Some commenters recommended that
CMS finalize the proposed choice among documentation methodologies
while stakeholders work with CMS to refine what the coding and payment
changes should be.
After considering the comments, for 2019 we are finalizing several
of our documentation proposals that will provide some significant and
immediate burden reduction, but are unrelated to changes to payment and
coding. Specifically, we are finalizing the proposals regarding home
visits and redundant data recording (discussed further in this
section), as proposed, effective January 1, 2019.
After considering the comments, especially those suggesting that
implementation of significant payment and coding changes requires time
for practitioners, vendors, health systems, and other stakeholders to
prepare, we are finalizing modified changes in payment coding, and
associated documentation rules for E/M office/outpatient visits for
2021. These changes, detailed below, incorporate many significant
changes from our proposals based on suggestions from the many comments
we received. In brief summation, we are finalizing a significant
reduction in the current payment variation in office/outpatient E/M
visit levels by paying a single rate for E/M office/outpatient visit
levels 2, 3, and 4 (one for established and another for new patients)
beginning in 2021. However, we are not finalizing the inclusion of E/M
office/outpatient level 5 visits in the single payment rate, to better
account for the care and needs of particularly complex patients. Also,
after consideration of public comments, we are not finalizing aspects
of our proposal that would have: Reduced payment when E/M office/
outpatient visits are furnished on the same day as procedures,
established separate podiatric E/M visit codes, or standardized the
allocation of PE RVUs for the codes that describe these services. We
are finalizing a policy for 2021 to adopt add-on codes that describe
the additional resources inherent in visits for primary care and
particular kinds of specialized medical care. As discussed further
below, these codes will only be reportable with E/M office/outpatient
level 2 through 4 visits, and their use generally will not impose new
per-visit documentation requirements. These codes are neither required
nor restricted by physician specialty, though we acknowledge that,
[[Page 59630]]
like many other physicians' services for which payment is made under
the PFS, they are specifically intended to describe services that
clinicians practicing in some specialties are more likely to perform
than those in other specialties. We are also finalizing a policy for
2021 to adopt a new ``extended visit'' add-on code for use only with E/
M office/outpatient level 2 through 4 visits to account for the
additional resources required when practitioners need to spend extended
time with the patient.
For CY 2019 and 2020, we will continue the current coding and
payment structure for E/M office/outpatient visits, and, therefore,
practitioners should continue to use either the 1995 or 1997 versions
of the E/M guidelines to document E/M office/outpatient visits billed
to Medicare for 2019 and 2020 (with the exception of our final policy
to eliminate redundant data recording).
Beginning in 2021, for E/M office/outpatient levels 2 through 5
visits, we will allow for flexibility in how visit levels are
documented, specifically a choice to use the current framework, MDM or
time. For E/M office/outpatient level 2 through 4 visits, beginning in
2021 we will also apply a minimum supporting documentation standard
associated with level 2 visits when practitioners use the current
framework or MDM to document the visit.
We intend to engage in further discussions with the public over the
next several years to potentially further refine our policies, through
future notice and comment rulemaking, for 2021. We discuss the public
comments, our responses to the specific concerns and perspectives
offered by commenters, and final policies in greater detail in this
section.
b. Public Comments and Responses
(1) Lifting Restrictions Related to E/M Documentation
(a) Eliminating Extra Documentation Requirements for Home Visits
Medicare pays for E/M visits furnished in the home (a private
residence) under CPT codes 99341 through 99350. The payment rates for
these codes are slightly more than for office visits (for example,
approximately $30 more for a level 5 established patient, non-
facility). The beneficiary need not be confined to the home to be
eligible for such a visit. However, there is a Medicare Claims
Processing Manual provision requiring that the medical record must
document the medical necessity of the home visit made in lieu of an
office or outpatient visit (Pub. 100-04, Medicare Claims Processing
Manual, Chapter 12, Section 30.6.14.1.B., available on the CMS website
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). Stakeholders have suggested that whether a
visit occurs in the home or the office is best determined by the
practitioner and the patient without applying additional rules. We
agreed, so we proposed to remove the requirement that the medical
record must document the medical necessity of furnishing the visit in
the home rather than in the office. We welcomed public comments on this
proposal, including any potential, unintended consequences of
eliminating this requirement.
Comment: Commenters were generally supportive of our proposal to
remove the requirement that the medical record must document the
medical necessity of furnishing the visit in the home rather than in
the office. Many commenters included this proposal in a list of
appropriate changes CMS should make immediately regarding documentation
of E/M visits, effective January 1, 2019.
Response: We are finalizing this policy change to remove the
requirement that the medical record must document the medical necessity
of furnishing the visit in the home rather than in the office, as
proposed, effective January 1, 2019.
(b) Public Comment Solicitation on Eliminating Prohibition on Billing
Same-Day Visits by Practitioners of the Same Group and Specialty
The Medicare Claims Processing Manual states, ``As for all other E/
M services except where specifically noted, the Medicare Administrative
Contractors (MACs) may not pay two E/M office visits billed by a
physician (or physician of the same specialty from the same group
practice) for the same beneficiary on the same day unless the physician
documents that the visits were for unrelated problems in the office,
off campus-outpatient hospital, or on campus-outpatient hospital
setting which could not be provided during the same encounter'' (Pub.
100-04, Medicare Claims Processing Manual, Chapter 12, Section
30.6.7.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
This instruction was intended to reflect the idea that multiple
visits with the same practitioner, or by practitioners in the same or
very similar specialties within a group practice, on the same day as
another E/M service would not be medically necessary. However,
stakeholders have provided a few examples where this policy does not
make sense with respect to the current practice of medicine as the
Medicare enrollment specialty does not always coincide with all areas
of medical expertise possessed by a practitioner--for example, a
practitioner with the Medicare enrollment specialty of geriatrics may
also be an endocrinologist. If such a practitioner was one of many
geriatricians in the same group practice, they would not be able to
bill separately for an E/M visit focused on a patient's
endocrinological issue if that patient had another more generalized E/M
visit by another geriatrician on the same day. Stakeholders have
pointed out that in these circumstances, practitioners often respond to
this instruction by scheduling the E/M visits on two separate days,
which could unnecessarily inconvenience the patient. Given that the
number and granularity of practitioner specialties recognized for
purposes of Medicare enrollment continue to increase over time
(consistent with the medical community's requests), the value to the
Medicare program of the prohibition on same-day E/M visits billed by
physicians in the same group and medical specialty may be diminishing,
especially as we believe it is becoming more common for practitioners
to have multiple specialty affiliations, but would have only one
primary Medicare enrollment specialty. We believe that eliminating this
policy may better recognize the changing practice of medicine while
reducing administrative burden. The impact of this proposal on program
expenditures and beneficiary cost sharing is unclear. To the extent
that many of these services are currently merely scheduled and
furnished on different days in response to the instruction, eliminating
this manual provision may not significantly increase utilization,
Medicare spending and beneficiary cost sharing.
We solicited public comment on whether we should eliminate the
manual provision given the changes in the practice of medicine or
whether there is concern that eliminating it might have unintended
consequences for practitioners and beneficiaries.
We recognize that this instruction may be appropriate only in
certain clinical situations, so we also solicited public comments on
whether and how we should consider creating exceptions to, or modify
this manual provision rather than eliminating it entirely. We also
requested that the public provide additional examples and situations in
[[Page 59631]]
which the current instruction is not clinically appropriate.
Comment: We received many comments in response to this
solicitation.
Response: We thank the commenters for all of the information
submitted, and will review the many public comments we received on this
topic and consider this issue further for potential future rulemaking.
(2) Documentation Changes for Office or Other Outpatient E/M Visits and
Home Visits
(a) Providing Choices in Documentation--Medical Decision-Making, Time
or Current Framework
Informed by comments and examples that we have received stating
that the current E/M documentation guidelines are outdated with respect
to the current practice of medicine, and in our efforts to simplify
documentation for the purposes of coding E/M visit levels, we proposed
to allow practitioners to choose, as an alternative to the current
framework specified under the 1995 or 1997 guidelines, either MDM or
time as a basis to determine the appropriate level of E/M visit. This
would allow different practitioners in different specialties to choose
to document the factor(s) that matter most given the nature of their
clinical practice. It would also reduce the impact Medicare may have on
the standardized recording of history, exam and MDM data in medical
records, since practitioners could choose to no longer document many
aspects of an E/M visit that they currently document under the 1995 or
1997 guidelines for history, physical exam and MDM. Although we
initially considered reducing the number of key components that
practitioners needed to document in choosing the appropriate level of
E/M service to bill, feedback from the stakeholder community led us to
believe that offering practitioners a choice to either retain the
current framework or choose among new options that involve a reduced
level of documentation would be less burdensome for practitioners, and
would allow more stability for practitioners who may need time to
prepare for any potential new documentation framework.
We sought to be clear that as part of this proposal, practitioners
could use MDM, or time, or they could continue to use the current
framework to document an E/M visit. In other words, we would be
offering the practitioner the choice to continue to use the current
framework by applying the 1995 or 1997 documentation guidelines for all
three key components. However, our proposals on payment for office-
based/outpatient E/M visits described later in this section would apply
to all practitioners, regardless of their selected documentation
approach. Under our proposal, all practitioners, even those choosing to
retain the current documentation framework, would be paid at the
proposed new payment rate described in the CY 2019 PFS proposed rule
(one rate for new patients and another for established patients), and
could also report applicable G-codes as we proposed (83 FR 35839
through 35843).
We also sought to be clear that we proposed to retain the current
CPT coding structure for E/M visits (along with our proposal to create
new replacement codes for podiatry office/outpatient E/M visits).
Practitioners would report on the professional claim whatever level of
visit (1 through 5) they believe they furnished using CPT codes 99201-
99215. Because we believed the adoption of replacement G-codes to
describe the visit levels 2 through 5 might result in unnecessary
disruption to current billing systems and practices, we did not propose
to modify the existing CPT coding structure for E/M visits. Since we
proposed to create a single rate under the PFS that would be paid for
services billed using the current CPT codes for level 2 through 5 E/M
visits, under our proposal, it would not have been material to
Medicare's payment decision which CPT code (of levels 2 through 5) is
reported on the claim, except to justify billing a level 2 or higher
visit in comparison to a level 1 visit (provided the visit itself was
reasonable and necessary). We stated that we expected that, for record
keeping purposes or to meet requirements of other payers, many
practitioners would continue to choose and report the level of E/M
visit they believed to be appropriate under the CPT coding structure.
Even though under our proposal, there would have been no payment
differential for E/M visits based on which of the codes describing
visit levels 2 through 5 were reported, we believed we would still need
to simplify and change our documentation requirements to better align
with the current practice of medicine and eliminate unnecessary aspects
of the current documentation framework. As a corollary to our proposal
to adopt a single payment amount for office/outpatient E/M visit levels
2 through 5 (83 FR 35839 through 35843), we proposed to apply a minimum
documentation standard where, for the purposes of PFS payment for an
office/outpatient E/M visit, practitioners would only need to meet
documentation requirements currently associated with a level 2 visit
for history, exam and/or MDM, except when using time to document the
service. Practitioners could choose to document more information for
clinical, legal, operational or other purposes, and we anticipated that
for those reasons, practitioners would continue generally to seek to
document medical record information that is consistent with the level
of care furnished. For purposes of our medical review, however, for
practitioners using the current documentation framework or, as we
proposed, MDM, Medicare would only require documentation to support the
medical necessity of the visit and the documentation that is associated
with the current level 2 CPT visit code.
For example, for a practitioner choosing to document using the
current framework (1995 or 1997 guidelines), our proposed minimum
documentation for any billed level of E/M visit from levels 2 through 5
could include: (1) A problem-focused history that does not include a
review of systems or a past, family, or social history; (2) a limited
examination of the affected body area or organ system; and (3)
straightforward medical decision making measured by minimal problems,
data review, and risk (two of these three). If the practitioner was
choosing to document based on MDM alone, Medicare would only require
documentation supporting straightforward medical decision-making
measured by minimal problems, data review, and risk (two of these
three).
Some commenters had suggested that the current framework of
guidelines for the MDM component of visits would need to be changed
before MDM could be relied upon by itself to distinguish visit levels.
We proposed to allow practitioners to rely on MDM in its current form
to document their visit, and solicited public comment on whether and
how guidelines for MDM might be changed in subsequent years.
As described earlier, we currently allow time or duration of visit
to be used as the governing factor in selecting the appropriate E/M
visit level only when counseling and/or coordination of care accounts
for more than 50 percent of the face-to-face physician/patient
encounter (or, in the case of inpatient E/M services, the floor time).
Our proposal to allow practitioners the choice of using time to
document office/outpatient E/M visits would have meant that this time-
based standard is not limited to E/M visits in which counseling and/or
care coordination
[[Page 59632]]
accounts for more than 50 percent of the face-to-face practitioner/
patient encounter. Rather, the amount of time personally spent by the
billing practitioner face-to-face with the patient could be used to
document the E/M visit regardless of the amount of counseling and/or
care coordination furnished as part of the face-to-face encounter.
Some commenters had raised concerns with reliance on time to
distinguish visit levels, for example the potential for abuse,
inequities among more- or less-efficient practitioners, and specialties
for which time is less of a factor in determining visit complexity. We
noted in the proposed rule that relying on time as the basis for
identifying the E/M visit level would also raise the issue of what
would be required by way of supporting documentation; for example, what
amount of time should be documented, and whether the specific
activities comprising the time need to be documented and to what
degree. However, a number of stakeholders had suggested that, within
their specialties, time is a good indicator of the complexity of the
visit or patient, and requested that we allow practitioners to use time
as the single factor in all E/M visits, not just when counseling or
care coordination dominate a visit. We agreed that for some
practitioners and patients, time may be a good indicator of complexity
of the visit, and proposed to allow practitioners the option to use
time as the single factor in selecting visit level and documenting the
E/M visit, regardless of whether counseling or care coordination
dominate the visit. We stated that if finalized, we would monitor the
results of this policy for any program integrity issues, administrative
burden or other issues.
For practitioners choosing to support their coding and payment for
an E/M visit by documenting the amount of time spent with the patient,
we proposed to require the practitioner to document the medical
necessity of the visit and show the total amount of time spent by the
billing practitioner face-to-face with the patient. We solicited public
comment on what that total time should be for payment of the single,
new rate for E/M visits levels 2 through 5. We presented the typical
time for our proposed new single payment for E/M visit levels 2 through
5 (the weighted average of the intra-service times across the current
E/M visit utilization) and suggested we could use this time. We noted
that currently the PFS does not require the practitioner to spend or
document a specified amount of time with a given patient in order to
receive payment for an E/M visit, unless the visit is dominated by
counseling/care coordination and, on that account, the practitioner is
using time as the basis for code selection. The times for E/M visits
and most other PFS services in the physician time files, which are used
to set PFS rates, are typical times rather than requirements, and were
recommended by the AMA RUC and then reviewed and either adopted or
adjusted for Medicare through our usual ratesetting process as
``typical,'' but not strictly required.
We presented a potential alternative to apply the AMA's CPT
codebook provision that, for timed services, a unit of time is attained
when the mid-point is passed,\5\ such that we would require
documentation that at least 16 minutes for an established patient (more
than half of 31 minutes) and at least 20 minutes for a new patient
(more than half of 38 minutes) were spent face-to-face by the billing
practitioner with the patient, to support making payment at the
proposed single rate for visit levels 2 through 5 when the practitioner
chose to document the visit using time.
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\5\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------
We presented another potential alternative to require documentation
that the typical time for the CPT code that is reported (which is also
the typical time listed in the AMA's CPT codebook for that code) was
spent face-to-face by the billing practitioner with the patient. For
example, a practitioner reporting CPT code 99212 (a level 2 established
patient visit) would be required to document having spent a minimum of
10 minutes, and a practitioner reporting CPT code 99214 (a level 4
established patient visit) would be required to document having spent a
minimum of 25 minutes. Under this approach, the total amount of time
spent by the billing practitioner face-to-face with the patient would
inform the level of E/M visit (of levels 2 through 5) coded by the
billing practitioner. We noted that in contrast to other proposed
documentation approaches discussed above, this approach of requiring
documentation of the typical time associated with the CPT visit code
reported on the claim would introduce unique payment implications for
reporting that code, especially when the time associated with the
billed E/M code is the basis for reporting prolonged E/M services.
We solicited public comments on the use of time as a framework for
documentation of office/outpatient E/M visits, and whether we should
adopt any of these approaches or specify other requirements with
respect to the proposed option for documentation using time.
In providing us with feedback, we requested that commenters take
into consideration ways in which the time associated with, or required
for, the billing of any add-on codes (especially the proposed prolonged
E/M visit add-on code(s) described in the CY 2019 PFS proposed rule (83
FR 35844)) would intersect with the time spent for the base E/M visit,
when the practitioner is documenting the E/M visit using only time.
Currently, when reporting prolonged E/M services, we expect the
practitioner to exceed the typical time assigned for the base E/M visit
code (also commonly referred to as the companion code). For example, in
the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for
the commenters' suggestion to display the typical times associated with
relevant services. We also discussed, and in response to those
comments, decided to post a file annually that notes the times assumed
to be typical for purposes of PFS ratesetting for practitioners to use
as a reference in deciding whether time requirements for reporting
prolonged E/M services are met. We stated that although these typical
times are not required for a practitioner to bill the displayed base
codes, we expect that only time spent in excess of these times will be
reported using a non-face-to-face prolonged service code. We proposed
to formalize this policy in the case where a practitioner uses time to
document a visit, since there would be a stricter time requirement
associated with the base E/M code. Specifically, we proposed that, when
a practitioner chooses to document using time and also reports
prolonged E/M services, we would require the practitioner to document
that the typical time required for the base or ``companion'' visit is
exceeded by the amount required to report prolonged services. Further
discussion of our proposal regarding reporting prolonged E/M services
is available in the CY 2019 PFS proposed rule (83 FR 35844).
We believed that allowing practitioners to choose the most
appropriate basis for distinguishing among the levels of E/M visits and
applying a minimum documentation requirement, together with reducing
the payment variation among E/M visit levels, would significantly
reduce administrative burden for practitioners, and would avoid the
current need to make coding and documentation decisions based on codes
and documentation guidelines that are not a good fit with current
medical practice. The practitioner could choose to use
[[Page 59633]]
MDM, time or the current documentation framework, and could also apply
the proposed policies discussed below regarding redundancy and who can
document information in the medical record.
We solicited public comment on these proposals to provide
practitioners choice in the basis for documenting E/M visits in an
effort to allow for documentation alternatives that better reflect the
current practice of medicine and to alleviate documentation burden. We
stated our interest in receiving public comments on practitioners'
ability to avail themselves of these choices for how they would impact
clinical workflows, EHR templates, and other aspects of practitioner
work.
Stakeholders had requested that CMS not merely shift burden by
implementing another framework that might avoid issues caused by the
current guidelines, but that would be equally complex and burdensome.
Our primary goal was to reduce administrative burden so that the
practitioner can focus on the patient, and we were interested in
commenters' opinions as to whether our E/M visit proposals would, in
fact, support and further this goal. We believed our proposals would
allow practitioners to exercise greater clinical judgment and
discretion in what they document, focusing on what is clinically
relevant and medically necessary for the patient rather than what will
illustrate that the appropriate visit level was reported. Although we
proposed to no longer apply much of the E/M documentation guidelines
involving history, physical exam and, for those choosing to document
based on time, documentation of medical decision-making, we stated our
expectation that practitioners would continue to perform as medically
necessary for the patient and document E/M visits to ensure quality and
continuity of care. For example, we believed that it remains an
important part of care for the practitioner to understand the patient's
social history, even though certain documentation options we proposed
would no longer require that history to be re-documented to bill
Medicare for the visit.
Comment: Many commenters supported the proposal to allow choice in
documentation between the current framework, medical decision making or
time. However, some commenters stated that such a policy would
introduce too much variation in medical record format and content, or
too many potential frameworks against which an auditor might review a
claim. Commenters were unsure whether CMS envisioned the choice being
made on a case-by-case basis or with some regularity. Other commenters
noted that time alone is not an accurate measure of visit complexity or
would be subject to gaming, or that CMS did not provide enough detail
regarding time thresholds and documentation requirements to allow them
to assess potential impact.
Many of the commenters did not support the proposal, as a corollary
to our proposal to adopt a single payment amount for office-outpatient
E/M visit levels 2 through 5, to apply a minimum level 2 documentation
standard. These commenters were concerned that this standard would
result in inadequate documentation for patient care, legal and other
purposes. They noted that CMS overestimated the associated reduction in
burden that would result from this proposal, and instead believe the
level 2 documentation standard would reduce burden to a lesser degree
than we estimated, or potentially increase burden. They indicated that
there would be costs in terms of time and resources to update EHRs and
train staff, and that they expected there would be the need to continue
documenting many elements included in the current code definitions for
patient care and other purposes, including other payers. Many
commenters expressed concern that the documentation could potentially
increase due to misalignment in documentation rules between payers, as
they presume that Medicaid, commercial payers and secondary payers
would not likely adopt Medicare's payment changes, at least not
immediately. Several commercial payers or their associations expressed
similar concerns and recommended implementing a more limited set of
documentation changes and ongoing monitoring.
MedPAC and a few other commenters recommended paying for visits on
the basis of time alone. MedPAC recommended requiring the time spent to
be reported on the claim so CMS can collect data on current times
actually spent and use it to more accurately set rates in the future.
A few commenters indicated what the time requirement should be when
using time to document. Most of these commenters noted that CMS should
require the typical time associated with the CPT code reported on the
claim. One commenter who opposed the single payment rate stated that if
CMS did finalize a single payment rate, then CMS should require only
the time associated with the level 2 CPT codes (10 minutes for an
established patient and 20 minutes for a new patient). Some commenters
expressed support for requiring that this time be spent by the billing
practitioner face-to-face with the patient, and a few commenters
expressed support for allowing time spent by individuals other than the
billing practitioner and/or time spent furnishing non-face-to-face care
to count.
Response: For CY 2019 and 2020, we will continue the current coding
and payment structure for E/M office/outpatient visits, and, therefore,
practitioners should continue to use either the 1995 or 1997 versions
of the E/M guidelines to document E/M office/outpatient visits billed
to Medicare for 2019 and 2020 (with the exception of our final policy
to eliminate redundant data recording).
We appreciate the issues raised by commenters but continue to
believe our proposals allowing for flexibility in how E/M office/
outpatient visit levels are documented and the applying of a minimum
documentation standard as a corollary to establishing single payment
rates for E/M office/outpatient visits will significantly reduce burden
for clinicians and support them in making coding and documentation
decisions that better align with current medical practice. Beginning in
2021, for E/M office/outpatient levels 2 through 5 visits, we will
allow for flexibility in how visit levels are documented, allowing
billing practitioners the choice to use the current framework, MDM or
time. Specifically, for level 5 visits, for PFS payment purposes a
practitioner can use the current framework with the documentation
requirements applicable to a level 5 visit or the current definition of
level 5 MDM. As an another alternative, the practitioner can document
using time, which will require documentation of the medical necessity
of the visit and that the billing practitioner personally spent at
least the typical time associated with the level 5 CPT code that is
reported face-to-face with the patient (40 minutes for an established
patient and 60 minutes for a new patient). Since there will be no new
intra-service time associated with the level 5 visit codes, we are
finalizing our proposed alternative to use the typical time associated
with the CPT code reported on the claim, consistent with current policy
when counseling and/or coordination of care accounts for more than 50
percent of the face-to-face physician/patient encounter.
For E/M office/outpatient level 2 through 4 visits, in 2021 we will
also allow choice of documentation methodology (current framework, MDM
or time). For practitioners using the current documentation framework
or
[[Page 59634]]
MDM, for PFS payment purposes, we will apply a minimum supporting
documentation standard associated with E/M office/outpatient level 2
visits such that we only require documentation that is associated with
the current level 2 CPT visit code (new or established patient, as
applicable). For example, if the practitioner is choosing to document
based on MDM alone, for PFS payment purposes we will only require
documentation supporting straight forward medical decision-making
measured by minimal problems, data review, and risk (two of these
three). If choosing to document using time, for PFS payment purposes we
will require the billing practitioner to document that the visit was
medically reasonable and necessary and that the billing practitioner
personally spent the current typical time for the CPT code reported
(for example, 15 minutes when reporting CPT code 99213 (a level 3
established patient visit)). For administrative simplicity, it may be
most straight forward to track to the typical time for the CPT code.
We address the public comments on our burden reduction estimate and
changes to our estimate based on our final policies further below (see
section VII. of this final rule, Regulatory Impact Analysis). We intend
to engage in further discussions with the public over the next several
years to potentially further refine our policies for 2021.
As we noted in the CY 2019 PFS proposed rule, we heard from a few
commenters on the CY 2018 PFS proposed rule that some practitioners
rely on unofficial Marshfield clinic or other criteria to help them
document E/M visit levels. These commenters conveyed that the
Marshfield ``point system'' is commonly used to supplement the E/M
documentation guidelines, because of a lack of concrete criteria for
certain elements of medical decision making in the 1995 and 1997
guidelines or in CPT guidance. Accordingly, in the CY 2019 PFS proposed
rule, we solicited public comment on whether Medicare should use or
adopt any aspects of other E/M documentation systems that may be in use
among practitioners, such as the Marshfield tool. We were interested in
feedback as to whether the 1995 and 1997 guidelines contain adequate
information for practitioners to use in documenting visits under our
proposals, or whether these versions of the guidelines would need to be
supplemented in any way.
The following is a summary of the comments we received on whether
Medicare should use or adopt any aspects of other E/M documentation
systems that may be in use among practitioners, such as the Marshfield
tool, and also whether the 1995 and 1997 guidelines contain adequate
information for practitioners to use in documenting visits under our
proposals, or whether these versions of the guidelines would need to be
supplemented in any way.
Comment: We received a few comments clarifying how the Marshfield
tool is currently used, but the commenters provided reasons not to use
it as a replacement standard for current measures of visit complexity
specified in the 1995 and 1997 documentation guidelines. A few
commenters suggested new methods that could be used to support the
level of E/M visit reported, such as risk adjustment with CMS's
Hierarchical Condition Category scores used in Medicare Advantage; and
some commenters recommended that CMS use medical decision making alone
or in combination with time to distinguish visit/patient complexity. A
few commenters recommended ways in which medical decision making could
be relied upon, and ways that it should be changed, suggesting that
history and physical exam might be incorporated with medical decision
making. Many commenters recommended that CMS should continue to work
with the AMA/CPT, specialty associations and other stakeholders to come
up with revised measures of visit complexity, recommending between
three to five levels.
Response: We appreciate commenters' feedback on this solicitation,
and we considered it in the context of making a final decision. As
stated previously, we are finalizing a significant reduction in the
current payment variation in office/outpatient E/M visit levels by
paying a single rate for E/M office/outpatient visit levels 2, 3, and 4
(one for established and another for new patients). However, we are not
finalizing the inclusion of E/M office/outpatient level 5 visits in the
single payment rate, in order to better account for the care and needs
of particularly complex patients. Beginning in 2021, for E/M office/
outpatient levels 2 through 5 visits, we will allow for flexibility in
how visit levels are documented, specifically a choice to use the
current framework, MDM or time, discussed previously. For E/M office/
outpatient level 2 through 4 visits, in 2021 we will also apply a
minimum supporting documentation standard associated with level 2
visits, also discussed previously. We intend to engage in further
discussions with the public over the next several years to potentially
further refine our policies for 2021.
(b) Removing Redundancy in E/M Visit Documentation
Stakeholders have recently expressed that CMS should not require
documentation of information in the billing practitioner's note that is
already present in the medical record, particularly with regard to
history and exam. Currently, both the 1995 and 1997 guidelines provide
such flexibility for certain parts of the history for established
patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent
past, family, and/or social history (PFSH) obtained during an earlier
encounter does not need to be re-recorded if there is evidence that the
physician reviewed and updated the previous information. This may occur
when a physician updates his/her own record or in an institutional
setting or group practice where many physicians use a common record.
The review and update may be documented by:
Describing any new ROS and/or PFSH information or noting
there has been no change in the information; and
Noting the date and location of the earlier ROS and/or
PFSH.
Documentation Guidelines ``DG'': The ROS and/or PFSH may be
recorded by ancillary staff or on a form completed by the patient. To
document that the physician reviewed the information, there must be a
notation supplementing or confirming the information recorded by others
(https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf).
We proposed to expand this policy to further simplify the
documentation of history and exam for established patients such that,
for both of these key components, when relevant information is already
contained in the medical record, practitioners would only be required
to focus their documentation on what has changed since the last visit
or on pertinent items that have not changed, rather than re-documenting
a defined list of required elements such as review of a specified
number of systems and family/social history. Practitioners would still
review prior data, update as necessary, and indicate in the medical
record that they had done so. Practitioners would conduct clinically
relevant and medically necessary elements of history and physical exam,
and conform to the general principles of medical record documentation
in the 1995 and 1997 guidelines. However,
[[Page 59635]]
practitioners would not need to re-record these elements (or parts
thereof) if there is evidence that the practitioner reviewed and
updated the previous information.
Comment: Commenters were very supportive of this proposal. Many
commenters included this proposal in a list of appropriate changes CMS
should make immediately regarding documentation of E/M visits,
effective January 1, 2019.
Response: We are finalizing this policy to simplify the
documentation of history and exam for established patients for E/M
office/outpatient visits as proposed, effective January 1, 2019.
Accordingly, when relevant information is already contained in the
medical record, practitioners may choose to focus their documentation
on what has changed since the last visit, or on pertinent items that
have not changed, and need not re-record the defined list of required
elements if there is evidence that the practitioner reviewed the
previous information and updated it as needed. Practitioners should
still review prior data, update as necessary, and indicate in the
medical record that they have done so. We note that this policy to
simplify and reduce redundancy in documentation is optional for
practitioners, and they may choose to continue the current process of
entering, re-entering and bringing forward information (83 FR 35838).
The option to continue current documentation processes may be
particularly important for practitioners who lack time to adjust
workflows, templates and other aspects of their work by January 1,
2019.
We solicited comment on whether there may be ways to implement a
similar provision for any aspects of medical decision-making, or for
new patients, such as when prior data is available to the billing
practitioner through an interoperable EHR or other data exchange. We
stated our belief that there would be special challenges in realizing
documentation efficiencies with new patients, since they may not have
received exams or histories that were complete or relevant to the
current complaint(s), and the information in the transferred record
could be more likely to be incomplete, outdated or inaccurate.
Comment: A few commenters indicated that there might be ways to
recognize some documentation efficiencies for referred new patients or
situations where data are available through an interoperable EHR, but
did not provide detail about what kinds of data are commonly available
and how they might be relevant to the receiving practitioner for
purposes of visit documentation.
Response: We appreciate the commenters' feedback in this area and
will continue to consider this issue.
We similarly proposed that for both new and established patients,
practitioners would no longer be required to re-enter information in
the medical record regarding the chief complaint and history that are
already entered by ancillary staff or the beneficiary. The practitioner
could simply indicate in the medical record that they reviewed and
verified this information. Our goal was to allow practitioners more
flexibility to exercise greater clinical judgment and discretion in
what they document, focusing on what is clinically relevant and
medically necessary for the patient.
Comment: Commenters were very supportive of this proposal. Many
commenters included this proposal in a list of appropriate changes CMS
should make immediately regarding documentation of E/M visits,
effective January 1, 2019.
Response: We are finalizing our proposal that, effective January 1,
2019, for new and established patients for E/M office/outpatient
visits, practitioners need not re-enter in the medical record
information on the patient's chief complaint and history that has
already been entered by ancillary staff or the beneficiary. The
practitioner may simply indicate in the medical record that he or she
reviewed and verified this information. We note that this policy to
simplify and reduce redundancy in documentation is optional for
practitioners, and they may choose to continue the current process of
entering, re-entering and bringing forward information (83 FR 35838).
The option to continue current documentation processes may be
particularly important for practitioners who lack time to adjust
workflows, templates and other aspects of their work by January 1,
2019.
(c) Podiatry Visits
As described in the CY 2019 PFS proposed rule (83 FR 35843), as
part of our proposal to improve payment accuracy by creating a single
PFS payment rate for E/M visit levels 2 through 5 (with one proposed
rate for new patients and one proposed rate for established patients),
we proposed to create separate coding for podiatry visits that are
currently reported as E/M office/outpatient visits. We proposed that,
rather than reporting visits under the general E/M office/outpatient
visit code set, podiatrists would instead report visits under new G-
codes that more specifically identify and value their services. We
proposed to apply substantially the same documentation standards for
these proposed new podiatry-specific codes as we proposed for other
office/outpatient E/M visits.
If a practitioner chose to use time to document a podiatry office/
outpatient E/M visit, we proposed to apply substantially the same rules
as those we proposed for documenting on the basis of time for other
office/outpatient E/M visits. For practitioners choosing to use time to
provide supporting documentation for the podiatry visit, we would
require documentation supporting the medical necessity of the visit and
showing the total amount of time spent by the billing practitioner
face-to-face with the patient. We solicited public comment on what that
total time would be for payment of the proposed new podiatry G-codes.
The typical times for these proposed codes were 22 minutes for an
established patient and 28 minutes for a new patient, and we noted we
could use these times. Alternatively, we noted we could apply the AMA's
CPT codebook provision that, for timed services, a unit of time is
attained when the mid-point is passed,\6\ such that we would require
documentation that at least 12 minutes for an established patient (more
than half of 22 minutes) or at least 15 minutes for a new patient (more
than half of 28 minutes) were spent face-to-face by the billing
practitioner with the patient, to support making payment for these
codes when the practitioner chose to document the visit using time. We
solicited comment on the use of time as a basis for documentation of
our proposed podiatric E/M visit codes, and whether we should adopt any
of these approaches or further specify other requirements with respect
to this proposed option for podiatric practitioners to document their
visits using time.
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\6\ 2017 CPT Codebook Introduction, p.xv.
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Comment: We did not receive any comments on how the proposed
podiatric codes should be documented. A few commenters noted that our
proposal to apply the same documentation rules to the proposed new
podiatric codes as for all other office/outpatient E/M visits
demonstrated that these visits were essentially the same, and that
podiatry should not be singled out for the creation of separate codes.
Response: We believe the absence of comments on our proposals for
documentation of the proposed podiatric codes is due to a lack of
general support for creation of the new
[[Page 59636]]
codes to describe podiatric E/M visits, as noted below in the comment
summary on that topic. As discussed below, we are not finalizing our
proposal to create new codes to describe podiatric E/M visits, and
accordingly, we are not finalizing any rules regarding documentation of
those codes.
(3) Minimizing Documentation Requirements by Simplifying Payment
Amounts
As we have explained above, and in prior rulemaking, we believe
that the coding, payment, and documentation requirements for E/M visits
are overly burdensome and no longer aligned with the current practice
of medicine. We believe the current set of 10 CPT codes for new and
established office-based and outpatient E/M visits and their respective
payment rates no longer appropriately reflect the complete range of
services and resource costs associated with furnishing E/M services to
all patients across the different physician specialties, and that
documenting these services using the current guidelines has become
burdensome and out of step with the current practice of medicine. To
alleviate the effects and mitigate the burden associated with continued
use of the outdated CPT code set, we proposed to simplify the office-
based and outpatient E/M payment rates and documentation requirements,
and create new add-on codes to better capture the differential
resources involved in furnishing certain types of E/M visits.
In conjunction with our proposal to reduce the documentation
requirements for E/M visit levels 2 through 5, we proposed to simplify
the payment for those services by paying a single rate for the level 2
through 5 E/M visits. The visit level of the E/M service is tied to the
documentation requirements in the 1995 and 1997 Documentation
Guidelines for E/M Services, which may not be reflective of changes in
technology or, in particular, the ways that electronic medical records
have changed documentation and the patient's medical record.
Additionally, current documentation requirements may not account for
changes in care delivery, such as a growing emphasis on team based
care, increases in the number of recognized chronic conditions, or
increased emphasis on access to behavioral health care. However, based
on the feedback we have received from stakeholders, it was clear to us
that the burdens associated with documenting the selection of the level
of E/M service arise from not only the documentation guidelines, but
also from the coding structure itself. Like the documentation
guidelines, the distinctions between visit levels reflect a reasonable
assessment of variations in care, effort, and resource costs as
identified and articulated several decades ago. We believed that the
most important distinctions between the kinds of visits furnished to
Medicare beneficiaries are not well reflected by the current E/M visit
coding. Most significantly, we have understood from stakeholders that
current E/M coding does not reflect important distinctions in services
and differences in resources. At present, we believed the current
payment for E/M visit levels, generally distinguished by common
elements of patient history, physical exam, and MDM, that may have been
good approximations for important distinctions in resource costs
between kinds of visits in the 1990s, when the CPT developed the E/M
code set, are increasingly outdated in the context of changing models
of care and information technologies.
As described earlier in this section, we proposed to change the
documentation requirements for E/M levels such that practitioners have
the choice to use the 1995 guidelines, 1997 guidelines, time, or MDM to
determine the E/M level. We believed that these proposed changes would
better reflect the current practice of medicine and represent
significant reductions in burdens associated with documenting visits
using the current set of E/M codes.
In alignment with our proposed documentation changes, we proposed
to develop a single set of RVUs under the PFS for E/M office-based and
outpatient visit levels 2 through 5 for new patients (CPT codes 99202
through 99205) and a single set of RVUs for visit levels 2 through 5
for established patients (CPT codes 99212 through 99215). Although we
considered creating new HCPCS G-codes that would describe the services
associated with these proposed payment rates, given the wide and
longstanding use of these visit codes by both Medicare and private
payers, we believed it would have created unnecessary administrative
burden to propose new coding. Therefore, we instead proposed to
maintain the current code set. Of the five levels of office-based and
outpatient E/M visits, the vast majority of visits are reported as
levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit
level 3 and level 4 for new patients) made up around 32 percent and 44
percent, respectively, of the total allowed charges for CPT codes
99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit
level 3 and 4 for established patients) made up around 39 percent and
50 percent, respectively, of the allowed charges for CPT codes 99211-
99215. If our proposals to simplify the documentation requirements and
to pay a single PFS rate for new patient E/M visit levels 2 through 5
and a single rate for established patient E/M visit levels 2 through 5
were finalized, practitioners would still bill the CPT code for
whichever level of E/M service they furnished and they would be paid at
the single PFS rate. However, we believed that eliminating the
distinction in payment between visit levels 2 through 5 would eliminate
the need to audit against the visit levels, and therefore, would
provide immediate relief from the burden of documentation. A single
payment rate would also eliminate the increasingly outdated distinction
between the kinds of visits that are reflected in the current CPT code
levels in both the coding and the associated documentation rules.
In order to set RVUs for the proposed single payment rate for new
and established patient office/outpatient E/M visit codes, we proposed
to develop resource inputs based on the current inputs for the
individual E/M codes, generally weighted by the frequency at which they
are currently billed, based on the 5 most recent years of Medicare
claims data (CY 2012 through CY 2017). Specifically, we proposed a work
RVU of 1.90 for CPT codes 99202 through 99205, a physician time of
37.79 minutes, and direct PE inputs that sum to $24.98, each based on
an average of the current inputs for the individual codes weighted by 5
years of accumulated utilization data. Similarly, we proposed a work
RVU of 1.22 for CPT codes 99212 through 99215, with a physician time of
31.31 minutes and direct PE inputs that sum to $20.70. These inputs
were based on an average of the inputs for the individual codes,
weighted by volume based on utilization data from the past 5 years (CY
2012 through CY 2017). Tables 19 and 20 reflect the payment rates in
dollars that would result from the approach described above were it to
have been implemented for CY 2018. In other words, the dollar amounts
in the charts below reflect how the changes we proposed for CY 2019
would have impacted payment rates for CY 2018.
[[Page 59637]]
Table 19--Preliminary Comparison of Payment Rates for Office Visits
[New patients]
------------------------------------------------------------------------
CY 2018 non-
CY 2018 facility
non- payment rate
HCPCS code facility under the
payment proposed
rate methodology
------------------------------------------------------------------------
99201......................................... $45 $44
99202......................................... 76 135
99203......................................... 110
99204......................................... 167
99205......................................... 211
------------------------------------------------------------------------
Table 20--Preliminary Comparison of Payment Rates for Office Visits
[Established patients]
------------------------------------------------------------------------
Current
non- Proposed non-
HCPCS code facility facility
payment payment rate
rate
------------------------------------------------------------------------
99211......................................... $22 $24
99212......................................... 45 93
99213......................................... 74
99214......................................... 109
99215......................................... 148
------------------------------------------------------------------------
Although we believed that the proposed rates for E/M visit levels 2
through 5 represent the valuation of a typical E/M service, we also
recognized that the current E/M code set itself does not appropriately
reflect differences in resource costs between certain types of E/M
visits. As a result, we believed that the way we currently value the
resource costs for E/M services through the existing HCPCS CPT code set
for office-based and outpatient E/M visits does not appropriately
reflect the resources used in furnishing the range of E/M services that
are provided through the current the practice of medicine. Based on
stakeholder comments and examples and our review of the literature on
E/M services, we identified three types of E/M visits that differ from
the typical E/M visit and are not appropriately reflected in the
current office/outpatient E/M code set and valuation. Rather, these
three types of E/M visits can be distinguished by the mode of care
provided and, as a result, have different resource costs. The three
types of E/M visits that differ from the typical E/M service are (1)
separately identifiable E/M visits furnished in conjunction with a
global procedure, (2) primary care E/M visits for continuous patient
care, and (3) certain types of specialist E/M visits, including those
with inherent visit complexity. We addressed each of these
distinguishable visit types in the proposed rule.
The following is a summary of the comments we received on the
proposed blended payment rate for new and established office/outpatient
E/M visit levels 2 through 5.
Comment: While many commenters agreed that the current E/M coding
for office/outpatient visits is flawed and some agreed that the current
coding and valuation systematically undervalues primary care visits and
visits furnished in the context of non-procedural specialty care, most
commenters opposed this proposal. Many commenters stated that using a
single payment rate for new and established office/outpatient E/M visit
levels 2 through 5 could have highly variable negative repercussions at
the specialty, practice, and practitioner level. Some commenters
suggested that the proposed single payment rate for these visits was
inherently not resource-based. Many commenters stated that the proposed
single payment rate that did not vary based on patient complexity from
levels 2 through 5 was insufficient to account for the resource
differential associated with treating complex patients, and that,
without accurate payment, physicians would be likely to either schedule
multiple visits or stop taking on complex patients all together.
The few commenters who supported the proposal stated that the
negative payment implications of the single proposed payment rate are
outweighed by the reduction in documentation burden. While
acknowledging that the initial years following adoption of a single
payment rate for the level 2 through 5 E/M visit codes would be
challenging, these commenters noted that over time, potential
reductions in payment would be offset by the time saved from
unnecessary documentation. Other commenters, while urging CMS not to
finalize the proposed single payment rate for these codes, did provide
suggested alternative coding structures. Of these comments, there was a
consensus that three levels of coding for office and outpatient E/M
services is preferable to two, whether that be accomplished through
blended payment rates for levels 2 through 3 and 4 through 5, or
through a blended rate for levels 2 through 4. Most commenters pointed
to the joint CPT/AMA E/M workgroup formed in response to CMS' proposal,
and urged CMS to wait for forthcoming coding and documentation
definitions generated by that group and recommendations regarding
valuation developed through the RUC process.
Response: We appreciate the number and broad range of interested
commenters who responded to our proposal. After reviewing all of the
comments received, we understand the broad consensus regarding the
potential negative implications of the proposal for patients with the
most complex needs and the clinicians who serve them. In attempting to
eliminate the reliance on the current outmoded E/M coding structure as
it is used for purposes of payment, we recognize that the alternative
coding and payment structure we proposed lacked an element that we
agree is critical in making accurate payment: Namely, accounting for
resource costs for the most complex patients. While we believe that our
proposal to address the inherent complexity involved in furnishing
certain kinds of care combined with our proposed payment for visits
that take additional time might have accounted for a significant
portion of the resource costs associated with particularly complex
patients, we recognize the concerns expressed by commenters that these
payment adjustments might be insufficient in some cases. We also
recognize the potential negative consequences to clinicians and access
to care that could result if we do not ensure that coding and payment
appropriately account for patients with the most complex needs.
We do not believe, however, that appropriate care for complex
patients currently requiring visit levels 2 through 4 are nearly as
dependent on the current payment variations for these services. Given
that the significant majority of the volume is concentrated in the
level 3 and 4 new and established patient visits, we believe the
concerns expressed by commenters about potential shifts in practitioner
behavior would be likely to occur. We believe it would simply not be
practical for clinicians to prioritize seeing the relatively few
potential patients requiring level 2 visits in order to maximize their
revenue relative to per patient costs. Likewise, because the level 4
established patient E/M visit is the most commonly reported code among
the 5 levels for both new and established patients, any effort to avoid
treating patients requiring care that is currently reported as a level
4 visit would likely result in significantly reduced volume and overall
revenue for physician practices. We will, however, monitor utilization
of these services and make any necessary adjustments through future
rulemaking. Additionally, we recognize that because level 5 visits
represent a very small proportion of visits reported under current E/M
coding, maintaining
[[Page 59638]]
differential payment rates and documentation for these visits will
strike an appropriate balance, simplifying and reducing the burden in
distinguishing among CPT codes for the vast majority of E/M visits,
while retaining a separate payment rate for the level of care furnished
to the most complex patients.
On that basis, we are finalizing for 2021, a single payment rate
for levels 2 through 4 E/M office/outpatient visits (one rate for new,
and one for established patients) and maintaining separate payment
rates for new and established patients for level 5 E/M office/
outpatient visits to account for the most complex patients and visits.
We are finalizing a policy, modified from our proposal, to develop a
set of single payment rates for visit levels 2 through 4 (one each for
new and established patients), instead of levels 2 through 5, as
proposed. We are finalizing development of payment rates for levels 2
through 4 visits using the weighted average of the current inputs (work
RVUs, direct PE inputs, time and specialty mix) assigned to the
individual codes, based on the most recent 5 years of utilization for
each of the constituent codes. For the level 1 and level 5 office/
outpatient E/M visits we are finalizing payment rates that rely on
current inputs. The inputs we will use (in the absence of intervening
changes to CPT coding or the development of other considerations) to
develop proposed values for these services for 2021 appear in the Table
21.
Table 21--Finalized Inputs for E/M Office/Outpatient Codes for 2021
----------------------------------------------------------------------------------------------------------------
Physician Malpractice Sum of direct
HCPCS time Work RVU RVU PE inputs
----------------------------------------------------------------------------------------------------------------
99201........................................... 17.00 0.48 0.05 $13.97
99202........................................... 34.43 1.76 0.17 24.37
99203........................................... 34.43 1.76 0.17 24.37
99204........................................... 34.43 1.76 0.17 24.37
99205........................................... 67.00 3.17 0.28 30.92
99211........................................... 7.00 0.18 0.01 11.31
99212........................................... 30.26 1.18 0.08 20.41
99213........................................... 30.26 1.18 0.08 20.41
99214........................................... 30.26 1.18 0.08 20.41
99215........................................... 55.00 2.11 0.14 27.83
----------------------------------------------------------------------------------------------------------------
We are also finalizing separate, add-on payments for visit
complexity inherently associated with primary care and non-procedural
specialty care, as well as separate payment for extended visits via
HCPCS G-codes. These codes and the associated policies will be
discussed in greater detail in the discussion below. We recognize that
many commenters, including the AMA, the RUC, and specialties that
participate as members in those committees, have stated intentions of
the AMA and the CPT Editorial Panel to revisit coding for E/M office/
outpatient services in the immediate future. We note that the 2-year
delay in implementation will provide the opportunity for us to respond
to the work done by the AMA and the CPT Editorial Panel, as well as
other stakeholders. We will consider any changes that are made to CPT
coding for E/M services, and recommendations regarding appropriate
valuation of new or revised codes, through our annual rulemaking
process.
(4) Recognizing the Resource Costs for Different Types of E/M Visits
As a corollary to our proposal to adopt a single payment rate for
office and outpatient E/M services for level 2 through 5 E/M visits, we
stated that we could better capture differential resource costs and
minimize reporting and documentation burden by proposing several
additional payment policies and ratesetting adjustments. These
additional proposals were intended to reflect the important
distinctions between the kinds of visits furnished to Medicare
beneficiaries, and to reduce the burden of billing and documentation
rules to effectuate payment.
In response to the CY 2018 comment solicitation on burden reduction
for E/M visits (82 FR 53163 through 53166), we received several
comments that highlighted the inadequacy of the E/M code set to
accurately pay for the resources associated with furnishing visits,
particularly for primary care visits, and visits associated with
treating patients with particular conditions for which there is not
additional procedural coding. One commenter stated that the current
structure and valuation of the E/M code set inadequately describes the
range of services provided by different specialties, and in particular
primary care services. This commenter noted that although the 10
office/outpatient E/M codes make up the bulk of the services reported
by primary care practitioners, the valuation does not reflect their
particular resource costs. Another commenter pointed out that for
specialties that principally rely on E/M visit codes to bill for their
professional services, the complex medical decision making and the
intensity of their visits is not reflected in the E/M code set or
documentation guidelines.
In view of the comments we received, we proposed the following
adjustments to better capture the variety of resource costs associated
with different types of care provided in E/M visits: (1) An E/M
multiple procedure payment adjustment to account for duplicative
resource costs when E/M visits and procedures with global periods are
furnished together; (2) HCPCS G-code add-ons to recognize additional
relative resources for primary care visits and inherent visit
complexity that require additional work beyond that which is accounted
for in the single payment rates for new and established patient levels
2 through level 5 visits; (3) HCPCS G-codes to describe podiatric E/M
visits; (4) an additional prolonged face-to-face services add-on HCPCS
G-code; and (5) a technical modification to the PE methodology to
stabilize the allocation of indirect PE for visit services.
(a) Accounting for E/M Resource Overlap Between Stand-Alone Visits and
Global Periods
Under the PFS, E/M services are generally paid in one of two ways:
As standalone visits using E/M visit codes, or included in global
procedural codes. In both cases, RVUs are allocated to the services to
account for the estimated relative resources involved in furnishing
professional E/M services. In the case of procedural codes with global
periods,
[[Page 59639]]
the overall resource inputs reflect the costs of the E/M work
considered to be typically furnished with the procedure. Therefore, the
standalone E/M visit codes are not billable on the same day as the
procedure codes unless the billing professional specifically indicates
that the visit is separately identifiable from the procedure.
In cases where a physician furnishes a separately identifiable E/M
visit to a beneficiary on the same day as a procedure, payment for the
procedure and the E/M visit is based on rates generally developed under
the assumption that these services are typically furnished
independently. In CY 2017 PFS rulemaking, we noted that the current
valuation for services with global periods may not accurately reflect
much of the overlap in resource costs (81 FR 80209). We were
particularly concerned that when a standalone E/M visit occurs on the
same day as a 0-day global procedure, there are significant overlapping
resource costs that are not accounted for. We believe that separately
identifiable visits occurring on the same day as 0-day global
procedures have resources that are sufficiently distinct from the costs
associated with furnishing one of the 10 office/outpatient E/M visits
to warrant payment adjustment. There are other existing policies under
the PFS where we reduce payments if multiple procedures are furnished
on the same day to the same patient. Medicare has a longstanding policy
to reduce payment by 50 percent for the second and subsequent surgical
procedures furnished to the same patient by the same physician on the
same day, largely based on the presence of efficiencies in PE and pre-
and post-surgical physician work. Effective January 1, 1995, the MPPR
policy, with the same percentage reduction, was extended to nuclear
medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803,
78806, and 78807). In the CY 1995 PFS final rule with comment period
(59 FR 63410), we indicated that we would consider applying the policy
to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS
proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated
that we planned to analyze nonsurgical services commonly furnished
together (for example, 60 to 75 percent of the time) to assess whether
an expansion of the MPPR policy could be warranted. MedPAC encouraged
us to consider duplicative physician work, as well as PE, in any
expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule
with comment period, CMS finalized the application of the MPPR to
always-therapy services on the justification that there was significant
overlap in the PE portion of these services (75 FR 73233).
Using the surgical MPPR as a template, we proposed that, as part of
our proposal to make payment for the E/M levels 2 through 5 at a single
PFS rate, we would reduce payment by 50 percent for the least expensive
global procedure or visit that the same physician (or a physician in
the same group practice) furnishes on the same day as a separately
identifiable E/M visit, currently identified on the claim by an
appended modifier -25. We believed that the efficiencies associated
with furnishing an E/M visit in combination with a same-day global
procedure were similar enough to those accounted for by the surgical
MPPR to merit a reduction in the relative resources of 50 percent. We
estimated that, based on CY 2017 Medicare claims data, applying a 50
percent MPPR to E/M visits furnished as separately identifiable
services on the same day as a global procedure would reduce
expenditures under the PFS by approximately 6.7 million RVUs. To
accurately reflect resource costs of the different types of E/M visits
that we previously identified while maintaining work budget neutrality
within this proposal, we proposed to allocate those RVUs toward the
values of the add-on codes that reflect the additional resources
associated with E/M visits for primary care and inherent visit
complexity, similar to existing policies. As we articulated in the CY
2012 PFS final rule with comment period, where the aggregate work RVUs
within a code family change but the overall actual physician work
associated with those services does not change, we make work budget
neutrality adjustments to hold the aggregate work RVUs constant within
the code family, while maintaining the relativity of values for the
individual codes within that set (76 FR 73105).
Comment: Many commenters opposed this proposal. Commenters
generally objected to the underlying principle of the application of an
MPPR to office/outpatient E/M codes billed on the same day as a minor
procedure. Many of these commenters stated that the current billing
rules allow these services to be billed only when modifier -25 is used,
and that modifier makes it clear that the visits are significant and
separately identifiable. Consequently, these commenters stated that no
payment adjustment should apply. Many commenters pointed to the RUC
review process wherein procedures that are typically furnished with a
same day visit are subject to adjustments to account for any resource
costs that the RUC considers to be typically duplicative. Commenters
stated that by applying an MPPR adjustment to these services, CMS was
making an unwarranted second adjustment to account for efficiencies the
RUC already considers to be addressed. A few commenters stated that CMS
provided insufficient rationale for the choice to propose a 50 percent
payment reduction instead of other potential adjustments. Several
commenters also pointed out that there are a number of 0-day global
procedure codes that are valued not to include any evaluation and
management, such as CPT codes 98925-98929 (Osteopathic manipulative
treatment (OMT)). Commenters urged CMS to exempt these codes from the
MPPR adjustment.
Many commenters, including both physician specialty organizations
and patient advocacy groups, expressed concerns about how physicians
would respond to the financial incentives resulting from the
application of an MPPR adjustment in the context of patient care.
Commenters noted that it is often convenient for both the beneficiary
and the practitioner to address multiple concerns in a single visit.
Many commenters stated that there would be a strong financial incentive
to bring patients back for necessary visits on a different day so as to
avoid triggering the payment reduction. This would result in
inconvenience to the beneficiary, as they would experience treatment
delays and be forced to return for a visit. Some commenters suggested
this approach would result in additional cost sharing for patients.
Several commenters also highlighted programmatic concerns, stating
that an MPPR adjustment would incentivize fractured care and undermine
the goals of patient-centered and value-based care. Commenters also
requested that CMS clarify whether certain other visits, such as the
annual wellness visit, would also be subject to the MPPR adjustment.
Others stated that inconsistent guidance, differing policies, and
varying edits among the MACs would result in confusion and
administrative burden in the implementation of this proposal.
A few commenters, including MedPAC, supported the proposal. MedPAC
stated that when a standalone E/M visit occurs on the same day as a
procedure, there are efficiencies (for example, in pre-service and
post-service clinician work and practice expense) that are not
accounted for in the current payment system. MedPAC concluded
[[Page 59640]]
that applying an MPPR to the procedure or visit would account for these
efficiencies. Additional commenters suggested alternative percentages
for the reduction, such as 5 percent or 25 percent. A few commenters
stated that, if the MPPR were to be implemented, services performed by
primary care specialties such as internal medicine, family practice,
geriatrics, and pediatrics should be exempt.
Response: We appreciate commenters' feedback on this aspect of the
proposal, particularly the comments regarding the potentially
troublesome incentives and undesirable consequences associated with the
financial incentives.
We continue to have significant concerns about the appropriate
payment when codes with global periods, especially 0 and 10-day global
periods, are billed on the same day as an E/M visit. Generally, we
understand that the global codes are valued to include the typical
amount of evaluation and management furnished to patients as part of
the service. We understand that when these codes are reported, the -25
modifier is used with an E/M code to report a significant, separately
identifiable E/M visit that is furnished on the same day. We also note
that the CPT descriptor of the -25 modifier includes language
suggesting that the modifier can be used whenever care beyond the usual
preoperative and postoperative care associated with the procedure is
performed. We note further that the values for global codes are
intended to incorporate the typical amount of pre- and post-operative
care. However, given the CPT description of the -25 modifier, a
separately reportable visit could be billed in any case where the pre-
or post-operative care exceeds the typical amount. In contrast, there
does not appear to be a way to similarly account for cases where the
needs of a particular patient require less than the typical amount of
preoperative and postoperative work.
Although many commenters suggested that the overlapping resource
costs between global codes and E/M visits billed on the same day have
already been accounted for, we are not persuaded by the statements that
the RUC process has achieved this goal, and we agree with MedPAC's
assessment of the significant problem with valuation of codes that
describe global services. We acknowledge and appreciate the efforts of
the RUC to address overlaps when they recognize that a code is usually
reported with a same day E/M visit. However, as observers to the RUC
process, we have noted a general tendency for the RUC to recommend only
minor adjustments in physician time and direct PE inputs to account for
overlap. We also often make adjustments to the RUC recommended
valuation in cases where the agency believes there is overlap between
services frequently billed together that has not been adequately
addressed through the RUC process. More importantly, even if the RUC
valuation process better accounted for the overlapping resource costs,
those adjustments would be made to national valuation of particular
codes based on snapshot, national claims data for a given year, and
would apply to all physicians reporting the services regardless of
whether or not these particular physicians were achieving the
efficiencies that occur when visits are reported on the same day as
codes with global periods. Because this dynamic is an inherent part of
valuation based on the typical case for discrete services, we routinely
prioritize review of high-volume services. However, we believe the
application of this methodology in valuing global services is
particularly problematic because there are several thousand codes with
global periods and it is impractical to conduct these kinds of code-
level reviews as frequently as would be necessary to improve the
accuracy of accounting for these efficiencies.
We agree with commenters that if practitioners began deliberately
scheduling visits on separate days, when they could be furnished
together on the same day, in order to avoid the payment adjustment that
could create a significant undue burden for beneficiaries. We have
heard this concern before regarding other MPPRs. We note that we have
major concerns about this kind of manipulation of patient scheduling,
especially as it relates to the fundamental requirement that Medicare
payment may be made only for reasonable and necessary medical care, and
intend to consider this concern more broadly for future rulemaking.
Because we are obligated to develop PFS payments based on the relative
resources involved in furnishing services, we believe the total of
payments to practitioners for physicians' services from both Medicare
and beneficiaries should reflect efficiencies inherent in furnishing
two services that can be furnished together without prompting
manipulative scheduling practices that result in inconvenience and
potential medical risks to Medicare beneficiaries.
After consideration of the public comments, we recognize that we
must balance concerns about appropriate valuation with the potential
disruptions to patient care suggested by commenters. Though we find the
possible practice of scheduling medical services to maximize payment
without regard to patient needs or costs to be highly problematic, we
take these concerns seriously given the broad-based consensus within
the medical and stakeholder community regarding likely behavioral
changes in response to the proposal. After weighing these concerns, we
are not finalizing the proposal to apply an MPPR to a separately
identifiable office/outpatient E/M visit furnished on the same day as a
global procedure. We intend to consider ways to address the practice of
scheduling patients to avoid payment adjustments in future rulemaking.
Given the variety of comments we received regarding the valuation
of specific codes, especially codes with global periods that are
perceived to include no resource costs associated with evaluation and
management, we intend to reconsider the appropriate global period
assigned to certain services. We welcome stakeholder input regarding
appropriate global period assignment through our routine valuation
processes. We will also continue to consider how to address what we
believe to be a significant problem of accurately accounting for
duplicative resource costs in ways that will protect Medicare
beneficiaries' access to appropriate care.
(b) HCPCS G-Code Add-Ons To Recognize Additional Relative Resources for
Certain Kinds of Visits
The distribution of E/M visits is not uniform across medical
specialties. We have found that certain specialists, like neurologists
and endocrinologists, for example, bill higher level E/M codes more
frequently than procedural specialists, such as dermatologists. We
believed this tendency reflects a significant and important distinction
between the kinds of E/M visits furnished by professionals whose
treatment approaches are primarily reported using visit codes versus
those professionals whose treatment approaches are primarily reported
using available procedural or testing codes. However, based on feedback
we received from the medical professionals who furnish primary care and
have visits with greater complexity, we did not believe the current
visit definitions and the associated documentation burdens are the most
accurate descriptions of the variation in work. Instead, we believed
these professionals have been particularly burdened by the
documentation requirements, given that so much of their medical
treatment is
[[Page 59641]]
described imperfectly by relatively generic visit codes.
Similarly, stakeholders such as the commenters responding to the CY
2018 PFS proposed rule have articulated persuasively that visits
furnished for the purpose of primary care also involve distinct
resource costs. In developing this proposal, we consulted a variety of
resources, including the American Academy of Family Physicians (AAFP)
definition of primary care that states that the resource costs
associated with furnishing primary care services particularly include
time spent coordinating patient care, collaborating with other
physicians, and communicating with patients (see https://www.aafp.org/about/policies/all/primary-care.html). Despite our efforts in recent
years to pay separately for certain aspects of primary care services,
such as through the chronic care management or the transitional care
management services, the currently available coding still does not
adequately reflect the full range of primary care services, nor does it
allow payment to fully capture the resource costs involved in
furnishing a face-to-face primary care E/M visit. We recognized that
primary care services frequently involve substantial non-face-to-face
work, and noted that there is currently coding available to account for
many of those resources, such as chronic care management (CCM),
behavioral health integration (BHI), and prolonged non-face-to-face
services. In light of the existing coding, our proposal only addressed
the additional resources involved in furnishing the face-to-face
portion of a primary care service. As the point of entry for many
patients into the healthcare system, primary care visits frequently
require additional time for communicating with the patient, patient
education, consideration and review of the patient's medical needs. We
believed the proposed value for the single payment rate for the E/M
levels 2 through 5 new and established patient visit codes does not
reflect these additional resources inherent to primary care visits, as
evidenced by the fact that primary care visits are generally reported
using level 4 E/M codes. Therefore, to more accurately account for the
type and intensity of E/M work performed in primary care-focused
visits, we proposed to create a HCPCS add-on G-code that could be
billed with the generic E/M code set to adjust payment to account for
additional costs beyond the typical resources accounted for in the
single payment rate for the levels 2 through 5 visits.
We proposed to create a HCPCS G-code for primary care services,
HCPCS code GPC1X (Visit complexity inherent to evaluation and
management associated with primary medical care services that serve as
the continuing focal point for all needed health care services (Add-on
code, list separately in addition to an established patient evaluation
and management visit)). As we believe a primary care visit is partially
defined by an ongoing relationship with the patient, this code would
describe furnishing a visit to an established patient. HCPCS code GPC1X
could also be reported for other forms of face-to-face care management,
counseling, or treatment of acute or chronic conditions not accounted
for by other coding. We noted that we believed the additional resources
to address inherent complexity in E/M visits associated with primary
care services are associated only with stand-alone E/M visits as
opposed to separately identifiable visits furnished within the global
period of a procedure. Separately identifiable visits furnished within
a global period are identified on the claim using modifier -25, and
would be subject to the MPPR. We noted that we created separate coding
that describes non-face-to-face care management and coordination, such
as CCM and BHI; however, these services describe non-face-to-face care
and can be provided by any specialty as long as they meet the
requirements for those codes. HCPCS code GPC1X was intended to capture
the additional resource costs, beyond those involved in the base E/M
codes, of providing face-to-face primary care services for established
patients. HCPCS code GPC1X would be billed in addition to the E/M visit
for an established patient when the visit includes primary care
services. For HCPCS code GPC1X, we proposed a work RVU of 0.07,
physician time of 1.75 minutes, no direct PE inputs, and an MP RVU of
0.01. This proposed valuation accounted for the additional resource
costs associated with furnishing primary care that distinguishes E/M
primary care visits from other types of E/M visits, and would maintain
work budget neutrality across the office/outpatient E/M code set.
Furthermore, the proposed add-on G-code for primary care-focused E/M
services would help to mitigate potential payment instability that
could result from our adoption of single payment rates that apply for
E/M code levels 2 through 5. As this add-on G-code would account for
the inherent resource costs associated with furnishing primary care E/M
services, we anticipated that it would be billed with every primary
care-focused E/M visit for an established patient. Although we expected
that this code would mostly be utilized by the primary care
specialties, such as family practice or pediatrics, we were also aware
that, in some instances, certain specialists function as primary care
practitioners--for example, an OB/GYN or a cardiologist. Although the
definition of primary care is widely agreed upon by the medical
community and we intended for this G-code to account for the resource
costs of performing those types of visits, regardless of Medicare
enrollment specialty, we also solicited comment on how best to identify
whether or not a primary care visit was furnished, particularly in
cases where a specialist is providing those services. For especially
complex patients, we also expected that this G-code would be billed
alongside the new code we proposed for prolonged E/M services described
later in this section.
We also solicited comment on whether this policy adequately
addresses the deficiencies in CPT coding for E/M services in describing
current medical practice, and concerns about the impact on payment for
primary care and other services under the PFS.
We also proposed to create a HCPCS G-code to be reported with an E/
M service to describe the additional resource costs for specialty
professionals for whom E/M visit codes make up a large percentage of
their overall allowed charges and whose treatment approaches we
believed are generally reported using the level 4 and level 5 E/M visit
codes rather than procedural coding. Due to these factors, the proposed
single payment rate for E/M levels 2 through 5 visit codes would not
necessarily reflect the resource costs of those types of visits.
Therefore, we proposed to create a new HCPCS code GCG0X (Visit
complexity inherent to evaluation and management associated with
endocrinology, rheumatology, hematology/oncology, urology, neurology,
obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology,
or interventional pain management-centered care (Add-on code, list
separately in addition to an evaluation and management visit)). Given
their billing patterns, we believed that these are specialties that
apply predominantly non-procedural approaches to complex conditions
that are intrinsically diffuse to multi-organ or neurologic diseases.
Although some of these specialties are surgical in nature, we believed
these surgical specialties are providing increased non-procedural care
of high complexity in the Medicare population. The high complexity of
these services is reflected
[[Page 59642]]
in the large proportion of level 4 and level 5 visits that we believed
are reported by these specialties, and the extent to which E/M visits
are a high proportion of these specialties' total allowed charges.
Consequently, these are specialties for which the resource costs of the
visits they typically perform are not fully captured in the proposed
single payment rate for the levels 2 through level 5 office/outpatient
visit codes. When billed in conjunction with standalone office/
outpatient E/M visits for new and established patients, the combined
valuation more accurately accounts for the intensity associated with
higher level E/M visits. To establish a value for this add-on service
to be applied with a standalone E/M visit, we proposed a crosswalk to
75 percent of the work and time of CPT code 90785 (Interactive
complexity), which would result in a work RVU of 0.25, no direct PE
inputs, and an MP RVU of 0.01, as well as 8.25 minutes of physician
time based on the CY 2018 valuation for CPT code 90785. Interactive
complexity is an add-on code that may be billed when a psychotherapy or
psychiatric service requires more resources due to the complexity of
the patient. We believed that the proposed valuation for CPT code 90785
would be an accurate representation of the additional work associated
with the higher level complex visits. We noted that we believed the
additional resources to address inherent complexity in E/M visits are
associated with stand-alone E/M visits. Additionally, we acknowledged
that resource costs for primary care are reflected with the proposed
HCPCS code GPC1X, as opposed to the proposed HCPCS code GCG0X. We note
that there are additional codes available that include face-to-face and
non-face-to-face work, depending on the code, that previously would
have been considered part of an E/M visit, such as the codes for CCM,
BHI, and CPT code 99483 (Assessment of and care planning for a patient
with cognitive impairment, requiring an independent historian, in the
office or other outpatient, home or domiciliary or rest home, with all
of the following required elements: Cognition-focused evaluation
including a pertinent history and examination; Medical decision making
of moderate or high complexity; Functional assessment (e.g., basic and
instrumental activities of daily living), including decision-making
capacity; Use of standardized instruments for staging of dementia
(e.g., functional assessment staging test [FAST], clinical dementia
rating [CDR]); Medication reconciliation and review for high-risk
medications; Evaluation for neuropsychiatric and behavioral symptoms,
including depression, including use of standardized screening
instrument(s); Evaluation of safety (e.g., home), including motor
vehicle operation; Identification of caregiver(s), caregiver knowledge,
caregiver needs, social supports, and the willingness of caregiver to
take on caregiving tasks; Development, updating or revision, or review
of an Advance Care Plan; Creation of a written care plan, including
initial plans to address any neuropsychiatric symptoms, neuro-cognitive
symptoms, functional limitations, and referral to community resources
as needed (e.g., rehabilitation services, adult day programs, support
groups) shared with the patient and/or caregiver with initial education
and support. Typically, 50 minutes are spent face-to-face with the
patient and/or family or caregiver), which were developed to reflect
the additional work of those practitioners furnishing primary care
visits. Likewise, we proposed that practitioners in the specialty of
psychiatry would not use either add-on code because psychiatrists may
utilize CPT code 90785 to describe work that might otherwise be
reported with a level 4 or level 5 E/M visit.
Given the broad scope of our proposals related to E/M services, we
solicited feedback on any unintended consequences of those proposals.
We also solicited comment on any other concerns related to primary care
that we might consider for future rulemaking.
Comment: Many commenters stated that CMS needed to clarify the
definition of primary care services that would fall under the scope of
the primary care complexity add-on.
Some commenters suggested that ambiguity around the definition of
the primary care add-on would create additional documentation burden
and concern regarding audit risk. For example, many commenters
presented examples of physicians of many different specialties
furnishing particular services that might be considered to be primary
care, such as when a dermatologist prescribes an anti-hypertensive
medication, and what documentation would be required to justify billing
of the add-on code.
In response to CMS' solicitation for accepted definitions of
primary care, the AAFP stated that primary care services are performed
by practitioners ``specifically trained for and skilled in
comprehensive first contact and continuing care for persons with any
undiagnosed sign, symptom, or health concern.'' The primary care
physician ``provides definitive care to the undifferentiated patient at
the point of first contact and takes continuing responsibility for
providing the patient's comprehensive care.'' Because the definition of
a primary care service hinges on the ongoing relationship with the
patient, the AAFP recommended that the add-on code not be limited to
established patients, but expanded to new patients when the physician
has an expectation that an ongoing relationship will develop.
In response to CMS' request for comment on the circumstances when
it would be appropriate for a specialist to bill for primary care
services, the AAFP stated that while physicians who are not trained in
the core primary care specialties can provide services focused on
``specific patient care needs related to prevention, health
maintenance, acute care, chronic care, or rehabilitation'' but not
within the context of ``comprehensive, first contact, and continuing
care.'' Therefore, the AAFP stated that these practitioners were not
providing primary care.
Response: We are appreciative of the concerns commenters shared
regarding the potential risks of ambiguity in knowing when the code, as
proposed, would be appropriately reported, and how the documentation
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with primary
care visits was intended to account for appropriate resource variation
between primary care and other kinds of visits without imposing
additional documentation to justify its being reported for each and
every visit with a beneficiary. We note that this proposal was in
keeping with our longstanding assessment that there are certain
complexities inherent in furnishing some kinds of E/M visits that the
current E/M coding and visit levels do not fully recognize. We also
believe that in almost all cases where physicians and other
professionals are furnishing primary care, information already in the
medical record or on the claim, such as physician specialty, diagnosis
codes, other service codes billed (chronic care or transitional care
management services), or patient relationship codes would serve as
sufficient documentation that the furnished visit met the primary care
description. For example, we would expect that most practitioners
enrolled in such specialties as family medicine, internal medicine,
pediatrics, and geriatrics would be billing the primary care visit
complexity add-on with every office/outpatient E/M visit. The visits
themselves would still need to be
[[Page 59643]]
medically reasonable and necessary in order for the practitioner to
report the service, and the documentation would need to illustrate
medical necessity of the visit, but we believe the appropriateness of
using the primary care add-on to the visit would not necessitate
additional documentation. We also agree with the AAFP that billing this
code should not be limited to established patients, as a primary care
visit may also be a new patient visit where the expectation of an
ongoing relationship is present.
For example, a 68-year-old woman with progressive congestive heart
failure (CHF), diabetes and gout on multiple medications transfers care
to a new primary care clinician. During a visit to establish care, the
clinician discusses the patient's current health issues that includes
confirmation that her CHF symptoms have remained stable over the past 3
months. She also denies symptoms to suggest hyper or hypoglycemia, but
does note pain in her right wrist and knee. Based on the patient's
history, physical exam findings and discussion, the clinician adjusts
the dosage of some of the patient's medications, instructs the patient
to take acetaminophen for her joint pain, request copies of prior
diagnostic studies from his former providers, and orders laboratory
tests to assess glycemic control, metabolic status and kidney function.
The practitioner also discusses age appropriate prevention with the
patient and orders a pneumonia vaccination and screening colonoscopy.
In this case, since the practitioner is furnishing care for
conditions across a spectrum of diagnoses and organ systems and
coordinating the patient's care among multiple health care providers,
the practitioner would report the primary care resource add-on with the
appropriate E/M code. We anticipate that the issues addressed by a
physician will often track with the physician's specialty training.
Therefore, it would not be unexpected for this physician to be
reporting the primary care resource add-on code for almost all E/M
visits, provided they are furnishing primary care during those visits.
We would expect that claims records would include the billing
physician's specialty and that the medical record would include the
diagnoses for the patient, and the clinician's assessment and plan for
that visit. This information would serve as sufficient documentation
that the furnished visit met the primary care complexity description
and so there would be no need to provide additional documentation.
We agree with AAFP that the vast majority of visits billed with the
primary care complexity add-on would be performed by the previously
mentioned specialties; however, we also recognize that there is not
consensus among medical specialties on this definition. We also believe
that there are clinical scenarios when a specialist may perform primary
care. For example:
A cardiologist serving beneficiaries in a rural location provides
care for complex cardiac conditions as well as primary care in her
clinical practice. This practitioner sees a 75-year-old female with
hypertension, coronary artery disease, and osteoarthritis for routine
follow up care. During the visit, the patient describes a worsening
pain in her hip and dizziness for the past month. The clinician notes
gait instability and painful motion of her hip, and significant
orthostasis upon standing. The clinician observes that the patient has
made errors in filling her pill box, and has a new counter anti-
histamine that the patient obtained from her friend to help with sleep.
The clinician conducts a brief cognitive test, ascertains that the
patient had not fallen, and recommends stopping the anti-cholinergic
medication, and adjustment of her blood pressure medications with close
follow-up monitoring. In addition to reviewing the patients' cardiac
status, initiating imaging to evaluate the hip, the clinician also
recommends a home safety evaluation and schedules a follow-up visit to
include her adult daughter who lives nearby. In this case, since the
clinician is furnishing primary care services as well as specialty
cardiology services, the physician would appropriately be reporting the
primary care complexity add-on in addition to the appropriate E/M visit
code. We would expect that the claims record would include the billing
physician's specialty. The medical record would also include the
diagnoses for the patient and clinician's assessment and plan for that
visit.
This information would serve as sufficient documentation that the
furnished visit met the primary care and non-procedural specialty care
complexity adjustment descriptions and so there would be no need to
provide additional documentation.
Comment: Some commenters supported the creation of an add-on code
for primary care visit complexity, but pointed out that, as proposed,
the primary care add-on code was significantly undervalued,
particularly in comparison to the add-on code for visit complexity
associated with specialty care. Commenters were critical of the
approach CMS used to value the proposed primary care add-on code. A few
commenters suggested that CMS should equalize the values between the
two add-on codes.
The AAFP did not support the add-on code, and instead suggested
that CMS provide a 15 percent increase in payment to physicians who
list their primary practice designation as family medicine, internal
medicine, pediatrics, or geriatrics.
Response: The proposed valuation for the primary care complexity
add-on code was based on the application of family budget neutrality to
the proposed changes in other codes and payment policies--most notably
applying an MPPR to E/M office/outpatient visit codes furnished in the
same day as a procedure. While we continue to believe that budget
neutrality within the code family can be an appropriate approach to
assess relative resources under the PFS, we appreciate and agree with
commenters' concerns regarding the asymmetry between the proposed
values for the add-on codes for non-procedural specialty care
complexity and primary care complexity. We also note that we are not
finalizing the proposed multiple procedure payment adjustment for these
E/M office/outpatient visit codes.
Comment: Many commenters did not support separate payment for an
add-on code to account for the resource costs for the inherent
complexity associated with furnishing non-procedural specialty visits.
Commenters assumed that billing the visit complexity add-on code was
limited to the specialties included in the code descriptor,
constituting specialty-specific payment prohibited by statute.
Commenters also stated that CMS was unclear about the rationale for
which specialties were included in the code descriptor, and that the
explanation provided was ambiguous and not clinically derived. Several
commenters expressed concern that CMS did not include the work of a
number of specialties that routinely furnish non-procedural specialist
care and that primarily report that care through the office/outpatient
E/M code set. Many commenters representing these specialties requested
that CMS include them in the code descriptor. These include:
Nephrology, infectious disease, gastroenterology, psychiatry,
ophthalmology, pediatric ophthalmology, orthopedic surgery, sports
medicine, neuro-ophthalmology, hepatology, interventional radiology,
pulmonology, dermatology, medical oncology, Hematopoietic Cell
Transplantation and Cellular Therapy (HCTCT), hospice, and palliative
medicine. Some commenters also noted
[[Page 59644]]
that nurse practitioners are frequently specialized and recommended
that they be eligible to bill for the specialty complexity add-on. A
few commenters stated that Medicare enrollment specialty was a poor
proxy for patient complexity, and that instead, CMS should rely on the
patient's diagnosis. Several commenters did not agree with the proposed
values for the add-on code, but none provided alternatives for CMS to
consider.
Many commenters were also concerned about the documentation
requirements that would be associated with the new coding, stating that
CMS was replacing the burden of documenting the level of E/M visit with
the burden of documenting proper use of the visit complexity add-ons. A
few commenters did support the add-on codes in concept as a useful way
of adjusting payment for different types of visits, although several
commenters pointed out that the add-on codes were not valued
sufficiently to overcome any reduction in payment due to the proposed
single payment rate for visit levels. Commenters requested that CMS
clarify whether the add-on codes could be billed concurrently for the
same visit.
Response: We are appreciative of the concerns commenters shared
regarding the potential risks of ambiguity in knowing when the code, as
proposed, would be appropriately reported, and how the documentation
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with non-
procedural specialty care visits was intended to account for
appropriate resource variation between non-procedural specialty care
and other kinds of visits without imposing additional documentation to
justify its being reported for each and every visit with a beneficiary.
We noted that this proposal was in keeping with our longstanding
assessment that there are certain complexities inherent in furnishing
some kinds of E/M visits that the visit levels do not fully recognize.
We also believed that in almost all cases where physicians and other
professionals are furnishing specialty care that is centered around
separately reportable office/outpatient visit codes (as opposed to
procedural codes with global periods, for example), information already
in the medical record or in the claims history for that practitioner,
such as physician specialty, diagnosis codes, and/or other service
codes billed (chemotherapy administration) would serve as sufficient
documentation that the furnished visit met the description of non-
procedural specialty care. For example, we would expect that most
practitioners enrolled in the specialties used as descriptive examples
in the proposed descriptor would report the complexity add-on with
every office/outpatient E/M visit. The visits themselves would still
need to be medically reasonable and necessary in order for the
practitioner to report the service, and the documentation would need to
illustrate medical necessity of the visit, but we believe the
appropriateness of routinely using the add-on to the visit would not
necessitate additional documentation for each and every visit.
A clinical scenario for the use of this proposed add-on code would
be a 72-year-old female with colon cancer who sees her oncologist to
discuss her treatment plan, including surgical and chemotherapeutic
options. Since this E/M visit focuses on oncologic care, the physician
would report the specialty care add-on in addition to the appropriate
E/M visit code. It would not be unexpected for this physician to be
reporting the non-procedural specialty care complexity add-on code for
almost all E/M visits, provided they are providing oncologic care
during those visits. We would expect that the claims record would
include the billing physician's specialty. The medical record would
also include the diagnoses for the patient and clinician's assessment
and plan for that visit. This information would serve as sufficient
documentation that the furnished visit met the description of non-
procedural specialty care complexity and so there would be no need to
provide additional documentation.
We also agree with commenters that the code descriptor omitted
several specialties that provide this type of visit, such as
nephrology, psychiatry, pulmonology, infectious disease, and hospice
and palliative care medicine. We also believe that there are
circumstances where specialties not included in the code descriptor
would appropriately bill this add-on code for inherent visit
complexity. As discussed previously, appropriate reporting of the
specialty care resource add-on code should be apparent based on the
nature of the clinical issues addressed at the E/M visit, and not
limited by the practitioner's specialty.
In cases where appropriate reporting of the add-on code is not as
apparent, we understand that some degree of visit-specific
documentation might be necessary for purposes of demonstrating that the
add-on code was reported appropriately. For example, a physician
enrolled in Medicare as a pathologist may serve a broader role in a
rural community, including furnishing primary care. In this instance,
we expect that there would be documentation in the medical record to
illustrate that it was appropriate for this physician to bill using the
primary care complexity add-on. However, we do not believe that such
scenarios would represent the majority of instances of appropriate use
of the code. Additionally, we note that information usually included in
medical documentation, combined with diagnosis coding, would likely
suffice for purposes of documentation.
After consideration of the comments, we are finalizing for 2021 the
proposal to introduce add-on codes that would adjust payment for new
and established E/M office/outpatient visits to account for inherent
complexity in primary care and non-procedural specialty care. We are
finalizing the code descriptor for the add-on code for inherent
complexity of E/M furnished primary care (HCPCS code GPC1X) as
described in Table 22. We are also finalizing the code descriptor for
the add-on code for inherent complexity of E/M furnished with non-
procedural specialty care (HCPCS code GCG0X) in Table 22, and we note
that we have included refinements to refer to additional kinds of non-
procedural specialty care as suggested by commenters and clarifying
that it could be reported for both new and established patients. We
note that we are not including in the descriptor references to
specialty care that routinely involves significant procedural
interventions, such as interventional radiology and dermatology, since
we do not agree with commenters that these kinds of specialty care are
routinely considered to be ``non-procedural specialist care.'' However,
we note that when clinical circumstances support it, practitioners not
enrolled among the specialties expressly listed within the code
descriptor may bill the inherent visit complexity add-on codes. We are
also finalizing as proposed the code descriptor for inherent complexity
of E/M furnished with primary care (HCPCS code GPC1X) with the
refinement of including that it could be reported for both new and
established patients. The add-on codes to account for inherent
complexity in primary care and non-procedural specialty care could only
be reported with E/M office/outpatient levels 2 through 4 visits. We
note that for this and the other HCPCS G-codes we are finalizing for CY
2021, we are retaining the placeholder HCPCS code numbers until they
are replaced through our standard process.
[[Page 59645]]
Table 22--Finalized Code Descriptors for Visit Complexity Add-Ons
------------------------------------------------------------------------
HCPCS Descriptor
------------------------------------------------------------------------
GPC1X........................ Visit complexity inherent to evaluation
and management associated with primary
medical care services that serve as the
continuing focal point for all needed
health care services (Add-on code, list
separately in addition to level 2
through 4 office/outpatient evaluation
and management visit, new or
established).
GCG0X........................ Visit complexity inherent to evaluation
and management associated with non-
procedural specialty care including
endocrinology, rheumatology, hematology/
oncology, urology, neurology, obstetrics/
gynecology, allergy/immunology,
otolaryngology, interventional pain
management, cardiology, nephrology,
infectious disease, psychiatry, and
pulmonology (Add-on code, list
separately in addition to level 2
through 4 office/outpatient evaluation
and management visit, new or
established).
------------------------------------------------------------------------
We again note that we are finalizing the add-on codes for primary
care and non-procedural specialized care complexity adjustment, as well
as other payment and coding changes to be implemented for E/M office/
outpatient visits for CY 2021. We are specifying the later date, in
great part, so that we have an opportunity to fully consider public
comments and other important input from stakeholders on potential
refinements in code and service definitions that can be used with ease,
when appropriate, and by practitioners whom we currently believe are
disproportionately burdened under the current coding and documentation
requirements and, more generally, other important information involving
coding and payment for E/M services.
After considering the public comments, we agree that the complexity
associated with furnishing a primary care visit is equivalent to that
associated with furnishing a non-procedural specialty care visit, and
therefore, the two codes should be valued equally. We are finalizing,
for 2021, the input values for these two codes as reflected in Table
23.
We note that these inputs reflect our proposed valuation of the
non-procedural specialty complexity code, based on a modified crosswalk
from CPT code 90785 as discussed in the CY 2019 PFS proposed rule (83
FR 35842).
Table 23--Inputs for HCPCS Codes GCG0X and GPC1X Finalized for 2021
------------------------------------------------------------------------
Physician
HCPCS time Work RVU MP RVU
------------------------------------------------------------------------
GCG0X............................ 8.25 0.25 0.02
GPC1X............................ 8.25 0.25 0.02
------------------------------------------------------------------------
We also note that, while our policy will result in our inclusion of
these input values in developing proposed rates for CY 2021, we also
recognize that we routinely accept recommendations from the RUC and
other stakeholders regarding appropriate valuation for PFS services,
and would consider such recommendations regarding appropriate valuation
for these services under our usual, annual process for receiving
recommendations for PFS services.
In response to the commenters' concerns regarding the interactions
between this code and the other codes that describe more complex E/M
visits, we are clarifying that these add-on codes are intended to serve
as a corollary to the single payment rate for E/M office/outpatient
visit codes defined as levels 2 through 4 to provide for more
appropriate recognition of the variations in resources involved in
furnishing those services, and not to be used in association with E/M
office/outpatient level 1 or level 5 visits.
While we believe that in most cases practitioners would only be
reporting either the primary care complexity code or non-procedural
specialty care complexity code, we believe there are some very rare
circumstances where use of both codes might be appropriate. We return
to our example of the cardiologist serving beneficiaries in a rural
location who provides care for complex cardiac conditions as well as
primary care in her clinical practice. Since the needs of the community
prompt this physician to provide primary care services as well as
specialty cardiology services, we would expect that she would report
the primary care complexity add-on code and non-procedural specialty
care complexity add-on code in addition to the appropriate E/M visit
code when both primary care and non-procedural specialty care are
furnished in connection with E/M visits.
(c) HCPCS G-Coded To Describe Podiatric E/M Visits
As described earlier, the vast majority of podiatric visits are
reported using lower level E/M codes, with most E/M visits billed at a
level 2 or 3, reflecting the type of work done by podiatrists as part
of an E/M visit. Therefore, while the proposed consolidation of
documentation and payment for E/M code levels 2 through 5 was intended
to better reflect the universal elements of E/M visits across
specialties and patients, we believed that podiatric E/M visits were
not accurately represented by the consolidated E/M structure. In order
for payment to reflect the resource costs of podiatric visits, we
proposed to create two HCPCS G codes, HCPCS codes GPD0X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, new patient) and GPD1X (Podiatry
services, medical examination and evaluation with initiation of
diagnostic and treatment program, established patient), to describe
podiatric E/M services. Under this proposal, podiatric E/M services
would be billed using these G-codes instead of the generic office/
outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211
through 99215). We proposed to create these separate G-codes for
podiatric E/M services to differentiate the resources associated with
podiatric E/M visits rather than propose a negative add-on adjustment
relative to the proposed single payment rates for the generic E/M
levels 2 through 5 codes. Therefore, we proposed to create separate
coding to describe these services, taking into account that most
podiatric visits are billed as level 2 or 3 E/M codes. We based the
coding structure and code descriptor on CPT codes 92004
(Ophthalmological services: Medical examination and evaluation with
initiation of diagnostic and treatment program; comprehensive, new
patient, 1 or more visits) and 92012
[[Page 59646]]
(Ophthalmological services: Medical examination and evaluation, with
initiation or continuation of diagnostic and treatment program;
intermediate, established patient), which describe visits specific to
ophthalmology. To accurately reflect payment for the resource costs
associated with podiatric E/M visits, we proposed a work RVU of 1.35, a
physician time of 28.11 minutes, and direct PE inputs totaling $22.53
for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.60
minutes, and direct PE inputs totaling $17.07 for HCPCS code GPD1X.
These values were based on the average rate for the level 2 and 3 E/M
codes (CPT codes 99201-99203 and CPT codes 99211-99212, respectively),
weighted by podiatric volume.
Comment: Commenters opposed making separate payment for podiatric
E/M visits using distinct coding. Commenters stated that, by creating
separate coding and payment to describe these types of visits, CMS was
singling out podiatrists and devaluing podiatric physicians' status
among their peer physicians. Some commenters questioned the legality of
our proposal since it would effectively pay physicians of different
specialties different amounts for services that CPT considers to be the
same. Furthermore, commenters stated that the proposed rates for
podiatric E/M visits did not reflect the resource costs associated with
providing podiatric care. Commenters also objected to the use of the
ophthalmology visit codes as a precedent, stating that the significant
practice expense associated with ophthalmologic visits was the impetus
for separate coding for those services.
Response: Based on our consideration of the information presented
by commenters, we are persuaded that there could be a perceived
devaluation of the breadth and value of care associated with podiatric
visits by use of separate coding for these visits. Given these
potential negative consequences, we are not finalizing the proposal to
adopt separate coding for podiatric E/M visits. However, as our
discussion in the preceding sections reflects, we do not agree with the
commenters that all office/outpatient visits furnished by physicians
are only distinguishable by visit levels under the current CPT
definitions. Instead, we believe that, like procedural services, visit
services and their associated relative resource costs can vary greatly
by the kind of care that is provided by particular physicians. We also
believe that physician specialties can often reflect different
approaches to medical care, and that the nomenclature used to describe
and define various clinical specialties is useful for purposes of
distinguishing among the types of services, including visits, furnished
by physicians using these different approaches.
We also acknowledge that our proposal should have clearly
articulated that we were not proposing to prohibit podiatrists from
reporting the E/M office/outpatient visit codes under circumstances
where those codes more accurately described visits with particular
patients or, more broadly, visits generally furnished by particular
podiatrists.
We also would like to note that our analysis of claims data
indicates that the vast majority of podiatric visits are reported as
level 2 and 3 visits. We believe that these claims data are an
important piece of evidence regarding the relative resource costs of
office/outpatient visits that are podiatric in nature. Therefore, we do
not agree with the commenters that stated that our proposal did not
reflect resource-based valuation, since we consider Medicare claims
data to be one of the best sources of data regarding the resources
involved in furnishing PFS services.
After considering the comments regarding this proposal, we are not
finalizing our proposal to create separate coding for podiatric E/M
services and establish payment rates for podiatric E/M visits based on
historical billing patterns. We acknowledge the commenters' concerns
that creating specific coding as we proposed could suggest a
devaluation of services furnished by podiatrists. Therefore, we are not
finalizing creation of specific coding and payment values for podiatric
E/M visits. For CY 2021, podiatric E/M visits would be reported and
paid using the E/M coding and payment structure applicable to other E/M
office/outpatient visits.
(d) Adjustment to the PE/HR Calculation
As we explain in section II.B. of this final rule, Determination of
Practice Expense (PE) Relative Value Units (RVUs), we generally
allocate indirect costs for each code on the basis of the direct costs
specifically associated with a code and the greater of either the
clinical labor costs or the work RVUs. Indirect expenses include
administrative labor, office expense, and all other PEs that are not
directly attributable to a particular service for a particular patient.
Generally, the proportion of indirect PE allocated to a service is
determined by calculating a PE/HR based upon the mix of specialties
that bill for a service.
As described earlier, E/M visits comprise a significant portion of
allowable charges under the PFS and are used broadly across specialties
such that our proposed changes can greatly impact the change in payment
at the specialty level and at the practitioner level. Our proposals
sought to simplify payment for E/M visit levels 2 through 5, and to
additionally take into consideration that there are inherent
differences in primary care-focused E/M services and in more complex E/
M services such that those visits involve greater relative resources,
while seeking to maintain overall payment stability across specialties.
However, establishing a single PFS rate for new and established patient
E/M levels 2 through 5 would have a large and unintended effect on many
specialties due to the way that indirect PE is allocated based on the
mixture of specialties that furnish a service. The single payment rates
proposed for E/M levels 2 through 5 could not reflect the indirect PE
previously allocated differentially across those 8 codes. Historically,
a broad blend of specialties and associated PE/HR has been used in the
allocation of indirect PE and MP RVUs to E/M services to determine
payment rates for these services. As this proposal would have
significantly altered the PE/HR allocation for the office/outpatient E/
M codes and any previous opportunities for the public to comment on the
data would not have applied to these kinds of E/M services, we did not
believe it was in the public interest to allow the allocation of
indirect PE to have such an outsized impact on the payment rates for
this proposal. Due to the magnitude of the proposed coding and payment
changes for E/M visits, it was unclear how the distribution of
specialties across E/M services would change. We were concerned that
such changes could produce anomalous results for indirect PE
allocations since we did not yet know the extent to which specialties
would utilize the proposed simplified E/M codes and proposed G-codes.
In the past, when utilization data are not available or do not
accurately reflect the expected specialty mix of a new service, we have
proposed to crosswalk the PE/HR value from another specialty (76 FR
73036). As such, we proposed to create a single PE/HR value for E/M
visits (including all of the proposed HCPCS G-codes discussed above) of
approximately $136, based on an average of the PE/HR across all
specialties that bill these E/M codes, weighted by the volume of those
specialties' allowed E/M services. We believed that this was consistent
with
[[Page 59647]]
the methodology used to develop the inputs for the proposed simplified
E/M payment for the levels 2 through 5 E/M visit codes, and that, for
purposes of consistency, the new PE/HR should be applied across the
additional E/M codes. We believed a new PE/HR value would more
accurately reflect the mix of specialties billing both the generic E/M
code set and the add-on codes. If we finalized this proposal, we would
have considered revisiting the PE/HR after several years of claims data
become available.
The following is a summary of the comments we received on this
proposal.
Comment: Many commenters noted that the application of a single PE/
HR value to E/M visit codes had significant, if unintended,
consequences for the allocation of indirect PE across the PFS.
Commenters also stated that CMS did not provide enough information as
to how we arrived at the PE/HR value, which resulted in difficulty
among external stakeholders in modeling the proposal.
Response: We appreciate commenters highlighting the broad
ramifications of this proposal.
After consideration of these comments, we will not be finalizing a
separate PE/HR for office/outpatient E/M visits.
(e) HCPCS G-Code for Extended Visit Services
Time is often an important determining factor in the level of care,
which we consider in our proposal described earlier that physicians and
other practitioners can use time as the basis for documenting and
billing the appropriate level of E/M visit for purposes of Medicare
payment. Currently there is inadequate coding to describe services
where the primary resource of a service is physician time. CPT codes
99354 (Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; first hour (List separately in addition to
code for office or other outpatient Evaluation and Management or
psychotherapy service)) and 99355 (Prolonged evaluation and management
or psychotherapy service(s) (beyond the typical service time of the
primary procedure) in the office or other outpatient setting requiring
direct patient contact beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service))
describe additional time spent face-to-face with a patient and may be
billed when the applicable amount of time exceeds the typical service
time of the primary procedure.
Stakeholders have informed CMS that the ``first hour'' time
threshold in the descriptor for CPT code 99354 is difficult to meet and
is an impediment to billing these codes (81 FR 80228). In response to
stakeholder feedback and as part of our proposal to implement a single
payment rate for E/M visit levels 2 through 5 while maintaining payment
accuracy across the specialties, we proposed to create a new HCPCS code
GPRO1 (Prolonged evaluation and management or psychotherapy service(s)
(beyond the typical service time of the primary procedure) in the
office or other outpatient setting requiring direct patient contact
beyond the usual service; 30 minutes (List separately in addition to
code for office or other outpatient Evaluation and Management or
psychotherapy service)). Given that the physician time of HCPCS code
GPRO1 is half of the physician time assigned to CPT code 99354, we
proposed a work RVU of 1.17, which is half the work RVU of CPT code
99354.
Comment: Many commenters, including the AMA, were supportive of the
creation of this code in isolation from the rest of the E/M coding and
payment proposals. Other commenters stated that the code was
unnecessary, that current coding was sufficient to account for
additional time spent with patients, and that it was unrealistic to
expect that most physicians would be able to meet the time threshold in
enough volume to offset the negative impacts of the single payment rate
for E/M office/outpatient new and established patient visit levels 2
through 5. Some commenters suggested more documentation would be
necessary to bill this new code. Many commenters also stated that
referring to this code as ``prolonged services'' was inconsistent with
coding conventions and CPT definitions, as the CPT Editorial Panel
defined prolonged services as an unusual amount of time spent beyond
the typical time and these commenters understood from the proposal that
the code was intended to be reported more frequently. Many commenters
stated that it would be difficult to assess how the code might be used
without more specific guidelines regarding how time would be counted,
particularly with regard to how many minutes would be assumed to be
associated with the companion visit code and whether or not we adopt
the usual CPT coding convention for appropriate reporting of the time-
based code when over half the number of minutes (16 in this case) have
been spent. Several commenters suggested that 16 minutes beyond the
time associated with the proposed single payment rate (31 minutes as
described by many of these commenters) would mean that the code could
only be reported after 47 minutes spent with an established patient.
These commenters suggested that that threshold would likely result in
the code being used rarely.
Response: We agree with commenters that current coding describing
prolonged services is not sufficient to capture additional time spent
with patients, especially in the context of creating a single payment
rate for office/outpatient E/M levels 2 through 4. We believe that time
is a critical resource cost for physicians and other practitioners, and
the time spent with patients is a great benefit to Medicare
beneficiaries. We also note that we are required by statute to consider
time, along with intensity, in establishing the work relative value
units that determine PFS payments. We are therefore finalizing for 2021
separate payment for HCPCS code GPRO1, and are finalizing the input
values as proposed.
We appreciate commenters' concerns regarding the current
definitions and use of ``prolonged'' as applying to unusually long
visits. We believe that time spent with patients ought to vary based on
the particular needs of the patient and that variations in time spent
face-to-face with the patient can be critical in defining differences
between the services being furnished. Consequently, we agree that for
many practitioners, times that extend beyond what we, or the CPT
Editorial Panel, consider to be typical under the current visit code
descriptors and definitions, might, in actual practice, be routine. We
also note that many services, such as psychotherapy, are currently
defined and paid based on the duration of the service.
However, since commenters have suggested that the term
``prolonged'' has been established in coding convention as applying
only to unusually long visits as opposed to use in describing routine
variations in the amount of time spent during visits with patients, we
believe using an alternative term, like ``extended visit'' may serve to
underscore our expectation that the length of some visits might exceed
the typical length, but would not be unusual for certain practices or
patients.
We also note that, for audit purposes, we would expect the medical
record to reflect that the billing practitioner actually spent the
amount of time with the patient described by the code and that the
visit itself, in its entirety, was medically necessary; but we would
not
[[Page 59648]]
expect additional documentation to demonstrate that the difference in
time between the visit code and the extended visit code was, in
isolation of the visit, medically necessary.
For CY 2021, we are finalizing a coding and payment policy to
account for the additional resources required when practitioners need
to spend extended time with their patients during particular E/M
office/outpatient level 2 through 4 visits, regardless of the kind of
care the practitioner is furnishing or whether or not the medical
complexity of the visit is the determining factor for the length of
visit. After considering the comments, we believe that 30 additional
minutes (which, in accordance with CPT coding conventions for timed
codes, can be reported after 15 additional minutes is spent with the
patient) is an appropriate interval of time after which to reflect the
additional resource costs associated with patient visits that require
more time than is typical for the visit. After considering the
questions and concerns expressed by commenters about how the new add-on
code would be used, and in particular, the number of minutes that would
serve as the basis for counting time toward an extended visit (for
example, whether we would look to the typical time for the companion E/
M code level and use the CPT coding convention for time-based codes),
we acknowledge that it would not be workable to use the same
conventions as are used for the prolonged service codes.
Under the current conventions used in reporting the existing
prolonged service codes, the prolonged codes are defined by a set
number of additional minutes beyond time associated with individual
companion visit codes. For example, the initial prolonged services code
describes 60 minutes of prolonged time beyond the time associated with
the individual companion visit code. The current level 5 existing
patient code is described by CPT as typically requiring 40 minutes with
the patient, so that when reporting 99215 with the prolonged service
code, the time being described is a total of 100 minutes (40 minutes
for the level 5 code and 60 minutes for the initial prolonged code).
Under applicable coding conventions, the code is reportable, when at
least half the number of described minutes for the prolonged code is
spent. This means that the initial prolonged service code can be
reported with a level 5 existing patient code after 70 minutes (40
minutes for the full time associated with the level 5 visit and 30
minutes for half the number of minutes described by the initial
prolonged service code).
We recognize that to implement use of either new or even the
existing prolonged services code in the context of using a single
payment rate for codes of varying levels, we would need to be clear
about what time should be used for the companion visit codes.
Currently, practitioners rely on the CPT ``typical'' times to determine
the time for the visit codes of varying levels. This means that the
thresholds for visit time required before the prolonged services can be
reported are higher when higher level visits are reported in comparison
to lower level visits. Under current payment rates, this situation is
offset to some degree by the higher overall payment in circumstances
where the higher level visit code is reported.
Because we are finalizing a single payment rate for levels 2-4,
however, use of the ``typical'' CPT times as the basis for reporting
add-on codes that describe additional time would mean that lower level
visits that take more time would be paid at higher rates than higher
visit rates that take the same amount of time. We believe that because
we are paying a single rate for these services (as each of the codes
describe a single ``typical'' for purposes of payment), we should also
use a single number of minutes for purposes of reporting time-based
add-on codes: The weighted average of the ``typical'' times associated
with each of the codes that comprise the single payment rate.
One approach to implementing this would be to revise our billing
rules to instruct practitioners to use the weighted average of the
``typical'' times associated with each of the codes that comprise the
single payment rate, instead of the ``typical'' CPT times associated
with the individual billed codes. We could apply this definition
broadly to specify use of the weighted average typical times for level
2-4 codes regardless of whether or not they are being reported with
time-based add-on codes, but we do not want to prevent practitioners
from appropriately reporting visits based on the time defined as
typical under the CPT code descriptors for office/outpatient E/M
visits, especially since we are adopting a policy to allow clinicians
to use time as the basis for documentation and code selection.
Alternatively, we could require practitioners to use the weighted
average of the ``typical'' times associated with each of the codes that
comprise the single payment rate only in cases where time-based add-on
codes are also being reported. However, we believe using two separate
rules, especially one that deviates from the typical times established
for the different visit levels that will continue to be routinely
reported by a wide range of practitioners, would be likely to cause
confusion.
After consideration of these issues and considering the
alternatives, we are finalizing a code descriptor for the extended
visit code that describes a single range of minutes that applies to the
overall duration of face-to-face time during the visit, without regard
to which level 2, 3, or 4 E/M office/outpatient visit was reported.
This range is 34 to 69 minutes, so that the add-on code for extended
visits would be appropriately reported in any case where a medically
necessary E/M office/outpatient visit, reported using levels 2 through
4, required between 34 and 69 minutes (for established patients) and
between 38 and 89 minutes (for new patients) of face-to-face time with
the billing practitioner. We calculated the lower end of the range by
summing the weighted average of intraservice times for the component
codes that make up the single payment rate for level 2 through 4 visits
(23 minutes for new and 19 minutes for established) and the additional
amount of time required to bill the proposed add-on code (15 minutes
under coding convention for prolonged services). The upper range of the
use of the extended visit code is 69 minutes for established patients
and 89 minutes for new patients.
We note that to report the current prolonged codes or the new
extended services code, practitioners need to note that the requisite
number of minutes were spent with the patient. We also note that we are
finalizing the policy to allow practitioners the choice to use time as
the basis for code selection for level 2 through 5 all office/
outpatient E/M codes beginning in 2021 regardless of whether or not
counseling and/or coordination of care accounts for more than 50
percent of the face-to-face physician/patient encounter. Under the new
policy, then, any visits that exceed the length of the time ranges of
the level 2 through 4 visit codes plus the extended visit code, could
be reported using the level 5 visit code and the existing prolonged
services code. Table 24A illustrates these rules:
[[Page 59649]]
Table 24A--Minutes Spent on Extended Outpatient Visits
[Established and new patients]
----------------------------------------------------------------------------------------------------------------
Established patient New patient
----------------------------------------------------------------------------------------------------------------
Level Minutes spent Codes reported Level Minutes spent Codes reported
----------------------------------------------------------------------------------------------------------------
1................ N/A 1................ N/A
-------------------------------------- -------------------------------------
2................ 34-69 99212/3/4+extended 2................ 38-89 99203/4/5+extended
services G-code. services G-code.
3................ 3................
4................ 4................
-------------------------------------- -------------------------------------
5................ 70+ 99215+99354......... 5................ 90+ 99205+99354.
----------------------------------------------------------------------------------------------------------------
The new extended services code will be described as GPRO1 (Extended
time for evaluation and management service(s) in the office or other
outpatient setting, when the visit requires direct patient contact of
34-69 total face-to-face minutes overall for an existing patient or 38-
89 minutes for a new patient (List separately in addition to code for
level 2 through 4 office or other outpatient Evaluation and Management
service)). We again note that we are finalizing payment and coding
changes to be implemented for E/M office/outpatient visits for CY 2021.
We will consider any changes that are made to CPT coding, including for
prolonged services, and recommendations regarding appropriate valuation
of new or revised codes, through our annual rulemaking process.
In order to estimate the potential impact of the proposed changes
in the proposed rule, we modeled the results of several options and
examined the estimated resulting impacts in overall Medicare allowed
charges by physician specialty. Because we are not finalizing many of
the changes for CY 2019 as proposed, we believe the inclusion of those
same discussions in this final rule is unnecessary and could
potentially be confusing. We point readers to the CY 2019 PFS proposed
rule, (83 FR 35844 through 35847) for discussion of the analyses
relevant to the proposals. For analysis regarding the potential impacts
of the alternatives considered in development of this final rule, we
direct readers to the section VII. of this final rule, Regulatory
Impact Analysis, in addition to the discussion that follows.
To compare the overall payment impact for the changes in payment
for visit services between the current policy as of 2018 and the
policies we are finalizing starting in 2021, we provide a narrative
example in the paragraph below and Table 24B. In CY 2018, a physician
would bill a level 4 E/M visit and document using the existing
documentation framework for a level 4 E/M visit. The payment rate would
be approximately $109 in the office setting. In CY 2021, the physician
would bill the same visit code for a level 4 E/M visit, with the option
to document the visit according to the minimum documentation
requirements for a level 2 E/M visit if they choose to document based
on MDM, or the 1995 or 1997 guidelines, or to document on the basis of
time. The physician might also bill either of the proposed add-on codes
(HCPCS codes GPC1X or GCG0X) depending on the type of patient care
furnished, and could bill the extended services code if she met the
time threshold for this code. The combined payment rate for the E/M
visit code, plus the extended services code, and either HCPCS code
GPC1X or GCG0X would be approximately $170.
[GRAPHIC] [TIFF OMITTED] TR23NO18.039
[[Page 59650]]
(f) Alternatives Considered
We considered a number of other options for simplifying coding and
payment for E/M services to align with the proposed reduction in
documentation requirements and to better account for the resources
associated with inherent complexity, visit complexity, and visits
furnished on the same day as a 0-day global procedure. As we are
finalizing a policy very similar to one of the alternatives we
considered for the proposed rule, we believe it would be confusing to
include a detailed discussion of that policy as an alternative
considered. We therefore direct interested readers to the CY 2019 PFS
proposed rule (83 FR 35847).
Section 101(f) of the MACRA added a new subsection (r) under
section 1848 of the Act entitled Collaborating with the Physician,
Practitioner, and Other Stakeholder Communities to Improve Resource Use
Measurement. Section 1848(r) of the Act requires the establishment and
use of classification code sets: Care episode and patient condition
groups and codes; and patient relationship categories and codes. As
described in the CY 2018 PFS final rule, we finalized use of Level II
HCPCS Modifiers as the patient relationship codes and finalized that
Medicare claims submitted for items and services furnished by a
physician or applicable practitioner on or after January 1, 2018,
should include the applicable patient relationship codes, as well as
the NPI of the ordering physician or applicable practitioner (if
different from the billing physician or applicable practitioner). We
noted that for CY 2018, reporting of the patient relationship modifiers
would be voluntary and the use and selection of the modifiers would not
be a condition of payment (82 FR 53234). The patient relationship codes
are as follows: X1: Continuous/broad; X2: Continuous/focused; X3:
Episodic/focused; X4: Episodic/broad; and X5: Only as ordered by
another physician. These codes are to be used to help define and
distinguish the relationship and responsibility of a clinician with a
patient at the time of furnishing an item or service, facilitate the
attribution of patients and episodes to one or more clinicians, and to
allow clinicians to self-identify their patient relationships.
We considered proposing the use of the care episode and patient
relationship codes to adjust payment for E/M visits to the extent that
these codes are indicative of differentiated resources provided in E/M
visits, and we considered using these codes as an alternative to the
proposed use of G-codes to reflect visit complexity inherent to
evaluation and management in primary care and certain other specialist
services, as a way to more accurately reflect the resource costs
associated with furnishing different kinds of E/M visits. We solicited
comment on this alternative. We were particularly interested in whether
the modifiers would accurately reflect the differences between
resources for E/M visits across specialties and would therefore be
useful to adjust payment differentially for the different types of E/M
visits that we previously identified. The following is a summary of the
comments we received on these items.
Comment: AAFP urged CMS not to use the patient relationship codes
for the purposes of making differential payment, stating that these
modifiers were never intended to adjust payment or reflect visit
complexity, only to denote the relationship of the beneficiary and
practitioner at any given encounter. One commenter stated that using
patient relationship codes to adjust payment was an intriguing idea
that should be researched further.
Response: We thank commenters for their input and will consider
whether to adopt these codes for use to adjust payment at a later date
through notice and comment rulemaking. We note, however, that we
believe the use of the continuous care patient relationship codes
stands as a good example of evidence in the claims record to support
use of the primary care inherent complexity add-on code, as discussed
previously.
In Table 24C, we estimate the specialty level impacts of the E/M
payment and coding policies we are finalizing for 2021, calculated as
if they were implemented for CY 2019.
Table 24C--Estimated Specialty Level Impacts of Final E/M Payment and Coding Policies if Implemented for 2019
----------------------------------------------------------------------------------------------------------------
(A) (B) (C) (D) (E) (F)
Specialty Allowed Impact of work Impact of PE Impact of MP Combined
charges RVU changes RVU changes RVU changes impact
(mil) (%) (%) (%) (%)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology.............. $239 0 0 0 0
Anesthesiology.................. 1,981 -1 0 0 -2
Audiologist..................... 68 -1 1 0 0
Cardiac Surgery................. 294 -1 -1 0 -2
Cardiology...................... 6,618 -1 -1 0 -2
Chiropractor.................... 754 -1 0 0 -1
Clinical Psychologist........... 776 -1 1 0 0
Clinical Social Worker.......... 728 -2 2 0 0
Colon And Rectal Surgery........ 166 0 1 0 0
Critical Care................... 342 -2 -1 0 -3
Dermatology..................... 3,486 1 3 0 4
Diagnostic Testing Facility..... 733 0 -5 0 -5
Emergency Medicine.............. 3,121 -2 -1 0 -2
Endocrinology................... 482 -1 -1 0 -2
Family Practice................. 6,208 1 1 0 2
Gastroenterology................ 1,757 -2 -1 0 -3
General Practice................ 429 2 1 0 3
General Surgery................. 2,093 0 0 0 -1
Geriatrics...................... 197 -1 -1 0 -1
Hand Surgery.................... 214 1 1 0 3
Hematology/Oncology............. 1,741 0 -1 0 0
Independent Laboratory.......... 646 -1 3 0 3
Infectious Disease.............. 649 -1 -1 0 -1
Internal Medicine............... 10,767 0 0 0 0
[[Page 59651]]
Interventional Pain Mgmt........ 868 1 2 0 3
Interventional Radiology........ 386 0 -2 0 -2
Multispecialty Clinic/Other Phys 149 -1 -1 0 -2
Nephrology...................... 2,190 -1 -1 0 -2
Neurology....................... 1,529 -1 0 0 -1
Neurosurgery.................... 804 -1 -1 0 -1
Nuclear Medicine................ 50 -1 -1 0 -3
Nurse Anes/Anes Asst............ 1,242 -2 0 0 -2
Nurse Practitioner.............. 4,065 2 1 0 3
Obstetrics/Gynecology........... 638 2 2 0 5
Ophthalmology................... 5,448 -1 -2 0 -3
Optometry....................... 1,309 0 -1 0 -1
Oral/Maxillofacial Surgery...... 68 0 0 0 1
Orthopedic Surgery.............. 3,743 0 1 0 1
Other........................... 31 -1 3 0 2
Otolarngology................... 1,210 3 3 0 5
Pathology....................... 1,165 -1 -1 0 -2
Pediatrics...................... 61 1 0 0 1
Physical Medicine............... 1,107 -1 0 0 -2
Physical/Occupational Therapy... 3,950 -1 -2 0 -3
Physician Assistant............. 2,457 2 1 0 4
Plastic Surgery................. 377 0 0 0 1
Podiatry........................ 1,974 4 6 0 10
Portable X-Ray Supplier......... 99 0 0 0 0
Psychiatry...................... 1,187 3 2 0 5
Pulmonary Disease............... 1,715 -1 -1 0 -2
Radiation Oncology And Radiation 1,766 -1 -1 0 -1
Therapy Centers................
Radiology....................... 4,911 -1 -1 0 -2
Rheumatology.................... 541 0 -1 0 -1
Thoracic Surgery................ 358 -1 -1 0 -2
Urology......................... 1,738 2 3 0 4
Vascular Surgery................ 1,148 0 -2 0 -2
-------------------------------------------------------------------------------
Total....................... 92,771 0 0 0 0
----------------------------------------------------------------------------------------------------------------
Table 24C illustrates the estimated specialty level impacts
associated with implementing our finalized policies for E/M coding and
payment in CY 2019, rather than delaying until CY 2021. Table 24C shows
the estimated impacts of adopting single payment rates for new and
established patient E/M office/outpatient visit levels 2 through 4
(with the rates determined using input values that reflect the 5 year
weighted average of current inputs for codes describing those visit
levels), keeping separate rates for new and established patient E/M
visit level 5 (with the rates determined using the current input values
for level 5 visits), and adopting add-on codes with equal rates to
adjust for the inherent visit complexity of primary care and non-
procedural specialty care (with the rates determined using the input
values from the proposed rule for the non-procedural specialty care
complexity code). Under our finalized policies, specialties who
disproportionately report lower level visits, such as podiatry, and
specialties that report office/outpatient visits in conjunction with
minor procedures, such as dermatology, would see the significant
increases. Specialties that predominantly furnish higher level visits
would have their payment decreases significantly mitigated by the
maintenance of the level 5 visit and the add-on codes for inherent
visit complexity for primary and non-procedural specialty care.
Specialties that do not furnish office/outpatient visits generally
would see modest reductions in overall payment.
We note that because our original proposal was developed more
generally to maintain overall RVUs within the range of codes describing
office/outpatient E/M visits, but, in response to public comment, we
are not finalizing several elements of those proposals including, and
especially, the multiple procedure payment reduction relating to global
services billed with same day E/M services, the overall number of RVUs
allocated to office/outpatient services would be increased relative to
other PFS services. Under our established methodology and consistent
with the governing statute, we usually apply a budget neutrality
adjustment in the PFS conversion factor to account for the changes in
overall RVUs. This adjustment would apply to all PFS services, and we
are not finalizing any deviation from that approach for 2021. However,
we also note that in some cases, we have proposed and finalized inputs
for particular services that are designed to maintain the overall RVUs
for those services despite changes in coding. For more detailed
information on this approach to addressing valuation for families of
services, we direct readers to the CY 2012 PFS final rule with comment
period (76 FR 73105). We also note that while it has been our standard
practice to avoid scaling the full set of work RVUs to maintain budget
neutrality, we could also consider that alternative given the
significance of office/outpatient visit codes in PFS relativity. Were
we to consider either of these alternative
[[Page 59652]]
approaches for 2021, we would address them through future rulemaking.
g. Emergency Department and Other E/M Visit Settings
As we mentioned above, the E/M visit code set is comprised of
individual subsets of codes that are specific to various clinical
settings including office/outpatient, observation, hospital inpatient,
emergency department, critical care, nursing facility, domiciliary or
rest home, and home services. Some of these code subsets have three E/M
levels of care, while others have five. Some of these E/M code subsets
distinguish among levels based heavily on time, while others do not.
Recent public comments have noted that some E/M code subsets intersect
more heavily than others with hospital conditions of participation
(CoP). For example, the American Psychiatric Association (APA)
submitted a letter to CMS indicating that Medicare requires specific
documentation in the medical record as part of the CoPs for inpatient
psychiatric facilities. The APA believed that the required initial
psychiatric evaluation for inpatients currently closely follows the E/M
criteria for CPT codes 99221-99223, which are the codes that would be
used to bill for these services. The APA stated that any changes in
these E/M codes, without corresponding changes in the CoPs, could lead
to the unintended consequence of adding to the burden of documentation
by essentially requiring two different sets of data or areas of focus
to be included, or two different documentation formats being required.
Regarding emergency department visits (CPT codes 99281-99285), we
received more recent feedback through our coordinated efforts with ONC
this year, emphasizing that these codes may benefit from a coding or
payment compression into fewer levels of codes, or that documentation
rules may need to be reduced or altered. However, in public comments to
the CY 2018 PFS proposed rule, commenters noted several issues unique
to the emergency department setting that we believe require further
consideration. For example, commenters stated that intensity, and not
time, is the main determinant of code level in emergency departments.
They requested that CMS use caution in changing required elements for
documentation so that medical information used for legal purposes (for
example, meeting the prudent layperson standard) is not lost. They
urged caution and requested that CMS not immediately implement any
major changes. They recommended refocusing documentation on presenting
conditions and medical decision-making. Some commenters were supportive
of leaving it largely to the discretion of individual practitioners to
determine the degree to which they should perform and document the
history and physical exam in the emergency department setting. Other
commenters suggested that CMS encourage use of standardized guidelines
and minimum documentation requirements to facilitate post-treatment
evaluation, as well as analysis of records for various clinical, legal,
operational and other purposes. The commenters discussed the importance
of extensive histories and exams in emergency departments, where
usually there is no established relationship with the patient and
differential diagnosis is critical to rule out many life-threatening
conditions. They were cognizant of the need for a clear record of
services rendered and the medical necessity for each service,
procedure, diagnostic test, and MDM performed for every patient
encounter.
In addition, although the RUC is in the process of revaluing this
code set, some commenters stated that the main issue is not that the
emergency department visit codes themselves are undervalued. Rather,
these commenters noted that a greater percentage of emergency
department visits are at a higher acuity level, yet payers often do not
pay at a higher level of care and the visit is often inappropriately
down-coded based on retrospective review. These commenters noted that
the documentation needed to support a higher level of care is too
burdensome or subjective. In addition, it seems that policy proposals
regarding emergency department visits billed by physicians might best
be coordinated with parallel changes to payment policy for facility
billing of these codes, which would require more time and analyses.
Accordingly, we did not propose any changes to the emergency
department E/M code set or to the E/M code sets for settings of care
other than office-based and outpatient settings at this time. However,
we solicited public comment on whether we should make any changes to it
in future years, whether by way of documentation, coding, and/or
payment and, if so, what the changes should be.
Consistent with public feedback to date, we are taking a step-wise
approach and limiting our policy proposals this year to the office/
outpatient E/M code set (and the limited proposal above regarding
documentation of medical necessity for home visits in lieu of office
visits). We may consider expanding our efforts more broadly to
additional sections of the E/M visit code set in future years, and
solicited public comment broadly on how we might proceed in this
regard.
We received a few comments on this solicitation. We thank the
commenters for their feedback and will take it into account for future
rulemaking.
(h) Implementation Date
We proposed that our proposed E/M visit policies would be effective
January 1, 2019. However, we were sensitive to commenters' suggestions
that we should consider a multi-year process and proceed cautiously,
allowing adequate time to educate practitioners and their staff; and to
transition clinical workflows, EHR templates, institutional processes
and policies (such as those for provider-based practitioners), and
other aspects of practitioner work that would be impacted by these
policy changes. We emphasized that our proposed documentation changes
for office/outpatient E/M visits would be optional, and practitioners
could choose to continue to document these visits using the current
framework and rules, which may reduce the need for a delayed
implementation. Nevertheless, practitioners who choose a new
documentation framework may need time to deploy it. A delayed
implementation date for our documentation proposals would also allow
the AMA time to develop changes to the CPT coding definitions and
guidance prior to our implementation, such as changes to MDM or code
definitions that we could then consider for adoption. It would also
allow other payers time to react and potentially adjust their policies.
Accordingly, we solicited comment on whether a delayed implementation
date, such as January 1, 2020, would be appropriate for our proposals.
Comment: With the exception of several documentation proposals,
most of the commenters urged us not to finalize the E/M visit
proposals, or to delay their implementation by at least one year. With
the exception of our proposals regarding home E/M visits and reducing
redundant recording of data, most commenters recommended that CMS
engage in further work with the AMA and other stakeholders in the
coming months to develop alternative approaches. Many commenters noted
that our proposals regarding home E/M visits and reducing redundant
recording of data would not impact payment or require extensive
training or other extended preparatory time. The commenters largely
recommended that CMS finalize these proposals for 2019,
[[Page 59653]]
but defer other documentation, coding and payment reforms to future
years after obtaining additional stakeholder input. Some commenters did
recommend that CMS finalize the proposed policy to allow choice among
documentation methodologies while working with stakeholders to refine
any coding and payment changes. A few commenters were supportive of a
minimum level 2 documentation standard and intimated that this could be
accomplished without changes to coding or payment, but other commenters
opposed this approach.
Many stakeholders, including some commercial insurers and EHR-
related associations, commented that if CMS were to finalize its
proposals, the industry would need more time to prepare and CMS should
delay implementation a year or more. Some commenters noted that CMS
should consider not setting a date for implementation until the
necessary structure is in place. Most commenters, including some
insurers, urged CMS to work with the AMA or other stakeholders on
alternative policies. For example, some insurers were concerned that
the proposals would not allow them to understand the true complexity of
care being delivered and recommended that documentation requirements
should continue to be linked to complexity and, if the proposal were
finalized, CMS would need to monitor various program integrity issues.
They were concerned that the collapsed payment rate for level 2 through
5 E/M visits would disincentivize treatment of complex patients. Some
health plans expressed concern that medical record data used to inform
their payments and risk adjustment and HEDIS scores might be impacted.
In response to our proposed rule, several organizations stated they are
forming workgroups to conduct data analysis and develop policy
alternatives, including the AMA and the Cognitive Care Alliance. The
American Health Insurance Plans believed documentation requirements
should continue to be linked to complexity.
Commenters were concerned there would not be enough time for
developers and clinicians to make changes, leading to confusion in the
market and disparate systems with other payers, in addition to other
concerns about the coding and payment proposals discussed further
below. The commenters were concerned about not having enough time to
develop differing documentation based on payer status, and said that
the burden on the clinician to determine which payer and which
documentation method should not be underestimated.
Response: After consideration of public comments, we are not
finalizing aspects of our proposal that would have reduced payment when
E/M office/outpatient visits are furnished on the same day as certain
procedures, established separate podiatric E/M visit codes, or
standardized the allocation of PE RVUs for E/M visit codes. After
considering the comments, for 2019 we are finalizing several of our
documentation proposals that will provide some significant and
immediate burden reduction but are unrelated to changes to payment and
coding. Specifically, we are finalizing the proposals regarding home
visits and redundant data recording (discussed above), as proposed and
effective January 1, 2019. We are delaying implementation of our other
final policies relating to payment for E/M visits to January 1, 2021.
J. Teaching Physician Documentation Requirements for Evaluation and
Management Services
1. Background
Per 42 CFR part 415, subpart D, Medicare Part B makes payment under
the PFS for teaching physician services when certain conditions are
met, including that medical record documentation must reflect the
teaching physician's participation in the review and direction of
services performed by residents in teaching settings. Under Sec.
415.172(b), for certain procedural services, the participation of the
teaching physician may be demonstrated by the notes in the medical
records made by a physician, resident, or nurse; and for E/M visits,
the teaching physician is required to personally document their
participation in the medical record. We received stakeholder feedback
suggesting that documentation requirements for E/M services furnished
by teaching physicians are burdensome and duplicative of notations that
may have previously been included in the medical records by residents
or other members of the medical team.
2. Implementation
We proposed to revise our regulations to eliminate potentially
duplicative requirements for notations that may have previously been
included in the medical records by residents or other members of the
medical team. These modifications are intended to align and simplify
teaching physician E/M service documentation requirements. We believed
these changes would reduce burden and duplication of effort for
teaching physicians. We proposed to amend Sec. 415.172(b) to provide
that, except for services furnished as set forth in Sec. Sec. 415.174
(concerning an exception for services furnished in hospital outpatient
and certain other ambulatory settings), 415.176 (concerning renal
dialysis services), and 415.184 (concerning psychiatric services), the
medical records must document that the teaching physician was present
at the time the service is furnished. Additionally, the revised
paragraph would specify that the presence of the teaching physician
during procedures and E/M services may be demonstrated by the notes in
the medical records made by a physician, resident, or nurse. We also
proposed to amend Sec. 415.174, by deleting paragraph (a)(3)(v) which
requires the teaching physician to document the extent of their
participation in the review and direction of the services furnished to
each beneficiary. We proposed to add new paragraph (a)(6) to Sec.
415.174 to provide that the medical record must document the extent of
the teaching physician's participation in the review and direction of
services furnished to each beneficiary, and that the extent of the
teaching physician's participation may be demonstrated by the notes in
the medical records made by a physician, resident, or nurse.
Comment: Many commenters supported the proposed regulatory changes
without modifications.
Response: We appreciate the commenters' support of our proposals.
Comment: Some commenters disagreed with the proposed changes and
indicated teaching physicians should continue to be personally
responsible for documenting their physical presence and for
verification with patients of all medical team members' documentation
as it relates to the patient encounters. The commenters were concerned
that the proposed changes would shift the documentation burden and
responsibility from the teaching physician to the resident or nurse who
has a limited number of hours of work. One commenter stated that the
nurse would not be an inherent party to the teaching physician's or
resident's involvement in an E/M service.
Response: While we appreciate the commenters' concerns, the purpose
of these revisions to the regulations is to eliminate potentially
duplicative requirements for notations that may have previously been
included in the medical records by residents or other members of the
medical team. The teaching physician continues to be
[[Page 59654]]
responsible for reviewing and verifying the accuracy of notations
previously included by residents and members of the medical team, along
with further documenting the medical record if the notations previously
provided did not accurately demonstrate the teaching physician's
involvement in an E/M service. After consideration of the comments
received, we are finalizing the proposed changes to Sec. Sec.
415.172(b) and 415.174 without modification.
K. GPCI Comment Solicitation
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(D) of the Act requires us to establish the GPCIs using the
most recent data available. The last GPCI update was implemented in CY
2017; therefore, we are required to review and make any necessary
revisions to the GPCIs for CY 2020. Please refer to the CY 2017 PFS
final rule with comment period for a discussion of the last GPCI update
(81 FR 80261 through 80270). Some commenters have continued to express
concerns regarding some of the data sources used in developing the
indices for PFS geographic adjustment purposes, specifically that we
use residential rent data as a proxy for commercial rent in the rent
index component of the PE GPCI--that is, the data that are used to
develop the office rent component of the PE GPCI. We will continue our
efforts to identify a nationally representative commercial rent data
source that could be made available to CMS. In support of that effort,
we were particularly interested in, and solicited comments regarding
potential sources of commercial rent data for potential use in the next
GPCI update for CY 2020.
We received a few comments in response to the comment solicitation,
and we appreciate the commenters' feedback and input. We will consider
the suggestions and information received for future rulemaking, and in
particular for the CY 2020 statutorily required update to the GPCIs.
L. Therapy Services
1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate
Therapy
Section 50202 of the Bipartisan Budget Act of 2018 amended section
1833(g) of the Act, effective January 1, 2018, to repeal the
application of the Medicare outpatient therapy caps and the therapy cap
exceptions process while retaining and adding limitations to ensure
therapy services are furnished when appropriate. Section 50202 also
adds section 1833(g)(7)(A) of the Act which requires that after
expenses incurred for the beneficiary's outpatient therapy services for
the year have exceeded one or both of the previous therapy cap amounts,
all therapy suppliers and providers must continue to use an appropriate
modifier such as the KX modifier on claims for subsequent services in
order for Medicare to pay for the services. We implemented this
provision by continuing to use the existing KX modifier. By applying
the KX modifier to the claim, the therapist or therapy provider is
confirming that the services are medically necessary as justified by
appropriate documentation in the medical record. Just as with the
incurred expenses for the prior therapy cap amounts, there is one
amount for physical therapy (PT) and speech language pathology (SLP)
services combined and a separate amount for occupational therapy (OT)
services. These KX modifier threshold amounts are indexed annually by
the Medicare Economic Index (MEI). For CY 2018, the KX modifier
threshold amount was $2,010 for PT and SLP services combined, and
$2,010 for OT. After the beneficiary's incurred expenditures for
outpatient therapy services exceed the KX modifier threshold amount for
the year, claims for outpatient therapy services without the KX
modifier are denied.
Along with the KX modifier thresholds, section 50202 also adds
section 1833(g)(7)(B) of the Act that retains the targeted medical
review (MR) process (first established through section 202 of the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a
lower threshold amount of $3,000. For CY 2018 (and each successive
calendar year until 2028, at which time it is indexed annually by the
MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for
OT services. The targeted MR process means that not all claims
exceeding the MR threshold amount are subject to review as they once
were.
Section 1833(g)(8) of the Act, as re-designated by section 50202 of
the Bipartisan Budget Act of 2018, retains the provider liability
procedures which first became effective January 1, 2013, extending
limitation of liability protections to beneficiaries who receive
outpatient therapy services, when services are denied for certain
reasons, including failure to include a necessary KX modifier.
2. Payment for Outpatient PT and OT Services Furnished by Therapy
Assistants
Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018)
amended the Act to add a new subsection 1834(v) that addresses payment
for outpatient therapy services for which payment is made under section
1848 or section 1834(k) of the Act that are furnished on or after
January 1, 2022, in whole or in part by a therapy assistant (as defined
by the Secretary). The new section 1834(v)(1) of the Act provides for
payment of those services at 85 percent of the otherwise applicable
Part B payment amount for the service. In accordance with section
1834(v)(1) of the Act, the reduced payment amount for such outpatient
therapy services is applicable when payment is made directly under the
PFS as specified in section 1848 of the Act, for example when payment
is made to therapists in private practice (TPPs); and when payment is
made based on the PFS as specified in section 1834(k)(3) of the Act,
for example, when payment is made for outpatient therapy services
identified in sections 1833(a)(8) and (9) of the Act, including payment
to providers that submit institutional claims for therapy services such
as outpatient hospitals, rehabilitation agencies, skilled nursing
facilities, home health agencies and comprehensive outpatient
rehabilitation facilities (CORFs). The reduced payment rate under
section 1834(v)(1) of the Act for outpatient therapy services when
furnished in whole or in part by a therapy assistant is not applicable
to outpatient therapy services furnished by critical access hospitals
for which payment is made as specified in section 1834(g) of the Act.
To implement this payment reduction, section 1834(v)(2)(A) of the
Act requires us to establish a new modifier, in a form and manner
specified by the Secretary, by January 1, 2019 to indicate, in the case
of an outpatient therapy service furnished in whole or in part by a
therapy assistant, that the service was furnished by a therapy
assistant. Although we generally consider all genres of outpatient
therapy services together (PT/OT/SLP), we did not believe there are
therapy assistants in the case of SLP services, so we proposed to apply
the new modifier only to services furnished in whole or in part by a
physical therapist assistant (PTA) or an occupational therapy assistant
(OTA). Section 1834(v)(2)(B) of the Act requires that each request for
payment or bill submitted for an outpatient PT or OT
[[Page 59655]]
service furnished in whole or in part by a therapy assistant on or
after January 1, 2020, must include the established modifier. As such,
the modifier will be required to be reported on claims for outpatient
PT and OT services with dates of service on and after January 1, 2020,
when the service is furnished in whole or in part by a therapy
assistant, regardless of whether the reduced payment under section
1834(v)(1) of the Act is applicable. However, the required payment
reductions do not apply for these services until January 1, 2022, as
required by section 1834(v)(1) of the Act.
To implement this provision, we proposed to establish two new
modifiers to separately identify PT and OT services that are furnished
in whole or in part by PTAs and OTAs, respectively. We proposed to
establish two modifiers because the incurred expenses for PT and OT
services are tracked and accrued separately in order to apply the two
different KX modifier threshold amounts as specified by section
1833(g)(2) of the Act; and the use of the two proposed modifiers would
facilitate appropriate tracking and accrual of services furnished in
whole or in part by PTAs and OTAs. We additionally proposed that these
two new therapy modifiers would be added to the existing three therapy
modifiers--GP, GO, and GN--that are currently used to identify all
therapy services delivered under a PT, OT or SLP plan of care,
respectively. The addition of the two new modifiers as therapy
modifiers would bring the total to five therapy modifiers, with four
therapy modifiers used to report and track PT and OT services, instead
of two. The GP, GO, and GN modifiers have existed since 1998 to track
outpatient therapy services that were subject to the therapy caps.
Although the therapy caps were repealed through amendments made to
section 1833(g) of the Act by section 50202 of the Bipartisan Budget
Act of 2018, as discussed in the above section, the statute continues
to require that we track and accrue incurred expenses for all PT, OT,
and SLP services, including those above the specified per beneficiary
amounts for medically necessary therapy services for each calendar
year; one amount for PT and SLP services combined, and another for OT
services.
For purposes of implementing section 1834(v) of the Act through
rulemaking as required under section 1834(v)(2)(C) of the Act, we
proposed to define therapy assistant as an individual who meets the
personnel qualifications set forth at Sec. 484.4 of our regulations
for a PTA and OTA. We proposed that the two new therapy modifiers would
be used to identify services furnished in whole or in part by a PTA or
an OTA; and, that these new therapy modifiers would be used instead of
the GP and GO modifiers that are currently used to report PT and OT
services delivered under the respective plan of care whenever the
service is furnished in whole or in part by a PTA or OTA.
Effective for dates of service on and after January 1, 2020, the
new therapy modifiers that identify services furnished in whole or in
part by a PTA or OTA would be required to be used on all therapy claims
instead of the existing modifiers GP and GO, respectively. As a result,
in order to implement the provisions of the new subsection 1834(v) of
the Act and carry out the continuing provisions of section 1833(g) of
the Act as amended, we proposed that, beginning in CY 2020, five
therapy modifiers be used to track outpatient therapy services instead
of the current three. These five therapy modifiers would include two
new therapy modifiers to identify PT and OT services furnished by PTAs
and OTAs, respectively, and three existing therapy modifiers--GP, GO
and GN--that will be used when PT, OT, and SLP services, respectively,
are fully furnished by therapists or when fully furnished by or
incident to physicians and NPPs.
The creation of therapy modifiers specific to PT or OT services
delivered under a plan of care and furnished in whole or in part by a
PTA or OTA would necessitate that we make changes to the descriptors of
the existing GP and GO modifiers to clarify which qualified
professionals, for example, therapist, physician, or NPP, can furnish
the PT and OT services identified by these modifiers, and to
differentiate them from the therapy modifiers specific to the services
of PTAs and OTAs. We also proposed to revise the GN modifier descriptor
to conform to the changes to the GP and GO modifiers by clarifying the
qualified professionals that furnish SLP therapy services.
We proposed to define the two new therapy modifiers for services
furnished in whole or in part by therapy assistants and to revise the
existing therapy modifier descriptors as follows:
New PT Assistant services modifier (to be used instead of
the GP modifier currently reported when a PTA furnishes services in
whole or in part): Services furnished in whole or in part by a physical
therapist assistant under an outpatient physical therapy plan of care;
New OT Assistant services modifier (to be used instead of
the GO modifier currently reported when an OTA furnishes services in
whole or in part): Services furnished in whole or in part by
occupational therapy assistant under an outpatient occupational therapy
plan of care.
We proposed that the existing GP modifier, ``Services delivered
under an outpatient physical therapy plan of care'' would be revised to
read as follows:
Revised GP modifier: Services fully furnished by a
physical therapist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
physical therapy plan of care.
We proposed that the existing GO modifier, ``Services delivered
under an outpatient occupational therapy plan of care'' would be
revised to read as follows:
Revised GO modifier: Services fully furnished by an
occupational therapist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
occupational therapy plan of care.
We proposed that the existing GN modifier, ``Services delivered
under an outpatient speech-language pathology plan of care'' would be
revised to be consistent with the revisions to the GP and GO modifiers
to read as follows:
Revised GN modifier: Services fully furnished by a speech-
language pathologist or by or incident to the services of another
qualified clinician--that is, physician, nurse practitioner, certified
clinical nurse specialist, or physician assistant--under an outpatient
speech-language pathology plan of care.
As finalized in CY 2005 PFS final rule with comment period (69 FR
66351 through 66354), and as required as a condition of payment under
our regulations at Sec. Sec. 410.59(a)(3)(iii), 410.60(a)(3)(iii), and
410.62(a)(3)(iii), the person furnishing outpatient therapy services
incident to the physician, PA, NP or CNS service must meet the
therapist personnel qualification and standards at Sec. 484.4, except
for licensure per section 1862(a)(20) of the Act. As such, we noted
that only a therapist, not a therapy assistant, can furnish outpatient
therapy services incident to the services of a physician or a non-
physician practitioner (NPP), so the new PT- and OT-Assistant therapy
modifiers cannot be used on the line of service when the rendering
practitioner identified on the claim is a physician or an NPP. For
therapy services billed by physicians or NPPs, whether furnished
[[Page 59656]]
personally or incident to their professional services, the GP or GO
modifier is required for those PT or OT services furnished under an
outpatient therapy plan.
We proposed that all services that are furnished in whole or in
part by a PTA or OTA are subject to the use of the new therapy
modifiers. A new therapy modifier would be required to be used whenever
a PTA or OTA furnishes all or part of any covered outpatient therapy
service. However, we did not believe the provisions of section 1834(v)
of the Act were intended to apply when a PTA or OTA performs portions
of the service such as administrative tasks that are not related to
their qualifications as a PTA or OTA. Rather, we believed the
provisions of section 1834(v) of the Act were meant to apply when a PTA
or OTA is involved in providing some or all of the therapeutic portions
of an outpatient therapy service. We proposed to define ``in part,''
for purposes of the proposed new modifiers, to mean any minute of the
outpatient therapy service that is therapeutic in nature, and that is
provided by the PTA or OTA when acting as an extension of the
therapist. Therefore, a service furnished in part by a therapy
assistant would not include a service for which the PTA or OTA
furnished only non-therapeutic services that others without the PTA's
or OTA's training can do, such as scheduling the next appointment,
greeting and gowning the patient, and preparing or cleaning the room.
We remind therapists and therapy providers that we do not recognize
PTAs and OTAs to wholly furnish PT and OT evaluations and
reevaluations, that is, CPT codes 97161 through 97164 for PT and CPT
codes 97165 through 97168 for OT, but to the extent that they do
furnish part of an evaluative service, the appropriate therapy modifier
must be used on the claim to signal that the service was furnished in
part by the PTA or OTA, and the payment reduction should be applied
once it goes into effect. We continue to believe that the clinical
judgment and decision making involved in furnishing an evaluation or
re-evaluation is similar to that involved with establishing the therapy
plan that can only be established by a therapist, physician, or NPP
(NP, CNS, or PA) as specified in Sec. 410.61 of our regulations. In
addition, PTAs and OTAs are not recognized separately in the statute to
enroll as practitioners for purposes of independently billing for their
services under the Medicare program. For these reasons, Pub. 100-02,
Medicare Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2
state that PTAs and OTAs may not provide evaluative or assessment
services, make clinical judgments or decisions; develop, manage, or
furnish skilled maintenance program services; or take responsibility
for the service. Although we expect that the therapist will continue to
furnish the majority of an evaluative procedure service, section
1834(v)(1) of the Act requires that the adjusted payment amount (85
percent of the otherwise applicable Part B payment amount) be applied
when a therapy assistant furnishes a therapy service in part, including
part of an evaluative service.
Additionally, we would like to clarify that the requirements for
evaluations, including those for documentation, are separate and
distinct from those for plans of care (plans). The plan is a statutory
requirement under section 1861(p) of the Act for outpatient PT services
(and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient
OT and SLP services, respectively) and may only be established by a
therapist or physician. Through Sec. 410.61(b)(5), NPs, CNSs, and PAs
are also permitted to establish the plan. This means that if the
evaluative procedure is furnished in part by an assistant, the new
therapy modifiers that distinguish services furnished by PTAs or OTAs
must be applied to the claim; however, the plan, which is not
separately reported or paid, must be established by the supervising
therapist who furnished part of the evaluation services as specified at
Sec. 410.61(b). When an evaluative therapy service is billed by a
physician or an NPP as the rendering provider, either the physician/NPP
or the therapist furnishing the service incident to the services of the
physician or NPP, may establish the therapy plan in accordance with
Sec. 410.61(b). All regulatory and subregulatory plan requirements
continue to apply.
To implement the new statutory provision at section 1834(v)(2)(A)
of the Act, we proposed to establish two new therapy modifiers to
identify the services furnished in whole or in part by PTAs and OTAs.
As required under section 1834(v)(2)(B) of the Act, claims from all
providers of PT and OT services furnished on and after January 1, 2020,
will be required to include these new PT- and OT-Assistant therapy
modifiers for services furnished in whole or in part by a PTA or OTA.
We proposed that these therapy modifiers would be required, when
applicable, in place of the GP and GO modifiers currently used to
identify all PT and OT services furnished under an outpatient plan of
care, including the services furnished by PTAs and OTAs. To test our
systems ahead of the required implementation date of January 1, 2020,
we anticipated allowing voluntary reporting of the new modifiers at
some point during CY 2019, which we would announce to our contractors,
therapists and therapy providers through a Change Request, as part of
our usual change management process.
We solicited comments on these proposals.
The following is a summary of the comments we received on these
proposals.
Comment: Some commenters opposed paying differently for the
services furnished in whole or in part by OTAs and PTAs while other
commenters supported the payment differential, with a few comparing it
to the 85 percent payment rate for certain NPPs.
Response: While we appreciate hearing various commenters' views,
the new statutory provision at section 1834(v) of the Act added by
section 53107 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123,
enacted February 9, 2018) requires CMS to implement through notice and
comment rulemaking a reduced rate for the services furnished on or
after January 1, 2022, in whole or in part by therapy assistants at 85
percent of the otherwise applicable Part B payment amount for the
service. Section 1834(v) of the Act further requires that we establish
a modifier to identify services furnished in whole or in part by a
therapy assistant by January 1, 2019, and that claims for outpatient
therapy services furnished in whole or in part by therapy assistant on
or after January 1, 2020, must include the modifier. As such, we are
following statutory directives to implement section 1834(v) of the Act.
Comment: Some commenters supported our proposal to establish two
modifiers, instead of one, to separately identify PT and OT services
that are furnished in whole or in part by PTAs and OTAs, respectively.
Several commenters expressed support for our proposal defining therapy
assistant as an individual who meets the personnel qualifications set
forth in Sec. 484.4 of our regulations for PTAs and OTAs.
Response: We thank the many commenters who supported our proposals
to (a) establish two new modifiers instead of one to separately define
therapy assistant services furnished by PTAs and OTAs, and (b) to
define the PTA and OTA as individuals who meet the personnel
qualifications set forth in regulations at 42 CFR part 484. Although we
stated that these personnel qualifications were located at Sec. 484.4,
we note that, effective January 13, 2018, the personnel qualifications
for PTAs and OTAs were moved from
[[Page 59657]]
Sec. 484.4 and redesignated without changes at Sec. Sec. 484.115(g)
and (i), respectively (82 FR 4504, January 13, 2017).
Comment: Most commenters did not choose to comment specifically
about our proposal to establish the two new modifiers as therapy
modifiers for services furnished by PTAs and OTAs that are to be used
instead of the current GP and GO modifiers used to capture the these
services. However, several commenters opposed the structure we proposed
for the modifiers that would be required on therapy claims when
services are furnished by PTAs and OTAs which would change from the
current two therapy modifiers, GP and GO, to identify all therapy
services delivered under an outpatient PT or OT plan of care, to four
therapy modifiers. Instead, they urged us to adopt new modifiers that
would be used in tandem with, rather than replace, the respective
existing GP and GO therapy modifiers on the same claim line of service
to identify services delivered in whole or in part by PTAs and OTAs.
The commenters stated that their suggested approach would mitigate
administrative burden for all PT and OT professionals, as well as
therapy assistants. Specifically, commenters stated that their
therapists and therapy assistants use the same chargemasters, and their
charge systems are hardcoded to default to either the PT or OT therapy
modifier (GP or GO) that are now required on these claims, which saves
both the therapists and therapy assistants from having to add the GP or
GO therapy modifier to each claim line for the services they furnish.
According to the commenters, under our proposal, both therapists and
assistants would have to add one of the four modifiers for PT and OT
services to the claim line and they would no longer be able to default
their charge systems to report the GP or GO modifiers. This would mean
that new PTA- and OTA-specific systems would need to be duplicated,
creating undue chargemaster confusion and adding training and education
burden to both therapists and therapy assistants for reporting one the
four therapy modifiers. The commenters stated that adopting their
proposal to add the new therapy assistant modifiers to the same claim
line of service alongside the existing GP and GO modifiers eliminates
the administrative burden on therapists since only therapy assistants
would be required to use the new modifiers, and charge systems could
remain hardcoded to default to the GP or GO modifiers as they are now
to include all PT and OT services.
Response: We appreciate the commenters' concerns and agree that
their suggested approach to use the new modifiers for services
furnished in whole or in part by PTAs and OTAs on the same line of
service as the existing GP and GO therapy modifiers, instead of
replacing them, has merit, since it preserves the current use of the GP
and GO therapy modifiers to identify outpatient therapy services
furnished by both therapists and therapy assistants under a PT or OT
plan of care. We also agree that adding the new therapy assistant
modifiers to the same claim line of service alongside the existing GP
and GO modifiers will prevent undue burden for physical therapists and
occupational therapists, as only PTAs and OTAs will add the new
modifiers to the claim line of service.
After considering the comments on the establishment and use of the
new modifiers, the statutory changes, and our other payment policies
for therapy services, we are not finalizing the new modifiers for
therapy assistant services as therapy modifiers as proposed. Instead,
we will use the two new modifiers for therapy assistant services as a
type of payment modifier that will be used alongside of, instead of
replacing, the GP and GO therapy modifiers, to identify the services
furnished in whole or in part by PTAs or OTAs that will be tied to the
reduced payment for the respective PT or OT discipline in CY 2022. By
using the new modifiers for therapy assistants as payment modifiers,
rather than therapy modifiers, services furnished by PTAs and OTAs will
continue to be captured by the GP and GO therapy modifiers, as they are
now, when delivered under the an outpatient PT or OT plan of care,
respectively. We considered the commenters' requests not to use the two
new modifiers for services furnished by PTAs and OTAs as therapy
modifiers in addition to the current two therapy modifiers, GP and GO,
respectively. We took into account their concerns about the reporting
burden for both therapists and therapy assistants that would result if
we were to double the number of therapy modifiers used to report the
services delivered under PT and OT plans of care. We also considered
the unintended consequences that could result from changing the long-
standing nature of our three existing discipline-specific therapy
modifiers used to report all services delivered under an outpatient
plan of care for PT, OT, and SLP services. These consequences could be
significant, especially since the existing modifiers are used by many
other government payers and private insurers. Additionally, our claims
processing systems have numerous edits tied to the therapy modifiers
because these modifiers are used to track and accrue incurred costs of
therapy services furnished under the outpatient therapy benefit by
therapists and their assistants, as well as those services that
physicians and NPPs furnish and bill as therapy services. Consequently,
we agree with commenters that it is preferable to use the two new
modifiers as payment modifiers to identify the services furnished in
whole or in part by therapy assistants, instead of changing the overall
configuration of our therapy modifiers established through CY 1998
rulemaking and designed to track services to the then therapy cap
amounts for outpatient therapy services furnished under PT, OT, and SLP
plans of care.
This approach--using payment modifiers rather than therapy
modifiers--necessitates revisions to the descriptors we proposed for
the new therapy assistant modifiers. As therapy modifiers, the new
modifiers were proposed to define the PTA or OTA services delivered
under an outpatient PT or OT plan of care, respectively. Modifying our
proposal to instead use the two new modifiers as payment modifiers, we
are removing references to the services being delivered under an
outpatient PT or OT plan of care because the plan is specific to the GP
and GO therapy modifiers. We also retained the terminology of ``in
whole or in part'' as part of the definition of these therapy assistant
payment modifiers, as specified at section 1834(v) of the Act, and
clarified the therapy assistants' services are included as part of the
corresponding PT or OT discipline. As a result, we are finalizing the
two new payment modifiers to identify services furnished in whole or in
part by a PTA and OTA, modifiers CQ and CO (C, capital letter O),
respectively as follows.
PTA Modifier CQ: Outpatient physical therapy services
furnished in whole or in part by a physical therapist assistant.
OTA Modifier CO: Outpatient occupational therapy services
furnished in whole or in part by an occupational therapy assistant.
Because we are establishing the two new modifiers for the services
furnished in whole or in part by a PTA or OTA as payment modifiers
instead of as therapy modifiers, it is no longer necessary to revise
the existing GP, GO, and GN therapy modifiers as we initially proposed
to differentiate which professionals may furnish services using the GP,
GO, and GN therapy modifiers in the absence of therapy modifiers used
[[Page 59658]]
specifically to identify services furnished in whole or in part by PTAs
and OTAs. As a result, we are not finalizing our proposal to change the
descriptors for the current therapy modifiers: GP, GO and GN--their
descriptors and their use remains unchanged, as follows:
GP--services delivered under an outpatient physical
therapy plan of care.
GO--services delivered under an outpatient occupational
therapy plan of care.
GN--services delivered under an outpatient speech-language
pathology plan of care.
As part of the proposed rule, we noted that therapy assistants are
precluded from furnishing outpatient therapy services incident to the
services of a physician or NPP, and as such, the new PTA and OTA
modifiers cannot be used on the line of service of the professional
claim when the rendering NPI identified on the claim is a physician or
an NPP. This is because PTAs and OTAs don't meet the qualifications of
a physical or occupational therapist that is set forth as conditions of
payment in the regulatory provisions at Sec. Sec. 410.59(a)(3)(iii)
and 410.60(a)(3)(iii). We are clarifying that this payment policy
applies similarly when the CQ and CO modifiers are used as payment
modifiers. We plan to revise our manual provisions at Pub. 100-02,
Medicare Benefit Policy Manual, Chapter 15, section 230, as
appropriate, to reference the new CQ and CO modifiers that will be used
to identify services furnished in whole or in part by a PTA or OTA
starting in CY 2020.
Comment: Several commenters referenced therapist and therapy
assistant shortages, and stated that this discounted payment rate for
services furnished in whole or in part by therapy assistants will
increase financial hardships to retain therapists and therapy
assistants. Commenters requested that CMS exempt therapy services
furnished in rural areas, health professional shortage areas (HPSAs),
and medically underserved areas (MUAs) from application of the reduced
payment rate when a therapy assistant is involved.
Response: We understand the commenters' concerns. Given the
parameters of the statute at section 1834(v) of the Act, we do not have
authority to exempt services furnished in whole or in part by therapy
assistants from application of the reduced payment rate when furnished
in rural areas, HPSAs, and MUAs. As we do for other services, we will
monitor for potential access issues and consider how to address them
should they arise. We do not currently have information on the
geographic distribution or quantity of services furnished in whole or
in part by PTAs and OTAs, and look forward to reviewing this
information as it becomes available after January 1, 2020, when the new
therapy assistant modifiers are required to be reported on claims.
Comment: Many commenters expressed concerns about different aspects
of our proposed interpretation of the statutory reference to services
furnished ``in whole or in part'' by PTAs and OTAs. Commenters also
expressed concern about our proposal to define ``in part'' to mean any
minute of therapeutic services delivered by a PTA or OTA. Several
commenters raised concerns about the reduced payment associated with
the future use of the new modifiers to describe services furnished in
whole or in part by PTAs and OTAs, and asked us to consider the
practical day-to-day implications of using these modifiers. These
commenters stated that requiring the new modifiers to be applied when
any minute of outpatient therapy is delivered by the PTA or OTA has
serious implications for beneficiary access to care.
Some commenters stated that documenting in the medical record the
therapy services that are delivered in part by a therapy assistant will
be burdensome for those services not fully or wholly furnished by an
OTA or PTA, and some suggested that the reduced payment rates should
only apply when the PTA or OTA furnishes the entire service.
Many commenters objected to our definition of ``in part'' and
offered several alternatives. Some commenters suggested that we should
not define when a PTA or OTA furnishes a service in whole or in part,
but instead consider whether a therapist furnishes a service in whole
or in part, stating that the PTA/OTA modifiers should not apply in
cases where the therapist, not the assistant, furnishes the majority of
the service.
Several commenters were concerned that applying the modifier when
any minute of outpatient therapy is delivered by a therapy assistant
has serious implications for beneficiary access to care and asked us to
not finalize the definition of ``in part'' until CY 2020 rulemaking,
when the new modifiers for services of therapy assistants are required
on claims. The commenters stated that this delay would allow CMS
additional time to engage in an extensive discussion with various
external stakeholders in order to consider their input before CY 2020
rulemaking. Instead of waiting to define ``in part'' during CY 2020
rulemaking, one commenter suggested that we adopt a blended fee
schedule rate for services furnished for more than 50 percent of the
time by a therapist, including the services of both the 15-minute timed
codes or untimed service-based codes, meaning that the rate paid would
be 92.5 percent, halfway between 85 and 100 percent. Other commenters
stated that the modifiers to identify services of PTAs and OTAs should
not apply when the therapist fully furnished the services and the
assistant merely lent a second pair of hands during the treatment for
example, for safety reasons, such as where the patient is morbidly
obese or has flaccid limb(s) and the completion of such services
require more than one therapy professional.
Many commenters raised concerns about the application of our
definition of ``in part'' when therapists and therapy assistants work
together collaboratively. Some commenters raised concerns about
applying the modifier for therapy assistant services when therapists
and their assistants work interchangeably without a clear line between
when the physical therapist might stop delivering treatment and the
therapy assistant resumes treatment, and when the assistant acts as a
second pair of hands to the therapist. Some commenters stated that when
a therapist and assistant work together in a team-based approach,
regardless of the amount of time the PTA or OTA contributes, that the
new modifiers identifying services for application of the discounted
payment rate should not apply. Some of these commenters requested that
we exclude the use of new modifiers for therapy evaluations and re-
evaluations because a therapy assistant is not permitted to fully
furnish these services and these services require the therapist's
clinical skill, judgment, and decision-making throughout. Others
commenters requested that the modifiers should not apply for group
therapy services, which are often provided collaboratively between the
assistant and therapist because it is not fair to affix the discounted
payment modifier to every patient in the group when a PTA or OTA
furnishes one minute of the group service. Some commenters suggested we
apply an 8-minute rule to the codes defined by 15-minute increments,
stating that the modifiers should apply only when the PTA/OTA furnishes
at least 8 minutes of the service, while other commenters asked us not
to apply the assistant modifiers when these intervention services are
furnished collaboratively by the therapist and
[[Page 59659]]
assistant. Several commenters recommended that CMS allow for reporting
of the same code on the same day for the same beneficiary on two
different claim lines to distinguish between those code units furnished
by a therapist and those furnished by a therapy assistant in reference
to the 15-minute timed intervention codes and the group therapy code
(CPT code 97150).
Response: We acknowledge the views of the many commenters regarding
our proposed interpretation of the statutory reference to therapy
services furnished in whole or ``in part'' by PTAs and OTAs as part of
the requirement that we establish a modifier to identify such services
on claims beginning January 1, 2020, and apply a discounted payment
rate to those services beginning January 1, 2022. We offer
clarification on some of the commenters' concerns and alternatives, as
follows. We do not agree that the statutory provision at section
1834(v) of the Act, which specifies a discounted payment rate for
services furnished ``in whole or in part'' by a therapy assistant,
could be interpreted to apply only when the therapy assistant furnishes
the entire service. We also clarify that the modifiers would not apply
to those services that are exclusively furnished by therapists without
the assistance of PTAs or OTAs. However, the extent to which the
modifiers apply to clinical scenarios in which the therapist and
therapy assistant work together to furnish services collaboratively may
be dependent on whether the therapy assistant's services are furnished
in the absence of the therapist, whose time could then no longer be
attributed to that patient. We do not agree that services in which the
therapist and therapy assistant work collaboratively or in tandem are
necessarily services that are not furnished ``in part'' by a therapy
assistant. Rather, when a therapist and therapy assistant work together
in furnishing a therapy service, we would generally view that service
as being furnished in part by a therapy assistant, especially when the
therapist is absent for a portion of the service, as explained above.
We recognize there are other clinical scenarios and types of services
where it is less obvious whether the service should be considered
furnished ``in part'' by a therapy assistant when a therapist and
therapy assistant work collaboratively together to treat one patient,
and we anticipate addressing applicability of the modifiers in
additional clinical scenarios through further rulemaking for CY 2020.
We also clarify that the statutory provision at section 1834(v) of the
Act requiring the reduced payment at 85 percent for services furnished
in whole or in part by a therapy assistant beginning in CY 2022, does
not permit us to make payment at 92.5 percent, as suggested by some
commenters. We also note the concerns of the few commenters requesting
that we allow the same procedure code for the same patient on the same
day to appear on multiple claim lines, some of which might include the
new modifier for therapy assistant services and others of which would
not. CMS claims processing systems already allow, when not constrained
by other policies such as Medically Unlikely Edits (MUEs), the same
procedure code to be reported on two different claim lines as long as
there is a different modifier used to uniquely identify the service and
prevent the service from being considered a duplicate. For example, if
a therapy assistant furnished one unit (15 minutes) and the therapist
furnished 2 units (30 minutes) of the same procedure code that is
defined to be billable in 15-minute increments, one unit of the
procedure code would be billed on the claim line with the modifier for
the therapy assistant's services and two units of the procedure code
would be billed on another claim line without the assistant modifier.
We do not agree with the commenters' suggestion that we define ``in
part'' to mean a therapy service for which a PTA or OTA furnishes 50
percent or a majority of the service, or an otherwise substantial part
of the service. The discounted payment rate specified under section
1834(v)(1) of the Act is required to be applied for services furnished
``in whole or in part'' by a therapy assistant. We do not believe ``in
whole or in part'' means that the discounted payment rate would apply
only to services for which 50 percent or more of the service was
furnished by a therapy assistant.
In our review of section 1834(v)(1) of the Act, we believe that the
phrase ``in part'' could be read to mean that if a therapy assistant
participates only in a very small (so insubstantial as to not be
meaningful) portion of the service, the discounted payment rate would
not apply. In the proposed rule, we proposed that ``in part'' would not
include the non-therapeutic portions of a service that could be
performed by others without the training of PTAs or OTAs. Along those
same lines, after further consideration of the public comments
explaining the fluid nature of clinical practice between therapists and
therapy assistants and the complexity of identifying and documenting
when a service is furnished in part by a therapy assistant, we believe
it would be appropriate to define a therapy assistant's participation
in furnishing a therapy service ``in part'' to mean that the therapy
assistant furnished more than a de minimis portion of the therapy
service. Specifically, we believe it would be appropriate to specify
that a therapy assistant is considered to furnish a therapy service
``in part'' when they perform more than 10 percent of the service. If,
instead of specifying as we proposed that the modifiers are applicable
when any minute of a therapeutic service is furnished by a PTA or OTA,
we specified that the modifiers apply when more than 10 percent of a
service is furnished by the therapy assistant, 1.5 minutes of a 15-
minute unit could be furnished by the PTA or OTA without being subject
to the discounted payment rate. If this 10 percent de minimis standard
is applied to an untimed service, for example to a therapy evaluation
for which the typical time is 45 minutes, the PTA or OTA could furnish
up to 4.5 minutes of the service before the modifier and discounted
payment rate would apply. We anticipate addressing applicability of the
ten percent de minimis standard for other clinical scenarios in further
rulemaking for CY 2020.
After consideration of the public comments, the following reflects
a full summary of our finalized policies.
We are finalizing the establishment of two modifiers, one to
identify services furnished in whole or in part by PTAs and the other
to identify services furnished in whole or in part by OTAs. We are also
finalizing our proposal to define PTAs and OTAs as those individuals
meeting the personnel qualifications set forth in part 484.
Instead of finalizing the new modifiers to identify services
furnished by PTAs and OTAs as therapy modifiers, we are adopting a
final policy to use these new modifiers as a payment modifier that will
be appended on the same line of service with the respective PT or OT
therapy modifier. This modified approach necessitates revisions to the
proposed descriptors of the new CQ and CO modifiers, and allows us to
proceed without making the proposed revisions to the current
descriptors for the three therapy modifiers--GP, GO and GN. We are
finalizing the new payment modifiers as follows.
CQ Modifier: Outpatient physical therapy services
furnished in whole or in part by a physical therapist assistant.
CO Modifier: Outpatient occupational therapy services
furnished
[[Page 59660]]
in whole or in part by an occupational therapy assistant.
We are not revising the three therapy modifiers as we had proposed.
Instead, they will continue in effect, unmodified, as follows:
GP--services delivered under an outpatient physical
therapy plan of care.
GO--services delivered under an outpatient occupational
therapy plan of care.
GN--services delivered under an outpatient speech-language
pathology plan of care.
Instead of finalizing our proposed definition of a service that is
furnished in whole or in part by a PTA or OTA as a service for which
any minute of a therapeutic service is furnished by a PTA or OTA, we
are finalizing a de minimis standard under which a service is furnished
in whole or in part by a PTA or OTA when more than 10 percent of the
service is furnished by the PTA or OTA. We anticipate addressing
application of the therapy assistant modifiers and the 10 percent
standard more specifically, including their application for different
scenarios and types of services, in rulemaking for CY 2020.
3. Functional Reporting Modifications
Since January 1, 2013, all providers of outpatient therapy
services, including PT, OT, and SLP services, have been required to
include functional status information on claims for therapy services.
In response to the Request for Information (RFI) on CMS Flexibilities
and Efficiencies that was issued in the CY 2018 PFS proposed rule (82
FR 34172 through 34173), we received comments requesting burden
reduction related to the functional reporting requirements that were
adopted to implement section 3005(g) of the Middle Class Tax Relief and
Jobs Creation Act (MCTRJCA) of 2012 (Pub. L. 112-96, January 1, 2013).
More information about these requirements can be found in the CY 2019
PFS proposed rule (83 FR 35852).
We proposed to discontinue the functional reporting requirements
for services furnished on or after January 1, 2019. Specifically, we
proposed to amend our regulations by removing the following: (1)
Conditions of payment at Sec. Sec. 410.59(a)(4), 410.60(a)(4),
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP
services, respectively, to contain prescribed information on patient
functional limitations; and, (2) the functional reporting-related
phrase that requires the plan's goals to be consistent with functional
information on the claim at Sec. 410.61(c) for outpatient PT, OT, and
SLP services and at Sec. 410.105(c)(1)(ii) for the PT, OT, and SLP
services in CORFs. In addition, we would (1) remove the functional
reporting subregulatory requirements implemented primarily through
Change Request 8005 last issued on December 21, 2012, via Transmittal
2622, (2) eliminate the functional reporting standard systems edits we
have applied to claims, and (3) remove the functional reporting
requirement provisions in our internet Only Manual (IOM) provisions
including the Medicare Claims Processing Manual, Chapter 5 and the
functional reporting requirements in Chapters 12 and 15 of the Medicare
Benefits Policy Manual.
Our proposal would end the requirements for the reporting and
documentation of functional limitation G-codes (HCPCS codes G8978
through G8999 and G9158 through G9186) and severity modifiers (in the
range CH through CN) for outpatient therapy claims with dates of
service on and after January 1, 2019. Accordingly, with the conclusion
of our functional reporting system for dates of service after December
31, 2018, we proposed to delete the applicable non-payable HCPCS G-
codes specifically developed to implement that system through the CY
2013 PFS final rule with comment period (77 FR 68598 through 68978).
We sought comment on these proposals. The following is a summary of
the comments we received on these proposals.
Comment: Many commenters supported the proposal to eliminate the
functional reporting requirements for outpatient therapy services and
urged us to end these requirements for reporting and documenting the G-
codes and severity modifiers on claims for PT, OT, and SLP services
beginning January 1, 2019. Many commenters agreed that these
requirements are overly complex and burdensome for therapy providers.
Response: We appreciate the commenters' support of our proposal to
end the reporting and documentation requirements effective January 1,
2019.
Comment: Some commenters disagreed with our proposal to end the
functional reporting and documentation requirements beginning in CY
2019. One commenter who liked our functional reporting system suggested
that we retain a reduced version of it. Two other commenters supported
our requirement for assessment tools or outcome measures to be used to
quantify the severity of dysfunction or disability. One commenter
representing a software developer supported the flexibility in our
rules permitting professional judgment of therapists to select from a
composite outcome measure a single functional measure that reflects a
more accurate disability rating. Another commenter representing a large
private payer asked us to retain our functional reporting requirements
because they believe that information about functional status of
therapy patients remains an essential source of information for health
plan care management activities such as health plan care coordination
programs and to accurately complete risk adjustment requirements. This
commenter also noted that the end of Medicare functional reporting
requirements may cause therapists to stop documenting information about
their patients' functional status, and this, along with the repeal of
the therapy caps, could instead prompt therapists to furnish non-
covered long-term custodial care services that are not medically
necessary.
Response: We appreciate the commenters' support for the claims-
based functional reporting system requirements currently in place
including the use by the private payer of the functional status
information reported on claims for health plan care management
activities. While we acknowledge that functional status will no longer
be required to be reported on Medicare claims and, thus, will not be
available for use on claims for health plan care management activities,
we do not share the commenter's concern though that the lack of a
functional reporting requirement to document the non-payable HCPCS
codes and related severity modifiers or the repeal of the therapy caps
will cause therapists to begin furnishing therapy services that do not
meet the statutory requirement for reasonable and necessary services or
keep them from documenting other information required about patients'
physical status in medical records. The documentation requirements
specified in Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15,
section 220.3 titled Documentation Requirements for Therapy Services,
in subsection C. for Evaluation/Re-Evaluation and Plan of Care, which
were established prior to the MCTRJCA provisions' mandate, would remain
in place. These documentation instructions continue to require that
therapists document in the beneficiary's medical record, either in the
evaluation or in the plan of care containing the evaluation, objective,
measurable beneficiary physical function. In order to meet these
requirements, therapists may use one of
[[Page 59661]]
four measurement instruments, including National Outcomes Measurement
System (NOMS) by the American Speech-Language Hearing Association,
Activity Measure--Post Acute Care (AM-PAC), Patient Inquiry by Focus On
Therapeutic Outcomes, Inc. (FOTO), or OPTIMAL by Cedaron through the
American Physical Therapy Association; or, when one of these tools is
not used, they may use (a) functional assessment individual item and
summary scores from commercially available therapy outcomes
instruments, (b) functional assessment scores from tests and
measurements validated in the professional literature that are
appropriate for the condition/function being measured; or (c) other
measurable progress towards identified goals for functioning in the
home environment at the conclusion of the therapy episode of care. For
these reasons, we believe therapists will continue to use the
measurement tools they have used in the past to identify measureable
physical functional status even after we discontinue the claims-based
functional reporting requirements.
After consideration of the public comments, we are finalizing our
proposed changes to discontinue the functional reporting requirements
for outpatient therapy services furnished on or after January 1, 2019.
Specifically, we are removing the following regulatory requirements:
(1) Conditions of payment at Sec. Sec. 410.59(a)(4), 410.60(a)(4),
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP
services, respectively, to contain prescribed information on patient
functional limitations; and, (2) the functional reporting-related
phrase that requires the plan's goals to be consistent with functional
information on the claim at Sec. 410.61(c) for outpatient PT, OT, and
SLP services and at Sec. 410.105(c)(1)(ii) for the PT, OT, and SLP
services in CORFs.
In addition to amending these regulations, we are ending the
requirements for the reporting and documentation of functional
limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through
G9186) and severity modifiers (in the range CH through CN) for
outpatient therapy claims with dates of service on and after January 1,
2019.
Instead of deleting the HCPCS G-codes effective for CY 2019 as
proposed, we are finalizing a modification of that proposal to retain
the set of 42 non-payable HCPCS G-codes until CY 2020 as this will
allow time for therapy providers and other private insurers who
currently use these HCPCS G-codes for purposes of functional reporting
to update their billing systems and policies. This will avoid a
situation where claims that inadvertently contain any of these G-codes
during CY 2019 can be processed, and are not unnecessarily returned or
rejected. The retention of HCPCS G-codes through CY 2019 will also
allow physical and occupational therapists to report six of these non-
payable HCPCS G-codes and the measures developed from them for purposes
of meeting the MIPS program requirements which are found in section
III.I.3. of this final rule.
We also intend to revise our manuals regarding the application of
the functional reporting requirements in our IOM, Pub. 100-02, Medicare
Benefits Policy Manual, Chapters 12 and 15, and Pub. 100-04, Medicare
Claims Processing Manual, Chapter 5.
4. Therapy KX Threshold Amounts
As noted above in this section, the KX modifier thresholds were
established through section 50202 of the Bipartisan Budget Act of 2018.
These KX modifier thresholds were formerly referred to as therapy caps
and are a permanent provision of the law, meaning that the statute does
not specify an end date. These per-beneficiary amounts under section
1833(g) of the Act (as amended by section 4541 of the Balanced Budget
Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year
based on the MEI. Specifically, these amounts are calculated by
updating the previous year's amount by the MEI for the upcoming
calendar year and rounding to the nearest $10.00. Increasing the CY
2018 KX modifier threshold amount of $2,010 by the CY 2019 MEI of 1.5
percent and rounding to the nearest $10.00 results in a CY 2019 KX
threshold amount of $2,040 for PT and SLP services combined and $2,040
for OT services.
Along with the KX modifier thresholds, section 50202 of the
Bipartisan Budget Act of 2018 also added section 1833(g)(7)(B) of the
Act which retains the targeted medical review process, but at a lower
threshold amount of $3,000 (until CY 2028) as detailed previously in
this section. For CY 2018, the MR threshold is $3,000 for PT and SLP
services combined and $3,000 for OT services. Under the established
targeted review process, some, but not all claims exceeding the MR
threshold amount are subject to review. For information on the targeted
manual medical review process, go to https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
CMS tracks each beneficiary's incurred expenses for therapy
services annually and counts them toward the KX modifier and MR
thresholds by applying the PFS rate for each service less any
applicable multiple procedure payment reduction (MPPR) amount for
services of CMS-designated ``always therapy'' services.
As required by section 1833(g)(6)(B) of the Act, added by section
603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240, January 2, 2013) and extended by subsequent legislation, including
section 50202 of the Bipartisan Budget Act of 2018, the PFS-rate
accrual process is applied to outpatient therapy services furnished by
critical access hospitals (CAHs) even though they may be paid on a cost
basis (effective January 1, 2014).
For Maryland hospitals paid under the Maryland All-Payer Model,
currently being tested under the authority of section 1115A of the Act
(effective January 1, 2016), we use the submitted charge amounts to
accrue to the KX modifier and MR thresholds.
After expenses incurred for the beneficiary's outpatient therapy
services for the year have exceeded one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. By using the KX
modifier, the therapist is attesting that the services above the KX
modifier thresholds are reasonable and necessary and that there is
documentation of medical necessity for the services in the
beneficiary's medical record. Claims for outpatient therapy services
that exceed the KX modifier thresholds but do not include the KX
modifier are denied.
M. Part B Drugs: Application of an Add-On Percentage for Certain
Wholesale Acquisition Cost (WAC)-Based Payments
Consistent with statutory provisions in section 1847A of the Act,
many current Medicare Fee-For-Service (FFS) payments for separately
payable drugs and biologicals furnished by providers and suppliers
include an add-on set at 6 percent of the volume-weighted average sales
price (ASP) or wholesale acquisition cost (WAC) for the drug or
biological (the ``6 percent add-on''). Although section 1847A of the
Act does not specifically state what the 6 percent add-on represents,
it is widely believed to include services associated with drug
acquisition that are not separately paid for, such as handling,
storage, other overhead, as well as additional mark-
[[Page 59662]]
ups in drug distribution channels. The 6 percent add-on described in
section 1847A of the Act has raised concerns because more revenue can
be generated from percentage-based add-on payments for expensive drugs,
and an opportunity to generate more revenue may create an incentive for
the use of more expensive drugs (MedPAC Report to the Congress:
Medicare and the Health Care Delivery System June 2015, http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf, pages 65
through 72). Also, the Office of the Assistant Secretary for Planning
and Evaluation (ASPE) March 8, 2016, Issue Briefing pointed out that
administrative complexity and overhead costs are not exactly
proportional to the price of a drug (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives). Thus, the suitability of
using a percentage of the volume-weighted ASP or WAC of the drug or
biological for an add-on payment may vary depending on the price of the
drug or how the payment rate has been determined.
Although the add-on percentage for drug payments made under section
1847A of the Act is typically applied to the ASP, a 6 percent add-on is
also applied to the WAC to determine the Part B drug payment allowances
in the following situations. First, for single source drugs, as
authorized in section 1847A(b)(4) of the Act, payment is made using the
lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires that
a 6 percent add-on be applied regardless of whether WAC or ASP is less.
Second, for drugs and biologicals where the ASP during first quarter of
sales is unavailable, section 1847A(c)(4) of the Act allows the
Secretary to determine the payment amount for the drug or biological
based on the WAC or payment methodologies in effect on November 1,
2003. We note that this provision does not specify that an add-on
percentage be applied if WAC-based payment is used, nor is an add-on
percentage specified in the implementing regulations at Sec.
414.904(e)(4). The application of the add-on percentage to WAC-based
payments during a period where partial quarter ASP data was available
was discussed in the 2011 PFS final rule with comment (75 FR 73465
through 73466). Third, in situations where Medicare Administrative
Contractors (MACs) determine pricing for drugs that do not appear on
the ASP pricing files and for new drugs, WAC-based payment amounts may
also be used, as discussed in Chapter 17, Section 20.1.3 of the
Medicare Claims Processing Manual. This section of the manual describes
the use of a 6 percent add-on.
The incorporation of discounts in the determination of payment
amounts made for Part B drug varies. Most Part B drug payments are
based on the drug's or biological's ASP; as provided in section
1847A(c)(3) of the Act, the ASP is net of many discounts such as volume
discounts, prompt pay discounts, cash discounts, free goods that are
contingent on any purchase, chargebacks, and rebates (other than
rebates under Medicaid drug rebate program). In contrast, the WAC of a
drug or biological is defined in section 1847A(c)(6)(B) of the Act as
the manufacturer's list price for the drug or biological to wholesalers
or direct purchasers in the United States, not including prompt pay or
other discounts, rebates or reductions in price, for the most recent
month for which the information is available, as reported in wholesale
price guides or other publications of drug or biological pricing data.
Because the WAC does not include discounts, it typically exceeds ASP,
and the use of a WAC-based payment amount for the same drug results in
higher dollar payments than the use of an ASP-based payment amount.
Although discussions about the add-on tend to focus on ASP-based
payments (because ASP-based payments are more common than WAC-based
payments), the add-on for WAC-based payments has also been raised in
the June 2017 MedPAC Report to the Congress (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 42
through 44). The MedPAC report focused on how the 2 quarter lag in
payments determined under section 1847A of the Act led to a situation
where undiscounted WAC-based payment amounts determined using
information from 2 quarters earlier were used to pay for drugs that
providers purchased at a discount. To determine the extent of the
discounts, MedPAC sampled new, high-expenditure Part B drugs and found
that these drugs' ASPs were generally lower than their WACs. Seven out
of the 8 drugs showed pricing declines from initial WAC to ASP one year
after being listed in the ASP pricing files with the remaining product
showing no change, which suggests purchasers received discounts that
WAC did not reflect. MedPAC further cited a 2014 OIG report (OIG,
Limitations in Manufacturer Reporting of Average Sales Price Data for
Part B Drugs, (OEI-12-13-00040), July 2014) to illustrate that there
may be differences between WAC and ASP in other instances in which CMS
utilizes WAC instead of ASP and noted that OIG found that ``WACs often
do not reflect actual market prices for drugs.'' MedPAC also
characterized Part B payments based on undiscounted list prices for
products that were available at a discount as excessive. The report
suggested that greater parity between ASP-based acquisition costs and
WAC-based payments for Part B drugs could be achieved and recommended
changing the 6 percent add-on for WAC-based payments to 3 percent. A 3
percent change was recommended based on statements made by industry,
MedPAC's analysis of new drug pricing, and OIG data. The report also
mentioned that discounts on WAC, such as prompt pay discounts, were
available soon after the drug went on the market.
In the case of a drug or biological during an initial sales period
in which data on the prices for sales for the drug or biological is not
sufficiently available from the manufacturer, section 1847A(c)(4) of
the Act permits the Secretary to make payments that are based on WAC.
In other words, although payments under this section may be based on
WAC, unlike section 1847A(b) of the Act (which specifies that certain
payments must be made with a 6 percent add-on), section 1847A(c)(4) of
the Act does not require that a particular add-on amount or percentage
be applied to partial quarter WAC-based pricing. Consistent with
section 1847A(c)(4) of the Act, we proposed that effective January 1,
2019, WAC based payments for Part B drugs made under section
1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6
percent add-on that is currently being used. We proposed a 3 percent
add-on because this percentage is consistent with MedPAC's analysis and
recommendations discussed in the paragraph above and cited in its June
2017 Report to the Congress. Although other approaches for modifying
the add-on amount, such as a flat fee, or percentages that vary with
the cost of a drug, are possible, we proposed a fixed percentage in
order to be consistent with other provisions in section 1847A of the
Act that specify fixed add-on percentages of 6 percent (section
1847A(b) of the Act) or 3 percent (section 1847A(d)(3)(C) of the Act).
A fixed percentage is also administratively simple to implement and
administer, predictable, and easy for manufacturers, providers and the
public to understand.
We have also reviewed corresponding regulation text at Sec.
414.904(e)(4). To conform the regulation text more closely to the
statutory language at section
[[Page 59663]]
1847A(c)(4) of the Act, we also proposed to strike the word
``applicable'' from paragraph (e)(4) of Sec. 414.904. Section
1847A(c)(4) of the Act does not use the term ``applicable'' to describe
the payment methodologies in effect on November 1, 2003.
We also discussed changing the policy articulated in the Medicare
Claims Processing Manual that describes the application of the 6
percent add-on to payment determinations made by MACs for new drugs and
biologicals. Chapter 17 section 20.1.3 of the Claims Processing Manual
(https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf) states that WAC-based payment limits for drugs
and biologicals that are produced or distributed under a new drug
application (or other new application) approved by the Food and Drug
Administration, and that are not included in the ASP Medicare Part B
Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are
based on 106 percent of WAC. Invoice-based pricing is used if the WAC
is not published. In the Hospital Outpatient Prospective Payment System
(OPPS) program, the payment allowance limit is 95 percent of the
published Average Wholesale Price (AWP). We discussed permitting MACs
to use an add-on percentage of up to 3 percent for WAC-based payments
for new drugs. MACs have longstanding authority to make payment
determinations when we do not publish a payment limit in our national
Part B drug pricing files and when a new drug becomes available. This
proposal intended to preserve consistency with our proposed national
pricing policy and would apply when MACs perform pricing
determinations, for example during the period when ASPs have not been
reported. The proposed policy would not alter OPPS payment limits;
however, the CY 2019 OPPS proposed rule (83 FR 37046) includes a
discussion about proposed changes to certain WAC-based drug payments
under the OPPS.
We note that the PFS rule proposals do not include WAC-based
payments for single source drugs under section 1847A(b) of the Act,
that is, where the statute specifies that the payment limit is 106
percent of the lesser of ASP or WAC.
We have stated in previous rulemaking (80 FR 71101) that it is
desirable to have fair reimbursement in a healthy marketplace that
encourages product development. We have also stated that we seek to
promote innovation to provide more options to patients and physicians,
and competition to drive prices down (82 FR 53183). These positions
have not changed. However, since 2011, concern about the impact of drug
pricing and spending on Part B drugs has continued to grow. From 2011
to 2016, Medicare Part B drug spending increased from $17.6 billion to
$28.0 billion, representing a compound annual growth rate of 9.8
percent, with per capita spending increasing 54 percent, from $532 to
$818 (Based on Spending and Enrollment Data from the CMS Office of
Enterprise Data and Analytics). These increases affect the spending by
Medicare and beneficiary out-of-pocket costs. In the context of these
concerns, we believe that implementation of these proposals would
improve Medicare payment rates by better aligning payments with drug
acquisition costs, especially for the growing number of drugs with high
annual spending and high launch prices where single doses can cost tens
or even hundreds of thousands of dollars. The proposals would also
decrease beneficiary cost sharing. A 3 percentage point reduction in
the total payment allowance will reduce a patient's 20 percent Medicare
Part B copayment--for a drug that costs many thousands of dollars per
dose, this can result in significant savings to an individual. The
proposed approach would help Medicare beneficiaries afford to pay for
new drugs by reducing out of pocket expenses and would help counteract
the effects of increasing launch prices for newly approved drugs and
biologicals. Finally, the proposals are consistent with recent MedPAC
recommendations.
The following is a summary of the comments we received on these
proposals.
Comment: Many commenters expressed concerns about the proposed add-
on reduction and its effect on providers. Many of these commenters
focused on the percentage portion of the add-on, stating that the
proposed lower add-on would result in payment at ASP + 1.35 percent
because of the sequester reduction.
Response: The Budget Control Act of 2011 (Pub. L. 112-25, enacted
August 2, 2011) requires mandatory across-the-board reductions in
Federal spending, also known as sequestration. The application of
sequestration (after the American Taxpayer Relief Act of 2012 (Pub. L.
112-240, enacted January 2, 2013) postponed sequestration for 2 months)
requires the reduction of Medicare payments by 2 percent for many
Medicare FFS claims with dates-of-service on or after April 1, 2013.
The proposed change to the add-on percentage does not include
reductions applied to Medicare payments under sequestration, as
sequestration is independent of Medicare payment policy. However, we
understand the concerns about the reduction to the add-on and the
effects of the sequester resulting in a situation where payment amounts
could be potentially insufficient to cover acquisition costs for
expensive drugs, such as for specialties like rheumatology, which
utilize a narrow range of drugs with similar prices, and for providers
who may not be able to acquire drugs below the ASP. The policy we
proposed would reduce the add-on for WAC-based payment to 3 percent; it
would be limited to new drugs and would not apply to the add-on to ASP-
based payment amounts. The 3 percent reduction is discussed in further
detail in the comment responses below.
Comment: A number of commenters stated that the 6 percent markup is
intended to account for specific costs, such as handling, storage and
other administrative expenses.
Response: Section 1847A of the Act does not specifically state what
the 6 percent add-on represents, and the accompanying Conference Report
to the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, which added section 1847A to the Act, similarly does not
discuss the purpose of the 6 percent add-on (see Conference Report on
H.R. 1, November 20, 2003). Although section 1847A of the Act does not
specifically state what the add-on represents, it is believed by many
that the 6 percent add on includes various activities associated with
drug acquisition that are not separately paid for, such as handling,
and storage, as well as additional costs, such as overhead and mark-ups
in drug distribution channels; however, there is no consensus on the
intent of the add-on (MedPAC Report to the Congress: Medicare and the
Health Care Delivery System June 2016, http://www.medpac.gov/docs/default-source/reports/june-2016-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf?sfvrsn=0, page 127).
Comment: Commenters expressed concerns that a payment reduction of
3 percent would affect physicians and limit their utilization of new
drugs, particularly in practices where margins are small, such as rural
practices and small practices. Commenters were concerned that payments
for drugs under the proposed reduction would not cover overhead (such
as costs to order and store drugs, and rising costs for compliance with
standards for the preparation of sterile drugs for administration to a
patient), and other
[[Page 59664]]
costs (such as taxes and markups from intermediaries like wholesalers).
Commenters stated that such payment reductions would require physicians
to take a loss on new drugs or would prevent physicians from providing
new drugs in the office. Several commenters disagreed that the markup
incentivizes the use of more expensive drugs, while others agreed that
financial incentives to use Part B drugs exist, particularly in the
case of expensive drugs. One commenter noted that Part B includes some
of the most expensive drugs available in the United States. Several
commenters also noted that MedPAC data suggested that WAC-based
payments with a 3 percent add-on could sometimes be less than ASP based
payments with a 6 percent add-on.
Response: The payment methodology in section 1847A of the Act was
authorized by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8,
2003). Since then, drug prices have increased significantly, sometimes
reaching into the tens and even hundreds of thousands of dollars for a
single dose of a drug. We agree with commenters that Part B includes
payments for very expensive drugs, and at least one GAO study has
pointed out that the most new Part B drugs are costly and tend to be
biologicals (Medicare Part B: Expenditures for New Drugs Concentrated
among a Few Drugs, and Most Were Costly for Beneficiaries. (GAO
Publication No. GAO-16-12; https://www.gao.gov/assets/680/673304.pdf)).
As stated in the previous comment response, the purpose of the 6
percent add-on is not clear, however, we are interested in striking a
balance between concerns about providers' overhead costs and concerns
about addressing financial incentives that may lead to excessive drug
use.
If the add-on is intended to account for administrative complexity,
handling, storage and other overhead costs, these factors are not
considered to be exactly proportional to current drug prices (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives).
The application of the 6 percent add-on results in large dollar value
payments for new drugs that are proportional only to the price of the
drug. Further, the application of a 6 percent add-on to an undiscounted
price like WAC, rather than a market-based price, can result in
additional differences between acquisition cost and payment. This
difference can become significant, particularly for higher cost drugs
where the 6 percent add-on can be hundreds or even thousands of
dollars, and can become even more substantial when WAC exceeds ASP or
acquisition cost. We are concerned that as drug prices continue to
increase, the add-on is continuing to evolve into a financial incentive
that is not consistent with the appropriate use of new Part B drugs.
Many new drugs are expensive; single doses may cost thousands of
dollars. Six percent add-ons for expensive drugs may be excessive
relative to factors such as the cost to acquire a drug, handling and
storage, and other overhead costs. We believe that overhead costs for
most new drugs and biologicals are generally comparable to the overhead
costs for most other injectable Part B drugs. For example, many heavily
utilized injectable Part B drugs and biologicals, including new
products, appear to be readily available since they are listed in drug
wholesalers' catalogues. With certain exceptions, such as biologicals
made from autologous cells, prescribing information indicates that many
injectable Part B drugs and biologicals are stable under refrigeration
or room temperature and do not require highly specialized storage or
shipping conditions. We also note that many newer injectable drugs are
also produced in ready to use liquid form, thus additional
reconstitution and complicated dose preparation steps are not
necessary. For many newer injectable products that were added to the
ASP drug files in 2018, prescribing information indicates that dose
preparation is comparable to many other sterile injectables and
consists of drawing up the drug into a syringe using aseptic technique,
and sometimes diluting the dose in a small volume bag of intravenous
fluid. Some of the newer products are available in ready to use
syringes which are administered directly to the patient with no special
preparation steps.
We believe that the 3 percent reduction will help encourage the
appropriate utilization of new drugs by lessening the financial
incentive to overutilize drugs during their initial period of sales. We
will discuss the percentage in more detail in the next comment
response, but in general we believe that this reduction will not reduce
margins for Part B drugs to an extent that would significantly and
negatively affect providers, for several reasons. First, the overhead
for many new drugs and biologicals is not likely to be significantly
higher than the overhead for existing Part B injectable drugs (as
discussed in the paragraph above). Second, the add-on is based on an
undiscounted list price that is usually higher than market prices, and
many new drugs and biologicals are costly. When the add-on is based on
an undiscounted list price, this may contribute to potentially
excessive add-on payments, particularly for expensive new drugs. As the
WAC of a drug increases, so does the dollar value of the add-on, and
this increase is not tied to any other factors, such actual market
cost, administrative complexity of ordering the drug, or additional
overhead costs, for example. The add-on for a costly drug can add
significantly to the payment for a drug; a 6 percent add-on for a
$5,000 dose of a drug is $300, while the 6 percent add-on for a $10,000
dose is $600. Third, the duration of the reduction to WAC-based
payments for new drugs would be brief, applying only during an initial
period as stipulated in section 1847A(c)(4) of the Act, where ASP data
for drugs or biologicals (including biosimilars) is not sufficiently
available to determine an ASP-based payment. Fourth, based on recent
additions to the ASP drug pricing files, the change would affect only a
small number of drugs each year. Typically, several drugs are added to
the ASP Drug Pricing files each quarter, and not all of those drugs are
priced based on WAC; some are added to the pricing files after the
initial period of sales and are paid based on ASP. For these reasons,
we are not persuaded that the reduction of the add-on for new drugs
would have significant impact on margins for most physicians or other
providers, including small and rural practices.
While some WAC based payments for new drugs could be less than ASP-
based payments, the WAC exceeds the ASP for most new drugs entering the
market. Our approach using a percentage of the WAC-based amount
provides an administratively simple and straightforward solution for
new Part B drugs.
We reiterate that our proposal did not include payments for single
source drugs under section 1847A(b)(4) of the Act, where payment is
made using the lesser of ASP or WAC. (This methodology applies after
CMS receives ASP data for the drug.) Section 1847A(b)(1) of the Act
requires that a 6 percent add-on be applied regardless of whether WAC
or ASP is less; legislation would be required to change the percentage
of the add-on that is specified in this provision.
Comment: Several commenters stated that the MedPAC analysis was too
limited and did not support a 3 percent add-on. Some suggested that
delaying the add-on reduction and conducting more research was a
reasonable alternative. Several commenters noted that manufacturers
could increase WAC in response to CMS' change in policy.
[[Page 59665]]
Response: The MedPAC analysis encompassed drugs with ASP data after
2005 that were in the top 20 highest expenditures in 2014. The analysis
indicated that ASP was lower than WAC soon after a drug is marketed; a
range of percentages from 0.0 to -2.7 percent was reported. We believe
that the 0.0 to -2.7 percent range may underestimate the average
difference between WAC and ASP because the MedPAC's group of 8 drugs
did not encompass codes where WAC substantially exceeded ASP, such as
certain biosimilars. We also note that this analysis of drugs was not
the only factor for MedPAC's recommendation of a 3 percent add-on. The
report stated that the recommendation for 3 percent change was also
based on industry statements regarding prompt-pay discounts, and
previous OIG research (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 43, 44, 52, and 68). For
these reasons, we disagree with commenters that the MedPAC analysis was
too limited.
Although the number of new drugs that appear on the ASP Drug
Pricing Files with a WAC-based payment amount is limited, we stated in
the proposed rule (83 FR 36047) that the average difference between WAC
and ASP-based payment limits for a group of 3 recently approved drugs
and biologicals that appeared on the ASP Drug Pricing Files (including
one biosimilar biological product) was 9.0 percent. Excluding the
biosimilar biological product results in a difference of 3.5 percent.
These findings agree with the MedPAC's analysis and support the use of
a 3 percent reduction to WAC-based payments for new drugs. Given the
limited application of this policy change, the sources used by the
MedPAC (which include industry statements), and our internal review, we
do not believe that additional study or delay is necessary.
We are aware that ASP-based payments may exceed payments based on
WAC if the percentage for the WAC add-on is smaller than the ASP add-
on. The proposal for this policy change was limited to payments under
section 1847A(c)(4) of the Act. We do not have authority to change the
add-on for WAC based payments made under section 1847A(b)(4) of the Act
or payments based on the ASP, and we have not addressed such payments
in this rule. We believe that implementation of this relatively minor
change without further delay is a positive step toward addressing high
drug prices, including list prices. We acknowledge that manufacturers
may increase Part B drug prices and that price increases could apply to
both list prices like WAC and market-based prices, such as ASP. Section
1847A of the Act does not provide us with authority to addresses most
increases for Part B drug prices (we have limited authority to
substitute AMP-based prices for ASP, and authority to use alternative
prices in response to certain public health emergencies). Price
increases from manufacturers and other sources that add to high drug
costs will be considered as we continue our work to address concerns
about high drug prices.
Comment: Several commenters pointed out that the proposal does not
address prices after the initial period of drug marketing, and that the
MedPAC's recommendations about reducing the WAC payment add-on
percentage were part of several proposals about Part B drug pricing.
Several commenters also stated that the proposal to decrease WAC
payments is not consistent with the President's goal to decrease list
prices for drugs.
Response: This proposal encompassed a change in policy that could
be implemented in a relatively short time period and without additional
legislation. The proposal is also consistent with the 2019 President's
Budget's proposal. Language in the Major Savings and Reforms document
states that if discounts are available for new Part B drugs, the use of
WAC-based payments results in Medicare paying more than under ASP-based
pricing (https://www.whitehouse.gov/wp-content/uploads/2018/02/msar-fy2019.pdf, page 150). The Budget proposal also contained other agenda
items that are similar to the MedPAC's 2017 recommendations and would
require legislation to implement. Such legislative changes, including
authority to limit or to otherwise regulate WAC or other list prices
for drugs are outside the scope of this rule; however, other
information pertaining to drug pricing will be made public as it is
developed. We also note that the use of list prices to determine the
payment for Part B drugs is limited and the number of drugs paid using
list prices is small. As we continue to work on other approaches to
address high drug prices, we plan to monitor Part B drug prices and
changes to drug costs that may be related to this policy.
Comment: Many commenters focused on potential negative effects on
patients, and expressed concerns that a negative impact on physicians
would lead to fewer offices providing new drugs, leading to shifts to
higher cost care settings like hospital outpatient departments, and
ultimately leading to higher cost sharing payments. A few commenters
stated that direct reductions in cost sharing (that is, the amount of
money paid by a patient) would be minimal because secondary insurance
(like Medigap) or alternative sources of payment are typically
available and pay for much of Part B drug cost sharing.
In contrast, several commenters agreed that cost sharing could
drop, though the effect would be transient (limited to the early phase
of a drug's marketing). However, these commenters generally agree that
the CMS proposal was a step in the right direction for addressing the
high cost of drugs.
Response: Overall, as discussed in an earlier comment response, we
believe that the scope of these changes is modest, will affect few
drugs, and will exert a brief effect on Part B drug payment, applying
only during the initial quarters when a new drug enters the market. As
stated earlier in this section, the overhead for many new drugs and
biologicals is not likely to be significantly higher than the overhead
for existing Part B injectable drugs, the add-on is based on an
undiscounted list price that tends to be higher than market prices, and
many new drugs and biologicals are expensive, thus we do not expect a
significant effect on providers' margins. Because we do not anticipate
a significant or prolonged effect on providers' margins, we also
disagree with the position that physicians' offices will be reluctant
to administer new drugs and that this reduction to the add-on will
negatively affect beneficiaries access to drugs at offices resulting in
shifting patients to more expensive settings. As we stated in the
proposed rule (83 FR 36047), we believe that the reduction in the WAC-
based payment add-on can positively impact individual beneficiaries in
situations where they encounter out of pocket cost sharing payments for
new and expensive drugs entering the market. We acknowledge that many
beneficiaries that receive Part B drugs have supplementary insurance,
but for beneficiaries that do not have supplementary insurance, this
policy will help reduce out of pocket costs. We would like to reiterate
that single doses of new drugs may costs thousands of dollars or more
and a 3 percent reduction in the add-on percentage can result in
meaningful savings to individual patients. We agree with commenters
that a change to the add-on for new drugs is a step in the right
direction for addressing the high cost of drugs. Overall, this policy
will also provide a modest reduction in spending
[[Page 59666]]
for drugs by lowering the total payment for new Part B drugs.
After considering the comments submitted in response to our
proposal, consistent with section 1847A(c)(4) of the Act, we are
finalizing our proposal to reduce the add-on percentage for WAC based
payments for new drugs. Effective January 1, 2019, WAC based payments
for new Part B drugs made under section 1847A(c)(4) of the Act, will
utilize a 3 percent add-on in place of the 6 percent add-on that is
currently being used. Our final policy is consistent with the
President's Budget and affects an area where we have flexibility to
make a change through regulation. The percentage reduction is also
consistent with the MedPAC's analysis and recommendations discussed in
this section and cited in its June 2017 Report to the Congress. A fixed
percentage is also administratively simple to implement and administer,
is predictable, and is easy for manufacturers, providers and the public
to understand. We believe that the 3 percent reduction to the add-on
for WAC-based payments will create greater parity overall between WAC
and ASP for new drugs, biologicals and biosimilars and continue to
encourage appropriate utilization of drugs. We are not persuaded that
this modest and brief reduction in payments will impair access to new
drugs or shift patient care to other settings.
This change does not apply to single source drugs or biologicals
paid under section 1847A(b)(4) of the Act where payment is made using
the lesser of ASP or WAC; section 1847A(b)(1) of the Act requires that
a 6 percent add-on be applied regardless of whether WAC or ASP is less.
Comment: We received no specific comments on the proposal to
conform the regulation text more closely to the statutory language at
section 1847A(c)(4) of the Act. We proposed striking ``applicable''
from regulation text at Sec. 414.904(e)(4).
Response: We are finalizing this change as proposed and revising
regulation text at Sec. 414.904(e)(4) so that the language is more
consistent with the statute.
Comment: Several commenters opposed our intent to change the policy
articulated in Chapter 17 of the Medicare Claims Processing Manual that
describes the application of the 6 percent add-on to payment
determinations made by MACs for new drugs and biologicals to reflect
our proposal, if finalized. Commenters opposed the Manual changes for
the same general reasons that they opposed the proposal to change the
WAC-based add-on percentage under section 1847A(c)(4) of the Act.
Commenters were also concerned about whether the use of an add-on that
could be less than 3 percent would create additional financial stress
for providers and whether the manual changes would apply to any WAC-
based payment. The commenters also questioned whether CMS has authority
to make these changes.
Response: The discussion about changes to Chapter 17 of the
Medicare Claims Processing Manual was intended to provide notice of a
potential corresponding subregulatory change to align with our
regulatory policy if the provision to change the add-on percentage was
finalized. Because we finalized the proposal to reduce the WAC-based
payment add-on for payments made under the authority in section
1847A(c)(4) of the Act, in the near future we plan to issue Manual
instructions that will address contractor pricing for new Part B drugs.
We are clarifying that changes to payments for WAC based drugs
discussed in this rule apply only to new drugs and only during the time
period while an ASP-based payment limit is not available. This time
period begins when a drug is marketed and no ASP data is available for
the manufacturer to report to us and ends at the end of the partial
quarter pricing period when partial quarter ASP data becomes available
to us. We will provide additional guidance or program instructions as
appropriate.
The variable percentage that we plan to utilize in the manual, that
is, the use of an add-on that is up to 3 percent, addresses the wide
range of Part B drug prices. As discussed earlier in this section, the
6 percent add-on payment amount for very expensive drugs can result in
very high add-on payments. For example, 6 percent of a $30,000 drug is
$1800, while 6 percent of $300,000 is $18,000. We are aware of recently
approved Part B drugs that have per dose price points up to several
hundred thousand dollars. Our intent is to address the add-on payment
that is associated with new drugs before national pricing and
potentially other related policies, such as coverage, are developed.
Our approach is consistent with provisions in section 1847A(c)(4) of
the Act, which does not set a specific percentage for the add-on for
drugs where ASP is not available. We also note that section 1847A(c)(5)
of the Act provides authority to issue program instructions to
implement section 1847A of the Act.
Comment: One commenter expressed concern about the lack of lead
time for the changes in drug payment policy.
Response: Notice and comment rulemaking associated with Part B drug
payments made under the methodology in section 1847A of the Act
typically appears in the annual PFS Rule. Finalized changes to the add-
on percentage will not be implemented until January 1, 2019. We believe
that using the established process for notice and comment rulemaking is
acceptable and provides sufficient notice for the public. As stated
earlier in this section, we believe that this change is modest, and its
effects on payment for individual drugs will be brief. Further, this
change does not require any billing or claims processing changes.
In addition to the comments on the Part B drug add-on percentage
for certain drugs discussed previously in this section, we received
comments that suggested other alterations to the payment methodology
under section 1847A of the Act. These suggestions include replacing a
percentage add-on with a flat fee, changes to WAC-based pricing for
drugs that are not new, changing payments for drugs that are not paid
for under section 1847A of the Act (such as radiopharmaceuticals used
in the office), the use of competitive acquisition or value-based
payment for Part B drugs, making direct pricing interventions with
manufacturers, requiring greater transparency for drug pricing, and
educating (or otherwise influencing) providers about Part B drug
prescribing. We also received comments pertaining to ASP reporting by
manufacturers. Several commenters also questioned the authority for
Part B drug payment reductions associated with the sequester. Comments
on these issues are also outside the scope of this rule. Therefore,
these comments are not addressed in this final rule.
N. Potential Model for Radiation Therapy
Section 3(a) of the Patient Access and Medicare Protection Act
(PAMPA) (Pub. L. 114-115, enacted December 28, 2015) revised section
1848 of the Act so that, for the fee schedule established under section
1848(b) of the Act in 2017 and 2018, we must apply the same code
definitions and work RVUs under section 1848(c)(2)(C)(ii) of the Act,
and the same direct inputs for the PE RVUs for radiation treatment
delivery and related imaging services under section 1848(c)(2)(C)(ii)
of the Act as those definitions, units, and inputs for such services
for the fee schedule established for services furnished in 2016.
Section 51009 of the Bipartisan Budget Act of
[[Page 59667]]
2018 extended these policies through 2019. Furthermore, section 3(b) of
the PAMPA requires the Secretary of Health and Human Services to submit
to Congress a report on the development of an episodic APM for payment
under the Medicare program under title XVIII of the Act for radiation
therapy (RT) services furnished in non-facility settings (``Report to
Congress''). In the Report to Congress \7\ delivered in November 2017,
we discussed the current status of RT services and payment, and
reviewed model design considerations for a potential APM for RT
services.
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\7\ Report to Congress: Episodic Alternative Payment Model for
Radiation Therapy Services. https://innovation.cms.gov/Files/reports/radiationtherapy-apm-rtc.pdf.
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For the Report to Congress, the CMS Center for Medicare and
Medicaid Innovation (Innovation Center) conducted an environmental scan
of current evidence, as well as held a public listening session
followed by an opportunity for RT stakeholders to submit written
comments about a potential APM. A review of the applicable evidence in
the Report to Congress demonstrated that episode payment models can be
a tool for improving care and reducing expenditures. We believe that
radiation oncology is a promising area of health care for bundled
payments, in part, based on the findings in the Report to Congress. The
CMS Innovation Center has and will continue to use public information
regarding commercial initiatives, as well as stakeholder feedback to
help inform the development, implementation, and refinement of design
and testing of a potential model that tests payment for RT services
under the authority of section 1115A of the Act.
III. Other Provisions of the Proposed Rule
A. Clinical Laboratory Fee Schedule
1. Background
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS)
under sections 1832, 1833(a), (b), and (h), and 1861 of the Social
Security Act (the Act). Under the previous methodology, CDLTs were paid
based on the lesser of: (1) The amount billed; (2) the local fee
schedule amount established by the Medicare Administrative Contractor
(MAC); or (3) a national limitation amount (NLA), which is a percentage
of the median of all the local fee schedule amounts (or 100 percent of
the median for new tests furnished on or after January 1, 2001). In
practice, most tests were paid at the NLA. Under the previous system,
the CLFS amounts were updated for inflation based on the percentage
change in the Consumer Price Index for All Urban Consumers (CPI-U), and
reduced by a multi-factor productivity adjustment and other statutory
adjustments, but were not otherwise updated or changed.
Section 1834A of the Act, as established by section 216(a) of the
Protecting Access to Medicare Act of 2014 (PAMA), required significant
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final
rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment
System (CLFS final rule), published in the Federal Register on June 23,
2016, implemented section 1834A of the Act. Under the CLFS final rule,
``reporting entities'' must report to CMS during a ``data reporting
period'' ``applicable information'' collected during a ``data
collection period'' for their component ``applicable laboratories.''
Applicable information is defined at Sec. 414.502 as, with respect to
each CDLT for a data collection period: Each private payor rate for
which final payment has been made during the data collection period;
the associated volume of tests performed corresponding to each private
payor rate; and the specific Healthcare Common Procedure Coding System
(HCPCS) code associated with the test. Applicable information does not
include information about a test for which payment is made on a
capitated basis. An applicable laboratory is defined at Sec. 414.502,
in part, as an entity that is a laboratory (as defined under the
Clinical Laboratory Improvement Amendments (CLIA) definition at Sec.
493.2) that bills Medicare Part B under its own National Provider
Identifier (NPI). In addition, an applicable laboratory is an entity
that receives more than 50 percent of its Medicare revenues during a
data collection period from the CLFS and/or the Physician Fee Schedule
(PFS). We refer to this component of the applicable laboratory
definition as the ``majority of Medicare revenues threshold.'' The
definition of applicable laboratory also includes a ``low expenditure
threshold'' component which requires an entity to receive at least
$12,500 of its Medicare revenues from the CLFS for its CDLTs that are
not advanced diagnostic laboratory tests (ADLTs).
The first data collection period, for which applicable information
was collected, occurred from January 1, 2016 through June 30, 2016. The
first data reporting period, during which reporting entities reported
applicable information to CMS, occurred January 1, 2017 through March
31, 2017. On March 30, 2017, we announced a 60-day enforcement
discretion period of the assessment of civil monetary penalties (CMPs)
for reporting entities that failed to report applicable information.
Additional information about the 60-day enforcement discretion period
is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
In general, the payment amount for each CDLT on the CLFS furnished
beginning January 1, 2018, is based on the applicable information
collected during the data collection period and reported to us during
the data reporting period, and is equal to the weighted median of the
private payor rates for the test. The weighted median is calculated by
arraying the distribution of all private payor rates, weighted by the
volume for each payor and each laboratory. The payment amounts
established under the CLFS are not subject to any other adjustment,
such as geographic, budget neutrality, or annual update, as required by
section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of
the Act, implemented at Sec. 414.507(d), provides a phase-in of
payment reductions, limiting the amounts the CLFS rates for each CDLT
(that is not a new ADLT or new CDLT) can be reduced as compared to the
payment rates for the preceding year. For the first 3 years after
implementation (CY 2018 through CY 2020), the reduction cannot be more
than 10 percent per year, and for the next 3 years (CY 2021 through CY
2023), the reduction cannot be more than 15 percent per year. For most
CDLTs, the data collection period, data reporting period, and payment
rate update occur every 3 years. As such, the next data collection
period for most CDLTs will be January 1, 2019 through June 30, 2019,
and the next data reporting period will be January 1, 2020 through
March 31, 2020, with the next update to CLFS occurring on January 1,
2021. Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101).
2. Recent Stakeholder Feedback
As we discussed in the CY 2019 PFS proposed rule (83 FR 35856),
after the initial data collection and data reporting periods, we
received feedback on a range of topics related to the private payor
rate-based CLFS. Some commenters expressed concern that the
[[Page 59668]]
CY 2018 CLFS payments rates are based on applicable information from
only a relatively small number of laboratories. Some commenters stated
that, because most hospital-based laboratories were not applicable
laboratories, and therefore, did not report applicable information
during the initial data reporting period, the CY 2018 CLFS payment
rates do not reflect their information and are inaccurate. Other
commenters were concerned that the low expenditure threshold excluded
most physician office laboratories and many small independent
laboratories from reporting applicable information.
We noted in the proposed rule that, in determining payment rates
under the private payor rate-based CLFS, one of our objectives is to
obtain as much applicable information as possible from the broadest
possible representation of the national laboratory market on which to
base CLFS payment amounts, for example, from independent laboratories,
hospital outreach laboratories, and physician office laboratories,
without imposing undue burden on those entities. As we noted throughout
the CLFS final rule, we believe it is important to achieve a balance
between collecting sufficient data to calculate a weighted median that
appropriately reflects the private market rate for a CDLT, and
minimizing the reporting burden for entities. In response to this
feedback and in the interest of facilitating our goal, we proposed a
change to the Medicare CLFS for CY 2019 in section III.A. of the CY
2019 PFS proposed rule. We stated that we believe this proposal may
result in more data being used on which to base CLFS payment rates.
In addition to this proposal, we solicited public comments on other
approaches that have been requested by some stakeholders who suggested
that such approaches would result in CMS receiving even more applicable
information to use in establishing CLFS payment rates. The approaches
include revising the definition of applicable laboratory and changing
the low expenditure threshold. These topics are discussed in this
section.
3. Change to the Majority of Medicare Revenues Threshold in Definition
of Applicable Laboratory
In order for a laboratory to meet the majority of Medicare revenues
threshold, section 1834A(a)(2) of the Act requires that, ``with respect
to its revenues under this title, a majority of such revenues are
from'' the CLFS and the PFS in a data collection period. In the CLFS
final rule, we stated that ``revenues under this title'' are payments
received from the Medicare program, which includes fee-for-service
payments under Medicare Parts A and B, as well as Medicare Advantage
(MA) payments under Medicare Part C, and prescription drug payments
under Medicare Part D, and any associated Medicare beneficiary
deductible or coinsurance amounts for Medicare services furnished
during the data collection period (81 FR 41043). This total Medicare
revenues amount (the denominator in the majority of Medicare revenues
threshold calculation) is compared to the total of Medicare revenues
received from the CLFS and/or PFS (the numerator in the majority of
Medicare revenues threshold calculation). If the numerator is greater
than 50 percent of the denominator for a data collection period, the
entity has met the majority of Medicare revenues threshold criterion.
We reflected that requirement in Sec. 414.502 in the third paragraph
of the definition of applicable laboratory.
As we explained in the CY 2019 PFS proposed rule, we have
considered that our current interpretation of total Medicare revenues
may have the effect of excluding laboratories that furnish Medicare
services to a significant number of beneficiaries enrolled in MA plans
under Medicare Part C from meeting the majority of Medicare revenues
threshold criterion, and therefore, from qualifying as applicable
laboratories. For instance, if a laboratory has a significant enough
Part C component so that it is receiving greater than 50 percent of its
total Medicare revenues from MA payments under Part C, it would not
meet the majority of Medicare revenues threshold because its revenues
derived from the CLFS and/or PFS would not constitute a majority of its
total Medicare revenues. We stated that we believe if we were to
exclude MA plan revenues from total Medicare revenues, more
laboratories of all types may meet the majority of Medicare revenues
threshold, and therefore, the definition of applicable laboratory,
because it would have the effect of decreasing the amount of total
Medicare revenues and increase the likelihood that a laboratory's CLFS
and PFS revenues would constitute a majority of its Medicare revenues.
We stated in the proposed rule that we believe section 1834A of the
Act permits an interpretation that MA plan payments to laboratories not
be included in the total Medicare revenues component of the majority of
Medicare revenues threshold calculation. Rather, MA plan payments to
laboratories can be considered to only be private payor payments under
the CLFS. We emphasized in the CY 2019 PFS proposed rule that this
characterization of MA plan payments is limited to only the CLFS for
purposes of defining applicable laboratory. Whether MA plan payments to
laboratories or other entities are considered Medicare ``revenues'' or
``private payor payments'' in other contexts in the Medicare program is
not relevant to our proposal, and our characterization of MA plan
payments as private payor payments for purposes of the CLFS has no
bearing on any aspect of the Medicare program other than the CLFS.
As noted above, we defined total Medicare revenues for purposes of
the majority of Medicare revenues threshold calculation to include fee-
for-service payments under Medicare Parts A and B, as well as MA
payments under Medicare Part C, prescription drug payments under
Medicare Part D, and any associated Medicare beneficiary deductible or
coinsurance amounts for Medicare services furnished during the data
collection period. However, section 1834A(a)(8) of the Act, which
defines the term ``private payor,'' identifies at section
1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of
private payor. Under the private payor rate-based CLFS, CLFS payment
amounts are based on private payor rates that are reported to CMS.
Accordingly, an applicable laboratory that receives MA plan payments is
to consider those MA plan payments in identifying its applicable
information, which must be reported to CMS. We explained in the
proposed rule that we believe it is more logical to not consider MA
plan payments under Part C to be both Medicare revenues for determining
applicable laboratory status and private payor rates for purposes of
reporting applicable information. Congress contemplated that applicable
laboratories would furnish MA services, as reflected in the requirement
that private payor rates must be reported for MA services. However,
under our current definition of applicable laboratory, laboratories
that furnish MA services, particularly those that furnish a significant
amount, are less likely to meet the majority of Medicare revenues
threshold, which means they would be less likely to qualify as
applicable laboratories, and as a result, to report private payor rates
for MA services.
Therefore, we stated in the proposed rule that after further review
and consideration of the new private payor rate-based CLFS, we believe
it is appropriate to include MA plan revenues as only private payor
payments rather than both Medicare revenues, for the purpose of
[[Page 59669]]
determining applicable laboratory status, and private payor payments,
for the purpose of specifying what is applicable information. Such a
change would have the effect of eliminating the laboratory revenue
generated from a laboratory's Part C-enrolled patient population as a
factor in determining whether a majority of the laboratory's Medicare
revenues are comprised of services paid under the CLFS or PFS. We noted
that we believe this change would permit a laboratory with a
significant Medicare Part C revenue component to be more likely to meet
the majority of Medicare revenues threshold and qualify as an
applicable laboratory. In other words, MA payments are currently
included as total Medicare revenues (the denominator). In order to meet
the majority of Medicare revenues threshold, the statute requires a
laboratory to receive the majority of its Medicare revenues from the
CLFS and or PFS. If MA plan payments were excluded from the total
Medicare revenues calculation, the denominator amount would decrease.
If the denominator amount decreases, the likelihood increases that a
laboratory would qualify as an applicable laboratory. Therefore, we
stated that we believe this proposal responds directly to stakeholders'
concerns regarding the number of laboratories for which applicable
information must be reported because a broader representation of the
laboratory industry may qualify as applicable laboratories, which means
we would receive more applicable information to use in setting CLFS
payment rates.
For these reasons, we proposed that MA plan payments under Part C
would not be considered Medicare revenues for purposes of the
applicable laboratory definition. We noted in the CY 2019 PFS proposed
rule that if finalized, we would revise paragraph (3) of the definition
of applicable laboratory at Sec. 414.502 accordingly. We reiterated
that not characterizing MA plan payments under Medicare Part C as
Medicare revenues would be limited to the definition of applicable
laboratory under the CLFS, and would not affect, reflect on, or
otherwise have any bearing on any other aspect of the Medicare program.
In an effort to provide stakeholders a better understanding of the
potential reporting burden that may result from this proposal, we
provided a summary of the distribution of data reporting that occurred
for the first data reporting period. We explained that if we were to
finalize the proposed change to the majority of Medicare revenues
threshold component of the definition of applicable laboratory,
additional laboratories of all types serving a significant population
of beneficiaries enrolled in Medicare Part C could potentially qualify
as applicable laboratories, in which case their data would be reported
to us. As discussed in the proposed rule, we received over 4.9 million
records from 1,942 applicable laboratories for the initial data
reporting period, which we used to set CY 2018 CLFS rates. Additional
analysis shows that the average number of records reported for an
applicable laboratory was 2,573. The largest number of records reported
for an applicable laboratory was 457,585 while the smallest amount was
1 record. A summary of the distribution of reported records from the
first data collection period is illustrated in the Table 25.
Table 25--Summary of Records Reported for First Data Reporting Period
[By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentile distribution of records
Total records Average Min records Max records -------------------------------------------------
records 10th 25th 50th 75th 90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877................................................... 2,573 1 457,585 23 79 294 1,345 4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assuming a similar distribution of data reporting for the next data
reporting period, the mid-point of reported records for an applicable
laboratory would be approximately 300 (50th percentile for the first
data reporting period was 294). However, as illustrated in Table 25,
the number of records reported varies greatly, depending on the volume
of services performed by a given laboratory. Laboratories with larger
test volumes, for instance at the 90th percentile, should expect to
report more records as compared to the midpoint used for this analysis.
Likewise, laboratories with smaller test volume, for instance at the
10th percentile, should expect to report fewer records as compared to
the midpoint.
The following is a summary of the comments we received and our
responses to the comments regarding our proposal to modify the
definition of applicable laboratory to exclude MA plan payments under
Part C as Medicare revenues.
Comment: Many commenters supported CMS' proposal to exclude MA plan
payments under Part C from total Medicare revenues and agreed it would
help achieve CMS' goal of increasing the number of laboratories
reporting applicable information. They stated that by excluding MA plan
payments from total Medicare revenues, the denominator of the majority
of Medicare revenues threshold, more laboratories of all types with a
significant share of revenues from Medicare Part C would be more likely
to qualify as an applicable laboratory and report applicable
information to CMS. They also agreed that removal of MA plan payments
from total Medicare revenues is consistent with the statute, which
defines MA plans as a private payor, and therefore will help enable
more laboratories to qualify as applicable laboratories. The commenters
that supported excluding MA plan payments under Part C from total
Medicare revenues urged CMS to finalize the proposal. However, some
stakeholders objected to CMS' proposal because it would result in
administrative reporting burden for additional laboratories without
having a perceptible impact on CLFS rates (because the largest
laboratories with the highest test volumes will continue to dominate
the weighted median of private payor rates). They stated that
increasing the number of laboratories qualifying for applicable
laboratory status and imposing additional data reporting burden, with
no perceptible impact expected on the CLFS rates, is in direct conflict
with the Administration's goal of reducing regulatory burden.
Response: As discussed in the proposed rule, including MA plan
payments as total Medicare revenues in the majority of Medicare
revenues threshold (as we currently do) dilutes the percentage of total
Medicare revenues attributed to CLFS and PFS revenues. As a result,
laboratories performing tests for a significant Medicare Part C
population are less likely to qualify as an applicable
[[Page 59670]]
laboratory and, therefore, to report applicable information to us.
For the additional data reporting burden, as discussed in the
Regulatory Impact Analysis in section VII. of the proposed rule (83 FR
36048), we estimated that excluding MA plan payments from total
Medicare revenues (the denominator) of the majority of Medicare
revenues threshold, and keeping the numerator constant (that is,
revenues from only the CLFS and or PFS) yielded an increase of 49
percent in the number of laboratories meeting the majority of Medicare
revenues threshold.
We also noted in the proposed rule that there would only be an
associated impact to the Medicare rates to the extent the additional
applicable laboratories are paid at a higher (or lower) private payor
rate, as compared to other laboratories that reported previously and to
the extent the volume of services performed by these additional
applicable laboratories is significant enough to make an impact on the
weighted median of private payor rates. Given that the largest
laboratories with the highest test volumes dominate the weighted median
of private payor rates, and the largest laboratories reported data for
the determination of CY 2018 CLFS rates and are expected to report
again, we stated that we do not expect the additional reported data
resulting from our proposed change to the majority of Medicare revenues
threshold to have a predictable, direct impact on CLFS rates. By this
we mean that we cannot predict whether the additional applicable
laboratories reporting applicable information are paid at a higher (or
lower) private payor rate, as compared to other laboratories that
reported previously and whether the private payor rate volume of
services performed by these additional applicable laboratories is
significant enough to make an impact on the weighted median of private
payor rates.
However, as we noted in the proposed rule, our proposal to exclude
MA plan payments from total Medicare revenues responded directly to
stakeholder concerns regarding the number of applicable laboratories
reporting applicable information for the initial data reporting period.
We believe that enabling more laboratories of all types that furnish
testing to a significant Medicare Part C population to qualify as
applicable laboratories and report data to CMS directly supports our
goal of collecting as much applicable information as possible from the
broadest representation of the national laboratory market on which to
base CLFS payment amounts. Therefore, we believe receiving additional
applicable information from more laboratories of all laboratory types
outweighs the additional reporting burden on laboratories.
Comment: One commenter disagreed with CMS' proposal to define MA
plan payments as private payor payments and not Medicare revenues for
the purpose of determining applicable laboratory status. The commenter
stated that MA plans are Medicare plans that rarely negotiate a rate
that varies from the Medicare payment rate and that using MA plan
payments to develop Medicare rates is simply a circular reference. The
commenter also stated that Medicaid managed care plans should not be
considered as a private payor because state Medicaid programs may set
laboratory test rates at a percentage of the Medicare CLFS, for
example, 80 percent of the Medicare CLFS rate. As such, the commenter
stated that the use of Medicaid managed care plan data will create a
``downward spiral'' of CLFS rates.
Response: Sections 1834A(a)(8)(B) and (C) of the Act define a
private payor to include a Medicare Advantage plan under Part C, and a
Medicaid managed care organization (as defined in section 1903(m) of
the Act), respectively. Therefore, the statute would not permit us to
exclude a Medicare Advantage plan under Part C or a Medicaid managed
care organization from the definition of private payor for the purposes
of determining the applicable information reported to us from which to
set CLFS rates. We understand the commenter's concern regarding the
potential circularity of using Medicaid managed care and MA plan data
to set Medicare CLFS rates to the extent that Medicaid managed care and
MA plan rates are established based on Medicare rates. However, we note
that section 1834A(a) of the Act explicitly directs us to use such data
in setting the CLFS rates. For the suggestion that including Medicaid
managed care plan data will result in a ``downward spiral,'' we note
that the statute anticipates that rates will decrease under the new
private payor rate-based CLFS and provides a phase-in of payment
reductions. Section 1834A(b)(3) of the Act, implemented at Sec.
414.507(d), limits the amounts the CLFS rates for each CDLT (that is
not a new ADLT or new CDLT) can be reduced as compared to the payment
rates for the preceding year. For the first 3 years after
implementation (CY 2018 through CY 2020), the reduction cannot be more
than 10 percent per year, and for the next 3 years (CY 2021 through CY
2023), the reduction cannot be more than 15 percent per year. We also
note that the Medicaid managed care plans may or may not be obligated
to continue to use Medicare rates (or a reduction thereof) as a basis
for their rates were such a ``downward spiral'' to occur.
Comment: One commenter urged CMS to conduct a more robust and
transparent analysis of this proposal to identify the types of
laboratories to which this policy would apply and the relative impact
on payment rates. The commenter also requested that CMS release the
number of clinical laboratories that previously reported applicable
information, based on market segment and geographic locations. The
commenter asserted that without such information, it would be premature
to implement a proposal that will only increase administrative burden
on hospitals and other organizations which will be forced to re-
determine their applicable laboratory status.
Response: As discussed previously, our proposal to exclude MA plan
payments from the total Medicare revenues for purposes of applying the
majority of Medicare revenues threshold would affect laboratories of
all types, that is hospital laboratories, large and small independent
laboratories, and physician office laboratories that furnish services
to a significant Medicare Part C enrollment population. We also
explained that since the largest laboratories with the highest test
volumes dominate the weighted median of private payor rates, and the
largest laboratories reported data for the determination of CY 2018
CLFS rates and are expected to report again, we did not expect the
additional reported data resulting from our proposed change to the
majority of Medicare revenues threshold to have a predictable, direct
impact on CLFS rates. As we noted previously, this means that we cannot
predict whether the additional applicable laboratories reporting
applicable information are paid at a higher (or lower) private payor
rate, as compared to other laboratories that reported previously and
whether the private payor rate volume of services performed by these
``additional'' applicable laboratories is significant enough to make an
impact on the weighted median of private payor rates. However, we noted
that we believe this proposal responded directly to stakeholder
concerns regarding the number of applicable laboratories reporting
applicable information for the initial data reporting period (83 FR
36049). We also noted that in the previous data reporting period we
received applicable information from 1,942 applicable laboratories from
every state, the District of Columbia, and
[[Page 59671]]
Puerto Rico, and that additional summary information regarding data
reporting for the Medicare CLFS from the first data reporting period is
available on the CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
Given that section 1834A(a)(8)(B) of the Act specifically defines
MA plans under Part C as private payors, and an applicable laboratory
that receives MA plan payments must consider those MA plan payments in
identifying its applicable information for reporting, we believe that
it is more logical to consider MA plan payments only as private payor
rates for purposes of reporting applicable information, rather than
both private payor rates and Medicare revenues. We believe this is
consistent with the statute and will help to increase laboratory
participation from all types of laboratories. At the same time, we
recognize the administrative concerns raised by some commenters
regarding the data reporting requirements for laboratories with a
significant Medicare Part C revenue component, particularly as some of
these laboratories may be small physician offices or independent
laboratories, which we have previously discussed as having a
significant burden in reporting applicable information. However, as
discussed previously in response to comments, we believe that modifying
our definition of applicable laboratory so that we may receive
applicable information from more laboratories that furnish tests to a
significant Medicare Part C population, which are less likely to
qualify for applicable laboratory status under the current policy,
outweighs the additional reporting burden placed on these laboratories
as well as directly supports our goal of collecting as much applicable
information as possible from the broadest representation of the
national laboratory market on which to base CLFS payment amounts. For
these reasons we are finalizing our proposal to modify the definition
of applicable laboratory to exclude MA plan revenues from total
Medicare revenues (the denominator of the majority of Medicare revenues
threshold). We are revising paragraph (3) of the definition of
applicable laboratory at Sec. 414.502 accordingly.
Comment: In addition to CMS' proposal to exclude MA plan payments
from total Medicare revenues, one commenter recommended that CMS also
remove prescription drug payments under Medicare Part D from the
description of total Medicare revenues in the applicable laboratory
definition. The commenter stated that including Part D payments is
illogical because there is no circumstance under which such payments
would be related to laboratory testing.
Response: As discussed previously, we are finalizing our proposal
to modify the definition of applicable laboratory to exclude MA plan
payments from total Medicare revenues, the denominator of the majority
of Medicare revenues threshold, so that more types of laboratories may
qualify as an applicable laboratory. While the agency did not propose
or solicit comments on the possibility of excluding Medicare Part D
revenues from total Medicare revenues, we will take the commenter's
suggestion into consideration for future refinements to the CLFS.
However, we note that if the commenter is correct that there is no
circumstance under which such payments would be related to laboratory
testing, then whether Part D payments are included or excluded from the
denominator would have no effect on the calculation.
4. Solicitation of Public Comments on Other Approaches To Defining
Applicable Laboratory
As discussed in the CY 2019 PFS proposed rule (83 FR 35858), and as
noted previously, we define applicable laboratory at the NPI level,
which means the laboratory's own billing NPI is used to identify a
laboratory's revenues for purposes of determining whether it meets the
majority of Medicare revenues threshold and the low expenditure
threshold components of the applicable laboratory definition. For
background purposes, the following summarizes some of the
considerations we made in establishing this policy.
In the CLFS proposed rule, entitled Medicare Clinical Diagnostic
Laboratory Tests Payment System, published in the October 1, 2015
Federal Register, we proposed to define applicable laboratory at the
TIN level so that an applicable laboratory would be an entity that
reports tax-related information to the IRS under a TIN with which all
of the NPIs in the entity are associated, and was itself a laboratory
or had at least one component that was a laboratory, as defined in
Sec. 493.2. In the CLFS proposed rule, we discussed that we considered
proposing to define applicable laboratory at the NPI level. However, we
did not propose that approach because we believed private payor rates
for CDLTs are negotiated at the TIN level and not by individual
laboratory locations at the NPI level. Numerous stakeholders had
indicated that the TIN-level entity is the entity negotiating pricing,
and therefore, is the entity in the best position to compile and report
applicable information across its multiple NPIs when there are multiple
NPIs associated with a TIN-level entity. We stated that we believed
defining applicable laboratory by TIN rather than NPI would result in
the same applicable information being reported, and would require
reporting by fewer entities, and therefore, would be less burdensome to
applicable laboratories. In addition, we stated that we did not believe
reporting at the TIN level would affect or diminish the quality of the
applicable information reported. To the extent the information is
accurately reported, we expected reporting at a higher organizational
level to produce exactly the same applicable information as reporting
at a lower level (80 FR 59391 through 59393).
Commenters who objected to our proposal to define applicable
laboratory at the TIN level stated that our definition would exclude
hospital laboratories because, in calculating the applicable
laboratory's majority of Medicare revenues amount, which looks at the
percentage of Medicare revenues from the PFS and CLFS across the entire
TIN-level entity, virtually all hospital laboratories would not be
considered an applicable laboratory. Many commenters expressed
particular concern that our proposed definition would exclude hospital
outreach laboratories, stating that hospital outreach laboratories,
which do not provide laboratory services to hospital patients, are
direct competitors of the broader independent laboratory market, and
therefore, excluding them from the definition of applicable laboratory
would result in incomplete and inappropriate applicable information,
which would skew CLFS payment rates. Commenters maintained that CMS
needed to ensure reporting by a broad scope of the laboratory market to
meet what they viewed as the intent of the statute that all sectors of
the laboratory market be included to establish accurate market-based
rates (81 FR 41045).
In issuing the CLFS final rule, we found particularly compelling
the comments that urged us to adopt a policy that would better enable
hospital outreach laboratories to be applicable laboratories because we
agreed hospital outreach laboratories should be included in determining
the new CLFS payment rates. We believed it was important to facilitate
reporting of private payor rates for hospital outreach laboratories to
ensure a broader representation of the national laboratory
[[Page 59672]]
market to use in setting CLFS payment amounts (81 FR 41045).
We also stated in the CLFS final rule that we believed the intent
of the statute was to effectively exclude hospital laboratories as
applicable laboratories, based on the statutory language, in
particular, regarding the majority of Medicare revenues threshold
criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the
Act provides that, to qualify as an applicable laboratory, an entity's
revenues from the CLFS and the PFS need to constitute a majority of its
total Medicare payments received from the Medicare program for a data
collection period. What we found significant was that most hospital
laboratories would not meet that majority of Medicare revenues
threshold because their revenues under the Inpatient Prospective
Payment System (IPPS) and Outpatient Prospective Payment System (OPPS)
alone would likely far exceed the revenues they received under the CLFS
and PFS. Therefore, we stated that we believe the statute intended to
limit reporting primarily to independent laboratories and physician
offices (81 FR 41045 through 41047). For a full discussion of the
definition of applicable laboratory, see the CLFS final rule (81 FR
41041 through 41051).
a. Stakeholder Continuing Comments and Stakeholder-Suggested
Alternative Approaches
As noted above, in response to public comments, we had previously
finalized that an applicable laboratory is the NPI-level entity so that
a hospital outreach laboratory assigned a unique NPI, separate from the
hospital of which it is a part, is able to meet the definition of
applicable laboratory and its applicable information can be used for
CLFS rate-setting. We stated in the CY 2019 PFS proposed rule that we
continue to believe that the NPI is the most effective mechanism for
identifying Medicare revenues for purposes of determining applicable
laboratory status and identifying private payor rates for purposes of
reporting applicable information. Once a hospital outreach laboratory
obtains its own unique billing NPI and bills for services using its own
unique NPI, Medicare and private payor revenues are directly
attributable to the hospital outreach laboratory. By defining
applicable laboratory using the NPI, Medicare payments (for purposes of
determining applicable laboratory status) and private payor rates and
the associated volume of CDLTs can be more easily identified and
reported to us. We also noted that we believe that finalizing our
proposal to exclude MA plan payments under Medicare Part C from total
Medicare revenues in the definition of applicable laboratory may
increase the number of entities meeting the majority of Medicare
revenues threshold, and therefore, allow them to qualify for applicable
laboratory status. We stated that we believe that finalizing the change
to the total Medicare revenues component of the applicable laboratory
definition and our current policy that requires an entity to bill
Medicare Part B under its own NPI, may increase the number of hospital
outreach laboratories qualifying as applicable laboratories.
In addition, we noted that we are confident that our current policy
supports our collecting sufficient applicable information in the next
data reporting period, and that we received sufficient and reliable
applicable information with which we set CY 2018 CLFS rates, and that
those rates are accurate. We noted that we received applicable
information from laboratories in every state, the District of Columbia,
and Puerto Rico. This data included private payor rates for almost 248
million laboratory tests conducted by 1,942 applicable laboratories,
with over 4 million records of applicable information. As we have
noted, the largest laboratories dominate the market, and therefore,
most significantly affect the payment weights (81 FR 41049). We stated
that given that the largest laboratories reported their applicable
information to CMS in the initial data reporting period, along with
many smaller laboratories, we believe the data we used to calculate the
CY 2018 CLFS rates was sufficient and resulted in accurate weighted
medians of private payor rates.
However, we noted that we continue to consider refinements to our
policies that could lead to including even more applicable information
for the next data reporting period. Therefore, the comments and
alternative approaches suggested by commenters, even though some were
first raised prior to the CLFS final rule, were presented and offered
for comment as part of the proposed rule.
(1) Using Form CMS-1450 UB 04 (and Electronic Equivalent, 837I) 14X
Type of Bill (TOB) To Determine Majority of Medicare Revenues and Low
Expenditure Thresholds
Although an NPI-based definition of applicable laboratories
includes more hospital outreach laboratories than a TIN-based
definition, some commenters expressed concern that the NPI-based
definition of applicable laboratory may not be sufficient to capture
all of the hospital outreach laboratories. These commenters suggested
we revise the definition specifically for the purpose of including more
hospital outreach laboratories. Under a suggested approach, a
laboratory could determine whether it meets the majority of Medicare
revenues threshold and low expenditure threshold using only the
revenues from services reported on the Form CMS-1450 (approved Office
of Management and Budget number 0938-0997) 14x Type of Bill (TOB),
which is used only by hospital outreach laboratories. The CMS-1450 14X
TOB is the uniform bill (also known as the UB-04) for institutional
providers that was approved by the National Uniform Billing Committee
(NUBC) \8\ at its February 2005 meeting.
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\8\ Copyright (copyright) 2012 the American Hospital
Association, Chicago, Illinois. Reproduced with permission. No
portion of this publication may be copied without the express
written consent of the AHA.
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The data elements referenced in the UB-04 manual are also used in
the electronic claim standard as required by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191,
enacted August 21, 1996) as per of sections 1171 and 1172 of the Act.
Consequently, there was additional emphasis placed on aligning the
reporting instructions to closely mirror the HIPAA claim standard for
institutional providers for both paper and electronic claims. The TOB
is a required element on both the UB 04 and electronic equivalent of
the 837I transaction of the HIPAA compliant 005010 standard
transaction. The NUBC defines the 14X TOB as an outpatient hospital
TOB, and it is used by hospitals to bill a payor for outreach
laboratory services for non-patients. As discussed in Transmittal 3425,
a non-patient is defined as a beneficiary who is neither an inpatient
nor an outpatient of a hospital, but who has a specimen that is
submitted for analysis to a hospital and the beneficiary is not
physically present at the hospital for purposes of the laboratory
service. All hospitals (including Critical Access Hospitals) bill non-
patient laboratory tests on a TOB 14X. They are paid under the CLFS,
and the Part B deductible and coinsurance do not apply. We believe that
laboratory services billed on the CMS 1450 14X encompass all of the
laboratory testing services.
To address this stakeholder's concern of including hospital
outreach laboratories, we solicited public comments in the CY 2019 PFS
on revising the definition of applicable laboratory to permit the
revenues identified on the Form CMS-1450 14x
[[Page 59673]]
TOB to be used instead of the revenues associated with the NPI that the
laboratory uses in order to determine whether it meets the majority of
Medicare revenues threshold (and the low expenditure threshold). Under
this approach, the applicable revenues would be based on the bills used
for hospital laboratory services provided to non-patients, which are
paid under Medicare Part B (that is, the 14x TOB). If we pursued this
approach, we explained that we would have to modify the definition of
applicable laboratory in Sec. 414.502 by indicating that an applicable
laboratory may include an entity that bills Medicare Part B on the Form
CMS-1450 14x TOB.
Although using the 14x TOB could alleviate some initial, albeit
limited, administrative burden on hospital outreach laboratories to
obtain a unique billing NPI, we explained that we would have
operational and statutory authority concerns about defining applicable
laboratory by the Form CMS-1450 14x TOB, as indicated below.
First, we explained that defining an applicable laboratory using
the Form CMS-1450 14x TOB does not identify an entity the same way an
NPI does. Whereas an NPI is associated with a provider or supplier to
determine specific Medicare revenues, the 14x TOB is merely a billing
mechanism that is currently used only for a limited set of services.
Under an approach that permits laboratories to meet the majority of
Medicare revenues threshold using the 14x TOB, private payor rates (and
the volume of tests paid at those rates) would have to be identified
that are associated with only the outreach laboratory services of a
hospital's laboratory business. However, some private payors, such as
MA plans, may not require hospital outreach laboratories to use the 14x
TOB for their outreach laboratory services. To the extent a private
payor does not require hospital outreach laboratory services to be
billed on a 14x TOB (which specifically identifies outreach services),
hospitals may need to develop their own mechanism for identifying and
reporting only the applicable information associated with its hospital
outreach laboratory services. In light of this possible scenario, we
requested public comments about the utility of using the 14x TOB in the
way we have described and on the level of administrative burden created
if we defined applicable laboratory using the Form CMS-1450 14x TOB.
Second, we questioned whether hospitals would have sufficient time
after publication of a new final rule that included using the Form CMS-
1450 14x TOB, and any related subregulatory guidance, to develop and
implement the information systems necessary to collect private payor
rate data before the start of the next data collection period, that is,
January 1, 2019. Therefore, we solicited public comments as to whether
revising the definition of applicable laboratory to use the Form CMS-
1450 14x TOB would allow laboratories sufficient time to make the
necessary systems changes to identify applicable information before the
start of the next data collection period.
Third, we noted that we believe defining applicable laboratory at
the NPI level, as we currently do, provides flexibility for hospital
outreach laboratories to not obtain a unique billing NPI, which may be
burdensome, particularly where a hospital outreach laboratory performs
relatively few outreach services under Medicare Part B. For example,
under the current definition of applicable laboratory, if a hospital
outreach laboratory's CLFS revenues in a data collection period are
typically less than the low expenditure threshold, the hospital of
which it is a part could choose not to obtain a separate NPI for its
outreach laboratory and could thus avoid determining applicable
laboratory status for its outreach laboratory component. In contrast,
if laboratories were permitted to use the Form CMS-1450 14x TOB,
revenues attributed to the hospital outreach laboratory would have to
be calculated in every instance where those services exceeded the low
expenditure threshold. This would be true even for a hospital outreach
laboratory that performs relatively few outreach services under
Medicare Part B. Therefore, we also solicited comments concerning this
aspect of using the 14x TOB definition.
Fourth, and significantly, we stated that we believe that if we
were to utilize such an approach in defining applicable laboratory, all
hospital outreach laboratories would meet the majority of Medicare
revenues threshold. We noted, at that time, we believed this approach
would be inconsistent with the statute. By virtue of the majority of
Medicare revenues threshold, the statute defines applicable laboratory
in such a way that not all laboratories qualify as applicable
laboratories. However, if we were to use the CMS-1450 14x TOB to define
an applicable laboratory, all hospital outreach laboratories that use
the 14x TOB would meet the majority of Medicare revenues threshold.
Accordingly, we requested public comments regarding whether this
definition would indeed be inconsistent with the statute, as well as
comments that could identify circumstances under this definition
whereby a hospital outreach laboratory would not meet the majority of
Medicare revenues threshold.
The following is a summary of the comments we received and our
responses to the comments regarding the use of the CMS-1450 14x TOB to
define an applicable laboratory.
Comment: We received conflicting comments on this potential
refinement to the definition of an applicable laboratory. Some
commenters supported using the CMS-1450 14x TOB as a mechanism to
define an applicable laboratory, and others were opposed to this
approach. The commenters who supported this believe that it provides an
opportunity for hospital outreach laboratories that have not obtained
an NPI separate from the hospital to qualify as an applicable
laboratory and report applicable information. These commenters opined
that since the 14X TOB is used only to submit claims by hospital
outreach laboratories for non-patient claims, this approach would
include hospital laboratories without their own NPI who compete in the
marketplace with independent clinical laboratories. These commenters
also noted that, in their view, this approach would effectuate
Congress' intent to determine whether a majority of Medicare revenues
attributable to the laboratory part of the hospital--as opposed to the
entire hospital--was from the CLFS and/or PFS.
Another commenter stated their view that considerable burden is
associated with requiring a hospital outreach laboratory to obtain its
own NPI. According to this commenter, a hospital would need to re-
credential under a new NPI with each of their payors in order to submit
claims and receive payment from each of their payors for their hospital
outreach laboratory services. This commenter stated that this process
could take more than a year to complete. Accordingly, this commenter
concluded that hospital outreach laboratories rarely obtain their own
unique NPI (separate from the hospital) and it would not be practical
to do so for the single purpose of reporting applicable information to
CMS.
Additional commenters in support of refinements to the definition
responded to CMS' concern that revenues attributed to the hospital
outreach laboratory would have to be calculated in every instance where
those services exceeded the low expenditure threshold, even for a
hospital outreach laboratory that performs relatively few outreach
services under Medicare Part
[[Page 59674]]
B. In response to this concern, commenters noted that this refinement
to the definition would require hospital outreach laboratories to have
the same obligations as other laboratories that exceed the low
expenditure threshold and that serve non-hospital patients.
Furthermore, commenters suggested that if CMS is concerned that
refinements to the definition would result in all hospital outreach
laboratories meeting the majority of Medicare revenues threshold, that
is the case for almost all independent laboratories, as well, where
hospital outreach laboratories compete with independent laboratories in
the marketplace. Furthermore, they stated it is reasonable that a
laboratory whose revenues are derived primarily from the CLFS and/or
PFS and that meets the low expenditure threshold be included in data
reporting, regardless if it is a hospital outreach laboratory.
In contrast, several commenters strongly opposed the use of Form
CMS-1450 14x TOB to define an applicable laboratory because of their
views of the additional administrative burden for hospitals relative to
the effect on CLFS rates. These commenters stated that even if every
hospital outreach laboratory were to report private payor data, it is
unlikely that it would result in a significant change to the weighted
median of private payor rates due to the massive amount of data that
would be reported by the large independent laboratories. They also
agreed with the potential operational feasibility concerns we raised in
the proposed rule.
Response: We appreciate the comments raised about the
administrative aspects of obtaining an NPI for a hospital outreach
laboratory for the sole purpose of reporting data to CMS and the
associated administrative burden. We agree that one advantage of using
the Form CMS-1450 14x TOB to define an applicable laboratory is that it
provides an opportunity for more hospital outreach laboratories to
report data for calculating CLFS rates. However, we also recognize that
this will result in additional administrative burden on the hospital
industry, such as changes to collect and report applicable information.
We discuss specific operational concerns in more detail in the sections
below. However, we generally believe that this advantage outweighs the
potential burden for hospital outreach laboratories, the data collected
from hospital outreach laboratories will create a dataset that is a
more robust representation of the laboratory testing market, and that
this outweighs the potential burden to hospital outreach laboratories.
Accordingly, we are finalizing the use of the Form CMS-1450 14x TOB to
define applicable laboratories for the next data collection period
(January 1, 2019, through June 30, 2019) and the next data reporting
period (January 1, 2020, and ends March 31, 2020), subject to other
regulatory and subregulatory requirements, such as the regulatory low
expenditure threshold.
We also considered the comments regarding the limited impact of
this additional data to the weighted median of private payor rates. We
believe that we will only know the impact of the data on CLFS rates by
collecting data from hospital outreach laboratories. We believe
inclusion of this information so that the CLFS rates better reflect the
market outweighs the potential added burden on one segment of the
market. However, if it becomes apparent that data from hospital
outreach laboratories do not result in a significant change in the
weighted median of private payor rates, we will revisit the use of the
CMS-1450 14x TOB through future rulemaking.
Comment: A few commenters stated that CMS should not be concerned
that hospitals will need to develop additional mechanisms to identify
applicable information if private payors do not require hospital
outreach laboratories to use the CMS-1450 14x TOB. They noted that this
point is not relevant to reporting private payor rates because once
applicable laboratory status is determined, the hospital outreach
laboratory ``can simply report its private payor data for all of its
fee for service work that is not part of a capitated plan.'' The
commenters stated that the reporting entities for all other laboratory
types would have the same burden as hospital outreach laboratories,
that is, of identifying and reporting accurate applicable information.
In contrast, several stakeholders raised concerns about the
implications this alternative approach would have on identifying
applicable information for purposes of reporting that data to us. They
stated that the Form CMS-1450 14x TOB will only capture Medicare Part B
revenues, while private payor data would not be captured. In other
words, the 14x TOB will correctly identify Medicare Part B revenues for
purposes of determining applicable laboratory status, but that the
hospital would be responsible for correctly identifying and collecting
applicable information associated solely with the hospital outreach
laboratory. Several commenters stated that billing systems for hospital
outreach laboratories are not set up in a manner that allows this type
of information to be easily extracted, and therefore, this approach to
defining an applicable laboratory would pose a significant operational
burden on hospitals.
Response: We note that hospital outreach laboratories who meet the
definition of an applicable laboratory would have the same burden of
identifying and reporting accurate applicable information as all other
laboratory types that meet the definition of an applicable laboratory.
Comment: Some commenters stated that they believe hospitals would
have sufficient time to develop and implement the information systems
necessary to collect private payor rate data before the start of the
next data collection period, and noted that even though the CLFS final
rule was published less than 2 weeks prior to the end of the first data
collection period, applicable laboratories were able to develop and
implement the information systems necessary to collect private payor
rate data and report it to CMS. However, several commenters expressed
serious concerns about developing the systems to collect applicable
information before the next data reporting period. They indicated that
finalizing this alternative approach for defining an applicable
laboratory would not allow hospital outreach laboratories sufficient
time to make the necessary systems changes prior to the start of the
next data collection, and as a result, there would be a risk that
inaccurate data would be reported.
Response: As discussed previously in this section, the next data
collection period is January 1, 2019, through June 30, 2019. A 6-month
window follows the data collection period from July 1, 2019, through
December 31, 2019 and the next data reporting period begins January 1,
2020, and ends March 31, 2020. While several commenters raised concerns
about the operational changes needed for reporting before the next data
collection period, we believe that, similar to the retroactive data
collection that occurred under the initial private payor rate-based
CLFS, hospitals, including the part of the hospital represented by
their hospital outreach laboratories, could develop these operational
changes in time. For example, hospitals, including the part of the
hospital represented by their hospital outreach laboratories, could use
the time before and during the next data collection period to develop
processes to collect applicable information, the 6-month window between
the collection and reporting periods to determine applicable laboratory
status and retroactively collect applicable
[[Page 59675]]
information to report it before the close of the next data reporting
period (March 31, 2020).
Comment: Many commenters noted the concern that hospital outreach
laboratories would lose the flexibility to not obtain an NPI for low
volume hospital outreach laboratories. For instance, they stated all
hospitals would be required to go through the exercise of determining
applicable laboratory status for their hospital outreach laboratory
components. However, a few commenters indicated that hospital outreach
laboratories would have the same obligations as every other laboratory
to determine whether it is an applicable laboratory. Therefore, in
their view, the loss of flexibility for hospital outreach laboratories
to not obtain an NPI should not be a concern.
Response: We agree that the use of Form CMS-1450 14x TOB to define
an applicable laboratory will require hospitals to assess applicable
laboratory status for all outreach laboratory components, similar to
the obligations of other laboratory types. For instance, all
independent and physician office laboratories billing Medicare Part B
under their own NPI must assess whether they qualify as an applicable
laboratory, and if so, report applicable information to us.
Consequently, independent and physician office laboratories do not have
the flexibility of not reporting private payor data that is currently
afforded to hospital outpatient laboratories. Use of the 14x TOB to
define an applicable laboratory would equalize the obligations across
laboratories, regardless of their affiliation with a hospital, to
determine whether they qualify for applicable laboratory status. We
note that, insofar as commenters expressed concern about low volume
hospital outreach laboratories, our policy regarding laboratories
receiving less than a minimum in CLFS revenues remains unchanged.
Specifically, hospital outreach laboratories that do not receive at
least $12,500 in CLFS revenues on the 14X TOB during a data collection
period would be exempt from the reporting requirements.
Comment: Several commenters noted that by using the 14x TOB to
define an applicable laboratory, all hospital outreach laboratories
would meet the majority of Medicare revenues threshold. They,
therefore, raised concerns about the legality of this approach. For
instance, some commenters stated their view that Congress did not
intend for all hospital outreach laboratories to qualify as applicable
laboratories. In contrast, some commenters stated their view that
Congress clearly intended for the CLFS to reflect a market-based system
that includes hospital outreach laboratories and that it is reasonable
for a laboratory with revenues derived primarily from the CLFS and/or
PFS that also meets the low expenditure threshold to be an applicable
laboratory, regardless of whether it is a hospital outreach laboratory
or not.
Response: After further review of this issue, we believe that using
Form CMS-1450 14x TOB provides a means of distinguishing services
furnished by a hospital outreach laboratory from other services
furnished and billed by a hospital using the same NPI. The statute
specifically directs us to identify applicable ``laboratories'' and not
``providers'' or ``suppliers.'' We believe that hospital outreach
laboratories without unique NPIs furnish clinical laboratory tests paid
under the CLFS and PFS, albeit to Medicare beneficiaries who are not
hospital patients. Accordingly, we believe such laboratories, should
not be exempt from reporting the applicable data merely due to their
shared use of a billing entity with a hospital.
Using the laboratory's own billing NPI as the basis for defining
applicable laboratory, as we currently do, results in all independent
laboratories meeting the statutory ``majority of Medicare revenues''
requirement because most, if not all, of an independent laboratory's
Medicare revenues are received from the PFS and or CLFS. Similar to how
the use of the NPI results in all independent laboratories meeting the
majority of Medicare revenues threshold, using the Form CMS-1450 14x
TOB as the basis for defining applicable laboratory would identify all
hospital outreach laboratories that meet the statutorily required
``majority of Medicare revenues'' component of applicable laboratory.
We believe that the use of Form CMS-1450 14x TOB as a mechanism for
applying the majority of Medicare revenues threshold identifies
hospital outreach laboratories that meet this threshold, consistent
with the statutory requirement for applicable laboratory status. We
further believe that, absent having an NPI separate from the hospital,
these hospital outreach laboratories otherwise would be excluded. We do
not believe that the statute excludes laboratories that meet the
majority of Medicare revenues threshold from potentially qualifying as
an applicable laboratory. Therefore, using the 14x TOB to define
applicable laboratory is consistent with the statute.
As stated above, accordingly, we are finalizing the use of the Form
CMS-1450 14x TOB to define applicable laboratories, subject to other
regulatory and subregulatory requirements, such as the regulatory low
expenditure threshold.
Comment: Two commenters stated that it is unclear whether the
burden associated with considering every hospital outreach laboratory
to meet the majority of Medicare revenues threshold and an applicable
laboratory (if the low expenditure threshold is also met) would
outweigh the additional applicable information that would be reported.
Therefore, they requested that we continue evaluating this approach
before implementing any changes.
Response: As we stated previously, we generally believe that the
advantage of including private payor data from hospital outreach
laboratories in setting CLFS rates outweighs the potential burden for
hospital outreach laboratories; data collected from hospital outreach
laboratories will create a dataset that is a more robust representation
of the laboratory testing market. We also note that the timing of the
data collection and reporting periods, and the 6 month window in
between provide time for laboratories to implement needed operational
changes.
Comment: One commenter suggested that an alternative approach to
identifying applicable laboratories would be for the hospital to
develop an ``adjustment factor'' based on its payment-to-charges ratio
to estimate laboratory revenues received from the IPPS and OPPS. The
same commenter suggested that we remove the requirement that an
applicable laboratory is an entity that bills Medicare Part B under its
own NPI and that we amend the majority of Medicare revenues threshold
so that ``Medicare revenues'' means payment for claims submitted on a
CMS 1500, a CMS 1450 using a 14x TOB, or their electronic equivalents.
Response: We appreciate this suggested approach and we may consider
it in future rulemaking.
In conclusion, as stated previously and for the reasons described
previously, we are finalizing the use of the Form CMS-1450 14x TOB to
define applicable laboratories, subject to other regulatory and
subregulatory requirements, such as the regulatory low expenditure
threshold.
We note that because of the low expenditure threshold, not all
hospital outreach laboratories would meet the definition of an
applicable laboratory and therefore not all hospital outreach
laboratories would be required to report applicable information to us.
In other words, hospital outreach laboratories
[[Page 59676]]
that do not receive at least $12,500 in CLFS revenues on the 14X TOB
during a data collection period would be exempt from the reporting
requirements.
We believe that defining applicable laboratory by the NPI may be
preferable to using the CMS-1450 14x TOB for some hospitals and so
expect that some hospital outreach laboratories may still want to
obtain their own billing NPI separate from the hospital. As such, they
may do so and may qualify as an applicable laboratory in this manner.
If so, they would report applicable information during the next data
reporting period beginning January 1, 2020, through March 31, 2020.
We note that we utilize ongoing subregulatory guidance and provider
education materials to provide more details regarding how applicable
laboratories, both those identified through NPIs and hospital outreach
laboratories identified through the combination of NPI and services
reported using the 14x TOBs, are to report the applicable data to CMS.
We also note that for hospitals which have an applicable laboratory,
whether via its own NPI for its outreach laboratory or by identifying
its status with the 14X TOB, the applicable laboratory would be
required to report applicable information by March 31, 2020, for
services reimbursed for the period between January 1, 2019, and June
30, 2019.
In conclusion, as stated previously, we are finalizing the use of
the Form CMS-1450 14x TOB to define applicable laboratories. In other
words, we are finalizing modification of the definition of applicable
laboratory to also include 14X TOB revenues. We will also revise
paragraph (2) of the definition of applicable laboratory at Sec.
414.502 accordingly.
(2) Using CLIA Certificate To Define Applicable Laboratories
Some commenters requested that we use the CLIA certificate rather
than the NPI to identify a laboratory that would be considered an
applicable laboratory. We discussed in the CLFS proposed rule (80 FR
59392) why not all entities that meet the CLIA regulatory definition at
Sec. 493.2 would be applicable laboratories, and therefore, we did not
propose to use the CLIA certificate as the mechanism for defining
applicable laboratory. However, some commenters to the CLFS proposed
rule suggested we use the CLIA certificate to identify the
organizational entity that would be considered an applicable laboratory
so that each entity that had a CLIA certificate would be an applicable
laboratory (81 FR 41045). We considered those comments in the CLFS
final rule and discussed why we chose not to adopt that approach.
Among other reasons, we explained in the CLFS final rule that we
believed a CLIA certificate-based definition of applicable laboratory
would be overly inclusive by including all hospital laboratories, as
opposed to just hospital outreach laboratories. In addition, the CLIA
certificate is used to certify that a laboratory meets applicable
health and safety regulations in order to furnish laboratory services.
Unlike, for example, the NPI, with which revenues for specific services
can easily be identified, the CLIA certificate is not associated with
Medicare billing and cannot be used to identify revenues for specific
services. We also indicated that we did not know how a hospital would
determine whether its laboratories would meet the majority of Medicare
revenues threshold (and the low expenditure threshold) using the CLIA
certificate as the basis for defining an applicable laboratory. In
addition, we stated that, given the difficulties many hospitals would
likely have in determining whether their laboratories are applicable
laboratories, we also believed hospitals may object to using the CLIA
certificate (81 FR 41045).
However, in light of stakeholders' suggestions to use the CLIA
certificate to include hospital outreach laboratories in the definition
of applicable laboratories, we solicited public comments on that
approach. Under such an approach, the majority of Medicare revenues
threshold and low expenditure threshold components of the definition of
applicable laboratory would be determined at the CLIA certificate level
instead of the NPI level. We explained that if we pursued such an
approach, we would have to modify the definition of applicable
laboratory in Sec. 414.502 to indicate that an applicable laboratory
is one that holds a CLIA certificate under Sec. 493.2 of the chapter.
We noted in the CY 2019 PFS proposed rule that we would have concerns,
however, about defining applicable laboratory by the CLIA certificate.
First, we explained that as we discussed in the CLFS final rule,
given that information regarding the CLIA certificate is not required
on the Form CMS-1450 14x TOB, which is the billing form used by
hospitals for their laboratory outreach services, it is not clear how a
hospital would identify and distinguish revenues generated by its
separately CLIA-certified laboratories for their outreach services.
Therefore, we solicited public comments regarding the mechanisms a
hospital would need to develop to identify revenues if we used the CLIA
certificate for purposes of determining applicable laboratory status,
as well as comments about the administrative burden associated with
developing such mechanisms.
In addition, we understood there could be a scenario where one CLIA
certificate is assigned to a hospital's entire laboratory business,
which would include laboratory tests performed for hospital patients as
well as non-patients (that is, patients who are not admitted inpatients
or registered outpatients of the hospital). For example, hospital
laboratories with an outreach laboratory component would be assigned a
single CLIA certificate if the hospital outreach laboratory has the
same mailing address or location as the hospital laboratory. We noted
that in this scenario, the majority of Medicare revenues threshold
would be applied to the entire hospital laboratory, not just its
outreach laboratory component. If a single CLIA certificate is assigned
to the hospital's entire laboratory business, the hospital laboratory
would be unlikely to meet the majority of Medicare revenues threshold
because its laboratory revenues under the IPPS and OPPS alone would
likely far exceed the revenues it receives under the CLFS and PFS. As a
result, a hospital outreach laboratory that could otherwise meet the
definition of applicable laboratory, as currently defined at the NPI
level, would not be an applicable laboratory if we were to require the
CLIA certificate to define applicable laboratory. Given that this
approach could have the effect of decreasing as opposed to increasing
the number of applicable laboratories, we requested public comments on
this potential drawback of defining applicable laboratory at the CLIA
certificate level. We stated in the comment solicitation that feedback
on this topic could help inform us regarding potential refinements to
the definition of applicable laboratory, and that depending on the
comments we receive, it is possible we would consider approaches
described in that section. The following is a summary of the comments
we received and our responses to the comments regarding the use of the
CLIA certificate to define an applicable laboratory.
Comment: Many commenters did not support using the CLIA certificate
to define applicable laboratory because of the administrative
complexity associated with this approach. Commenters stated that the
CLIA certificate has no relationship to actual laboratory revenues,
like the NPI does, and therefore, laboratories would need to develop
their own mechanisms to attribute Medicare revenues to the CLIA
[[Page 59677]]
certificate. Commenters stated that any ``workaround'' to resolve these
issues would be extremely burdensome to develop and implement. These
same commenters also noted that when one CLIA certificate is assigned
to a hospital's entire laboratory business, which would include
laboratory tests performed for hospital patients as well as non-
patients, the total Medicare revenues component of the majority of
Medicare revenues threshold equation would be ``overly inclusive.''
Therefore, they agreed with CMS' concern that hospital outreach
laboratories would be unlikely to meet the majority of Medicare
revenues threshold under those circumstances because revenues from the
IPPS and OPPS alone would likely far exceed the revenues those
laboratories receive under the CLFS and PFS. For these reasons, they
encouraged CMS to reject the use of the CLIA certificate for defining
an applicable laboratory.
Response: We agree that defining applicable laboratory by the CLIA
certificate would result in substantial administrative burden for the
laboratory industry. From an administrative perspective, we believe the
using the CLIA certificate unworkable for the purpose of determining
applicable laboratory status because the CLIA certificate is not
required on the CMS 1450 14x TOB which is the billing form used by
hospital outreach laboratories. Therefore, no revenues can be readily
identified by the CLIA certificate. Even if the hospital developed its
own mechanism to identify revenues by the CLIA certificate, the CLIA
certificate could be assigned to the hospital's entire laboratory
business, which includes laboratory tests performed for hospital
patients, as well as non-patients. For example, we understand hospital-
based laboratories with an outreach component would be assigned a
single CLIA certificate if the hospital outreach laboratory has the
same mailing address or location as the main laboratory. In this
scenario, the applicable laboratory criteria would be applied to the
CLIA certificate of the entire hospital laboratory not just its
outreach laboratory component. When a single CLIA certificate is
assigned to the hospital's entire laboratory business, we believe it
would result in the hospital laboratory not meeting the majority of
Medicare revenues threshold because its laboratory revenues under the
IPPS and OPPS alone will far exceed the revenues it receives under the
CLFS and PFS. We also understand that a hospital could have multiple
outreach laboratories each with its own CLIA certificate. Therefore, we
believe those hospitals would also have difficulties separating
Medicare revenues and applicable information among their various CLIA
certificates as described below.
Comment: One commenter stated that it is unlikely that a single
CLIA certificate would be assigned to both its outreach laboratory
(non-patients) and its laboratory that that provides testing for its
hospital inpatients and hospital outpatients. The commenter stated that
it would be more likely that the outreach laboratory would be at a
different location than the hospital and therefore, be assigned its own
CLIA certificate even though the outreach laboratory is enrolled in the
Medicare program under the hospital's NPI. As such, the commenter
stated that an outreach laboratory operates as a distinct laboratory
entity by virtue of having its own CLIA certificate and billing on the
Form CMS-1450 14x TOB. The commenter suggested that the 14x TOB could
be used in combination with each individual CLIA certificate to define
applicable laboratory.
Response: We understand that the assignment of CLIA certificates
for hospital outreach laboratories could vary depending on the location
of the outreach laboratory. As discussed previously, Medicare revenues
are not attributed to the CLIA certificate and information regarding
the CLIA certificate is not required on the Form CMS-1450 14x TOB. As
such, we believe the commenter's suggestion would result in defining
applicable laboratory by the Form CMS-1450 14x TOB. We note that in
cases in which a hospital owns and operates multiple outreach
laboratories at different locations, we believe the administrative
burden of attributing Medicare revenues to the CLIA certificate would
be even more substantial as there could be several CLIA certificates
assigned under the same NPI. In such cases, the hospital would need to
attribute laboratory revenues among multiple CLIA certificates under
the same billing entity. In other words, if the 14x TOB is used by a
hospital to bill for laboratory tests furnished by more than one CLIA
certificate under the same NPI, the hospital would need to devise a
mechanism to attribute Medicare revenues to each individual CLIA
certificate.
5. Solicitation of Public Comments on the Low Expenditure Threshold in
the Definition of Applicable Laboratory
a. Decreasing the Low Expenditure Threshold
In the CLFS final rule, we established a low expenditure threshold
component in the definition of applicable laboratory at Sec. 414.502,
which is reflected in paragraph (4). To be an applicable laboratory, at
least $12,500 of an entity's Medicare revenues in a data collection
period must be CLFS revenues (with the exception that there is no low
expenditure threshold for an entity with respect to the ADLTs it
furnishes). We established $12,500 as the low expenditure threshold
because we believed it achieved a balance between collecting sufficient
data to calculate a weighted median that appropriately reflects the
private market rate for a test, and minimizing the reporting burden for
laboratories that receive a relatively small amount of revenues under
the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once
we obtained applicable information under the new payment system, we may
decide to reevaluate the low expenditure threshold in future years and
propose a different threshold amount through notice and comment
rulemaking.
We explained in the CY 2019 PFS proposed rule that we recently
heard from some laboratory stakeholders that the low expenditure
threshold excludes most physician office laboratories and many small
independent laboratories from reporting applicable information, and
that by excluding so many laboratories, the payment rates under the new
private payor rate-based CLFS reflect incomplete data, and therefore,
inaccurate CLFS pricing.
As noted previously, we discussed in the CLFS final rule that we
believed a $12,500 low expenditure threshold would reduce the reporting
burden on small laboratories. In the CLFS final rule (81 FR 41051), we
estimated that 95 percent of physician office laboratories and 55
percent of independent laboratories would not be required to report
applicable information under our low expenditure criterion. Although we
substantially reduced the number of laboratories qualifying as
applicable laboratories (that is, approximately 5 percent of physician
office laboratories and approximately 45 percent of independent
laboratories), we estimated that the percentage of Medicare utilization
would remain high. That is, approximately 5 percent of physician office
laboratories would account for approximately 92 percent of CLFS
[[Page 59678]]
spending on physician office laboratories and approximately 45 percent
of independent laboratories would account for approximately 99 percent
of CLFS spending on independent laboratories (81 FR 41051).
We stated that it is our understanding that physician offices are
generally not prepared to identify, collect, and report each unique
private payor rate from each private payor for each laboratory test
code subject to the data collection and reporting requirements, and the
volume associated with each unique private payor rate. As such, we
explained that we believe revising the low expenditure threshold so
that more physician office laboratories are required to report
applicable information would likely impose significant administrative
burdens on physician offices. We stated that we also believe that
increasing participation from physician office laboratories would have
minimal overall impact on payment rates given that the weighted median
of private payor rates is dominated by the laboratories with the
largest test volume. We noted that our participation simulations from
the first data reporting period show that increasing the volume of
physician office laboratories reporting applicable information has
minimal overall impact on the weighted median of private payor rates.
For more information on our participation simulations, please visit the
CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
We stated in the proposed rule that we continue to believe the
current low expenditure threshold strikes an appropriate balance
between collecting enough private payor rate data to accurately
represent the weighted median of private payor rates while limiting the
administrative burden on small laboratories. In addition, as discussed
previously in this section, we are finalizing excluding MA plan
revenues under Part C from total Medicare revenues in the definition of
applicable laboratory, and we noted that we expect more laboratories of
all types, including physician office laboratories, may meet the
majority of Medicare revenues threshold.
However, we recognized from stakeholders that some physician office
laboratories and small independent laboratories that are not applicable
laboratories because they do not meet the current low expenditure
threshold may still want to report applicable information despite the
administrative burden associated with qualifying as an applicable
laboratory. Therefore, we sought public comment on revising the low
expenditure threshold to increase the level of participation among
physician office laboratories and small independent laboratories.
In the proposed rule we explained that one approach could be for us
to decrease the low expenditure threshold by 50 percent, from $12,500
to $6,250, in CLFS revenues during a data collection period. Under such
an approach, a laboratory would need to receive at least $6,250 in CLFS
revenues in a data collection period. We stated that if we were to
adopt such an approach, we would need to revise paragraph (4) of the
definition of applicable laboratory at Sec. 414.502 to replace $12,500
with $6,250. We solicited public comments on this approach.
We noted that we were particularly interested in comments from the
physician community and small independent laboratories as to the
administrative burden associated with such a revision to the low
expenditure threshold. Specifically, we requested comments on the
following issues: (1) Whether physician offices and small independent
laboratories currently have adequate staff levels to meet the data
collection and data reporting requirements; (2) whether data systems
are currently in place to identify, collect, and report each unique
private payor rate from each private payor for each CLFS test code and
the volume of tests associated with each unique private payor rate; (3)
if physician offices and small independent laboratories are generally
not prepared to conduct the data collection and data reporting
requirements, what is the anticipated timeframe needed for physician
office and small independent laboratories to be able to meet the data
collection and data reporting requirements; and (4) any other
administrative concerns that decreasing the low expenditure threshold
may impose on offices and small independent laboratories.
The following is a summary of the comments we received and our
responses to the comments regarding the approach of decreasing the low
expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS
revenues during a data collection period.
Comment: Many commenters were opposed to reducing the low
expenditure threshold because of the administrative burden it would
place on physician office laboratories and small independent
laboratories. Commenters noted that they experienced difficulties
during the initial data collection and data reporting period with
determining whether they met the definition of applicable laboratory
and therefore if they were required to report applicable information.
Some commenters that did report applicable information stated that they
experienced significant administrative burden in collecting and
compiling information, especially for test codes that involved numerous
different sources of payment (such as the beneficiary's primary private
payor, the beneficiary's secondary insurance, and coinsurance
requirements). Some commenters reported having to remove staff from
regular duties to work full time on preparing to report applicable
information to CMS. A few commenters noted that physician office
laboratories and small independent laboratories do not have the
staffing or resources currently available, nor do they anticipate
having them available in the future, to identify, collect and report
each unique private payor rate for each CLFS test code and the volume
of tests associated with each unique private payor rate. As such,
commenters encouraged CMS not to decrease the low expenditure threshold
component of the definition of applicable laboratory.
Response: We appreciate the comments regarding the administrative
burden imposed by the data collection and reporting requirements on
physician office laboratories and small independent laboratories and
understand that reducing the low expenditure threshold by 50 percent
would add more burden on this segment of the laboratory industry. We
will consider the commenters' input regarding the low expenditure
threshold as we continue to evaluate and refine Medicare CLFS payment
policy in the future.
Comment: A few commenters suggested alternative approaches to
lowering the low expenditure threshold that involve collecting data for
physician office dependent tests and allowing laboratories to
voluntarily report applicable information. For example, two commenters
suggested that CMS identify laboratory tests predominantly performed by
physician office laboratories and collect a statistically
representative sample of data from physician office laboratories for
the range of tests commonly performed in this setting. Under the
commenters' approach, physician office laboratories would be required
to report those tests. The commenters stated that this would ensure
that the private payor rates for tests mostly performed by physician
office laboratories are
[[Page 59679]]
represented in the weighted median of private payor rates used to
determine CLFS rates. Moreover, a few other commenters suggested that
CMS permit voluntary reporting so that laboratories that do not meet
the current low expenditure threshold may report applicable information
if they choose to.
Response: The suggestions to identify physician office laboratory
dependent tests and to permit voluntary reporting have already been
addressed in previous rulemaking and we chose not to adopt them (81 FR
41048). We noted that statute is clear about the particular information
that is to be reported and on which we must base the new CLFS payment
rates. Only applicable information of applicable laboratories is to be
reported, and section 1834A(a)(3) of the Act indicates that applicable
information is private payor rate information. We also explained that
the statute imposes parameters on the collection and reporting of
private payor rate information, and section 1834A(b) of the Act
specifies that the payment amounts for CDLTs are to be based on the
median of the private payor rate information. As such, we stated that
we believe the statute supports our policy to prohibit information
other than statutorily specified private payor rate information of
applicable laboratories from being reported and used to set CLFS
payment amounts under the revised CLFS. We also noted that we did not
agree with the commenters' recommendation to allow voluntary reporting
and at Sec. 414.504(g), we finalized that an entity that does not meet
the definition of an applicable laboratory may not report applicable
information. We continue to believe that our policy to not allow
voluntary reporting is the most appropriate interpretation of the
statute, and that applicable information may not be reported for an
entity that does not meet the definition of an applicable laboratory.
b. Increasing the Low Expenditure Threshold
We also discussed in the CY 2019 PFS proposed rule that we
recognize many small laboratories may not want the additional
administrative burden of data collection and reporting and, because
their test volume is relatively low, their data is unlikely to have a
meaningful impact on the weighted median of private payor rates for
CDLTs under the CLFS. In response to comments from smaller laboratories
that they prefer to not be applicable laboratories because of the
burden of collecting and reporting applicable information, we stated
that we could increase the low expenditure threshold in the definition
of applicable laboratory by 50 percent, from $12,500 to $18,750, in
CLFS revenues during a data collection period. Because physician office
laboratories would be less likely to meet a higher threshold, such an
approach would decrease the number of physician office laboratories and
small independent laboratories required to collect and report
applicable information. We noted that we expected decreasing the number
of physician office laboratories and small independent laboratories
reporting applicable information would have minimal impact on
determining CLFS rates because the largest laboratories with the
highest test volumes dominate the weighted median of private payor
rates.
We stated that if we were to adopt such an approach, we would need
to revise paragraph (4) of the definition of applicable laboratory at
Sec. 414.502 to replace $12,500 with $18,750. We explained in the
proposed rule that we were particularly interested in comments from the
physician community and small independent laboratories on the
administrative burden and relief of increasing the low expenditure
threshold and noted that we believe that feedback on the topics
discussed in this section would help inform us regarding potential
refinements to the low expenditure threshold. We noted that depending
on the comments we received, we would consider approaches described in
this section.
The following is a summary of the comments we received and our
responses to the comments regarding the approach of increasing the low
expenditure threshold by 50 percent, from $12,500 to $18,750, in CLFS
revenues during a data collection period.
Comment: Several commenters did not support raising the low
expenditure threshold because it would further reduce the amount of
applicable information reported from small laboratories. However, one
commenter encouraged CMS to increase the low expenditure threshold to
exclude even more small laboratories from the administrative burden of
collecting and reporting applicable information. A few commenters
suggested that CMS not make any changes to the low expenditure
threshold at this time and encouraged CMS to allow the program to
mature and to only make changes after a careful and transparent review
of the data with additional opportunities for public comment.
Response: We appreciate the comments from stakeholders on raising
the low expenditure threshold and understand that increasing the low
expenditure threshold by 50 percent would lead to fewer physician
office laboratories and small independent laboratories from reporting
applicable information for purposes of calculating CLFS rates. We will
consider the commenters input on increasing the low expenditure
threshold as we continue to evaluate and refine Medicare CLFS payment
policy in the future, but make no changes to this policy at this time.
c. Additional Comments Received
Comment: Many commenters stated that CMS' implementation of the new
private payor rate-based CLFS does not reflect the cost or the value of
performing clinical laboratory services and that without meaningful
changes to how data is collected from laboratories, Medicare
beneficiaries will lose access to the vital laboratory services they
rely on to monitor their health and prevent and treat many diseases and
conditions. The commenters stated that CMS' regulations, which
implemented the private payor rate-based CLFS required under PAMA,
prohibit most independent laboratories and physician office
laboratories, and virtually all hospital laboratories, from providing
data to set Medicare rates, and therefore, results in ``skewed data''
that does not represent true market rates. The commenters stated that
Congress directed CMS to implement a market-based payment system in
which private market data from all segments of the laboratory industry,
including independent laboratories, hospital laboratories, and
physician office laboratories, would be collected in order to determine
Medicare reimbursement for laboratory tests. To implement a true market
based payment system the commenters encouraged CMS to develop payment
rates through a statistically valid process to ensure that the private
payer data collected accurately represents all sectors of the
laboratory market.
Response: In general, section 1834A of the Act requires the payment
amount for each CDLT on the CLFS to be based on the applicable
information collected from applicable laboratories during a data
collection period and reported to CMS during a data reporting period.
For most tests on the CLFS, the statute requires the payment amount to
be equal to the weighted median of the private payor rates for each
test and specifies that the weighted median is calculated by arraying
the distribution of all private payor rates, weighted by the volume for
each payor and each laboratory. Given that the largest
[[Page 59680]]
laboratories reported their applicable information to CMS in the
initial data reporting period, as well as many smaller laboratories, we
believe the data we used to calculate the CY 2018 CLFS rates was
sufficient and resulted in accurate weighted medians of private payor
rates per test as required by the statute. As discussed previously in
this section, we are finalizing our proposal to exclude MA plan
payments under Part C from total Medicare revenues for purposes of the
applicable laboratory definition. We believe this change will permit
laboratories of all types with a significant Medicare Part C revenue
component to be more likely to meet the majority of Medicare revenues
threshold and qualify as an applicable laboratory. As a result of this
change, we believe that applicable information from a broader segment
of the laboratory industry will be reported for purposes of calculating
the CLFS rates. As stated previously, we are finalizing the use of the
Form CMS-1450 14x TOB to define applicable laboratories, subject to
other regulatory and subregulatory requirements, such as the regulatory
low expenditure threshold.
Comment: One commenter stated that the reductions in Medicare
payment rates for laboratory tests result directly from CMS' regulatory
decisions to relieve most laboratories of reporting burdens. According
to the commenter, excluding so many laboratories from the data
reporting requirements results in median prices that are not
representative across the clinical laboratory industry. As such, the
commenter noted that the market data upon which Medicare reimbursement
is based does not reflect the market composition of the clinical
laboratory industry. In other words, exempting low-volume and many
hospital laboratories from reporting does not allow for Medicare prices
to reflect the full range of payment amounts paid to varying entities.
The commenter encouraged CMS to collect data from a broader segment of
the laboratory industry and suggested that we weight private payor
rates by market share (that is, prices typically paid per reporting
entity), instead of based on overall volume per test.
Response: As discussed in response to the previous comment, section
1834A of the Act generally requires the payment amount for each CDLT on
the CLFS to be based on the applicable information collected from
applicable laboratories during a data collection period and reported to
CMS during a data reporting period. Because for most tests, the payment
amount is equal to the median of the private payor rates weighted by
volume, the largest laboratories with the highest test volumes will
most significantly affect the payment rates. Because of this, we
established and implemented a low expenditure threshold to alleviate
administrative burden on small laboratories. We believe that our
current method of calculating the weighted median of private payor
rates is appropriate and consistent with the statute. Given that the
largest laboratories reported their applicable information to us in the
initial data reporting period, along with many smaller laboratories, we
believe the data we used to calculate the CY 2018 CLFS rates was
sufficient and resulted in accurate weighted medians of private payor
rates as required by statute. As noted above, we are finalizing changes
to the definition of an applicable laboratory, which we believe will
lead to an even more robust data collection from which to calculate
payment rates for the next CLFS update.
Comment: Many commenters stated that the administrative burden for
the first data reporting period was overwhelming and they offered
suggestions on how to reduce the reporting burden on applicable
laboratories. Many commenters suggested that CMS implement a ``data
aggregation system'' consistent with statutory authority. In addition,
a few commenters requested that CMS allow flexibility to exclude manual
remittances from the definition of applicable information and therefore
from data reporting. One commenter requested an ``across the board
waiver'' from the reporting requirement for all small medical
practices.
Response: We addressed the comment requesting exclusion of manual
remittances from the definition of applicable information in the CLFS
final rule (81 FR 41053 through 41054). We explained that the statute
is clear that applicable information, which is used to set CLFS payment
amounts, must be reported for applicable laboratories for a data
collection period, and it defines applicable information, in part, as
the payment rate that was paid by each private payor for the test
during a data collection period and the volume of such tests for each
such payor for the data collection period. As such, we stated that we
believe the statute does not support selective reporting of applicable
information for applicable laboratories. If the laboratory meets the
definition of applicable laboratory, the applicable information for
that laboratory must be reported. In addition, given that the statute
requires applicable information to be reported for applicable
laboratories, we do not believe granting an ``across the board waiver''
from the reporting requirements for all small laboratories would be
consistent with statute. We believe that the low expenditure threshold
would continue to exclude the majority of small laboratories from the
applicable laboratory definition and, therefore, from data reporting.
With regard to the commenters suggesting that we implement
aggregate reporting, we note that section 1834A(a)(6) of the Act
permits the Secretary, beginning with January 1, 2019, to establish
rules to aggregate reporting in situations where an applicable
laboratory has more than one payment rate for the same payor for the
same test or more than one payment rate for different payors for the
same test. While the agency did not propose or solicit comments on
implementing aggregate data reporting, we will take the commenters'
suggestion into consideration for future refinements to the CLFS.
However, to help reduce administrative burden for the next data
reporting period, we will allow reporting entities the option to
condense certain applicable information at the TIN-level, instead of
reporting for each applicable laboratory individually at the NPI level.
We will provide more information regarding the condensed reporting
option through subregulatory guidance during the next data collection
period.
Comment: One commenter suggested that CMS adopt a 90-day data
collection period instead of the current 6-month data collection period
to alleviate some of the burden associated with collecting applicable
information.
Response: While we did not propose or solicit comments on changing
the data collection period, we will take the commenter's suggestion
into consideration for future refinements to the CLFS.
Comment: One commenter raised concerns about the integrity of the
data reported during the first data reporting period. The commenter
mentioned that the CLFS final rule was released just prior to the end
of the first data collection period and as a result, laboratories
struggled to collect information and submit the required data
accurately. The commenter noted that many laboratories still do not
have the systems in place to determine the private payor payment rates
for each test and the associated volume paid at each rate, therefore
exacerbating the potential for inaccurate reporting in the next data
reporting period. The commenter was particularly concerned about how
inaccurate data affects newer tests in which the volume of services has
[[Page 59681]]
remained relatively low as compared to well established laboratory
procedures. For instance, because of the low volume of applicable
information being reported for Tier 1 and Tier 2 molecular pathology
procedures, the commenter stated that any inaccurate data reported has
a greater impact on these test codes. The commenter noted that
expanding the definition of an applicable laboratory would likely
result in additional reporting errors and therefore, did not support
any revisions to the definition of an applicable laboratory. Instead,
the commenter urged CMS to refine the reporting process and implement
measures to safeguard data integrity in future reporting periods.
Specifically, the commenter requested that CMS consider implementing a
data aggregation system for future data reporting periods, consistent
with statutory authority. The commenter noted that a data aggregation
system may guarantee more complete reporting and expand the ability of
laboratories to report accurate data.
Response: We share the commenter's interest in collecting accurate
data. As discussed previously, we are finalizing changes to the
definition of applicable laboratory in Sec. 414.502. We did not
propose changes to the CLFS data reporting requirements or solicit
comments on how to safeguard against inaccurate data. We will consider
the issues raised by the commenter for future rulemaking. As noted in
response to another comment, for the next data reporting period we will
permit the reporting entity to condense applicable information for its
applicable laboratories at the TIN level, instead of reporting for each
of its applicable laboratories individually, and will issue
subregulatory guidance on this topic.
Comment: One commenter stated that in general ``our market based
system is flawed'' because it allows companies to profit on people's
health. The commenter stated that the CLFS should be based on
recovering costs only and not profit. The commenter noted that such
approach will lead to a decrease in cost for laboratory testing and a
standardization of fees across the industry.
Response: As previously noted, section 1834A of the Act generally
requires the payment amount for each CDLT on the CLFS to be based on
the applicable information collected from applicable laboratories
during a data collection period and reported to us during a data
reporting period. Basing CLFS rates on laboratory costs would not be
permissible under the statute.
Comment: One commenter stated that uncertainty regarding the
definition of an ADLT has discouraged some laboratories from applying
for ADLT status, and suggested that we should implement the regulatory
requirements in a manner that ``recognizes the uniqueness of the
results generated by each precision diagnostic test due to its use of a
proprietary algorithm validated in a unique patient cohort.''
Response: We did not propose or solicit any comments regarding
changes to the definition of an ADLT, therefore, this comment is not
within the scope of this rulemaking.
B. Changes to the Regulations Associated With the Ambulance Fee
Schedule
1. Overview of Ambulance Services
a. Ambulance Services
Under the ambulance fee schedule, the Medicare program pays for
ambulance transportation services for Medicare beneficiaries under
Medicare Part B when other means of transportation are contraindicated
by the beneficiary's medical condition and all other coverage
requirements are met. Ambulance services are classified into different
levels of ground (including water) and air ambulance services based on
the medically necessary treatment provided during transport.
These services include the following levels of service:
For Ground--
++ Basic Life Support (BLS) (emergency and non-emergency).
++ Advanced Life Support, Level 1 (ALS1) (emergency and non-
emergency).
++ Advanced Life Support, Level 2 (ALS2).
++ Paramedic ALS Intercept (PI).
++ Specialty Care Transport (SCT).
For Air--
++ Fixed Wing Air Ambulance (FW).
++ Rotary Wing Air Ambulance (RW).
b. Statutory Coverage of Ambulance Services
Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B
(Supplemental Medical Insurance) covers and pays for ambulance
services, to the extent prescribed in regulations, when the use of
other methods of transportation would be contraindicated by the
beneficiary's medical condition.
The House Ways and Means Committee and Senate Finance Committee
Reports that accompanied the 1965 Social Security Amendments suggest
that the Congress intended that--
The ambulance benefit cover transportation services only
if other means of transportation are contraindicated by the
beneficiary's medical condition; and
Only ambulance service to local facilities be covered
unless necessary services are not available locally, in which case,
transportation to the nearest facility furnishing those services is
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404,
89th Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that transportation may also be provided from
one hospital to another, to the beneficiary's home, or to an extended
care facility.
c. Medicare Regulations for Ambulance Services
The regulations relating to ambulance services are set forth at 42
CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section
410.10(i) lists ambulance services as one of the covered medical and
other health services under Medicare Part B. Therefore, ambulance
services are subject to basic conditions and limitations set forth at
Sec. 410.12 and to specific conditions and limitations included at
Sec. Sec. 410.40 and 410.41. Subpart H of part 414 describes how
payment is made for ambulance services covered by Medicare Part B.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
Section 146(a) of the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA), (Pub. L. 110-275, enacted July 15, 2008)
amended section 1834(l)(13)(A) of the Act to specify that, effective
for ground ambulance services furnished on or after July 1, 2008, and
before January 1, 2010, the ambulance fee schedule amounts for ground
ambulance services shall be increased as follows:
For covered ground ambulance transports that originate in
a rural area or in a rural census tract of a metropolitan statistical
area, the fee schedule amounts shall be increased by 3 percent.
For covered ground ambulance transports that do not
originate in a rural area or in a rural census tract of a metropolitan
statistical area, the fee schedule amounts shall be increased by 2
percent.
The payment add-ons under section 1834(l)(13)(A) of the Act have
been extended several times. Most recently, section 50203(a)(1) of the
Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted February
9, 2018) amended section 1834(l)(13)(A) of the Act to extend the
payment add-ons through
[[Page 59682]]
December 31, 2022. Thus, these payment add-ons apply to covered ground
ambulance transports furnished before January 1, 2023. We proposed to
revise Sec. 414.610(c)(1)(ii) to conform the regulations to this
statutory requirement. (For further information regarding the
implementation of this provision for claims processing, please see CR
10531. For a discussion of past legislation extending section
1834(l)(13) of the Act, please see the CY 2014 PFS final rule with
comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule
with comment period (79 FR 67743) and the CY 2016 PFS final rule with
comment period (80 FR 71071 through 71072)).
This statutory requirement is self-implementing. A plain reading of
the statute requires only a ministerial application of the mandated
rate increase, and does not require any substantive exercise of
discretion on the part of the Secretary.
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the 5-year extension of the add-on
payments and appreciates CMS' implementation of the statutory
requirement, and stated these provisions are critical to ensuring the
delivery of ambulance services. Another commenter stated that due to
the staffing and distances that might be involved in the use of
ambulance services in varying areas (for example, urban, rural and
super rural), these add-ons payments will assist in appropriate
reimbursements for these services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(1)(ii) to
conform the regulations to this statutory requirement.
b. Amendment to Section 1834(l)(12) of the Act
Section 414(c) of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (Pub. L. 108-173, enacted December 8, 2003)
(MMA) added section 1834(l)(12) to the Act, which specified that, in
the case of ground ambulance services furnished on or after July 1,
2004, and before January 1, 2010, for which transportation originates
in a qualified rural area (as described in the statute), the Secretary
shall provide for a percent increase in the base rate of the fee
schedule for such transports. The statute requires this percent
increase to be based on the Secretary's estimate of the average cost
per trip for such services (not taking into account mileage) in the
lowest quartile of all rural county populations as compared to the
average cost per trip for such services (not taking into account
mileage) in the highest quartile of rural county populations. Using the
methodology specified in the July 1, 2004 interim final rule (69 FR
40288), we determined that this percent increase was equal to 22.6
percent. As required by the MMA, this payment increase was applied to
ground ambulance transports that originated in a ``qualified rural
area,'' that is, to transports that originated in a rural area included
in those areas comprising the lowest 25th percentile of all rural
populations arrayed by population density. For this purpose, rural
areas included Goldsmith areas (a type of rural census tract). This
rural bonus is sometimes referred to as the ``Super Rural Bonus'' and
the qualified rural areas (also known as ``super rural'' areas) are
identified during the claims adjudicative process via the use of a data
field included in the CMS-supplied ZIP code file.
The Super Rural Bonus under section 1834(l)(12) of the Act has been
extended several times. Most recently, section 50203(a)(2) of the BBA
amended section 1834(l)(12)(A) of the Act to extend this rural bonus
through December 31, 2022. Therefore, we are continuing to apply the
22.6 percent rural bonus described in this section (in the same manner
as in previous years) to ground ambulance services with dates of
service before January 1, 2023 where transportation originates in a
qualified rural area. Accordingly, we proposed to revise Sec.
414.610(c)(5)(ii) to conform the regulations to this statutory
requirement. (For further information regarding the implementation of
this provision for claims processing, please see CR 10531. For a
discussion of past legislation extending section 1834(l)(12) of the
Act, please see the CY 2014 PFS final rule with comment period (78 FR
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR
67743 through 67744) and the CY 2016 PFS final rule with comment period
(80 FR 71072)).
This statutory provision is self-implementing. It requires an
extension of this rural bonus (which was previously established by the
Secretary) through December 31, 2022, and does not require any
substantive exercise of discretion on the part of the Secretary.
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the 5-year extension of this
provision and appreciates CMS' implementation of the statutory
requirement and noted this provision is critical to ensuring the
delivery of ambulance services. Another commenter stated that due to
the staffing and distances that might be involved in the use of
ambulance services in varying areas (for example, urban, rural and
super rural), these add-ons payments will assist in appropriate
reimbursements for these services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(5)(ii) to
conform the regulations to this statutory requirement.
3. Amendment to Section 1834(l)(15) of the Act
Section 637 of the American Taxpayer Relief Act of 2012 (ATRA)
(Pub. L. 112-240, enacted January 2, 2013) added section 1834(l)(15) of
the Act to specify that the fee schedule amount otherwise applicable
under the preceding provisions of section 1834(l) of the Act shall be
reduced by 10 percent for ambulance services furnished on or after
October 1, 2013, consisting of non-emergency BLS services involving
transport of an individual with end-stage renal disease for renal
dialysis services (as described in section 1881(b)(14)(B) of the Act)
furnished other than on an emergency basis by a provider of services or
a renal dialysis facility. In the CY 2014 PFS final rule with comment
period (78 FR 74440), we revised Sec. 414.610 by adding paragraph
(c)(8) to conform the regulations to this statutory requirement.
Section 53108 of the BBA amended section 1834(l)(15) of the Act to
increase the reduction from 10 percent to 23 percent effective for
ambulance services (as described in section 1834(l)(15) of the Act)
furnished on or after October 1, 2018. The 10 percent reduction applies
for ambulance services (as described in section 1834(l)(15) of the Act)
furnished during the period beginning on October 1, 2013 and ending on
September 30, 2018. Accordingly, we proposed to revise Sec.
414.610(c)(8) to conform the regulations to this statutory requirement.
This statutory requirement is self-implementing. A plain reading of
the statute requires only a ministerial application of the mandated
rate decrease, and does not require any substantive exercise of
discretion on the part of the Secretary. Accordingly, for ambulance
services described in section
[[Page 59683]]
1834(l)(15) of the Act furnished during the period beginning on October
1, 2013 and ending on September 30, 2018, the fee schedule amount
otherwise applicable (both base rate and mileage) is reduced by 10
percent, and for ambulance services described in section 1834(l)(15) of
the Act furnished on or after October 1, 2018, the fee schedule amount
otherwise applicable (both base rate and mileage) is reduced by 23
percent. (For further information regarding application of this
mandated rate decrease, please see CR 10549.)
We received two comments on this proposal. The following is a
summary of those comments along with our response.
Comment: One commenter supported the reduction of payment for these
ambulance services and stated that the payment adjustment for non-
emergency, BLS transports for ESRD beneficiaries is at an appropriate
level. Another commenter stated that for accountable care
organizations, transportation for dialysis services constitutes the
largest portion of ambulance spending. According to the commenter,
because patients often do not receive medical care during the
transportation, they supported the reduction to the ambulance fee
schedule for the transportation of patients with ESRD for renal
dialysis services.
Response: We appreciate the commenters' support.
After consideration of the comments received, we are finalizing our
proposal, without modification, to revise Sec. 414.610(c)(8) to
conform the regulations to the statutory requirement described above.
C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Payment for Care Management Services
In the CY 2018 PFS final rule, we revised the payment methodology
for Chronic Care Management (CCM) services furnished by RHCs and FQHCs,
and established requirements and payment for general Behavioral Health
Integration (BHI) and psychiatric Collaborative Care Management (CoCM)
services furnished in RHCs and FQHCs, beginning on January 1, 2018.
For CCM services furnished by RHCs or FQHCs between January 1,
2016, and December 31, 2017, payment is at the PFS national average
payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM
services furnished by RHCs or FQHCs on or after January 1, 2018, we
established 2 new HCPCS codes. The first HCPCS code, G0511, is a
General Care Management code for use by RHCs or FQHCs when at least 20
minutes of qualified CCM or general BHI services are furnished to a
patient in a calendar month. The second HCPCS code, G0512, is a
psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes
of initial psychiatric CoCM services or 60 minutes of subsequent
psychiatric CoCM services are furnished to a patient in a calendar
month.
The payment amount for HCPCS code G0511 is set at the average of
the 3 national non-facility PFS payment rates for the CCM and general
BHI codes and updated annually based on the PFS amounts. The 3 codes
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60
minutes or more of complex CCM services), and CPT 99484 (20 minutes or
more of BHI services).
The payment amount for HCPCS code G0512 is set at the average of
the 2 national non-facility PFS payment rates for CoCM codes and
updated annually based on the PFS amounts. The 2 codes are CPT 99492
(70 minutes or more of initial psychiatric CoCM services) and CPT 99493
(60 minutes or more of subsequent psychiatric CoCM services).
For practitioners billing under the PFS, we proposed for CY 2019 a
new CPT code, 994X7, which would correspond to 30 minutes or more of
CCM furnished by a physician or other qualified health care
professional and is similar to CPT codes 99490 and 99487. For RHCs and
FQHCs, we proposed to add CPT code 994X7 as a general care management
service and to include it in the calculation of HCPCS code G0511. That
is, we proposed that starting on January 1, 2019, RHCs and FQHCs would
be paid for HCPCS code G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and
994X7. We note that CPT code 994X7 was a placeholder code, and the
final code is CPT code 99491.
We proposed to revise Sec. 405.2464 to reflect the current payment
methodology that was finalized in the CY 2018 PFS and incorporate the
addition of the new CPT code to HCPCS code G0511.
2. Communication Technology-Based and Remote Evaluation Services
RHC and FQHC visits are face-to-face (in-person) encounters between
a patient and an RHC or FQHC practitioner during which time one or more
RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners, physician
assistants, certified nurse midwives, clinical psychologists, and
clinical social workers, and under certain conditions, a registered
nurse or licensed practical nurse furnishing care to a homebound RHC or
FQHC patient. A Transitional Care Management service can also be an RHC
or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a
Medical Nutrition Therapy (MNT) service furnished by a certified DSMT
or MNT provider may also be an FQHC visit.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary,
face-to-face visits with an RHC practitioner. The rate is subject to a
payment limit, except for those RHCs that have an exception to the
payment limit for being ``provider-based'' (see Sec. 413.65). FQHCs
are paid the lesser of their charges or the FQHC Prospective Payment
System (PPS) rate for medically-necessary, face-to-face visits with an
FQHC practitioner. Only medically-necessary medical, mental health, or
qualified preventive health services that require the skill level of an
RHC or FQHC practitioner can be RHC or FQHC billable visits.
The RHC and FQHC payment rates reflect the cost of all services and
supplies that an RHC or FQHC furnishes to a patient in a single day,
and are not adjusted for the complexity of the patient health care
needs, the length of the visit, or the number or type of practitioners
involved in the patient's care.
Services furnished by auxiliary personnel (such as nurses, medical
assistants, or other clinical personnel acting under the supervision of
the RHC or FQHC practitioner) are considered incident to the visit and
are included in the per-visit payment. This may include services
furnished prior to or after the billable visit that occur within a
medically appropriate time period, which is usually 30 days or less.
RHCS and FQHCs are also paid for care management services,
including chronic care management services, general behavioral health
integration services, and psychiatric Collaborative Care Model
services. These are typically non-face-to-face services that do not
require the skill level of an RHC or FQHC practitioner and are not
included in the RHC or FQHC payment methodologies.
For practitioners billing under the PFS, we proposed for CY 2019
separate payment for certain communication technology-based services.
This includes what is referred to as ``Brief Communication Technology-
Based Services'' for a ``virtual check-in'' and separate payment for
remote evaluation of recorded video and/or images. The ``virtual check-
in'' visit would be
[[Page 59684]]
billable when a physician or non-physician practitioner has a brief (5
to 10 minutes), non-face-to-face check in with a patient via
communication technology to assess whether the patient's condition
necessitates an office visit. This service could be billed only in
situations where the medical discussion was for a condition not related
to an E/M service provided within the previous 7 days, and does not
lead to an E/M service or procedure within the next 24 hours or at the
soonest available appointment. We also proposed payment for
practitioners billing under the PFS for remote evaluation services.
This payment would be for the remote evaluation of patient-transmitted
information conducted via pre-recorded ``store and forward'' video or
image technology, including interpretation with verbal follow-up with
the patient within 24 business hours, not originating from a related E/
M service provided within the previous 7 days nor leading to an E/M
service or procedure within the next 24 hours or soonest available
appointment. We stated that both of these services would be priced
under the PFS at a rate that reflects the resource costs of these non-
face-to-face services relative to other PFS services, including face-
to-face and in-person visits.
The RHC and FQHC payment models are distinct from the PFS model in
that the payment is for a comprehensive set of services and supplies
associated with an RHC or FQHC visit. A direct comparison between the
payment for a specific service furnished in an RHC or FQHC and the same
service furnished in a physician's office is not possible, because the
payment for RHCs and FQHCs is a per diem payment that includes the cost
for all services and supplies rendered during an encounter, and payment
for a service furnished in a physician's office and billed under the
PFS is only for that service.
We recognize that there are occasions when it may be beneficial to
both the patient and the RHC or FQHC to utilize communication
technology-based services to determine the course of action for a
health issue. Currently under the RHC and FQHC payment systems, if the
communication results in a face-to-face billable visit with an RHC or
FQHC practitioner, the cost of the prior communication would be
included in the RHC AIR or the FQHC PPS. However, if as a result of the
communication it is determined that a visit is not necessary, there
would not be a billable visit and there would be no payment.
RHCs and FQHCs furnish services in rural and urban areas that have
been determined to be medically underserved areas or health
professional shortage areas. They are an integral component of the
Nation's health care safety net, and we want to ensure that Medicare
patients who are served by RHCs and FQHCs are able to communicate with
their RHC or FQHC practitioner in a manner that enhances access to
care, consistent with evolving medical care. Particularly in rural
areas where transportation is limited and distances may be far, we
believe the use of communication technology-based services may help
some patients to determine if they need to schedule a visit at the RHC
or FQHC. If it is determined that a visit is not necessary, the RHC or
FQHC practitioner would be available for other patients who need their
care.
When communication technology-based services are furnished in
association with an RHC or FQHC billable visit, the costs of these
services are included in the RHC AIR or the FQHC PPS and are not
separately billable. However, if there is no RHC or FQHC billable
visit, these costs are not paid as part of an RHC AIR or FQHC PPS
payment. We therefore proposed that, effective January 1, 2019, RHCs
and FQHCs receive an additional payment for the costs of communication
technology-based services or remote evaluation services that are not
already captured in the RHC AIR or the FQHC PPS payment when the
requirements for these services are met.
We proposed that RHCs and FQHCs receive payment for communication
technology-based or remote evaluation services when at least 5 minutes
of communication technology-based or remote evaluation services are
furnished by an RHC or FQHC practitioner to a patient who has been seen
in the RHC or FQHC within the previous year. These services may only be
billed when the medical discussion or remote evaluation is for a
condition not related to an RHC or FQHC service provided within the
previous 7 days, and does not lead to an RHC or FQHC service within the
next 24 hours or at the soonest available appointment, since in those
situations the services are already paid as part of the RHC or FQHC
per-visit payment.
We proposed to create a new virtual communication G-code for use by
RHCs and FQHCs only, with a payment rate set at the average of the PFS
national non-facility payment rates for HCPCS code GVCI1 for
communication technology-based services, and HCPCS code GRAS1 for
remote evaluation services. RHCs and FQHCs would be able to bill the
virtual communication G-code either alone or with other payable
services. The payment rate for the virtual communication G-code would
be updated annually based on the PFS amounts. We note that HCPCS codes
GCVI1 and GRAS1 were placeholder codes, and the final HCPCS codes are
G2012 and G2010, respectively.
We also proposed to waive the RHC and FQHC face-to-face
requirements when these services are furnished to an RHC or FQHC
patient. Coinsurance would be applied to FQHC claims, and coinsurance
and deductibles would apply to RHC claims for these services. Services
that are currently being furnished and paid under the RHC AIR or FQHC
PPS payment methodology will not be affected by the ability of the RHC
or FQHC to receive payment for additional services that are not
included in the RHC AIR or FQHC PPS.
3. Other Options Considered
We considered other options for payment for these services. First,
we considered adding communication technology-based and remote
evaluation services as an RHC or FQHC stand-alone service. Under this
option, payment for RHCs would be at the AIR, and payment for FQHCs
would be the lesser of total charges or the PPS rate. We did not
propose this payment option because these services do not meet the
requirements for an RHC or FQHC billable visit and payment at the RHC
AIR or FQHC PPS would result in a payment rate incongruent with
efficiencies inherent in the provision of the technology-based
services.
The second option we considered was to allow RHCs and FQHCs to bill
HCPCS codes G2012 or G2010 separately on an RHC or FQHC claim. We did
not propose this payment option because we believe that a combined G-
code is less burdensome and will allow expansion of these services
without adding additional codes on an RHC or FQHC claim.
4. Comments and Responses
We invited comments on this proposal. In particular, we were
interested in comments regarding the appropriateness of payment for
communication technology-based and remote evaluation services in the
absence of an RHC or FQHC visit, the burden associated with
documentation for billing these codes (RHC or FQHC practitioner's time,
medical records, etc.), and any potential impact on the per diem nature
of RHC and FQHC billing and payment structure as a result of payment
for these services.
[[Page 59685]]
The following is a summary of the comments we received regarding
the addition of CPT code 99491 to the codes used to determine the
payment for HCPCS code G0511 in RHCs and FQHCs, and the proposed
requirements and payment for a new G-code for virtual communication for
payment for communication technology-based and remote evaluation
services. The majority of the commenters were very supportive of both
proposals, and some requested clarification on issues related to
billing, cost reporting, and payment for care management and virtual
communication services in RHCs and FQHCs.
Comment: Several commenters requested clarification of how the
inclusion of the new chronic care management code, CPT code 99491
(previously referred to as CPT code 994X7), would impact the payment of
HCPCS code G0511 (the RHC and FQHC General Care Management code), and
requested assurance that adding this code to the codes used to
determine the payment for HCPCS code G0511 would not result in a lower
payment rate.
Response: In the CY 2018 PFS final rule, we stated that if a new
care management code is proposed and subsequently finalized for
practitioners billing under the PFS, we would review the new code to
determine if it should be included in the calculation of the RHC and
FQHC General Care Management Code. The determination of whether a new
care management code should be added to the codes used to determine the
payment rate is based on the applicability of the service in RHCs and
FQHCs, and may result in either an increase or decrease in the payment
amount for HCPCS code G0511.
CPT code 99491 is for 30 minutes or more of CCM furnished by a
physician or other qualified health care professional. Since this is
similar to CPT codes 99490 and 99487, we determined that it should be
included in the RHC and FQHC General Care Management code, which is
paid using HCPCS code G0511. The CY 2019 payment rate for this code is
expected to be $74.26, and the payment rate for CY 2019 payment rate
for HCPCS code G0511 is expected to be approximately $67, which will
result in a higher payment for HCPCS code G0511 than it would have been
if CPT code 99491 was not added to the codes used to determine the
rate. The rate is adjusted annually based on the PFS payment rates for
these codes.
Comment: A commenter stated that the care management services
included in the PFS are already contemplated and included in the RHC
AIR and the FQHC PPS payments, which are designed to cover all
activities related to a comprehensive primary care visit, even if they
do not occur on the same day. The commenter did not support separate
payment to RHCs and FQHCs for care management services, and stated that
paying separately for these services results in duplicative payment.
The commenter also noted that because the care management payment is
made through the RHC and FQHC payment systems, it does not trigger a
budget-neutrality adjustment and therefore represents additional
spending for the Medicare program and its beneficiaries.
Response: Comprehensive, high quality, and coordinated primary care
has always been an integral part of RHC and FQHC services in their
communities, We respectfully disagree with the suggestion that the type
of structured chronic care management and behavioral health integration
services that are now separately paid as care management are already
included in the RHC AIR or the FQHC PPS payment methodologies. These
services have specific requirements which have not typically or
routinely been provided by RHCs or FQHCs, and therefore have not been
factored into either the RHC AIR or the FQHC PPS rate. RHC and FQHC
payments are not subject to the budget neutrality provisions of the
PFS, and we believe that the cost-saving potential of these services is
likely to offset any additional Medicare spending.
Comment: A commenter encouraged CMS to evaluate the additional
costs of providing CCM services for people with limited English
proficiency and to adjust payment accordingly in future rulemaking.
Response: We are aware that some RHCs and FQHCs have a higher than
average rate of patients with limited English proficiency, which may
sometimes require additional time or resources. However, once the
minimum requirements for care management are met, the RHC or FQHC can
bill for the service, and the rate is based on the average cost of
furnishing the services.
Comment: Several commenters noted their support for a new G-code
for payment for communication technology[hyphen]based and remote
evaluation services and requested that CMS investigate its authority to
allow FQHCs to serve as distant site providers for telehealth services
to Medicare beneficiaries.
Response: Although both telehealth and virtual communication
services use technology to communicate, these are separate and distinct
services. Telehealth services are considered a substitute for an in-
person visit, and are therefore paid at the same rate as it would have
been had it been furnished in person. With some exceptions, telehealth
services require the use of interactive audio and digital
telecommunication systems that permit real-time communication between
the practitioner at the distant site and the beneficiary at the
originating site. The communication technology-based and remote
evaluation services that we proposed are not a substitute for a visit,
but are instead brief discussions with the RHC or FQHC practitioner to
determine if a visit is necessary. If the discussion between the RHC or
FQHC practitioner and the Medicare beneficiary results in a billable
visit, then the usual RHC or FQHC billing would occur. The virtual
communication G-code would only be separately payable if the discussion
between the RHC or FQHC practitioner does not result from or lead to an
RHC or FQHC billable visit. The payment rate for communication
technology-based services are valued based on the shorter duration of
time and the efficiencies associated with the use of communication
technology.
Section 1834(m)(4)(C)(ii) of the Act authorizes RHCs and FQHCs to
serve as telehealth ``originating sites'' (that is, where the patient
is located) for qualified telehealth services. Section 1834(m)(1) of
the Act, which describes distant site telehealth services (where the
practitioner is located), does not include RHCs and FQHCs. We do not
have the authority to allow RHCs and FQHCs to furnish distant site
telehealth services, and RHCs and FQHCs may not bill for distant site
telehealth services under the PFS.
Comment: Some commenters supported a separate payment for
communication technology-based and remote evaluation services using a
virtual communication G-code because these new services were not
included in the calculation of the Medicare FQHC PPS rate, but
requested that CMS reconsider the payment amount for these services.
The commenters suggested that because an FQHC practitioner is required
and the face-to-face requirements for these services are waived, the
payment should be on par with a traditional FQHC visit.
Response: We disagree with the suggestion that the payment be on
par with a regular FQHC visit. If the communication technology-based or
remote evaluation service results in a face-to-face visit with an RHC
or FQHC practitioner, the cost of the brief communication with the RHC
or FQHC practitioner would already be included in the RHC AIR or the
FQHC PPS payment. If the communication
[[Page 59686]]
technology-based or remote evaluation service does not originate from
or result in a face-to-face visit with an RHC or FQHC practitioner, the
RHC or FQHC may bill using the new virtual communication G-code. The
payment rate for these services under the PFS reflects the resource
costs of these non-face-to-face services relative to other PFS
services, including face-to-face and in-person visits. We did not
propose payment for these services as an RHC or FQHC visit or at the
same payment rate as an RHC or FQHC visit because these services do not
meet the requirements for an RHC or FQHC billable visit, and payment at
the RHC AIR or FQHC PPS would result in a payment rate incongruent with
efficiencies inherent in the provision of these communication services.
Comment: Commenters recommended not implementing any type of
frequency limitation, especially as RHCs and FQHCs learn to utilize
these services for their patients. Commenters stated that any frequency
limitation would be arbitrary, may have the opposite effect of the
provision's intended purpose to encourage innovative ways to provide
comprehensive care to Medicare beneficiaries, that the reimbursement
rate does not provide a financial incentive for overuse of this
service, and that the cost of virtual visits, even if unlimited, would
more than offset the cost of even one emergency room visit.
Response: We agree that frequency limitations should not be
implemented at this time.
Comment: Some commenters questioned the feasibility of billing for
virtual communication services because they noted that the coinsurance
requirement will discourage individuals from utilizing virtual
communication services to assess whether or not they need to come in
for an E/M visit, and will create patient confusion and dissatisfaction
if they receive a bill for these services.
Response: We are aware that coinsurance can be a barrier for some
beneficiaries, but we do not have the statutory authority to waive the
coinsurance requirement. RHCs and FQHCs should inform their patients
that coinsurance applies, and provide information on the availability
of assistance to qualified patients in meeting their cost sharing
obligations, or any other programs to provide financial assistance, if
applicable.
Comment: A few commenters expressed concern about how care
management is currently reported and how virtual communication services
will be reported on the RHC cost report. The commenters stated that
although care management services are considered RHC services, they are
reported separately on line 80 in the non-reimbursable section of the
cost report, and as a result, they are not considered allowable costs
on the RHC cost report. The commenters stated that this process is
administratively cumbersome, exposes the RHC to an audit risk, and
represents a significant barrier for RHCs in offering care management
services. The commenters suggested that the costs included on line 80
should only be the direct costs associated with care management
services, which would allow RHCs to more easily identify those costs
and assure them that they are completing this form correctly. The
commenters noted similar concerns for the reporting of virtual
communication services, and recommended that CMS allow the costs
associated with virtual communication to be reported in the
reimbursable section of the RHC cost report.
Response: Reducing administrative burden and encouraging the
appropriate use of services is a high priority for CMS, and we
appreciate the detailed comments and suggested changes regarding the
reporting of care management and virtual communication services on the
RHC cost report. Cost reporting information in typically provided in
subregulatory guidance, and we will carefully consider these comments.
Comment: A commenter questioned how virtual communication that
occurs during non-RHC hours would be billed and calculated on the cost
report.
Response: Services such as care management and virtual
communication services are not billable visits in RHCs and FQHCs and
may occur outside of the RHC's or FQHC's posted hours. As stated
previously, information on cost reporting will be provided in
subregulatory guidance.
Comment: Some commenters recommended removing the timeframe
restrictions for billing virtual communication services, stating that
they are vague, arbitrary, administratively burdensome, or that
allowing daily check in would improve health and reduce costs. Other
commenters suggested modifying the timeframe limitations with a clear
cut-off that RHCs and FQHCs can track and calculate, such as within the
previous 3 days or subsequent 24 hours, or the previous and subsequent
24 hours. One commenter stated that the timeframe restrictions would
require RHCs and FQHCs to review prior patient clinical activity,
assess the diagnostic category of any recent activity, and then delay
for 24 hours to ascertain whether the service is followed by a clinical
visit, rather than billing immediately for the services. This commenter
also stated that most computer billing systems are not set up for this
type of review, and a supplemental billing process would be costly, and
noted that there are no restrictions on face-to-face visits in RHCs or
FQHCs.
Response: PFS payments for HCPCS code G2012 (communication
technology-based services), and HCPCS code G2010 (remote evaluation
services) are based on the descriptor for CPT code 99441 (Telephone
evaluation and management service by a physician or other qualified
health care professional who may report evaluation and management
services provided to an established patient, parent, or guardian not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion). HCPCS code G0071, the new virtual communication G-code for
RHCs and FQHCs, is set at the average of the PFS national non-facility
payment rates for HCPCS codes G2012 and G2010, and would be billed by
the RHC or FQHC when the minimum requirements for either of these codes
are met.
Except for the Initial Preventive Physical Exam and the Annual
Wellness Visit, RHC and FQHC visits do not have frequency limitations,
and a patient could have more than one RHC or FQHC billable visit in
the same week if it is a medically-necessary, face-to-face visit with
an RHC or FQHC practitioner. If a service is not medically-necessary,
or is not furnished by an RHC or FQHC practitioner, or does not require
the skill level of an RHC or FQHC practitioner, it would not be a
billable visit. Since the RHC AIR and FQHC PPS payment methodologies
are designed to include all services and supplies incident to a visit,
the absence of time restrictions could result in duplicate payment to
the RHC or FQHC. Since the virtual communication payment is designed to
provide payment to the RHC or FQHC when there is no billable visit, the
time restrictions are necessary to avoid any duplicate payment.
Communication technology-based and remote evaluation services are
initiated by a patient who has been seen in the past year by the RHC or
FQHC practitioner, and in many cases, a review of prior patient
clinical activity and diagnoses would be necessary as part of the
virtual communication with the patient. Since most RHCs and FQHCs are
utilizing electronic health records, we expect that RHCs and
[[Page 59687]]
FQHCs will be able to comply with the time restrictions without any
additional burden. It is also our understanding that most RHCs and
FQHCs (like other providers and supplies) may not always submit a claim
immediately upon furnishing a service. As with any new service, we
expect that there would be a period of adjustment, and we will monitor
implementation to determine if changes are necessary.
Comment: Commenters questioned if an RHC could bill for virtual
communication services if the discussion results in the patient going
to an emergency room, an urgent care center, or a specialist not
affiliated with the RHC or FQHC, or if it leads to an ``incident-to''
service at the RHC (such as an injection) that is not a billable visit.
Response: If the discussion with the RHC or FQHC practitioner does
not occur within 7 days of an RHC or FQHC visit, and does not result in
an RHC or FQHC visit with 24 hours or the soonest available appointment
with an RHC or FQHC practitioner, and all other requirements are met,
the RHC or FQHC could bill for virtual communication services. This
would apply even if the patient is subsequently seen in an emergency
room, urgent care center, or by a non-RHC or FQHC practitioner, or has
a subsequent non-billable service in the RHC or FQHC such as an
injection.
Comment: A commenter questioned if communication technology-based
and remote evaluation services could be used by RHC and FQHC
practitioners to help beneficiaries determine whether they should visit
an RHC or FQHC for DSMT services, and states that this would allow RHC
and FQHC practitioners to reach beneficiaries in both rural and urban
underserved area and improve the lives of beneficiaries with diabetes.
Another commenter questioned if the new virtual communication codes for
RHCs and FQHCs would impact payment for DSMT in FQHCs.
Response: We agree that outreach and education to communities on
diabetes prevention services are important, especially in rural and
urban underserved areas. However, communication technology-based and
remote evaluation services would be billable by RHCs and FQHCs only
when the discussion requires the skill level of the RHC or FQHC
practitioner. If the discussion could be conducted by a nurse, health
educator, or other clinical personnel, it would not be billable as a
virtual communication service. Payment for DSMT in FQHCs would not be
impacted by the new virtual communication codes.
Comment: A commenter agreed that virtual communication services
should be limited to established patients (seen by an RHC or FQHC
practitioner within the previous year), and recommends that audio-only
technology (that is, telephone) should be allowed for virtual check-ins
because many RHC or FQHC patients may not have access to technology
capabilities beyond audio-only communication.
Response: We note that while other technology can be used,
telephone discussions are acceptable for billing the virtual
communication G-code.
Comment: A commenter suggested that CMS should consider redefining
what constitutes a billable RHC visit and develop a new and expansive
definition so that new healthcare services such as care management and
virtual communication services can be incorporated in the RHC cost-
based model in the same manner as face-to-face billable visits.
Response: We welcome suggestions on modifying program requirements,
but redefining RHC and FQHC billable visits is outside the scope of
this regulation.
Comment: A commenter stated that the proposed PFS change for CPT
code 99213 will result in independent RHCs and provider-based RHCs with
more than 50 beds being paid $10 less per visit than practitioners
billing under the PFS. The commenter stated that this will cause some
RHCs to leave the RHC program, resulting in higher costs to Medicare,
and questioned what can be done to raise the RHC capped encounter
payment.
Response: RHCs are paid based on their costs, subject to a payment
limit set out at section 1833(f) of the Act, except for those RHCs that
have an exception to the payment limit, and is adjusted annually based
on the Medicare Economic Index. We do not have the authority to make
changes in the RHC payment rate.
Comment: A commenter questioned if this proposed change will impact
the FQHC payment rate.
Response: The RHC AIR and the FQHC PPS would not be impacted by
these changes.
Comment: A commenter questioned if the new virtual communication G-
code would be accepted by Medicare Advantage Plans.
Response: HCPCS code G0071 is part of the HCPCS code set and must
be accepted by all payers as a HIPAA standard (45 CFR 162.1002). RHCs
and FQHCs should consult their associated MA plans for billing
information.
Comment: A commenter questioned whether the two new add-on codes
proposed for inherent visit complexity would apply to RHCs and FQHCs
and be eligible for separate payment in addition to their standard all
inclusive rate, and several commenters requested that RHCs and FQHCs be
allowed to bill separately for interprofessional internet
consultations.
Response: The two new add-on codes proposed for inherent visit
complexity are for practitioners billing under the PFS, and do not
apply to RHCs and FQHCs. The RHC AIR and the FQHC PPS includes all
costs associated with a billable visit, and therefore consultations
with other practitioners are not separately billable.
Comment: We received comments on allowing RNs to provide billable
visits in RHCs, allowing FQHCs to bill for assessment and care planning
for patients with cognitive impairment, reducing the requirements for
psychiatric collaborative care management services in RHCs and FQHCs,
providing separate payment to RHCs and FQHCs for medications to treat
alcohol and substance use disorders, revising payment for pneumococcal
vaccines, and reducing the requirements for patient consent for care
management services.
Response: These comments are beyond the scope of this rule.
5. Finalized Provisions
As a result of the comments, we are finalizing the following
provisions:
Effective January 1, 2019, the payment rate for HCPCS code
G0511 (General Care Management Services) is set at the average of the
national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, and 99491.
Effective January 1, 2019, RHCs and FQHCs are paid for
HCPCS code G0071 (Virtual Communication Services), when HCPCS code
G0071 is on an RHC or FQHC claim, either alone or with other payable
services, and at least 5 minutes of communication technology-based or
remote evaluation services are furnished by an RHC or FQHC practitioner
to a patient who has had an RHC or FQHC billable visit within the
previous year, and the medical discussion or remote evaluation is for a
condition not related to an RHC or FQHC service provided within the
previous 7 days, and does not lead to an RHC or FQHC visit within the
next 24 hours or at the soonest available appointment. We are adding a
new paragraph (e) to Sec. 405.2464 to reflect this payment and making
additional minor conforming changes to this section.
HCPCS code G0071 is set at the average of the national
non-facility PFS payment rates for HCPCS code G2012
[[Page 59688]]
(communication technology-based services) and HCPCS code G2010 (remote
evaluation services) and is updated annually based on the PFS national
non-facility payment rate for these codes.
RHC and FQHC face-to-face requirements are waived when
these services are furnished to an RHC or FQHC patient. Coinsurance and
deductibles apply to RHC claims for G0071 and coinsurance applies to
FQHC claims for G0071.
6. Other Regulatory Updates
In addition to the regulatory change described in this section of
the rule, we are finalizing the following technical corrections for
accuracy:
Removal of the extra section mark in the definition of
``Federally qualified health center (FQHC)'' in Sec. 405.2401.
Replacing the word ``his'' with ``his or her'' in the
definition of ``Secretary'' in Sec. 405.2401.
Reordering the occurrence of RHC and FQHC in Sec.
405.2462(g).
7. Substance Use-Disorder Prevention That Promotes Opioid Recovery and
Treatment (SUPPORT) for Patients and Communities Act
Section 6083 of the SUPPORT for Patients and Communities Act (Pub.
L. 115-271, enacted on October 24, 2018) provides additional payments
to RHCs and FQHCs for services furnished for the treatment of opioid
use disorders by practitioners meeting certain requirements. We
anticipate guidance from the Department of Health and Human Services on
the implementation of this provision will be forthcoming.
D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, enacted April 1, 2014) amended Title XVIII of the Act
to add section 1834(q) of the Act directing us to establish a program
to promote the use of appropriate use criteria (AUC) for advanced
diagnostic imaging services. The CY 2016 PFS final rule with comment
period addressed the initial component of the new Medicare AUC program,
specifying applicable AUC. In that rule (80 FR 70886), we established
an evidence-based process and transparency requirements for the
development of AUC, defined provider-led entities (PLEs) and
established the process by which PLEs may become qualified to develop,
modify or endorse AUC. The first list of qualified PLEs was posted on
the CMS website at the end of June 2016 at which time their AUC
libraries became specified applicable AUC for purposes of section
1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the
second component of this program, specification of qualified clinical
decision support mechanisms (CDSMs). In the CY 2017 PFS final rule (81
FR 80170), we defined CDSM, identified the requirements CDSMs must meet
for qualification, including preliminary qualification for mechanisms
documenting how and when each requirement is reasonably expected to be
met, and established a process by which CDSMs may become qualified. We
also defined applicable payment systems under this program, specified
the first list of priority clinical areas, and identified exceptions to
the requirement that ordering professionals consult specified
applicable AUC when ordering applicable imaging services. The first
list of qualified CDSMs was posted on the CMS website in July 2017.
The CY 2018 PFS final rule addressed the third component of this
program, the consultation and reporting requirements. In the CY 2018
PFS final rule (82 FR 53190), we established the start date of January
1, 2020 for the Medicare AUC program for advanced diagnostic imaging
services. It is for services ordered on and after this date that
ordering professionals must consult specified applicable AUC using a
qualified CDSM when ordering applicable imaging services, and
furnishing professionals must report AUC consultation information on
the Medicare claim. We further specified that the AUC program will
begin on January 1, 2020 with a year-long educational and operations
testing period during which time AUC consultation information is
expected to be reported on claims, but claims will not be denied for
failure to include proper AUC consultation information. We also
established a voluntary period from July 2018 through the end of 2019
during which ordering professionals who are ready to participate in the
AUC program may consult specified applicable AUC through qualified
CDSMs and communicate the results to furnishing professionals, and
furnishing professionals who are ready to do so may report AUC
consultation information on the claim (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf). Additionally, to incentivize early use of
qualified CDSMs to consult AUC, we established in the CY 2018 Updates
to the Quality Payment Program; and Quality Payment Program: Extreme
and Uncontrollable Circumstances Policy for the Transition Year final
rule with comment period and interim final rule (hereinafter ``CY 2018
Quality Payment Program final rule'') a high-weight improvement
activity for ordering professionals who consult specified AUC using a
qualified CDSM for the Merit-based Incentive Payment System (MIPS)
performance period that began January 1, 2018 (82 FR 54193).
In the CY 2019 PFS proposed rule, we proposed additions to the
definition of applicable setting, clarification around who may perform
the required AUC consultation using a qualified CDSM under this
program, clarification that reporting is required across claim types
and by both the furnishing professional and furnishing facility,
changes to the policy for significant hardship exceptions for ordering
professionals under this program, mechanisms for claims-based
reporting, and a solicitation of feedback regarding the methodology to
identify outlier ordering professionals.
1. Background
AUC present information in a manner that links: A specific clinical
condition or presentation; one or more services; and an assessment of
the appropriateness of the service(s). Evidence-based AUC for imaging
can assist clinicians in selecting the imaging study that is most
likely to improve health outcomes for patients based on their
individual clinical presentation. For purposes of this program, AUC is
a set or library of individual appropriate use criteria. Each
individual criterion is an evidence-based guideline for a particular
clinical scenario based on a patient's presenting symptoms or
condition.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians access the AUC during the patient workup. They can be
standalone applications that require direct entry of patient
information, but may be more effective when they are integrated into
electronic health records (EHRs). Ideally, practitioners would interact
directly with the CDSM through their primary user interface, thus
minimizing interruption to the clinical workflow.
2. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directs the Secretary to establish a new program to
promote the use of AUC. Section 1834(q)(4) of the Act requires
[[Page 59689]]
ordering professionals to consult with specified applicable AUC through
a qualified CDSM for applicable imaging services furnished in an
applicable setting and paid for under an applicable payment system; and
payment for such service may only be made if the claim for the service
includes information about the ordering professional's consultation of
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, and each component has its own implementation date:
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of
the Act); (2) identification of mechanisms for consultation with AUC by
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by
ordering professionals, and reporting on AUC consultation by January 1,
2017 (section 1834(q)(4) of the Act); and (4) annual identification of
outlier ordering professionals for services furnished after January 1,
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms
for consultation by April 1, 2016. Therefore, we did not require
ordering professionals to consult CDSMs or furnishing professionals to
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component of the Medicare AUC program under section 1834(q)(2) of
the Act--the requirements and process for establishment and
specification of applicable AUC, along with relevant aspects of the
definitions under section 1834(q)(1) of the Act. This included defining
the term ``provider-led entity'' and finalizing requirements for the
rigorous, evidence-based process by which a PLE would develop AUC, upon
which qualification is based, as provided in section 1834(q)(2)(B) of
the Act and in the CY 2016 PFS final rule with comment period. Using
this process, once a PLE is qualified by us, the AUC that are
developed, modified or endorsed by the qualified PLE are considered to
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We
defined PLE to include national professional medical societies, health
systems, hospitals, clinical practices and collaborations of such
entities such as the High Value Healthcare Collaborative or the
National Comprehensive Cancer Network. Qualified PLEs may collaborate
with third parties that they believe add value to their development of
AUC, provided such collaboration is transparent. We expect qualified
PLEs to have sufficient infrastructure, resources, and the relevant
experience to develop and maintain AUC according to the rigorous,
transparent, and evidence-based processes detailed in the CY 2016 PFS
final rule with comment period.
In the same rule we established a timeline and process under Sec.
414.94(c)(2) for PLEs to apply to become qualified. Consistent with
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB
Control Number 0938-1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we addressed the second major
component of the Medicare AUC program--the specification of qualified
CDSMs for use by ordering professionals for consultation with specified
applicable AUC under section 1834(q)(3) of the Act, along with relevant
aspects of the definitions under section 1834(q)(1) of the Act. This
included defining the term CDSM and finalizing functionality
requirements of mechanisms, upon which qualification is based, as
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS
final rule. CDSMs may receive full qualification or preliminary
qualification if most, but not all, of the requirements are met at the
time of application. The preliminary qualification period began June
30, 2017 and ends when the AUC consulting and reporting requirements
become effective on January 1, 2020. The preliminarily qualified CDSMs
must meet all requirements by that date. We defined CDSM as an
interactive, electronic tool for use by clinicians that communicates
AUC information to the user and assists them in making the most
appropriate treatment decision for a patient's specific clinical
condition. Tools may be modules within or available through certified
EHR technology (as defined in section 1848(o)(4) of the Act) or private
sector mechanisms independent from certified EHR technology or a
mechanism established by the Secretary.
In the CY 2017 PFS final rule, we established a timeline and
process in Sec. 414.94(g)(2) for CDSM developers to apply to have
their CDSMs qualified. Consistent with this timeline, the first list of
qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).
c. AUC Consultation and Reporting
In the CY 2018 PFS final rule, we addressed the third major
component of the Medicare AUC program--consultation with applicable AUC
by the ordering professional and reporting of such consultations under
section 1834(q)(4) of the Act. We established a January 1, 2020
effective date for the AUC consultation and reporting requirements for
this program. We also established a voluntary period during which early
adopters can begin reporting limited consultation information on
Medicare claims from July 2018 through December 2019. During the
voluntary period there is no requirement for ordering professionals to
consult AUC or furnishing professionals to report information related
to the consultation. On January 1, 2020, the program will begin with an
educational and operations testing period and during this time we will
continue to pay claims whether or not they correctly include AUC
consultation information. Ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system and ordered on or after January 1, 2020; and furnishing
professionals must report the AUC consultation information on the
Medicare claim for these services ordered on or after January 1, 2020.
Consistent with section 1834(q)(4)(B) of the Act, we also
established that furnishing professionals must report the following
information on Medicare claims for advanced diagnostic imaging services
as specified in section 1834(q)(1)(C) of the Act and defined in Sec.
414.94(b), furnished in an applicable setting as defined in section
1834(q)(1)(D) of the Act, paid for under an applicable payment system
as defined in section 1834(q)(4)(D) of the Act, and ordered on or after
January 1, 2020: (1) The qualified CDSM consulted by the ordering
professional; (2) whether the service ordered would or would not adhere
to specified applicable AUC, or whether the specified applicable AUC
consulted was not applicable to the service ordered; and (3) the NPI of
the ordering professional (if different from the furnishing
professional). Clarifying revisions to the reporting requirement are
discussed later in this preamble.
Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC
consultation and reporting requirements in the case of: A service
ordered for an
[[Page 59690]]
individual with an emergency medical condition, a service ordered for
an inpatient and for which payment is made under Medicare Part A, and a
service ordered by an ordering professional for whom the Secretary
determines that consultation with applicable AUC would result in a
significant hardship. In the CY 2017 PFS final rule, we adopted a
regulation at Sec. 414.94(h)(1)(i) to specify the circumstances under
which AUC consultation and reporting requirements are not applicable.
These include applicable imaging services ordered: (1) For an
individual with an emergency medical condition (as defined in section
1867(e)(1) of the Act); (2) for an inpatient and for which payment is
made under Medicare Part A; and (3) by an ordering professional who is
granted a significant hardship exception to the Medicare EHR Incentive
Program payment adjustment for that year under Sec. 495.102(d)(4),
except for those granted under Sec. 495.102(d)(4)(iv)(C). In the CY
2019 PFS proposed rule, we proposed changes to the conditions for
significant hardship exceptions, and we summarize and respond to public
comments on our proposals later in this preamble. We remind readers
that, consistent with section 1834(q)(4)(A) of the Act, ordering
professionals must consult AUC for every applicable imaging service
furnished in an applicable setting and paid under an applicable payment
system unless a statutory exception applies.
Section 1834(q)(4)(D) of the Act specifies the applicable payment
systems for which AUC consultation and reporting requirements apply
and, in the CY 2017 PFS final rule, consistent with the statute, we
defined applicable payment system in our regulation at Sec. 414.94(b)
as: (1) The PFS established under section 1848(b) of the Act; (2) the
prospective payment system for hospital outpatient department services
under section 1833(t) of the Act; and (3) the ambulatory surgical
center payment system under section 1833(i) of the Act.
Section 1834(q)(1)(D) of the Act specifies the applicable settings
in which AUC consultation and reporting requirements apply: A
physician's office, a hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any other
``provider-led outpatient setting determined appropriate by the
Secretary.'' In the CY 2017 PFS final rule, we added this definition to
our regulation at Sec. 414.94(b). Proposed additional applicable
settings are discussed later in this preamble.
d. Identification of Outliers
The fourth component of the Medicare AUC program is specified in
section 1834(q)(5) of the Act, Identification of Outlier Ordering
Professionals. The identification of outlier ordering professionals
under this paragraph facilitates a prior authorization requirement that
applies for outlier professionals beginning January 1, 2020, as
specified under section 1834(q)(6) of the Act. Because we established a
start date of January 1, 2020 for AUC consultation and reporting
requirements, we will not have identified any outlier ordering
professionals by that date. As such, implementation of the prior
authorization component is delayed. However, we did finalize in the CY
2017 PFS final rule the first list of priority clinical areas to guide
identification of outlier ordering professionals as follows:
Coronary artery disease (suspected or diagnosed).
Suspected pulmonary embolism.
Headache (traumatic and non-traumatic).
Hip pain.
Low back pain.
Shoulder pain (to include suspected rotator cuff injury).
Cancer of the lung (primary or metastatic, suspected or
diagnosed).
Cervical or neck pain.
We did not include proposals to expand or modify the list of
priority clinical areas in this final rule.
4. Proposals for Continuing Implementation
In the CY 2019 PFS proposed rule, we proposed to amend Sec. 414.94
of our regulations, ``Appropriate Use Criteria for Certain Imaging
Services,'' to reflect the following policies.
a. Expanding Applicable Settings
Section 1834(q)(1)(D) of the Act specifies that the AUC
consultation and reporting requirements apply only in an applicable
setting, which means a physician's office, a hospital outpatient
department (including an emergency department), an ambulatory surgical
center, and any other provider-led outpatient setting determined
appropriate by the Secretary. In the CY 2017 PFS final rule, we
codified this definition in Sec. 414.94(b). We proposed to revise the
definition of applicable setting to add an independent diagnostic
testing facility (IDTF).
We believe the addition of IDTFs to the definition of applicable
setting will ensure that the AUC program is in place across outpatient
settings in which outpatient advanced diagnostic imaging services are
furnished. IDTFs furnish services for a large number of Medicare
beneficiaries; nearly $1 billion in claims for 2.4 million
beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a
hospital or physician's office and diagnostic tests furnished by an
IDTF are performed by licensed, certified non-physician personnel under
appropriate physician supervision (Sec. 410.33). Like other applicable
settings, IDTFs must meet the requirements specified in Sec. 410.33 of
our regulations to be enrolled to furnish and bill for advanced
diagnostic imaging and other IDTF services. Services that may be
provided by an IDTF include, but are not limited to, magnetic resonance
imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a
fixed location, a mobile entity, or an individual non-physician
practitioner, and diagnostic procedures performed by an IDTF are paid
under the PFS. IDTF services must be furnished under the appropriate
level of physician supervision as specified in Sec. 410.33(b); and all
procedures furnished by the IDTF must be ordered in writing by the
patient's treating physician or non-physician practitioner. As such, we
believe the IDTF setting is a provider-led outpatient setting
appropriate for addition to the list of applicable settings under
section 1834(q)(1)(D), and we proposed to add IDTF to our definition of
applicable setting under Sec. 414.94(b) of the regulations.
We note that under the PFS, payment for many diagnostic tests
including the advanced diagnostic imaging services to which the AUC
program applies can be made either ``globally'' when the entire service
is furnished and billed by the same entity; or payment can be made
separately for the technical component (TC) of the service and the
professional component (PC) when those portions of the service are
furnished and billed by different entities. In general, the TC for an
advanced diagnostic imaging service is the portion of the test during
which the patient is present and the image is captured. The PC is the
portion of the test that involves a physician's interpretation and
report on the captured image. For example, when a CT scan is ordered by
a patient's treating physician, the entire test (TC and PC) could be
furnished by a radiologist in their office and billed as a ``global''
service. Alternatively, the TC could be furnished and billed by an
IDTF, and the PC could be furnished and billed by a radiologist in
private practice. By adding IDTFs as an
[[Page 59691]]
applicable setting, we believe we would appropriately and consistently
apply the AUC program across the range of outpatient settings where
applicable imaging services are furnished.
We proposed to revise the definition of applicable setting under
Sec. 414.94(b) to include an IDTF. We invited comments on this
proposal and on the possible inclusion of any other applicable setting.
We reminded commenters that application of the AUC program is not only
limited to applicable settings, but also to services for which payment
is made under applicable payment systems (the PFS, the OPPS, and the
ASC payment system).
The following is a summary of the comments we received on revising
the definition of applicable setting under Sec. 414.94(b) to include
an IDTF and on the possible inclusion of any other applicable setting.
Comment: The majority of commenters supported adding IDTF to the
definition of applicable setting. These commenters agreed that this
addition would apply the AUC program appropriately and consistently
across outpatient settings where applicable advanced diagnostic imaging
services are furnished and reported. In contrast, a few commenters were
concerned with expanding the definition of applicable setting until CMS
and other impacted stakeholders have a better understanding of the
program and 3 to 5 years of experience with it. These commenters
suggested that any expanded definition will add complexity and make
implementation even more difficult by the 2020 required start date as
the addition of another applicable setting would require broader
reporting of AUC consultation information. To this end, these
commenters requested modification to the proposal to allow some
flexibility on the timeline to add IDTFs as an applicable setting.
Finally, a few commenters requested that the definition of applicable
setting be further expanded to include any office-based service,
including for example, situations in which physicians have an MRI in
their own office.
Response: We appreciate these perspectives by the commenters. We
continue to believe that the IDTF setting is a provider-led outpatient
setting appropriate for addition to the list of applicable settings
under section 1834(q)(1)(D) of the Act, and are finalizing this
definition as proposed. We disagree that the definition will add
complexity as we seek consistency in applying our regulations across
outpatient settings in which outpatient advanced diagnostic imaging
services are furnished, and would be concerned with applying these
requirements in different settings along different timelines. Because
we did not propose adding other settings to this definition we will not
expand it further in this final rule, but will continue to monitor
claims for advanced diagnostic imaging services across the Medicare
program. We remind readers that the physician's office (including one
where advanced imaging equipment is located), hospital outpatient
department (including an emergency department), and an ambulatory
surgical center are already included in the definition of applicable
setting.
After considering the comments, we are finalizing the proposal
revising the definition of applicable setting under Sec. 414.94(b) to
include an IDTF.
b. Consultations by Ordering Professionals
Section 1834(q)(1)(E) of the Act defines the term ``ordering
professional'' as a physician (as defined in section 1861(r)) or a
practitioner described in section 1842(b)(18)(C) who orders an
applicable imaging service. The AUC consultation requirement applies to
these ordering professionals. We proposed that the consultation with
AUC through a qualified CDSM may be performed by auxiliary personnel
under the direction of the ordering professional and incident to the
ordering professional's services, when the consultation is not
performed personally by the ordering professional whose NPI will be
listed on the order for an advanced imaging service.
In response to the CY 2018 PFS proposed rule, we received several
public comments requesting clarification regarding who is required to
perform the consultation of AUC through a qualified CDSM. Commenters
not only sought clarification, but also provided recommendations for
requirements around this topic. Some commenters recommended that CMS
strictly interpret the statutory language and only allow the clinician
placing the order to perform the consultation and others recommended
that CMS allow others to perform the AUC consultation on behalf of the
clinician.
Section 1834(q)(4)(A)(i) of the Act requires an ordering
professional to consult with a qualified CDSM, and this was codified in
our regulations at Sec. 414.94(j). The statute does not explicitly
provide for consultations under the AUC program to be fulfilled by
other professionals, individuals or organizations on behalf of the
ordering professional; however, we continue to seek ways to minimize
the burden of this new Medicare program and understand that many
practices currently use clinical staff, working under the direction of
the ordering professional, to interact with the CDSM for AUC
consultation and subsequent ordering of advanced diagnostic imaging.
Therefore, we proposed to modify paragraph Sec. 414.94(j) to specify
that additional individuals may perform the required AUC consultation.
When the AUC consultation is not performed personally by the
ordering professional, we proposed the consultation may be performed by
auxiliary personnel incident to the ordering physician or non-physician
practitioner's professional service. We believed this approach was
appropriate under this program and still accomplishes the goal of
promoting the use of AUC. This proposed policy would allow the ordering
professional to exercise their discretion to delegate the performance
of this consultation. It is important to note that the ordering
professional is ultimately responsible for the consultation as their
NPI is reported by the furnishing professional on the claim for the
applicable imaging service; and that it is the ordering professional
who could be identified as an outlier ordering professional and become
subject to prior authorization based on their ordering pattern.
We proposed to revise the AUC consultation requirement specified at
Sec. 414.94(j) to specify that the AUC consultation may be performed
by auxiliary personnel under the direction of the ordering professional
and incident to the ordering professional's services.
The following is a summary of the comments we received on this
proposal. Overall commenters either agreed or disagreed with the
proposal to expand who can perform the consultation with a qualified
CDSM, and the commenters that agreed with the concept of the proposal
either requested clarification around the term auxiliary personnel or
recommended that we use more specific language to describe eligible
personnel.
Comment: Some commenters were completely against the concept of
this proposal and did not support allowing anyone beyond the ordering
professional to perform the AUC consultation stating that allowing
anyone other than the ordering professional to perform the consultation
would undermine the intent of the AUC program and increase
administrative burden. A few of those commenters suggested that
expanding the scope of individuals who can perform the consultation
would actually increase
[[Page 59692]]
burden and confusion for ordering professionals. Others opposed the
proposal on the basis that the educational goals of the program would
be undermined or auxiliary personnel would manipulate the information
to achieve adherent responses. These commenters wanted ordering
professionals to be directly exposed to AUC. Some of the commenters
that agreed with the proposal specifically stated that the intent of
the AUC program would not be diminished by expanding AUC consultation
beyond the ordering professional. However, the vast majority of
commenters agreed that expanding beyond the ordering professional
allows flexibility and the opportunity for the AUC consultation
requirement to be less burdensome on the ordering professional.
Response: We agree that the AUC program should be a learning
program for ordering professionals. However, to balance the burden put
upon ordering professionals and their offices to comply with this
program as well as focus on the educational component of this program,
we maintain that expanding AUC consultations to individuals beyond the
ordering professional is an important step. We envision that the
ordering professionals will, even when they do not personally perform
the AUC consultation, remain closely involved and will engage with the
individual to whom they delegate the task of performing the
consultation. For many ordering professionals, this delegation may save
time when they routinely order tests that are consistently considered
to adhere to AUC. In those cases, the back-and-forth between the
ordering professional and the individual who conducts the consultation
may be minimal. We anticipate that, when an AUC consultation is
performed by someone other than the ordering professional and the
result is that the imaging service does not adhere to the consulted
AUC, that information will be provided back to the ordering
professional to allow them to consider whether a different test (or no
test) should be ordered, or if the original order is still appropriate
for the patient. Additionally, ordering professionals may still choose
to personally perform the consultation. This may be ideal for ordering
professionals with CDSMs that allow for seamless interaction, such as
the case of a CDSM integrated within an EHR.
Regardless of who performs the AUC consultation, the ordering
professional is ultimately responsible for the order and may become
subject to prior authorization if they demonstrate a pattern of non-
adherent orders. Therefore, the ordering professional not only has a
vested interest in terms of providing the right test for their patient,
but also to monitor the frequency with which they order tests that do
not adhere to AUC.
Comment: While the majority of commenters agreed with expanding
who, beyond the ordering professional, can personally perform the
consultation with a qualified CDSM, they expressed either confusion
with the term ``auxiliary personnel'' or recommended additional
regulatory language to more specifically identify the scope of
individuals who could perform the AUC consultation. Other commenters
questioned the applicability of ``incident to'' provisions since
consulting AUC through a CDSM is not a billable service.
Some commenters suggested additional language that would identify
specific licensed professionals, lay out training requirements, allow
for medical assistants or credentialed clinical staff, cite state scope
of practice laws, or require that the individual be present in the
office of the ordering professional. These commenters stated that the
AUC consultation should not be an administrative task that can be
performed by any staff member, such as a receptionist or data entry
clerk. The underlying concern of commenters that wanted to explicitly
allow only clinical personnel to consult AUC was that the individual
performing an AUC consultation would need to understand the patient's
medical information, the advanced imaging service being recommended and
the clinical information that is returned by the CDSM. Commenters
stated that this understanding on the part of the individual who
performs the AUC consultation was particularly important when a CDSM
indicates that the order is not adherent to AUC.
Some commenters specifically addressed our proposal that the
individual who consults AUC must be under the direction of the ordering
professional. At least one commenter noted the need for direct
supervision while another said the individual should be physically
located in the office of the ordering professional as opposed to off-
site. Other commenters suggested that we use language that allows for
maximum flexibility.
One commenter gave an example that drew parallels between CDSMs and
Computerized Provider Order Entry (CPOE) systems, and suggested the
same requirements should apply to individuals consulting CDSMs. The
commenter stated that for CPOE entries to count toward meeting Medicaid
Meaningful Use thresholds, the entry must be made by a licensed
healthcare professional or credentialed medical assistant. Similarly,
the commenter suggested the consultation should be performed consistent
with state scope of practice laws since the use of CPOE is limited to
those individuals referenced above, as it is within their state scope
of practice to enter orders into medical records.
Response: We agree with comments suggesting that the language we
proposed could potentially cause confusion, and we understand the
disagreement among commenters regarding precisely who, beyond the
ordering professional, should be eligible to perform the AUC
consultation. We further agree that the concept of services incident to
a physician's professional services may not be directly relevant to the
action of consulting AUC using a CDSM. We proposed using ``incident
to'' as a description of the relationship between the ordering
professional and the auxiliary personnel consulting the AUC.
We also agree that there are similarities between CPOE systems and
CDSMs, and that individuals using these systems should have some level
of knowledge of the clinical information they are inputting and,
importantly, the information they receive back from the system.
However, we also agree with the view of most commenters that ordering
professionals should have flexibility to delegate the AUC consultation
task. We also agree that the learning and educational aspects of AUC
are more likely to be realized when there is real communication between
the ordering professional and the person performing the consultation.
While we proposed the consultation could be performed incident to the
ordering professional's service, we agree with commenters that the
``incident to'' concept is difficult to apply to a service that is not
billable and does not require the patient to be present. We further
agree with comments recommending that there be good communication and a
close relationship between the ordering professional and individual
consulting the AUC. In the case of consulting AUC, we believe it is
important that the individual who uses the CDSM is working under the
ordering professional, and that the individual is available to the
ordering professional to discuss the results of the consultation and
any responsive adjustments to planned orders.
Comment: A few commenters suggested allowing the furnishing
professional to occasionally consult AUC using a CDSM. Another
[[Page 59693]]
commenter questioned whether auxiliary personnel would be permitted to
change the order based on the AUC consultation and an additional
commenter questioned whether physical therapists could write orders.
Response: While a furnishing professional may consult AUC as they
wish for other purposes, such a consultation would not suffice for
purposes of the AUC consultation required under this program. The AUC
consultation must be performed by the ordering professional or an
individual to whom the ordering professional has delegated it; and the
ordering professional may only delegate the required AUC consultation
to an individual as specified in our final policy. The furnishing
professional may perform their own AUC consultation to verify
information; however, that would not replace the consultation that is
required to be performed by the ordering professional or their
appropriately designated surrogate. The AUC program does not change the
scope of professionals permitted under law to write or change orders
for advanced diagnostic imaging services.
Comment: Some commenters questioned whether there was statutory
authority to allow anyone other than the ordering professional to
personally perform the AUC consultation with a CDSM.
Response: We do not believe it is inconsistent with the statute to
allow an individual other than the ordering professional to perform the
AUC consultation with a qualified CDSM. Moreover, regardless of who
performs the act of consulting with a qualified CDSM, it is important
to understand that the ordering professional remains ultimately
responsible for the AUC consultation and communication of the
consultation information to the furnishing professional.
Comment: A commenter who disagreed with our proposal to permit
certain individuals other than the ordering professional to perform the
AUC consultation suggested that the proposal is counter to the intent
of the existing regulation at Sec. 414.94(k) finalized in the CY 2018
PFS final rule. The commenter suggested that educating ordering
professionals regarding the optimal use of advanced imaging services
can only be accomplished when ordering professionals are directly
exposed to AUC.
Response: We believe the intent of the statutory provisions
requiring the AUC program is to increase appropriate ordering of
advanced imaging services through a learning system, and that can still
be achieved even if we allow delegation of the consultation when the
individual performing it has the proper training and is working under
the appropriate direction of the ordering professional.
Comment: One commenter requested a specific set of standards or
training requirements for such auxiliary personnel to ensure that
diagnostic imaging services comply with AUC requirements.
Response: At this time, we are not in a position to establish
training requirements or standards tailored to the AUC program for
individuals that may be delegated the AUC consultation.
Based on the public comments received, we do not believe it would
be appropriate to move forward with the proposal to specify the scope
of individuals who can perform the AUC consultation as auxiliary
personnel. We are modifying our proposal in response to comments, and
conforming the regulation at Sec. 414.94(j)(2), to clarify that, in
the event of a significant hardship, the requirement to consult AUC
does not apply and specify that, when not personally performed by the
ordering professional, the consultation with a qualified CDSM may be
performed by clinical staff under the direction of the ordering
professional. We have used the term clinical staff elsewhere in the
Medicare program to identify the individuals that may perform care
management services including chronic care management (CCM), behavioral
health integration (BHI) and transitional care management (TCM)
services. These services involve some non-face-to-face services along
with clinical activities around the care plan and communication and
coordination with the patient's other healthcare professionals. For
care management, the clinical staff requirement ensures that the
individual performing the service must have the level of clinical
knowledge necessary to effectively coordinate and communicate with the
treating clinician. Similarly, in the case of the AUC program, the
individual performing the AUC consultation must have sufficient
clinical knowledge to interact with the CDSM and communicate with the
ordering professional. After considering public comments on our
proposal, we have concluded that allowing clinical staff to perform the
AUC consultation under the direction of the ordering professional is a
better fit with the AUC program than our proposal, and is responsive to
public comments asserting that the concept of ``incident to'' is not
relevant in the context of the AUC program. We believe the policy we
are finalizing, to allow the AUC consultation to be performed by
clinical staff under the direction of the ordering professional,
further reflects a balance between those commenters who wanted only the
ordering professional to perform the consultation and those who
suggested we should allow the consultation to be delegated. Clinical
staff will have a level of knowledge that allows for effective
communication of advanced diagnostic imaging orders, interaction with
AUC, and engagement with the ordering professional, while they remain
under the direction of the ordering professional.
c. Reporting AUC Consultation Information
Section 1834(q)(4)(B) of the Act requires that payment for an
applicable imaging service furnished in an applicable setting and paid
for under an applicable payment system may only be made if the claim
for the service includes certain information about the AUC
consultation. As such, the statute requires that AUC consultation
information be included on any claim for an outpatient advanced
diagnostic imaging service, including those billed and paid under any
applicable payment system (the PFS, OPPS or ASC payment system). When
we initially codified the AUC consultation reporting requirement in
Sec. 414.94(k) through rulemaking in the CY 2018 PFS final rule, we
specified only that ``furnishing professionals'' must report AUC
consultation information on claims for applicable imaging services.
This led some stakeholders to believe that AUC consultation information
would be required only on practitioner claims. To better reflect the
statutory requirements of section 1834(q)(4)(B) of the Act, we proposed
to revise our regulations to clarify that AUC consultation information
must be reported on all claims for an applicable imaging service
furnished in an applicable setting and paid for under an applicable
payment system. The revised regulation would more clearly express the
scope of advanced diagnostic imaging services that are subject to the
AUC program, that is, those furnished in an applicable setting and paid
under an applicable payment system.
The language codified in Sec. 414.94(k) uses the term furnishing
professional to describe who must report the information on the
Medicare claims. We recognize that section 1834(q)(1)(F) of the Act
specifies that a ``furnishing professional'' is a physician (as defined
in section 1861(r)) or a practitioner described in section
1842(b)(18)(C) who furnishes an applicable imaging service.
[[Page 59694]]
However, because section 1834(q)(4)(B) of the Act, as described above,
clearly includes all claims paid under applicable payment systems
without exclusion, we believe that the claims from both furnishing
professionals and facilities must include AUC consultation information.
In other words, we would expect this information to be included on the
practitioner's claim for the PC of the applicable advanced diagnostic
imaging service and on the provider's or supplier's claim for the
facility portion or TC of the imaging service.
As such, we proposed to revise Sec. 414.94(k) to clearly reflect
the scope of claims for which AUC consultation information must be
reported, and to clarify that the requirement to report AUC
consultation information is not limited to the furnishing professional.
The following is a summary of the comments we received.
Comment: Some commenters stated that they appreciate the
clarification that the requirement to report AUC consultation
information is not limited to the furnishing professional. These
commenters thanked CMS for addressing the increasingly common instances
in which the TC and PC of an advanced diagnostic imaging service are
performed at separate locations. Additionally, these commenters
acknowledged that the clarification recognizes situations when payment
can be made globally, to include both the TC and PC furnished and
billed by the same entity, and situations of Method II billing by
critical access hospitals. In contrast, other commenters opposed the
reporting of AUC consultation information on all claims, specifically
the facility claims, for an applicable imaging service furnished in an
applicable setting and paid under an applicable payment system. These
commenters noted that requiring the reporting of AUC consultation
information does not appropriately target the ordering professionals
for whom the AUC program is intended, and creates a duplicative effort
when CMS receives AUC consultation information from both facilities and
furnishing professionals for different parts of the same exam. A few
other commenters expressed concern that requiring two sources of AUC
consultation information that relates to the same test for the same
patient could result in situations where one source was inaccurate or
provides conflicting information.
Response: The statutory requirement under section 1834(q)(4)(B) of
the Act specifies that payment for an applicable imaging service
furnished in an applicable setting and paid for under an applicable
payment system may only be made if the claim for the service includes
certain information about the AUC consultation. We recognize that this
requirement to report AUC consultation information is not placed on the
ordering professional, but rather on those submitting claims for the
advanced diagnostic imaging service that the ordering professional
orders. We also recognize that the TC or facility portion of an
applicable imaging service is frequently furnished and billed by a
different entity than the PC portion of the service. We do not
currently do any matching or comparison of separate claims for the PC
and TC or facility portion of an advanced diagnostic imaging service.
Rather, we process these separate claims individually, and have no
immediate plans to begin doing otherwise for purposes of the AUC
program. We hope to learn more about the implementation of this
program, including issues such as these commenters have raised, during
the educational and operations testing period.
After considering the comments, we are finalizing without
modification the proposal to revise Sec. 414.94(k) to clearly reflect
the scope of claims for which AUC consultation information must be
reported, and to make this requirement consistent with section
1834(q)(4)(B) of the Act.
d. Claims-Based Reporting
In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a
combination of G-codes and modifiers to report the AUC consultation
information on the Medicare claim. We received numerous public comments
objecting to this potential solution. In the 2018 PFS final rule, we
agreed with many of the commenters that additional approaches to
reporting AUC consultation information on Medicare claims should be
considered, and we learned from many commenters that reporting a unique
consultation identifier (UCI) would be a less burdensome and preferred
approach. The UCI would include all the information required under
section 1834(q)(4)(B) of the Act including an indication of AUC
adherence, non-adherence and not applicable responses. Commenters noted
that capturing a truly distinguishing UCI on the claim will allow for
direct mapping from a single AUC consultation to embedded information
within a CDSM. We indicated that we would work with stakeholders to
further explore the concept of using a UCI to satisfy the requirements
of section 1834(q)(4)(B) of the Act, which will be used for Medicare
claims processing and, ultimately, for the identification of outlier
ordering professionals, and consider developing a taxonomy for a UCI.
We had the opportunity to engage with some stakeholders over the
last 6 months and we understand that some commenters from the previous
rule continue to be in favor of a UCI, while some may have changed
their position upon further consideration.
We provide the following information to summarize alternatives we
considered. We had originally considered assigning a G-code for every
qualified CDSM with a code descriptor containing the name of the
qualified CDSM. The challenge to this approach arises when there is
more than one advanced imaging service on a single claim. We could
attribute a single G-code to all of the applicable imaging services for
the patient's clinical condition on the claim, which might be
appropriate if each AUC consultation for each service was through the
same CDSM. If a different CDSM was used for each service (for example,
when services on a single claim were ordered by more than one ordering
professional and each ordering professional used a different CDSM) then
multiple G-codes could be needed on the claim. Each G-code would appear
on the claim individually as its own line item. As a potential
solution, we considered the use of modifiers, which are appealing
because they would appear on the same line as the CPT code that
identifies the specific billed service. Therefore, information entered
onto a claim would arrive into the claims processing system paired with
the relevant AUC consultation information.
When reporting the required AUC consultation information based on
the response from a CDSM: (1) The imaging service would adhere to the
applicable AUC; (2) the imaging service would not adhere to such
criteria; or (3) such criteria were not applicable to the imaging
service ordered, three modifiers could be developed. These modifiers,
when placed on the same line with the CPT code for the advanced imaging
service would allow this information to be easily accessed in the
Medicare claims data and matched with the imaging service.
Stakeholders have made various suggestions for a taxonomy that
could be used to develop a UCI to report the required information.
Stakeholders have also considered where to place the UCI on the claim.
We understand the majority of solutions suggested by stakeholders
involving a UCI are claim-
[[Page 59695]]
level solutions and would not allow us to attribute the CDSM used or
the AUC adherence status (adherent or not adherent, or not applicable)
to a specific imaging service. As such, the approach of using a UCI
would not identify whether an AUC consultation was performed for each
applicable imaging service reported on a claim form, or be useful for
purposes of identifying outlier ordering professionals in accordance
with section 1834(q)(5) of the Act.
We have received ideas from stakeholders that are both for and
against the two approaches we have identified; and we appreciate the
stakeholders that have provided additional information or engaged us in
this discussion. Internally, we have explored the possibility of using,
and feasibility of developing, a UCI; and concluded that, although we
initiated this approach during the CY 2018 PFS final rule, it is not
feasible to create a uniform UCI taxonomy, determine a location of the
UCI on the claims forms, obtain the support and permission by national
bodies to use claim fields for this purpose, and solve the underlying
issue that the UCI seems limited to claim-level reporting. Using coding
structures that are already in place (such as G-codes and modifiers)
would allow us to establish reporting requirements prior to the start
of the program (January 1, 2020).
Since we did not finalize a proposal in the CY 2018 PFS final rule,
we proposed in this rule to use established coding methods, to include
G-codes and modifiers, to report the required AUC information on
Medicare claims. This would allow the program to be implemented by
January 1, 2020. We will consider future opportunities to use a UCI and
look forward to continued engagement with and feedback from
stakeholders.
The following is a summary of comments we received on this
proposal.
Comment: The majority of commenters agreed with our proposed
approach of using G-codes and modifiers to append AUC information on
claims. Of those commenters, most stated that the approach is not
without flaws, including increased workflow challenges and complexity,
time needed for staff to learn and incorporate these changes into
billing practices, and the limited information modifiers may convey for
outlier identification purposes. We summarize and respond to comments
on these issues below. However, they acknowledged that there is a lack
of better alternatives. Other commenters disagreed with the proposal,
and recommended CMS not require claims-based reporting until a UCI can
be reported on claims. In addition to those recommending a delay in
reporting, others suggested that CMS not require claims-based reporting
at all and instead allow information to be transmitted directly from
qualified CDSMs to CMS.
Response: We agree with commenters that G-codes and modifiers may
not be the ideal solution. However, it is important that we make
strides to implement this program and prepare stakeholders for the
method of reporting in the immediate years of the program. We will
continue to discuss with stakeholders the potential of using a UCI in
the future. There are hurdles to overcome with respect to the use of a
UCI that are discussed in the comment summaries and responses below.
Some of these include understanding how UCI information would be used
in the development of the eventual outlier ordering professional
methodology, and where it would be appended to the claim. In addition,
there is disagreement among stakeholders regarding whether the UCI
would contain a taxonomy and embed meaningful information.
Additionally, as we have consulted with stakeholders responsible for
updating the claims forms, which would be necessary to establish a
field to report a UCI on claims, we understand that it would be a
matter of years before the forms could be updated. As such, the
prospect of developing and using a UCI is not a realistic immediate
solution.
Comment: There were disagreements and concerns among commenters
that support the use of G-codes to identify which qualified CDSM was
consulted. Some were concerned that CMS could not develop G-codes
quickly enough to keep pace with newly qualified CDSMs and that the
total number of G-codes would be unwieldy. Others supported the use of
a single generic G-code to describe that a qualified CDSM was consulted
but would not identify a particular CDSM. Another commenter pointed out
that a G-code would not be necessary on claims when a CDSM was not
consulted, rather, only a modifier (placed on the same line as the CPT
code for the imaging service) would be used in these circumstances.
Commenters pointed out that claims for both the furnishing facility
and furnishing professional are capable of reporting G-codes and
modifiers, but identified an issue related to resorting of information
on claims as they are processed through the system. In other words, the
codes billed on separate claim lines can come through the system and
end up in a different order than how they originally appeared when the
claim was submitted. This means CMS cannot presume to pair an imaging
service reported on a specific claim line with a specific G-code when
more than one imaging service appears on the claim. A commenter
suggested that furnishing professionals could split their claims so
only one imaging service and one G-code would appear on each claim.
Commenters pointed out that while this is possible on the furnishing
professional claim, it is not possible on the furnishing facility claim
due to other rules involving facility billing and same-day procedures.
Response: We are optimistic that we can issue G-codes in a timely
manner upon qualifying new CDSMs. There are a number of CDSMs already
qualified and G-codes could be issued for those prior to the start of
the educational and operations testing period set to begin in 2020. We
could secure additional G-codes with general descriptors to describe
``newly qualified CDSM A,'' ``newly qualified CDSM B,'' etc. to be
ready for assignment to a specific CDSM upon qualification. That would
allow some time for the descriptor to be changed to reflect the name of
the CDSM, but also enable immediate use of the appropriate G-code for
reporting purposes. This information will be contained in standard
coding information issued by the agency as well as on the AUC website
that lists all qualified CDSMs.
Regarding the use of one generic G-code to describe that a
qualified CDSM was consulted, we are not confident that this would
satisfy the statutory requirement under section 1834(q)(4)(B) of the
Act to report which qualified CDSM was consulted. However, we may find
that generic codes are needed as a temporary measure as we move forward
with implementation.
If a CDSM is not consulted, for example due to the ordering
professional attesting to a significant hardship, then we agree that a
distinct G-code for that purpose is not necessary. Rather the modifier
describing that hardship could be placed on the same claim line as the
CPT code for the imaging service.
We agree with commenters that the issue of claims processing system
resorting of claims information is problematic. When multiple imaging
services are reported on a single claim, it will not be possible to
pair the G-code describing which CDSM was consulted with the imaging
service for which it was consulted. While we could require the
furnishing professional to split the claim, we are not committing to
that solution at this point but will explore that option as we move
forward with implementation. Another possible
[[Page 59696]]
solution, though still imperfect, could be to list the G-code on a line
and place the modifiers describing AUC adherence on the line with the
CPT code describing the imaging service. This model could work when the
same ordering professional has ordered all of the furnished imaging
services on the claim, and if we presume that an ordering professional
will consistently use only one qualified CDSM. We appreciate commenters
raising these issues and we will continue to explore options to address
them.
Comment: One commenter suggested that, instead of G-codes, CPT
codes should be developed to identify the qualified CDSM consulted.
Response: Initially we do not believe it will be possible for AMA-
CPT to issue CPT codes identifying qualified CDSMs in time for the
program to begin. We do, however, understand that there may be benefits
to making these codes Level 1 HCPCS codes that are issued by AMA-CPT as
opposed to HCPCS Level 3 codes (G-codes). We will look into the
benefits and potential problems of using CPT codes to describe which
qualified CDSM was consulted. An initial concern we have, in addition
to timing to accommodate the start of the AUC program, is whether CPT
code descriptors could be changed quickly enough to accommodate newly
qualified CDSMs and whether CPT codes would be set aside for future
use.
Comment: Many commenters observed that, under this AUC program,
qualified CDSMs must generate and provide a certification or
documentation at the time of order that documents which qualified CDSM
was consulted, the name and NPI of the ordering professional that
consulted the CDSM, and whether the service ordered would or would not
adhere to specified applicable AUC or whether the specified applicable
AUC consulted was not applicable to the service ordered. As a result,
these commenters assumed that the CDSM would also communicate the
relevant G-codes and modifiers, and requested that CMS clarify that
qualified CDSMs are required to explicitly communicate their assigned
G-code and the adherence modifier to the ordering professional. The
commenters stated that absent this clarification, some CDSMs may simply
convey their name and an indication (other than the relevant modifier)
as to whether the ordered service ``adhered,'' or ``didn't adhere,'' or
the AUC ``didn't apply'' to the imaging test. The commenters were
concerned that if CDSMs provide AUC consultation results in this way,
it would create additional burden for ordering professionals to
manually assign coding information to be transmitted for billing
purposes.
A few of these commenters stated that they requested this
clarification because they noted: (1) Each qualified CDSM will know its
G-code and can readily convert their adherence rating system into
modifiers, (2) the required data could be transmitted between EHR and
CDSM vendors and communicated between professionals in a standardized
manner, and (3) accuracy of consultation reporting would improve.
Response: Commenters accurately described what information must be
included in the certification or documentation generated by a qualified
CDSM at the time of order, and this is specified in our regulation at
Sec. 414.94(g)(1)(vi). As we move forward in finalizing our approach
for claims-based reporting where CDSMs will be represented through G-
codes, and AUC adherence represented through modifiers, we agree with
commenters that CDSMs should include the G-codes and modifiers in their
certification or documentation. We would like to see CDSMs begin to do
this as the specific G-codes and modifiers become available. And as the
commenters noted, this would seem to be a simple thing for CDSMs to do.
If we do not see CDSMs making such adjustments to their certification
or documentation, we will consider imposing a requirement in
regulation.
Comment: Commenters had varying views of using a UCI to report
consultation information on claims. Some commenters were interested in
moving forward with the UCI requirement when the claims forms are
adjusted to accommodate this new information. Others disagreed on
whether or not a taxonomy with embedded meaning was necessary. Some of
these commenters supported a UCI issued by the qualified CDSM that was
unique to that CDSM. A G-code would also appear on the claim that would
identify which qualified CDSM was consulted and then the UCI would be
used to pair the information with the data in the CDSM specific to that
consultation. Others supported a UCI with a taxonomy with embedded
meaning so one could look at the UCI and know, without accessing
additional information, which CDSM was consulted and the outcome of
that consultation. We also heard from commenters that the UCI could be
lengthy and therefore prone to transcription errors when entering
information on the order or the claim form.
Response: We will continue to consult with stakeholders about the
future possibility of using the UCI.
Comment: Numerous commenters were concerned about the requirements
for claims-based reporting of AUC consultation information when the
claims are not yet able to accommodate new types of information. Most
of these commenters expressed concern about the placement of the UCI
and other commenters pointed out that the furnishing facility claim
does not contain a designated location for the ordering professional's
NPI.
Response: We agree with these concerns and will work with the
appropriate stakeholders to identify a possible future location for a
UCI to be appended to claims. We are not committing to using the UCI at
this time but will be open to exploring the possibility of developing a
UCI that could be appended to claims in the future. We will also work
to better understand and identify a potentially appropriate place on
the furnishing facility claim to include the ordering professional's
NPI, and to understand whether changes to that claim form may be
needed. In the short term we will consider other implementation options
so that fields on the claims are not used improperly.
Comment: Several commenters sought clarification on how, absent a
UCI, AUC claims-based information as reported by the furnishing
professional and facility would be reconciled with the AUC consultation
performed by the ordering professional as there is interest in
establishing best practices for retaining this information. These
commenters requested clarification on who bears responsibility if such
data are not available during an audit, considering that the ordering
professional interacts with the CDSM and provides the information that
the furnishing provider submits on the claim.
Response: It is the responsibility of the ordering professional to
consult AUC and to provide that consultation information to the
furnishing professional; and it is the responsibility of the furnishing
professional and facility to accurately report that information on
claims for applicable imaging services. We will take into account the
specific roles of ordering and furnishing professionals and facilities
as the program develops and we begin to engage in program monitoring
activities.
Comment: Many commenters noted the practice of ``exam
substitution'' permitted by Sections 80.6.2-80.6.4 of Chapter 15 of the
Medicare Benefit Policy Manual when the furnishing
[[Page 59697]]
professional determines a different diagnostic imaging service should
be ordered in certain circumstances and the ordering practitioner is
not available to provide a new order. To this end, commenters
recommended additional proposals to modify the reporting method using
G-codes and modifiers by creating additional modifiers for those orders
that (1) are initiated in one location and furnished at a different
point of service, (2) furnished after a second consultation has
occurred, or (3) are the result of interpretation-only services.
Response: We thank these commenters for their suggestions on
additional modifiers and will consider these recommendations during
implementation.
Based on the public comments we are finalizing the proposal to use
G-codes and modifiers to report consultation information on claims. We
appreciate that commenters pointed out concerns and technical issues
regarding this approach and we will work to address them during
implementation.
e. Significant Hardship Exception
We proposed to revise Sec. 414.94(i)(3) of our regulations to
adjust the significant hardship exception requirements under the AUC
program. We proposed criteria specific to the AUC program and
independent of other programs. An ordering professional experiencing
any of the following when ordering an advanced diagnostic imaging
service would not be required to consult AUC using a qualified CDSM,
and the claim for the applicable imaging service would not be required
to include AUC consultation information. The proposed criteria include:
Insufficient internet access;
EHR or CDSM vendor issues; or
Extreme and uncontrollable circumstances.
Insufficient internet access is specific to the location where an
advanced diagnostic imaging service is ordered by the ordering
professional. EHR or CDSM vendor issues may include situations where
ordering professionals experience temporary technical problems,
installation or upgrades that temporarily impede access to the CDSM,
vendors cease operations, or we de-qualify a CDSM. We expect these
situations to generally be irregular and unusual. Extreme and
uncontrollable circumstances include disasters, natural or man-made,
that have a significant negative impact on healthcare operations, area
infrastructure or communication systems. These could include areas
where events occur that have been designated a federal Emergency
Management Agency (FEMA) major disaster or a public health emergency
declared by the Secretary. Based on 2016 data from the Medicare EHR
Incentive Program and the 2019 payment year MIPS eligibility and
special status file, we estimate that 6,699 eligible clinicians could
submit such a request due to extreme and uncontrollable circumstances
or as a result of a decertification of an EHR, which represents less
than 1 percent of available ordering professionals.
In the CY 2017 PFS final rule, for purposes of the AUC program
significant hardship exceptions, we provided that those who received
significant hardship exceptions in the following categories from Sec.
495.102(d)(4) would also qualify for significant hardship exceptions
for the AUC program:
Insufficient internet Connectivity (as specified in Sec.
495.102(d)(4)(i)).
Practicing for less than 2 years (as specified in Sec.
495.102(d)(4)(ii)).
Extreme and Uncontrollable Circumstances (as specified in
Sec. 495.102(d)(4)(iii)).
Lack of Control over the Availability of CEHRT (as
specified in Sec. 495.102(d)(4)(iv)(A)).
Lack of Face-to-Face Patient Interaction (as specified in
Sec. 495.102(d)(4)(iv)(B)).
In the CY 2018 PFS proposed rule, we proposed to amend the AUC
significant hardship exception regulation to specify that ordering
professionals who are granted reweighting of the Advancing Care
Information (ACI) performance category to zero percent of the final
score for the year under MIPS per Sec. 414.1380(c)(2) due to
circumstances that include the criteria listed in Sec.
495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined
in the bulleted list above) would be excepted from the AUC consultation
requirement during the same year that the re-weighting applies for
purposes of the MIPS payment adjustment. This proposal removed Sec.
495.102(d)(4)(ii), practicing for less than 2 years, as a criterion
since these clinicians are not MIPS eligible clinicians and thus would
never meet the criteria for reweighting of their MIPS ACI performance
category for the year.
In response to public comments, we did not finalize the proposed
changes to the significant hardship exceptions in the CY 2018 PFS final
rule and instead decided further evaluation was needed before moving
forward with any modifications. Our original intention was to design
the AUC significant hardship exception process in alignment with the
process for the Medicare EHR Incentive Program for eligible
professionals, and then for the MIPS ACI (now Promoting
Interoperability) performance category. Under section 1848(a)(7)(A) of
the Act, the downward payment adjustment for eligible professionals
under the Medicare EHR Incentive Program will end in 2018, and we are
unable to continue making reference to a regulation relating to a
program that is no longer in effect. As we have continued to evaluate
both policy options and operational considerations for the AUC
significant hardship exception, we have concluded that the most
appropriate approach, which we consider to be more straightforward and
less burdensome than the current approach, involves establishing
significant hardship criteria and a process that is independent from
other Medicare programs. We also note as we have in the past that the
AUC program is a real-time program with a need for real-time
significant hardship exceptions. This is in contrast to the way
significant hardship exceptions are handled under MIPS where the
hardship might impact some or all of a performance period, or might
impact reporting, both of which occur well before the MIPS payment
adjustment is applied in a subsequent year. We recognize that when a
significant hardship arises, an application process to qualify for an
exception becomes a time consuming hurdle for health care providers to
navigate, and we believe that it is important to minimize the burden
involved in seeking significant hardship exceptions. As such, we
proposed that ordering professionals would self-attest if they are
experiencing a significant hardship at the time of placing an advanced
diagnostic imaging order and such attestation would be supported with
documentation of significant hardship. Ordering professionals attesting
to a significant hardship would communicate that information to the
furnishing professional with the order and it would be reflected on the
furnishing professional's and furnishing facility's claim by appending
a HCPCS modifier. The modifier would indicate that the ordering
professional has self-attested to experiencing a significant hardship
and communicated this to the furnishing professional with the order.
Claims for advanced diagnostic imaging services that include a
significant hardship exception modifier would not be required to
include AUC consultation information.
In addition to the proposals above, we invited the public to
comment on any
[[Page 59698]]
additional circumstances that would cause the act of consulting AUC to
be particularly difficult or challenging for the ordering professional,
and for which it may be appropriate for an ordering professional to be
granted a significant hardship exception under the AUC program.
Although we understand the desire by some for significant hardship
categories unrelated to difficulty in consulting AUC through a CDSM, we
remind readers that circumstances that are not specific to AUC
consultation, such as the ordering professional being in clinical
practice for a short period of time or having limited numbers of
Medicare patients, would not impede clinicians from consulting AUC
through a CDSM as required to meet the requirements of this program.
The following is a summary of the comments we received on the
modifications to the significant hardship exceptions and additional
circumstances for consideration as needing significant hardship
exceptions.
Comment: Some commenters requested that clinicians in the Quality
Payment Program be excepted from or considered automatically in
compliance with the AUC program requirements. Some of these commenters
specified that an exception should apply to all primary care
practitioners, others suggested an exception should apply to all
clinicians in the Quality Payment Program, and several commenters
requested that hospitals and health systems be exempt from reporting
AUC consultation information. One commenter requested that facility and
institutional providers be exempt. Acknowledging that the statutory
language in section 218(b) of the PAMA does not include such an
exception, some of these commenters clarified that CMS should seek
legislative authority to add such an exception.
Response: As added by section 218(b) of the PAMA, section
1834(q)(4)(B) of the Act specifies that AUC consultation information
must be included on all claims for applicable imaging services when
furnished in an applicable setting and paid under an applicable payment
system, which includes the physician fee schedule, prospective payment
system for hospital outpatient department services and the ambulatory
surgical center payment system. Section 1834(q)(4)(C) of the Act also
set forth specific exceptions, including for a service ordered for an
individual with an emergency medical condition, a service ordered for
an inpatient for which payment is made under Medicare Part A, or for a
service ordered by an ordering professional for whom AUC consultation
would result in a significant hardship. In the case of significant
hardship, section 1834(q)(4)(C)(iii) of the Act provides for such
exceptions in situations when the Secretary determines, on a case-by-
case basis, that an ordering professional is exempt because
``consultation with applicable appropriate use criteria would result in
a significant hardship, such as in the case of a professional who
practices in a rural area without sufficient internet access.'' Given
these statutory provisions, blanket exceptions, considered significant
hardships or otherwise, for clinicians in the Quality Payment Program,
for facility or institutional providers, or for hospitals and health
systems, would not be consistent with the statutory requirements. While
we understand that stakeholders may view the AUC program as duplicative
of the Quality Payment Program, we also note that there are specific
and distinct differences between the programs. The AUC program was
established to promote appropriate use of advanced diagnostic imaging
and improve ordering patterns for these services through the
consultation of AUC with real time reporting requirements and payment
implications. While some components of the Quality Payment Program can
involve using AUC and clinical decision support, their use is not
mandatory, and the Quality Payment Program provides numerous options
for participation across all MIPS performance categories. In contrast,
consultation with AUC using a CDSM is required for each order for an
applicable imaging service furnished in an applicable setting and paid
under an applicable payment system under the AUC program. If amendments
are made to the AUC statutory provisions, we will adjust our
regulations throughout Sec. 414.94 accordingly. However, at this time,
we do not have the authority to include exceptions to the AUC program
beyond the scope of those specified in section 1834(q)(4)(C) of the
Act.
Comment: Some commenters requested an additional significant
hardship category based on a low-volume threshold for practices with
low patient volumes, low number of covered services or a low number of
Medicare charges. Some commenters supported this request by noting the
increased cost and burden a small practice would be required to
undertake to meet the requirements of the AUC program.
Response: As noted above, we believe that significant hardships are
reflective of situations that would impede clinicians from consulting
AUC through a CDSM. As the program is structured and given the
availability of qualified CDSMs that are free of charge, we do not
agree that ordering professionals in practices with low patient
volumes, low number of covered services or a low number of Medicare
charges would be impeded from consulting AUC. While we do understand
that participation in the AUC program may result in increased cost and
burden, which could arguably be disproportionate for these types of low
volume practices, we do not have the authority to include exceptions to
the AUC program beyond the scope of those specified in section
1834(q)(4)(C) of the Act.
Comment: Several commenters provided recommendations for other
categories of significant hardship exceptions. One commenter requested
an exception for professionals when the PLE they rely upon becomes
unavailable, and another commenter requested a significant hardship
exception when there is a lack of AUC for the service(s) requiring
consultation or AUC are outdated. Another commenter suggested that new
physicians be excepted from the AUC program and another identified
imaging services ordered as the result of a clinical research protocol
as a potential significant hardship.
Response: We disagree with adding these scenarios to the
significant hardship exceptions under this program. For unavailable
PLEs and AUC, we established specific requirements for both qualified
PLEs and CDSMs that address the two situations included above. First,
qualified CDSMs are required to make available, at a minimum, specified
applicable AUC that reasonably address common and important clinical
scenarios within all priority clinical areas and be able to incorporate
specified applicable AUC from more than one qualified PLE. Should a
qualified PLE cease to exist or otherwise become unavailable, then the
qualified CDSM through which the AUC for that qualified PLE is
consulted would no longer meet the requirements to be a qualified CDSM
(assuming it does not incorporate AUC from another qualified PLE), and
as such, would be de-qualified as a CDSM under this program. As noted
above, de-qualification of a CDSM would be an allowable circumstance
for an ordering professional to attest to a significant hardship due to
EHR or CDSM vendor issues. Second, when an ordering professional
consults a qualified CDSM and there are no AUC applicable to the
service ordered, that information would be reported on the claim as
such. In these situations, the qualified CDSM is required under Sec.
414.94(g)(1)(vi) to
[[Page 59699]]
generate and provide a certification or documentation at the time of
order that documents whether the specified applicable AUC consulted was
not applicable to the service ordered. The ordering professional is
then required to provide that information to the furnishing
professional and facility so that it can be reported as specified under
Sec. 414.94(k). The absence of applicable AUC does not constitute an
exception from the requirement to consult AUC using the qualified CDSM
in an effort to find specified applicable AUC for the order. Third,
qualified PLEs are required to review their AUC regularly and update
them at least annually when appropriate; and qualified CDSMs are
required to make any updated AUC content available within 12 months of
the qualified PLE's update(s). Finally, we do not believe that being a
new physician or conducting clinical research would cause the act of
consulting AUC to be particularly difficult or challenging for the
ordering professional.
Comment: Several commenters revisited previously expressed concerns
about the emergency services exception. The commenters requested
clarification around what constitutes an emergency medical condition.
One commenter suggested that CMS revise the regulatory language to
allow exceptions when an emergency medical condition is suspected for
cases in which clinicians, in their best judgment, believe a patient
may be experiencing a medical emergency at the time of order. This
commenter noted that this approach was the intent of section 218(b) of
the PAMA as explained by a member of Congress who was involved in
drafting the statutory language, and that the reference to section
1867(e) of the Act instead of section 1867(a) of the Act was an
inadvertent drafting error. One commenter requested that CMS delay
requiring AUC consultations in the emergency department until the
ambiguity over what services are considered emergency services is
resolved.
Response: Section 1834(q)(4)(C)(i) of the Act provides for an
exception to the AUC consultation and reporting requirements in the
case of a service ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act, not section
1867(a) of the Act as the commenter suggests. The regulation reflects
the current statutory language and we will not amend our regulation in
response to these comments. As stated in our response to comments in
the CY 2017 PFS final rule with comment, we agree that exceptions
granted for an individual with an emergency medical condition include
instances where an emergency medical condition is suspected, but not
yet confirmed. This may include, for example, instances of severe pain
or severe allergic reactions. In these instances, the exception is
applicable even if it is determined later that the patient did not in
fact have an emergency medical condition.
Comment: Many commenters generally supported the proposed
significant hardship categories and self-attestation approach, with one
commenter specifically encouraging oversight of AUC and the use of
significant hardship exceptions. However, many other commenters
challenged the proposed approach to annotating the significant hardship
self-attestation on every Medicare claim. Specifically, they requested
that a blanket exception or single attestation be applied over a period
of time to avoid increased burden of communicating and reporting a
significant hardship attestation on every advanced diagnostic imaging
order, and suggested using a significant hardship exception modifier on
the subsequent claim(s) after the single attestation. One commenter
noted that the approach as proposed by CMS is more burdensome than
requiring the use of an applications process.
Response: Because the AUC program requires real time reporting on
Medicare claims, we believe the best way to ensure clinicians have the
ability and flexibility to use the significant hardships allowable
under this program is to establish a mechanism for real time
application of significant hardship attestations. To accomplish this,
inclusion of the relevant significant hardship modifier on each
Medicare claim offers the most straightforward approach, enabling
ordering professionals to use a significant hardship exception as
needed and without more complicated, time consuming steps that could
result in a delay in the transmission, acceptance and processing of the
imaging order for the ordering and furnishing professionals, as well as
a delay in care for the patient. We note that applying a blanket
exception for a specific period of time for ordering professionals
based on a single significant hardship attestation would introduce a
level of complexity and burden to the process that was not identified
by requestors. Following such a single attestation, furnishing
professionals (as well as CMS) would need to keep track of which
ordering professionals had attested to a significant hardship as well
as the period of time applicable to each attestation every time an
order is received and a claim is prepared, submitted and processed. We
disagree with commenters that inclusion of significant hardship
information on each imaging order and subsequent claim imposes
extensive burden, or that other approaches would be less burdensome and
achieve the same goal of allowing for a real time significant hardship
exception process under the real time AUC program.
Comment: Many commenters posed specific requests for clarification
around the proposed significant hardship exception categories. One
commenter requested further clarity and a broader application of
insufficient internet access and extreme and uncontrollable
circumstances to include, respectively, situations out of the control
of the ordering professional like slow internet and no physical access
to the CDSM, lost CDSM usernames and passwords and other situations
preventing an ordering professional from consulting at the time of the
patient encounter. Other commenters requested clarification around how
orders would be made during downtime and how and when to document the
significant hardship and by whom. A few commenters did not understand
how de-certification of an EHR would qualify as a significant hardship
since there are no certification requirements related to the AUC
program. Others requested further information on how hardship
information must be reported on the claim, specific information on
coding a significant hardship, how to handle emergency situations and
what to report when orders are changed.
Response: We appreciate the comments submitted requesting further
clarification around exactly how significant hardship exceptions will
be operationalized. We note that many of the questions posed are
specific to claims reporting details. We expect to provide further
details and clarification in the claims processing instructions that we
expect to release following the final rule.
We describe insufficient internet access as specific to the
location where an advanced diagnostic imaging service is ordered by the
ordering professional. To further clarify, we note that in addition to
ordering imaging services in an area without sufficient internet
access, a significant hardship may apply when ordering professionals
would face insurmountable barriers to obtaining infrastructure to have
internet access (that is, lack of broadband). We do not believe that
occasions of slow internet constitute a significant hardship.
[[Page 59700]]
We describe EHR or CDSM vendor issues as situations where ordering
professionals experience temporary technical problems, installation or
upgrades that temporarily impede access to the CDSM, vendors cease
operations, or we de-qualify a CDSM and note that we expect these
situations to be irregular and unusual. De-certification of an EHR
would qualify as a significant hardship when the ordering
professionals' qualified CDSM is integrated into their EHR, and the
ordering professional's access to the CDSM is temporarily impeded due
to installation issues associated with switching to a new vendor. We do
not agree that losing CDSM usernames and passwords constitutes a
significant hardship under the AUC program. Self-attestation for this
significant hardship should be used as needed when the situations
described above occur. We have not established limitations around using
the EHR or CDSM vendor issues or the other significant hardship
exceptions, but may monitor the use of these exceptions to ensure
misuse or overuse does not become a problem.
We describe extreme and uncontrollable circumstances to include
disasters, natural or man-made, that have a significant negative impact
on healthcare operations, area infrastructure or communication systems.
We also explain these may include areas where events occur that have
been designated by FEMA as a major disaster or a public health
emergency declared by the Secretary. To further clarify, these
circumstances are events that are entirely outside the control of the
ordering professional that prevent the ordering professional from
consulting AUC through a qualified CDSM. We believe the hardship
criteria under this program are similar to other programs such as MIPS
and Promoting Interoperability, particularly the flexibility that is
given to clinicians to identify extreme and uncontrollable
circumstances.
Comment: Several commenters submitted a variety of additional
comments and questions about the proposed significant hardship
exceptions. One commenter questioned why the AUC hardships are not
completely aligned with Quality Payment Program hardships. One stated
that interpretation-only services do not need to include documentation
of AUC consultation because professionals with no face-to-face
encounters are excepted. One commenter questioned why an ordering
professional with a significant hardship exception would need to
communicate AUC consultation information, and suggested that they
should only need to communicate the exception information to the
furnishing professional and facility. A few commenters recommended that
furnishing professionals should be held harmless when ordering
professionals self-attest to experiencing a significant hardship.
Response: As explained above, the AUC program requires real time
reporting of information on the Medicare claims for payment purposes.
The Quality Payment Program is not a real time program but instead uses
data from prior performance years to determine status and potential
payment adjustments in future years. This distinct and significant
difference, along with statutory differences between the programs,
necessitates a separate significant hardship exception approach and
process for the AUC program. As discussed throughout this section, we
have made efforts to align significant hardship exception concepts with
the Quality Payment Program as closely as possible; however, we are
unable to achieve full alignment due to the innate programmatic
differences. For ordering professionals without face-to-face patient
interactions, we did not include this circumstance in our proposals and
do not provide for such an exception in this final rule. The degree of
patient interaction does not create in itself a significant hardship to
consultation with applicable AUC. For communicating consultation
information on the imaging order when a significant hardship is
experienced, the commenter is correct. No AUC consultation information
is to be communicated when an ordering professional self-attests to
experiencing a significant hardship and communicates that on the order.
This confusion likely arose from language that we inadvertently
included in the preamble and have corrected for the final rule. Section
1834(q)(4)(B) of the Act requires certain information to be included on
the claim for applicable imaging services under this program. As long
as the furnishing professional and facilities correctly include the
required information or append the appropriate hardship modifier, the
claims will not be denied for failing to include AUC consultation
information, and the furnishing professionals and facilities are not
held responsible for the self-attestation made by the ordering
professional. As noted above, we may monitor the use of these
exceptions to ensure misuse or overuse does not become a problem, with
the understanding that they reflect the ordering professional's self-
attestation, not a representation made by the furnishing professional
or facility. It is not appropriate for furnishing professionals or
facilities to append significant hardship modifiers at their
discretion; and we note that support for the use of such a modifier
should be included by the ordering professional in the patient's
medical record.
After considering the public comments, we are finalizing the
significant hardship categories of insufficient internet access, EHR or
CDSM vendor issues, and extreme and uncontrollable circumstances and
updating this language in Sec. 414.94(i)(3) of our regulations. We are
also finalizing our proposal to allow ordering professionals
experiencing a significant hardship to self-attest and include that
information on the order for the advanced diagnostic imaging service,
which the furnishing professional or facility would then communicate on
the Medicare claim for the service by appending a HCPCS modifier
identifying the ordering professional's self-attested significant
hardship category.
f. Identification of Outliers
As previously mentioned, the fourth component of the AUC program
specified in section 1834(q)(5) of the Act, is the identification of
outlier ordering professionals. In our efforts to start a dialogue with
stakeholders, we invited the public to submit their ideas on a possible
methodology for the identification of outlier ordering professionals
who would eventually be subject to a prior authorization process when
ordering advanced diagnostic imaging services. Specifically, we
solicited comments on the data elements and thresholds that we should
consider when identifying outliers. We also intend to perform and use
analysis to assist us in developing the outlier methodology for the AUC
program. Our existing prior authorization programs generally do not
specifically focus on outliers. We are interested in hearing ideas from
the public on how outliers could be determined for the AUC program.
Because we would be concerned about data integrity and reliability, we
do not intend to include data from the educational and operations
testing period in CY 2020 in the analysis used to develop our outlier
methodology. Since we intend to evaluate claims data to inform our
methodology we expect to address outlier identification and prior
authorization more fully in CY 2022 or 2023 rulemaking. We appreciate
the feedback received from public commenters and as noted above, we
[[Page 59701]]
expect to solicit additional public comment to inform our methodology
through rulemaking before finalizing our approach.
5. Summary
We appreciate the commenters that continue to provide their
perspective and feedback on this program. Based on those comments we
will finalize the following:
We will finalize as proposed to add IDTFs to the definition of
applicable settings under Sec. 414.94(b) of this program. We will also
finalize as proposed that furnishing professionals and all furnishing
entities are required to report AUC consultation information on the
claim as specified under Sec. 414.94(k). In addition we will finalize
as proposed the significant hardship exception criteria and process
under Sec. 414.94(i)(3) to be specific to the AUC program and
independent of other Medicare programs.
We will not finalize as proposed the proposal to allow the AUC
consultation, when not personally performed by the ordering
professional, to be performed by auxiliary personnel incident to the
ordering professional's services. Rather we are finalizing under Sec.
414.94(j)(2) that when delegated by the ordering professional, clinical
staff under the direction of the ordering professional may perform the
AUC consultation with a qualified CDSM.
Additionally, we will move forward with plans to use G-codes and
modifiers to report AUC consultation information on the Medicare
claims.
We will continue to post information on our website for this
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.
E. Medicaid Promoting Interoperability Program Requirements for
Eligible Professionals (EPs)
1. Background
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for the incentive payments made to Medicaid EPs and eligible
hospitals for the adoption, implementation, upgrade, and meaningful use
of CEHRT. We have implemented these statutory provisions in prior
rulemakings to establish the Medicaid Promoting Interoperability
Program.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act, and the definition of ``meaningful EHR user'' in regulations at
Sec. 495.4, one of the requirements of being a meaningful EHR user is
to successfully report the clinical quality measures selected by CMS to
CMS or a state, as applicable, in the form and manner specified by CMS
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting electronic clinical quality measures (eCQMs)
for EPs to report under the Promoting Interoperability Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting otherwise required. We have
taken steps to align various quality reporting and payment programs
that include the submission of eCQMs.
In the ``Medicare Program; Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and the Long-Term Care Hospital
Prospective Payment System and Policy Changes and Fiscal Year 2018
Rates; Quality Reporting Requirements for Specific Providers; Medicare
and Medicaid Electronic Health Record (EHR) Incentive Program
Requirements for Eligible Hospitals, Critical Access Hospitals, and
Eligible Professionals; Provider-Based Status of Indian Health Service
and Tribal Facilities and Organizations; Costs Reporting and Provider
Requirements; Agreement Termination Notices'' final rule (82 FR 37990,
38487) (hereafter referred to as the ``FY 2018 IPPS/LTCH PPS final
rule''), we established that, for 2017, Medicaid EPs would be required
to report on any six eCQMs that are relevant to the EP's scope of
practice. In proposing and finalizing that change, we indicated that it
is our intention to align eCQM requirements for Medicaid EPs with the
requirements of Medicare quality improvement programs, to the extent
practicable.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting
Interoperability Program for 2019
CMS annually reviews and revises the list of eCQMs for each MIPS
performance year to reflect updated clinical standards and guidelines.
In section III.I.3.h.(2)(b)(i) of this final rule, we amend the list of
available eCQMs for the CY 2019 performance period. To keep eCQM
specifications current and minimize complexity, we proposed to align
the eCQMs available for Medicaid EPs in 2019 with those available for
MIPS eligible clinicians for the CY 2019 performance period (83 FR
35871). Specifically, we proposed that the eCQMs available for Medicaid
EPs in 2019 would consist of the list of quality measures available
under the eCQM collection type on the final list of quality measures
established under MIPS for the CY 2019 performance period.
We explained that we believed that this proposal would be
responsive to stakeholder feedback supporting quality measure alignment
between MIPS and the Medicaid Promoting Interoperability Program for
EPs, and that it would encourage EP participation in the Medicaid
Promoting Interoperability Program by allowing those that are also MIPS
eligible clinicians the ability to report the same eCQMs as they report
for MIPS in 2019. In addition, we explained that we believed that
aligning the eCQMs available in each program would ensure the most
uniform application of up-to-date clinical standards and guidelines
possible.
We explained that we anticipated that this proposal would reduce
burden for Medicaid EPs by aligning the requirements for multiple
reporting programs, and that the system changes required for EPs to
implement this change would not be significant, particularly in light
of our belief that many EPs will report eCQMs to meet the quality
performance category of MIPS and therefore should be prepared to report
on the available eCQMs for 2019. We explained that we expected that
this proposal would have only a minimal impact on states, by requiring
minor adjustments to state systems for 2019 to maintain current eCQM
lists and specifications.
We also requested comments on whether in future years of the
Medicaid Promoting Interoperability Program beyond 2019, we should
include all e-specified measures from the core set of quality measures
for Medicaid and the Children's Health Insurance Program (CHIP) (the
Child Core Set) and the core set of health care quality measures for
adults enrolled in Medicaid (Adult Core Set) (hereinafter together
referred to as ``Core Sets'') as additional options for Medicaid EPs.
Sections 1139A and 1139B of the Act require the Secretary to
identify and publish core sets of health care quality measures for
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries.
These measure sets are required by statute to be updated annually and
are voluntarily reported by states to CMS. These core sets comprise
measures that specifically focus on populations served by the Medicaid
and CHIP programs and are of particular importance to their care.
Several of these Core Set measures are included in the MIPS eCQM list,
but some are not. We explained that we believe that including, as eCQM
reporting options for Medicaid EPs, the e-specified measures from the
Core Sets that are not
[[Page 59702]]
also on the MIPS eCQM list would increase EP utilization of these
measures and provide states with better data to report. At this time,
the only measure within the Core Sets that would not be available as an
option for Medicaid EPs in 2019 (because it is not on the MIPS eCQM
list for Performance Year 2019) is NQF-1360, ``Audiological Diagnosis
No Later Than 3 Months of Age.'' However, as these Core Sets are
updated annually, in future years there may be other eCQMs that would
not be on the MIPS eCQM list, and that could be included.
For 2019, we proposed that Medicaid EPs would report on any six
eCQMs that are relevant to their scope of practice, regardless of
whether they report via attestation or electronically. After we removed
the NQS domain requirements for Medicaid EPs' 2017 eCQM submissions in
the FY 2018 IPPS/LTCH PPS final rule, we have found that allowing EPs
to report on any six quality measures that are relevant to their
practice has increased EPs' flexibility to report pertinent data. In
addition, this policy of allowing Medicaid EPs to report on any six
measures relevant to their scope of practice would generally align with
the MIPS data submission requirement for eligible clinicians using the
eCQM collection type for the quality performance category, which is
established at Sec. 414.1335(a)(1). MIPS eligible clinicians who elect
to submit eCQMs must generally submit data on at least six quality
measures, including at least one outcome measure (or, if an applicable
outcome measure is not available, one other high priority measure). We
refer readers to Sec. 414.1335(a) for the data submission criteria
that apply to individual MIPS eligible clinicians and groups that elect
to submit data with other collection types.
We proposed that for 2019 the Medicaid Promoting Interoperability
Program would adopt the MIPS requirement that EPs report on at least
one outcome measure (or, if an outcome measure is not available or
relevant, one other high priority measure).
We also requested comments on how high priority measures should be
identified for Medicaid EPs. We proposed (83 FR 35872) to use all three
of the following methods to identify which of the available measures
are high priority measures, but invited comments on other
possibilities.
1. We proposed to use the same set of high priority measures for
EPs participating in the Medicaid Promoting Interoperability Program
that the MIPS program has identified for eligible clinicians. As
discussed in section III.I.3.h.(2)(b)(i) of this final rule, we
proposed to amend Sec. 414.1305 to revise the definition of high
priority measure for purposes of MIPS to mean an outcome (including
intermediate-outcome and patient-reported outcome), appropriate use,
patient safety, efficiency, patient experience, care coordination, or
opioid-related quality measure, beginning with the 2021 MIPS payment
year.
2. For 2019, we also proposed to identify as high priority measures
the available eCQMs that are included in the previous year's Core Sets
and that are also included on the MIPS list of eCQMs. We explained that
because the Core Sets are released at the beginning of each year, it
would not be possible to update the list of high-priority eCQMs with
those added to the current year's Core Sets. We also explained that CMS
has already identified the measures included in the Core Sets as ones
that specifically focus on populations served by the Medicaid and CHIP
programs and are particularly important to their care. The eCQMs that
would be available for Medicaid EPs to report in 2019, that are both
part of the Core Sets and on the MIPS list of eCQMs, and that would be
considered high priority measures under our proposal are: CMS2,
``Preventive Care and Screening: Screening for Depression and Follow-Up
Plan''; CMS4, ``Initiation and Engagement of Alcohol and Other Drug
Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (>9%)''; CMS125, ``Breast Cancer Screening''; CMS128, ``Anti-
depressant Medication Management''; CMS136, ``Follow-Up Care for
Children Prescribed ADHD Medication (ADD)''; CMS153, ``Chlamydia
Screening for Women''; CMS155, ``Weight Assessment and Counseling for
Nutrition and Physical Activity for Children and Adolescents''; and
CMS165, ``Controlling High Blood Pressure.''
3. We also proposed to give each state the flexibility to identify
which of the available eCQMs selected by CMS are high priority measures
for Medicaid EPs in that state, with review and approval from CMS,
through their State Medicaid HIT Plans (SMHP), similar to the
flexibility granted states to modify the definition of Meaningful Use
at Sec. 495.332(f). We explained that we believe this proposal would
give states the ability to identify as high priority those measures
that align with their state health goals or other programs within the
state. We proposed to amend Sec. 495.332(f) to provide for this state
flexibility to identify high priority measures.
We proposed that any eCQMs identified via any of these mechanisms
be considered to be high priority measures for EPs participating in the
Medicaid Promoting Interoperability Program for 2019.
We also proposed that the eCQM reporting period for EPs in the
Medicaid Promoting Interoperability Program would be a full CY in 2019
for EPs who have demonstrated meaningful use in a prior year, in order
to align with the corresponding performance period in MIPS for the
quality performance category. We explained that we continue to align
Medicaid Promoting Interoperability Program requirements with
requirements for other CMS quality programs, such as MIPS, to the
extent practicable, to reduce the burden of reporting different data
for separate programs. In addition, we explained that we have found
that clinical quality data from an entire year reporting period is
significantly more useful than partial year data for quality
measurement and improvement because it gives states a fuller picture of
a health care provider's care and patient outcomes. We proposed that
the eCQM reporting period for Medicaid EPs demonstrating meaningful use
for the first time, which was established in the final rule entitled
``Medicare and Medicaid Programs; Electronic Health Record Incentive
Program-Stage 3 and Modifications to Meaningful Use in 2015 Through
2017'' (80 FR 62762) (hereafter referred to as ``Stage 3 final rule''),
would remain any continuous 90-day period (80 FR 62892).
We explained that we will adjust future years' requirements for
reporting eCQMs in the Medicaid Promoting Interoperability Program
through rulemaking, and will continue to align the quality reporting
requirements, as logical and feasible, to minimize EP burden.
Comment: Many commenters stated that they support the alignment of
the eCQMs available for Medicaid EPs in 2019 with those available for
MIPS eligible clinicians for the CY 2019 performance period. These
commenters stated that alignment between the two programs helps reduce
health care provider reporting burden. In addition, several commenters
noted that the MIPS eCQM list is geared toward adults and that
including measures from the Child Core Set in future years, after 2019,
would add measures that are more applicable to certain specialties that
serve Medicaid and CHIP beneficiaries, such as pediatricians and
pediatric dentists.
Response: We appreciate these comments, and we continue to look for
[[Page 59703]]
opportunities to align programs, make measures more relevant to
Medicaid EPs, and reduce reporting burden when possible.
Comment: Several commenters supported the proposal to include any
e-specified measures from the Adult Core Set and Child Core Set that
are not also on the MIPS eCQM list, in order to align with other CMS
programs, as well as to provide a wider variety of measures that are
specifically applicable to Medicaid EPs.
Response: We agree that the measures included in the Adult Core Set
and the Child Core Set are targeted toward Medicaid patients and
Medicaid health care providers. These Core Sets are tools states can
use to monitor and improve the quality of health care provided to
Medicaid and CHIP enrollees. Although under statute, state reporting on
these measure sets is voluntary, we aim to increase the number of
states reporting on a uniform set of measures and to support states in
using these measures to drive quality improvement for the beneficiaries
they serve.
Comment: One commenter stated that the e-specified Adult Core Set
and Child Core Set measures that are not also on the MIPS eCQM list
should not be included in future years of the Medicaid Promoting
Interoperability Program beyond 2019 because the Medicaid Promoting
Interoperability Program is approaching the final years of
participation and Medicaid EPs are already aware of the requirements
they need to meet to be a meaningful EHR user. In addition, the same
commenter stated that adding additional measures from the Core Sets
would create a large burden on all states to update their attestation
systems for the one or two remaining participation years.
Response: We appreciate this comment, but point out that the burden
to states would be no greater than including any additional measures
that may be added to the MIPS eCQM set in future years, if CMS
continues to align the MIPS and Medicaid Promoting Interoperability
Program eCQM requirements. We also point out that many of the positive
comments regarding this proposal came from states that appreciated the
proposal to align with other CMS reporting requirements. Those
commenters did not indicate that such a requirement would impose a
significant burden on states.
After careful consideration of the comments, we are finalizing
without change our proposal to amend the list of available eCQMs for
the CY 2019 performance period. To keep eCQM specifications current and
minimize complexity, we are aligning the eCQMs available for Medicaid
EPs in 2019 with those available for MIPS eligible clinicians for the
CY 2019 performance period. Specifically, the eCQMs available for
Medicaid EPs in 2019 will consist of the list of quality measures
available under the eCQM collection type on the final list of quality
measures established under MIPS for the CY 2019 performance period.
We did not propose to include the e-specified measures within the
Adult Core Set and Child Core Set that are not also on the MIPS eCQM
list for eCQM reporting in the Medicaid Promoting Interoperability
Program in 2019, due to timing and logistical feasibility. However, we
intend to reevaluate whether to add these measures when proposing eCQM
reporting requirements for the Medicaid Promoting Interoperability
Program for 2020 and beyond.
Comment: Many commenters stated their support for aligning the
Medicaid Promoting Interoperability Program with the MIPS requirement
that eligible clinicians who elect to submit eCQMs must generally
submit data on at least six quality measures, including at least one
outcome measure (or, if an applicable outcome measure is not available,
one other high priority measure).
Response: We thank these commenters and we will continue to look
for opportunities to align the programs and reduce reporting burden
when possible.
Comment: One commenter stated that there are relatively few
pediatric-appropriate measures in the Medicaid Promoting
Interoperability Program and MIPS, and therefore recommended that CMS
provide specific clarification that pediatric providers would not be
held responsible for adult measures that are not necessarily applicable
to pediatrics.
Response: We acknowledge that not all Medicaid EPs may find six
measures applicable to their scope of practice. Therefore, we note that
our policy continues to allow Medicaid EPs to report eCQMs with zero in
the denominator, which indicates that they have no data on that eCQM in
their EHR from the reporting period. If fewer than six measures are
relevant to a Medicaid EP's scope of practice, he or she may submit
``zero denominator'' eCQMs that his or her CEHRT is able to calculate
to meet the requirement to report six measures. If an EP's CEHRT
contains no data on a specific eCQM, when states are auditing EP's
submissions, it may create a rebuttable presumption that that measure
falls outside of the EP's scope of practice. However, unless they
cannot otherwise report on six measures, we encourage EPs to report on
eCQMs that contain data, which are more likely to be within their scope
of practice, instead of reporting eCQMs with a zero denominator.
Comment: One commenter stated that some specialists may have
difficulty finding an outcome or high priority measure applicable to
their scope of practice. The commenter also noted that this difficulty
is alleviated under MIPS with the group reporting option, which is not
available under the Medicaid Promoting Interoperability Program.
Response: In light of this concern, we now explain that if no
outcome or high priority measures apply to a Medicaid EP's scope of
practice and there is no data for any of the outcome or high priority
measures reportable by his or her CEHRT, he or she may report on six
non-outcome and non-high priority measures that are applicable to his
or her scope of practice.
Comment: One commenter inquired as to a state's responsibility for
auditing the eCQMs a Medicaid EP submits, how a state would ensure that
the reported eCQMs are within the EP's scope of practice, and how a
state would know whether there was an unselected relevant outcome or
high priority measure.
Response: Under Sec. 495.368, states are required to combat fraud
and abuse and ensure that incentive payments are made properly per the
requirements of the program, including the eCQM reporting requirements.
In regard to this particular requirement, we believe that Medicaid EPs
are in the best position to determine which measures are applicable to
their scope of practice, not the state. Therefore, when verifying EPs'
submissions, either at prepayment or during a post-payment audit,
states should give Medicaid EPs the widest reasonable latitude to
determine which eCQMs are relevant to their scope of practice. For
instance, an EP should be able to meet the eCQM reporting requirements
by submitting non-zero data for six relevant eCQMs, including one
outcome or high-priority measure, regardless of whether there may be an
unselected eCQM more relevant to his or her practice. That is, as we
noted above, we do not think EPs should be reporting on eCQMs with a
zero denominator unless that is the only way the EP can report on six
measures. We encourage states to provide technical assistance to
Medicaid EPs and to design their attestation systems in such a way that
will assist EPs to meet this program requirement, and that will help
avoid recouping incentive payments.
After careful consideration of the comments, we are finalizing our
[[Page 59704]]
proposal that for 2019, Medicaid EPs will report on any six eCQMs that
are relevant to the EP's scope of practice, regardless of whether they
report via attestation or electronically. We are also finalizing the
proposal that for 2019 the Medicaid Promoting Interoperability Program
will adopt the MIPS requirement that EPs report on at least one outcome
measure (or, if an applicable outcome measure is not available or
relevant, one other high priority measure). Additionally, in response
to comments summarized above, we now explain that if no outcome or high
priority measure is relevant to a Medicaid EP's scope of practice, he
or she may report on any six eCQMs that are relevant.
Comment: Some commenters approved of our proposal to allow states
to indicate which eCQMs are high priority measures for that state's
Medicaid agency.
Response: We thank these commenters for their comments.
Comment: A few commenters opposed offering states the flexibility
to identify high priority eCQMs because it can cause additional cost to
states for technology updates, and additional burden for vendors to
customize and make software updates in a short timeframe. They also
commented that having differences among states can cause burden on
Medicaid EPs.
Response: We do not believe that this flexibility and variation
between states will cause any additional burden for states, vendors or
Medicaid EPs. Allowing states to identify their own high priority
measures is entirely optional. If a state chooses not to identify
additional high priority measures, the state would need to take no
additional action. Furthermore, we expect that providing this option
for states will reduce Medicaid EP burden, as it will give EPs a wider
range of options to meet the requirement that they report on at least
one outcome measure, or on at least one high priority measure if an
outcome measure is not available or relevant. Additionally, as we
explain above, if no outcome or priority measure is relevant to a
Medicaid EP's scope of practice, he or she may instead report on any
six measures that are relevant.
Finally, this proposal should not increase burden on CEHRT vendors.
States may select high priority measures only from the list of eCQMs
that are already available for Medicaid EPs to meet the requirements of
the program. Medicaid EPs are not required to select any of their
state-specific high priority measures. Therefore, the CEHRT need not
vary between states, but must be able to calculate and report on at
least one outcome measure (or, if an applicable outcome measure is not
available or relevant, one other high priority measure) relevant to the
provider's scope of practice, whether or not that is a state-specific
high priority measure.
We received no comments on the first and second methods of
identifying high priority measures for the Medicaid Promoting
Interoperability Program. After careful consideration of the comments
on our proposed approach to how high priority measures would be
identified, we are finalizing it without modification.
Comment: Several commenters stated their support for aligning the
eCQM reporting period for EPs in the Medicaid Promoting
Interoperability Program with the corresponding performance period in
MIPS, because they agreed this proposal would reduce EP burden. In
addition, commenters noted that consistency with previous years will
reduce confusion among EPs.
Response: We appreciate these comments and will continue to align
when possible.
Comment: Several commenters urged CMS to adopt a 90-day eCQM
reporting period within CY 2019 for all Medicaid EPs. A couple
commenters indicated that the transition between 2014 Edition and 2015
Edition CEHRT during the year may create difficulty for Medicaid EPs to
report a full year of data.
Response: We acknowledge that many Medicaid EPs might be upgrading
or implementing new CEHRT in 2019. However, Medicaid EPs frequently
upgrade or implement new CEHRT, regardless of the reporting year.
Regardless of what CEHRT the EP used during the eCQM reporting period,
the data that Medicaid EPs are required to report for eCQMs is a
snapshot based on the data within the CEHRT, taken at the time of
attestation, for the reporting period. Medicaid EPs are only
responsible for reporting exactly the data that their CEHRT produces.
As certified, 2015 Edition CEHRT should accurately calculate and report
the eCQM data for the full reporting period, in accordance with the
relevant certification requirements at 45 CFR 170.315(c), even if that
2015 Edition CEHRT was not implemented for the entire reporting period.
Vendors should ensure that their CEHRT is performing in accordance with
relevant 2015 Edition Certification requirements as defined by the
Office of the National Coordinator for Health IT. The reporting process
for EPs should be no different regardless of the length of the
reporting period.
After careful consideration of the comments, we are finalizing
without change our proposal that the eCQM reporting period for EPs in
the Medicaid Promoting Interoperability Program will be a full CY in
2019 for EPs who have demonstrated meaningful use in a prior year, in
order to align with the corresponding performance period in MIPS for
the quality performance category. The eCQM reporting period for
Medicaid EPs demonstrating meaningful use for the first time, which was
established in the Stage 3 final rule, will remain any continuous 90-
day period (80 FR 62892).
3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting
Period in 2021 for EPs Participating in the Medicaid Promoting
Interoperability Program
In the July 28, 2010 final rule titled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program'' at 75 FR 44319,
we established that, in accordance with section 1903(t)(4)(A)(iii) of
the Act, in no case may any Medicaid EP receive an incentive after 2021
(see Sec. 495.310(a)(2)(v)). Therefore, December 31, 2021 is the last
date that states could make Medicaid Promoting Interoperability Program
payments to Medicaid EPs (other than pursuant to a successful appeal
related to 2021 or a prior year).
For states to make payments by that deadline, there must be
sufficient time after EHR and eCQM reporting periods end for Medicaid
EPs to attest to states, for states to conduct their prepayment
processes, and for states to issue payments. Therefore, we proposed to
amend Sec. 495.4 to provide that the EHR reporting period in 2021 for
all EPs in the Medicaid Promoting Interoperability Program would be a
minimum of any continuous 90-day period within CY 2021, provided that
the end date for this period falls before October 31, 2021, to help
ensure that the state can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021. Similarly, we proposed
to change the eCQM reporting period in 2021 for EPs in the Medicaid
Promoting Interoperability Program to a minimum of any continuous 90-
day period within CY 2021, provided that the end date for this period
falls before October 31, 2021, to help ensure that the state can issue
all Medicaid Promoting Interoperability Program payments on or before
December 31, 2021.
We explained that we understand that the October 31, 2021 date
might not provide some states with sufficient time to process payments
by December 31,
[[Page 59705]]
2021. We also explained that we believe that states are best positioned
to determine the last possible date in CY 2021 by which the EHR or eCQM
reporting periods for Medicaid EPs must end, and the deadline for
receiving EP attestations, so that the state is able to issue all
payments by December 31, 2021. Therefore, we proposed to allow states
the flexibility to set alternative, earlier final deadlines for EHR or
eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval
from us, through their State Medicaid HIT Plans (SMHP). If a state
establishes an alternative, earlier date within CY 2021 by which all
EHR or eCQM reporting periods in CY 2021 must end, Medicaid EPs in that
state would continue to have a reporting period of a minimum of any
continuous 90-day period within CY 2021. The end date for the reporting
period would have to occur before the day of attestation, which must
occur prior to the final deadline for attestations established by their
state. We proposed to amend Sec. 495.332(f) to provide for this state
flexibility to identify an alternative date by which all EHR reporting
periods or eCQM reporting periods for Medicaid EPs in CY 2021 must end.
We believe there is no reason why a state would need to set a date
by which EHR reporting periods and eCQM reporting periods must end for
Medicaid EPs that is earlier than the day before that state's
attestation deadline for EPs. Doing so would restrict Medicaid EPs'
ability to select EHR and eCQM reporting periods. Therefore, we
proposed that any alternative deadline for CY 2021 EHR and eCQM
reporting periods set by a state may not be any earlier than the day
prior to the attestation deadline for Medicaid EPs attesting to that
state.
The following is a summary of the comments we received regarding
these proposals.
Comment: Multiple commenters stated their support for the proposal
that the EHR reporting period in 2021 for all EPs in the Medicaid
Promoting Interoperability Program would be a minimum of any continuous
90-day period within CY 2021, provided that the end date for this
period falls before October 31, 2021. They agreed that this would help
ensure that states can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021. They also stated their
support of the 90-day period for eCQM reporting, and for state
flexibility to set earlier final deadlines for EHR or eCQM reporting
periods for Medicaid EPs in CY 2021.
Response: We appreciate these comments and thank the commenters for
their input.
Comment: A commenter pointed out that the earlier in the year a
state sets the reporting period and attestation deadline, the more
burden is put on Medicaid EPs to attest after a 90 day EHR and eCQM
reporting period in 2021. They requested that we balance the burden
between states and Medicaid EPs by setting a regulatory date before
which a state could not set an attestation deadline.
Response: The commenters raise important questions about whether
burden should be reduced on state staff and systems to the disadvantage
of Medicaid EPs. Therefore, while we are finalizing the proposed
policies without change, we are considering whether to propose in
future rulemaking that no state may set a reporting period deadline for
CY 2021 that is earlier than June 30, 2021 or an attestation deadline
that is earlier than July 1, 2021. In the meanwhile, we welcome input
from states and other interested parties on whether any state would
need more than 6 months to process Medicaid EPs' attestations, perform
the required prepayment validations, and disburse incentive payments.
Comment: One commenter requested that CMS provide outreach and
educational materials to providers about the 2021 deadline, as they
anticipate confusion.
Response: We will work with State Medicaid Agencies and provider
communities to ensure that outreach and education are provided about
the final attestation deadline and the end of the program.
Comment: Some commenters requested that CMS consider making the
eCQM reporting period any 90 days within CY 2020 as well. They note
that a full year reporting period may create significant backlogs of
2020 and 2021 attestations in 2021 that may create difficulty for
states to issue payments by the statutory deadline.
Response: We understand that this is a concern. We will continue to
monitor this issue as we develop proposed rules for the Medicaid
Promoting Interoperability Program in 2020.
After careful consideration of the comments, we are finalizing our
proposal to amend Sec. 495.4 to provide that the EHR reporting period
in 2021 for all EPs in the Medicaid Promoting Interoperability Program
will be a minimum of any continuous 90-day period within CY 2021,
provided that the end date for this period falls before October 31,
2021, to help ensure that states can issue all Medicaid Promoting
Interoperability Program payments on or before December 31, 2021. We
are also finalizing our proposal to change the eCQM reporting period in
2021 for EPs in the Medicaid Promoting Interoperability Program to a
minimum of any continuous 90-day period within CY 2021, provided that
the end date for this period falls before October 31, 2021, to help
ensure that states can issue all Medicaid Promoting Interoperability
Program payments on or before December 31, 2021.
In addition, we are finalizing our proposal to allow states the
flexibility to set alternative, earlier final deadlines for EHR or eCQM
reporting periods for Medicaid EPs in CY 2021, with prior approval from
us, through their State Medicaid HIT Plan (SMHP). Any alternative
deadline for CY 2021 EHR and eCQM reporting periods set by a state may
not be any earlier than the day prior to the attestation deadline for
Medicaid EPs attesting to that state.
Although we did not address reporting periods in 2021 for eligible
hospitals in the proposed rule, we acknowledge that there will be a
similar issue if there are still hospitals eligible to receive Medicaid
Promoting Interoperability Program payments in 2021, including
Medicaid-only eligible hospitals as well as ``dually-eligible''
eligible hospitals and critical access hospitals (CAHs) (those that are
eligible for an incentive payment under Medicare for meaningful use of
CEHRT and/or subject to the Medicare payment reduction for failing to
demonstrate meaningful use of CEHRT, and are also eligible to earn a
Medicaid incentive payment for meaningful use of CEHRT). However, based
on attestation data and information from states' SMHPs regarding the
number of years states disburse Medicaid Promoting Interoperability
Program payments to hospitals, we believe that there will be no
hospitals eligible to receive Medicaid Promoting Interoperability
Program payments in 2021 due to the requirement that, after 2016,
eligible hospitals cannot receive a Medicaid Promoting Interoperability
Program payment unless they have received such a payment in the prior
fiscal year. At this time, we believe that there are no hospitals that
will be able to receive incentive payments in 2020 or 2021. We invited
comments and suggestions on whether this belief is accurate, and if
not, how we could address the issue in a manner that limits the burden
on hospitals and states. The following is a summary of the comments we
received on this issue.
Comment: One commenter stated that CMS's belief is accurate, and
that they
[[Page 59706]]
do not anticipate any hospitals to participate in program years 2020 or
2021. However, the commenter requested that CMS take into consideration
the audit and appeals process, which may result in payments made during
those years.
Response: We acknowledge that Medicaid Promoting Interoperability
Program incentive payments might still be made to hospitals after
hospitals' participation years, or even after December 31, 2021, in the
limited circumstance of a successful hospital appeal related to
participation in the Medicaid Promoting Interoperability Program in a
prior year.
We did not propose any specific policy regarding eligible hospital
reporting periods for 2021 in this rule and thus are not finalizing any
policy in this area now, but we expect to solicit additional comment on
the issue in a future proposed rule that is more specifically related
to hospital payment.
4. Revisions to Stage 3 Meaningful Use Measures for Medicaid EPs
a. Change to Objective 6 (Coordination of Care Through Patient
Engagement)
In the Stage 3 final rule, we adopted a phased approach under Stage
3 for EP Objective 6 (Coordination of care through patient engagement),
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure
Electronic Messaging). This phased approach established a 5 percent
threshold for both measures 1 and 2 of this objective for an EHR
reporting period in 2017. (80 FR 62848 through 62849) In the same rule,
we established that the threshold for Measure 1 would rise to 10
percent, beginning with the EHR reporting period in 2018, and that the
threshold for Measure 2 would rise to 25 percent, beginning with the
EHR reporting period in 2018. We stated that we would continue to
monitor performance on these measures to determine if any further
adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR
38493), we established a policy allowing EPs, eligible hospitals, and
CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination
of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in
CY 2018, and depending on which Edition(s) they use, to attest to the
Modified Stage 2 objectives and measures or the Stage 3 objectives and
measures. In doing so, we also delayed the rise of the Objective 6
Measure 1 and Measure 2 thresholds until 2019.
We explained that based on feedback we have received, we understand
that these two measures are the largest barrier to successfully
demonstrating meaningful use, especially in rural areas and at safety
net clinics. Stakeholders have reported a variety of causes that have
resulted in lower patient participation than was anticipated when the
Stage 3 final rule was issued. The data that we have collected via
states for Medicaid EPs and at CMS from Medicare EPs for previous
program years support this feedback. The primary issue is that the
view, download, transmit measure requires a positive action by
patients, which cannot be controlled by an EP. Medicaid populations
that are at the greatest risk have lower levels of internet access,
internet literacy and health literacy than the general population.
Although the Secure Electronic Messaging measure does not require
patient action, only that the EP send a secure message, we have
received feedback that this functionality is not highly utilized by
patients. Although we encourage Medicaid EPs to continue to reach out
to patients via secure messaging to engage them in their health care
between office visits, it is not productive for EPs to send messages to
patients who are unlikely to see them or take action. Retaining the
current threshold of 5 percent for both measures would continue to
incentivize Medicaid EPs to engage patients in their own care without
raising the requirements to unattainable thresholds for EPs who serve
vulnerable Medicaid patients. Therefore, we proposed to amend Sec.
495.24(d)(6)(i) such that the thresholds for Measure 1 (View, Download,
or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful
Use Stage 3 EP Objective 6 (Coordination of care through patient
engagement) would remain 5 percent for 2019 and subsequent years.
The following is a summary of the comments we received on this
proposal.
Comment: The majority of commenters stated that they support CMS's
proposal for the Objective 6 threshold to remain at 5 percent for the
remainder of the Medicaid Promoting Interoperability Program, and that
raising the thresholds would place undue burden on EPs.
Response: We thank the many commenters who stated their support.
Comment: One commenter stated that certain populations,
specifically older adults, may struggle to engage with technology,
which created challenges for health care providers and recommended
giving special consideration to health care providers who struggle to
meet this objective.
Response: We understand that some Medicaid EPs struggle to meet the
objective due to factors outside of their control. However, this
comment further supports our decision to keep the Objective 6 threshold
at 5 percent rather than increasing it, as would happen without this
rule change.
Comment: Several commenters noted that the Medicaid Promoting
Interoperability Program and the Medicare Promoting Interoperability
category of MIPS are still not fully aligned, and that this creates
reporting burdens for providers. These commenters requested further
alignment, between these two Objective 6 measures, which were proposed
for removal under MIPS, as well as more broadly between the two
programs.
Response: We agree that alignment of MIPS and the Medicaid
Promoting Interoperability Program, to the degree practicable, is
advantageous. The greater the discrepancy between the program
requirements, the greater the reporting burden on health care providers
who participate in both programs. We are finalizing our proposed
changes to the Objective 6 measures without change, because we
anticipate that doing so will reduce Medicaid EP burden. However,
especially in light of these comments, we will also consider proposing
further changes to the Medicaid Promoting Interoperability Program in
future rulemaking, to improve alignment with the objectives and
measures under the MIPS program. In the meanwhile, we welcome input
from the public on this topic, and on additional ways that CMS can
improve alignment between the two programs.
In addition, we note that the change from the Modified Stage 2
objectives and measures will make this objective easier for Medicaid
EPs to meet. There are three measures under ``Objective 6: Coordination
of Care through Patient Engagement.'' To be a meaningful EHR user, an
EP must attest to all three measures, but only meet the thresholds for
two of those three. Under Modified Stage 2, both Measure 1 (View,
Download, or Transmit) and Measure 2 (Secure Electronic Messaging) were
required (but not under the same objective) and Measure 3 was not an
option. Both Measure 2 and Measure 3 do not rely on any patient action,
but only require Medicaid EPs' action.
After reviewing the comments, we are finalizing without change the
proposal to amend Sec. 495.24(d)(6)(i) so that the thresholds for
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure
Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6
(Coordination of care through patient engagement) will remain 5 percent
for 2019 and subsequent years.
[[Page 59707]]
b. Change to the Syndromic Surveillance Reporting Measure
In the proposed rule, we explained that in the Stage 3 final rule,
we established that the syndromic surveillance reporting measure for
EPs was limited to those who practice in urgent care settings (80 FR
62866 through 62870). Since then, we have received feedback from states
and public health agencies that while many are unable to accept non-
emergency or non-urgent care ambulatory syndromic surveillance data
electronically, some public health agencies can and do want to receive
data from health care providers in non-urgent care settings. We also
explained that we believe that public health agencies that set the
requirements for data submission to public health registries are in a
better position to judge which health care providers can contribute
useful data.
Therefore, we proposed to amend Sec. 495.24(d)(8)(i)(B)(2), EP
Objective 8 (Public health and clinical data registry reporting),
Measure 2 (Syndromic surveillance reporting measure), to amend the
language restricting the use of syndromic surveillance reporting for
meaningful use only to EPs practicing in an urgent care setting. We
proposed to include any EP defined by the state or local public health
agency as a provider who can submit syndromic surveillance data. This
change would not alter the exclusion for this measure at Sec.
495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health
care providers from which ambulatory syndromic surveillance data is
collected by their jurisdiction's syndromic surveillance system, as
defined by the state or local public health agency. Furthermore, we did
not propose to create any requirements for syndromic surveillance
registries to include all EPs. Additionally, we noted that under the
specifications for the 2015 Edition of CEHRT for syndromic
surveillance, it is possible that an EP could own CEHRT and submit
syndromic surveillance in a format that is not accepted by the local
jurisdiction. In this case, the EP may take an exclusion for syndromic
surveillance.
The following is a summary of the comments we received on this
proposal.
Comment: Several commenters stated their support of our proposal to
include any EP defined by the state or local public health agency as a
provider who can submit syndromic surveillance data.
Response: We thank the commenters for their support.
After careful consideration of the comments, we are finalizing
without change our proposal to amend Sec. 495.24(d)(8)(i)(B)(2), EP
Objective 8 (Public health and clinical data registry reporting),
Measure 2 (Syndromic surveillance reporting measure), to amend the
language restricting the use of syndromic surveillance reporting for
meaningful use only to EPs practicing in an urgent care setting. The
new objective will also include any other setting from which ambulatory
syndromic surveillance data are collected by the state or local public
health agency. This change does not alter the exclusion for this
measure at Sec. 495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a
category of health care providers from which ambulatory syndromic
surveillance data is collected by their jurisdiction's syndromic
surveillance system, as defined by the state or local public health
agency. Furthermore, this does not create any requirements for
syndromic surveillance registries to include all EPs. Additionally,
under the specifications for the 2015 Edition of CEHRT for syndromic
surveillance, it is possible that an EP could own CEHRT and submit
syndromic surveillance in a format that is not accepted by the local
jurisdiction. In this case, the EP may take an exclusion for syndromic
surveillance.
F. Medicare Shared Savings Program
As required under section 1899 of the Act, we established the
Medicare Shared Savings Program (Shared Savings Program) to facilitate
coordination and cooperation among health care providers to improve the
quality of care for Medicare fee-for-service (FFS) beneficiaries and
reduce the rate of growth in expenditures under Medicare Parts A and B.
Eligible groups of providers and suppliers, including physicians,
hospitals, and other health care providers, may participate in the
Shared Savings Program by forming or participating in an Accountable
Care Organization (ACO). The final rule establishing the Shared Savings
Program appeared in the November 2, 2011 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the
``November 2011 final rule'')). A subsequent major update to the
program rules appeared in the June 9, 2015 Federal Register (Medicare
Program; Medicare Shared Savings Program: Accountable Care
Organizations; Final Rule (80 FR 32692) (hereinafter referred to as the
``June 2015 final rule'')). The final rule entitled, ``Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Revised Benchmark Rebasing Methodology, Facilitating
Transition to Performance-Based Risk, and Administrative Finality of
Financial Calculations,'' which addressed changes related to the
program's financial benchmark methodology, appeared in the June 10,
2016 Federal Register (81 FR 37950) (hereinafter referred to as the
``June 2016 final rule'')).
In August 2018, we issued the ``Medicare Program: Medicare Shared
Savings Program; Accountable Care Organizations--Pathways to Success''
proposed rule (hereinafter referred to as the ``August 2018 proposed
rule'') which addressed a number of proposed policy changes including
redesign of the participation options available under the program to
encourage ACOs to transition to two-sided models; new tools to support
coordination of care across settings and strengthen beneficiary
engagement; revisions to ensure rigorous benchmarking; and policies
promoting use of interoperable electronic health record technology
among ACO providers/suppliers (83 FR 41786). In section V. of this
final rule, we are finalizing the following proposals from the August
2018 proposed rule:
A voluntary 6-month extension for existing ACOs whose
participation agreements expire on December 31, 2018 and the
methodology for determining financial and quality performance for this
6-month performance year from January 1, 2019, through June 30, 2019;
Policies implementing the Bipartisan Budget Act of 2018
provisions on voluntary alignment;
Modifications to the definition of primary care services
used in assigning beneficiaries to ACOs to reflect recent code changes;
Extension of policies providing relief for ACOs and their
clinicians impacted by extreme and uncontrollable circumstances during
2017 to performance year 2018 and subsequent years; and
Policies to promote interoperability among ACO providers/
suppliers, including establishing a new program eligibility requirement
regarding CEHRT use and retiring the CEHRT quality measure (ACO-11).
We expect to address the remaining proposals in the August 2018
proposed rule in a forthcoming final rule.
We have also made use of the annual calendar year (CY) PFS rules to
address quality reporting for the Shared Savings Program and certain
other issues. In the CY 2018 PFS final rule (82 FR 53209 through
53226), we finalized revisions to several different policies under the
[[Page 59708]]
Shared Savings Program, including the assignment methodology, quality
measure validation audit process, use of the skilled nursing facility
(SNF) 3-day waiver, and handling of demonstration payments for purposes
financial reconciliation and establishing historical benchmarks. In
addition, in the CY 2017 and CY 2018 Quality Payment Program final
rules (81 FR 77255 through 77260, and 82 FR 53688 through 53706,
respectively), we finalized policies related to the Alternative Payment
Model (APM) scoring standard under the Merit-Based Incentive Payment
System (MIPS), which reduces the reporting burden for MIPS eligible
clinicians who participate in MIPS APMs, such as the Shared Savings
Program, by: (1) Using the CAHPS for ACOs survey and the ACO reported
CMS Web Interface quality data for purposes of assessing quality
performance in the Shared Savings Program and to score the MIPS quality
performance category for these eligible clinicians; (2) automatically
awarding MIPS eligible clinicians participating in Shared Savings
Program ACOs a minimum of one-half of the total points in the MIPS
improvement activities performance category; (3) requiring ACO
participants to report Advancing Care Information (ACI) data at the
group practice level or solo practitioner level; and (4) not assessing
MIPS eligible clinicians on the MIPS cost performance category because,
through their participation in the ACO, they are already being assessed
on cost and utilization under the Shared Savings Program.
As a general summary, in the CY 2019 PFS proposed rule, we proposed
the following changes to the quality performance measures that will be
used to assess quality performance under the Shared Savings Program for
performance year 2019 and subsequent years:
Changes to Patient Experience of Care Survey measures.
Changes to CMS Web Interface and Claims-Based measures.
In addition, in the August 2018 proposed rule, we proposed another
change to the Shared Savings Program quality measure set, which we are
finalizing in section V.B.2.f. of this final rule. We proposed to
remove the ACO-11--Use of Certified EHR Technology measure (83 FR 41908
through 41911). We refer readers to section V.B.2.f. of this final rule
for a description of that proposal and a discussion of related public
comments.
1. Quality Measurement
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both.
In the November 2011 final rule, we established a quality measure set
spanning four domains: Patient experience of care, care coordination/
patient safety, preventive health, and at-risk population (76 FR 67872
through 67891). Since the Shared Savings Program was established, we
have updated the measures that comprise the quality performance measure
set for the Shared Savings Program through the annual rulemaking in the
CY 2015, 2016, and 2017 PFS final rules (79 FR 67907 through 67920, 80
FR 71263 through 71268, and 81 FR 80484 through 80489, respectively).
As we stated in the November 2011 final rule establishing the
Shared Savings Program (76 FR 67872), our principal goal in selecting
quality measures for ACOs has been to identify measures of success in
the delivery of high-quality health care at the individual and
population levels, with a focus on outcomes. For performance year 2018,
31 quality measures will be used to determine ACO quality performance
(81 FR 80488 and 80489). The information used to determine ACO
performance on these quality measures will be submitted by the ACO
through the CMS Web Interface, submitted by ACO participant TINs to
MIPS for the Promoting Interoperability (PI) performance category
(formerly Advancing Care Information), calculated by CMS from
administrative claims data, and collected via a patient experience of
care survey referred to as the Consumer Assessment of Healthcare
Provider and Systems (CAHPS) for ACOs Survey. The CAHPS for ACOs survey
is based on the Clinician and Group Consumer Assessment of Healthcare
Providers and Systems (CG-CAHPS) Survey and includes additional,
program specific questions that are not part of the CG-CAHPS. The CG-
CAHPS survey is maintained, and periodically updated, by the Agency for
Healthcare Research and Quality (AHRQ) in HHS.
The quality measures collected through the CMS Web Interface in
2015 and 2016 were used to determine whether eligible professionals
participating in an ACO would avoid the PQRS and automatic Physician
Value-Based Payment Modifier (Value Modifier) downward payment
adjustments for 2017 and 2018 and to determine if ACO participants were
eligible for upward, neutral or downward adjustments based on quality
measure performance under the Value Modifier. Beginning with the 2017
performance period, which impacts payments in 2019, PQRS and the Value
Modifier were replaced by the MIPS. Eligible clinicians who are
participating in an ACO and who are subject to MIPS (MIPS eligible
clinicians) will be scored under the APM scoring standard under MIPS
(81 FR 77260). These MIPS eligible clinicians include any eligible
clinicians who are participating in an ACO in a track of the Shared
Savings Program that is not an Advanced APM, as well as those
participating in an ACO in a track that is an Advanced APM, but who do
not become Qualifying APM Participants (QPs) as specified in Sec.
414.1425, and are not otherwise excluded from MIPS. Beginning with the
2017 reporting period, measures collected through the CMS Web Interface
will be used to determine the MIPS quality performance category score
for MIPS eligible clinicians participating in a Shared Savings Program
ACO. Starting with the 2018 performance period, the quality performance
category under the MIPS APM Scoring Standard for MIPS eligible
clinicians participating in a Shared Savings Program ACO will include
measures collected through the CMS Web Interface and the CAHPS for ACOs
survey measures.
The CAHPS for ACOs Survey includes the core questions contained in
the CG-CAHPS, plus additional questions to measure access to and use of
specialist care, experience with care coordination, patient involvement
in decision-making, experiences with a health care team, health
promotion and patient education, patient functional status, and general
health. The 2018 CAHPS for ACOs Survey 3.0 incorporates updates made by
AHRQ to the CG-CAHPS survey based on feedback from survey users and
stakeholders, as well as analyses of multiple data sets. For a summary
of the history of changes to the CAHPS for ACOs survey, please refer to
the CY 2019 PFS proposed rule (83 FR 35875). Additional information on
the CG-CAHPS survey update is available on the AHRQ website at https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/about/proposed-changes-cahps-c&g-survey2015.pdf.
In addition to incorporating changes based on the AHRQ survey
update, CMS removed all items included in the
[[Page 59709]]
Summary Survey Measures (SSMs), Helping You to Take Medications as
Directed and Between Visit Communication from the 2018 survey. These
optional SSMs were not part of the scored measures. The update resulted
in a reduction in the number of survey questions from 80 to 58. The
CAHPS for ACOs SSMs that contribute to the ACO performance score for
performance year 2018, as finalized in the CY 2017 PFS final rule (81
FR 80488) are as follows: Getting Timely Care, Appointments &
Information; How Well Your Providers Communicate; Patients' Rating of
Provider; Access to Specialists; Health Promotion and Education; Shared
Decision Making; Health Status & Functional Status; and Stewardship of
Patient Resources. In addition, the core survey includes SSMs on Care
Coordination and Courteous & Helpful Office Staff. However, because
these measures are not included in the Shared Savings Program quality
measure set for 2018, scores for these measures will be provided to
ACOs for informational purposes only and will not be used in
determining the ACOs' quality scores.
b. Proposals for Changes to the CAHPS Measure Set
To enhance the Patient/Caregiver Experience domain and align with
MIPS (82 FR 54163), we proposed to begin scoring the 2 SSMs that are
currently collected with the administration of the CAHPS for ACOs
survey and shared with the ACOs for informational purposes only. Under
this proposal, we would add the following CAHPS for ACOs SSMs that are
already collected and provided to ACOs for informational purposes to
the quality measure set for the Shared Savings Program as ACO-45,
CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care
Coordination. These measures would be scored and included in the ACO
quality determination starting in 2019. Both of these SSMs are
currently designated by AHRQ as CG CAHPS core measures.
The Courteous and Helpful Office Staff SSM, which we proposed to
add as ACO-45, asks about the helpfulness, courtesy and respectfulness
of office staff. This SSM has been a CG-CAHPS core measure in the
previous two versions of the CG-CAHPS survey, but was previously
provided for informational purposes only and not included in the ACO
quality score determination. We also proposed to add the SSM, CAHPS:
Care Coordination to the CAHPS for ACOs measures used in ACO quality
score determination as ACO-46. The Care Coordination SSM asks questions
about provider access to beneficiary information and provider follow-
up. This SSM was designated a core measure in the most recent version
of the CG-CAHPS survey.
Including these measures in the quality measure set that is used to
assess the quality performance of ACOs under the Shared Savings Program
would place greater emphasis on outcome measures and the voice of the
patient and provide ACOs with an additional incentive to act upon
opportunities for improved care coordination and communication, and
would align with the MIPS measure set finalized in the CY 2018 Quality
Payment Program final rule (82 FR 54163). Care Coordination and patient
and caregiver engagement are goals of the Shared Savings Program. The
Care Coordination SSM emphasizes the care coordination goal, while the
Courteous and Helpful Office Staff SSM supports patient engagement as
it addresses a topic that has been identified as important to
beneficiaries in testing. For performance year 2016, the mean
performance rates across all ACOs for these two measures, which were
not included in the ACO quality score determination, were 87.18 for the
Care Coordination SSM and 92.12 for Courteous and Helpful Office Staff
SSM.
Consistent with Sec. 425.502(a)(4), regarding the scoring of newly
introduced quality measures, we proposed that these additional SSMs
would be pay-for-reporting for all ACOs for 2 years (performance years
2019 and 2020). The measures would then phase into pay-for-performance
in the program, according to the schedule in Table 26 beginning in
performance year 2021. We solicited comment on this proposed change to
the quality measure set.
The following is a summary of the comments we received on this
proposed change to the CAHPS measures included in the Shared Savings
Program quality measure set.
Comment: The majority of commenters supported our proposal. Several
commenters noted that ACOs have had experience with these measures for
some time now and that patient experience measures help to keep
providers accountable for patient-centered care. A few commenters
indicated support for the proposal but noted reservations, including
the potentially limited ability of ACOs that include independent
physician groups and hospitals as ACO participants to impact
performance on ACO-45, a concern that the subjectivity of the CAHPS for
ACOs measures (especially ACO-45) may put too much emphasis on aspects
of care that have little effect on quality outcomes, and a
recommendation to consider expanding ACO-45 (Courteous and Helpful
Office Staff) to include medical assistants and nurses. Some commenters
recommended delaying implementation of the proposal. A commenter
suggested that we work with the Core Quality Measures Collaborative
(CQMC) to re-evaluate the ACO quality measures, before implementing
this proposed change. Another commenter recommended that we streamline
the Shared Savings Program quality measure set. In addition, one
commenter noted its support in principle for adding a quality measure
to assess patients' experience with office staff, but indicated that
adding a measure with a high average performance rate seems unnecessary
for improving care.
Response: We believe that adding ACO-45 CAHPS: Courteous and
Helpful Office Staff puts greater emphasis on the voice of the patient
and provides ACOs with an additional incentive to act upon
opportunities for improved communication. With regard to the comment
that ACOs that include independent physician groups and hospitals as
ACO participants may not be able to influence the outcomes of ACO-45
CAHPS: Courteous and Helpful Office Staff, we note that this SSM has
been provided for informational purposes as part of the CAHPS for ACO
survey for several years. Therefore, we believe ACOs have had
sufficient experience with the SSM and have had the opportunity to
monitor the survey results and make improvements, as needed. Scoring
this measure would also provide ACOs with a stronger incentive to
improve performance on this measure that has been identified as
important by the beneficiaries they serve. We would also re-emphasize
that measures newly added to the scored measures set will be pay-for-
reporting for the first 2 years after inclusion, giving ACOs additional
time to work toward improvement. With regard to the concern that the
proposed new CAHPS measures do not impact quality outcomes, we
disagree. We consider the patient's experience of care to be a quality
outcome. We also note that the Courteous and Helpful Office Staff
measure focuses on an issue that has been identified as important to
beneficiaries in testing and that the Care Coordination SSM addresses a
primary objective of the Shared Savings Program. With regard to
commenters' suggestions that we delay implementation of the proposal to
score these measures, including the suggestion that we work with the
CQMC
[[Page 59710]]
to re-evaluate the ACO quality measures first, we disagree with
delaying the scoring of these important SSMs. These measures assess
performance in areas that the beneficiaries served by ACOs have
identified as valuable and that are central to the fundamental purpose
of the Shared Savings Program to promote care coordination and improve
quality of care. Again, we note that the newly-scored measures would be
pay-for-reporting for the first 2 years after their addition, giving
ACOs additional time to become familiar with them before the
performance rates are considered in scoring. In response to the
commenter's suggestion that we streamline the Shared Savings Program
quality measure set, we do not have plans at this time to reduce the
number of CAHPS measures for which ACOs are held accountable. The two
CAHPs measures we proposed to add to the quality measure set for
scoring purposes are already being collected and reported to ACOs for
informational purposes; thus, the addition of these measures should not
result in significant additional burden on ACOs. Moreover, we note that
overall, we are reducing the total number of quality measures in the
ACO quality measure set, as detailed below and summarized in Table 26
of this final rule.
With regard to the comment supporting the intent of our proposal to
start scoring performance on the Courteous and Helpful Office Staff
measure, but stating that it is unnecessary to add a measure with a
high average performance rate, we believe that this is an important
area for continued measurement as beneficiaries have expressed its
importance to them in testing, as noted previously. In addition, we
believe it is important to continue monitoring this measure because it
is an important factor in patient experience of care. By scoring this
measure, we acknowledge its continued importance as a patient
experience measure. With regard to the comment that we consider
expanding ACO-45 to include medical assistants and nurses, we will take
this comment under consideration for further analysis as part of any
potential future measure refinement.
After considering the comments, we are finalizing our proposal to
begin scoring ACO-45 and ACO-46 as part of the CAHPS for ACO survey
beginning with quality reporting for performance years during 2019.
Consistent with our existing policy regarding the scoring of newly
introduced quality measures, these additional SSMs will be pay-for-
reporting for all ACOs for 2 years (performance years during 2019 and
performance year 2020). The measures would then phase into pay-for-
performance beginning in performance year 2021 (Sec. 425.502(a)(4)).
The phase-in schedule for the 2019 ACO quality measures set that we are
finalizing in this rule is presented in Table 26.
Additionally, we solicited comment on potentially converting the
Health and Functional Status SSM (ACO-7) to pay-for-performance in the
future. The Health and Functional Status SSM is currently pay-for-
reporting for all years. We have not scored this measure because the
scores on the Health and Functional Status SSM may reflect the
underlying health of beneficiaries seen by ACO providers/suppliers as
opposed to the quality of the care provided by the ACO. We also sought
stakeholder feedback on possible options for enhancing the collection
of health and functional status data, including potentially changing
our data collection procedures to collect data from the same ACO's
assigned beneficiaries over time. We noted that such a change could
allow for measurement of functional status changes that occurred while
beneficiaries were receiving care from ACO providers/suppliers. We also
solicited other recommendations regarding the potential inclusion of a
functional status measure in the assessment of ACO quality performance
in the future.
The following is a summary of the comments we received regarding
potentially converting the Health and Functional Status SSM (ACO-7) to
pay-for-performance in the future.
Comment: The majority of commenters opposed including ACO-7--Health
and Functional Status as a pay-for-performance measure in future years,
noting that the measure is largely outside of the physician's control.
Some commenters were supportive of including a Health and Functional
Status measure as pay-for-performance, but expressed concerns with
inclusion of the measure as it is currently structured. For example,
one commenter stated that the current structure of the SSM captures
patient health and functional status at a single point in time but not
as a change in status over time. A number of commenters emphasized this
point, noting that a lack of baseline data for this measure for the
ACO-assigned beneficiary population means the results cannot be
attributed to ACOs. One commenter acknowledged the potential for
collecting longitudinal data, but questioned the effectiveness of this
approach given that ACOs may not have the same beneficiaries assigned
over multiple years. Another commenter expressed concern regarding the
lack of benchmark information against which ACOs might measure their
performance to date. A commenter encouraged CMS to conduct analyses
using existing CAHPS data to identify models that allow for a fair
comparison across ACOs. Another commenter suggested an approach to
scoring health and functional status using another survey instrument
(such as Patient Reported Outcomes Measurement Information System), or
collecting baseline data for an ACO and implementing adjustments to
account for differences in patient mix across ACOs.
Response: We appreciate the comments. We agree that additional
analytic work would be needed in order to assess the potential
implications of adding a scored health and functional status measure to
the ACO quality measure set in the future. As we plan for future
updates and changes to the Shared Savings Program measure set, we will
consider this feedback from commenters further before making any
proposal to begin scoring ACO-7--Health and Functional Status or to
include a different scored heath and functional status measure.
Comment: We also received a few general comments on the
applicability of the CAHPS for ACOs SSM to institutional providers,
including a comment that raised concerns about low response rates and
low reliability of the results.
Response: We made no proposals to adjust the application of the
CAHPS for ACOs survey for any specific provider types under the Shared
Savings Program. The CAHPS for ACO survey is focused on beneficiaries'
experience of care received from clinicians in ambulatory care
settings. Consequently, we note that CMS currently excludes
beneficiaries from CAHPS sampling if 100 percent of their primary care
service visits were performed in an institutional setting (as
determined using HCPCS codes). However, after reviewing our current
CAHPS sampling process, starting with the CAHPS sample for performance
year 2018, we will also begin excluding beneficiaries if their last
primary care service visit (as determined using HCPCS codes) during the
sampling timeframe was performed in an institutional setting. We
believe this change will help to ensure that beneficiaries who are
residing in institutional settings are appropriately excluded from
CAHPS sampling. Patient experience is a key component of quality
measurement under the Shared Savings Program, and at this time we do
not have plans to provide exemptions from patient experience measures
for
[[Page 59711]]
specific ACOs. We will monitor this issue, and may in the future
consider whether additional changes to measures of patient experience
would be appropriate moving forward, based on the goals and priorities
of the Shared Savings Program.
c. Proposed Changes to the CMS Web Interface and Claims-Based Quality
Measure Sets
In developing the proposals we made in the CY 2019 PFS proposed
rule, we considered the agency's efforts to streamline quality
measures, reduce regulatory burden and promote innovation as part of
the agency's Meaningful Measures initiative (see CMS Press Release, CMS
Administrator Verma Announces New Meaningful Measures Initiative and
Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October
30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). As noted in the proposed rule, under the Meaningful Measures
initiative, we have committed to assessing only those core issues that
are most vital to providing high-quality care and improving patient
outcomes, with the aim of focusing on outcome-based measures, reducing
unnecessary burden on providers, and putting patients first. In
considering the quality reporting requirements under the Shared Savings
Program, we also considered the quality reporting requirements under
other initiatives, such as the MIPS and Million Hearts Initiative, and
consulted with the measures community to ensure that the specifications
for the measures used under the Shared Savings Program are up-to-date
with current clinical guidelines, focus on outcomes over process,
reflect agency and program priorities, and reduce reporting burden.
Since the Shared Savings Program was first established in 2012, we
have updated the quality measure set to reduce reporting burden and
focus on more meaningful, outcome-based measures. The most recent
updates to the Shared Savings Program quality measure set were made in
the CY 2017 PFS final rule (81 FR 80484 through 80489) to adopt the ACO
measure recommendations made by the Core Quality Measures
Collaborative, a multi-stakeholder group with the goal of aligning
quality measures for reporting across public and private initiatives to
reduce provider reporting burden. Currently, more than half of the 31
Shared Savings Program quality measures are outcome-based, including:
Patient-reported outcome measures collected through the
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
Outcome measures supporting effective communication and
care coordination, such as unplanned admission and readmission
measures.
Intermediate outcome measures that address the effective
treatment of chronic disease, such as hemoglobin A1c control for
patients with diabetes.
In the CY 2019 PFS proposed rule, we proposed to reduce the total
number of measures in the Shared Savings Program quality measure set.
The proposals were intended to reduce the burden on ACOs and their
participating providers and suppliers by lowering the number of
measures they are required to report through the CMS Web Interface and
on which they are assessed using claims data. Reducing the number of
measures on which ACOs are assessed would reduce the number of
performance metrics that they are required to track and eliminate
redundancies between measures that target similar populations. The
proposed reduction in the number of measures would enable ACOs to
better utilize their resources toward improving patient care. The
proposed reduction in the number of measures would further reduce
burden by aligning with the proposed changes to the CMS Web Interface
measures that are reported under MIPS as discussed in Tables A, C, and
D of Appendix 1: Proposed MIPS Quality Measures of the proposed rule.
We recognize that ACOs and their participating providers and suppliers
dedicate resources to performing well on our quality metrics, and we
believe that reducing the number of metrics and aligning them across
programs would allow them to more effectively target those resources
toward improving patient care. We proposed to reduce the number of
measures by minimizing measure overlap and eliminating several process
measures. The proposal to remove process measures also aligns with our
proposal to reduce the number of process measures within the MIPS
measure set as discussed in section III.H.b.iii of this final rule and
would support the CMS goal of moving toward outcome-based measurement.
We proposed to retire the following claims-based quality measures,
which have a high degree of overlap with other measures that would
remain in the measure set:
ACO-35--Skilled Nursing Facility 30-Day All-Cause
Readmission Measure (SNFRM).
ACO-36--All-Cause Unplanned Admissions for Patients with
Diabetes.
ACO-37--All-Cause Unplanned Admission for Patients with
Heart Failure.
Within the claims-based quality measures, a high degree of overlap
exists between measures with respect to the population being measured
(the denominator), because a single admission may be counted in
multiple measures. For example, ACO-35 addresses unplanned readmissions
from a SNF, and the vast majority of these SNF readmissions are also
captured in the numerator of ACO-8 Risk-Standardized All Condition
Readmission. Similarly, ACO-36 and ACO-37 address unplanned admissions
for patients with diabetes and heart failure and most of these
admissions are captured in the numerator of ACO-38 Risk-Standardized
Acute Admission Rates for Patients with Multiple Chronic Conditions
(please note that the measure name has been updated to align with
changes made by the measure steward). Therefore, to reduce redundancies
within the Shared Savings Program measure set, we proposed to remove
ACO-35, ACO-36, and ACO-37 from the measure set. However, because these
measures are claims-based measures and therefore do not impose any
reporting burden on ACOs, we intend to continue to provide information
to ACOs on their performance on these measures for use in their quality
improvement activities through a new quarterly claims-based quality
outcome report that ACOs began receiving in August 2018.
We also proposed to retire claims-based measure ACO-44--Use of
Imaging Studies for Low Back Pain, as this measure is restricted to
individuals 18-50 years of age, which results in low denominator rates
under the Shared Savings Program, meaning that the measure is not a
meaningful reflection of the beneficiaries cared for by Shared Savings
Program ACOs. Although this measure was originally added to the Shared
Savings Program quality measure set in order to align with the Core
Quality Measures Collaborative, we proposed to remove this measure as a
result of low denominators for many ACOs. We also indicated that
removing this measure would align ACO quality measurement with the MIPS
requirements as this measure was removed for purposes of reporting
under the MIPS program in the CY 2018 Quality Payment Program final
rule (82 FR 54159). However, in recognition of the value in providing
feedback to providers on potential overuse of diagnostic procedures, we
noted that we intended to continue to provide ACOs feedback on
performance on this
[[Page 59712]]
measure as part of the new quarterly claims based quality report.
We welcomed public comment on our proposal to retire these 4
claims-based measures from the quality measure set.
The following is a summary of the comments we received on our
proposal to retire ACO-35--Skilled Nursing Facility 30-Day All-Cause
Readmission Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for
Patients with Diabetes, and ACO-37--All-Cause Unplanned Admission for
Patients with Heart Failure from the quality measure set.
Comment: The majority of commenters supported our proposal to
remove these measures stating that they appreciated our efforts to
modernize the quality measurement requirements and reduce measure
overlap. However, a commenter who supported our proposal cautioned,
``that there may be a tipping point at which the choice of measures
becomes too narrowed. . . .'' Another commenter expressed concern that
diabetes is not included as one of the multiple chronic conditions for
purposes of ACO-38--All-Cause Unplanned Admissions for Patients with
Multiple Chronic Conditions (MCC). The commenter noted that the
retirement of ACO-36--All-Cause Unplanned Admissions for Patients with
Diabetes, without an adequate alternative to measure performance in
this area could cause a potential decline in provider performance and
care quality. This commenter emphasized that reducing admission rates
of diabetic patients should be a shared goal and priority of CMS and
ACOs. Another commenter asked if we considered adding diabetes as a
qualifying condition for ACO-38.
Response: We acknowledge the concerns raised by commenters with
respect to the proposed removal of ACO-36 All-Cause Unplanned
Admissions for Patients with Diabetes. However, we disagree with the
commenter who stated that without a comparable diabetes measure to
replace ACO-36 there would be a decline in provider performance and
care quality. An analysis of ACO data from the 2015 performance year
found that, as a result of the other comorbidities included for
purposes of ACO-38, 48 percent of assigned ACO beneficiaries included
in the diabetes measure were also included in the MCC measure. Measure
overlap was even higher when considering the number of unplanned
admissions shared by the two measures. Almost three-fourths (73
percent) of the unplanned admissions for assigned ACO beneficiaries
under ACO-36 were also unplanned admissions for purposes of ACO-38, and
thus were counted in both measures. In addition, we note that the
Shared Savings Program measure set still includes a diabetes measure
that monitors Hemoglobin A1c control (ACO-27: Diabetes Hemoglobin A1c
(HbA1c) Poor Control (9%)) which is reported via the CMS Web
Interface. Consequently, we believe that removing ACO-36 will not
negatively impact patients with diabetes as the majority of
readmissions for these patients are captured by ACO-38. In addition, we
note that we plan to continue providing metrics on ACO-36 and ACO-37 in
the quarterly claims-based measure reports for informational purposes
only, which will allow ACOs to continue to monitor their results for
these metrics. We are not considering revisions to add diabetes as a
qualifying condition for ACO-38 at this time, but we will consider any
changes to the ACO-38 cohort during the annual measure update. In
response to the comment that there may be a point at which the measure
set becomes too narrow, we understand the concern and will continue to
carefully consider the balance between burden reduction and meaningful
measurement in order to retain a sufficiently robust measure set
against which ACO performance can be measured.
After considering the comments, we are finalizing our proposal to
remove ACO-35--Skilled Nursing Facility 30-Day All-Cause Readmission
Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for Patients
with Diabetes, and ACO-37--All-Cause Unplanned Admission for Patients
with Heart Failure from the Shared Savings Program quality measure set
effective for quality reporting for performance years during 2019.
The following is a summary of the comments we received on our
proposal to retire ACO-44--Use of Imaging Studies for Low Back Pain
from the quality measure set.
Comment: A majority of commenters supported our proposal stating
that they agreed the measure should be removed due to low denominators
in the Medicare population and because the measure was retired from
MIPS. MedPAC opposed the removal of this measure stating, ``According
to our analysis, imaging for patients with nonspecific low back pain
affects between 3.1 to 8.9 percent of Medicare beneficiaries.'' MedPAC
encouraged CMS to consider respecifying the measure to include
beneficiaries over the age of 50 and retaining the measure in the ACO
quality measure set.
Response: We appreciate the recommendation to respecify the ACO
imaging for low-back pain measure to include beneficiaries over age 50
and recognize the value of including over-utilization of care measures
in the ACO quality measure set. However, we note that CMS is not the
measure steward for this measure. We have raised the issue with the
measure steward and will continue to coordinate with the measure owner.
Additionally, we note that we proposed to remove this measure to align
ACO quality measurement with the MIPS reporting requirements as this
measure was removed from the quality measure set under the MIPS program
in the CY 2018 Quality Payment Program final rule (82 FR 54159).
After considering the comments, we are finalizing our proposal to
remove ACO-44 from the Shared Savings Program quality measure set
effective for quality reporting for performance years during 2019.
Although we proposed to retire ACO-35 Skilled Nursing Facility 30-
Day All-Cause Readmission Measure (SNFRM) from the set of quality
measures that are scored for the Shared Savings Program, we recognize
the value of measuring the quality of care furnished to Medicare
beneficiaries in SNFs. Therefore, we solicited comment on the
possibility of adding the Skilled Nursing Facility Quality Reporting
Program (SNFQRP) measure ``Potentially Preventable 30-Day Post-
Discharge Readmission Measure for Skilled Nursing Facilities'' to the
Shared Savings Program quality measure set through future rulemaking.
This measure differs from ACO-35--SNFRM, which we are removing from the
quality measure set as discussed above, as the SNFQRP measure looks
only at unplanned, potentially preventable readmissions for Medicare
FFS beneficiaries within 30 days of discharge to a lower level of care
from a SNF, while ACO-35 assesses hospital readmissions from a SNF,
that occur within 30 days following discharge from a hospital for
beneficiaries admitted to a SNF after hospital discharge. As a result,
the SNFQRP measure would have less overlap with ACO-8 (Risk-
Standardized All Cause Readmission measure) because the readmission
windows for the two measures are different. Specifically, the
readmission window for the SNFQRP measure is 30 days following
discharge from a SNF, while the readmission window for ACO-8 is 30 days
following discharge from a hospital.
The following is a summary of the comments we received on the
possibility of adding the SNFQRP measure ``Potentially Preventable 30-
Day Post-Discharge Readmission Measure for Skilled Nursing Facilities''
[[Page 59713]]
to the Shared Savings Program quality measure set through future
rulemaking.
Comment: A few commenters supported the potential inclusion of the
SNFQRP measure to the Shared Savings Program quality measure set
through future rulemaking stating that the SNFQRP measure would
potentially add more value to the Shared Savings Program measure set
than ACO-35 as it is more targeted. Additionally, a few commenters
suggested that we should test the measure in the ACO population and
consider risk-adjusting the measure for sociodemographic factors prior
to proposing the measure for inclusion into the Shared Savings Program
quality measure set. However, the majority of commenters were opposed
to potentially adding this measure to the Shared Savings Program
quality measure set. One commenter stated that the SNFQRP measure
assumes that the ACO has input into the care processes at the SNF and
has the ability to direct patients to higher quality facilities, which
is not always the case. Another commenter stated that as the measure is
already used in the SNFQRP, they would not support inclusion in the
Shared Savings Program quality measure set because they support
avoiding the use of duplicative measures across CMS programs. Some of
the commenters further stated that they believed this measure would
still overlap with ACO-8 Risk-Standardized All Condition Readmission
measure.
Response: As we plan for future updates and changes to the Shared
Savings Program quality measure set, we will consider this feedback
prior to making any proposals regarding the SNFQRP measure.
Further, as we stated in the CY 2019 PFS proposed rule (83 FR
35877), we seek to align with changes made to the CMS Web Interface
measures under the Quality Payment Program. In the 2017 PFS final rule,
we stated that we do not believe it is beneficial to propose CMS Web
interface measures for ACO quality reporting separately (81 FR 80499).
Therefore, in order to avoid confusion and duplicative rulemaking, we
adopted a policy that any future changes to the CMS Web interface
measures would be proposed and finalized through rulemaking for the
Quality Payment Program, and that such changes would be applicable to
ACO quality reporting under the Shared Savings Program. In accordance
with the policy adopted in the CY 2017 PFS final rule (81 FR 80501), we
did not make any specific proposals related to changes in CMS Web
Interface measures reported under the Shared Savings Program. Rather,
we referred readers to Tables A, C, and D of Appendix 1: Proposed MIPS
Quality Measures in the proposed rule for a complete discussion of the
proposed changes to the CMS Web Interface measures. Based on the
changes being finalized in Tables A, C and D of Appendix 1: Finalized
MIPS Quality Measures of this final rule, ACOs will no longer be
responsible for reporting the following measures for purposes of the
Shared Savings Program starting with reporting for performance years
during 2019:
ACO-12 (NQF #0097) Medication Reconciliation Post-
Discharge.
ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older
Adults.
ACO-16 (NQF #0421) Preventive Care and Screening: Body
Mass Index (BMI) Screening and Follow Up.
ACO-41 (NQF #0055) Diabetes: Eye Exam.
ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of
Aspirin or another Antithrombotic.
We note that ACO-41 is one measure within a two-component diabetes
composite that is currently scored as one measure. The removal of ACO-
41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor Control
(>9%)) will now be assessed as an individual measure. As discussed in
section III.I.2.B.i of this final rule, lists of the measures being
finalized for purposes of MIPS are in Tables A, C and D of Appendix 1:
Finalized MIPS Quality Measures.
Additionally, we proposed to add the following measure to the CMS
Web Interface for purposes of the Quality Payment Program:
ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and
Plan of Care to Prevent Future Falls.
Based on the policies being finalized for purposes of MIPS in Table
A of Appendix 1: Finalized MIPS Quality Measures, Shared Savings
Program ACOs will not be responsible for reporting this measure
starting with quality reporting for performance years during 2019.
Table 26 shows the Shared Savings Program quality measure set for
performance years during 2019 and subsequent performance years.
BILLING CODE 4120-01-P
[[Page 59714]]
[GRAPHIC] [TIFF OMITTED] TR23NO18.040
[[Page 59715]]
[GRAPHIC] [TIFF OMITTED] TR23NO18.041
BILLING CODE 4120-01-C
In this section of this final rule, we are finalizing proposals to
eliminate 9 measures and to add 2 measures to the Shared Savings
Program quality measure set. Separately, in August 2018 proposed rule,
we also proposed to remove ACO-11--Percent of Primary Care Physicians
Who Successfully Meet Meaningful Use Requirements (83 FR 41910 and
41911). We are finalizing the removal of ACO-11 in section V.B.2.f. of
this final rule and refer readers to that section for a summary of that
proposal and a discussion of public comments related to it. The net
result of the final policies included in this final rule is a set of 23
measures on which ACOs' quality performance will be assessed for
performance years during 2019 and subsequent performance years. The 4
domains will include the following numbers of quality measures (See
Table 27):
Patient/Caregiver Experience of Care--10 measures.
Care Coordination/Patient Safety--4 measures.
Preventive Health--6 measures.
At Risk Populations--3 measures.
Table 27 provides a summary of the number of measures by domain and
the total points and domain weights that will be used for scoring
purposes under the changes to the quality measure set finalized in this
rule.
[GRAPHIC] [TIFF OMITTED] TR23NO18.042
G. Physician Self-Referral Law
1. Background
Section 1877 of the Act, also known as the physician self-referral
law: (1) Prohibits a physician from making referrals for certain
designated health services (DHS) payable by Medicare to an entity with
which he or she (or an immediate family member) has a financial
relationship (ownership or compensation), unless an exception applies;
and (2) prohibits the entity from filing claims with Medicare (or
billing another individual, entity, or third party payer) for those
referred services. The statute establishes a number of specific
exceptions, and grants the Secretary the authority to create regulatory
exceptions for financial relationships that pose no risk of program or
patient abuse. Additionally, the statute mandates refunding any amount
collected under a bill for an item or service furnished under a
prohibited referral. Finally, the statute imposes reporting
requirements and provides for sanctions, including civil monetary
penalty provisions.
Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123, enacted February 9, 2018) added provisions to section 1877(h)(1)
of the Act pertaining to the writing and
[[Page 59716]]
signature requirements in certain compensation arrangement exceptions
to the statute's referral and billing prohibitions. Although we believe
that the newly enacted provisions in section 1877(h)(1) of the Act are
principally intended merely to codify in statute existing CMS policy
and regulations with respect to compliance with the writing and
signature requirements, we proposed revisions to our regulations to
address any actual or perceived difference between the statutory and
regulatory language, to codify in regulation our longstanding policy
regarding satisfaction of the writing requirement found in many of the
exceptions to the physician self-referral law, and to make the
Bipartisan Budget Act of 2018 policies applicable to compensation
arrangement exceptions issued using the Secretary's authority in
section 1877(b)(4) of the Act.
In the CY 2016 PFS final rule with comment period (80 FR 70885), we
revised Sec. 411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease
arrangement or personal service arrangement to continue indefinitely
beyond the stated expiration of the written documentation describing
the arrangement under certain circumstances. Section 50404 of the
Bipartisan Budget Act of 2018 added substantively identical holdover
provisions to section 1877(e) of the Act. Because the new statutory
holdover provisions effectively mirror the existing regulatory
provisions, we do not believe it is necessary to revise Sec.
411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory
revisions. Therefore, we made no proposals to these provisions.
2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(D) &
(E) of the Act)
Many of the exceptions for compensation arrangements in Sec.
411.357 require that the arrangements are set out in writing and signed
by the parties. (See Sec. 411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i),
(e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained
in Sec. 1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both
incorporating the requirements contained in Sec. 411.357(e)(1)(i)),
(v)(7), (w)(7), (x)(1)(i), and (y)(1).) \9\ As described above, section
50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the
Act with respect to the writing and signature requirements in the
statutory compensation arrangement exceptions. As detailed in this
section, we proposed a new special rule on compensation arrangements at
Sec. 411.354(e) and proposed to amend existing Sec. 411.353(g) to
codify the statutory provisions in our regulations.
---------------------------------------------------------------------------
\9\ We note that, where the writing requirement appears in the
statutory and regulatory exceptions, we interpret it uniformly,
regardless of any minor differences in the language of the
requirement. See 80 FR 71315. Similarly, we interpret the signature
requirement uniformly where it appears, regardless of any minor
differences in the language of the statutory and regulatory
exceptions.
---------------------------------------------------------------------------
a. Writing Requirement (Sec. 411.354(e))
In the CY 2016 PFS final rule with comment period, we stated CMS'
longstanding policy that the writing requirement in various
compensation arrangement exceptions in Sec. 411.357 can be satisfied
by ``a collection of documents, including contemporaneous documents
evidencing the course of conduct between the parties'' (80 FR 71315).
Our guidance on the writing requirement appeared in the preamble of the
CY 2016 PFS final rule with comment period but was not codified in
regulations. Section 50404 of the Bipartisan Budget Act of 2018 added
subparagraph D, ``Written Requirement Clarified,'' to section
1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that,
in the case of any requirement in section 1877 of the Act for a
compensation arrangement to be in writing, such requirement shall be
satisfied by such means as determined by the Secretary, including by a
collection of documents, including contemporaneous documents evidencing
the course of conduct between the parties involved.
In light of the recently added statutory provision at section
1877(h)(1)(D) of the Act, we proposed to add a special rule on
compensation arrangements at Sec. 411.354(e). Proposed Sec.
411.354(e) provides that, in the case of any requirement in 42 CFR part
411, subpart J, for a compensation arrangement to be in writing, the
writing requirement may be satisfied by a collection of documents,
including contemporaneous documents evidencing the course of conduct
between the parties. The proposed special rule at Sec. 411.354(e)
codifies our existing policy on the writing requirement, as previously
articulated in the CY 2016 PFS final rule with comment period. (See 80
FR 71314 et seq.)
b. Special Rule for Certain Arrangements Involving Temporary
Noncompliance With Signature Requirements (Sec. 411.353(g))
Many of the exceptions for compensation arrangements in Sec.
411.357 require that the arrangement (that is, the written
documentation evidencing the arrangement) is signed by the parties to
the arrangement. Under our existing special rule for certain
arrangements involving temporary noncompliance with signature
requirements at Sec. 411.353(g)(1), an entity that has a compensation
arrangement with a physician that satisfies all the requirements of an
applicable exception in Sec. 411.355, Sec. 411.356 or Sec. 411.357
except the signature requirement may submit a claim and receive payment
for a designated health service referred by the physician, provided
that: (1) The parties obtain the required signature(s) within 90
consecutive calendar days immediately following the date on which the
compensation arrangement became noncompliant (without regard to whether
any referrals occur or compensation is paid during such 90-day period);
and (2) the compensation arrangement otherwise complies with all
criteria of the applicable exception. Existing Sec. 411.353(g)(1)
specifies the paragraphs where the applicable signature requirements
are found and existing Sec. 411.353(g)(2) limits an entity's use of
the special rule at Sec. 411.353(g)(1) to only once every 3 years with
respect to the same referring physician.
Section 50404 of the Bipartisan Budget Act of 2018 added
subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the
Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any
requirement in section 1877 of the Act for a compensation arrangement
to be in writing and signed by the parties, the signature requirement
is satisfied if: (1) Not later than 90 consecutive calendar days
immediately following the date on which the compensation arrangement
became noncompliant, the parties obtain the required signatures; and
(2) the compensation arrangement otherwise complies with all criteria
of the applicable exception. Notably, under the newly added section
1877(h)(1)(E) of the Act, an applicable signature requirement is not
limited to specific exceptions and entities are not limited in their
use of the rule to only once every 3 years with respect to the same
referring physician. In addition, section 1877(h)(1)(E) of the Act does
not include a reference to the occurrence of referrals or the payment
of compensation during the 90-day period when the signature requirement
is not met.
To conform the regulations with the recently added statutory
provision at section 1877(h)(1)(E) of the Act, we proposed to amend
existing Sec. 411.353(g) by: (1) Revising the reference at Sec.
411.353(g)(1) to specific exceptions and signature requirements; (2)
deleting the reference at Sec. 411.353(g)(1) to the
[[Page 59717]]
occurrence of referrals or the payment of compensation during the 90-
day period when the signature requirement is not met; and (3) deleting
the limitation at Sec. 411.353(g)(2). In the alternative, we proposed
to delete Sec. 411.353(g) in its entirety and codify in proposed Sec.
411.354(e) the special rule for signature requirements in section
1877(h)(1)(E) of the Act. We solicited comments regarding the best
approach for codifying in regulation this provision of the Bipartisan
Budget Act of 2018.
The following is a summary of the comments we received regarding
the best approach for codifying in regulation sections 1877(h)(1)(D) &
(E) of the Act.
Comment: We received a few comments in support of our proposal to
codify our existing policy on the writing requirement in a special rule
on compensation arrangements at Sec. 411.354(e). No commenters opposed
the proposal or suggested revisions or additions to the proposed
regulatory text in Sec. 411.354(e).
Response: We are finalizing proposed Sec. 411.354(e) without
modification. We remind readers that Sec. 411.354(e) codifies our
longstanding policy on the writing requirement in various compensation
exceptions, as explained in detail in the CY 2016 PFS final rule with
comment period. (See 80 FR 71314 et seq.)
Comment: We received a few comments expressing general support for
the special rule on temporary noncompliance with signature
requirements. Commenters appreciated the flexibility that the special
rule affords. We received no comments in opposition to our proposal.
Commenters approved of our efforts to align our regulations pertaining
to temporary noncompliance with signature requirements with the
statutory provision at section 1877(h)(1)(E) of the Act. Most
commenters did not note if it would be better to codify section
1877(h)(1)(E) of the Act at Sec. 411.353(g) or to delete Sec.
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act
in the special rules on compensation arrangements at Sec. 411.354(e).
A couple of commenters acknowledged that both proposals provide
clarification but expressed a preference that we delete Sec.
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act
in proposed Sec. 411.354(e), asserting that such a change would
provide a ``clear reflection of the statute.''
Response: We believe it would be less disruptive to provider and
supplier compliance efforts to amend Sec. 411.353(g), a regulation
that has been in place for over 10 years. Therefore, we are finalizing
our proposal to revise the special rule for temporary noncompliance
with signature requirements at Sec. 411.353(g), thus aligning Sec.
411.353(g) with the newly added section 1877(h)(1)(E) of the Act.
Comment: We received a few comments seeking physician self-referral
law regulatory changes that were not proposed.
Response: These comments are beyond the scope of this rulemaking
and are not addressed in this final rule.
Finally, we note that the effective date of section 50404 of the
Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9,
2018, parties who meet the requirements of section 1877(h)(1)(E) of the
Act, including parties who otherwise would have been barred from
relying on the special rule for certain arrangements involving
temporary noncompliance with signature requirements at Sec.
411.353(g)(1) because of the 3-year limitation at Sec. 411.353(g)(2),
may avail themselves of the new statutory provision at section
1877(h)(1)(E) of the Act.
After reviewing the comments, we are finalizing the special rule on
compensation arrangements at Sec. 411.354(e) as proposed, and we are
finalizing the modifications to Sec. 411.353(g) as proposed.
N. Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS
Codes
1. General
Section 1877 of the Act prohibits a physician from referring a
Medicare beneficiary for certain designated health services (DHS) to an
entity with which the physician (or a member of the physician's
immediate family) has a financial relationship, unless an exception
applies. Section 1877 of the Act also prohibits the DHS entity from
submitting claims to Medicare or billing the beneficiary or any other
entity for Medicare DHS that are furnished as a result of a prohibited
referral.
Section 1877(h)(6) of the Act and Sec. 411.351 of our regulations
specify that the following services are DHS:
Clinical laboratory services.
Physical therapy services.
Occupational therapy services.
Outpatient speech-language pathology services.
Radiology services.
Radiation therapy services and supplies.
Durable medical equipment and supplies.
Parenteral and enteral nutrients, equipment, and supplies.
Prosthetics, orthotics, and prosthetic devices and
supplies.
Home health services.
Outpatient prescription drugs.
Inpatient and outpatient hospital services.
2. Annual Update to the Code List
a. Background
In Sec. 411.351, we specify that the entire scope of four DHS
categories is defined in a list of CPT/HCPCS codes (the Code List),
which is updated annually to account for changes in the most recent CPT
and HCPCS Level II publications. The DHS categories defined and updated
in this manner are:
Clinical laboratory services.
Physical therapy, occupational therapy, and outpatient
speech-language pathology services.
Radiology and certain other imaging services.
Radiation therapy services and supplies.
The Code List also identifies those items and services that may
qualify for either of the following two exceptions to the physician
self-referral prohibition:
EPO and other dialysis-related drugs furnished in or by an
ESRD facility (Sec. 411.355(g)).
Preventive screening tests, immunizations, or vaccines
(Sec. 411.355(h)).
The definition of DHS at Sec. 411.351 excludes services for which
payment is made by Medicare as part of a composite rate (unless the
services are specifically identified as DHS and are themselves payable
through a composite rate, such as home health and inpatient and
outpatient hospital services). Effective January 1, 2011, EPO and
dialysis-related drugs furnished in or by an ESRD facility (except
drugs for which there are no injectable equivalents or other forms of
administration), have been reimbursed under a composite rate known as
the ESRD prospective payment system (ESRD PPS) (75 FR 49030).
Accordingly, EPO and any dialysis-related drugs that are paid for under
ESRD PPS are not DHS and are not listed among the drugs that could
qualify for the exception at Sec. [thinsp]411.355(g) for EPO and other
dialysis-related drugs furnished by an ESRD facility.
ESRD-related oral-only drugs, which are drugs or biologicals with
no injectable equivalents or other forms of administration other than
an oral form, were scheduled to be paid under ESRD PPS beginning
January 1, 2014 (75 FR 49044). However, there have been several delays
of the implementation of payment of these drugs under ESRD PPS. On
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a
Better Life Experience Act of 2014
[[Page 59718]]
(ABLE) (Pub. L. 113-295) was enacted and delayed the inclusion of these
oral-only drugs under the ESRD PPS until 2025. Until that time, such
drugs furnished in or by an ESRD facility are not paid as part of a
composite rate and thus, are DHS.
The Code List was last updated in Tables 44 and 45 of the CY 2018
PFS final rule (82 FR 53339).
b. Response to Comments
We received no comments relating to the Code List that became
effective January 1, 2018.
c. Revisions Effective for CY 2019
The updated, comprehensive Code List effective January 1, 2019, is
available on our website at http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.html.
Additions and deletions to the Code List conform it to the most
recent publications of CPT and HCPCS Level II and to changes in
Medicare coverage policy and payment status.
Tables 28 and 29 identify the additions and deletions,
respectively, to the comprehensive Code List that become effective
January 1, 2019. Tables 28 and 29 also identify the additions and
deletions to the list of codes used to identify the items and services
that may qualify for the exception in Sec. 411.355(g) (regarding
dialysis-related outpatient prescription drugs furnished in or by an
ESRD facility) and in Sec. 411.355(h) (regarding preventive screening
tests, immunizations, and vaccines).
Table 28--Additions to the Physician Self-Referral List of CPT \1\ HCPCS
Codes
------------------------------------------------------------------------
-------------------------------------------------------------------------
Clinical Laboratory Services:
0018U Onc thyr 10 microrna seq alg.
0019U Onc rna tiss predict alg.
0020U Rx test prsmv ur w/def conf.
0021U Onc prst8 detcj 8 autoantb.
0022U Trgt gen seq dna&rna 23 gene.
0023U Onc aml dna detcj/nondetcj.
0024U Glyca nuc mr spectrsc quan.
0025U Tenofovir liq chrom ur quan.
0026U Onc thyr dna&mrna 112 genes.
0027U Jak2 gene trgt seq alys.
0028U Cyp2d6 gene cpy nmr cmn vrnt.
0029U Rx metab advrs trgt seq alys.
0030U Rx metab warf trgt seq alys.
0031U Cypia2 gene.
0032U Comt gene.
0033U Htr2a htr2c genes.
0034U Tpmt nudt15 genes.
0035U Neuro csf prion prtn qual.
0036U Xome tum & nml spec seq alys.
0037U Trgt gen seq rgt gen seq dna 324 genes.
0038U Vitamin d srm microsamp quan.
0039U Dna antb 2strand hi avidity.
0040U Bcr/abl1 gene major bp quan.
0041U B brgdrferi antb 5 prtn igm.
0042U B brgdrferi antb 12 prtn igg.
0043U Tbrg b grp antb 4 prtn igm.
0044U Tbrf b grp antb 4 prtn igg.
0045U Onc brst dux carc is 12 gene.
0046U Flt3 genie itd variants quan.
0047U Onc prst8 mrna 17 gene alg.
0048U Onc sld org neo dna 468 gene.
0049U Npm1 gene analysis quan.
0050U Trgt gen seq dna 194 genes.
0051U Rx mntr lc-ms/ms ur 31 pnl.
0052U Lpoprtn bld w/5 maj classes.
0053U Onc prst8 ca fish alys 4 gen.
0054U Rx mntr 14+ drugs & sbsts.
0055U Card hrt trnspl 96 dna seq.
0056U Hem aml dna gene reargmt.
0057U Onc sld org neo mrna 51 gene.
0058U Onc merkel cll carc srm quan.
0059U Onc merkel cll carc srm+/-.
0060U Twn zyg gen seq alys chrms2.
0061U Tc meas 5 bmrk sfdi m-s alys.
0011M Onc prst8 ca mrna 12 gen alg.
0012M Onc mrna 5 gen rsk urthl ca.
0013M Onc mrna 5 gen recr urthl ca.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
Pathology Services:
{No additions.{time}
Radiology and Certain Other Imaging Services:
0508T Pls echo us b1 dns meas tib.
76391 Mr elastography.
76978 Us trgt dyn mbubb 1st les.
76979 Us trgt dyn mbubb ea addl.
76981 Use parenchyma.
76982 Use 1st target lesion.
76983 Use ea addl target lesion.
77046 Mri breast c-unilateral.
77047 Mri breast c-bilateral.
77048 Mri breast c-+ w/cad uni.
77049 Mri breast c-+ w/cad bi.
C8937 Cad breast Mri.
C9407 Iodine i-131 iobenguane, dx.
Q9950 Inj sulf hexa lipid microsph.
Radiation Therapy Services and Supplies:
A9513 Lutetium Lu 177 dotatat ther.
C9408 Iodine i-131 iobenguane, tx.
Drugs Used by Patients Undergoing Dialysis:
{No additions.{time}
Preventive Screening Tests, Immunizations and Vaccines:
81528 Oncology colorectal scr.
90689 Vacc IIv4 no prsrv 0.25ml im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
are reserved and applicable FARS/DFARS clauses apply.
Table 29--Deletions From the Physician Self-Referral List of CPT \1\
HCPCS Codes
------------------------------------------------------------------------
-------------------------------------------------------------------------
Clinical Laboratory Services:
78270 Vit B-12 absorption exam.
78271 Vit B-12 absrp exam int fac.
78272 Vit B-12 absorp combined.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
Pathology Services:
64550 Appl surface neurostimulator.
96111 Developmental testing.
Radiology and Certain Other Imaging Services:
0159T Cad breast mri.
0346T Ultrasound elastography.
C9744 Abd us w/contrast.
77058 Mri one breast.
77059 Mri both breasts.
77776 Apply interstit radiat simpl.
77785 HDR brachytx 1 channel.
77786 HDR brachytx 2-12 channel.
C9457 Lumason contrast agent.
C9461 Choline C 11, diagnostic.
G0173 Linear acc stereo radsur com.
G0251 Linear acc based stero radio.
Radiation Therapy Services and Supplies:
0190T Place intraoc radiation src.
Drugs Used by Patients Undergoing Dialysis:
{No deletions{time} .
Preventive Screening Tests, Immunizations and Vaccines:
G0389 Ultrasound exam AAA screen.
G0464 Colorec CA scr, sto bas DNA.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
are reserved and applicable FARS/DFARS clauses apply.
I. CY 2019 Updates to the Quality Payment Program
1. Executive Summary
a. Overview
This final rule will make payment and policy changes to the Quality
Payment Program starting January 1, 2019, except as noted for specific
provisions elsewhere in this final rule. The Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16,
2015) amended title XVIII of the Act to repeal the Medicare sustainable
growth rate (SGR) formula, to reauthorize the Children's Health
Insurance Program, and to strengthen Medicare access by improving
physician and other clinician payments and making other improvements.
The MACRA advances a forward-looking, coordinated framework for
clinicians to successfully participate in the Quality Payment Program,
which rewards value in one of two ways:
The Merit-based Incentive Payment System (MIPS).
Advanced Alternative Payment Models (Advanced APMs).
As we move into the third year of the Quality Payment Program, we
have taken all stakeholder input into consideration, including
recommendations made by the Medicare Payment Advisory Commission
(MedPAC), an independent congressional agency established by the
Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997)
to advise the U.S. Congress on issues
[[Page 59719]]
affecting the Medicare program, such as payment policies under
Medicare, the factors affecting expenditures for the efficient
provision of services, and the relationship of payment policies to
access and quality of care for Medicare beneficiaries. We will continue
to implement the Quality Payment Program as required, smoothing the
transition where possible and offering targeted educational resources
for program participants. A few examples of how we are working to
address stakeholder input are evident in our work around burden
reduction and reshaping our focus of interoperability. We have heard
the concern about process-based measures, and we are continuing to move
towards the development and use of more outcome measures by way of
removing process measures that are topped out and funding new quality
measure development, as required by section 102 of MACRA. We have also
developed new episode-based cost measures, with stakeholder feedback,
for inclusion in the cost performance category beginning in 2019, with
additional measure development occurring for potential inclusion in
future years.
Additionally, we have also received feedback from stakeholders
regarding the added value of the Quality Payment Program. To that
point, CMS has begun a series of strategic planning sessions to (1)
assess the current value of the program for clinicians and
beneficiaries alike and (2) implement the program in a way that is
understandable to beneficiaries, as they are the core of the Medicare
program.
As a priority for the Quality Payment Program Year 3, we are
committed to continue using the framework established by the Patients
over Paperwork initiative to assist in reducing clinician burden,
implementing the Meaningful Measures Initiative, promoting
interoperability, continuing our support of small and rural practices,
empowering patients, and promoting price transparency.
Reducing Clinician Burden
We are committed to reducing clinician burden by simplifying and
streamlining the program for participating clinicians. Examples
include:
Implementing the Meaningful Measures Initiative, which is
a framework that applies a series of cross-cutting criteria to identify
and utilize the most meaningful measures with the least amount of
burden and greatest impact on patient outcomes;
Promoting advances in interoperability; and
Establishing an automatic extreme and uncontrollable
circumstances policy for MIPS eligible clinicians.
Improving Patient Outcomes and Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing regulatory burden are high
priorities for CMS. To reduce the regulatory burden on the healthcare
industry, lower health care costs, and enhance patient care, we
launched the Meaningful Measures Initiative in October 2017.\10\ This
initiative is one component of our agency-wide Patients Over Paperwork
Initiative,\11\ which is aimed at evaluating and streamlining
regulations with a goal to reduce unnecessary cost and burden, increase
efficiencies, and improve beneficiary experience. The Meaningful
Measures Initiative is aimed at identifying the highest priority areas
for quality measurement and quality improvement to assess the core
quality of care issues that are most vital to advancing our work to
improve patient outcomes. The Meaningful Measures Initiative represents
a new approach to quality measures that fosters operational
efficiencies, and reduces cost associated with collection and reporting
burden, while producing quality measurement that is more focused on
meaningful outcomes.
---------------------------------------------------------------------------
\10\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\11\ See Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
---------------------------------------------------------------------------
The Meaningful Measures Framework has the following principles for
identifying measures that:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures where
possible, such as electronic clinical quality measures);
Significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
To achieve these objectives, we have identified 19 Meaningful
Measures areas and mapped them to six overarching quality priorities as
shown in Table 30.
Table 30--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
Quality priority Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm Healthcare-Associated
Caused in the Delivery of Care. Infections.
Preventable Healthcare Harm.
Strengthen Person and Family Engagement Care is Personalized and
as Partners in Their Care. Aligned with Patient's Goals.
End of Life Care according to
Preferences.
Patient's Experience of Care.
Patient Reported Functional
Outcomes.
Promote Effective Communication and Medication Management.
Coordination of Care. Admissions and Readmissions to
Hospitals.
Transfer of Health Information
and Interoperability.
Promote Effective Prevention and Preventive Care.
Treatment of Chronic Disease. Management of Chronic
Conditions.
Prevention, Treatment, and
Management of Mental Health.
Prevention and Treatment of
Opioid and Substance Use
Disorders.
Risk Adjusted Mortality.
Work with Communities to Promote Best Equity of Care.
Practices of Healthy Living. Community Engagement.
[[Page 59720]]
Make Care Affordable................... Appropriate Use of Healthcare.
Patient-focused Episode of
Care.
Risk Adjusted Total Cost of
Care.
------------------------------------------------------------------------
By including Meaningful Measures in our programs, we believe that
we can also address the following cross-cutting measure criteria:
Eliminating disparities;
Tracking measurable outcomes and impact;
Safeguarding public health;
Achieving cost savings;
Improving access for rural communities; and
Reducing burden.
We believe that the Meaningful Measures Initiative will improve
outcomes for patients, their families, and health care providers while
reducing burden and costs for clinicians and providers and promoting
operational efficiencies.
In the quality performance category under MIPS, clinicians have the
flexibility to select and report the measures that matter most to their
practice and patients. However, we have received feedback that some
clinicians find the performance requirements confusing, and the program
makes it difficult for them to choose measures that are meaningful to
their practices and have more direct benefit to beneficiaries. For the
2019 MIPS performance period, we are finalizing the following updates:
(1) Adding 8 new MIPS quality measures that include 4 patient reported
outcome measures, 6 high priority measures, and 2 measures on important
clinical topics in the Meaningful Measures framework; and (2) removing
26 quality measures.
In addition to having the right measures, we want to ensure that
the collection of information is valuable to clinicians and worth the
cost and resources of collecting the information.
Promoting Interoperability Performance Category
As required by MACRA, the Quality Payment Program includes a MIPS
performance category that focuses on meaningful use of certified EHR
technology, referred to in the CY 2017 and CY 2018 Quality Payment
Program final rules as the ``advancing care information'' performance
category. As part of our approach to promoting and prioritizing
interoperability of healthcare data, in Quality Payment Program Year 2,
we changed the name of the performance category to the Promoting
Interoperability performance category.
We have prioritized interoperability, which we define as health
information technology, that enables the secure exchange of electronic
health information with, and use of electronic health information from,
other health information technology without special effort on the part
of the user; allows for complete access, exchange, and use of all
electronically accessible health information for authorized use under
applicable law; and does not constitute information blocking as defined
by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13,
2016). We are committed to working with the Office of the National
Coordinator for Health IT (ONC) on implementation of the
interoperability provisions of the 21st Century Cures Act to have
seamless but secure exchange of health information for clinicians and
patients, ultimately enabling Medicare beneficiaries to get their
claims information electronically. In addition, we are prioritizing
quality measures and improvement activities that support
interoperability.
To further CMS' commitment to implementing interoperability, at the
2018 Healthcare Information and Management Systems Society (HIMSS)
conference, CMS Administrator Seema Verma announced the launching of
the MyHealthEData initiative.\12\ This initiative aims to empower
patients by ensuring that they control their healthcare data and can
decide how their data is going to be used, all while keeping that
information safe and secure. The overall government-wide initiative is
led by the White House Office of American Innovation with participation
from HHS--including its CMS, ONC, and the National Institutes of Health
(NIH)--as well as the U.S. Department of Veterans Affairs (VA).
MyHealthEData aims to break down the barriers that prevent patients
from having electronic access and true control of their own health
records from the device or application of their choice. This effort
will approach the issue of healthcare data from the patient's
perspective.
---------------------------------------------------------------------------
\12\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-03-06.html.
---------------------------------------------------------------------------
For the Promoting Interoperability performance category, we require
MIPS eligible clinicians to use 2015 Edition certified EHR technology
beginning with the 2019 MIPS performance period to make it easier for:
Patients to access their data.
Patient information to be shared between doctors and other
health care providers.
Continuing To Support Small and Rural Practices
We understand that the Quality Payment Program is a big change for
clinicians, especially for those in small and rural practices. We
intend to continue to offer tailored flexibilities to help these
clinicians to participate in the program. For example, in this rule we
are finalizing our proposal to retain a small practice bonus under MIPS
by moving it to the quality performance category. We will also continue
to support small and rural practices by offering free and customized
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative
along with our other no-cost technical assistance.
Further, we note that we are finalizing our proposal to amend our
regulatory text to allow small practices to continue using the Medicare
Part B claims collection type. We are also finalizing our proposal to
revise the regulatory text to allow a small practice to submit quality
data for covered professional services through the Medicare Part B
claims submission type for the quality performance category, as
discussed further in section III.I.3.h. of this final rule. Finally, in
the CY 2018 Quality Payment Program final rule, we finalized a policy
to allow small practices to continue to choose to participate in MIPS
as a virtual group (82 FR 53598).
Empowering Patients Through the Patients Over Paperwork Initiative
Our Patients Over Paperwork initiative establishes an internal
process to evaluate and streamline regulations with a goal to reduce
unnecessary burden, to increase efficiencies, and to
[[Page 59721]]
improve the beneficiary experience.\13\ This administration is
dedicated to putting patients first, empowering consumers of healthcare
to have the information they need to be engaged and active decision-
makers in their care. As a result of this consumer empowerment,
clinicians will gain competitive advantage by delivering coordinated,
high-value quality care.
---------------------------------------------------------------------------
\13\ Patients Over Paperwork web page available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.
---------------------------------------------------------------------------
The policies for the Quality Payment Program in this final rule
promote competition and empower patients. We are consistently
listening, and we are committed to using data-driven insights,
increasingly aligned and meaningful quality measures, and technology
that empowers patients and clinicians to make decisions about their
healthcare.
In conjunction with development of the Patients Over Paperwork
initiative, we are making progress toward developing a patient-centered
portfolio of measures for the Quality Payment Program, including 7 new
outcome measures included on the 2017 CMS Measures Under Consideration
List,\14\ 5 of which are directly applicable to the prioritized
specialties of general medicine/crosscutting and orthopedic surgery.
Finally, on September 21, 2018, CMS awarded seven organizations new
cooperative agreements to partner with the agency in developing,
improving, updating, or expanding quality measures for Medicare's
Quality Payment Program. Awardees will work to establish more
appropriate measures for clinical specialties underrepresented in the
current measure set with the goal of improving patient care, and focus
on outcome measures, including patient-reported and functional-status
measures, to better reflect what matters most to patients.\15\
---------------------------------------------------------------------------
\14\ Centers for Medicare & Medicaid Services. List of Measures
Under Consideration for December 1, 2017. Baltimore, MD: US
Department of Health and Human Services; 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/Measures-under-Consideration-Listfor2017.pdf. Accessed May 4, 2018.
\15\ CMS Awards Funding for Quality Measure Development, https://www.cms.gov/newsroom/press-releases/cms-awards-funding-quality-measure-development.
---------------------------------------------------------------------------
b. Summary of the Major Provisions
In May 2018, CMS announced that 91 percent of MIPS eligible
clinicians participated in the 2017 transition year. (See https://www.cms.gov/blog/quality-payment-program-exceeds-year-1-participation-goal.) This CY 2017 performance period data were incorporated for this
final rule when estimating eligibility and payment adjustment for the
CY 2019 MIPS performance period. One important finding is that many
more clinicians than reported in the CY 2019 PFS proposed rule are
expected to participate in MIPS using the group reporting option. This
increase means more clinicians are covered in MIPS and are measured on
their performance.
(1) Quality Payment Program Year 3
During the first 2 years of the program, we have heard concerns
from clinicians that were not eligible to participate. Under MIPS, for
year 3, we are expanding in this final rule the opportunities to
participate, while still understanding the burden required to
participate, to include physical therapists, occupational therapists,
qualified speech-language pathologists, qualified audiologists,
clinical psychologists, and registered dietitians or nutrition
professionals in the list of MIPS eligible clinicians. We also are
finalizing an opt-in policy that allows some clinicians, who otherwise
would have been excluded under the low-volume threshold, the option to
participate in MIPS.
We believe the third year of the Quality Payment Program should
build upon the foundation that has been established in the first 2
years, which provides a trajectory for clinicians moving to a
performance-based payment system. This trajectory provides clinicians
the ability to participate in the program through two pathways: MIPS
and Advanced APMs.
(2) Payment Adjustments
As discussed in section VII.F.8. of this final rule, for the 2021
payment year and based on Advanced APM participation during the 2019
MIPS performance period, we estimate that between 165,000 and 220,000
clinicians will become Qualifying APM Participants (QP). As a QP, an
eligible clinician is not subject to the MIPS reporting requirements
and payment adjustment, and qualifies for a lump sum APM incentive
payment equal to 5 percent of their aggregate payment amounts for
covered professional services for the year prior to the payment year.
We estimate that the total lump sum APM incentive payments will be
approximately $600-800 million for the 2021 Quality Payment Program
payment year.
Again, we estimate that approximately 798,000 clinicians would be
MIPS eligible clinicians in the 2019 MIPS performance period, an
increase of almost 148,000 from the estimate we provided in the CY 2019
PFS proposed rule, which reflects growth in group reporting and our
ability to better capture group reporting. The final number will depend
on several factors, including the number of eligible clinicians
excluded from MIPS based on their status as QPs or Partial QPs, the
number that report as groups, and the number that elect to opt-in to
MIPS. In the 2021 MIPS payment year, MIPS payment adjustments, which
only apply to covered professional services, will be applied based on
MIPS eligible clinicians' performance on specified measures and
activities within four integrated performance categories. We estimate
that MIPS payment adjustments will be approximately equally distributed
between negative MIPS payment adjustments ($390 million) and positive
MIPS payment adjustments ($390 million) to MIPS eligible clinicians, as
required by the statute to ensure budget neutrality. Positive MIPS
payment adjustments will also include up to an additional $500 million
for exceptional performance to MIPS eligible clinicians whose final
score meets or exceeds the additional performance threshold of 75
points that we are establishing in this final rule. However, the
distribution will change based on the final population of MIPS eligible
clinicians for the 2021 MIPS payment year and the distribution of final
scores under the program.
2. Definitions
At Sec. 414.1305, subpart O--
We are revising in this final rule the regulation to
define the following terms:
++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
++ Collection type.
++ Health IT vendor.
++ MIPS determination period.
++ Submission type.
++ Submitter type.
++ Third party intermediary.
We are revising in this final rule the definitions of the
following terms:
++ High priority measure.
++ Hospital-based MIPS eligible clinician
++ Low-volume threshold.
++ MIPS eligible clinician.
++ Non-patient facing MIPS eligible clinician.
++ Qualified clinical data registry (QCDR).
++ Qualifying APM Participant (QP).
++ Small practice.
These terms and definitions are discussed in detail in relevant
sections of this final rule.
[[Page 59722]]
3. MIPS Program Details
a. MIPS Eligible Clinicians
Under Sec. 414.1305, a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, is
defined as any of the following (excluding those identified at Sec.
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a
physician assistant, nurse practitioner, and clinical nurse specialist
(as such terms are defined in section 1861(aa)(5) of the Act); a
certified registered nurse anesthetist (as defined in section
1861(bb)(2) of the Act); and a group that includes such clinicians.
Section 1848(q)(1)(C)(II) of the Act provides the Secretary with
discretion, beginning with the 2021 MIPS payment year, to specify
additional eligible clinicians (as defined in section 1848(k)(3)(B) of
the Act) as MIPS eligible clinicians. Such clinicians may include
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section
1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in
section 1861(gg)(2) of the Act); clinical social workers (as defined in
section 1861(hh)(1) of the Act); clinical psychologists (as defined by
the Secretary for purposes of section 1861(ii) of the Act); and
registered dietitians or nutrition professionals.
As discussed in the CY 2019 PFS proposed rule (83 FR 35883 through
35884), we received feedback from non-physician associations
representing each type of additional eligible clinician through
listening sessions and meetings with various stakeholder entities and
through public comments discussed in the CY 2017 Quality Payment
Program final rule (81 FR 77038). Commenters generally supported the
specification of such clinicians as MIPS eligible clinicians beginning
with the 2021 MIPS payment year. In order to assess whether these
additional eligible clinicians could successfully participate in MIPS,
we evaluated whether there would be sufficient measures and activities
applicable and available for each of the additional eligible clinician
types. We finalized in the CY 2018 Quality Payment Program final rule
(82 FR 53780), that having sufficient measures for the quality
performance category, means having sufficient measures applicable and
available means that we can calculate a quality performance category
percent score for the MIPS eligible clinician because at least one
quality measure is applicable and available to the clinician. For the
improvement activities performance category, we stated the belief that
all MIPS eligible clinicians will have sufficient activities applicable
and available. We focused our analysis on the quality and improvement
activities performance categories because these performance categories
require submission of data. We did not focus on the Promoting
Interoperability performance category because there is extensive
analysis regarding who can participate in the Promoting
Interoperability performance category under the current exclusion
criteria. In addition, in section III.I.3.h.(5) of this final rule, we
are finalizing a policy to automatically assign a zero percent
weighting for the Promoting Interoperability performance category for
these new types of MIPS eligible clinicians. We did not focus as part
of our analysis on the cost performance category because we are only
able to assess cost performance for a subset of eligible clinicians--
specifically, those who are currently eligible as a result of not
meeting any of the current exclusion criteria. So the impact of the
cost performance category for these additional eligible clinicians will
continue to be considered but is currently not a decisive factor for
successful participation in MIPS. From our analysis, we found that
improvement activities would generally be applicable and available for
each of the additional eligible clinician types. However, for the
quality performance category, we found that not all of the additional
eligible clinician types would have sufficient MIPS quality measures
applicable and available. As discussed in section III.I.3.h.(2)(b)(iii)
of this final rule, for the quality performance category, we are
finalizing our proposals to remove several MIPS quality measures. In
the CY 2019 PFS proposed rule (83 FR 35883 through 35884), we explained
that if those measures were finalized for removal, we anticipated that
qualified speech-language pathologists, qualified audiologists,
certified nurse-midwives, and registered dietitians or nutrition
professionals would each have less than 6 MIPS quality measures
applicable and available to them. However, if the quality measures were
not finalized for removal, we would reassess whether these eligible
clinicians would have an adequate amount of MIPS quality measures
available to them. We proposed to include these additional clinicians
in the MIPS eligible clinician definition if we found that they do have
at least 6 MIPS quality measures available to them. As discussed in
``Appendix 1: Finalized MIPS Quality Measures'', TABLE Group C. of this
final rule, we are retaining one of the MIPS quality measures that was
proposed for removal: ``Colonoscopy Interval for Patients with a
History of Adenomatous Polyps--Avoidance of Inappropriate Use''
(Quality #185). We do not believe that this measure is applicable to
any of the proposed additional eligible clinicians. Therefore, it does
not affect the number of available measures for these clinicians. We
refer readers to section III.I.3.h.(2) of this final rule for more
information regarding quality measures.
We focused on the quality performance category because the quality
and improvement activities performance categories require submission of
data. We believed there would generally be applicable and available
improvement activities for each of the additional eligible clinician
types, but that not all of the additional eligible clinician types
would have sufficient MIPS quality measures applicable and available if
the proposed MIPS quality measures were removed from the program. In
our analysis, we did find QCDR measures approved for the CY 2018
performance period that are either high priority and/or outcome
measures that, if approved for the CY 2019 performance period, may be
applicable to these additional eligible clinicians. However, this would
necessitate that the clinician utilize a QCDR in order to be successful
in MIPS. Further, we have heard some concerns from the non-physician
associations, through written correspondence, that since their
clinicians would be joining the program 2 years after its inception, we
should consider several ramp-up policies in order to facilitate an
efficient integration of these clinicians into MIPS. We note that the
MIPS program is still ramping up, and we will continue to increase the
performance threshold to ensure a gradual and incremental transition to
the performance threshold that will be used in the Quality Payment
Program Year 6. Therefore, if specified as MIPS eligible clinicians
beginning with the 2021 MIPS payment year, the additional eligible
clinicians would have 4 years in the program in order to ramp up.
Conversely, if specified as MIPS eligible clinicians beginning in a
future year, they would be afforded less time to ramp up the closer the
program gets to Quality Payment Program Year 6.
We requested comments on our proposal to amend Sec. 414.1305 to
modify the definition of a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, to
mean any of
[[Page 59723]]
the following (excluding those identified at Sec. 414.1310(b)): A
physician (as defined in section 1861(r) of the Act); a physician
assistant, nurse practitioner, and clinical nurse specialist (as such
terms are defined in section 1861(aa)(5) of the Act); a certified
registered nurse anesthetist (as defined in section 1861(bb)(2) of the
Act); beginning with the 2021 MIPS payment year, a physical therapist,
occupational therapist, a clinical social worker (as defined in section
1861(hh)(1) of the Act), a clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and a group
that includes such clinicians. Alternatively, we proposed that if the
quality measures proposed for removal were not finalized, then we would
include additional eligible clinician types in the definition of a MIPS
eligible clinician beginning with the 2021 MIPS payment year
(specifically, qualified speech-language pathologists, qualified
audiologists, certified nurse-midwives, and registered dietitians or
nutrition professionals), provided that we determine that each
applicable eligible clinician type would have at least 6 MIPS quality
measures available to them. In addition, we requested comments on: (1)
Specifying qualified speech-language pathologists, qualified
audiologists, certified nurse-midwives, and registered dietitians or
nutrition professionals as MIPS eligible clinicians beginning with the
2021 MIPS payment year; and (2) delaying the specification of one or
more additional eligible clinician types as MIPS eligible clinicians
until a future MIPS payment year.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported our proposal to expand the
definition of MIPS eligible clinicians to physical therapists,
occupational therapists, clinical social workers, and clinical
psychologists. A few commenters encouraged us to ensure that a
reasonable number of measures are maintained for these newly eligible
clinicians. Other commenters specifically discussed adding qualified
audiologist and qualified speech-language pathologists as MIPS eligible
clinicians, stating that there are enough discipline-specific measures
for these clinicians to be included in the program. One commenter
specifically stated that registered dietitians have seven quality
measures on which to report, and, therefore should be included in the
program. A few commenters requested that we include the following
additional clinicians as MIPS eligible clinicians: Nurse navigators,
oncology staff nurses, and clinical pharmacists, stating that adding
more clinicians would enable better understanding of healthcare data
across other specialties.
Response: We appreciate the additional information provided
regarding the quality measures available to the additional eligible
clinicians. After review of the additional information regarding
quality measures we revisited our findings and found support for the
comments. We were persuaded by the arguments of the specialties who
requested to be included in the program including: Physical therapists,
occupational therapists, speech-language pathologists, audiologists,
clinical psychologists, and dieticians or nutrition professionals.
However, we believe that clinical social workers may not have six
applicable quality measures to report. For example, some measures may
contain CPT codes utilized by clinical social workers, but may not be
applicable to their practice. We do believe that there is at least one
quality measure that clinical social workers could report for MIPS. We
encourage the clinicians within the specialty provide feedback during
the specialty measure set solicitation process to create a measure set
applicable to clinical social workers for implementation in future
rulemaking. This will ensure proper scoring based on applicable
measures and will not hold clinical social workers accountable for
measures that are outside their scope. Therefore, we are modifying our
proposal by removing clinical social workers from our proposed list and
including qualified speech-language pathologists, qualified
audiologists, and registered dieticians who were not in our proposed
list but have requested inclusion as MIPS eligible clinicians. We are
finalizing to modify Sec. 414.1305 the definition of a MIPS eligible
clinician to include: Beginning with the 2021 MIPS payment year, a
physical therapist, occupational therapist, qualified speech-language
pathologist; a qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians. We note that we do not have discretion under the statute to
include clinicians other than those specified in section
1848(q)(1)(C)(II) of the Act. Thus, nurses and pharmacists would not be
able to participate in MIPS.
Comment: A few commenters requested that clinical social workers
not be included in MIPS. They stated several reasons why they believe
that clinical social workers should not be included in MIPS: (1) Many
of their clinicians are solo or small group practices and do not have
the technology infrastructure in place to effectively meet expectations
in the Promoting Interoperability performance category; (2) many are in
private practice and have limited ability to influence the overall care
of patients limiting their ability to manage the overall cost of the
beneficiary; (3) while there are more than six measures available in
the mental/behavioral health measure set there are only four claims
measures appropriate for use by clinical social workers as determined
by eligible CPT codes and scope of practice; and (4) some of the
available MIPS CQM measures are limited by patient diagnosis, such as
dementia, which may further limit a clinical social workers ability to
effectively report on six quality measures, as there are only two
outcome measures in the Mental/Behavioral health measure set for
clinical social workers and they require the utilization of the PHQ-9
measure which is only reportable via EHR. When a clinical social worker
does not utilize EHR technology there may be further limitations to
reporting adequate measures.
Response: After review of the additional information regarding
quality measures, we revisited our findings and found support for the
comments. We were persuaded by the arguments of the specialties who
requested to be included in the program including: Physical therapists;
occupational therapists; speech-language pathologists; audiologists;
clinical psychologists; and dieticians or nutrition professionals. We
understand the issues that have been highlighted by the commenters and
believe that some clinical social workers may have a difficult time
successfully participating in MIPS. Therefore, we agree that clinical
social workers should not be added as a MIPS eligible clinician at this
time. However, we do believe that they may be able to participate at
some point in the future. From our analysis, clinical social workers
may not have six applicable quality measures to report at this time.
For example, some measures may contain CPT codes utilized by clinical
social workers, but may not be applicable to their practice. We do
believe that there is at least one quality measure that clinical social
workers
[[Page 59724]]
could report for MIPS. Therefore, we are modifying our proposal by
removing clinical social workers and certified nurse-midwives from our
proposed list and including qualified speech-language pathologists,
qualified audiologists, and registered dieticians who were not in our
proposed list but have requested inclusion as MIPS eligible clinicians.
We are finalizing to modify Sec. 414.1305 the definition of a MIPS
eligible clinician to include, beginning with the 2021 MIPS payment
year, a physical therapist, occupational therapist, qualified speech-
language pathologist; a qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians. We encourage clinicians who are not eligible to participate
in MIPS to voluntarily report on applicable measures and activities for
MIPS. The data received will not be used to assess performance for the
purpose of the MIPS payment adjustment; however, these clinicians will
have the opportunity to access feedback on their submitted MIPS data.
We agree that the two outcome measures within the mental/behavioral
health specialty measure set do require the utilization of the PHQ-9 to
measure the depression outcome; however, we disagree with the commenter
as this is not restricted to EHR and available by MIPS CQMs
Specification.
Comment: One commenter recommended that we adopt a standard
definition of a Quality Payment Program eligible provider, eligible
clinician and/or an eligible professional as it continues to expand the
list of eligible clinicians. The commenter recommended the word
``physician'' be replaced with provider and/or clinician, stating that
this terminology better reflects the collaboration of the current
inter-professional healthcare team.
Response: We understand the commenter to be suggesting that we
unify the definitions of eligible clinician and MIPS eligible
clinician. While we agree that a unified definition might have certain
benefits, we believe that two separate definitions are necessary as the
two tracks of the Quality Payment Program (MIPS and APM) have
distinctly different requirements for participation and the term
eligible clinicians reflects, a broader set of clinician types than the
term MIPS eligible clinicians. We note that both terms already refer to
clinicians.
Comment: Some commenters stated that inclusion of these additional
eligible clinicians in the program with just two months' notice is
overly burdensome and would ultimately prove counterproductive. One
commenter stated that because of the limited scope of MIPS reporting
that is applicable to these specialties, we should carefully evaluate
whether the expense and added burden of reporting for these specialties
is commensurate with the benefits. Another commenter noted that these
clinicians tend to have a high patient turnover rate, which could make
certain measures challenging. Several commenters opposed expanding the
definition of eligible clinician to the proposed clinician types,
stating that the clinician types do not, as a general rule, encompass
the same types of workflows as current MIPS eligible clinicians, and,
therefore, adding these clinicians could increase the cost, time, and
effort for reporting and documentation. Many commenters requested we
create ramp-up policies for the additional eligible clinicians, such as
a pick-your-pace approach or a 1-year delayed effective date. Likewise,
a few commenters requested that we allow the additional clinicians to
opt-in for the first year in which they are eligible to participate. A
few commenters requested that we consider a one-time bonus payment for
voluntary reporting, and requested modified quality benchmarks,
performance thresholds, reporting requirements, and data completeness
requirements.
Response: We acknowledge that adding these additional clinicians
will require some adaptation to the current systems and processes and
will take careful consideration by measure stewards to determine the
appropriateness of adding clinician encounters to align with measure
intent. However, we believe the benefits outweigh the costs as these
clinicians are an integral part of the health care delivery team. We
believe that all eligible clinicians benefit from participation in
quality reporting under MIPS and help reach one of our strategic
objectives to improve beneficiary outcomes and engage and empower
consumers by providing healthcare information useful for driving value
and making healthcare decisions. Regarding measures that are considered
challenging, the additional clinicians should choose measures and
activities that are applicable and meaningful to them. As noted in the
proposed rule (83 FR 35884), the MIPS program is still ramping up, and
we will continue to increase the performance threshold to ensure a
gradual and incremental transition to the performance threshold that
will be used in the Quality Payment Program Year 6. Therefore, if
specified as MIPS eligible clinicians beginning with the 2021 MIPS
payment year, the additional eligible clinicians would have 4 years in
the program in order to ramp up. Conversely, if specified as MIPS
eligible clinicians beginning in a future year, they would be afforded
less time to ramp up the closer the program gets to Quality Payment
Program Year 6. In addition, for the first 2 years of MIPS, clinicians
who are not MIPS eligible had the opportunity to voluntarily report to
become familiar with MIPS measures and reporting. For these reasons, we
do not believe we should adopt policies such as those suggested by the
commenters. We note that additional eligible clinicians that exceed at
least one, but not all, of the low-volume threshold criteria will have
the opportunity to opt-in to participate in MIPS as discussed in
section III.I.3.c.(5) of this final rule. We do not agree with offering
a one-time bonus payment for voluntary reporting as section
1848(q)(1)(C)(vi) of the Act precludes the application of a MIPS
adjustment factor (or additional MIPS adjustment factor) to an
individual who is not a MIPS eligible clinician. Finally, as these
additional clinicians will be defined as MIPS eligible clinicians, they
will be subject to the same requirements as other MIPS eligible
clinicians, including quality benchmarks, performance thresholds,
reporting requirements, and data completeness requirements.
Comment: Several commenters requested that we provide targeted
education on program requirements to additional eligible clinicians.
Specifically, the commenters urged us to provide compliance support to
small practices, by creating an industry pathway to EHR reporting. A
few commenters requested that we convene a Technical Expert Panel (TEP)
comprised of individuals representing the additional eligible clinician
types to inform adaptation of the Quality Payment Program to meet their
needs.
Response: We have consistently provided targeted education on
program requirements in the past and intend to continue doing so
through various means including: Webinars, national provider calls,
virtual office hours, speaking engagements, and tailored educational
resources for the additional clinicians. No cost technical assistance
is also available by contacting the Quality Payment Program Service
Center by phone at 1-866-288-8292, (TTY) 1-877-715-6222 or by email at
[email protected]. We will also continue to support small and rural
[[Page 59725]]
practices by offering free and customized resources available within
local communities, including direct, one-on-one support from the Small,
Underserved, and Rural Support Initiative along with our other no-cost
technical assistance. We appreciate the suggestion to convene a TEP
comprised of the additional clinicians. We will continue to explore
additional opportunities for this type of engagement in the future.
Comment: Many commenters noted their concern regarding whether the
Quality Payment Program could be utilized for these new clinician
types, asking us to consider if these clinicians are able to meet MIPS
reporting requirements across all performance categories before
expanding the list of MIPS-eligible clinicians. Specifically, some
commenters stated that the Promoting Interoperability performance
category would be difficult to meet without a change in meaningful use
guidelines, noting that because these clinicians rarely bill the
clinician group directly and may not be integrated with the clinician
group's EHR, interoperability remains a material issue. These
commenters requested that we weight the Promoting Interoperability
performance category at zero percent or allow new eligible clinicians
to opt-in to this performance category. Another commenter requested
clarification on whether the proposal to automatically assign a zero
percent weighting for the Promoting Interoperability performance
category for these new types of MIPS eligible clinicians applies to
both individual clinicians and groups. Another commenter asked for
clarification regarding if they could continue to report as a group.
One commenter questioned whether the additional clinicians would be
removed from the denominator for these measures. Other commenters asked
for clarification on how quality measures will be captured as most of
these clinicians may not have electronic medical records (EMRs).
Response: In the CY 2019 PFS proposed rule (83 FR 35883 through
35884) to assess whether these additional eligible clinicians could
successfully participate in MIPS, we evaluated whether there would be
sufficient measures and activities applicable and available for each of
the additional eligible clinician types. We did not focus on the
Promoting Interoperability performance category because for CY 2019 we
are finalizing to automatically assign a zero percent weighting for the
Promoting Interoperability performance category which will be
reweighted to the quality performance category for these new types of
MIPS eligible clinicians. In response to the comment, the proposal to
automatically assign a zero percent weighting for the Promoting
Interoperability performance category does apply to both individual
clinicians and groups. Clinicians may choose to report for MIPS as an
individual or as part of a group. If the clinician chooses to report as
part of a group, then under the policy we established previously (82 FR
53687), all of the MIPS eligible clinicians in the group must qualify
for a zero percent weighting in order for the Promoting
Interoperability performance category to be reweighted in the final
score. We refer readers to section III.I.3.h.(5)(h)(ii) of this final
rule for further details on the policy that we are finalizing in this
rule to automatically assign a zero percent weighting for the Promoting
Interoperability performance category. Regarding data submission
requirements for quality measures, the additional eligible clinicians
may submit their quality data through the same data collection types
available to all MIPS eligible clinicians including eCQMs, MIPS
Clinical Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B
claims measures, CMS Web Interface measures, the CAHPS for MIPS survey,
and administrative claims measures which may be submitted via one of
the submission types including: Direct; log in and upload; log in and
attest; Medicare Part B claims; and the CMS Web Interface. We refer
readers to section III.I.3.h.(1) in this final rule for further
information regarding performance category measures and reporting.
Comment: A few commenters requested that we be certain that we are
operationally prepared to support reporting and scoring for the
additional eligible clinician types, as clinicians have experienced
operational data submissions issues in the past.
Response: We intend to have our Quality Payment Program portal
ready to accept and process data for all MIPS eligible clinicians for
2021 MIPS payment year.
Comment: Several commenters requested clarification on how our
proposal would apply to eligible clinicians billing under a hospital-
or facility-based TIN. A few commenters stated that the rule does not
indicate whether hospitals should report the NPI of these clinicians on
the UB-04 claims used by hospitals and cautioned that adding these
clinician types to UB-04 claims would entail significant administrative
burden to hospitals. One commenter also stated that the majority of
facility-based outpatient therapy claims do not contain the rendering
NPI and usually contain just a facility NPI; therefore, most facility-
based outpatient therapy claims will not be eligible for MIPS. A few
commenters said that due to a technicality in how facility-based claims
(such as those submitted by inpatient rehabilitation facilities) are
submitted, only independently rendered, private practice outpatient
therapy services will be included in MIPS, and facility-based
outpatient therapy will generally not be included. One commenter
recommended that we operationalize the inclusion of facility-based
clinicians in MIPS by treating the facility NPI as a MIPS-participating
NPI and allow the facility to report measures under MIPS like a group.
Another commenter argued that facility-based outpatient therapy
clinicians should be included in the program. A few commenters sought
clarification of how clinicians of therapy services in skilled-nursing
facilities will be treated, stating that assessing individual
clinicians for quality and adjusting payment poses unique challenges in
this setting.
Response: These additional clinicians will be defined as MIPS
eligible clinicians and will be subject to the same requirements as
other MIPS eligible clinicians billing under a hospital- or facility-
based TIN. MIPS eligible clinician may report as an individual or as
part of a group. We finalized at Sec. 414.1380(e)(2)(i) and (ii) the
determination of a facility-based individual and facility-based group.
A facility-based individual is a MIPS eligible clinician that furnishes
75 percent or more of his or her covered professional services in sites
of service identified by the place of service codes used in the HIPAA
standard transaction as an inpatient hospital or emergency room setting
based on claims for a period prior to the performance period as
specified by CMS. A facility-based group is a group in which 75 percent
or more of its eligible clinician NPIs billing under the group's TIN
meet the facility-based individual determination. Therefore, if a MIPS
eligible clinician is submitting their data as part of a facility-based
group their NPI number would need to be annotated on the claim which is
part of normal billing practices. We refer readers to section
III.I.3.h.(2)(a)(iv) of this final rule for further details regarding
the application of facility-based measures. The definition of a
hospital-based clinician finalized at Sec. 414.1410 is primarily
applicable to the Promoting Interoperability performance category. We
refer readers to the CY 2018 Quality Payment Program final rule (82 FR
[[Page 59726]]
53684) for details on a hospital-based clinician. We are aware that
facility-based outpatient therapy and skilled nursing facility claims
do not contain the rendering NPI and usually contain just a facility
NPI; therefore, facility-based outpatient therapy and skilled nursing
facility claims will not be eligible for MIPS. For those billed
Medicare Part B allowed charges we are able to associate with a MIPS
eligible clinician at an NPI level, such covered professional services
furnished by such clinicians would be included for purposes of applying
any MIPS payment adjustment. It is our intention to provide clinicians
with their eligibility status prior to the performance period through
the Quality Payment Program portal eligibility determination tool. This
should allow clinicians to know ahead of time whether they are included
in MIPS or not. We will take these comments into consideration in
future rulemaking.
Comment: A few commenters noted that adding physical and
occupational therapists would affect the determination of practice
size. One commenter expressed concern that groups may lose their small
group status even though the composition of the practice did not
change.
Response: We do not anticipate that the small practice size
determination will be affected by adding additional clinicians to the
definition of MIPS eligible clinician. Small practice is defined at
Sec. 414.1305 to mean a practice consisting of 15 or fewer eligible
clinicians. Thus, the definition of small practice already accounts for
all eligible clinicians in the practice, including those that we are
adding to the definition of MIPS eligible clinician.
Comment: One commenter requested clarification regarding how the
additional MIPS eligible clinicians would be subject to payment
reductions if they do not meet the performance requirements under MIPS.
Response: The additional eligible clinicians, who are not otherwise
excluded, will be included in the performance requirements for a MIPS
eligible clinician for CY 2021 payment year. In addition, MIPS eligible
clinicians are subject to the MIPS payment adjustment factor.
Clinicians who are considered MIPS eligible and who do not report under
MIPS may receive a final score of zero and an associated negative
payment adjustment of 7 percent during the CY 2021 payment year.
Comment: Some commenters stated that the additional clinician types
could water down the performance pool, and increasing the number of
participants will create increased competition for an additional
performance threshold, making it more difficult for disadvantaged
clinicians to meaningfully participate in MIPS.
Response: Although the number of MIPS eligible clinicians will
increase, we do not anticipate that the additional clinicians will
substantially change the total number of MIPS eligible clinicians or
make it more difficult for other clinicians to meaningfully participate
in MIPS. Regarding the additional performance threshold, we note that
the eligible clinician must first qualify for the additional
performance threshold for exceptional performance. We do not believe
that the addition of new clinician types to be MIPS eligible implies
they are going to perform at a level that qualifies for the additional
performance threshold. We refer readers to Table 98 in section VII
(Regulatory Impact Analysis) of this final rule for information
regarding the impact of expanding the definition of MIPS eligible
clinicians on the total number of MIPS eligible clinicians and the
total estimated PFS amount paid.
Comment: One commenter believed it was unnecessary to include the
proposed additional eligible clinicians as they would more than likely
be ineligible because they would fall below the low-volume threshold.
Response: We understand that some of the additional eligible
clinicians may not exceed the low-volume threshold. However, as
discussed in section III.I.3.c.(5) of this final rule, we are also
finalizing an opt-in option that will allow eligible clinicians to opt-
in to MIPS if the eligible clinician or group meets or exceeds at least
one, but not all, of the low-volume threshold criteria. In addition,
MIPS eligible clinicians may participate in MIPS as part of a group or
virtual group which should improve their ability to exceed the low-
volume threshold. We believe this option would allow the additional
eligible clinicians the opportunity to participate in MIPS if they
desired to do so.
Comment: Several commenters suggested that there is misalignment
between the proposed expanded list of eligible clinician types for the
MIPS and the scope of clinician types for the Advanced Alternative
Payment Model path under the Quality Payment Program. Specifically, a
few commenters noted that, currently, a number of clinician types (for
example, clinical psychologists and certified nurse midwives) could be
in an Advanced APM, but that we are proposing to include clinician
types for MIPS that may not be eligible for the Advanced APM path under
the Quality Payment Program. Thus, commenters suggested that we
standardize the included clinician types across the Quality Payment
Program unless there are appropriate clinical reasons for differences.
One commenter requested clarification as to whether physical,
occupational, and speech therapists, as eligible clinicians, can
participate in the Advanced APMs path under the Quality Payment
Program. Another commenter requested that we provide guidance on how
APM entities, ACOs, and other health care organizations should identify
these clinician types on their clinician participation lists.
Response: We note that the proposed expanded list of eligible
clinician types for the MIPS is not misaligned with the scope of
eligible clinicians for the Advanced APMs path under the Quality
Payment Program. In accordance with section 1848(q)(1)(C)(i)(I) of the
Act, we defined MIPS eligible clinician for the 2019 and 2020 MIPS
payment years to include only physicians (as defined under section
1861(r) of the Act), physician assistants, nurse practitioners,
clinician nurse specialists, and certified registered nurse
anesthetists (and groups that include these clinicians). In contrast,
we explained in the CY 2017 Quality Payment Program final rule (81 FR
77405 through 77406), for the Advanced APM path under the Quality
Payment Program, the term ``eligible clinician'' is defined in section
1833(z)(3)(B) of the Act (by cross-reference to the definition of
``eligible professional'' in section 1848(k)(3)(B) of the Act), and
includes: Physicians, physician assistants, nurse practitioners,
clinical nurse specialists, certified registered nurse anesthetists,
certified nurse-midwives, clinical social workers, clinical
psychologists, registered dietitians or nutrition professionals,
physical or occupational therapists, qualified speech-language
pathologists, and qualified audiologists, and a group that includes
these professionals. Our proposed expansion of the list of MIPS
eligible clinician types would actually align with the current scope of
eligible clinicians under the Advanced APM path of the Quality Payment
Program. Currently, any of those eligible clinicians who participate
sufficiently in Advanced APMs can become QPs for a year and receive the
associated APM Incentive Payment. We note that each APM has its own
focus, and many offer participation opportunities for a broad scope of
eligible clinicians. Although the design of existing or future APMs is
beyond the scope of this final rule, we welcome ideas on how to further
engage
[[Page 59727]]
the full scope of eligible clinicians as we work hard to develop more
APM opportunities. Additionally, we finalized in the CY 2017 Quality
Payment Program final rule (81 FR 77442) that the eligible clinicians
for whom we would make QP determinations would be all the eligible
clinicians participating in an APM Entity in an Advanced APM, as
identified at each of three snapshot dates, during a QP Performance
Period. The eligible clinicians for whom we make QP determinations are
those identified on an Advanced APM's Participation List or Affiliated
Practitioner List on one of those three dates. Lastly, we note that
decisions about the eligible clinicians that are included on the
Participation List or Affiliated Practitioner List for any particular
Advanced APM are made based on the specific terms and conditions of the
Advanced APM, which can vary based on the model test, entities
involved, payment arrangements, and other factors.
After consideration of the public comments received, we are
finalizing a modification of our proposal to amend Sec. 414.1305 to
revise the definition of a MIPS eligible clinician, as identified by a
unique billing TIN and NPI combination used to assess performance, to
mean any of the following (excluding those identified at Sec.
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a
physician assistant, nurse practitioner, and clinical nurse specialist
(as such terms are defined in section 1861(aa)(5) of the Act); a
certified registered nurse anesthetist (as defined in section
1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a
physical therapist, occupational therapist, qualified speech-language
pathologist; qualified audiologist (as defined in section
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the
Secretary for purposes of section 1861(ii) of the Act); and registered
dietician or nutrition professional; and a group that includes such
clinicians.
b. MIPS Determination Period
As discussed in the proposed rule (83 FR 35884 through 35886),
currently MIPS uses various determination periods to identify certain
MIPS eligible clinicians for consideration for certain applicable
policies. For example, the low-volume threshold, non-patient facing,
small practice, hospital-based, and ambulatory surgical center (ASC)-
based determinations are on the same timeline with slight differences
in the claims run-out policies, whereas the facility-based
determinations has a slightly different determination period. The
virtual group eligibility determination requires a separate election
process. We proposed to add a virtual group eligibility determination
period beginning in CY 2020 as discussed in section III.I.3.f.(2)(a) of
this final rule. In addition, the rural and HPSA determinations do not
utilize a determination period.
Under Sec. 414.1305, the low-volume threshold determination period
is described as a 24[dash]month assessment period consisting of an
initial 12[dash]month segment that spans from the last 4 months of the
calendar year 2 years prior to the performance period through the first
8 months of the calendar year preceding the performance period, and a
second 12[dash]month segment that spans from the last 4 months of the
calendar year 1 year prior to the performance period through the first
8 months of the calendar year performance period. An individual
eligible clinician or group that is identified as not exceeding the
low-volume threshold during the initial 12[dash]month segment will
continue to be excluded under Sec. 414.1310(b)(1)(iii) for the
applicable year regardless of the results of the second 12-month
segment analysis. For the 2020 MIPS payment year and future years, each
segment of the low-volume threshold determination period includes a 30-
day claims run out.
Under Sec. 414.1305, the non-patient facing determination period
is described as a 24[dash]month assessment period consisting of an
initial 12[dash]month segment that spans from the last 4 months of the
calendar year 2 years prior to the performance period through the first
8 months of the calendar year preceding the performance period and a
second 12[dash]month segment that spans from the last 4 months of the
calendar year 1 year prior to the performance period through the first
8 months of the calendar year performance period. An individual
eligible MIPS clinician, group, or virtual group that is identified as
non-patient facing during the initial 12-month segment will continue to
be considered non-patient facing for the applicable year regardless of
the results of the second 12[dash]month segment analysis. For the 2020
MIPS payment year and future years, each segment of the non-patient
facing determination period includes a 30[dash]day claims run out.
In the CY 2018 Quality Payment Program final rule (82 FR 53581), we
finalized that for the small practice size determination period, we
would utilize a 12-month assessment period, which consists of an
analysis of claims data that spans from the last 4 months of a calendar
year 2 years prior to the performance period followed by the first 8
months of the next calendar year and includes a 30-day claims run out.
In the CY 2017 Quality Payment Program final rule (81 FR 77238
through 77240), we finalized that to identify a MIPS eligible clinician
as hospital-based we would use claims with dates of service between
September 1 of the calendar year 2 years preceding the performance
period through August 31 of the calendar year preceding the performance
period, but in the event it is not operationally feasible to use claims
from this time period, we would use a 12-month period as close as
practicable to this time period.
In the CY 2018 Quality Payment Program final rule (82 FR 53684
through 53685), we finalized that to identify a MIPS eligible clinician
as ASC-based, we would use claims with dates of service between
September 1 of the calendar year 2 years preceding the performance
period through August 31 of the calendar year preceding the performance
period, but in the event it is not operationally feasible to use claims
from this time period, we would use a 12-month period as close as
practicable to this time period.
In the CY 2018 Quality Payment Program final rule (82 FR 53760), we
discussed, but did not finalize, our proposal or the alternative option
for how an individual clinician or group would elect to use and be
identified as using facility-based measurement for the MIPS program.
Because we were not offering facility-based measurement until the 2019
MIPS performance period, we did not need to finalize either of these
for the 2018 MIPS performance period. However, as discussed in section
III.I.3.i.(1)(d) of this final rule, we proposed to amend Sec.
414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be
eligible for facility-based measurement. Specifically, that is, the
clinician furnishes 75 percent or more of his or her covered
professional services in sites of service identified by the place of
service codes used in the HIPAA standard transaction as an inpatient
hospital, on-campus outpatient hospital, or emergency room setting
based on claims for a 12-month segment beginning on October 1 of the
calendar year 2 years prior to the applicable performance period and
ending on September 30 of the calendar year preceding the applicable
performance period with a 30-days claims run out. We did not propose to
utilize the MIPS determination period for purposes of the facility-
based determination because for the facility-based determination, we
are only using the first segment of the MIPS determination period. We
are using the
[[Page 59728]]
first segment because the performance period for measures in the
hospital value-based purchasing program overlapped in part with that
determination period. If we were to use the second segment, we could
not be assured that the clinician actually worked in the hospital on
which their MIPS score would be based during that time. We believe this
approach provides clarity and is a cleaner than providing a special
exception for the facility-based determination in the MIPS
determination period for the second segment. We refer readers to
section III.I.3.i.(1)(d) for further details on the facility-based
determinations and the time periods that are applicable to those
determinations.
In the CY 2018 Quality Payment Program final rule (82 FR 53602
through 53604), we finalized that for the virtual group eligibility
determination period, we would utilize an analysis of claims data
during an assessment period of up to 5 months that would begin on July
1 and end as late as November 30 of the calendar year prior to the
applicable performance period and include a 30-day claims run out. To
capture a real-time representation of TIN size, we finalized that we
would analyze up to 5 months of claims data on a rolling basis, in
which virtual group eligibility determinations for each TIN would be
updated and made available monthly. We noted that an eligibility
determination regarding TIN size is based on a relative point in time
within the 5-month virtual group eligibility determination period, and
not made at the end of such 5-month determination period. Beginning
with the 2019 performance period, we proposed to amend Sec.
414.1315(c)(1) to establish a virtual group eligibility determination
period to align with the first segment of the MIPS determination
period, which includes an analysis of claims data during a 12-month
assessment period (fiscal year) that would begin on October 1 of the
calendar year 2 years prior to the applicable performance period and
end on September 30 of the calendar year preceding the applicable
performance period and include a 30-day claims run out. We refer
readers to section III.I.3.f.(2)(a) of this final rule for further
details on this proposal.
In addition, we have established other special status
determinations, including rural area and HPSA. Rural area is defined at
Sec. 414.1305 as a ZIP code designated as rural, using the most recent
Health Resources and Services Administration (HRSA) Area Health
Resource File data set available. HPSAs are defined at Sec. 414.1305
as areas designated under section 332(a)(1)(A) of the Public Health
Service Act.
We understand that the current use of various MIPS determination
periods is complex and causes confusion. Therefore, beginning with the
2021 MIPS payment year, we proposed to consolidate several of these
policies into a single MIPS determination period that would be used for
purposes of the low-volume threshold and to identify MIPS eligible
clinicians as non-patient facing, a small practice, hospital-based, and
ASC-based, as applicable. We did not propose to include the facility-
based or virtual group eligibility determination periods or the rural
and HPSA determinations in the MIPS determination period, as they each
require a different process or timeline that does not align with the
other determination periods, or do not utilize determination periods.
We invited public comments on the possibility of incorporating these
determinations into the MIPS determination period in the future.
There are several reasons we believe a single MIPS determination
period for most of the eligibility criteria is the most appropriate.
First, it would simplify the program by aligning most of the MIPS
eligibility determination periods. Second, it would continue to allow
us to provide eligibility determinations as close to the beginning of
the performance period as feasible. Third, we believe a timeframe that
aligns with the fiscal year is easier to communicate and more
straightforward to understand compared to the current determination
periods. Finally, it would allow us to extend our data analysis an
additional 30 days.
It is important to note that during the final 3 months of the
calendar year in which the performance period occurs, in general, we do
not believe it would be feasible for many MIPS eligible clinicians who
join an existing practice (existing TIN) or join a newly formed
practice (new TIN) to participate in MIPS as individuals. We refer
readers to section III.I.3.i.(2)(b) of this final rule for more
information on the proposed reweighting policies for MIPS eligible
clinicians who join an existing practice or who join a newly formed
practice during this timeframe.
We requested comments on our proposal that beginning with the 2021
MIPS payment year, the MIPS determination period would be a 24-month
assessment period including a two-segment analysis of claims data
consisting of: (1) An initial 12-month segment beginning on October 1
of the calendar year 2 years prior to the applicable performance period
and ending on September 30 of the calendar year preceding the
applicable performance period; and (2) a second 12-month segment
beginning on October 1 of the calendar year preceding the applicable
performance period and ending on September 30 of the calendar year in
which the applicable performance period occurs. The first segment would
include a 30[dash]day claims run out. The second segment would not
include a claims run out, but would include quarterly snapshots for
informational use only, if technically feasible. For example, a
clinician could use the quarterly snapshots to understand their
eligibility status between segments. Specifically, we believe the
quarterly snapshots would be helpful for new TIN/NPIs and TINs created
between the first segment and the second segment allowing them to see
their preliminary eligibility status sooner. Without the quarterly
snapshots, these clinicians would not have any indication of their
eligibility status until just before the submission period. An
individual eligible clinician or group that is identified as not
exceeding the low-volume threshold, or a MIPS eligible clinician that
is identified as non-patient facing, a small practice, hospital-based,
or ASC-based, as applicable, during the first segment would continue to
be identified as such for the applicable MIPS payment year regardless
of the second segment. For example, for the 2021 MIPS payment year, the
first segment would be October 1, 2017 through September 30, 2018, and
the second segment would be October 1, 2018 through September 30, 2019.
However, based on our experience with the Quality Payment Program, we
believe that some eligible clinicians, whose TIN or TIN/NPIs are
identified as eligible during the first segment and do not exist in the
second segment, are no longer utilizing these same TIN or TIN/NPI
combinations. Therefore, because those TIN or TIN/NPIs would not exceed
the low-volume threshold in the second segment, they would no longer be
eligible for MIPS. For example, in the 2019 performance period a
clinician exceeded the low-volume threshold during the first segment of
the determination period (data from the end of CY 2017 to early 2018)
under one TIN; then in CY 2019 the clinician switches practices under a
new TIN and during segment two of the determination period. Therefore,
it is determined that the clinician is not eligible (based on CY 2019
data) under either TIN. This clinician would not be eligible to
participate in MIPS based on either segment of the determination
[[Page 59729]]
period because the TIN that was assessed for the first segment of the
determination period no longer exists. So there are no charges or
services that would be available to assess in the second segment for
that TIN and the new TIN assessed during the second segment was not
eligible. In this scenario, though the clinician exceeded the low-
volume threshold criteria initially, the clinician is not required to
submit any data based on TIN eligibility determinations. However, it is
important to note that if a TIN or TIN/NPI did not exist in the first
segment but does exist in the second segment, these eligible clinicians
could be eligible for MIPS. For example, the eligible clinician may not
find their TIN or TIN/NPI in the Quality Payment Program lookup tool
but may still be eligible if they exceed the low-volume threshold in
the second segment. We proposed to incorporate this policy into our
proposed definition of MIPS determination period at Sec. 414.1305. We
also requested comments on our proposals to define MIPS determination
period at Sec. 414.1305 and modify the definitions of low-volume
threshold, non-patient facing, a small practice, hospital-based, and
ASC-based at Sec. 414.1305 to incorporate references to the MIPS
determination period.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Several commenters supported our proposal, noting that the
varying determination periods add unnecessary confusion and this policy
would reduce complexity. One commenter recommended we continue our
efforts to align the determination period with facility-based, virtual
groups, and rural and HPSA eligibility determinations.
Response: We appreciate the commenters' support.
Comment: Some commenters stated that in order for clinicians to
successfully perform over a 12-month period for the cost and quality
performance categories, the clinician must know before the start of the
performance period their full eligibility status for MIPS.
Response: We understand that it is important for clinicians to know
their eligibility status prior to the performance period. It is our
intention to provide eligibility determinations as close to the
beginning of the performance period as feasible. We would like to
assure commenters that we are working diligently to provide clinicians
with this information at the earliest time possible.
Comment: A few commenters supported using quarterly snapshots for
the second segment of the MIPS determination period to show preliminary
eligibility status. One commenter recommended that the first quarterly
snapshot for the second segment be mandated to be available in the
look-up tool no later than January 1, 2019, the first day of the CY
2019 performance period. One commenter recommended that if a clinician
does not exceed the low-volume threshold during the quarterly
snapshots, then they should be automatically excluded from MIPS unless
further snapshots allow for an opt-in similar to the proposed low-
volume threshold opt-in policy.
Response: While the statute does not require the use of quarterly
snapshots, we believe the snapshots may provide useful information for
eligible clinicians. Therefore, we are working to provide the quarterly
snapshots, if feasible. In addition, it is important to note that the
quarterly snapshots are being provided for informational use only and
are not final until after the second segment of the MIPS determination
period closes and a reconciliation between the segments occurs. Since
the quarterly snapshots are not final this information is subject to
change and should not be considered the final eligibility
determination. The eligibility determination will be made after a
reconciliation of the first and second segment of the MIPS
determination period.
Comment: Several commenters did not support the proposed 24-month
MIPS determination period, with most arguing for a single determination
period. These commenters recommended that the MIPS determination period
be a single, 12-month segment beginning on October 1 of the calendar
year preceding the applicable performance period and ending on
September 30 of the calendar year in which the applicable performance
period occurs. Another commenter stated that a preliminary assessment
for the exclusions would be useful, but the final decision should be
made only based on performance period data. One commenter stated that
the two segments lead to confusion and uncertainty about participation
status and requested that the second segment have an end date and
notification date prior to the start of the performance year. Another
commenter opposed the shift in determination period dates unless the
eligibility tool on the Quality Payment Program website is updated in a
timely fashion prior to the performance year.
Response: If we had a singular eligibility determination period we
would not be able to identify eligible clinicians who switch practices
between the first and second segments of the MIPS determination period.
We estimate that this would affect approximately 13 percent of MIPS
eligible clinicians who may switch practices between the first and
second determination periods. If we did not conduct the first segment
analyses then there would be no way to inform clinicians of their
eligibility status prior to the performance period. The second segment
accounts for the identification of additional, previously unidentified
individual eligible clinicians and groups who do not exceed the low-
volume threshold or meet other special circumstances. It is our
intention that the eligibility tool on the Quality Payment Program
website will be updated to provide eligibility determinations prior to
the start of the performance period.
Comment: A few commenters noted the challenge for clinicians who
exceeded the low-volume threshold during the first segment of the MIPS
determination period and then discovered late in the performance
period, after the second segment of the MIPS determination period that
they are no longer eligible. One commenter suggested that if a
clinician exceeds the low-volume threshold during the second segment of
MIPS eligibility determination period, the clinician should remain
excluded unless the clinician opts-in. One commenter noted that these
issues may be less of a problem if the opt-in proposal is finalized.
Another commenter requested the definition of the MIPS determination
period be expanded to account for scenarios when an eligible clinician
or group exceeded the low-volume threshold during the first segment but
falls below the low-volume threshold during the second segment or when
a eligible clinician or group is not categorized as a special status
(such as non-patient facing) during the first segment but gains special
status during the second segment.
Response: We agree that the issues identified by the commenters may
be alleviated with the opt-in policy. If an eligible clinician finds
out following the second segment of the MIPS determination period that
they are no longer eligible to participate in MIPS and they meet the
requirements of the opt-in policy they may choose to participate in
MIPS by opting-in to MIPS. Regarding changing statuses between the two
segments of the MIPS determination period, we are finalizing
[[Page 59730]]
the definition of the MIPS determination period at Sec. 414.1305(2)
that subject to Sec. 414.1310(b)(1)(iii), an individual eligible
clinician or group that is identified as not exceeding the low-volume
threshold or as having special status during the first segment of the
MIPS determination period will continue to be identified as such for
the applicable MIPS payment year regardless of the results of the
second segment of the MIPS determination period. An individual eligible
clinician or group for which the unique billing TIN and NPI combination
is established during the second segment of the MIPS determination
period will be assessed based solely on the results of that segment.
While we would like to ensure that there is as much flexibility as
possible within the MIPS program, we believe it is important that MIPS
eligible clinicians choose how they will participate in MIPS as a
whole, either as an individual or as a group. Whether MIPS eligible
clinicians participate in MIPS as an individual or group, it is
critical for us to assess the performance of individual MIPS eligible
clinicians or groups across the four performance categories
collectively as either an individual or group in order for the final
score to reflect performance at a true individual or group level and to
ensure the comparability of data.
After consideration of the public comments received, we are
finalizing our proposal to define MIPS determination period at Sec.
414.1305 beginning with the 2021 MIPS payment year, as a 24-month
assessment period including a two-segment analysis of claims data
consisting of: (1) An initial 12-month segment beginning on October 1
of the calendar year 2 years prior to the applicable performance period
and ending on September 30 of the calendar year preceding the
applicable performance period; and (2) a second 12-month segment
beginning on October 1 of the calendar year preceding the applicable
performance period and ending on September 30 of the calendar year in
which the applicable performance period occurs. The first segment would
include a 30-day claims run out. The second segment would not include a
claims run out, but would include quarterly snapshots for informational
use only, if technically feasible. In addition, we are finalizing that
subject to Sec. 414.1310(b)(1)(iii), an individual eligible clinician
or group that is identified as not exceeding the low-volume threshold
or as having special status during the first segment of the MIPS
determination period will continue to be identified as such for the
applicable MIPS payment year regardless of the results of the second
segment of the MIPS determination period. An individual eligible
clinician or group for which the unique billing TIN and NPI combination
is established during the second segment of the MIPS determination
period will be assessed based solely on the results of that segment.
Finally, at Sec. 414.1305 we are finalizing our proposal to modify the
definitions of low-volume threshold, non-patient facing MIPS eligible
clinician, a small practice, hospital-based MIPS eligible clinician,
and ASC-based MIPS eligible clinician at Sec. 414.1305 to incorporate
references to the MIPS determination period.
c. Low-Volume Threshold
(1) Overview
As discussed in the CY 2019 PFS proposed rule (83 FR 35886),
section 1848(q)(1)(C)(iv) of the Act, as amended by section
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that,
for performance periods beginning on or after January 1, 2018, the low-
volume threshold selected by the Secretary may include one or more or a
combination of the following (as determined by the Secretary): (1) The
minimum number of part B-enrolled individuals who are furnished covered
professional services (as defined in section 1848(k)(3)(A) of the Act)
by the eligible clinician for the performance period involved; (2) the
minimum number of covered professional services furnished to part B-
enrolled individuals by such clinician for such performance period; and
(3) the minimum amount of allowed charges for covered professional
services billed by such clinician for such performance period.
Under Sec. 414.1310(b)(1)(iii), for a year, eligible clinicians
who do not exceed the low-volume threshold for the performance period
with respect to a year are excluded from MIPS. Under Sec. 414.1305,
the low-volume threshold is defined as, for the 2019 MIPS payment year,
the low-volume threshold that applies to an individual eligible
clinician or group that, during the low-volume threshold determination
period, has Medicare Part B allowed charges less than or equal to
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare
beneficiaries. In addition, for the 2020 MIPS payment year and future
years, the low-volume threshold is defined as the low-volume threshold
that applies to an individual eligible clinician or group that, during
the low-volume threshold determination period, has Medicare Part B
allowed charges less than or equal to $90,000 or provides care for 200
or fewer Part B-enrolled Medicare beneficiaries. The low-volume
threshold determination period is a 24-month assessment period
consisting of: (1) An initial 12-month segment that spans from the last
4 months of the calendar year 2 years prior to the performance period
through the first 8 months of the calendar year preceding the
performance period; and (2) a second 12-month segment that spans from
the last 4 months of the calendar year 1 year prior to the performance
period through the first 8 months of the calendar year performance
period. An individual eligible clinician or group that is identified as
not exceeding the low-volume threshold during the initial 12-month
segment will continue to be excluded under Sec. 414.1310(b)(1)(iii)
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of
the low-volume threshold determination period includes a 60-day claims
run out. For the 2020 MIPS payment year, each segment of the low-volume
threshold determination period includes a 30-day claims run out.
(2) Amendments To Comply With the Bipartisan Budget Act of 2018
In the CY 2019 PFS proposed rule (83 FR 35887), we proposed to
amend Sec. 414.1305 to modify the definition of low-volume threshold
in accordance with section 1848(q)(1)(C)(iv) of the Act, as amended by
section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018.
Specifically, we requested comments on our proposals that for the 2020
MIPS payment year, we will utilize the minimum number (200 patients) of
Part B-enrolled individuals who are furnished covered professional
services by the eligible clinician or group during the low-volume
threshold determination period or the minimum amount ($90,000) of
allowed charges for covered professional services to Part B-enrolled
individuals by the eligible clinician or group during the low-volume
threshold determination period.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: A few commenters supported the technical amendments passed
by Congress in the Bipartisan Budget Act of 2018, specifically noting
support for the proposal to not use Part B drugs for the low-volume
threshold determinations, and to rely instead on covered professional
services (instead of all Medicare Part B items and services) to
determine MIPS eligibility. Other commenters supported that items or
services beyond the PFS, especially Part B drugs, would not be subject
to the
[[Page 59731]]
MIPS payment adjustment factor or the MIPS additional payment
adjustment factor.
Response: We appreciate the commenters' support.
Comment: One commenter expressed concern about using covered
professional services for low-volume threshold determinations because
it could make it difficult for eligible clinicians and groups to
predict whether they are subject or excluded from MIPS. Additionally,
the commenter recommended that we provide timely notification based on
the results of the first determination period.
Response: We understand that utilizing covered professional
services rather than all Medicare Part B items and services is a
different approach to calculating the low-volume threshold. For the CY
2018 and CY 2019 MIPS payment years, we have utilized two calculations
in order to make low-volume threshold determinations: The number of
patients and the amount of allowed charges for each eligible clinician
or group. These calculations were based on the patients who were
furnished any Part B item or service, and on the allowed charges for
all Part B items and services. Beginning for the 2020 MIPS payment
year, the calculations will instead be based only on covered
professional services. A clinician may identify and monitor a claim to
distinguish covered professional services from Part B items and
services by calculating one professional claim line with positive
allowed charges to be considered one covered professional service. In
addition, we believe the quarterly snapshots will be helpful for new
TIN/NPIs and TINs created between the first segment and the second
segment allowing them to see their preliminary eligibility status
sooner. In addition, we believe these policies will allow clinicians to
understand their eligibility determination as close to the beginning of
the performance period as feasible.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1305 to modify the
definition of low-volume threshold to mean for the 2020 MIPS payment
year, we will utilize the minimum number (200 patients) of Part B-
enrolled individuals who are furnished covered professional services by
the eligible clinician or group during the low-volume threshold
determination period or the minimum amount ($90,000) of allowed charges
for covered professional services to Part B-enrolled individuals by the
eligible clinician or group during the low-volume threshold
determination period.
(3) MIPS Program Details
In the CY 2019 PFS proposed rule (83 FR 35887), we requested
comments on our proposal to modify Sec. 414.1310 to specify in
paragraph (a), Program Implementation, that except as specified in
paragraph (b), MIPS applies to payments for covered professional
services furnished by MIPS eligible clinicians on or after January 1,
2019. We also requested comments on our proposal to revise Sec.
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible
clinician does not include an eligible clinician that is a Partial
Qualifying APM Participant (as defined in Sec. 414.1305) and does not
elect, as discussed in section III.I.4.e. of this final rule, to report
on applicable measures and activities under MIPS. Finally, we requested
comments on our proposal to revise Sec. 414.1310(d) to specify that,
in no case will a MIPS payment adjustment factor (or additional MIPS
payment adjustment factor) apply to payments for covered professional
services furnished during a year by eligible clinicians (including
those described in paragraphs (b) and (c) of this section) who are not
MIPS eligible clinicians, including those who voluntarily report on
applicable measures and activities under MIPS.
We did not receive any comments regarding these proposals.
We are finalizing our proposal to modify Sec. 414.1310 to specify
in paragraph (a), Program Implementation, that except as specified in
paragraph (b), MIPS applies to payments for covered professional
services furnished by MIPS eligible clinicians on or after January 1,
2019. We are also finalizing our proposal to revise Sec.
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible
clinician does not include an eligible clinician that is a Partial
Qualifying APM Participant (as defined in Sec. 414.1305) and does not
elect, as discussed in section III.I.4.e. of this final rule, to report
on applicable measures and activities under MIPS. Finally, we are
finalizing our proposal to revise Sec. 414.1310(d) to specify that, in
no case will a MIPS payment adjustment factor (or additional MIPS
payment adjustment factor) apply to payments for covered professional
services furnished during a year by eligible clinicians (including
those described in paragraphs (b) and (c) of this section) who are not
MIPS eligible clinicians, including those who voluntarily report on
applicable measures and activities under MIPS.
(4) Addition of Low-Volume Threshold Criterion Based on Number of
Covered Professional Services
In the CY 2018 Quality Payment Program final rule (82 FR 53591), we
received several comments in response to the proposed rule regarding
adding a third criterion of items and services for defining the low-
volume threshold. We refer readers to that rule for further details.
As discussed in the CY 2019 PFS proposed rule (83 FR 35887) for the
2021 MIPS payment year and future years, we proposed to add one
additional criterion to the low-volume threshold determination--the
minimum number of covered professional services furnished to Part B-
enrolled individuals by the clinician. Specifically, we requested
comments on our proposal, for the 2021 MIPS payment year and future
years, that eligible clinicians or groups who meet at least one of the
following three criteria during the MIPS determination period will not
exceed the low-volume threshold: (1) Those who have allowed charges for
covered professional services less than or equal to $90,000; (2) those
who provide covered professional services to 200 or fewer Part B-
enrolled individuals; or (3) those who provide 200 or fewer covered
professional services to Part B-enrolled individuals.
For the third criterion, we proposed to set the threshold at 200 or
fewer covered professional services furnished to Part B-enrolled
individuals for several reasons. First, in the CY 2018 Quality Payment
Program final rule (82 FR 53589 through 53590), although we received
positive feedback from stakeholders on the increased low-volume
threshold, we also heard from some stakeholders that they would like to
participate in the program. Second, setting the third criterion at 200
or fewer covered professional services, combined with our proposed
policy with respect to opting in to MIPS, allows us to ensure that a
significant number of eligible clinicians have the ability to opt-in if
they wish to participate in MIPS. Finally, when we considered where to
set the low-volume threshold for covered professional services, we
examined two options: 100 or 200 covered professional services. For 100
covered professional services, there is some historical precedent. In
the CY 2017 Quality Payment Program final rule (81 FR 77062), we
finalized a low-volume threshold that excluded individual eligible
clinicians or groups that have Medicare Part B allowed charges less
than $30,000 or that provide care for 100 or fewer Part B-
[[Page 59732]]
enrolled Medicare beneficiaries; we believe the latter criterion is
comparable to 100 covered professional services. Conversely for 200
covered professional services, in the CY 2018 Quality Payment Program
final rule with comment period (82 FR 53588), we discussed that based
on our data analysis, excluding individual eligible clinicians or
groups that have Medicare Part B allowed charges less than or equal to
$90,000 or that provide care for 200 or fewer Part B-enrolled Medicare
beneficiaries decreased the percentage of MIPS eligible clinicians that
come from small practices. In addition, in the CY 2018 Quality Payment
final rule (82 FR 53955), we codified at Sec. 414.1380(b)(1)(iv) that
the minimum case requirements for quality measures are 20 cases, which
both services thresholds being considered (100 or 200) exceed. We also
codified at Sec. 414.1380(b)(1)(v) that the minimum case requirement
for the all-cause hospital readmission measure is 200 cases, which only
the 200 services threshold consideration exceeds. We believe that
setting a threshold of 200 services for the third criterion, combined
with our proposed policy for opting in to MIPS, strikes the appropriate
balance between allowing a significant number of eligible clinicians
the ability to opt-in (as described in this section) to MIPS and
consistency with the previously established low-volume threshold
criteria. In section VII.F.8.b. of this final rule, we estimated no
additional clinicians would be excluded if we add the third criterion
because a clinician that cares for at least 200 beneficiaries would
have at least 100 or 200 services; however, we estimate 27,903
clinicians would opt-in with the low-volume threshold at 200 services,
as compared to 12,242 clinicians if we did not add the third criterion.
If we set the third criterion at 100 services, then we estimate 32,828
clinicians would opt-in.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported the low-volume threshold
criteria and the newly proposed criterion based on number of covered
professional services. Many commenters noted this policy will reduce
burden, will help mitigate adverse effects on solo and small or rural
practices, and combined with the opt-in policy, allow practices to
transition into MIPS. Commenters specifically noted that the addition
of the third criteria and the proposed opt-in policy will permit
clinicians who are ready to participate if they had been previously
excluded. Several commenters also mentioned the newly proposed
criterion would increase the number of eligible clinicians that are
able to participate in MIPS.
Response: We appreciate the commenters' support.
Comment: One commenter noted concern that MIPS reporting
requirements may place significant financial, administrative, and
operational burdens on clinicians treating a low volume of Medicare
patients.
Response: It is important to note that clinicians who treat a low-
volume of Part B Medicare beneficiaries may be excluded from MIPS if
they fall below the low-volume threshold.
Comment: Many commenters opposed the low-volume threshold criteria
because they noted the thresholds for the individual criteria are too
high and excluded too many clinicians and added complexity. Many of
these commenters stated that the proposed low-volume threshold limits
the number of clinicians in the budget neutral pool and effectively
precludes MIPS eligible clinicians with good performance from earning
more than a nominal payment adjustment. Several commenters expressed
concern that eligible clinicians who make large financial commitments
and organizational infrastructure modifications to obtain designation
as exceptional performers would be adversely affected. A few commenters
noted that practices with these types of clinicians do not have large
compliance staff and other resources that larger groups have, and
therefore, it may be difficult for these clinicians to report and
navigate the program with short notice. Many commenters also stated the
proposed low-volume threshold would not move the Quality Payment
Program toward value and could jeopardize clinicians, particularly
those in small or rural practices, by leaving them unprepared should
they become MIPS eligible. One commenter expressed concerned that the
threshold could make it difficult to benchmark data because fewer
practices would be expected to participate in the program. One
commenter requested lowering the performance threshold to the $30,000
in Part B claims or 100 Part B patients threshold that we utilized for
2017 MIPS performance period or lowering the criteria for the opt-in
policy. A few commenters recommended that we consider revisiting the
low-volume thresholds to increase the percentage of clinicians that are
eligible.
Response: We believe that the proposed low-volume threshold strikes
the correct balance by including a sufficient number of clinicians,
while excluding those who are not quite ready to participate and need
additional time to prepare, such as clinicians in small and rural
practices. The addition of the third criterion for covered professional
services, in conjunction with the opt-in policy, creates a highly-
desired opportunity to join MIPS and provides new flexibility for
clinicians otherwise excluded to drive value and improve patient
outcomes when they are prepared to meaningfully participate. We have
heard feedback from many clinicians indicating the desire to
participate in MIPS. This feedback was especially prominent from
clinicians in small practices who were initially included in the 2017
performance year, but excluded in 2018 due to the increase in the low-
volume threshold. The addition of the third criterion for covered
professional services, in conjunction with the opt-in policy, provides
new flexibilities to participate in MIPS, which creates opportunities
for clinicians to drive value and improve patient outcomes. While we
understand that the inclusion of any new element may add complexity, we
believe that this enhancement will benefit both clinicians and
beneficiaries. We will work closely with the clinician and stakeholder
community to develop educational resources to help clarify the
requirements and reduce any potential confusion. Further, we do not
believe that the addition of the third criterion for covered
professional services will exclude more clinicians, as clinicians who
are currently treating over 200 beneficiaries would likely also be
furnishing over 200 covered professional services. As discussed, in
section III.I.3.j. of this final rule, we are finalizing our proposal
to increase the MIPS performance threshold to 30 points and the
exceptional performance bonus to 75 points in 2019. We believe that
this will likely result in an evolving distribution of payment
adjustments for high performing clinicians who have made the
investments to advance quality improvement, enhance clinical practice,
and improve outcomes for beneficiaries.
We understand that some MIPS eligible clinicians may work in small
group practices and may not have the same resources as a large group.
As discussed in the proposed rule (83 FR 35882) we intend to continue
to offer tailored flexibilities to help these clinicians to participate
in the program. For example, we are finalizing to retain a small
practice bonus under MIPS by moving it to the quality performance
category. We will also continue to
[[Page 59733]]
support small and rural practices by offering free and customized
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative
along with our other no-cost technical assistance. Further, we note
that we are finalizing to amend our regulatory text to allow small
practices to continue using the Medicare Part B claims collection type
and submission types, either as an individual or as a group. Finally,
small practices may continue to choose to participate in MIPS as a
virtual group. In addition, we will continue offering the voluntary
reporting option, and encourage clinicians to pursue this pathway so
that they can familiarize themselves with the program requirements and
prepare to participate in future years. We clarify that for the first
several years of MIPS, which we view as transitional, we anticipate
that the distribution of MIPS payment adjustments will be spread across
many more clinicians and groups due to the moderate performance
thresholds and not necessarily because clinicians are excluded by the
low-volume threshold. For example, in 2017, the performance threshold
was set at 3 points, which resulted in an estimated participation rate
of 91 percent of MIPS eligible clinicians. As discussed in section
III.I.3.j. of this final rule, we are finalizing our proposal to
increase the MIPS performance threshold to 30 points and the
exceptional performance bonus to 75 points in 2019, which we anticipate
will likely result in an evolving distribution of payment adjustments
for high performing clinicians who have made the investments to advance
quality improvement, enhance clinical practice, and improve outcomes
for beneficiaries.
We do not believe that the total amount of dollars available for
the payment adjustments is low because too many clinicians are excluded
from the program. After incorporating the data submitted for the 2017
MIPS performance period (which we refer to as Quality Payment Program
Year 1 data) to estimate the CY 2021 MIPS payment year, an estimated
three-quarters (approximately $66.6B) of all PFS dollars will be
included in the CY 2021 MIPS payment year. Of the remaining one-quarter
(approximately $23.2B), only 2 percent (or less than 1 percent of total
PFS dollars) were associated with clinicians who did not meet the low-
volume threshold. The remaining clinicians excluded from the budget
neutral payment adjustments were Qualifying APM Participants,
clinicians with ineligible specialties, and newly enrolled clinicians
(11 percent of total PFS dollars). We considered the impact of lowering
the low-volume threshold to $30,000/100 beneficiaries/100 covered
professional services from the finalized low-volume threshold of this
final rule based on the budget neutrality distributions and the size of
the total payments. As seen in Figure 1, reducing the low-volume
threshold to $30,000/100 beneficiaries/100 covered professional
services) \16\ leads to an increase in the number of MIPS eligible
clinicians (by approximately 73,000 clinicians) and on the dollars
available in the budget neutral pool ($131M), but has minimal impact on
the maximum possible positive payment adjustment. The majority of
clinicians excluded from MIPS with the higher low-volume threshold are
clinicians in small practices with fewer than 15 clinicians. We
understand the importance of ensuring meaningful participation in the
program. We will continue to strike a balance between ensuring
sufficient participation in MIPS while also addressing the needs of
small practices that may find it difficult to meet the program
requirements.
---------------------------------------------------------------------------
\16\ The estimated values when the threshold is set to $30,000/
100 beneficiaries/100 covered professional services are not
reflective of actual MIPS results for the 2019 MIPS payment year.
There are slight differences in data sources and methods compared to
the 2019 MIPS payment year such as the low-volume threshold in this
model is based on covered PFS services and the model assumes a 33
percent opt-in assumption and uses the QP thresholds for the 2019 QP
performance period.
---------------------------------------------------------------------------
[[Page 59734]]
[GRAPHIC] [TIFF OMITTED] TR23NO18.043
Comment: One commenter encouraged us to continue reviewing the low-
volume threshold annually to ensure that the low-volume threshold
serves the purpose of excluding those for which the work of MIPS
reporting would outweigh the number of Medicare beneficiaries impacted.
A few commenters stated that the burden and cost of reporting for those
who do not exceed the low-volume threshold far exceeds any possible
benefit.
Response: We are committed to continuing program simplification and
burden reduction as we move into future years, including identifying
additional opportunities to help clinicians successfully participate.
We will continue to assess the low-volume threshold, as needed, to help
reduce burden for clinicians, especially those in small and rural
practices, who still find participation challenging. We believe that it
is important to implement the low-volume threshold in a way that
provides more time for clinicians to familiarize themselves with the
performance requirements under MIPS and, most importantly, prepare to
drive clinical quality improvement and improved outcomes for all
Medicare beneficiaries. We refer readers to the regulatory impact
analysis in section VII.F.8.b. of this final rule for further details
on the burden and cost of reporting.
Comment: A few commenters requested that we clarify how a covered
professional service would count when calculating the low-volume
threshold. Other commenters supported defining the concept of a covered
professional service as a single billing of a CPT code. One commenter
suggested 15-minute increments as the defining characteristic of a
professional service.
Response: For the CY 2018 and CY 2019 MIPS payment years, we have
utilized two calculations in order to make low-volume threshold
determinations: The number of patients and the amount of allowed
charges for each eligible clinician or group. These calculations were
based on the patients who were furnished any Part B item or service,
and on the allowed charges for all Part B items and services. Beginning
for the 2020 MIPS payment year, the calculations will instead be based
on covered professional services rather than all Part B items and
services.
Comment: One commenter requested clarification on the definition of
allowed charges for the low-volume threshold. The commenter asked if
allowed charges is equivalent to the full PFS amount or the PFS amount
minus the 20 percent co-pay. The commenter also asked about the
applicable Multiple Procedure Payment Reduction for a given session.
The commenter noted that each option would result in a different dollar
amount.
Response: In general, allowed charges refers to the maximum amount
Medicare will pay for a covered professional service under the PFS,
which is the PFS fee schedule amount reduced by the applicable
beneficiary co-payment. For purposes of MIPS low-volume threshold
determinations, allowed charges are calculated before any Multiple
Procedure Payment Reduction is applied. We refer readers to the CY 2018
Quality Payment Program final rule with comment period (82 FR 53578
through 53579) where we discuss the items and services to which the
MIPS payment adjustment could be applied under Part B.
Comment: A few commenters requested we outline a plan for the low-
volume threshold, such as a roadmap approach in which we propose and
adopt lower thresholds for several performance years at a time.
[[Page 59735]]
Additionally, the commenters requested that we describe if CMS has
plans to include currently excluded clinicians in the MIPS program in
the future. A few commenters asked for a report on the number of low-
volume clinicians that elect to be eligible and for us to use this
experience to modify the low-volume threshold criteria in future years
to move more clinicians into value-based programs.
Response: We agree that providing more clarity and stability into
the future of MIPS would be helpful and are interested in working with
stakeholders on what such future changes should look like. We are
working to provide as much consistency as possible for the low-volume
threshold while being flexible and considering changing needs. We note
that we are finalizing the low-volume threshold for the 2021 MIPS
payment year and future years, as well. Regarding a report on the
number of clinicians who are excluded due to the low-volume threshold
but elect to opt-in to MIPS, we will consider this suggestion for our
MIPS Experience Report.
After consideration of the public comments received, we are
finalizing our proposal to modify the definition of low-volume
threshold at Sec. 414.1305, to mean that for the 2021 MIPS payment
year and future years, that eligible clinicians or groups who meet at
least one of the following three criteria during the MIPS determination
period will not exceed the low-volume threshold: (1) Those who have
allowed charges for covered professional services less than or equal to
$90,000; (2) those who provide covered professional services to 200 or
fewer Part B-enrolled individuals; or (3) those who provide 200 or
fewer covered professional services to Part B-enrolled individuals.
(5) Low-Volume Threshold Opt-In
In the CY 2018 Quality Payment Program proposed rule (82 FR 30026),
we proposed the option to opt-in to MIPS participation if clinicians
might otherwise be excluded under the low-volume threshold. We received
general support from comments received on that final rule (82 FR
53589). However, we did not finalize the proposal for the 2019 MIPS
performance period at that time. We were concerned that we would not be
able to operationalize this policy in a low-burden manner to MIPS
eligible clinicians as it was proposed.
After consideration of operational and user experience implications
of an opt-in policy, we proposed an approach we believed could be
implemented in a way that provides the least burden to clinicians. As
discussed in the CY 2019 PFS proposed rule (83 FR 35887 through 35890),
we proposed to modify Sec. 414.1310(b)(1)(iii) to provide that
beginning with the 2021 MIPS payment year, if an eligible clinician or
group meets or exceeds at least one, but not all, of the low-volume
threshold determinations, including as defined by dollar amount (less
than or equal to $90,000) or number of beneficiaries (200 or fewer), or
number of covered professional services (200 or fewer), then such
eligible individual or group may choose to opt-in to MIPS.
This policy would apply to individual eligible clinicians and
groups who exceed at least one, but not all, of the low-volume
threshold criteria and would otherwise be excluded from MIPS
participation as a result of the low-volume threshold. We believed that
it would be beneficial to provide, to the extent feasible, such
individual eligible clinicians and groups with the ability to opt-in to
MIPS. Conversely, this policy would not apply to individual eligible
clinicians and groups who exceed all of the low-volume threshold
criteria, who unless otherwise excluded, are required to participate in
MIPS. In addition, this policy would not apply to individual eligible
clinicians and groups who do not exceed any of the low-volume threshold
criteria, who would be excluded from MIPS participation without the
ability to opt-in to MIPS. Although we believe we proposed the
appropriate balance for the low-volume threshold elements and the opt-
in policy, we requested comments on other low-volume threshold criteria
and supporting justification for the recommended criteria.
Under the proposed policies, we estimated clinician eligibility
based on the following (we refer readers to the regulatory impact
analysis in section VII.F.8.b. of this final rule for further details
on our assumptions): (1) Eligible because they exceed all three
criteria of the low-volume threshold and are not otherwise excluded
(estimated 770,000 based on our assumptions of who did individual and
group reporting); (2) eligible because they exceed at least one, but
not all, of the low-volume threshold criteria and elect to opt-in
(estimated 28,000 for a total MIPS eligible clinician population of
approximately 798,000); (3) potentially eligible if they either did
group reporting or elected to opt-in \17\ (estimated 390,000); (4)
excluded because they do not exceed any of the low-volume threshold
criteria (estimated 78,000); and (5) excluded due to non-eligible
specialty, newly enrolled, or QP status (estimated 209,000).
---------------------------------------------------------------------------
\17\ A clinician may be in a group that we estimated would not
elect group reporting, however, the group would exceed the low-
volume threshold on all three criteria if the group elected group
reporting. Similarly, an individual or group may exceed at least one
but not all of the low-volume threshold criteria, but we estimated
the clinician or group would not elect to opt-in to MIPS. In both
cases, these clinicians could be eligible for MIPS if the group or
individual makes choices that differ from our assumptions.
---------------------------------------------------------------------------
We proposed that applicable eligible clinicians who meet one or
two, but not all, of the criteria to opt-in and are interested in
participating in MIPS would be required to make a definitive choice to
either opt-in to participate in MIPS or choose to voluntarily report
before data submission (83 FR 35888). If they do not want to
participate in MIPS, they will not be required to do anything and will
be excluded from MIPS under the low-volume threshold. For those who do
want to participate in MIPS, we considered the option of allowing the
submission of data to signal that the clinician is choosing to
participate in MIPS. However, we anticipated that some clinicians who
utilize the quality data code (QDC) claims submission type may have
their systems coded to automatically append QDCs on claims for eligible
patients. We were concerned that they could submit a QDC code and
inadvertently opt-in when that was not their intention.
For individual eligible clinicians and groups to make an election
to opt-in or voluntarily report to MIPS, they will make an election via
the Quality Payment Program portal by logging into their account and
simply selecting either the option to opt-in (positive, neutral, or
negative MIPS adjustment) or to remain excluded and voluntarily report
(no MIPS adjustment). Once the eligible clinician has elected to
participate in MIPS, the decision to opt-in to MIPS will be irrevocable
and cannot be changed for the applicable performance period. Clinicians
who opt-in will be subject to the MIPS payment adjustment during the
applicable MIPS payment year. Clinicians who do not decide to opt-in to
MIPS will remain excluded and may choose to voluntarily report. Such
clinicians will not receive a MIPS payment adjustment factor. To assist
commenters in providing pertinent comments, we developed a website that
provided design examples of the different approaches to MIPS
participation in CY 2019. The website utilized wireframe (schematic)
drawings to illustrate the three different approaches to MIPS
participation: Voluntary reporting to MIPS, opt-in reporting to MIPS,
and required to
[[Page 59736]]
participate in MIPS. The website provided specific matrices
illustrating potential stakeholder experiences when opting-in or
voluntarily reporting.
The option to opt-in to participate in the MIPS as a result of an
individual eligible clinician or group exceeding at least one, but not
all, of the low-volume threshold elements differs from the option to
voluntarily report to the MIPS as established at Sec. 414.1310(b)(2)
and (d). Individual eligible clinicians and groups opting-in to
participate in MIPS will be considered MIPS eligible clinicians, and
therefore subject to the MIPS payment adjustment factor; whereas,
individual eligible clinicians and groups voluntarily reporting
measures and activities for the MIPS are not considered MIPS eligible
clinicians, and therefore not subject to the MIPS payment adjustment
factor. MIPS eligible clinicians and groups that made an election to
opt-in will be able to participate in MIPS at the individual, group, or
virtual group level for that performance period. Eligible clinicians
and groups that are excluded from MIPS, but voluntarily report, are
able to report measures and activities at the individual or group
level; however, such eligible clinicians and groups are not able to
voluntarily report for MIPS at the virtual group level.
In Table 31, we provided possible scenarios regarding which
eligible clinicians may be able to opt-in to MIPS depending upon their
beneficiary count, dollars, and covered professional services if the
proposed opt-in policy was finalized.
Table 31--Low-Volume Threshold Determination Opt-In Scenarios
----------------------------------------------------------------------------------------------------------------
Covered
Beneficiaries Dollars professional Eligible for opt-in
services
----------------------------------------------------------------------------------------------------------------
<=200......................................... <=90K <=200 Excluded not eligible to Opt-in.
<=200......................................... <=90K >200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
<=200......................................... >90K <=200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
>200.......................................... <=90K >200 Eligible to Opt-in, Voluntarily
Report, or Not Participate.
>200.......................................... >90K >200 Not eligible to Opt-in, Required
to Participate.
----------------------------------------------------------------------------------------------------------------
We recognize that the low-volume threshold opt-in option may expand
MIPS participation at the individual, group, and virtual group levels.
For solo practitioners and groups with 10 or fewer eligible clinicians
(including at least one MIPS eligible clinician) that exceed at least
one, but not all, of the elements of the low-volume threshold and are
interested in participating in MIPS via the opt-in and doing so as part
of a virtual group, such solo practitioners and groups will need to
make an election to opt-in to participate in the MIPS. Therefore,
beginning with the 2021 MIPS payment year, we proposed that a virtual
group election would constitute a low-volume threshold opt-in for any
prospective member of the virtual group (solo practitioner or group)
that exceeds at least one, but not all, of the low-volume threshold
criteria. As a result of the virtual group election, any such solo
practitioner or group will be treated as a MIPS eligible clinician for
the applicable MIPS payment year.
During the virtual group election process, the official virtual
group representative of a virtual group submits an election to
participate in the MIPS as a virtual group to CMS prior to the start of
a performance period (82 FR 53601 through 53604). The submission of a
virtual group election includes TIN and NPI information, which is the
identification of TINs composing the virtual group and each member of
the virtual group. As part of a virtual group election, the virtual
group representative is required to confirm through acknowledgement
that a formal written agreement is in place between each member of the
virtual group (82 FR 53604). A virtual group may not include a solo
practitioner or group as part of a virtual group unless an authorized
person of the TIN has executed a formal written agreement.
For a solo practitioner or group that exceeds only one or two
elements of the low-volume threshold, an election to opt-in to
participate in the MIPS as part of a virtual group would be represented
by being identified as a TIN that is included in the submission of a
virtual group election. Such solo practitioners and groups opting-in to
participate in the MIPS as part of a virtual group would not need to
independently make a separate election to opt-in to participate in the
MIPS. We note that being identified as a TIN in a submitted virtual
group election, any such TIN (represented as a solo practitioner or
group) that exceeds at least one, but not all, of the low-volume
threshold elements during the MIPS determination period is signifying
an election to opt-in to participate in MIPS as part of a virtual group
and recognizing that a MIPS payment adjustment factor would be applied
to any such TIN based on the final score of the virtual group. For a
virtual group election that includes a TIN determined to exceed at
least one, but not all, of the low-volume threshold elements during the
MIPS determination period, such election would have a precedence over
the eligibility determination made during the MIPS determination period
pertaining to the low-volume threshold and as a result, any such TIN
would be considered MIPS eligible and subject to a MIPS payment
adjustment factor due the virtual group election. Furthermore, we note
that a virtual group election would constitute an election to opt-in to
participate in MIPS and any low-volume threshold determinations that
result from segment 2 data analysis of the MIPS determination period
would not have any bearing on the virtual group election. Thus, a TIN
included as part of a virtual group election that submitted prior to
the start of the applicable performance period and does not exceed at
least one element of the low-volume threshold during segment 2 of the
MIPS determination period, such TIN would be considered MIPS eligible
and a virtual group participant by virtue of the virtual group's
election to participate in MIPS as a virtual group that was made prior
to the applicable performance period. For virtual groups with a
composition that may only consist of solo practitioners and groups that
exceed at least one, but not all of the low-volume threshold elements,
such virtual groups are encouraged to form a virtual group that would
include a sufficient number of TINs to ensure that such virtual groups
are able to meet program requirements such as case minimum criteria
that would allow measures to be scored. For example, if a virtual group
does not have a sufficient number of cases to report for quality
measures (minimum of 20 cases per measures), a virtual group would
[[Page 59737]]
not be scored on such measures (81 FR 77175).
We further noted that APM Entities in MIPS APMs, which meet one or
two, but not all, of the low-volume threshold elements to opt-in and
are interested in participating in MIPS under the APM scoring standard,
would be required to make a definitive choice at the APM Entity level
to opt-in to participate in MIPS. For such APM Entities to make an
election to opt-in to MIPS, they would make an election via a similar
process that individual eligible clinicians and groups will use to make
an election to opt-in. Once the APM Entity has elected to participate
in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be
changed for the performance period in which the data was submitted.
Eligible clinicians in APM Entities in MIPS APMs that opt-in would be
subject to the MIPS payment adjustment factor. APM Entities in MIPS
APMs that do not decided to opt-in to MIPS cannot voluntarily report.
Additionally, we proposed for applicable eligible clinicians
participating in a MIPS APM, whose APM Entity meets one or two, but not
all, of the low-volume threshold elements rendering the option to opt-
in and does not decide to opt-in to MIPS, that if their TIN or virtual
group does elect to opt-in, it does not mean that the eligible
clinician is opting-in on his/her own behalf, or on behalf of the APM
Entity, but that the eligible clinician is still excluded from MIPS
participation as part of the APM Entity even though such eligible
clinician is part of a TIN or virtual group. This is necessary because
low-volume threshold determinations are currently conducted at the APM
Entity level for all applicable eligible clinicians in MIPS APMs, and
therefore, the low-volume threshold opt-in option should similarly be
executed at the APM Entity level rather than at the individual eligible
clinician, TIN, or virtual group level. Thus, in order for an APM
Entity to opt-in to participate in MIPS at the APM Entity level and for
eligible clinicians within such APM Entity to be subject to the MIPS
payment adjustment factor, an election would need to be made at the APM
Entity level in a similar process that individual eligible clinicians
and groups would use to make an election to opt-in to participate in
MIPS.
We requested comments on our proposals: (1) To modify Sec.
414.1305 for the low-volume threshold definition at paragraph (3) to
specify that, beginning with the 2021 MIPS payment year, the low-volume
threshold that applies to an individual eligible clinician or group
that, during the MIPS determination period, has allowed charges for
covered professional services less than or equal to $90,000, furnishes
covered professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals; (2) that a clinician who is
eligible to opt-in would be required to make an affirmative election to
opt-in to participate in MIPS, elect to be a voluntary reporter, or by
not submitting any data the clinician is choosing to not report; and
(3) to modify Sec. 414.1310(b)(1)(iii) under Applicability to specify
exclusions as follows: Beginning with the 2021 MIPS payment year, if an
individual eligible clinician, group, or APM Entity group in a MIPS APM
exceeds at least one, but not all, of the low-volume threshold criteria
and elects to report on applicable measures and activities under MIPS,
the individual eligible clinician, group, or APM Entity group is
treated as a MIPS eligible clinician for the applicable MIPS payment
year. For APM Entity groups in MIPS APMs, only the APM Entity group
election can result in the APM Entity group being treated as MIPS
eligible clinicians for the applicable payment year.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Many commenters supported the opt-in policy as proposed.
Many commenters supported that clinicians electing to opt-in may have
either a negative or positive payment adjustment. One commenter stated
the opportunity for clinicians to opt-in to MIPS will help to offset
the additional exclusions resulting from the addition of a third low-
volume criterion. A few commenters noted the opt-in provides a
participation opportunity for clinicians who bill low-cost services and
would not otherwise exceed the low-volume threshold based on allowed
charges. Other commenters noted that MIPS is the only way for MIPS
eligible clinicians to earn a meaningful MIPS payment adjustment factor
and opt-in is the only way for eligible clinicians who do not exceed
the low-volume threshold to participate. Many commenters noted the
policy provides flexibility and may encourage those clinicians who are
not ready to have their payment affected by MIPS performance to test
their ability to gather and submit performance data and gain experience
with MIPS.
Response: We appreciate the commenters' support. We note that if an
eligible clinician chooses to opt-in to MIPS then they will be subject
to the MIPS payment adjustment during the applicable MIPS payment year.
If a clinician is eligible to opt-in but does not want to participate
in MIPS, and be subject to the MIPS payment adjustment, then we would
encourage clinicians to voluntarily report.
Comment: Many commenters opposed the opt-in policy. A few
commenters noted concern that the opt-in will reduce incentives to
participate in MIPS, with one specifically stating it does not align
with the agency's stated goal for MIPS to be a pathway to eventual
participation in APMs. Some commenters also noted concern with how the
opt-in may affect the overall scores, stating that (1) the additional
clinicians who voluntarily opt-in are likely to be above the MIPS
threshold, and therefore may reduce the amount of positive MIPS payment
adjustment factors for clinicians who are required to participate, (2)
the opt-in will likely continue to flatten the clinician's final score,
lowering the overall aggregate increase, and (3) if too many eligible
clinicians are excluded, positive payment adjustments would be
insufficient to help offset the investments practices health systems
must make to succeed under MIPS. Another commenter stated that CMS
should identify a core set of data on MIPS and its various exclusions
to be updated annually in conjunction with the proposed rule to allow
stakeholders to follow the impacts of those exclusions longitudinally.
Response: While we encourage clinicians who are excluded to opt-in
to the program once they are prepared to meaningfully participate as a
means of driving value and improving outcomes for more Medicare
beneficiaries, we believe that the opt-in policy does not undermine APM
participation or the transition of clinicians from MIPS to APMs because
the opt-in policy is applied at the APM Entity level for clinicians and
groups participating in APMs. For this final rule, we analyzed the
impact of the opt-in policy by running models which incorporate the
Quality Payment Program Year 1 submissions data. The models include
eligibility without opt-in, opt-in based on a random sample of 33
percent of clinicians who can elect to opt-in, and opt-in where only
high performers (that is, clinicians who can anticipate a positive
adjustment) elect to opt-in. To model the situation where only high
performers would opt-in to MIPS, we assumed 100 percent of clinicians
with final scores above the additional performance threshold would opt-
in and 50 percent of clinicians above the performance threshold but
below the additional performance threshold would
[[Page 59738]]
opt-in. We observed a very modest impact to the payment adjustment
irrespective of the opt-in assumption used. Please see Figure 2 for the
model by opt-in assumption. Lastly, we appreciate the request for
additional core data to be made available, we will continue to work
with stakeholders to identify the information that is valuable and
release it accordingly.
Comment: Many commenters supported an opt-in policy, but believed
the policy should be available to more clinicians. Of these commenters,
most believed that the opt-in should be available even if the clinician
did not exceed any of the low-volume criteria. A few commenters
indicated that MIPS should be voluntary for all clinicians. One
commenter requested that we make the opt-in policy retroactive to the
MIPS 2018 performance period for year-to-year consistency,
simplification, and to improve overall participation. Another commenter
stated that the clinicians who switch practices in the last three
months of MIPS performance period should be able to opt-in.
Response: We do not believe that we have the flexibility to allow
any clinician who wishes to participate in MIPS to opt-in nor to
retroactively apply the opt-in policy to the 2018 MIPS performance
period. Finally, as discussed in the section III.I.3.b. of this final
rule, during the final 3 months of the calendar year in which the
performance period occurs, in general, we do not believe it would be
feasible for many MIPS eligible clinicians who join an existing
practice (existing TIN) or join a newly formed practice (new TIN) to
participate in MIPS as individuals. To clarify if an eligible clinician
switches to an existing TIN or a new TIN they may be able to
participate in MIPS as a group. However, they would not be able to
participate as an individual.
Comment: Several commenters supported the proposal that eligible
clinicians who are eligible to opt-in would be required to make an
affirmative election to opt-in to participate in MIPS. One commenter
agreed that an affirmative election to report is necessary to avoid
confusion and possible inadvertent claims submissions that might
involuntarily opt-in a clinician to MIPS.
Response: We agree that even eligible clinicians submitting MIPS
data via claims must make an affirmative election.
Comment: Several commenters sought clarification on the deadline to
opt-in. A few commenters wondered if clinicians can choose to wait
until the data submission deadline for a performance year, or whether
they must elect to opt-in sooner than that. One commenter recommended
that clinicians should have a deadline of no later than the last day in
the month of February, or perhaps the 15th of March, for the
performance period in which they intend to participate. This commenter
stated that allowing the choice to opt-in at any point during the
performance period will only increase participatory rates among
clinicians or groups who have knowledge of favorable outcomes and will
excuse those whose outcomes were undesirable. One commenter encouraged
us to allow clinicians to opt-in at the time of data submission, as
this would create the least amount of burden on clinicians who wish to
opt-into the program. Another commenter urged us to allow an opt-in
decision at any point during the data submission window and to provide
confirmation of the decision to opt-in. Another commenter stated that
we should not make the opt-in decision irrevocable.
Response: We would like to create a process for eligible clinicians
who wish to opt-in to MIPS that is the least burdensome but also
provides the clinician with the most flexibility. We are exploring if
we can operationally allow clinicians to opt-in at any time prior to
the submission period and will provide further guidance via
subregulatory guidance if this becomes available. We are finalizing at
Sec. 414.1310(b)(1)(iii) under Applicability to specify exclusions as
follows: Beginning with the 2021 MIPS payment year, if an individual
eligible clinician, group, or APM Entity group in a MIPS APM exceeds at
least one, but not all, of the low-volume threshold criteria and elects
to report on applicable measures and activities under MIPS, the
individual eligible clinician, group, or APM Entity group is treated as
a MIPS eligible clinician for the applicable MIPS payment year. We
agree that allowing clinicians the choice to opt-in at any point during
the performance period may increase the potential that only high
performers will opt-in, but we believe that this policy accounts for
clinicians who identified in the second segment of the MIPS
determination period. Also, we plan to monitor this issue and will
address it through future rulemaking if necessary. Finally, regarding
the opt-in decision being irrevocable, we believe it is necessary for
the clinician to make a definitive decision regarding their
participation in MIPS. If the decision to opt-in was not definitive
then we believe the potential for a clinician to have an unfair
advantage is increased by their ability to review their final feedback
and scoring information available at submissions and subsequently alter
their participation decision.
Comment: One commenter noted that with the manual election to
indicate opt-in, the need for a low-volume threshold criterion based on
professional services should not make a difference in a clinician's
ability to opt-in. Other commenters opposed the requirement for the
eligible clinician to manually opt-in, noting that it would add
administrative burden. Another commenter stated that it is unnecessary
to create a MIPS opt-in policy for some low-volume clinicians as they
may not meet the case minimums for measures.
Response: We do not believe that the manual election to opt-in has
relevance to the clinician's covered professional services. We are
providing the third criterion of covered professional services to
expand the number of clinicians eligible to opt-in to the program.
Regarding the manual election to opt-in, we believe this is the least
burdensome approach to ensuring that clinicians are making an informed
decision regarding their MIPS participation. We believe that most MIPS
eligible clinicians that provide at least 200 covered professional
service will be able to meet the case minimums for measures.
Comment: A few commenters requested additional clarification on the
implication of the opt-in policy on the MIPS payment adjustment and on
how we estimated the number of opt-in clinicians.
Response: We described our approach to estimating the opt-in policy
in the regulatory impact analysis of the CY 2019 PFS proposed rule (83
FR 36057 through 36068). We sought comment on this approach and refer
readers to the Regulatory Impact Analysis (RIA) in section VII. of this
final rule for additional information. The RIA for this final rule
examined the impact of the opt-in policy on payment adjustments by
using two alternate opt-in assumptions: (1) If only clinicians with
scores above the performance threshold opt-in (the actual opt-in is
likely to be lower than this estimated number of clinicians opting-in);
and (2) if none of the clinicians elected to opt-in. See Figure 2 for a
summary of the results. As shown in Figure 2, the opt-in policy was
found to have a small impact on the budget neutral pool when we assumed
a random 33 percent of clinicians would opt-in irrespective of their
performance and a minimal impact on payment adjustments regardless of
the opt-in assumption used. Given these findings, we chose to use the
33 percent opt-in
[[Page 59739]]
assumption for all CY 2019 performance period estimates.
[GRAPHIC] [TIFF OMITTED] TR23NO18.044
Comment: A few commenters supported the proposal to only allow APM
entities to opt-in as a group. One commenter urged us to explain in-
depth the application of the low-volume threshold opt-in option for
MIPS APM TINs.
Response: We explained the application of the low-volume threshold
for APM Entities in MIPS APMs in detail in the CY 2019 PFS proposed
rule (83 FR 35889) and refer readers to that discussion.
Comment: One commenter did not agree that performance category data
submitted by a third party intermediary needed a separate opt-in
election. The commenter stated that in these instances, the clinician
or group has chosen to engage a third party intermediary for MIPS
reporting which the commenter believed is an affirmative event
demonstrating intent to participate in the MIPS program. The commenter
also noted that for clinicians or small-groups submitting quality data
via QDC codes on claims, if those clinicians and/or small groups also
submit any category data via a third-party intermediary, the Quality
Payment Program portal, or the CMS Web Interface, that should be
considered as an opt-in decision. One commenter requested that we
provide a technical interface/API which allows clinicians and groups to
opt-in through the service of third party intermediaries.
Response: We want to ensure that clinicians are making an informed
decision regarding opting-in to participate in MIPS. It is imperative
that they make a definitive decision since clinicians who opt-in will
be subject to the MIPS payment adjustment during the applicable MIPS
payment year. We believe that an election to opt-in to MIPS must be
made by the clinician or group through a definitive opt-in decision to
participate in MIPS regardless of the way in which the data is
submitted. In addition, in response to public comments, in instances
where a third party intermediary is representing a MIPS eligible
clinician, the third party intermediary must be able to transmit the
clinician's opt-in decision to CMS. We refer readers to section
III.I.3.k. of this final rule for more information regarding third
party intermediary requirements.
Comment: A few commenters requested information for clinicians and
groups to make an informed choice about the opt-in. One commenter urged
us to make it clear as to whether a clinician and group is eligible to
opt-in to MIPS, what this decision could mean in terms of reducing or
increasing their Medicare payments, and when the decision would be
final. A few commenters requested the eligibility information prior to
the start of the performance period, so that MIPS eligible clinicians
and groups who want to opt-in to MIPS have the information necessary to
make an informed choice about their participation options. Other
commenters requested information on how the two MIPS determination
periods work with the opt-in policy.
Response: We understand that it is important for clinicians to know
their eligibility status prior to the performance period. We are
working to provide quarterly snapshots, if feasible. We believe these
quarterly snapshots will provide important information to clinicians so
that they may make informed decisions regarding whether they should
opt-in to participate in MIPS. It is important to note that the
quarterly snapshots are being provided for informational use only and
not final until after the second segment of the MIPS determination
period closes (which is September 30 of the calendar year in which the
applicable performance period occurs) and a reconciliation occurs.
Since the quarterly snapshots are not final this information is subject
to change and should not be considered the final eligibility
determination. The eligibility determination will be made after a
reconciliation of the first and second segment of the MIPS
determination period. We are finalizing at Sec. 414.1310(b)(1)(iii)
under Applicability to specify exclusions that include, beginning with
the 2021 MIPS payment year, if an individual eligible clinician, group,
or APM Entity group in a MIPS APM exceeds at least one, but not all,
[[Page 59740]]
of the low-volume threshold criteria and elects to report on applicable
measures and activities under MIPS, the individual eligible clinician,
group, or APM Entity group is treated as a MIPS eligible clinician for
the applicable MIPS payment year.
Comment: One commenter recommended that we change the name of the
voluntary participation option to ensure that clinicians do not confuse
that option with opt-in participation. Since a voluntary participant is
only reporting data, they suggested changing that category to Voluntary
Reporting to ensure this is not confused with opt-in Participation.
Response: We agree and are modifying the participation terms on the
Quality Payment Program website to provide clear directions. Therefore,
we note that when clinicians are reporting for MIPS they may enter the
Quality Payment Program portal to choose the appropriate MIPS
participation. For those eligible clinicians or groups who exceed all
three criteria of the low-volume threshold their participation will be
automatically selected as they are required to participate. For
individual eligible clinicians and groups who are qualified they may
make an election to by choosing to either: Agree to opt-in
participation or to voluntarily report to MIPS, the clinician would
make an election via the Quality Payment Program portal by logging into
their account and simply selecting either the option to opt-in
participation (positive, neutral, or negative MIPS adjustment) or to
remain excluded and voluntarily report (no MIPS adjustment). So the
three options when reporting data through the Quality Payment Program
portal are: Voluntary reporting, opt-in participation, and required to
participate in MIPS. We referred readers to the Quality Payment Program
at qpp.cms.gov/design-examples to review the finalized wireframe
drawings.
After consideration of the public comments received, we are
finalizing our proposals: (1) To modify Sec. 414.1305 for the low-
volume threshold definition at paragraph (3) to specify that, beginning
with the 2021 MIPS payment year, the low-volume threshold that applies
to an individual eligible clinician, group, or APM Entity group that,
during the MIPS determination period, has allowed charges for covered
professional services less than or equal to $90,000, furnishes covered
professional services to 200 or fewer Medicare Part B-enrolled
individuals, or furnishes 200 or fewer covered professional services to
Medicare Part B-enrolled individuals; (2) that a clinician who is
eligible to opt-in would be required to make an affirmative election to
opt-in to participate in MIPS, elect to be a voluntary reporter, or by
not submitting any data the clinician is choosing to not report; and
(3) to modify Sec. 414.1310(b)(1)(iii) under Applicability to specify
exclusions as follows: Beginning with the 2021 MIPS payment year, if an
individual eligible clinician, group, or APM Entity group in a MIPS APM
exceeds at least one, but not all, of the low-volume threshold criteria
and elects to report on applicable measures and activities under MIPS,
the individual eligible clinician, group, or APM Entity group is
treated as a MIPS eligible clinician for the applicable MIPS payment
year. For such solo practitioners and groups that elect to participate
in MIPS as a virtual group (except for APM Entity groups in MIPS APMs),
the virtual group election under Sec. 414.1315 constitutes an election
under this paragraph and results in the solo practitioners and groups
being treated as MIPS eligible clinicians for the applicable MIPS
payment year. For such APM Entity groups in MIPS APMs, only the APM
Entity group election can constitute an election under this paragraph
and result in the APM Entity group being treated as MIPS eligible
clinicians for the applicable MIPS payment year. We note that a virtual
group election does not constitute a Partial QP election under revised
Sec. 414.1310(b)(1)(ii). In order for an individual eligible clinician
or APM Entity with a Partial QP status to explicitly elect to
participate in MIPS and be subject to the MIPS payment adjustment
factor, such individual eligible clinician or APM Entity would make
such election during the applicable performance period as a Partial QP
status becomes applicable and such option for election is warranted.
(6) Part B Services Subject to MIPS Payment Adjustment
Section 1848(q)(6)(E) of the Act, as amended by section
51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the
MIPS adjustment factor and, as applicable, the additional MIPS
adjustment factor, apply to the amount otherwise paid under Part B with
respect to covered professional services (as defined in subsection
(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a
year (beginning with 2019) and with respect to the MIPS eligible
clinician for such year.
In the CY 2019 PFS proposed rule (83 FR 35890), we requested
comments on our proposal to amend Sec. 414.1405(e) to modify the
application of both the MIPS adjustment factor and, if applicable, the
additional MIPS adjustment factor so that beginning with the 2019 MIPS
payment year, these adjustment factors will apply to Part B payments
for covered professional services (as defined in section 1848(k)(3)(A)
of the Act) furnished by the MIPS eligible clinician during the year.
We are making this change beginning with the first MIPS payment year
and note that these adjustment factors will not apply to Part B drugs
and other items furnished by a MIPS eligible clinician, but will apply
to covered professional services furnished by a MIPS eligible
clinician. We refer readers to section III.I.3.j. of this final rule
for further details on this modification.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: One commenter stated that they support the technical
amendment made by Congress in the Bipartisan Budget Act of 2018 to
clarify that items or services beyond the PFS, especially Part B drugs,
should not be included when determining MIPS eligibility and applying
the MIPS payment adjustment.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1405(e) to modify the
application of both the MIPS adjustment factor and, if applicable, the
additional MIPS adjustment factor so that beginning with the 2019 MIPS
payment year, these adjustment factors will apply to Part B payments
for covered professional services (as defined in section 1848(k)(3)(A)
of the Act) furnished by the MIPS eligible clinician during the year.
We are making this change beginning with the first MIPS payment year
and note that these adjustment factors will not apply to Part B drugs
and other items furnished by a MIPS eligible clinician, but will apply
to covered professional services furnished by a MIPS eligible
clinician.
d. Partial QPs
(1) Partial QP Elections Within Virtual Groups
In the CY 2017 Quality Payment Program final rule, we finalized
that following a determination that eligible clinicians in an APM
Entity group in an Advanced APM are Partial QPs for a year, the APM
Entity will make an election whether to report on applicable measures
and activities as required under MIPS. If the APM Entity elects to
report to MIPS, all eligible clinicians in
[[Page 59741]]
the APM Entity would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the APM Entity elects not
to report, all eligible clinicians in the APM Entity group will be
excluded from the MIPS reporting requirements and payment adjustments
for the relevant year (81 FR 77449).
We also finalized that in cases where the Partial QP determination
is made at the individual eligible clinician level, if the individual
eligible clinician is determined to be a Partial QP, the eligible
clinician will make the election whether to report on applicable
measures and activities as required under MIPS and, as a result, be
subject to the MIPS reporting requirements and payment adjustments (81
FR 77449). If the individual eligible clinician elects to report to
MIPS, he or she would be subject to the MIPS reporting requirements and
payment adjustments for the relevant year. If the individual eligible
elects not to report to MIPS, he or she will be excluded from the MIPS
reporting requirements and payment adjustments for the relevant year.
We also clarified how we consider the absence of an explicit
election to report to MIPS or to be excluded from MIPS. We finalized
that for situations in which the APM Entity is responsible for making
the decision on behalf of all eligible clinicians in the APM Entity
group, the group of Partial QPs will not be considered MIPS eligible
clinicians unless the APM Entity opts the group into MIPS
participation, so that no actions other than the APM Entity's election
for the group to participate in MIPS would result in MIPS participation
(81 FR 77449). For eligible clinicians who are determined to be Partial
QPs individually, we finalized that we will use the eligible
clinician's actual MIPS reporting activity to determine whether to
exclude the Partial QP from MIPS in the absence of an explicit
election. Therefore, if an eligible clinician who is individually
determined to be a Partial QP submits information to MIPS (not
including information automatically populated or calculated by CMS on
the Partial QP's behalf), we will consider the Partial QP to have
reported, and thus to be participating in MIPS. Likewise, if such an
individual does not take any action to submit information to MIPS, we
will consider the Partial QP to have elected to be excluded from MIPS
(81 FR 77449).
In the CY 2018 Quality Payment Program final rule, we clarified
that in the case of an eligible clinician participating in both a
virtual group and an Advanced APM who has achieved Partial QP status,
that the eligible clinician would be excluded from the MIPS payment
adjustment unless the eligible clinician elects to report under MIPS
(82 FR 53615). As discussed in the CY 2019 PFS proposed rule (83 FR
35890 through 35891), we incorrectly stated that affirmatively agreeing
to participate in MIPS as part of a virtual group prior to the start of
the applicable performance period would constitute an explicit election
to report under MIPS for all Partial QPs. As such, we also incorrectly
stated that all eligible clinicians who participate in a virtual group
and achieve Partial QP status would remain subject to the MIPS payment
adjustment due to their virtual group election to report under MIPS,
regardless of their Partial QP election. We note that an election made
prior to the start of an applicable performance period to participate
in MIPS as part of a virtual group is separate from an election made
during the performance period that is warranted as a result of an
individual eligible clinician or APM Entity achieving Partial QP status
during the applicable performance period. A virtual group election does
not equate to an individual eligible clinician or APM Entity with a
Partial QP status explicitly electing to participate in MIPS. In order
for an individual eligible clinician or APM Entity with a Partial QP
status to explicitly elect to participate in MIPS and be subject to the
MIPS payment adjustment factor, such individual eligible clinician or
APM Entity would make such election during the applicable performance
period as a Partial QP status becomes applicable and such option for
election is warranted. Thus, we are restating that affirmatively
agreeing to participate in MIPS as part of a virtual group prior to the
start of the applicable performance period does not constitute an
explicit election to report under MIPS as it pertains to making an
explicit election to either report to MIPS or be excluded from MIPS for
individual eligible clinicians or APM Entities that have Partial QP
status.
Related to this clarification, we are finalizing in section
III.I.4.e.(3) of this final rule to clarify that beginning with the
2021 MIPS payment year, when an eligible clinician is determined to be
a Partial QP for a year at the individual eligible clinician level, the
individual eligible clinician has the option to make an election
whether to report to MIPS. If the eligible clinician elects to report
to MIPS, he or she will be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician elects to not report to
MIPS, he or she will not be subject to MIPS reporting requirements and
payment adjustments. If the eligible clinician does not make any
affirmatively election to report to MIPS, he or she will not be subject
to MIPS reporting requirements and payment adjustments. As a result,
beginning with the 2021 MIPS payment year, for eligible clinicians who
are determined to be Partial QPs individually, we will not use the
eligible clinician's actual MIPS reporting activity to determine
whether to exclude the Partial QP from MIPS in the absence of an
explicit election.
Therefore, the finalized policy in section III.I.4.e.(3) of this
final rule eliminates the scenario in which affirmatively agreeing to
participate in MIPS as part of a virtual group prior to the start of
the applicable performance period will constitute an explicit election
to report under MIPS for eligible clinicians who are determined to be
Partial QPs individually and make no explicit election to either report
to MIPS or be excluded from MIPS. We believe this change is necessary
because QP status and Partial QP status, achieved at the APM Entity
level or eligible clinician level, is applied to an individual and all
of his or her TIN/NPI combinations, whereas virtual group participation
is determined at the TIN level. Therefore, we do not believe that it is
appropriate that the actions of the TIN in joining the virtual group
should deprive the eligible clinician who is a Partial QP, whether that
status was achieved at APM Entity level or eligible clinician level, of
the opportunity to elect whether or not to opt-in to MIPS.
e. Group Reporting
We refer readers to Sec. 414.1310(e) and the CY 2018 Quality
Payment Program final rule (82 FR 53592 through 53593) for a
description of our previously established policies regarding group
reporting.
In the CY 2018 Quality Payment Program final rule (82 FR 53593), we
clarified that we consider a group to be either an entire single TIN or
portion of a TIN that: (1) Is participating in MIPS according to the
generally applicable scoring criteria while the remaining portion of
the TIN is participating in a MIPS APM or an Advanced APM according to
the MIPS APM scoring standard; and (2) chooses to participate in MIPS
at the group level. We further clarify that we consider a group to be
an entire single TIN that chooses to participate in MIPS at the group
level. However, individual eligible clinicians (TIN/NPIs) within that
group may receive a MIPS payment adjustment
[[Page 59742]]
based on the APM scoring standard if they are on the participant list
of a MIPS APM. We proposed to amend Sec. Sec. 414.1310(e) and
414.1370(f)(2) to codify this policy and more fully reflect the scoring
hierarchy as discussed in section III.I.3.h.(6) of this final rule.
As discussed in the CY 2018 Quality Payment Program final rule (82
FR 53593), one of the overarching themes we have heard from
stakeholders is that we make an option available to groups that would
allow a portion of a group to report as a separate sub-group on
measures and activities that are more applicable to the sub-group and
be assessed and scored accordingly based on the performance of the sub-
group. We stated that in future rulemaking, we intend to explore the
feasibility of establishing group-related policies that would permit
participation in MIPS at a sub-group level and create such
functionality through a new identifier. In the CY 2018 Quality Payment
Program proposed rule (82 FR 30027), we solicited public comments on
the ways in which participation in MIPS at the sub-group level could be
established. In addition, in the CY 2018 Quality Payment Program final
rule (82 FR 53593), we sought comment on additional ways to define a
group, not solely based on a TIN. Because there are several operational
challenges with implementing a sub-group option, we did not propose any
such changes to our established reporting policies in this final rule.
Rather, we are considering facilitating the use of a sub-group
identifier in the Quality Payment Program Year 4 through future
rulemaking, as necessary. In addition, it has come to our attention
that providing a sub-group option may provide potential gaming
opportunities. For example, a group could manipulate scoring by
creating sub-groups that are comprised of only the high performing
clinicians in the group. Therefore, we requested comment on
implementing sub-group level reporting through a separate sub-group
sub-identifier in the Quality Payment Program Year 4 and possibly
future years of the program.
In the CY 2019 PFS proposed rule (83 FR 35891) we requested
comments on the following: (1) Whether and how a sub-group should be
treated as a separate group from the primary group: For example, if
there is 1 sub-group within a group, how would we assess eligibility,
performance, scoring, and application of the MIPS payment adjustment at
the sub-group level; (2) whether all of the sub-group's MIPS
performance data should be aggregated with that of the primary group or
should be treated as a distinct entity for determining the sub-group's
final score, MIPS payment adjustments, and public reporting, and
eligibility be determined at the whole group level; (3) possible low
burden solutions for identification of sub-groups: For example, whether
we should require registration similar to the CMS Web Interface or a
similar mechanism to the low-volume threshold opt-in that we proposed
and is discussed in section III.I.3.c.(5) of this final rule; and (4)
potential issues or solutions needed for sub-groups utilizing
submission mechanisms, measures, or activities, such as APM
participation, that are different than the primary group. We also
welcomed comments on other approaches for sub-group reporting that we
should consider. We received many comments on group reporting and will
take them into consideration for future rulemaking.
f. Virtual Groups
(1) Background
We refer readers to Sec. 414.1315 and the CY 2018 Quality Payment
Program final rule (82 FR 53593 through 53617) for our previously
established policies regarding virtual groups.
(2) Virtual Group Election Process
We refer readers to Sec. 414.1315(c) and the CY 2018 Quality
Payment Program final rule (82 FR 53601 through 53604) for our
previously established policies regarding the virtual group election
process.
We proposed to amend Sec. 414.1315(c) to continue to apply the
previously established policies regarding the virtual group election
process for the 2022 MIPS payment year and future years, with the
exception of the proposed policy modification discussed below (83 FR
35891 through 35892).
Under Sec. 414.1315(c)(2)(ii), an official designated virtual
group representative must submit an election on behalf of the virtual
group by December 31 of the calendar year prior to the start of the
applicable performance period. In the CY 2018 Quality Payment Program
final rule (82 FR 53603), we stated that such election will occur via
email to the Quality Payment Program Service Center using the following
email address for the 2018 and 2019 performance periods:
[email protected]. Beginning with the 2022 MIPS payment
year, we proposed to amend Sec. 414.1315(c)(2)(ii) to provide that the
election would occur in a manner specified by CMS. We anticipate that a
virtual group representative would make an election on behalf of a
virtual group by registering to participate in MIPS as a virtual group
via a web-based system developed by CMS. We believe that a web-based
system would be less burdensome for virtual groups given that the
interactions stakeholders would have with the Quality Payment Program
are already conducted via the Quality Payment Program portal, and would
provide stakeholders with a seamless user experience. Stakeholders
would be able to make a virtual group election in a similar manner to
all other interactions with the Quality Payment Program portal and
would no longer need to separately identify the appropriate email
address to submit such an election and email an election outside of the
Quality Payment Program portal. The Quality Payment Program portal is
the gateway and source for interaction with MIPS that contains a range
of information on topics including eligibility, data submission, and
performance reports. We believe that using the same web-based platform
to make a virtual group election would enhance the one-stop MIPS
interactive experience and eliminate the potential for stakeholders to
be unable to identify or erroneously enter the email address.
We solicited public comment on this proposal, which would provide
for an election to occur in a manner specified by CMS such as a web-
based system developed by CMS.
The following is a summary of the public comments received
regarding the proposal to continue to apply the previously established
policies regarding the virtual group election process for the 2022 MIPS
payment year and future years, with the exception of providing for an
election to occur in a manner specified by CMS, such as a web-based
system developed by CMS, and our responses.
Comment: Several commenters supported the proposal to facilitate
virtual group elections through the Quality Payment Program portal, as
opposed to email, and indicated that the use of portal would be less
burdensome for virtual groups and facilitate a more seamless user
experience. A few commenters noted that the web-based system linked to
the existing portal could give interested participants an easier means
of connecting with other possible virtual group members. The commenters
recommended that CMS explore the inclusion/development of a platform
within the portal that would facilitate interactions and connections
between parties interested in forming or joining a virtual group.
Additionally, the commenters requested that CMS clearly outline and
provide additional guidance on the election process via the
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Quality Payment Program website. Another commenter recommended that CMS
devise, as part of the portal, a direct way for clinicians to confirm
their virtual group[hyphen]eligibility status with 100 percent
reliability, and eliminate potential human errors when using a Quality
Payment Program representative as an intermediary.
Response: We will consider various means for providing information
and guidance to virtual groups regarding the election process, and
explore options for facilitating and supporting virtual group formation
and providing virtual group eligibility via the Quality Payment Program
portal in future years. It should be noted that all necessary
information pertaining to virtual groups will be published on the CMS
website prior to the virtual group election period, which occurs during
the calendar before the start of the applicable performance period.
After consideration of the public comments, we are finalizing our
proposal at Sec. 414.1315(c) to continue to apply the previously
established policies regarding the virtual group election process for
the 2022 MIPS payment year and future years, with the exception of
providing for an election to occur in a manner specified by CMS, such
as a web-based system developed by CMS.
(a) Virtual Group Eligibility Determinations
For purposes of determining TIN size for virtual group
participation eligibility for the CY 2018 and 2019 performance periods,
we coined the term ``virtual group eligibility determination period''
and defined it to mean an analysis of claims data during an assessment
period of up to 5 months that would begin on July 1 and end as late as
November 30 of the calendar year prior to the applicable performance
period and includes a 30-day claims run out (82 FR 53602). We proposed
to modify the virtual group eligibility determination period beginning
with the 2019 performance period (83 FR 35892 through 35893). We
proposed to amend Sec. 414.1315(c)(1) to establish a virtual group
eligibility determination period to mean an analysis of claims data
during a 12-month assessment period (fiscal year) that would begin on
October 1 of the calendar year 2 years prior to the applicable
performance period and end on September 30 of the calendar year
preceding the applicable performance period and include a 30-day claims
run out. The virtual group eligibility determination period aligns with
the first segment of data analysis under the MIPS eligibility
determination period. As part of the virtual group eligibility
determination period, TINs would be able to inquire about their TIN
size prior to making an election during a 5-month timeframe, which
would begin on August 1 and end on December 31 of a calendar year prior
to the applicable performance period. TIN size inquiries would be made
through the Quality Payment Program Service Center. For TINs that
inquire about their TIN size during such 5-month timeframe, it should
be noted that any TIN size information provided is only for
informational purposes and may be subject to change; official
eligibility regarding TIN size and all other eligibility pertaining to
virtual groups would be determined in accordance with the MIPS
determination period and other applicable special status eligibility
determination periods. The proposed modification would provide
stakeholders with real-time information regarding TIN size for
informational purposes instead of TIN size eligibility determinations
on an ongoing basis (between July 1 and November 30 of the calendar
year prior to the applicable performance period) due to technical
limitations.
For the 2018 and 2019 performance periods, TINs could determine
their status by contacting their designated TA representative as
provided at Sec. 414.1315(c)(1); otherwise, the TIN's status would be
determined at the time that the TIN's virtual group election is
submitted. We proposed to amend Sec. 414.1315(c)(1) to remove this
provision since the inquiry about TIN size would be for informational
purposes only and may be subject to change.
We believe that the utilization of the Quality Payment Program
Service Center, versus the utilization of designated TA
representatives, as the means for stakeholders to obtain information
regarding TIN size provides continuity and a seamless experience for
stakeholders. We note that the TA resources already available to
stakeholders would continue to be available. The following describes
the experience a stakeholder would encounter when interacting with the
Quality Payment Program Service Center to obtain information pertaining
to TIN size. For example, the applicable performance period for the
2022 MIPS payment year would be CY 2020. If a group contacted the
Quality Payment Program Service Center on September 20, 2019, the
claims data analysis would include the months of October of 2018
through August of 2019. If another group contacted the Quality Payment
Program Service Center on November 20, 2019, the claims data analysis
would include the months of October of 2018 through September of 2019
with a 30-day claims run out.
We believe this virtual group eligibility determination period
provides a real-time representation of TIN size for purposes of
determining virtual group eligibility and allows solo practitioners and
groups to know their real-time virtual group eligibility status and
plan accordingly for virtual group implementation. Beginning with the
2022 MIPS payment year, it is anticipated that starting in August of
each calendar year prior to the applicable performance period, solo
practitioners and groups would be able to contact the Quality Payment
Program Service Center and inquire about their TIN size. TIN size
determinations would be based on the number of NPIs associated with a
TIN, which may include clinicians (NPIs) who do not meet the definition
of a MIPS eligible clinician at Sec. 414.1305 or who are excluded from
MIPS under Sec. 414.1310(b) or (c).
We proposed to continue to apply the aforementioned previously
established virtual group policies for the 2022 MIPS payment year and
future years, with the exception of the following policy modifications:
The virtual group eligibility determination period would
align with the first segment of the MIPS determination period, which
includes an analysis of claims data during a 12-month assessment period
(fiscal year) that would begin on October 1 of the calendar year 2
years prior to the applicable performance period and end on September
30 of the calendar year preceding the applicable performance period and
include a 30-day claims run out. As part of the virtual group
eligibility determination period, TINs would be able to inquire about
their TIN size prior to making an election during a 5-month timeframe,
which would begin on August 1 and end on December 31 of a calendar year
prior to the applicable performance period.
MIPS eligible clinicians would be able to contact their
designated technical assistance representative or, beginning with the
2022 MIPS payment year, the Quality Payment Program Service Center, as
applicable, to inquire about their TIN size for informational purposes
in order to assist MIPS eligible clinicians in determining whether or
not to participate in MIPS as part of a virtual group. We anticipate
that starting in August of each calendar year prior to the applicable
performance period, solo practitioners and groups would be able to
contact the Quality Payment Program
[[Page 59744]]
Service Center and inquire about virtual group participation
eligibility.
A virtual group representative would make an election on
behalf of a virtual group by registering to participate in MIPS as a
virtual group in a form and manner specified by CMS. We anticipate that
a virtual group representative would make the election via a web-based
system developed by CMS.
We also proposed updates to Sec. 414.1315 in an effort to more
clearly and concisely capture previously established policies. These
proposed updates are not intended to be substantive in nature, but
rather to bring more clarity to the regulatory text.
The following is a summary of the public comments received on these
proposals and our responses.
Comment: One commenter requested that CMS revisit the virtual group
definition's current limit of ten clinicians because the definition of
eligible clinician will be expanded. The commenter recommended revising
the definition and measure virtual groups by setting an attributed
membership floor to improve reporting validity.
Response: In regard to determining TIN size for purposes of virtual
group eligibility, we count each NPI associated with a TIN in order to
determine whether or not a TIN exceeds the threshold of 10 NPIs, which
includes clinicians who are eligible and not eligible for MIPS. We
believe that such an approach provides continuity over time if the
definition of a MIPS eligible clinician is expanded in future years
under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible
clinicians (82 FR 53596). As discussed in the 2018 Quality Payment
Program final rule (82 FR 53596 through 53597), we considered an
alternative approach for determining TIN size, which would determine
TIN size for virtual group eligibility based on NPIs who are MIPS
eligible clinicians. However, as we conducted a comparative assessment
of the application of such alternative approach with the current
definition of a MIPS eligible clinician (as defined at Sec. 414.1305)
and a potential expanded definition of a MIPS eligible clinician, we
found that such an approach could create confusion as to which factors
determine virtual group eligibility and cause the pool of virtual group
eligible TINs to significantly be reduced once the definition of a MIPS
eligible clinician would be expanded, which may impact a larger portion
of virtual groups that intend to participate in MIPS as a virtual group
for consecutive performance periods. Such impact would be the result of
the current definition of a MIPS eligible clinician being narrower than
the potential expanded definition of a MIPS eligible clinician. We did
not pursue such an approach given that it did not align with our
objective of establishing virtual group eligibility policies that are
simplistic in understanding and provide continuity.
Furthermore, we note that given that the TIN size is already based
on the total number of NPIs within a TIN, the expanded definition of a
MIPS eligible clinician will not impact the population of TINs eligible
to form or join a virtual group. In regard to increasing the TIN size
threshold of 10, section 1848(q)(5)(I)(ii) of the Act establishes a
threshold of 10 and as a result, we do not have discretion to expand
virtual group participation to TINs with more than 10 NPIs.
Comment: A few commenters supported our proposal to align the
virtual group eligibility determination period with the first segment
of the MIPS determination period for consistency. The commenters also
supported the availability of TIN size information that can be
considered by groups prior to submitting a virtual group election. One
commenter requested that CMS provide notification regarding the
timeframe for the virtual group election process each year.
Response: In regard to the virtual group election period, we
publish the timeframe for virtual groups to make an election in
subregulatory guidance (that is, materials published and posted on the
CMS website and information disseminated via a listserv) each year on
the CMS website in advance of the start of the election period. Each
year, the virtual group election period will occur prior to the start
of an applicable performance period and have an end date of December
31.
Comment: One commenter requested clarification as to why a virtual
group election must be made prior to the performance period and
recommended that CMS postpone the deadline to the third quarter of the
performance year.
Response: Section 1848(q)(5)(I)(iii)(I) of the Act provides that
the virtual group election process must include the following
requirement: An individual MIPS eligible clinician or group electing to
be in a virtual group must make their election prior to the start of
the performance period and cannot change their election during the
performance period.
After consideration of the public comments, we are finalizing our
proposals to continue to apply the aforementioned previously
established virtual group policies for the 2022 MIPS payment year and
future years, with the exception of the following:
The virtual group eligibility determination period is the
first segment of the MIPS determination period (proposal finalized at
Sec. 414.1315(c)(1)(ii)), which consists of an analysis of claims data
during a 12-month assessment period (fiscal year) that begins on
October 1 of the calendar year 2 years prior to the applicable
performance period and ends on September 30 of the calendar year
preceding the applicable performance period and includes a 30-day
claims run out. As part of the virtual group eligibility determination
period, TINs will be able to inquire about their TIN size prior to
making an election during a 5-month timeframe, which will begin on
August 1 and end on December 31 of a calendar year prior to the
applicable performance period. We refer readers to section III.I.3.b.
of this final rule for more information regarding the MIPS
determination period.
MIPS eligible clinicians will be able to contact their
designated technical assistance representative or, beginning with the
2022 MIPS payment year, the Quality Payment Program Service Center, as
applicable, to inquire about their TIN size for informational purposes
in order to assist MIPS eligible clinicians in determining whether or
not to participate in MIPS as part of a virtual group. We anticipate
that starting in August of each calendar year prior to the applicable
performance period, solo practitioners and groups would be able to
contact the Quality Payment Program Service Center and inquire about
virtual group participation eligibility.
A designated virtual group representative must submit an
election, on behalf of the solo practitioners and groups that compose a
virtual group, to participate in MIPS as a virtual group for a
performance period in a form and manner specified by CMS by the
election deadline specified at Sec. 414.1315(b) (proposal finalized at
Sec. 414.1315(c)(2)(ii)) We anticipate that a virtual group
representative will make the election via a web-based system developed
by CMS.
Also, we are finalizing updates to Sec. 414.1315 in an effort to
more clearly and concisely capture previously established policies. The
updates are not intended to be substantive in nature, but rather to
bring more clarity to the regulatory text.
We note that we are further revising Sec. 414.1315 to consolidate
paragraphs (c)(2)(ii) and (iii) and redesignate paragraph (c)(2)(iv) as
paragraph (c)(2)(iii) for clarity. Additionally, we are revising
redesignated paragraph
[[Page 59745]]
(c)(2)(iii) to refer to ``the start of data submission'' rather than
``the start of an applicable submission period'' because ``submission
period'' is not an expressly defined term.
g. MIPS Performance Period
In the CY 2018 Quality Payment Program final rule (82 FR 53617
through 53619), we finalized at Sec. 414.1320(c)(1) that for purposes
of the 2021 MIPS payment year, the performance period for the quality
and cost performance categories is CY 2019 (January 1, 2019 through
December 31, 2019). We did not finalize the performance period for the
quality and cost performance categories for purposes of the 2022 MIPS
payment year or future years. We also redesignated Sec. 414.1320(d)(1)
and finalized at Sec. 414.1320(c)(2) that for purposes of the 2021
MIPS payment year, the performance period for the Promoting
Interoperability and improvement activities performance categories is a
minimum of a continuous 90-day period within CY 2019, up to and
including the full CY 2019 (January 1, 2019 through December 31, 2019).
As noted in the CY 2018 Quality Payment Program final rule, we
received comments that were not supportive of a full calendar year
performance period for the quality and cost performance categories.
However, we continue to believe that a full calendar year performance
period for the quality and cost performance categories will be less
confusing for MIPS eligible clinicians. As discussed in the CY 2019 PFS
proposed rule (83 FR 35893), we believe that a longer performance
period for the quality and cost performance categories will likely
include more patient encounters, which will increase the denominator of
the quality and cost measures. Statistically, larger sample sizes
provide more accurate and actionable information. Additionally, a full
calendar year performance period is consistent with how many of the
measures used in our program were designed to be performed and
reported. We also noted that the Bipartisan Budget Act of 2018 (Pub. L.
115-119, enacted February 9, 2018) has provided further flexibility to
the 3rd, 4th, and 5th years of MIPS to help continue the gradual
transition to MIPS.
Regarding the Promoting Interoperability performance category, we
have heard from stakeholders through public comments, letters, and
listening sessions that they oppose a full year performance period,
indicating that it is very challenging and may add administrative
burdens (83 FR 35893). Some stated that a 90-day performance period is
necessary in order to enable clinicians to have a greater focus on the
objectives and measures that promote patient safety, support clinical
effectiveness, and drive toward advanced use of health IT. They also
noted that as this performance category requires the use of CEHRT, a
90-day performance period will help relieve pressure on clinicians to
quickly implement changes and updates from their CEHRT vendors and
developers so that patient care is not compromised. Others cited the
challenges associated with reporting on a full calendar year for
clinicians newly employed by a health system or practice during the
course of a program year, switching CEHRT, vendor issues, system
downtime, cyber-attacks, difficulty getting data from old places of
employment, and office relocation. Most stakeholders stated that the
performance period should be 90 days in perpetuity, as this would
greatly reduce the reporting burden (83 FR 35893).
In the CY 2019 PFS proposed rule (83 FR 35893), in an effort to
provide as much transparency as possible so that MIPS eligible
clinicians and groups may plan for participation in the program, we
requested comments on our proposals at Sec. 414.1320(d)(1) that for
purposes of the 2022 MIPS payment year and future years, the
performance period for the quality and cost performance categories
would be the full calendar year (January 1 through December 31) that
occurs 2 years prior to the applicable MIPS payment year. For example,
for the 2022 MIPS payment year, the performance period would be 2020
(January 1, 2020 through December 31, 2020), and for the 2023 MIPS
payment year, the performance period would be CY 2021 (January 1, 2021
through December 31, 2021).
In addition, we requested comments on our proposal at Sec.
414.1320(d)(2) that for purposes of the 2022 MIPS payment year and
future years, the performance period for the improvement activities
performance category would be a minimum of a continuous 90-day period
within the calendar year that occurs 2 years prior to the applicable
MIPS payment year, up to and including the full calendar year. For
example, for the 2022 MIPS payment year, the performance period for the
improvement activities performance category would be a minimum of a
continuous 90-day period within CY 2020, up to and including the full
CY 2020 (January 1, 2020 through December 31, 2020). For the 2023 MIPS
payment year, the performance period for the improvement activities
performance category would be a minimum of a continuous 90-day period
within CY 2021, up to and including the full CY 2021 (January 1, 2021
through December 31, 2021) that occurs 2 years before the MIPS payment
year (83 FR 35893).
Finally, we requested comments on our proposal to add Sec.
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the
performance period for the Promoting Interoperability performance
category would be a minimum of a continuous 90-day period within the
calendar year that occurs 2 years prior to the applicable MIPS payment
year, up to and including the full calendar year. Thus, for the 2022
MIPS payment year, the performance period for the Promoting
Interoperability performance category would be a minimum of a
continuous 90-day period within CY 2020, up to and including the full
CY 2020 (January 1, 2020 through December 31, 2020) (83 FR 35893).
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters agreed with our proposal to maintain
the quality and cost performance periods as a full calendar year that
occurs 2 years prior to the applicable MIPS payment year, noting that
this proposal provides some of the stability needed for MIPS. One
commenter supported a full calendar year for the cost performance
category as this allows for a greater number of cases to be included in
each measure, which will give a more reliable performance result.
Another commenter supported a full calendar year for the quality and
cost performance categories because they stated that it is in the best
interest of patients encouraging clinicians to evolve in their approach
to delivering care.
Response: We appreciate the commenters' support.
Comment: Several commenters opposed a full calendar-year
performance period for the quality and cost performance categories and
urged CMS to establish a minimum 90-day performance period, consistent
with the other performance categories. Commenters noted that a minimum
of 90-day performance period would reduce the administrative burden in
MIPS, align the performance period across MIPS performance categories
and allow the agency to shorten the 2-year lag between performance and
payment. Other commenters requested that clinicians be allowed to
choose between 90 days up to a full year of reporting. Another
commenter urged CMS to consider adopting a 90-day performance period to
capture eligible clinicians who may join a group in the middle of a
performance year. One commenter agreed with the challenges CMS
[[Page 59746]]
outlined in the proposed rule (83 FR 35893) regarding the Promoting
Interoperability performance category and stated that these various
challenges create obstacles outside the control of the clinician, which
inhibits their ability to collect and report 12 months of MIPS data for
the quality performance category as well.
Response: We do not believe that it would be in the best interest
of MIPS eligible clinicians to have less than a full calendar year
performance period for the quality and cost performance categories for
the 2022 MIPS payment year and future years, as we are maintaining
consistency with the performance period established for the first 3
MIPS payment years. We believe this will be less burdensome and
confusing for MIPS eligible clinicians. As discussed in the CY 2018
Quality Payment Program final rule (82 FR 53618), statistically, larger
sample sizes provide more accurate and actionable information.
Additionally, a full calendar year performance period is consistent
with how many of the measures used in our program were designed to be
reported and performed; some of the measures do not allow for a 90-day
performance period. We believe these issues make the quality
performance category inherently different for reporting requirements
and measures than the Promoting Interoperability and improvement
activities performance categories. We do not believe reducing the
performance period for the quality and cost performance categories will
alleviate any issues with clinicians switching practices. Regarding
reducing the 2-year lag between performance and payment, as noted in
the CY 2017 Quality Payment Final Rule (81 FR 77077), the data
submission activities and claims for services furnished during the 1
year performance period (which could be used for claims- or
administrative claims-based quality or cost measures) may not be fully
processed until the following year. These circumstances require
adequate lead time to collect performance data, assess performance, and
compute the MIPS adjustment so the applicable MIPS adjustment can be
made available to each MIPS eligible clinician at least 30 days prior
to when the MIPS payment adjustment is applied each year. Finally, in
regard to the challenges we outlined in the proposed rule (83 FR
35893), these were specifically referring to the Promoting
Interoperability performance category. We do not believe that these
challenges affect the quality performance category, as well.
Comment: A few commenters noted that establishing a 90-day
performance period would give CMS an opportunity to set benchmarks
based on more current data, rather than from 4 years prior to the
applicable MIPS payment year.
Response: We believe that benchmarks based on data from a 90-day
performance period would be less reliable than those based on a full
calendar year because fewer reported instances would meet the case
minimum needed to be included in the benchmarks. This would also cause
some measures to not have an available benchmark that could be used for
scoring. In addition, using a 90-day performance period would not allow
the creation of benchmarks from more current data. This is because we
would still need to wait until the end of the data submission period
before we could create the benchmarks based on data submitted by all
MIPS eligible clinicians, and to publish historical benchmarks prior to
the beginning of the performance period, we would still need to use
data from 2 years prior to the performance period (4 years prior to the
MIPS payment year).
Comment: Several commenters supported the proposal to keep the
minimum performance period for the improvement activities performance
category at 90 days, noting the proposal maintains stability and
simplifies the program. One commenter stated that practices should be
able to complete improvement activities lasting 90 days even if the
performance spans over two performance periods. The commenter stated
that CMS should require practices to complete at least 45 consecutive
days during each of two consecutive performance periods to equal a
total of at least 90 days, noting that this lowers the burden on
clinicians and further encourages participation in this performance
category.
Response: We appreciate the support for our proposal. However, we
do not agree that an improvement activity should be split into two, 45-
day periods. As discussed in the CY 2017 Quality Payment Program final
rule (81 FR 77186), after researching several organizations, we believe
a minimum of 90 days is a reasonable amount of time required for
performing an activity. We do not believe that performance periods as
short as 45 days are sufficient for many of the available improvement
activities to ensure that the activities being performed result in
actual practice improvements.
Comment: One commenter opposed our proposal to keep the minimum
performance period for the improvement activities performance category
at 90-days and urged CMS to adopt a 12-month performance period. The
commenter noted that a 12-month performance period may be in the best
interest of patients and may evolve clinicians' approach to delivering
care.
Response: We appreciate the commenters' recommendation. However, we
believe that a minimum of a continuous 90-day performance period is
appropriate for MIPS eligible clinicians to perform improvement
activities that would improve clinical practice and provides more
flexibility as some improvement activities may be ongoing, while others
may be appropriately episodic.
Comment: Many commenters supported our proposal to keep the minimum
performance period for the Promoting Interoperability performance
category at 90 days, noting that this proposal maintains stability,
helps reduce administrative burden, provides clinicians with the time
needed to manage changes and updates from their CEHRT vendors and
developers, allows for effective measurement, and allows clinicians the
flexibility to address scheduled or unanticipated events such as
switching EHR vendors, system downtime, and cyber-attacks without
jeopardizing patient care. Several commenters requested that CMS
consider extending this performance period beyond the CY 2020 MIPS
performance period.
Response: We appreciate the commenters' support. We believe it is
premature to establish policy beyond CY 2020 at this time appreciating
the continued work in this area across HHS. We are finalizing the
Promoting Interoperability performance period specific to CY 2019. We
will take the comment into consideration for future rulemaking.
Comment: One commenter requested that CMS investigate ways to
shorten the time between performance periods and for future MIPS
payment years in the Quality Payment Program. This commenter noted
concern that 2 years is too long to impact practice patterns and lead
to meaningful changes in behavior.
Response: We understand the commenter's concern. However, as
discussed in the CY 2017 Quality Payment Program final rule (81 FR
77083), there is a ``2-year lag'' at this time, in order to account for
the post-submission processes of calculating the MIPS eligible
clinician's final score, establishing budget neutrality and issuing the
MIPS payment adjustment factors, and allowing for a targeted review
period to occur prior to the application of the MIPS payment
[[Page 59747]]
adjustment. We will continue working to shorten the ``2-year lag'' that
the commenter describes.
Comment: Several commenters urged CMS to consider the timing of
previous year MIPS feedback reports, which are released in July after
the close of the performance period, noting that this timeline does not
allow for clinicians to make necessary changes before the beginning of
the next performance period. Several commenters noted that, if the
performance period was reduced to a 90-day minimum with the option to
submit additional data, individuals and groups would have greater
flexibility to incorporate previous MIPS feedback into their
performance during the remaining portion of 2019, thereby increasing
quality and patient safety, and to focus more of their attention on
improving patient care.
Response: Regarding the release of the feedback reports for the 1st
year of MIPS, we provided 3 rounds of feedback including: (1) Round 1--
at the point of submission feedback; (2) round 2--pre-performance
feedback; and (3) round 3--performance feedback. First, in round 1, at
the point of submission we provided real time feedback that was
available from the opening to the close of the submission period.
Second, in round 2, we provided pre-performance feedback, which was
available at the beginning of the close of the submission period and
updated the round 2 feedback as new data became available such as CAHPS
for MIPS survey, all-cause readmission measure, and cost measures data.
Third, in round 3, we provided performance feedback that while it looks
similar to round 2 is different in that the data is final with no new
data being added and the payment adjustment(s) is included. This is the
data that can be used to determine if a targeted review is to be filed.
Considering there are opportunities for a clinician to gain insight
into their possible performance prior to the release of the performance
feedback in July, we encourage MIPS eligible clinicians to review the
preliminary feedback and make necessary process and performance
improvements, as needed. While we agree that there is some benefit to a
90-day performance period, we believe that more continuous feedback is
more beneficial. We also note that operationally our goal is to provide
as much continuous submission opportunity as we can support in the
future, including allowing clinicians to submit data during the
performance period, as feasible. The ability to receive more frequent
and continuous submissions will further our ability to provide more
frequent feedback to MIPS eligible clinicians.
Comment: A few commenters did not support the 90-day performance
period for the Promoting Interoperability performance category and
urged CMS to move to full calendar year reporting as soon as possible
to achieve value-based care, stating that patients and families should
be able to experience the benefits of health IT any day of the year,
rather than a particular 3-month period. One commenter noted that a 12-
month performance period would more effectively achieve the objectives
of MACRA. One commenter also noted that requiring full-year reporting
would be less burdensome because it aligns with performance period for
the quality performance category. Finally, one commenter also noted
that requiring full-year reporting is more likely to prompt changes to
clinician workflows.
Response: Although the performance period for the Promoting
Interoperability performance category is a minimum of a continuous 90-
day period during the calendar year, clinicians may report for a period
up to and including the full calendar year. In addition, we do not
believe that the duration of the performance period is indicative of
the availability of the EHR to patients. We believe it is likely that a
clinician who uses an EHR for a period of 90 days will continue to use
it year round.
Comment: One commenter urged us to consider the practical
implications of a 90-day performance period for Promoting
Interoperability measure reporting, emphasizing the need to ensure MIPS
eligible clinicians and groups maintain interoperability capabilities
in months that are not in the Promoting Interoperability performance
period. This commenter noted the reporting periods may vary across
eligible clinicians and groups and that a 90-day performance period
could reduce the MIPS program's incentives for interoperability and may
delay roll-out of enhanced interoperability functionality.
Response: While MIPS eligible clinicians are required to report for
a minimum of 90 days, they have the flexibility to report for a longer
performance if they choose. Further we believe that once CEHRT is being
utilized by the MIPS eligible clinician, it will be used on an ongoing
basis and not just during a 90-day performance period.
After consideration of the public comments received, we are
finalizing our proposal at Sec. 414.1320(d)(1) that for purposes of
the 2022 MIPS payment year and future years, the performance period for
the quality and cost performance categories would be the full calendar
year (January 1 through December 31) that occurs 2 years prior to the
applicable MIPS payment year. In addition, we are finalizing our
proposal at Sec. 414.1320(d)(2) that for purposes of the 2022 MIPS
payment year and future years, the performance period for the
improvement activities performance category would be a minimum of a
continuous 90-day period within the calendar year that occurs 2 years
prior to the applicable MIPS payment year, up to and including the full
calendar year. We are also finalizing our proposal to add at Sec.
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the
performance period for the Promoting Interoperability performance
category would be a minimum of a continuous 90-day period within the
calendar year that occurs 2 years prior to the applicable MIPS payment
year, up to and including the full calendar year. Finally, we are
finalizing revisions to Sec. 414.1320(b)(2) and (c)(2) to refer to the
new name of the Promoting Interoperability performance category.
h. MIPS Performance Category Measures and Activities
(1) Data Submission Requirements
(a) Background
We refer readers to Sec. 414.1325 and the CY 2017 and CY 2018
Quality Payment Program final rules (81 FR 77087 through 77095, and 82
FR 53619 through 53626, respectively) for our previously established
policies regarding data submission requirements.
(b) Collection Types, Submission Types and Submitter Types
It has come to our attention that the way we have previously
described data submission by MIPS eligible clinicians, groups and third
party intermediaries does not precisely reflect the experience users
have when submitting data to us. To clarify, we have previously used
the term ``submission mechanisms'' to refer not only to the mechanism
by which data is submitted, but also to certain types of measures and
activities on which data are submitted (for example, electronic
clinical quality measures (eCQMs) reported via EHR) and to the entities
submitting such data (for example, third party intermediaries on behalf
of MIPS eligible clinicians and groups). To ensure clarity and
precision for all users, we are proposing to revise existing and define
additional terminology to more precisely reflect the experience users
have when submitting data to the Quality Payment Program.
[[Page 59748]]
In the CY 2019 PFS proposed rule (83 FR 35894), we requested
comments on our proposal to define the following terms at Sec.
414.1305:
Collection type as a set of quality measures with
comparable specifications and data completeness criteria, including, as
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR
measures; Medicare Part B claims measures; CMS Web Interface measures;
the CAHPS for MIPS survey; and administrative claims measures. The term
MIPS CQMs would replace what was formerly referred to as registry
measures since entities other than registries may submit data on these
measures. These new terms are referenced in the collection type field
for the following measure tables of the appendices in the CY 2019 PFS
proposed rule (83 FR 36092 through 36358): Table Group A: Proposed New
Quality Measures for Inclusion in MIPS for the 2021 MIPS Payment Year
and Future Years; Table Group B: Proposed New and Modified MIPS
Specialty Measure Sets for the 2021 MIPS Payment Year and Future Years;
Table C: Quality Measures Proposed for Removal from the Merit-Based
Incentive Payment System Program for the 2019 Performance Period and
Future Years; and Table Group D: Measures with Substantive Changes
Proposed for the 2021 MIPS Payment Year and Future Years.
Submitter type as the MIPS eligible clinician, group, or
third party intermediary acting on behalf of a MIPS eligible clinician
or group, as applicable, that submits data on measures and activities
under MIPS.
Submission type as the mechanism by which a submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface. The direct submission type allows users to transmit data
through a computer-to-computer interaction, such as an API. The log in
and upload submission type allows users to upload and submit data in
the form and manner specified by CMS with a set of authenticated
credentials. The log in and attest submission type allows users to
manually attest that certain measures and activities were performed in
the form and manner specified by CMS with a set of authenticated
credentials. We note that there is no submission type for the
administrative claims collection type because we calculate measures for
this collection type based on administrative claims data available to
us.
In the CY 2019 PFS proposed rule (83 FR 35894), we solicited
additional feedback and alternative suggestions on terminology that
appropriately reflects the concepts described in the proposed
definitions of collection type, submitter type and submission type, as
well as the term MIPS CQMs to replace the formerly used term of
registry measures.
The following is a summary of the comments we received on
``Collection Types, Submission Types and Submitter Types''.
Comment: A few commenters supported the clarification of submission
terms, stating that the new definitions recognize the complexity of
measure types and submission options and reduce the potential for
confusion. Commenters asked whether, if we finalize these terminology
updates, educational information will be made available on the Quality
Payment Program website so that clinicians will understand and
appropriately apply these terms. One commenter also emphasized the
importance of ensuring that submitting and attesting to measures is
flexible and easy for clinicians to do.
Response: We intend to update the Quality Payment Program website
appropriately and provide any relevant educational materials.
Comment: One commenter recommended that, if the ``collection type''
definition only refers to quality measures, CMS change ``collection
type'' to ``quality measure type'' and requested that CMS provide a
definition for data collection recognizing that all performance
categories collect data. Another commenter also recommended that we
recommend that we change ``collection type'' to ``measure type'' or
``measure category'' to more intuitively and accurately reflect the
meaning of the term.
Response: The proposed definition of collection type states that it
is specific to a set of quality measures. Therefore, we do not agree
the suggested term of ``quality measure type'' would be the most
beneficial in clarifying the actual submission experience for the user,
in comparison to how submission mechanisms were discussed in our
previous policies. We also note that the usage of the term ``quality
measure type'' is commonly used to refer to mean a specific type of
measure such as process or outcome measure. While we agree that all
performance categories do in fact collect data, for purposes of
clarifying the user experience for data submission, it is most
beneficial to only refer to data collection in regards to the quality
performance category. The suggested terms ``measure type'' or ``measure
category'' could create further misunderstanding of the intent of the
definition. As far as ``measure type'', there are other measures
available in the program than just those available for reporting on in
the quality performance category. For the term ``measure category'', we
disagree as this could give the implication that this is another
performance category within the Quality Payment Program.
Comment: One commenter recommended that we change the term
``submission type'' to ``submission method'' and to define the
mechanisms by which CMS means by ``direct,'' ``log in,'' ``upload,''
and ``attest.''
Response: We agree that the term ``submission method'' is an
appropriate term for the proposed definition. However, the term did not
gain support during user testing that surpassed the proposed terms.
According to feedback from user testing, the proposed terms of
collection, submitter and submission type, were found to be intuitive
and to match the user experience when submitting data to the Quality
Payment Program. The direct, log in and upload, log in and attest modes
of data submission will be discussed in further detail in forthcoming
educational resources. We also encourage review of the terms and
wireframes for the submission types on qpp.cms.gov/design-examples.
Comment: One commenter recommended that we change ``submitter
type'' to ``submitting entity'' and define this as the entity who will
be submitting the eligible clinician's data.
Response: We believe that consistent terminology would be most
beneficial in providing clarity for users submitting data to the
Quality Payment Program. We also note that the term submitter type
includes both entities that would submit on a clinician's behalf, as
well as actions made directly by clinicians or their practice.
After consideration of the public comments received, we are
finalizing our proposal at Sec. 414.1305 to define the following
terms:
Collection type as a set of quality measures with
comparable specifications and data completeness criteria, including, as
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR
measures; Medicare Part B claims measures; CMS Web Interface measures;
the CAHPS for MIPS survey; and administrative claims measures. The term
MIPS CQMs would replace what was formerly referred to as registry
measures since entities other than registries may submit data on these
measures. These new terms are referenced in the collection type field
for the following measure tables of ``Appendix 1: Finalized MIPS
Quality
[[Page 59749]]
Measures'' in this final rule: Table Group A: Finalized New Quality
Measures for Inclusion in MIPS for the 2021 MIPS Payment Year and
Future Years; Table Group B: Finalized New and Modified MIPS Specialty
Measure Sets for the 2021 MIPS Payment Year and Future Years; Table
Group C: Quality Measures Finalized for Removal in the 2021 MIPS
Payment Year and Future Years; and Table Group D: Measures with
Substantive Changes Finalized for the 2021 MIPS Payment Year and Future
Years.
Submitter type as the MIPS eligible clinician, group, or
third party intermediary acting on behalf of a MIPS eligible clinician
or group, as applicable, that submits data on measures and activities
under MIPS.
Submission type as the mechanism by which a submitter type
submits data to CMS, including, as applicable: Direct, log in and
upload, log in and attest, Medicare Part B claims and the CMS Web
Interface. The direct submission type allows users to transmit data
through a computer-to-computer interaction, such as an API. The log in
and upload submission type allows users to upload and submit data in
the form and manner specified by CMS with a set of authenticated
credentials. The log in and attest submission type allows users to
manually attest that certain measures and activities were performed in
the form and manner specified by CMS with a set of authenticated
credentials. We note that there is no submission type for the
administrative claims collection type because we calculate measures for
this collection type based on administrative claims data available to
us.
(c) Performance Category Measures and Reporting
We previously finalized at Sec. 414.1325(a) and (e), respectively,
that MIPS eligible clinicians and groups must submit measures,
objectives, and activities for the quality, improvement activities, and
advancing care information performance categories and that there are no
data submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category; CMS will calculate performance on these measures
using administrative claims data. In the CY 2019 PFS proposed rule (83
FR 35894), we proposed to amend Sec. 414.1325(a) to incorporate Sec.
414.1325(e), as they both address which performance categories require
data submission; Sec. 414.1325(f) would be redesignated as Sec.
414.1325(e). We also proposed in the CY 2019 PFS proposed rule (83 FR
35894) at Sec. 414.1325(a)(2)(ii) that there is no data submission
requirement for the quality or cost performance category, as
applicable, for MIPS eligible clinicians and groups that are scored
under the facility-based measurement scoring methodology described in
Sec. 414.1380(e). We also recognized the need to clarify to users how
they submit data to us. In the CY 2019 PFS proposed rule (83 FR 35894),
there are five basic submission types that we proposed to define in
MIPS: Direct; log in and upload; login and attest; Medicare Part B
claims; and the CMS Web Interface. We proposed to reorganize Sec.
414.1325(b) and (c) by performance category in the CY 2019 PFS proposed
rule (83 FR 35894). We proposed in the CY 2019 PFS proposed rule (83 FR
35894) to also clarify at Sec. 414.1325(b)(1) that an individual MIPS
eligible clinician may submit their MIPS data for the quality
performance category using the direct, login and upload, and Medicare
Part B claims submission types. In the CY 2019 PFS proposed rule (83 FR
35894), similarly, we proposed to clarify at Sec. 414.1325(b)(2) that
an individual MIPS eligible clinician may submit their MIPS data for
the improvement activities or Promoting Interoperability performance
categories using the direct, login and upload, or login and attest
submission types. As for groups, we proposed in the CY 2019 PFS
proposed rule (83 FR 35894) to clarify at Sec. 414.1325(c)(1) that
groups may submit their MIPS data for the quality performance category
using the direct, login and upload, and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) submission types. Lastly,
we proposed to clarify at Sec. 414.1325(c)(2) that groups may submit
their MIPS data for the improvement activities or Promoting
Interoperability performance categories using the direct, login and
upload, or login and attest submission types in the CY 2019 PFS
proposed rule (83 FR 35894). We believe that these clarifications will
enhance the submission experience for clinicians and other
stakeholders. As technology continues to evolve, we will continue to
look for new ways that we can offer further technical flexibilities on
submitting data to the Quality Payment Program. In the CY 2019 PFS
proposed rule (83 FR 35894), we requested comment on these proposals.
To assist commenters in providing pertinent comments, we developed a
website that uses wireframe (schematic) drawings to illustrate a subset
of the different submission types available for MIPS participation.
Specifically, the wireframe drawings describe the direct, login and
attest, and login and upload submission types. We refer readers to the
Quality Payment Program at qpp.cms.gov/design-examples to review these
wireframe drawings. The website will provide specific matrices
illustrating potential stakeholder experiences when choosing to submit
data under MIPS.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. Although we would like to move towards the utilization of
electronic reporting by all clinicians and groups, we realize that
small practices face additional challenges, and this requirement may
limit their ability to participate. For this reason, we believe that
Medicare Part B claims measures should be available to small practices,
regardless of whether they are reporting as individual MIPS eligible
clinicians or as groups. Therefore, we proposed amending Sec.
414.1325(c)(1) to make the Medicare Part B claims collection type
available to MIPS eligible clinicians in small practices beginning with
the 2021 MIPS payment year in the CY 2019 PFS proposed rule (83 FR
35894). Although this will limit the current availability of Medicare
Part B claims measures for individual MIPS eligible clinicians that do
not meet the definition of a small practice, it will expand the
availability of such measures for small practices who choose to
participate in MIPS as a group, which currently does not have a claims-
based reporting option as a group.
Under Sec. 414.1325(c)(4), we previously finalized that groups may
submit their MIPS data using the CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) for the quality,
improvement activities, and promoting interoperability performance
categories. In the CY 2019 PFS proposed rule (83 FR 35894 through
35895), we proposed that the CMS Web Interface submission type would no
longer be available for groups to use to submit data for the
improvement activities and Promoting Interoperability performance
categories at Sec. 414.1325(c)(2). The CMS Web Interface has been
designed based on user feedback as a method for quality submissions
only; however, groups that elect to utilize the CMS Web Interface can
still submit improvement activities or promoting interoperability data
via direct, log in and attest or log in and upload submission types. We
also recognized that certain groups that have elected to use the CMS
Web Interface
[[Page 59750]]
may prefer to have their data submitted on their behalf by a third
party intermediary described at Sec. 414.1400(a). We recognized the
benefit and burden reduction in such a flexibility and therefore
proposed to allow third party intermediaries to submit data to the CMS
Web Interface in addition to groups in the CY 2019 PFS proposed rule
(83 FR 35895). Specifically, we proposed in the CY 2019 PFS proposed
rule (83 FR 35895) to redesignate Sec. 414.1325(c)(4) as Sec.
414.1325(c)(1) and amend Sec. 414.1325(c)(1) to allow third party
intermediaries to submit data using the CMS Web Interface on behalf of
groups. To further our efforts to provide flexibility in reporting to
the Quality Payment Program, we solicited comment in the CY 2019 PFS
proposed rule (83 FR 35895) on expanding the CMS Web Interface
submission type to groups consisting of 16 or more eligible clinicians
to inform our future rulemaking.
We previously finalized at Sec. 414.1325(e) that there are no data
submission requirements for the cost performance category and for
certain quality measures used to assess performance in the quality
performance category and that CMS will calculate performance on these
measures using administrative claims data. We also finalized at Sec.
414.1325(f)(2), (which, as noted, we proposed to redesignate as Sec.
414.1325(e)(2)) that for Medicare Part B claims, data must be submitted
on claims with dates of service during the performance period that must
be processed no later than 60 days following the close of the
performance period. We neglected to codify this requirement at Sec.
414.1325(e) (which, as noted, we proposed to consolidate with Sec.
414.1325(a)) for administrative claims data used to assess performance
in the cost performance category and for administrative claims-based
quality measures. Therefore, in the CY 2019 PFS proposed rule (83 FR
35895), we proposed to amend Sec. 414.1325(a)(2)(i) to reflect that
claims included in the measures are those submitted with dates of
service during the performance period that are processed no later than
60 days following the close of the performance period.
In the CY 2019 PFS proposed rule (83 FR 35895), a summary of these
proposed changes is included in Tables 32 and 33. For reference, Table
32 summarizes the data submission types for individual MIPS eligible
clinicians that we proposed at Sec. 414.1325(b) and (e) in the CY 2019
PFS proposed rule (83 FR 35895). Table 33 summarizes the data
submission types for groups that we proposed at Sec. 414.1325(c) and
(e) in the CY 2019 PFS proposed rule (83 FR 35895 through 35896). We
requested comment on these proposals.
The following is a summary of the comments we received on
``Performance Category Measures and Reporting''.
Comment: Many commenters supported our proposal to allow small
practices to use the Medicare Part B claims-based reporting option for
group reporting, with some noting that this option specifically
relieves the burden on rural providers. However, several of these
commenters opposed limiting the Medicare Part B claims reporting to
only clinicians in small practices, stating that many clinicians are
excluded from the special small practice policies despite operating as
small practices in all other respects, and there may be circumstances
where reporting via Medicare Part B claims as individuals is the best
option for clinicians in larger multispecialty practices to allow each
clinician to focus on quality measures most relevant to his/her
specialty and scope of practice. A few commenters stated that this
policy would result in a negative impact on clinicians who are part of
specialties that do not have relevant eCQMs available to them, but have
nonetheless implemented workflows to support reporting data using
Medicare Part B claims; requiring them to change these workflows based
solely on practice size would cause unnecessary clinician burden
without an offsetting benefit to the clinician already participating in
the program. Therefore, these commenters recommended that CMS retain
the Medicare Part B claims-based reporting option in the quality
performance category for all clinicians regardless of practice size.
One commenter also requested that we provide a definition for a small
practice in the final rule.
Response: We likewise acknowledge that many clinicians that are not
in a small practice currently report via Medicare Part B claims.
However, as we previously expressed in the CY 2017 Quality Payment
Program final rule (81 FR 77090), we want to move away from claims
reporting, as more measures are available through health IT mechanisms
such as registries, QCDRs, and health IT vendors. We believe it is
important to move away from manual methods of reporting and instead
utilize more electronic methods such as using EHRs, registries, QCDRs.
Also, as we have described above with our revised terms, clinicians
that are part of a practice that opts not to work with a third party
intermediary can submit data directly to us, which is a flexibility we
have under MIPS that was not available under the legacy programs. We
note that this change does not require the use of eCQMs by MIPS
eligible clinicians that are not considered to be part of a small
practice. Rather, MIPS eligible clinicians that do not meet the
definition of a small practice will have the ability to select from all
other collection types. We refer readers to Sec. 414.1305 for the
definition of small practice.
Comment: A few commenters did not support the proposal to make the
Medicare Part B claims collection type available to clinicians in small
practices, stating that it does not align with the objectives of
electronic reporting and Promoting Interoperability. Commenters
specifically stated that the small administrative burden to implement
CEHRT exceeds the cost of the various benefits of utilizing technology
to improve the quality of care and that CEHRT is the only method that
is completely accurate based upon the patient record and prevents
organizations from ``cherry-picking'' patients to meet the 60 percent
reporting threshold. One commenter also noted that registries are
available at very affordable costs for clinicians and groups. Another
commenter stated concern about how small and rural practices that have
made the financial investment into CEHRT would react to this proposed
update, stating that the proposal sends an inconsistent message to
those small and rural psychiatric practices that made the financial
investment to adopt CEHRT.
Response: To clarify, our policy is to make the Medicare Part B
claims collection type only available to small practices. We agree that
there are many benefits to CEHRT adoption and also agree that many
registries are available at low cost. We do not agree that this sends
an inconsistent message with the objectives of electronic reporting and
Promoting Interoperability as we still encourage all clinicians (small
practices and non-small practices) to submit electronically. However,
we recognize that small practices have additional challenges and
believe that continuing to allow the Medicare Part B claims collection
type only to small practices is beneficial. To further highlight
alignment in policy regarding small practices across performance
categories in MIPS, as discussed in section III.I.3.h.(5) of this final
rule for the Promoting Interoperability performance category, small
practices can apply for a significant hardship exception if they have
issues acquiring an EHR.
Comment: Several commenters opposed the proposed removal of
Medicare Part B claims-based reporting
[[Page 59751]]
as an option for clinicians. One commenter noted concern because the
proposal to expand the definition of a MIPS eligible clinician stated
it would also coincide with a decrease in the number of group practices
that will be considered a small practice. Commenters requested that CMS
finalize a future timeframe for retiring the Medicare Part B claims
based submission type for eligible clinicians, stating that: Medicare
Part B claims based submission of quality data is still an extremely
popular submission method in certain specialties; eliminating this
reporting option may reduce the number of clinicians who participate in
MIPS reporting; clinicians in many specialties, most notably those that
are hospital based, will have to transition to use of a qualified
registry or QCDR for quality measure reporting once claims based
reporting is no longer an option, and this will require new and
unplanned costs and further burden. Commenters also noted that
clinicians who elect to report via Medicare Part B claims-based
reporting, and choose to report topped out measures, are penalized in
their quality score under current methods by receiving a maximum of 7
of 10 points for each topped out measure; therefore there is not an
inappropriate incentive for continued use of this method. Another
commenter stated that the removal of Medicare Part B claims reporting
contradicts the provisions in the Bipartisan Budget Act of 2018 that
moves the Agency toward accepting more claims data. Another commenter
recommended waiting to see if the number of clinicians reporting
through Medicare Part B claims increases over the next years and then
determine if a future proposal is appropriate.
Response: We acknowledge that many clinicians that are not in a
small practice currently report via Medicare Part B claims. However, we
disagree that only allowing the reporting of this collection type to
small practices forces non-small practices to transition to the use of
a qualified registry or QCDR for quality measure reporting, as there
are other collection types and submitter types available in which non-
small practices can report (that is, eCQMs, MIPS CQMs, CMS Web
Interface measures, the CMS approved survey vendor measure and
Administrative claims measures). For example, a non-small practice that
does not wish to enter into an arrangement with a third party
intermediary can use the MIPS CQM collection type and either login and
upload their data or use the direct submission type for the quality
performance category. These submission types do not require the usage
of a third party intermediary, but we note that there are certain
technical capabilities that a practice must have to submit data in this
manner. Additional details on the form and manner requirements of these
submission types is available at qpp.cms.gov/design-examples.
We agree that choosing to report topped out measures is not
incentivized. As discussed in the CY 2019 PFS proposed rule (83 FR
35894), we want to move away from claims reporting, since approximately
69 percent of the Medicare Part B claims measures are topped out. This
is a contributing factor as to why we are looking to decrease the usage
of this option over time, as we have been signaling we would do for
many years. We will continue to work with stakeholders on providing
further transparency of the future of this collection type. It is
unclear to what reference the commenter is discussing where the removal
of claims reporting is a contradiction to provisions made in the
Bipartisan Budget Act of 2018. We do not believe that this proposal is
inconsistent with the Bipartisan Budget Act of 2018.
We do not believe further delay is warranted but will continue to
work with stakeholders to provide further clarity on the future of this
collection type. Lastly, we disagree that the expansion of the MIPS
eligible clinician type as discussed in section III.I.3.c. will
decrease the number of small practices. As defined at Sec. 414.1305, a
small practice is a TIN consisting of 15 or fewer eligible clinicians
during the MIPS determination period. We note that this definition
currently includes both eligible clinicians and MIPS eligible
clinicians, and therefore, the expansion of the MIPS eligible clinician
definition should not negatively impact a practice's ability to be
considered a small practice.
Comment: One commenter asked us to acknowledge that, from their
experiences participating in MIPS for the CY 2017 transition period,
when a group attests for promoting interoperability but uses Medicare
Part B claims to submit for the quality performance category as
individuals, every clinician must have quality data and this data does
not roll-up to the group.
Response: In the CY 2017 Quality Payment Program final rule (81 FR
77087 through 77088), Tables 1 and 2 summarized allowable individual
and group submission types. In the 2017 MIPS performance period,
Medicare Part B claims submissions for the quality performance category
could only be used by individuals, and no group score was calculated
for this collection type. In this final rule, we are finalizing our
proposal to allow small practices the option to report as individuals
or a group using Medicare Part B claims data so that a group
performance score can be calculated for quality and combined with other
group scores from other performance categories.
Comment: One commenter urged CMS to provide greater detail about
whether there is value in the data submitted through the Medicare Part
B claims measure collection type, given the reduced number of
clinically appropriate and applicable claims measures under Medicare
Part B, particularly considering data that is collected from claims
forms contains minimal clinical information.
Response: Medicare Part B Claims Measure Specifications do provide
value in the data submitted. Denominator eligibility can be determined
by billing already included within a Medicare Part B Claim. The
eligible clinician can submit a quality data code to attest to the
quality action defined by the measure specification. The Medicare Part
B Measure Specifications address a number of clinical outcomes on
prevalent health conditions (for example, diabetes, hypertension). In
addition to the outcomes, the Medicare Part B Claims Measure
Specifications provide eligible clinicians who provide services in a
small practice to participate within MIPS without incurring additional
costs in data abstraction by third party intermediaries.
Comment: One commenter urged CMS to provide greater detail about
whether small and rural practices who report their performance solely
through Medicare Part B claims measures would be afforded the
opportunity to submit fewer than 6 measures (including one outcome or
high priority measure) as currently required. This commenter also urged
CMS to provide greater detail about whether new Medicare Part B claims
quality measures would be accepted for inclusion in the rulemaking
process, or if only the current Medicare Part B claims quality measures
would be continued for use by small and rural practices.
Response: We did not propose any changes to the quality performance
submission criteria for the Medicare Part B claims collection type. We
validate the availability and applicability of quality measures for
clinicians who collect data via claims with fewer than six measures.
Clinicians would only need to report the measures that are applicable.
We refer readers to
[[Page 59752]]
section III.I.3.i.(1)(b)(vii) of this final rule for more discussion on
our data validation process. Any updates to the measures list would go
through future rulemaking. We want to clarify, that while reference was
made to both small and rural practices by the commenter, this policy is
limited to those that are small practices. We note that a practice that
is small and rural would be eligible to use the Medicare Part B claims
collection type, but only with meeting the special status designation
of being a small practice.
Comment: One commenter requested clarification on how CMS would
determine that a claims submission is intended for group reporting if
the group is only submitting data for the quality performance category
of MIPS.
Response: In the scenarios where we only receive Medicare Part B
claims submissions for a practice for the quality performance category
of MIPS, we intend on calculating the quality performance category for
the practice as both a group and as individuals and will apply the
quality performance category score that is the greater of the two. We
considered requiring an election for assessment as a group but believe
this would be unduly burdensome on small practices.
Comment: One commenter disagreed with our proposal to eliminate Web
Interface reporting for the improvement activities and Promoting
Interoperability performance categories, stating this reduces
flexibility for groups and adds unnecessary complexity.
Response: We clarify that the CMS Web Interface has been designed
as a method for quality submissions only, based on user feedback. As we
developed the CMS Web Interface for usage under the Quality Payment
Program, we engaged in user testing with stakeholders and the inclusion
of the improvement activities and promoting interoperability
performance categories within the CMS Web Interface tool negatively
impacted the design. Instead, what users experienced for submissions in
the first year of the program was a seamless interaction between the
CMS Web Interface and the ability to attest for these two performance
categories. With the finalization of this policy, users will have the
exact same experiences of reporting data for the promoting
interoperability and improvement activities performance categories
while still using the CMS Web Interface for the quality performance
category. We reiterate that we are simply updating our policy to
reflect the existing user experience that stakeholders encounter. We
would also like to highlight that groups that elect to utilize the CMS
Web Interface can still submit improvement activities or promoting
interoperability data via direct and log in and upload, if they choose
not to utilize the login and attest submission type.
Comment: One commenter supported our proposal to eliminate Web
Interface reporting for the improvement activities and Promoting
Interoperability performance categories.
Response: We appreciate the commenter's support.
Comment: One commenter appreciated that we clarified that groups
may submit their MIPS data for the improvement activities or Promoting
Interoperability performance categories using the direct, login and
upload, or login and attest submission types.
Response: Our intent was to provide clarity with the submission
experience for clinicians and other stakeholders.
Comment: A few commenters supported our proposal to allow third
party intermediaries to submit data using the CMS Web Interface on
behalf of groups, which alleviates burden on group practices to report
the data themselves.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1325(a) to incorporate Sec.
414.1325(e), as they both address which performance categories require
data submission; Sec. 414.1325(f) will be redesignated as Sec.
414.1325(e). We are finalizing our proposal at Sec. 414.1325(a)(2)(ii)
that there is no data submission requirement for the quality or cost
performance category, as applicable, for MIPS eligible clinicians and
groups that are scored under the facility-based measurement scoring
methodology described in Sec. 414.1380(e). We are finalizing our
proposals to reorganize Sec. 414.1325(b) and (c) by performance
category and to clarify at Sec. 414.1325(b)(1) that an individual MIPS
eligible clinician may submit their MIPS data for the quality
performance category using the direct, login and upload, and Medicare
Part B claims submission types. We are finalizing our proposal to
clarify at Sec. 414.1325(b)(2) that an individual MIPS eligible
clinician may submit their MIPS data for the improvement activities or
Promoting Interoperability performance categories using the direct,
login and upload, or login and attest submission types. We are
finalizing our proposal to clarify at Sec. 414.1325(c)(1) that groups
may submit their MIPS data for the quality performance category using
the direct, login and upload, and CMS Web Interface (for groups
consisting of 25 or more eligible clinicians) submission types. We are
also finalizing our proposal to clarify at Sec. 414.1325(c)(2) that
groups may submit their MIPS data for the improvement activities or
Promoting Interoperability performance categories using the direct,
login and upload, or login and attest submission types. We are
finalizing our proposal to amend Sec. 414.1325(c)(1) to make the
Medicare Part B claims collection type available to MIPS eligible
clinicians in small practices beginning with the 2021 MIPS payment
year. We are finalizing our proposal at Sec. 414.1325(c)(2) to state
that the CMS Web Interface submission type will no longer be available
for groups to use to submit data for the improvement activities and
Promoting Interoperability performance categories. We are finalizing
our proposal to redesignate Sec. 414.1325(c)(4) as Sec.
414.1325(c)(1) and amend Sec. 414.1325(c)(1) to allow third party
intermediaries to submit data using the CMS Web Interface on behalf of
groups. We are finalizing our proposal to redesignate Sec.
414.1325(f)(2) as Sec. 414.1325(e)(2) that for Medicare Part B claims,
data must be submitted on claims with dates of service during the
performance period that must be processed no later than 60 days
following the close of the performance period. Lastly, we are also
finalizing our proposal to amend Sec. 414.1325(a)(2)(i) to reflect
that claims included in the measures are those submitted with dates of
service during the performance period that are processed no later than
60 days following the close of the performance period. We received many
comments on our comment solicitation to expand the scope of practices
that can utilize the Web Interface and will take them into
consideration for future rulemaking.
[[Page 59753]]
Table 32--Data Submission Types for MIPS Eligible Clinicians Reporting as Individuals
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission type Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Individual or Third eCQMs.
Log in and upload...... Party Intermediary \2\. MIPS CQMs.
Medicare Part B claims Individual............. QCDR measures.
(small practices) \1\.. Medicare Part B claims
measures (small
practices).
Cost................................. No data submission Individual .......................
required \2\.
Promoting Interoperability........... Direct................. Individual or Third .......................
Log in and upload...... Party Intermediary.
Log in and attest......
Improvement Activities............... Direct................. Individual or Third .......................
Log in and upload...... Party Intermediary.
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
action or exclusion occurred.
Table 33--Data Submission Types for MIPS Eligible Clinicians Reporting as Groups
----------------------------------------------------------------------------------------------------------------
Performance category/submission
combinations accepted Submission types Submitter type Collection type
----------------------------------------------------------------------------------------------------------------
Quality.............................. Direct................. Group or Third Party eCQMs.
Log in and upload...... Intermediary. MIPS CQMs.
CMS Web Interface QCDR measures.
(groups of 25 or more CMS Web Interface
eligible clinicians).. measures.
Medicare Part B claims Medicare Part B claims
(small practices) \1\.. measures (small
practices).
CMS approved survey
vendor measure.
Administrative claims
measures.
Cost................................. No data submission Group .......................
required 1 2.
Promoting Interoperability........... Direct................. Group or Third Party .......................
Log in and upload...... Intermediary
Log in and attest......
Improvement Activities............... Direct................. Group or Third Party .......................
Log in and upload...... Intermediary
Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
action or exclusion occurred.
(d) Submission Deadlines
We previously finalized data submission deadlines in the CY 2017
Quality Payment Program final rule (81 FR 77095 through 77097) at Sec.
414.1325(f), which outlined data submission deadlines for all
submission mechanisms for individual eligible clinicians and groups for
all performance categories. As discussed in section III.I.3.h.(1) of
this final rule, the term submission mechanism, that includes
submission via the qualified registry, QCDR, EHR, Medicare Part B
claims, the CMS Web Interface and attestation, does not align with the
existing process of data submission to the Quality Payment Program. In
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to revise
regulatory text language at Sec. 414.1325(f), which, as noted, we
proposed to redesignate as Sec. 414.1325(e), to outline data
submission deadlines for all submission types for individual eligible
clinicians and groups for all performance categories. In the CY 2019
PFS proposed rule (83 FR 35896), we also proposed to revise Sec.
414.1325(e)(1) to allow flexibility for CMS to alter submission
deadlines for the direct, login and upload, the CMS Web Interface, and
login and attest submission types. We anticipate that in scenarios
where the March 31st deadline falls on a weekend or holiday, we will
extend the submission period to the next business day (that is,
Monday). There also may be instances where due to unforeseen technical
issues, the submission system may be inaccessible for a period of time.
If this scenario were to occur, we anticipate that we will extend the
submission period to account for this lost time, to the extent
feasible. We note that this revision would also revise the previously
finalized policy at Sec. 414.1325(e)(3) stating that data must be
submitted during an 8-week period following the close of the
performance period, and that the period must begin no earlier than
January 2 and end no later than March 31 for the CMS Web Interface. In
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to align the
deadline for the CMS Web Interface submission type with all other
submission type deadlines at Sec. 414.1325(e)(1), while we also
proposed to remove the previously finalized policy at Sec.
414.1325(e)(3) because it is no longer needed to mandate a different
submission
[[Page 59754]]
deadline for the CMS Web Interface submission type. In the CY 2019 PFS
proposed rule (83 FR 35896), we also proposed a number of other
technical revisions to Sec. 414.1325 to more clearly and concisely
reflect previously established policies.
The following is a summary of the comments we received on
``Submission Deadlines''.
Comment: Several commenters supported our proposal to align the
deadline for the CMS Web Interface submission type with all other
submission type deadlines and appreciated further aligning deadlines
within the program, stating that predictable and achievable deadlines
are preferred for planning and education purposes. Another commenter
urged us to make this new deadline clear to physicians by emphasizing
the different deadlines at the start of the performance year.
Response: We will take all feedback into consideration for future
educational materials.
Comment: One commenter opposed our proposal to align the deadline
for the CMS Web Interface submission type with all other submission
type deadlines, stating that this flexibility is being used to shorten
the deadline, and that the earliest deadline should be set at March 31.
Response: We disagree that this flexibility is being used to
shorten the deadline. We clarify that it is no longer necessary to
mandate a different submission deadline for the CMS Web Interface
submission type and this proposal will bring further alignment amongst
submission types. Furthermore, this policy extends the CMS Web
Interface submission deadline by approximately 4 additional weeks.
After consideration of the public comments received, we are
finalizing our proposal to redesignate Sec. 414.1325(f) as Sec.
414.1325(e), to outline data submission deadlines for all submission
types for individual eligible clinicians and groups for all performance
categories. We are finalizing our proposal to revise Sec.
414.1325(e)(1) to allow flexibility for CMS to alter submission
deadlines for the direct, login and upload, the CMS Web Interface, and
login and attest submission types. We are also finalizing our proposals
to align the deadline for the CMS Web Interface submission type with
all other submission type deadlines at Sec. 414.1325(e)(1), and to
remove the previously finalized policy at Sec. 414.1325(e)(3) because
it is no longer needed to mandate a different submission deadline for
the CMS Web Interface submission type.
(2) Quality Performance Category
(a) Background
We refer readers to Sec. Sec. 414.1330 through 414.1340 and the CY
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for
our previously established policies regarding the quality performance
category.
(i) Assessing Performance on the Quality Performance Category
As discussed in the CY 2019 PFS proposed rule (83 FR 35896), under
Sec. 414.1330(a), for purposes of assessing performance of MIPS
eligible clinicians on the quality performance category, we will use:
Quality measures included in the MIPS final list of quality measures;
and quality measures used by QCDRs. We proposed to amend Sec.
414.1330(a) to account for facility-based measurement and the APM
scoring standard. For that reason, we proposed at Sec. 414.1330(a) to
specify, for a MIPS payment year, that we use the following quality
measures, as applicable to assess performance in the quality
performance category: Measures included in the MIPS final list of
quality measures established by CMS through rulemaking; QCDR measures
approved by CMS under Sec. 414.1440; facility-based measures as
described under Sec. 414.1380; and MIPS APM measures as described at
Sec. 414.1370.
We did not receive any comments on the proposal of how we will
assess performance in the quality performance category. Therefore, we
are finalizing our proposal to amend Sec. 414.1330(a) to state that
for a MIPS payment year, we use the following quality measures, as
applicable, to assess performance in the quality performance category:
Measures included in the MIPS final list of quality measures
established by CMS through rulemaking; QCDR measures approved by CMS
under Sec. 414.1440; facility-based measures as described in Sec.
414.1380; and MIPS APM measures as described in Sec. 414.1370.
(ii) Contribution to Final Score
In the CY 2019 PFS proposed rule (83 FR 35896) under Sec.
414.1330(b)(2) and (3), we state that performance in the quality
performance category will comprise 50 percent of a MIPS eligible
clinician's final score for the 2020 MIPS payment year and 30 percent
of a MIPS eligible clinician's final score for each MIPS payment year
thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by
section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018,
provides that 30 percent of the final score shall be based on
performance with respect to the quality performance category, but that
for each of the 1st through 5th years for which MIPS applies to
payments, the quality performance category performance percentage shall
be increased so that the total percentage points of the increase equals
the total number of percentage points that is based on the cost
performance category performance is less than 30 percent for the
respective year. As discussed in section III.I.3.i.(c) of this final
rule, we proposed to weight the cost performance category at 15 percent
for the 2021 MIPS payment year. Accordingly, we proposed to amend Sec.
414.1330(b)(2) to provide that performance in the quality performance
category will comprise 50 percent of a MIPS eligible clinician's final
score for the 2020 MIPS payment year, and proposed at Sec.
414.1330(b)(3) that the quality performance category comprises 45
percent of a MIPS eligible clinician's final score for the 2021 MIPS
payment year.
We received the following comments on our proposals regarding the
quality performance category's contribution to the final score
proposal:
Comment: A few commenters supported our proposals.
Response: We thank the commenters for their support.
Comment: Several commenters did not support the proposed reduction
of the quality performance category weight to 45 percent from 50
percent for the 2021 MIPS payment year, suggesting that CMS maintain
the weight at 50 percent. The commenters indicated that adjusting the
weight downward sends the wrong message to physicians regarding quality
of care and that de-emphasizing quality runs contrary to the aim of
reforming toward a value-based system. Further, commenters stated that
altering the weight prematurely leads to less stability with the
program and adds complexity. A few commenters recommended that we
transfer the weight from the improvement activity category as needed to
preserve the weight of the quality category.
Response: As discussed in section III.I.3.h.(3) of this final rule,
we are finalizing the proposal to weight the cost performance category
at 15 percent for the 2021 MIPS payment year. Accordingly, section
1848(q)(5)(E)(i)(1) of the Act requires that the quality performance
category weight to be 45 percent. While we understand that the quality
performance category requires additional resources to report, we
believe that we are measuring value by rewarding performance in quality
while keeping down costs and that clinicians can influence the cost of
services that they do not personally perform by
[[Page 59755]]
improving care management with other clinicians and avoiding
unnecessary services. Regarding the commenters' recommendation that we
reduce the weight of the improvement activities performance category to
preserve the weight of the quality performance category, we note that
we do not have discretion to reduce the weight of the improvement
activities performance category except for scenarios where reweighting
can occur due to measures and activities and not being available and
applicable. Please refer to section III.I.3.i.(1)(e) for information on
our reweighting policies.
As discussed in section III.I.3.h.(3) of this final rule, we are
finalizing our proposal to weight the cost performance category at 15
percent for the 2021 MIPS payment year. After consideration of the
public comments received, we are finalizing our proposal to amend Sec.
414.1330(b)(2) to provide that performance in the quality performance
category comprises 50 percent of a MIPS eligible clinician's final
score for the 2020 MIPS payment year, and our proposal to amend Sec.
414.1330(b)(3) to provide that the quality performance category
comprises 45 percent of a MIPS eligible clinician's final score for the
2021 MIPS payment year.
(iii) Quality Data Submission Criteria
(A) Submission Criteria
(aa) Submission Criteria for Groups Reporting Quality Measures,
Excluding CMS Web Interface Measures and the CAHPS for MIPS Survey
Measure
In the CY 2019 Quality Payment Program proposed rule (83 FR 35896
through 35897), we referred readers to Sec. 414.1335(a)(1) for our
previously established submission criteria for quality measures
submitted via claims, registry, QCDR, or EHR. As discussed in section
III.I.3.h. of this final rule, we proposed revisions to existing and
additional terminology to clarify the data submission processes
available for MIPS eligible clinicians, groups and third party
intermediaries, to align with the way users actually submit data to the
Quality Payment Program. For that reason, we proposed to revise Sec.
414.1335(a)(1) to state that data would be collected for the following
collection types: Medicare Part B claims measures; MIPS CQMs; eCQMs; or
QCDR measures. Codified at Sec. 414.1335(a)(1)(i), MIPS eligible
clinicians and groups must submit data on at least six measures
including at least one outcome measure. If an applicable outcome
measure is not available, eligible clinicians and groups must report
one other high priority measure. If fewer than six measures apply to
the MIPS eligible clinician or group, they must report on each measure
that is applicable. Furthermore, we proposed beginning with the 2021
MIPS payment year to revise Sec. 414.1335(a)(1)(ii) to indicate that
MIPS eligible clinicians and groups that report on a specialty or
subspecialty measure set, must submit data on at least six measures
within that set, provided the set contain at least six measures. If the
set contains fewer than six measures or if fewer than six measures
apply to the MIPS eligible clinician or group, they must report on each
measure that is applicable.
As previously expressed in the 2017 Quality Payment Program final
rule (81 FR 77090), we want to move away from claims reporting, since
approximately 69 percent of the Medicare Part B claims measures are
topped out. As discussed in section III.I.3.h. of this final rule, we
proposed to limit the Medicare Part B claims submission type, and
therefore, the Medicare Part B claims measures, to MIPS eligible
clinicians in small practices. We refer readers to section III.I.3.h of
this final rule for discussion of this proposal.
The following is a summary of the public comments on these
proposals and our responses:
Comment: A few commenters did not support the proposed specialty or
subspecialty measure set submission criteria, citing the potential
difficulty in reporting measures within the set that are not
applicable. One commenter requested that, if the proposal is finalized,
CMS should clarify how the requirement applies when clinicians submit
both MIPS CQMs and QCDR measures to meet the quality performance
category requirements, recognizing that some eligible clinicians may
not be able to meet the requirement to report on all measures within a
specialty or subspecialty set. Another commenter recommended that CMS
revise its data submission criteria pertaining to specialty and
subspecialty measure sets and require clinicians to report at least one
outcome or high priority measure.
Response: To clarify, should a MIPS eligible clinician choose to
report on a specialty or a subspecialty measure set, they are only
required to submit data on six measures within that set, provided the
set contain at least six measures. If the set contains fewer than six
measures or if fewer than six measures apply to the MIPS eligible
clinician or group, they are required to report on each measure that is
applicable. If a MIPS eligible clinician chooses to report only on a
specialty or subspecialty measure set and reports on less than 6
quality measures through either the MIPS CQM or Medicare Part B claims
collection types, they will be subjected to the measure validation
process that will validate whether the clinician actually had less than
6 measures available or applicable to their scope of practice. If a
MIPS eligible clinician chooses to report via the QCDR measure
collection type, they will be required to meet the reporting
requirement of 6 quality measures. If a MIPS eligible clinician reports
fewer than 6 quality measures through a QCDR, they will receive zero
points for each unreported quality measure. As stated at revised Sec.
414.1335(a)(1)(ii), MIPS eligible clinicians are required to report at
least one outcome measure, or if no outcome measures are available or
applicable, report another high priority measure in lieu of an outcome
measure.
Comment: One commenter sought clarification on the proposed
specialty or subspecialty measure set submission criteria.
Specifically, the commenter questioned what a MIPS eligible clinician
or group is required to do if fewer than 6 measures apply to the MIPS
eligible clinician within their specialty or sub-specialty domain.
Additionally, the commenter requested clarification on whether outcome
measures or high-priority measures for specialty sets were required.
Response: The clinician is required to report at least one outcome
measure or, if an applicable outcome measure is not available, one
other high priority measure. If a MIPS eligible clinician chooses to
report on a specialty or subspecialty measure set, the set contains at
least 6 quality measures, and the clinician reports on fewer than 6
measures through the MIPS CQM or Medicare Part B claims collection
type, the clinician will be subjected to the measure validation
process, which will validate whether fewer than 6 measures were
actually available and applicable to their scope of practice. If the
measure validation process determines that at least 6 measures were
available and applicable to the clinician's scope of practice, they
will receive zero points for each unreported measure. We refer readers
to Appendix 1: Finalized MIPS Quality Measures in this final rule,
where the specialty sets are finalized in Table Group B. There are high
priority measures available in all the specialty sets, and therefore a
MIPS eligible clinician should be able to select a specialty set that
reflects their scope of practice, and be able to report on the measures
within that set, including the high-priority measures.
[[Page 59756]]
After consideration of the public comments received, we are
finalizing our proposal to amend Sec. 414.1335(a)(1) to state that
data would be collected for the following collection types: Medicare
Part B claims measures; MIPS CQMs; eCQMs; or QCDR measures. Codified at
Sec. 414.1335(a)(1)(i), MIPS eligible clinicians and groups must
submit data on at least six measures including at least one outcome
measure. If an applicable outcome measure is not available, they must
report one other high priority measure. If fewer than six measures
apply to the MIPS eligible clinician or group, report on each measure
that is applicable. We are also finalizing our proposal to amend Sec.
414.1335(a)(1)(ii) to state that MIPS eligible clinicians and groups
that report on a specialty or subspecialty measure set, must submit
data on at least six measures within that set, provided the set
contains at least six measures. If the set contains fewer than six
measures or if fewer than six measures apply to the MIPS eligible
clinician or group, they must report on each measure that is
applicable.
(bb) Submission Criteria for Groups Reporting CMS Web Interface
Measures
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not
propose any changes to the established submission criteria for CMS Web
Interface measures. For purposes of clarity and organization, we are
finalizing a technical change by moving the regulation text on the
sampling requirements for reporting CMS Web Interface measures from
Sec. 414.1335(a)(2) to Sec. 414.1340(c)(1). However, beginning with
the 2021 MIPS payment year, we proposed to revise the terminology with
which CMS Web Interface measures are referenced-to align with the
updated submission terminology as discussed in section III.I.3.h. of
this final rule. Therefore, we proposed to revise Sec. 414.1335(a)(2)
from ``via the CMS Web Interface-for groups consisting of 25 or more
eligible clinicians only'', to ``for CMS Web Interface measures''.
In order to ensure that the collection of information is valuable
to clinicians and worth the cost and burden of collecting information,
and address the challenge of fragmented reporting for multiple measures
and submission options, we solicited comment on expanding the CMS Web
Interface option to groups with 16 or more eligible clinicians.
Preliminary analysis has indicated that expanding the CMS Web Interface
option to groups of 16 or more eligible clinicians would likely result
in many of these new groups not being able to fully satisfy measure
case minimums on multiple CMS Web Interface measures. However, we could
possibly mitigate this issue if we require smaller groups (with 16-24
eligible clinicians) to report on only a subset of the CMS Web
Interface measures, such as the preventive care measures. We solicited
stakeholder feedback on the issue of expanding the CMS Web interface to
groups of 16 or more, as well as other factors we should consider with
such expansion. We received comments from stakeholders regarding
expanding the CMS Web Interface option to groups with 16 or more
eligible clinicians. We thank commenters for their input and may take
this input into consideration in future years.
As discussed in section III.F.1.c. of this final rule, changes
proposed and finalized through rulemaking to the CMS Web Interface
measures for MIPS would be applicable to ACO quality reporting under
the Shared Savings Program. As discussed in Table Group D: Measures
with Substantive Changes Proposed for the 2021 MIPS Payment Year and
Future Years of the measures appendix of this final rule, we proposed
to remove 6 measures from the CMS Web Interface in MIPS. If finalized,
groups reporting CMS Web Interface measures for MIPS would not be
responsible for reporting those removed measures. We refer readers to
the quality measure appendix for additional details on the proposals
related to changes in CMS Web Interface measures.
As discussed in the CY 2017 Quality Payment Program final rule (81
FR 77116), the CMS Web Interface has a two-step attribution process
that associates beneficiaries with TINs during the period in which
performance is assessed (adopted from the Physician Value-based Payment
Modifier (VM) program). The CAHPS for MIPS survey utilizes the same
two-step attribution process as the CMS Web Interface. The CY 2017
Quality Payment Program final rule (81 FR 77116) noted that attribution
would be conducted using the different identifiers in MIPS. For
purposes of the CMS Web Interface and the CAHPS for MIPS survey, we
clarified that attribution would be conducted at the TIN level (83 FR
35897).
We did not receive comments on the proposal to revise Sec.
414.1335(a)(2) from ``via the CMS Web Interface-for groups consisting
of 25 or more eligible clinicians only'', to ``for CMS Web Interface
measures''.
We are finalizing revisions to Sec. 414.1335(a)(2) to state that
via the CMS Web Interface measures- for groups consisting of 25 or more
eligible clinicians only, groups must report on all measure included in
the CMS Web Interface. The group must report on the first 248
consecutively ranked beneficiaries in the sample for each module.
(cc) Submission Criteria for Groups Electing to Report Consumer
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not
propose any changes to the established submission criteria for the
CAHPS for MIPS Survey at Sec. 414.1335(a)(3). However, beginning with
the 2021 MIPS payment year, we proposed to revise Sec. 414.1335(a)(3)
to clarify for the CAHPS for MIPS survey, for the 12-month performance
period, a group that wishes to voluntarily elect to participate in the
CAHPS for MIPS survey measure must use a survey vendor that is approved
by CMS for the applicable performance period to transmit survey measure
data to us.
We did not receive comments on the proposal to clarify the
requirement to use a CMS approved CAHPS for MIPS survey vendor.
We are finalizing our proposal to amend Sec. 414.1335(a)(3) to
clarify for the CAHPS for MIPS survey that beginning with the 2021 MIPS
payment year, for the 12-month performance period, a group that wishes
to voluntarily elect to participate in the CAHPS for MIPS survey
measure must use a survey vendor that is approved by CMS for the
applicable performance period to transmit survey measure data to us.
(B) Summary of Data Submission Criteria
In the CY 2019 PFS proposed rule (83 FR 35897), we did not propose
any changes to the quality data submission criteria for the 2021 MIPS
payment year; however, as discussed in section III.I.3.h. of this final
rule, we proposed changes to existing and additional submission related
terminology. Similarly, although we did not propose changes to the data
completeness criteria at Sec. 414.1340, we proposed changes to
existing and additional submission related terminology. For that
reason, we proposed to revise Sec. 414.1340 to specify that MIPS
eligible clinicians and groups submitting quality measures data on QCDR
measures, MIPS CQMs, or eCQMs must submit data on at least 60 percent
of the MIPS eligible clinician or group's patients that meet the
measure's denominator criteria, regardless of payer for MIPS payment
year 2021; MIPS eligible clinicians and groups submitting quality
measure data
[[Page 59757]]
on the Medicare Part B claims measures must submit data on at least 60
percent of the applicable Medicare Part B patients seen during the
performance period to which the measure applies for the 2021 MIPS
payment year; and groups submitting quality measures data on CMS Web
Interface measures or the CAHPS for MIPS survey measure, must meet the
data submission requirement on the sample of the Medicare Part B
patients CMS provides. Tables 34 and 35 clearly capture the data
completeness requirements and submission criteria by collection type
for individual clinicians and groups.
Table 34--Summary of Data Completeness Requirements and Performance
Period by Collection Type for the 2020 and 2021 MIPS Payment Years
------------------------------------------------------------------------
Performance
Collection type period Data completeness
------------------------------------------------------------------------
Medicare Part B claims Jan 1-Dec 31..... 60 percent of
measures. individual MIPS
eligible
clinician's, or
group's Medicare
Part B patients for
the performance
period.
Administrative claims measures Jan 1-Dec 31..... 100 percent of
individual MIPS
eligible clinician's
Medicare Part B
patients for the
performance period.
QCDR measures, MIPS CQMs, and Jan 1-Dec 31..... 60 percent of
eCQMs. individual MIPS
eligible
clinician's, or
group's patients
across all payers
for the performance
period.
CMS Web Interface measures.... Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients: Populate
data fields for the
first 248
consecutively ranked
and assigned
Medicare
beneficiaries in the
order in which they
appear in the
group's sample for
each module/measure.
If the pool of
eligible assigned
beneficiaries is
less than 248, then
the group would
report on 100
percent of assigned
beneficiaries.
CAHPS for MIPS survey measure. Jan 1-Dec 31..... Sampling requirements
for the group's
Medicare Part B
patients.
------------------------------------------------------------------------
Table 35--Summary of Quality Data Submission Criteria for MIPS Payment
Year 2020 and 2021 for Individual Clinicians and Groups
------------------------------------------------------------------------
Measure collection
Clinician type Submission criteria types (or measure
sets) available
------------------------------------------------------------------------
Individual Clinicians....... Report at least six Individual MIPS
measures including eligible clinicians
one outcome select their
measure, or if an measures from the
outcome measure is following
not available collection types:
report another high Medicare Part B
priority measure; claims measures
if less than six (individual
measures apply then clinicians in small
report on each practices only),
measure that is MIPS CQMs, QCDR
applicable. measures, eCQMs, or
Clinicians would reports on one of
need to meet the the specialty
applicable data measure sets if
completeness applicable.
standard for the
applicable
performance period
for each collection
type.
Groups (non-CMS Web Report at least six Groups select their
Interface). measures including measures from the
one outcome following
measure, or if an collection types:
outcome measure is Medicare Part B
not available claims measures
report another high (small practices
priority measure; only), MIPS CQMs,
if less than six QCDR measures,
measures apply then eCQMs, or the CAHPS
report on each for MIPS survey--or
measure that is reports on one of
applicable. the specialty
Clinicians would measure sets if
need to meet the applicable.
applicable data Groups of 16 or more
completeness clinicians who meet
standard for the the case minimum of
applicable 200 will also be
performance period automatically
for each collection scored on the
type. administrative
claims based all-
cause hospital
readmission
measure.
Groups (CMS Web Interface Report on all Groups report on all
for group of at least 25 measures includes measures included
clinicians). in the CMS Web in the CMS Web
Interface Interface measures
collection type and collection type and
optionally the optionally the
CAHPS for MIPS CAHPS for MIPS
survey. Clinicians survey.
would need to meet Groups of 16 or more
the applicable data clinicians who meet
completeness the case minimum of
standard for the 200 will also be
applicable automatically
performance period scored on the
for each collection administrative
type. claims based all-
cause hospital
readmission
measure.
------------------------------------------------------------------------
We received comments on the proposal to revise Sec. 414.1340 to
specify that MIPS eligible clinicians and groups submitting quality
measures data must submit data on at least 60 percent of the MIPS
eligible clinician or group's patients that meet the measure's
denominator criteria, regardless of payer for MIPS payment year 2021:
Comment: One commenter requested that CMS clarify the 90-day
performance period mentioned in Table 31 of the proposed rule. This
commenter requested more information concerning to which measures the
performance period would apply and expressed concerns about the
differing performance period for measures.
Response: We clarify that in the CY 2019 PFS proposed rule (83 FR
35898), the reference in Table 31 to a 90-day performance period for
certain measures was an inadvertent error. To clarify, there is no 90-
day performance period for any MIPS quality measure. For the 2020 and
2021 MIPS payment years, the performance period is 12 months. Table 34
Summary of Data Completeness Requirements and Performance Period by
Collection Type for the 2020 and 2021 MIPS Payment Years has been
updated to reflect this correction.
Comment: One commenter opposed a full calendar-year performance
period given the proposed 60 percent data completion requirement for
the quality performance category and the potential burden in developing
and implementing new applicable measures.
Response: While the data completeness requirement will remain at 60
percent for the 2019 performance
[[Page 59758]]
period, we have previously noted our interest in incorporating higher
data completeness thresholds in future years to ensure a more accurate
assessment of a MIPS eligible clinician's performance on quality
measures and to avoid measure selection bias as much as possible, but
believe it should be done so in a gradual manner. In the CY 2019 PFS
proposed rule (83 FR 35893), we noted our belief that a full calendar
year performance period for the quality and cost performance categories
will be less confusing for MIPS eligible clinicians. A longer
performance period for quality will likely include more patient
encounters, which will increase the denominator of the quality measures
reported. Statistically, a larger sample size provides more accurate
and actionable information. Furthermore, a full calendar year
performance period is consistent with how many of the measures used in
our program were designed to be performed and reported.
Comment: A few commenters supported the fact that our proposal to
maintain the 60 percent data completeness threshold and encouraged CMS
to retain this policy for future program years.
Response: We thank the commenters for their support.
Comment: One commenter recommended that CMS increase the data
completeness threshold to 100 percent. Other commenters noted that
because calculating and submitting an accurate reporting rate requires
an analysis of a full set of data and is often a manual and error-prone
process, they do not believe it significantly reduces provider burden
to have a 60 percent data completeness threshold as compared to 100
percent.
Response: As discussed in the CY 2018 Quality Payment Program final
rule (82 FR 53632), we noted concerns about the unintended consequences
of accelerating the data completeness threshold so dramatically, which
may jeopardize a MIPS eligible clinician's ability to participate and
perform well in MIPS, particularly with those clinicians who are not as
experienced with MIPS quality measure submission. While we do continue
to monitor the data completeness threshold with future intentions of
raising the threshold for data completeness, we want to ensure that the
data completeness requirement is achievable by all MIPS eligible
clinicians. We do agree that it is important to incorporate higher data
completeness thresholds in future years to ensure a more accurate
assessment of a MIPS eligible clinician's performance on quality
measures and to avoid measure selection bias as much as possible, but
believe it should be done so in a gradual manner.
Comment: One commenter requested clarification on whether the data
completeness criteria is 60 percent of the performance year, regardless
of time, or if MIPS eligible clinicians are mandated to include 60
percent of their patient data from the calendar year.
Response: As stated at Sec. 414.1340(b)(2), MIPS eligible
clinicians are required to submit data on at least 60 percent of the
applicable Medicare Part B patients seen during the performance period,
as illustrated in Table 34.
Comment: One commenter expressed support for updating the
terminology of the data completeness criteria, stating that it does not
change the data completeness criteria from the previous years.
Response: We thank the commenter for their support. We clarify that
we did not make any proposals or changes to the data completeness
criteria, and only made changes to existing and additional submission
related terminology, as explained in the CY 2019 PFS proposed rule (83
FR 35897).
After consideration of the public comments received, we are
finalizing revisions to Sec. 414.1340 to specify that MIPS eligible
clinicians and groups submitting quality measures data on QCDR
measures, MIPS CQMs, or the eCQMs must submit data on at least 60
percent of the MIPS eligible clinician or group's patients that meet
the measure's denominator criteria, regardless of payer for MIPS
payment year 2021; MIPS eligible clinicians and groups submitting
quality measure data on the Medicare Part B claims measures must submit
data on at least 60 percent of the applicable Medicare Part B patients
seen during the performance period to which the measure applies for the
2021 MIPS payment year; and groups submitting quality measures data on
CMS Web Interface measures or the CAHPS for MIPS survey measure, must
meet the data submission requirement on the sample of the Medicare Part
B patients CMS provides, as applicable.
(iv) Application of Facility-Based Measures
Under section 1848(q)(2)(C)(ii) of the Act, the Secretary may use
measures for payment systems other than for physicians, such as
measures used for inpatient hospitals, for purposes of the quality and
cost performance categories. However, the Secretary may not use
measures for hospital outpatient departments, except in the case of
items and services furnished by emergency physicians, radiologists, and
anesthesiologists. We refer readers to section III.I.3.i.(1)(d) of this
final rule for a full discussion of facility-based measures and scoring
for the 2021 MIPS payment year.
(b) Selection of MIPS Quality Measures for Individual MIPS Eligible
Clinicians and Groups Under the Annual List of Quality Measures
Available for MIPS Assessment
(i) Background and Policies for the Call for Measures and Measure
Selection Process
In the CY 2019 PFS proposed rule (83 FR 35898 through 35899), we
noted that developed and announced our Meaningful Measures
Initiative.\18\ By identifying the highest priority areas for quality
measurement and quality improvement, the Meaning Measures Initiative
identifies the core quality of care issues that advances our work to
improve patient outcomes. Through subregulatory guidance, we will
categorize quality measures by the 19 Meaningful Measure areas as
identified on the Meaningful Measures Initiative website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
The categorization of quality measures by Meaningful Measure area would
provide MIPS eligible clinicians and groups with guidance as to how
each measure fits into the framework of the Meaningful Measure
Initiative.
---------------------------------------------------------------------------
\18\ Link to Meaningful Measures web page on CMS site to be
provided at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
---------------------------------------------------------------------------
Furthermore, under Sec. 414.1305, a high priority measure is
defined as an outcome, appropriate use, patient safety, efficiency,
patient experience or care coordination quality measure. Due to the
immense impact of the opioid epidemic across the United States, we
believe it is imperative to promote the measurement of opioid use and
overuse, risks, monitoring, and education through quality reporting.
For that reason, beginning with the 2019 performance period, we
proposed at Sec. 414.1305 to amend the definition of a high priority
measure to include quality measures that relate to opioids and to
further clarify the types of outcome measures that are considered high
priority. Beginning with the 2021 MIPS payment year, we proposed to
define at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or
[[Page 59759]]
opioid-related quality measure. Outcome measures would include
intermediate-outcome and patient-reported outcome measures. We
requested comment on this proposal, specifically if stakeholders have
suggestions on what aspects of opioids should be measured--for example,
whether we should focus solely on opioid overuse. We summarize and
respond to the comments received on this proposal below.
Previously finalized MIPS quality measures can be found in the CY
2018 Quality Payment Program final rule (82 FR 53966 through 54174) and
in the CY 2017 Quality Payment Program final rule (81 FR 77558 through
77816). The new MIPS quality measures finalized for inclusion in MIPS
for the 2019 performance period and future years are found in Table
Group A of the ``Appendix 1: Finalized MIPS Quality Measures'' of this
final rule. The current specialty measure sets can be found in the CY
2018 Quality Payment Program final rule (82 FR 53976 through 54146).
The finalized new and modified quality measure specialty sets can be
found in Table Group B of the ``Appendix 1: Finalized MIPS Quality
Measures'' of this final rule and include new measures, previously
finalized measures with modifications, and previously finalized
measures with no modifications.
We note that modifications made to the specialty sets may include
the removal of certain previously finalized quality measures. Certain
MIPS specialty sets have further defined subspecialty sets, each of
which constitutes a separate specialty set. In instances where an
individual MIPS eligible clinician or group reports on a specialty or
subspecialty set, if the set has less than six measures, that is all
the clinician is required to report. MIPS eligible clinicians are not
required to report on the specialty measure sets, but they are
suggested measures for specific specialties. Please note that the
finalized specialty and subspecialty sets are not inclusive of every
specialty or subspecialty.
On January 9, 2018,\19\ we announced that we would be accepting
recommendations for potential new specialty measure sets for Year 3 of
MIPS under the Quality Payment Program. These recommendations were
based on the MIPS quality measures finalized in the CY 2018 Quality
Payment Program final rule, and includes recommendations to add or
remove the current MIPS quality measures from the specialty measure
sets. All specialty measure set recommendations submitted for
consideration were assessed to ensure that they meet the needs of the
Quality Payment Program.
---------------------------------------------------------------------------
\19\ Listserv messaging was distributed through the Quality
Payment Program listserv on January 9th, 2018, titled: ``CMS is
Soliciting Stakeholder Recommendations for Potential Consideration
of New Specialty Measure Sets and/or Revisions to the Existing
Specialty Measure Sets for the 2019 Program Year of Merit-based
Incentive Payment System (MIPS).''
---------------------------------------------------------------------------
In the CY 2017 Quality Payment Program final rule (81 FR 77137), we
finalized that substantive changes to MIPS quality measures, to include
but are not limited to, measures that have had measure specification
changes, measure title changes, or domain changes. MIPS quality
measures with finalized substantive changes can be found in Table Group
D of the ``Appendix 1: Finalized MIPS Quality Measures'' of this final
rule.
As referenced in the CY 2017 Quality Payment Program final rule (81
FR 77291), with regards to eCQMs, in the 2015 EHR Incentive Program
final rule, CMS required eligible clinicians, eligible hospitals, and
critical access hospitals (CAHs) to use the most recent version of an
eCQM for electronic reporting beginning in 2017 (80 FR 62893). We
proposed this policy for the end-to-end electronic reporting bonus
under MIPS and encourage MIPS eligible clinicians to work with their
EHR vendors to ensure they have the most recent version of the eCQM. We
will not accept an older version of an eCQM as a submission for the
MIPS program for the quality performance category or the end-to-end
electronic reporting bonus within that category. MIPS eligible
clinicians and groups reporting on the quality performance category are
required to use the most recent version of the eCQM specifications. The
annual updates to the eCQM specifications and any applicable addenda
are available on the electronic quality improvement (eCQI) Resource
Center website at https://ecqi.healthit.gov for the applicable
performance period. Furthermore, as discussed in section III.E. of this
final rule, the Medicaid Promoting Interoperability Program generally
intends to utilize eCQM measures as they are available in MIPS. We
refer readers to section III.E. of this final rule for additional
details and criteria on the Medicaid Promoting Interoperability
Program.
In MIPS, there are a limited number of CMS Web Interface measures.
We solicited comment on building upon the CMS Web Interface submission
type by expanding the core set of measures available for that
submission type to include other specialty specific measures (such as
surgery). We thank stakeholders for their comments, and will consider
it for future rulemaking.
To provide clinicians with a more cohesive reporting experience,
where they may focus on activities and measures that are meaningful to
their scope of practice, we discuss the development of public health
priority measurement sets that would include measures and activities
across the quality, Promoting Interoperability, and improvement
activities performance categories, focused on public health priorities
such as fighting the opioid epidemic, in section III.I.3.h.(5), of this
final rule. We refer readers to section III.I.3.h.(5) of this final
rule for additional details on this concept.
We received comments on the proposal to revise the definition of a
high priority measure, to include quality measures that relate to
opioids and to further clarify the types of outcome measures that are
considered high priority; and the policy that MIPS eligible clinicians
must use the most recent specification of MIPS eCQMs while reporting
for MIPS:
Comment: A few commenters expressed concern with the proposals to
revise the definition of high-priority measures to include opioid
related quality measures and to add several new measures to the MIPS
program specifically focused on opioid use. The commenters urged CMS to
consider the unintended consequences that could result if seriously ill
patients experience barriers to receiving appropriate pain management.
Specifically, commenters stated that, if the proposed policies are
finalized, they could create incentives to reduce opioid prescriptions,
even for patients with debilitating pain resulting from advanced
disease progression who would respond to opioid treatment with more
potential benefit than risk. The commenters also asked CMS to consider
protections that could be incorporated into opioid-focused measures,
such as exceptions for patients receiving hospice and palliative care
and other patients with advanced stage serious illness. Further,
commenters suggested that CMS rely on clinical evidence regarding the
reliability and validity of measures or activities to address public
health and safety concerns with opioids. One commenter also expressed
concerns that measures may not take into account numerous factors that
play a role in the opioid crisis, including habits outside of
clinicians' control such as combining opioids with other medicines,
using opioid for something other than pain, and failure to adhere to
medicines as prescribed. One commenter
[[Page 59760]]
recommended including quality measures that address the application of
non-addictive alternatives to pain management, whether in the form of
pharmacotherapeutics, medication-assisted treatment, or non-
pharmacological options.
Response: To clarify, our intention is not to create barriers for
seriously ill patients receiving appropriate pain management, we
encourage appropriate treatment, but also encourage proper monitoring,
management, follow-up, and education of patients. We believe it is
important to consider patients such as those receiving hospice and
palliative care, and will discuss with measure stewards of opioid-
related measures whether exceptions for such patients may be
appropriate. Furthermore, we have considered the reliability and
validity of measures, as we require that measures have completed
reliability and validity testing prior to them being considered as
quality measures in MIPS. We agree with commenters that the application
of non-addictive alternatives to pain management is an important area
to include in quality measurement, and encourage stakeholders to reach
out to the measure stewards for the consideration of their suggestions.
Based on the comments and concerns expressed by commenters, we are
clarifying that the finalized definition of a high priority measure is
broad enough to include all aspects of opioid-related measurement
rather than focus on a specific aspect of opioid measurement. We
believe there are multiple areas within opioid measurement that are
important; for example (but not limited to): Medication management,
patient education, patient outcomes, monitoring, pain management, and
follow-up.
Comment: Several commenters agreed that opioid-related measures
should be categorized as high-priority measures due to national
interest. The commenters encouraged CMS to evaluate the inclusion of
any opioid-related measures, especially eCQMs that measure developers
bring to the table. Commenters stated that any opioid-related quality
measures, especially if designated as high-priority measures, need to
recognize that numerous factors play a role in opioid use, including
factors such as pain control, patient use of other medicines combined
with opioids, patient use of opioids for something other than pain, and
patient failure to adhere to medicines as prescribed. One commenter
cautioned against focusing solely on overuse, but rather focus on a
combination of how well patient's pain is controlled, if functional
improvement goals have been met, and opioid use. A few commenters
indicated that identifying patients by daily use and daily dosage may
not, on its own, be a good indication of quality patient care.
Commenters also encouraged CMS to include patient-reported outcomes
measures that look at symptom management and pain interference.
Response: We will consider opioid-related quality measures as they
are submitted through the call for measures process or as QCDR
measures, and also encourage the development of fully tested eCQMs. We
agree with the commenters that factors such as pain control, use of
other medications, and adherence are all important factors and that
overuse should not be the only focus of measurement. We encourage
stakeholders to submit patient-reported outcomes measures that also
relate to opioids during the call for measures process or as QCDR
measures during the self-nomination process.
Comment: A few commenters expressed support of the policy to
require the reporting of the most current version of the eCQM. One
commenter recommended that to improve electronic capture, calculation,
and reporting of quality measures, CMS should incent the use of
standardized semantic content from recognized developers. Further, the
commenter encouraged CMS to incorporate this work into its
implementation guides to ensure eCQM calculations and benchmarks are
accurate and that EHRs are accurately capturing eCQMs. In addition, a
commenter noted that to continue to encourage eCQM reporting, CMS
should not remove the 8 eCQMs from the measure list in 2019 as
proposed.
Response: We will take these recommendations into consideration for
future years of MIPS. We note that eCQM calculation standards are also
included as a part of ONC's Health IT Certification Program to ensure
accuracy and consistency. We refer readers to the 2015 Edition Health
IT Certification Criterion at 45 CFR 170.315(c)(1) (Clinical quality
measures) for additional information on the criteria. Furthermore, we
have identified those 8 eCQMs for removal for reasons including the
measure having high, unvarying performance rates, or the measure is
being replaced by a more robust measure that has a more meaningful
quality action. Quality actions include steps taken to advance the
patient care provided, moving beyond documenting in the medical record
or conducting a standard of care process. For example, was a follow-up
examination conducted on the patient monitor changes in medical
condition or did the specialist follow-up with the primary care
physician to close the referral loop. We believe that it is important
to have measures in the program that provide meaningful quality
measurement, by demonstrating a performance gap and having a robust
quality action.
Comment: A few commenters did not support the timeline for removing
eCQMs from the measure set because of the time required for EHR vendors
to modify systems. One commenter recommended supporting the last two
versions of eCQMs to allow sufficient time for vendors and health care
organizations to develop and deploy the latest eCQM versions.
Response: As described in the CY 2017 Quality Payment Program final
rule (81 FR 77291), in the 2015 EHR Incentive Programs final rule, CMS
required EPs, eligible hospitals, and CAHs to use the most recent
version of an eCQM for electronic reporting beginning in 2017 (80 FR
62893). Furthermore, we update specifications annually in order to stay
relevant with the clinical guidelines, updates to terminology, and to
correct any identified issues. We will take this recommendation into
further consideration, as we plan for our annual update process
improvements.
Comment: A few commenters requested clarification on whether or not
practices will be required to use 2015 Edition CEHRT for the entire
performance year for quality and the latest version of eCQM to earn the
end-to-end bonus.
Response: As described at Sec. 414.1305, the definition of CEHRT
for 2019 and subsequent years is EHR technology (which could include
multiple technologies) certified under the ONC Health IT Certification
Program that meets the 2015 Edition Base EHR definition (as defined at
45 CFR 170.102), and has been certified to the 2015 Edition health IT
certification criteria. In the CY 2017 Quality Payment Program final
rule (81 FR 77297), we finalized that the CEHRT bonus would be
available to MIPS eligible clinicians who report via qualified
registries, QCDRs, EHRs, or the CMS Web Interface for the Quality
Payment Program, in a manner that meets the end-to-end reporting
requirements. Thus, in order for practices to earn the end-to-end bonus
for reporting eCQMs for the 2019 performance period, they will need to
be reporting using the latest version of the eCQM and will need to use
CEHRT that has been certified to the 2015 Edition.
[[Page 59761]]
Comment: A few commenters noted concern with the timeline for the
approval and communication of updated quality measures with the 12-
month performance period, noting that clinicians and groups relying on
this information for measure selection are unable to easily access a
measure list until months after the performance period begins.
Commenters also noted that QCDR measures have traditionally not been
approved until the end of December preceding the performance year,
leaving registries with limited time to update their dashboards in time
for the January 1 start of the new performance year. Commenters stated
that clinicians need additional time to work with their EHRs to ensure
that they are capturing the elements necessary to report on a measure.
Therefore, commenters urged CMS to approve and communicate updates
earlier.
Response: With regard to MIPS quality measures, the final
specifications of the measures can only be posted once the final rule
is published. For Year 2 of the program there was a delay in posting
the measures within the Quality Payment Program Explore Measures Tool
due to technical difficulties. However, the measure specifications were
made available on the Quality Payment Program resource library (http://qpp.cms.gov) prior to the beginning of the performance period. We will
continue to post the year 3 measure specifications on the Quality
Payment Program resource library prior to the beginning of the
performance period and will make every effort to update the Quality
Payment Program Explore Measures Tool with the year 3 measures prior to
the performance period, or as close to the beginning of the performance
period as technically feasible. We also note that we do not incorporate
the QCDR measures into the Quality Payment Program Explore Measures
Tool, rather these will be available on the Quality Payment Program
resource library. During the limited timeframe available between
November 1st and January 1st, we have reviewed over a thousand QCDR
measure submissions for consideration in the upcoming MIPS performance
period, communicated those decisions to the QCDRs, and posted the
qualified postings by January 1 of the performance period. QCDRs and
registries are notified prior to January 1 regarding which measures
will be approved for the upcoming performance period. In section
III.I.3.k.(3) of this final rule, we describe the finalized policy to
move the self-nomination period up to begin in July 1 and end on
September 1, thereby giving us an earlier start to evaluate and make
decisions on QCDR measures.
Comment: Many commenters stated that the current timeline for
release of measure specifications in December is overly burdensome and
hinders the consistency of measure data in terms of comparability of
results over time as it does not allow adequate time to build and test
systems prior to QCDRs reporting measures on January 1.
Response: We understand the commenters' concerns, and interpret
their reference to measures to mean the MIPS quality measure
specifications not the QCDR measure specifications. We clarify that it
is not technically feasible to release the MIPS quality measure
specifications until the final rule is published. We will take the
commenters suggestion in to consideration as we consider the
operational feasibility of releasing the MIPS quality measure
specifications earlier than December. As stated in the CY 2017 Quality
Payment Program final rule (81 FR 77368), in order for a QCDR to be
approved for a given performance period, they must support the minimum
of 6 quality measures to be approved. Similar to previous performance
periods, we plan to provide QCDRs and qualified registries with time to
select additional MIPS quality measures to support for the upcoming
performance period based upon their review of the measure
specifications. Furthermore, we note that we expect that QCDRs and
qualified registries would be up and running by January 1 of the
performance period to accept and retain data, to allow clinicians to
begin their data collection on January 1 of the performance period.
However, the data will not be submitted to us until the start of data
submission for the 2019 performance period.
After consideration of the public comments received, we are
finalizing our proposal, beginning with the 2021 MIPS payment year, to
define a high priority measure at Sec. 414.1305 as an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Outcome measures
include intermediate-outcome and patient-reported outcome measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77090), we
indicated that we intend to reduce the number of claims-based measures
in future program years as more measures become available through
electronic collection types such as eCQMs or MIPS CQMs. In section
III.I.3.h of this final rule, we are finalizing our proposal to limit
the Medicare Part B claims collection type to small practices, which
furthers our goal of moving away from Medicare Part B claims measures.
We strongly encourage measure stewards to keep this in mind as they
develop and submit measures for consideration, during the call for
measures process (specifically for the MIPS quality performance
category).
(ii) Topped Out Measures
In the CY 2018 Quality Payment Program final rule (82 FR 53637
through 53640), we finalized the 4-year timeline to identify topped out
measures, after which we may propose to remove the measures through
future rulemaking. After a measure has been identified as topped out
for 3 consecutive years through the benchmarks, we may propose to
remove the measure through notice and comment rulemaking. Therefore, in
the 4th year, if finalized through rulemaking, the measure would be
removed and would no longer be available for reporting during the
performance period. We refer readers to the 2018 MIPS Quality
Benchmarks' file, that is located on the Quality Payment Program
resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure
benchmarks are topped out for 2018 and would be subject to the cap if
they are also topped out in the 2019 MIPS Quality Benchmarks' file. It
should be noted that the final determination of which measure
benchmarks are subject to the topped out cap would not be available
until the 2019 MIPS Quality Benchmarks' file is released in late 2018.
In the CY 2019 PFS proposed rule (83 FR 35899 through 35900), we
proposed that once a measure has reached an extremely topped out status
(for example, a measure with an average mean performance within the
98th to 100th percentile range), we may propose the measure for removal
in the next rulemaking cycle, regardless of whether or not it is in the
midst of the topped out measure lifecycle, due to the extremely high
and unvarying performance where meaningful distinctions and improvement
in performance can no longer be made, after taking into account any
other relevant factors. We are concerned that topped out non-high
priority process measures require data collection burden without added
value for eligible clinicians and groups participating in MIPS. It is
important to remove these types of measures, so that available measures
provide meaningful value to
[[Page 59762]]
clinicians collecting data, beneficiaries, and the program. However, we
would also consider retaining the measure if there are compelling
reasons as to why it should not be removed (for example, if the removal
would impact the number of measures available to a specialist type or
if the measure addressed an area of importance to the Agency).
Since QCDR measures are not approved or removed from MIPS through
the rulemaking timeline or cycle, we proposed to exclude QCDR measures
from the topped out timeline that was finalized in the CY 2018 Quality
Payment Program final rule (82 FR 53640). When a QCDR measure reaches
topped out status, as determined during the QCDR measure approval
process, it may not be approved as a QCDR measure for the applicable
performance period. Because QCDRs have more flexibility to develop
innovative measures, we believe there is limited value in maintaining
topped out QCDR measures in MIPS.
We received comments on the following proposals: (1) Once a measure
has reached an extremely topped out status (for example, a measure with
an average mean performance within the 98th to 100th percentile range),
we may propose the measure for removal in the next rulemaking cycle,
regardless of whether or not it is in the midst of the topped out
measure lifecycle; and (2) to exclude QCDR measures from the topped out
timeline that was finalized in the CY 2018 Quality Payment Program
final rule:
Comment: Several commenters supported the topped out proposal,
stating that it would reduce clinician burden, discontinue measures
that have limited value to the Quality Payment Program, and continue to
focus on measures that are clinically meaningful to patients. One
commenter noted that this proposal will allow CMS to differentiate
between exceptional, high performing, and other clinicians. Several
commenters recommended that topped out measures be removed regardless
of the collection type.
Response: We disagree that topped out measures should be removed
regardless of the collection type. There have been instances where
measures have been specified through multiple collection types, but
have only become topped out in one or two of the collection types. If
there is an opportunity to collect more robust data on a measure, while
the measure is not topped out for that particular collection type, we
believe we should continue to do so.
Comment: Several commenters did not support the proposal to exclude
QCDR measures from the topped out timeline, indicating that review
processes for QCDR and MIPS measures should be standardized and provide
clinicians, groups, and measure stewards sufficient notice to review
and potentially replace topped out measures. One commenter indicated
that applying the topped out policy to QCDR measures will also ensure
consistency across the program and minimize complexity. A few
commenters indicated that maintaining QCDR measures in the program for
a minimum number of years will also limit measures with sufficient
historical data to set a benchmark that permits the evaluation of
performance. Several commenters noted that removal of topped out QCDR
measures would limit the number of specialty-specific measures
available and stated that and the proposal does not allow sufficient
time and volume of cases to determine if QCDR measures have a valid
benchmark. One commenter recommended a two-year retention policy for
extremely topped out QCDR measures to reduce burden and confusion for
clinicians.
Response: We note that the process and timeline in which MIPS
quality measures and QCDR measures are approved for a given MIPS
performance period is different, as is the criteria for consideration.
QCDRs are expected to be nimble and innovative enough to develop QCDR
measures that are robust in their quality action and demonstrate a
performance gap. We believe topped out measures do not add value in the
realm of quality measurement, and believe they should be removed from
the program as appropriate. We do not agree that removing topped out
QCDR measures would create complexity, since it is a well-established
process that QCDR measures are reviewed for approval on an annual
basis, and is something that stakeholders should be aware of. We also
do not believe that topped out QCDR measures should be retained in the
program for 2 years; this may inadvertently impact a high performing
clinician who may not receive a high score when compared to other
clinicians reporting on the same measure. For example, a clinician
whose performance rate is at 96 percent on a topped out measure may
receive fewer points than another clinician whose reporting rate is at
98 percent on the same measure, when both performance rates would be
considered high performing. We do not agree that the removal of topped
out QCDR measures would impact the number of available specialty-
specific measures available, since QCDR measures are reviewed and
approved on a more accelerated timeline in comparison to the MIPS
quality measures. Furthermore, MIPS eligible clinicians who wish to use
QCDRs, are not limited to reporting on QCDR measures.
Comment: Many commenters did not support the proposal to allow the
identification and removal of extremely topped out measures. Several
commenters noted that removal of measures will have a large impact on
small practices and specialists who have limited options regarding
relevant quality measures. Several commenters stated that more time is
needed to determine if measures are truly topped out because benchmarks
may reflect the performance of only top-performing clinicians rather
than performance across all clinicians. They stated that additional
time would allow for the collection of more robust data. Many
commenters stated that topped out measures should all have the same 4-
year timeline because the process to develop a measure that could
replace a topped out measure is lengthy and recommended close
communication with measure stewards. A few commenters recommended a 2-
year timeline for the removal of extremely topped out measures. A few
commenters encouraged CMS to defer to measure developers and national
endorsement organizations to define which measures are topped out. One
commenter noted that additional factors should be taken into
consideration prior to removing an extremely topped out measure,
including the type of measure, the length of time the measure is
reported, measure steward and specialist input, performance results,
reporting options, data sources, small sample size, public health
issues covered, and whether measures are used in other programs. One
commenter recommended that prior to removing a topped out measure, CMS
be transparent about the data used to determine topped out status, so
the public has an understanding of how many clinicians reported the
measure and the performance rate.
Response: We note that in addition to the quality measures
available in the MIPS quality measure set, QCDR measures are also
available. We review measure benchmarks as a part of our process for
identifying topped out and extremely topped out measures and believe
that extremely topped out measures, such as those with an average mean
performance within the 98th to 100th percentile, leave no room for
further quality improvement, thereby providing clinicians little value.
We
[[Page 59763]]
utilized the 2018 quality measure benchmarks as a part of the criteria
used to identify those measures for removal. The benchmarks are
reflective of the performance of those clinicians who have reported on
the measure and will continue to do so should the measure be available
in the program which is why we do not believe there will be variances
in the high performing data submitted if the measure is retained. We do
not believe that we should retain the extremely topped out measures
within a 4 year timeline because the measures take a lengthy time to
replace. While the timeline to add MIPS quality measures does typically
take about 2 years, we note there are additional measures (QCDR
measures) available for reporting through QCDRs. We appreciate the
commenters' feedback suggesting we defer to measure developers and
national endorsement organizations to define which measures are topped
out; we can take this suggestion in to future consideration. In the CY
2019 PFS proposed rule (83 FR 35900), we stated we would also consider
retaining the measure if there are compelling reasons as to why it
should not be removed (for example, if the removal would impact the
number of measures available to a specialist type or if the measure
addressed an area of importance to the Agency). We encourage
stakeholders to continue to submit quality measures that address
measurement gaps as we incrementally remove quality measures that are
extremely topped out, merely reflect the standard of care without a
quality action, or are duplicative of other more robust quality
measures, as we believe they no longer provide meaningful measurement
to clinicians.
After consideration of the public comments received, we are
finalizing our proposal that once the measure has reached an extremely
topped out status (for example, a measure with an average mean
performance within the 98th to 100th percentile range), we may propose
the measure for removal in the next rulemaking cycle, regardless of
whether or not it is in the midst of the topped out measure lifecycle,
due to the extremely high and unvarying performance where meaningful
distinctions and improvement in performance can no longer be made,
after taking into account any other relevant factors. However, we will
also consider retaining the measure if there are compelling reasons as
to why it should not be removed (for example, if the removal would
impact the number of measures available to a specialist type or if the
measure addressed an area of importance to CMS).
We are also finalizing our proposal to exclude QCDR measures from
the topped out timeline that was finalized in the CY 2018 Quality
Payment Program final rule (82 FR 53640). When a QCDR measure reaches
topped out status, as determined during the QCDR measure approval
process, it may not be approved as a QCDR measure for the applicable
performance period.
(iii) Removal of Quality Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77136
through 77137), we discussed removal criteria for quality measures,
including that a quality measure may be considered for removal if the
Secretary determines that the measure is no longer meaningful, such as
measures that are topped out. Furthermore, if a measure steward is no
longer able to maintain the quality measure, it would also be
considered for removal.
We have previously communicated to stakeholders our desire to
reduce the number of process measures within the MIPS quality measure
set. In the CY 2017 Quality Payment Program final rule (81 FR 77101),
we explained that we believe that outcome measures are more valuable
than clinical process measures and are instrumental to improving the
quality of care patients receive. In the CY 2018 Quality Payment
Program quality measure set, 102 of the 275 quality measures are
process measures that are not considered high priority. As discussed
above, beginning with the 2021 MIPS payment year, we proposed to define
at Sec. 414.1305 a high priority measure to mean an outcome,
appropriate use, patient safety, efficiency, patient experience, care
coordination, or opioid-related quality measure. Because the removal of
all non-high priority process measures would impact most specialty
sets, nearly 94 percent, we believe incrementally removing non-high
priority process measures through notice and comment rulemaking is
appropriate.
As described in the CY 2019 PFS proposed rule (83 FR 35900),
beginning with the 2019 performance period, we proposed to implement an
approach to incrementally remove process measures where prior to
removal, consideration will be given to, but is not limited to:
Whether the removal of the process measure impacts the
number of measures available for a specific specialty.
Whether the measure addresses a priority area highlighted
in the Measure Development Plan at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
Whether the measure promotes positive outcomes in
patients.
Considerations and evaluation of the measure's performance
data.
Whether the measure is designated as high priority or not.
Whether the measure has reached an extremely topped out
status within the 98th to 100th percentile range, due to the extremely
high and unvarying performance where meaningful distinctions and
improvement in performance can no longer be made, as described in
section III.I.3.(b)(ii) of this final rule.
We received the following comments on the proposal to implement a
process to incrementally remove process measures:
Comment: While some commenters supported the inclusion of
population measures, several commenters recommended the removal of
population health measures, which it believed are often incorrectly
attributed, especially for specialty clinicians and rural clinicians,
and often have a very low statistical reliability at the individual
clinician and group practice levels.
Response: We believe that population measures may reduce burden on
clinicians and allow for assessment of public health issues on a larger
scale. Reliability is one of the many important and scientific issues
that CMS addresses and tests during our measure development process
regardless of measure type (that is, whether the measures are
population-based or provider-specific measures). We recognize that
specialty clinicians and rural clinicians may be more likely to have a
smaller sample size, and that this may result in lower reliability. At
the same time, we also recognize that many clinicians or groups may
have sufficient volume depending on the measures under development, and
because measure reliability also depends on the particular cohort and
outcome of the specific measures under development. As part of the CMS
standardized measure development process, we will address the
reliability issue in several ways. We will consult national experts and
stakeholders including health care providers and patients in
conceptualizing and selecting measures for development and conduct
rigorous testing of the measure reliability and volume threshold for
use.
Comment: Many commenters supported the removal of 34 MIPS measures
to align with CMS's Meaningful Measures framework and allow eligible
clinicians to reduce and
[[Page 59764]]
prioritize other measures, providing a focus on improving patient care
and outcomes. A few commenters encouraged CMS to continue to review its
quality measure sets to identify the most meaningful measures and
further align hospital and clinician reporting requirements.
Response: We agree that alignment across quality programs is
important in an effort to reduce clinician burden, and will seek to
continue to look for ways to align with other programs while
maintaining the objective and goals of MIPS through future rulemaking.
Comment: Many commenters did not support the proposal to remove
measures, stating that many specialists will not have enough relevant
measures to meet reporting requirements, clinicians may still be
required to report removed measures to other payers, and process
measures are under the control of the clinician and often important
when coupled with other measures including cost measures. A few
commenters indicated that important quality of care aspects may only be
captured by a process measure, even those that are topped out. One
commenter disagreed with the removal of topped out measures generally
until the vast majority of peer reviewed literature demonstrates a
significant change in practice patterns. One commenter recommended
delaying the removal of measures, to allow time for clinicians to
comply with program requirements.
Response: We note that prior to proposing to remove quality
measures from the program, we take into consideration the impacts the
removal would have on the number of measures available to clinicians in
the program. We do not agree that we should delay the removal of
measures. We continue to believe that non-high priority process
measures impose data collection burden without adding value for
eligible clinicians and groups participating in MIPS. Typically,
process measures merely reflect the standard of care and do not have a
robust quality action. In many instances, process measures have high,
unvarying performance leaving no room for improvement. We understand
that there are some process measures that are valuable, but believe
that it is important that they address one of the high priority areas
and demonstrate a performance gap in order to be meaningful.
Furthermore, we do understand that important quality of care aspects
may only be captured by some topped out process measures, and encourage
clinicians to continue to measure and monitor their progress in these
areas; however, we do not believe that these measures provide value or
should be tied to a pay for performance program such as MIPS. If a MIPS
quality measure is removed from the program, it is because the measure
no longer has value in the performance payment program; however, we
believe that clinicians can still collect and evaluate data on these
metrics for their own internal quality improvement goals or areas of
improvement as outlined in peer reviewed literature. We are aware that
there are certain process measures that may be required to be reported
to other payers; however, note that this difference may reflect
different underlying goals of their program. Another consideration is
that these process measures with high, unvarying performance, may also
impact a MIPS eligible clinician's ability to receive a high score in
the quality performance category. While we agree that process measures
are under the control of the clinician and often important when coupled
with other measures including cost measures, we do not believe that
this justifies retaining extremely topped out measures in MIPS.
Comment: Several commenters expressed concern about the timeline
for removing measures. A few commenters requested that CMS maintain the
4-year measure removal policy since it would give clinicians,
professional societies, and third party vendors (for example,
registries) some time to prepare and develop an alternative reporting
strategy. One commenter recommended an incremental phased approach
according to a specified timeline, similar to the 4-year timeline
currently in place for removing topped out measures from the program in
order to ensure that the removal of the measures is truly warranted and
to allow clinicians time to begin implementing other measures for
reporting purposes. One commenter recommend that CMS only propose
removal of measures during the official measure process to assist with
predictability.
Response: To clarify, similar to how MIPS quality measures are
proposed and finalized into the MIPS program through notice-and-comment
rulemaking, we utilize a similar approach for removing measures from
the program. We do not believe that a 4-year timeline to remove all
measures is appropriate. A topped out measure timeline that is 4 years
long is appropriate for measures with high performance where special
scoring caps are applied as a response to the high unvarying
performance; however, we are still finalizing the policy to remove
extremely topped out measures (within the 98-100 percent range) through
the following rulemaking cycle after the measure is identified as
extremely topped out. This is to note that there are exceptions to the
4 year timeline, and in instances where there are more robust measures
being proposed and finalized, we believe it is appropriate to remove
duplicative measures through notice-and-comment rulemaking without
consideration to a longer timeline. In addition, measures that are not
maintained or updated to reflect current clinical guidelines are not
reflective of a clinician's scope of practice, should also be proposed
for removal in the next rulemaking cycle. Furthermore, the removal of
low-bar, standard of care process measures aligns with our goals to
have more outcomes based measures in the program. Furthermore, a 4-year
timeline does not take into consideration that we may propose new
quality measures that are more robust in their quality action that
would deem the existing process measure to be duplicative. Also, as
process measures top out, they will inadvertently impact a clinician's
ability to achieve a high score for that specific measure. As stated
earlier above, we will only propose the removal of MIPS quality
measures through formal notice-and-comment rulemaking, and we believe
that this annual process will provide stakeholders with sufficient
notice and opportunity to voice their concerns on specific measure
removals through the public comment process.
Comment: One commenter also requested that CMS evaluate measures
for removal based on the collection type. They stated that the
differences in collection types can be enough of a workflow and cost
consideration in alterations that it should be a factor in the
consideration of measures removal. For example, there are several eCQMs
proposed for removal due to a duplicative measure being available;
however, in most instances, that duplicative measure is not available
as an eCQM. This would potentially force practices to maintain
relationships and pay for reporting through multiple vendors to
maintain their list of measures.
Response: Initially, we proposed to remove specific MIPS quality
measures that were duplicative of new, robust measures. We have taken
the comments into consideration and in instances where the new measure
does not have eCQM available as a collection type, we have decided not
to remove the existing (duplicative) measure for the eCQM collection
type only. We refer readers to Appendix 1: Finalized Quality Measures
of this final rule for additional detail on
[[Page 59765]]
these eCQMs. We clarify that we do look at the availability of measures
through the different collection types as we review measures for
possible inclusion or removal, and will continue to monitor and
consider the availability through the collection types as criteria when
removing quality measures from MIPS.
After consideration of the public comments received, we are
finalizing our proposal, beginning with the 2021 MIPS payment year, to
implement an approach to incrementally remove process measures where
prior to removal, consideration will be given to, but will not be
limited to:
Whether the removal of the process measure impacts the
number of measures available for a specific specialty.
Whether the measure addresses a priority area highlighted
in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
Whether the measure promotes positive outcomes in
patients.
Considerations and evaluation of the measure's performance
data.
Whether the measure is designated as high priority or not.
Whether the measure has reached an extremely topped out
status within the 98th to 100th percentile range, due to the extremely
high and unvarying performance where meaningful distinctions and
improvement in performance can no longer be made.
(iv) Categorizing Measures by Value
In the CY 2019 PFS proposed rule (83 FR 35900), we outlined the
various types of MIPS quality and QCDR measures available for reporting
in the quality performance category, such as outcome, high-priority,
composite, and process measures, we acknowledge that not all measures
are created equal. For example, the value or information gained by
reporting on certain process measures does not equate that which is
collected on outcome measures. We seek to ensure that the collection
and submission of data is valuable to clinicians and worth the cost and
burden of collecting the information.
Based on this, we solicited comment on implementing a system where
measures are classified as a particular value (gold, silver or bronze)
and points are awarded based on the value of the measure. For example,
higher value measures that are considered ``gold'' standard, which
could include outcome measures, composite measures, or measures that
address agency priorities (such as opioids). The CAHPS for MIPS survey,
which collects patient experience data, may also be considered a high
value measure. Measures that are considered second tier, or at a
``silver'' standard would be measures that are considered process
measures that are directly related to outcomes and have a good gap in
performance (there is no high, unwavering performance) and demonstrate
room for improvement; or topped out outcome measures. Lower value
measures, such as standard of care process measures or topped out
process measures would be considered ``bronze'' measures. We refer
readers to section III.I.3.i.(1)(b)(xi) of this final rule for
discussion on the assignment of value and scoring based on measure
value.
We have received comments from stakeholders regarding categorizing
measure by value. We thank commenters for their input and may take this
input into consideration in future years.
(3) Cost Performance Category
For a description of the statutory basis and our existing policies
for the cost performance category, we refer readers to the CY 2017 and
CY 2018 Quality Payment Program final rules (81 FR 77162 through 77177,
and 82 FR 53641 through 53648, respectively).
(a) Weight in the Final Score
In the CY 2018 Quality Payment Program final rule, we established
that the weight of the cost performance category would be 10 percent of
the final score for the 2020 MIPS payment year (82 FR 53643). We had
previously finalized in the CY 2017 Quality Payment Program final rule
at Sec. 414.1350(b)(3) that beginning with the 2021 MIPS payment year,
the cost performance category would be 30 percent of the final score,
as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR
77166). Section 51003(a)(1)(C) of the Bipartisan Budget Act of 2018,
enacted on February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb)
of the Act such that for each of the second, third, fourth, and fifth
years for which the MIPS applies to payments, not less than 10 percent
and not more than 30 percent of the MIPS final score shall be based on
the cost performance category score. Additionally, this provision shall
not be construed as preventing the Secretary from adopting a 30 percent
weight if the Secretary determines, based on information posted under
section 1848(r)(2)(I) of the Act, that sufficient cost measures are
ready for adoption for use under the cost performance category for the
relevant performance period. Section 51003(a)(2) of the Bipartisan
Budget Act of 2018 amended section 1848(r)(2) of the Act to add a new
paragraph (I), which we discuss in section III.I.3.h.(3)(b)(i) of this
final rule.
In light of these amendments, in the proposed rule (83 FR 35900
through 35901), we proposed at Sec. 414.1350(d)(3) that the cost
performance category would make up 15 percent of a MIPS eligible
clinician's final score for the 2021 MIPS payment year. As discussed in
section III.I.3.h.(3)(b)(iv) of this final rule, Sec. 414.1350(b) will
be redesignated as Sec. 414.1350(d). We proposed to delete the
existing text under Sec. 414.1350(b)(3) and address the weight of the
cost performance category for the MIPS payment years following 2021 in
future rulemaking. We also proposed a technical change to the text at
Sec. 414.1350(b) (redesignated as Sec. 414.1350(d)) to state that the
cost performance category weight will be as specified under
redesignated Sec. 414.1350(d), unless a different scoring weight is
assigned by CMS under section 1848(q)(5)(F) of the Act (83 FR 35901).
We believe that measuring cost is an integral part of measuring
value, and we believe that clinicians have a significant impact on the
costs of patient care. However, we proposed to only modestly increase
the weight of the cost performance category for the 2021 MIPS payment
year from the 2020 MIPS payment year because we recognize that cost
measures are still relatively early in the process of development and
that clinicians do not have the level of familiarity or understanding
of cost measures that they do of comparable quality measures (83 FR
35900 through 35901). As described in section III.I.3.h.(3)(b)(ii) of
this final rule, we are finalizing the addition of 8 episode-based
measures to the cost performance category beginning with the 2019 MIPS
performance period. This is a first step in developing a more robust
and clinician-focused measurement of cost performance. We will continue
to work on developing additional episode-based measures that we may
consider proposing for the cost performance category in future years.
Introducing more measures over time would allow for more clinicians to
be measured in this performance category. It would also allow time for
more outreach to clinicians to better educate them on the cost
measures. We considered maintaining the weight of the cost performance
category at 10 percent for the 2021 MIPS payment year as we recognize
that clinicians are still learning about the cost performance category
and being introduced to new measures. We invited comment on
[[Page 59766]]
whether we should consider an alternative weight for the 2021 MIPS
payment year.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters supported our proposal to increase the
weight of the cost performance category to 15 percent for the 2021 MIPS
payment year, noting the importance of managing cost in measuring the
value of a clinician as well as the opportunity to gradually increase
the weight of the performance category.
Response: We thank the commenters for their support for this
proposal.
Comment: Several commenters opposed our proposal to increase the
weight of the cost performance category to 15 percent for MIPS payment
year 2021. They believed that the increased flexibility provided by the
Bipartisan Budget Act of 2018 should be used to maintain the weight at
10 percent for MIPS payment year 2021 and in future years. Some
commenters requested that the weight of the cost performance category
not be increased until CMS can address issues of social and complexity
risk factors and of clinical risk adjustment for measures in areas such
as oncology. Some commenters suggested maintaining the weight of the
cost performance category at 10 percent until CMS is able to provide
more detailed and actionable performance data and develop more reliable
and valid measures.
Additionally, several commenters opposed our proposal to increase
the weight of the cost performance category because we proposed to add
new episode-based measures (as detailed in section III.I.3.h.(3)(b)(ii)
of this rule) and clinicians should have time to learn about these
measures before the category weight is increased. Additionally, several
commenters suggested CMS wait to increase the cost performance category
weight until sufficient episode groups exist for additional
specialties.
Response: We continue to investigate ways to best accommodate the
issue of clinical and social risk adjustment in measures contained in
the cost performance category. All measures included in the cost
performance category are adjusted for clinical risk. We have adopted a
complex patient bonus at the final score level that adjusts again for
patient clinical complexity as well as some elements of social
complexity. We also continue to consider ways to offer actionable
feedback on cost measures to clinicians in the future.
In regards to the episode-based measures, we do not believe the
introduction of these new measures should mean that the weight of the
performance category should be maintained, especially since
stakeholders had the opportunity to gain experience with the new
measures through field testing in the fall of 2017. The performance
category also still includes two measures that were used in the first 2
years of MIPS. The Bipartisan Budget Act of 2018 gave CMS increased
flexibility to establish the weight of the cost performance category
for the first 5 years of MIPS, but the weight is still required to be
30 percent beginning with the 2024 MIPS payment year. Therefore, we
believe it is necessary to begin adjusting the weight gradually,
including increasing the weight to 15 percent for the 2021 MIPS payment
year. We will concurrently look to increase the number of clinicians
who are measured in the cost performance category by developing and
considering for inclusion in the Quality Payment Program more episode-
based measures that cover additional types of clinicians and
specialties.
After consideration of the public comments, we are finalizing our
proposal at Sec. 414.1350(d)(3) to weight the cost performance
category at 15 percent for the 2021 MIPS payment year as proposed.
Additionally, we are also finalizing our proposal to delete the
existing text under Sec. 414.1350(b)(3) and address the weight of the
cost performance category for the MIPS payment years following 2021 in
future rulemaking as proposed. Finally, we are finalizing our proposed
technical change to the text at Sec. 414.1350(b) (redesignated as
Sec. 414.1350(d)) to state that the cost performance category weight
will be as specified under redesignated Sec. 414.1350(d), unless a
different scoring weight is assigned by CMS under section 1848(q)(5)(F)
of the Act, as proposed.
In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we
will continue to evaluate whether sufficient cost measures are ready
for adoption under the cost performance category and move towards the
goal of increasing the weight to 30 percent of the final score. To
provide for a smooth transition, we anticipate that we would increase
the weight of the cost performance category by 5 percentage points each
year until we reach the required 30 percent weight for the 2024 MIPS
payment year. We invited comments on this approach to weighting the
cost performance category for the 2022 and 2023 MIPS payment years,
considering our flexibility in setting the weight between 10 percent
and 30 percent of the final score, the availability of cost measures,
and our desire to ensure a smooth transition to a 30 percent weight for
the cost performance category. We appreciate the comments we received
and will consider them as we develop proposals for future rulemaking.
(b) Cost Criteria
(i) Background
Under Sec. 414.1350(a), we specify cost measures for a performance
period to assess the performance of MIPS eligible clinicians on the
cost performance category. In the CY 2018 Quality Payment Program final
rule, we established two cost measures (total per capita cost measure
and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS
performance period and future performance periods (82 FR 53644). These
measures were previously established for the 2017 MIPS performance
period (81 FR 77168). We will continue to evaluate cost measures that
are included in MIPS on a regular basis and anticipate that measures
could be added or removed through rulemaking as measure development
continues. In general, we expect to evaluate cost measures according to
the measure reevaluation and maintenance processes outlined in the
``Blueprint for the CMS Measures Management System'' (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf). As described in section
2 of the Blueprint for the CMS Measures Management System Version 14.0,
we will conduct annual evaluations to review the continued accuracy of
the measure specifications. Annual updates ensure that the procedure,
diagnostic, and other codes used in the measure account for updates to
coding systems over time. To the extent that these updates would
constitute a substantive change to a measure, we would ensure the
changes are proposed for adoption through rulemaking. We will also
comprehensively reevaluate the measures every 3 years to ensure that
they continue to meet measure priorities. As a part of this
comprehensive reevaluation, we will gather information through
environmental scans and literature reviews of recent studies and new
clinical guidelines that may inform potential refinements. We will also
analyze measure performance rates and re-assess the reliability and
validity of the measures. Throughout these
[[Page 59767]]
reevaluation efforts, we will summarize and consider all stakeholder
feedback received on the measure specifications during the
implementation process, and may seek input through public comment
periods. In addition, the measure development contractor may acquire
individual input on measures by convening Technical Expert Panels
(TEPs) and clinical subcommittees. Aside from these regular measure
reevaluations, there may be ad-hoc reviews of the measures if new
evidence comes to light which indicates that significant revisions may
be required.
We will also continue to update the specifications to address
changes in coding, risk adjustment, and other factors. The process for
updating measure specifications will take place through ongoing
maintenance and evaluation, during which we expect to continue seeking
stakeholder input. As we noted above, any substantive changes to a
measure would be proposed for adoption in future years through notice
and comment rulemaking. We appreciate the feedback that we have
received so far throughout the measure development process and believe
that stakeholders will continue to provide feedback to the measure
development contractor on episode-based cost measures by submitting
written comments during public comment opportunities, by participating
in the clinical subcommittees convened by the measure development
contractor, or by attending education and outreach events. We will take
all comments and feedback into consideration as part of the ongoing
measure evaluation process.
As we noted in the CY 2017 Quality Payment Program final rule (81
FR 77137) regarding quality measures, which we believe would also apply
for cost measures, some updates may incorporate changes that would not
substantively change the intent of the measure. Examples of such
changes may include updated diagnosis or procedure codes or changes to
exclusions to the patient population or definitions. While we address
such changes on a case-by-case basis, we generally believe these types
of maintenance changes are distinct from substantive changes to
measures that result in what are considered new or different measures.
As described in section 3 of the Blueprint for the CMS Measures
Management System Version 14.0, if substantive changes to these
measures become necessary, we expect to follow the pre-rulemaking
process for new measures, including resubmission to the Measures Under
Consideration (MUC) list and consideration by the Measure Applications
Partnership (MAP). The MAP provides an additional opportunity for an
interdisciplinary group of stakeholders to provide feedback on whether
they believe the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. They also consider
whether the measures are scientifically acceptable and reflect current
clinical guidelines.
Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended
section 1848(r)(2) of the Act to add a new paragraph (I) requiring the
Secretary to post on the CMS website information on cost measures in
use under MIPS, cost measures under development and the time-frame for
such development, potential future cost measure topics, a description
of stakeholder engagement, and the percent of expenditures under
Medicare Part A and Part B that are covered by cost measures. This
information shall be posted no later than December 31 of each year
beginning with 2018. We expect this posting will provide a list of the
cost measures established for the cost performance category for the
current performance period (for example, the posting in 2018 would
include a list of the measures for the 2018 MIPS performance period),
as well as a list of any cost measures that may be proposed for a
future performance period through rulemaking. We will provide
hyperlinks to the measure specifications documents and include the
percent of Medicare Part A and Part B expenditures that are covered by
these cost measures. The posting will also include a list and
description of the measures under development at that time. We intend
to summarize the timeline for measure development, including the
stakeholder engagement activities undertaken, which may include a TEP,
clinical subcommittees, field testing, and education and outreach
activities, such as national provider calls and listening sessions.
Finally, the posting will provide an overview of potential future
topics in cost measure development, such as any clinical areas in which
measures may be developed in the future (83 FR 35901 through 35902).
(ii) Episode-Based Measures for the 2019 and Future Performance Periods
Episode-based measures differ from the total per capita cost
measure and MSPB measure because episode-based measure specifications
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given timeframe.
We discussed our progress in the development of episode-based
measures in the CY 2018 Quality Payment Program proposed rule (82 FR
30049 through 30050) and received significant positive feedback on the
process used to develop the measures as well as the measures' clinical
focus that was informed by expert opinion (82 FR 53644 through 53646).
The specific measures selected for the initial round of field testing
were included based on the volume of beneficiaries impacted by the
condition or procedure, the share of cost to Medicare impacted by the
condition or procedure, the number of clinicians/clinician groups
attributed, and the potential for alignment with existing quality
measures.
We have developed episode-based measures to represent the cost to
Medicare for the items and services furnished to a patient during an
episode of care (``episode''). Episode-based measures are developed to
let attributed clinicians know the cost of the care clinically related
to their initial treatment of a patient and provided during the
episode's timeframe. Specifically, we define cost based on the allowed
amounts on Medicare claims, which include both Medicare payments and
beneficiary deductible and coinsurance amounts. Episode-based measures
are calculated using Medicare Parts A and B fee-for-service claims data
and are based on episode groups. Episode groups:
Represent a clinically cohesive set of medical services
rendered to treat a given medical condition.
Aggregate all items and services provided for a defined
patient cohort to assess the total cost of care.
Are defined around treatment for a condition (acute or
chronic) or performance of a procedure.
Items and services in the episode group could be treatment
services, diagnostic services, and ancillary items and services
directly related to treatment (such as anesthesia for a surgical
procedure). They could also be items and services that occur after the
initial treatment period that may be furnished to patients as follow-up
care or to treat complications resulting from the treatment. An episode
is a specific instance of an episode group for a specific patient and
clinician. For example, in a given year, a clinician might be
attributed 20 episodes (instances of the episode group) from the
episode group for heart failure. In section III.I.3.h.(3)(b)(iv) of
this final rule, we discuss the attribution rules for cost measures.
[[Page 59768]]
After episodes are attributed to one or more clinicians, items and
services may be included in the episode costs if they are furnished
within a patient's episode window. Items and services will be included
if they are the trigger event for the episode or if a service
assignment rule identifies them as a clinically related item or service
during the episode. The detailed specifications for these measures,
which include information about the service assignment rules, can be
reviewed at qpp.cms.gov.
To ensure a more accurate comparison of cost across clinicians,
episode costs are payment standardized and risk adjusted. Payment
standardization adjusts the allowed amount for an item or service to
facilitate cost comparisons and limit observed differences in costs to
those that may result from health care delivery choices. Payment
standardized costs remove any Medicare payment differences due to
adjustments for geographic differences in wage levels or policy-driven
payment adjustments such as those for teaching hospitals. Risk
adjustment accounts for patient characteristics that can influence
spending and are outside of clinician control. For example, for the
elective outpatient PCI episode-based measure, the risk adjustment
model may account for a patient's history of heart failure.
The measure development contractor has continued to seek extensive
stakeholder feedback on the development of episode-based measures,
building on the processes outlined in the CY 2018 Quality Payment
Program final rule (82 FR 53644). These processes included convening a
TEP and clinical subcommittees to solicit expert and clinical input for
measure development, conducting national field testing on the episode-
based cost measures developed, and seeking input from clinicians and
stakeholders through engagement activities. Seven clinical
subcommittees were convened through an open call for nominations
between March 17, 2017 and April 24, 2017, composed of nearly 150
clinicians affiliated with almost 100 specialty societies. These
subcommittees met at an in-person meeting and through webinars from May
2017 to January 2018 to select an episode group or groups to develop
and provide detailed clinical input on each component of episode-based
cost measures. These components included episode triggers and windows,
item and service assignment, exclusions, attribution methodology, and
risk adjustment variables.
As described in the CY 2018 Quality Payment Program final rule (82
FR 53645), we provided an initial opportunity for clinicians to review
their performance based on the new episode-based measures developed by
the clinical subcommittees in the fall of 2017 through national field
testing.
During field testing, we sought feedback from stakeholders on the
draft measure specifications, feedback report format, and supplemental
documentation through an online form. We received over 200 responses,
including 53 comment letters, during the field test feedback period. We
shared the feedback on the draft measure specifications with the
clinical subcommittees who considered it in providing input on measure
refinements after the end of field testing. A field testing feedback
summary report is publicly available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-field-testing-feedback-summary-report.pdf.
To engage clinicians and stakeholders, we conducted extensive
outreach activities including hosting National Provider Calls (NPCs) to
provide information about the measure development process and field
test reports, and to give stakeholders the opportunity to ask
questions.
The new episode-based measures developed by the clinical
subcommittees were considered by the NQF-convened MAP, and were all
conditionally supported by the MAP, with the recommendation of
obtaining NQF endorsement. We intend to submit these episode-based
measures to NQF for endorsement in the future. The MAP provides an
opportunity for an interdisciplinary group of stakeholders to provide
input on whether the measures under consideration are attributable and
applicable to clinicians. The MAP also reviews measures for clinician
level feasibility, reliability, and validity. Following the successful
field testing and review through the MAP process, we proposed to add 8
episode-based measures listed in Table 36 as cost measures for the 2019
MIPS performance period and future performance periods (83 FR 35902).
The attribution methodology for these measures is discussed in
section III.I.3.h.(3)(b)(iv)(B) of this final rule. The detailed
specifications for these measures can be reviewed at qpp.cms.gov. These
specifications documents consist of (i) a methods document that
outlines the methodology for constructing the measures, and (ii) a
measure codes list file that contains the medical codes used in that
methodology. First, the methods document provides a high-level overview
of the measure development process, including discussion of the
detailed clinical input obtained at each step, and details about the
components of episode-based cost measures: Defining an episode group;
assigning costs to the episode group; attributing the episode group;
risk adjusting episode group costs; and aligning cost with quality. The
methods document also contains the detailed measure methodology that
describes each logic step involved in constructing the episode groups
and calculating the cost measure. Second, the measure codes list file
contains the codes used in the specifications, including the episode
triggers, exclusions, episode sub-groups, assigned items and services,
and risk adjustors.
Table 36--Episode-Based Measures Proposed for the 2019 MIPS Performance
Period and Future Performance Periods
------------------------------------------------------------------------
Measure topic Measure type
------------------------------------------------------------------------
Elective Outpatient Procedural.
Percutaneous Coronary
Intervention (PCI).
Knee Arthroplasty............ Procedural.
Revascularization for Lower Procedural.
Extremity Chronic Critical
Limb Ischemia.
Routine Cataract Removal with Procedural.
Intraocular Lens (IOL)
Implantation.
Screening/Surveillance Procedural.
Colonoscopy.
Intracranial Hemorrhage or Acute inpatient medical condition.
Cerebral Infarction.
Simple Pneumonia with Acute inpatient medical condition.
Hospitalization.
ST-Elevation Myocardial Acute inpatient medical condition.
Infarction (STEMI) with
Percutaneous Coronary
Intervention (PCI).
------------------------------------------------------------------------
[[Page 59769]]
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters supported our proposed adoption of the
8 episode-based measures under the cost performance category for the
2021 MIPS payment year. These commenters noted their support for the
significant clinician input into the measures.
Response: We thank the commenters for their support.
Comment: Several commenters supported the development of episode-
based measures but expressed concern about including them in the MIPS
cost performance category for the 2019 MIPS performance period. They
recommended that there be additional time for clinicians to understand
and address their performance on the measures. One commenter indicated
that although the measures had been made available as part of field
testing in the fall of 2017, the feedback that was made available did
not facilitate action to improve on the part of the clinician. Another
commenter suggested that CMS use 2019 as a pilot year to better test
these new episode-based measures.
Response: We will continue to work to make clinicians more familiar
with the measures through education and outreach activities. For
example, we have held cost performance category webinars to help
clinicians understand the cost measures in use for the MIPS 2018
performance period, and expect to hold similar webinars in the future.
We believe that the extensive field testing activities conducted in the
fall of 2017 in combination with future education and outreach will
help to ensure clinicians will understand these episode-based measures
and what actions they could take to improve their performance in the
measures. We do not believe that an additional year of pilot testing is
necessary at this time given the field testing and extensive
involvement of clinicians in the development of these measures.
Comment: Many commenters requested more detailed feedback on cost
measures in order to improve their performance, stating that it is
difficult to manage costs without receiving data on the patients
attributed to them for purposes of the cost measures. Some commenters
requested that CMS provide information on attributed patients on a
regular basis, such as quarterly. Some commenters expressed concern
that in contrast with the Value Modifier program, CMS has not provided
detailed feedback on cost measures, such as identifying beneficiaries
and the services they received for the 2017 MIPS performance period.
One commenter also suggested the use of an alternative metric, such as
the average ratio of the observed cost compared to the expected cost,
as a final comparison for the episode-based measures, as they believe
this to be more informative and actionable for clinicians.
Response: We have conducted user research on the feedback provided
for the first year of MIPS. In addition to that feedback, we are also
reviewing the QRURs from the legacy VM program and conducting user
research about what is valuable within the information provided
historically. We are committed to maturing the feedback experience for
year 2 and may consider providing beneficiary-level data on cost
measures in the future. Additionally, while we are unsure whether or
not the average ratio of the observed cost to expected cost would be
more informative than our current feedback reports, we will continue to
monitor the information provided, and explore ways to provide
actionable information to clinicians as we develop the measures for the
cost performance category.
Comment: A few commenters supported the development and inclusion
of episode-based measures but expressed concern that measures for their
particular specialty or focus area, such as urology, chiropractic
medicine, and medical oncology, were not yet included. A few commenters
suggested that CMS continue to engage with stakeholders and provide a
transparent process as CMS continues to develop additional episode-
based measures. One commenter recommended that CMS develop or include
quality measures in tandem with cost measures to prevent unintended
consequences of attempts to reduce cost which could adversely affect
quality of care.
Response: We continue to work to develop new episode-based measures
that could be considered for inclusion in the cost performance category
in future years. We expect that future measures may apply to a greater
range of specialties and clinical areas, such as urology and the other
focus areas suggested by commenters. Section 1848(r)(2)(D)(i)(I) of the
Act requires us to establish care episode groups and patient condition
groups, which account for a target of an estimated one half of
expenditures under parts A and B with such target increasing over time
as appropriate. While we have developed some episode-based measures to
target that goal as required, we shall continue our work to develop
additional measures focusing on both additional specialty types as well
as consider the important issue of measuring both cost and quality. By
continuing to gather detailed clinician and expert input on episode-
based measures, such as through clinical subcommittees and technical
expert panels, we hope to identify and mitigate potential unintended
consequences at each stage of measure development and testing.
Comment: A few commenters expressed concern with the overall
process for adding episode-based measures to the MIPS program on an
annual basis. They indicated that while clinician input is valuable in
defining the measures, it is also of particular importance to have an
underlying structure for episode-based measures that defines
responsibility for patients as they cross between multiple episodes.
They opposed inclusion of episode-based measures until these issues are
addressed. Additionally, several commenters offered alternative
frameworks to consider in the future development of episode-based
measures, including moving towards a tool that offers a multi-payer
perspective. One commenter urged CMS to develop episode-based measures
that are specific to discrete episodes of care. A few commenters
encouraged CMS to consider other factors when developing episode-based
measures including Activities of Daily Living (ADLs), counter quality
measures, patient specific pricing, and medical innovations.
Response: We rely on a comprehensive framework and systematic
process for creating episode-based measures that account for the roles
and responsibilities of individual clinicians in the care of individual
patients experiencing specific health conditions. This framework has
been applied in constructing all of the new cost measures for use in
MIPS, and in revising episode groups that had been developed under
section 1848(n)(9)(A) of the Act. Our current process includes: (1) A
transparent conceptual framework for creating episodes of care that
assigns costs for patients to those clinicians with the ability to
influence those costs; (2) a mechanism for incentivizing high quality
treatment that lowers preventable high cost future adverse health
events; and (3) a data-driven stakeholder input process for acquiring
and implementing clinical input that ensures clinical face validity and
actionability of constructed episode-based cost measures. This
framework was developed in part based on stakeholder comments on
measures in the Value Modifier program and overcomes the fundamental
shortcomings of earlier episode grouping approaches previously studied
[[Page 59770]]
by CMS. Shortcomings of previously studied episode grouping approaches
included lack of actionability arising from the unpredictable and
clinically inappropriate assignment of costs, limited relevance as
episode constructions did not focus on the role of attributed
clinicians in providing patient care, and limited transparency arising
from the use of complicated software algorithms.
Our conceptual framework provides a comprehensive foundation for
episode-based measures that can be used to incentivize high-value care
by attributed clinicians at each stage of the patient care continuum,
and allows for progressively adding new episode-based measures in a
logically cohesive and consistent manner. The framework involves three
distinct types of episode groups: Procedural, acute inpatient medical
condition, and chronic. Procedural episode groups are triggered by
performance of a major procedure, acute inpatient medical condition
episode groups are triggered by evaluation and management claims during
hospitalizations with specific DRGs, and chronic condition episode
groups are triggered by evaluation and management claims with
particular diagnoses. Attribution is determined by the clinician(s)
involved in the triggering claims, with consistent rules within each
type of episode group. Services, and their associated costs, are
assigned to an episode based on a clinical determination of whether a
service is under the influence of the attributed clinician (for
example, routine follow-up care or adverse health outcomes such as a
readmission). Clinical determinations of service assignment are made
using common criteria and methods across episode groups, to encourage
distinctions in service assignment and reflect differences in clinical
influence across episode groups. Risk adjustment employs a common
starting point of the CMS-HCC model across episode groups, but risk
adjustment models can be enhanced by the use of risk factors
specifically adapted for each episode group. This allows, for instance,
for adjustments to be made for an acute condition episode group based
on whether the condition is a stand-alone presentation of the condition
versus the exacerbation of an ongoing chronic condition. The framework
also allows for complete stratification in risk adjustment through the
use of episode sub-groups, with the definition of sub-groups (such as
unilateral vs. bilateral) being based on common principles across
episode groups. Episodes from distinct episode groups can overlap with
one another to ensure that each clinician treating a patient with
multiple health issues has incentives for providing high value care.
When a given service is clinically related to only one overlapping
episode, it is assigned only to that one. When a service is clinically
related to two overlapping episodes, it is assigned to both to ensure
joint accountability. Since each episode's cost is compared to a risk-
adjusted expected cost only for other episodes from the same episode
group, there is no issue of double counting. This approach allows for
development of distinct episode groups that cover a patient's care
continuum, including an underlying chronic condition as well as a
procedure or treatment for an exacerbation. As an example, a patient
receiving chronic care for coronary artery disease (CAD) (a chronic
episode) could have an acute incidence of STEMI requiring PCI for
stabilization (an acute inpatient medical condition episode), and due
to having severe CAD could later receive a coronary artery bypass graft
(CABG) procedure (a procedural episode). This logically, cohesive
framework for episode group development avoids a series of challenges
raised by previously studied episode grouping approaches that assign
services to only a single episode, including lack of transparency and
predictability in what an attributed clinician will be held accountable
for at the beginning of an episode. For information on how this
framework has been operationalized, refer to the measure specifications
available at https://qpp.cms.gov.
Using this conceptual framework, we have created a concrete process
for developing new measures over time. To prioritize the areas for
development of the new cost measures, our measure development
contractor convened a clinical committee, comprised of over 70
clinicians affiliated with over 50 specialty societies that provided
input necessary to develop a public posting of 117 episode groups for
development in December 2016. We then used criteria vetted by a
standing technical expert panel--comprised of 19 clinicians, health
researchers, and representatives of patient advocacy organizations--to
divide these 117 episode groups into 18 clinical areas. The
prioritization criteria focused on identifying areas where potential
episode-based measures could affect the highest number of beneficiaries
and clinicians, address particularly high cost procedures and
conditions, provide an opportunity for improvement, and best align with
quality measures.
Our measure development contractor has and is continuing to convene
clinical subcommittees for each of the priority clinical areas. The
composition of a subcommittee for an area principally consists of
practicing clinicians who are candidates for attribution of episode-
based measures developed for that area. Each clinical subcommittee
prioritizes specific episode measures for development within its area
based on the criteria above. The structure for developing specific cost
measures relies on a systematic data-based conceptual framework for
triggering logic, cohort definition, attribution, and cost assignment.
For the 8 episode-based measures discussed in this rule, nearly 150
clinicians affiliated with 98 specialty societies participated in the
clinical subcommittees in the creation of these measures. After
positive reception of the initial development process, 267 clinicians
affiliated with more than 120 specialty societies are now participating
in the clinical subcommittees and workgroups developing 11 additional
episode-based cost measures. The structure of episode-based cost
measure development provides a vehicle for continued stakeholder
engagement as additional measures are developed in the future.
Comment: A few commenters recommended that episode-based measures
not be included in the MIPS cost performance category if the measures
have not been endorsed by the NQF or supported by the MAP. They stated
that the NQF process gives important insights into the reliability,
validity, and usability of measures.
Response: The episode-based measures were reviewed by the MAP and
received the recommendation of ``conditional support for rulemaking,''
with the MAP recommending that the measures be submitted for NQF
endorsement. This review provided stakeholders with additional public
comment opportunities, which the MAP considered along with submission
materials regarding the scientific acceptability, reliability,
validity, and usability of the measures. We intend to submit the
episode-based measures for NQF endorsement in an upcoming review cycle.
Comment: One commenter expressed concern that particular episode-
based measures did not properly account for risk because of the nature
of their construction and lack of clinical data. Specifically, this
commenter stated that a combined measure of intracranial hemorrhage and
cerebral infraction
[[Page 59771]]
would produce distortions in results. This commenter also stated that
risk adjustment for this measure did not include a measure of stroke
severity. Another commenter expressed uncertainty about the risk
adjustment methodology and also suggested the use of both inpatient and
outpatient claims data to obtain a complete understanding of the
patient's risk factors. One commenter suggested excluding Implantable
Cardioverter Defibrillator (ICD) implantation MS-DRGs (222-227) from
the Elective Outpatient PCI and STEMI with PCI measures to ensure there
are no adverse incentives to providing a service that is both covered
and clinically indicated. One commenter expressed concern that the
episode-based measure for Revascularization for Lower Extremity Chronic
Critical Limb Ischemia should have a longer measurement period. One
commenter requested that post-discharge events unrelated to the initial
pneumonia hospitalization and any hospice costs be excluded for the
Simple Pneumonia episode-based measure. The same commenter also stated
that new episodes for the same measure should not be started for a
patient if they already have an ongoing episode.
Response: We understand the interest in risk adjustment and other
aspects of measure construction. To summarize, the risk adjustment for
the eight episode-based measures includes risk adjustors from the CMS-
HCC model and additional measure-specific risk adjustors recommended by
the Clinical Subcommittee for the measure. Risk adjustors are defined
using the beneficiary's Medicare claims history (including inpatient,
outpatient, and Part B Physician/Supplier claims) during the period
prior to the start of the episode. Claims from the triggering
hospitalization or on the triggering Part B Physician/Supplier claim
are typically not included, as we understand it may be difficult to
discern which claims are due to complications and which were already
present at the initiation of the episode. We believe that utilizing the
claims from the look back window adequately identifies patient
comorbidities. To address the specific comments, we believe that the
Intracranial Hemorrhage and Cerebral Infarction measure accurately
assesses clinician cost performance as there are separate sub-groups
for Intracerebral Hemorrhage and Cerebral Infarction such that patients
within each sub-group are compared only with each other (that is, a
patient being treated for Cerebral Infarction would only be compared to
other patients being treated for Cerebral Infarction). The risk
adjustors for this measure were developed with significant input from a
Neuropsychiatric Disease Management Clinical Subcommittee, which
recommended specific risk adjustors that include MS-DRG severity for
Intracranial Hemorrhage or Cerebral Infarction and Nonspecific
Cerebrovascular Disorders. Additional risk adjustors were included to
account for comorbidities that could lead to worse outcomes such as
aphasia and dysphagia. However, measures of stroke severity such as the
NIH stroke scale were not included in the risk adjustment model to
avoid possible unintended consequences (for example, coding of higher
severity for improvement of individual episode risk adjustment) and to
avoid penalizing clinicians who do not code for severity, especially
since ICD-10-CM codes for NIH Stroke Scale have only been operational
since October 2017. The Revascularization for Lower Extremity Chronic
Critical Limb Ischemia measure has a 30-day pre-trigger period and a
90-day post-trigger period. This episode window was determined through
extensive input from a Peripheral Vascular Disease Management Clinical
Subcommittee, which we believe to be an appropriate length of time for
which the attributed clinician can reasonably influence services. The
measure specifications, including the post-discharge assigned services,
for the Simple Pneumonia with Hospitalization measure were developed
with significant clinical input from the Pulmonary Disease Management
Clinical Subcommittee, which only assigned services they believed the
attributed clinician could reasonably influence. For this reason, the
costs associated with the hospice setting are not assigned to Simple
Pneumonia with Hospitalization episodes. We will conduct annual
evaluations to review the continued accuracy of the measure
specifications. Finally, we do not exclude episodes if a patient
already qualifies for another episode since we believe that allowing
for overlapping episodes incentivizes communication and care
coordination as a patient progresses through the care continuum. For
example, if a patient is re-hospitalized for pneumonia after an initial
pneumonia episode, this triggers two separate episodes of care for
pneumonia. The risk adjustment model adjusts for differences in
clinical complexity at the time each episode begins. This ensures that
the attributed clinicians managing each hospitalization face analogous
incentives to provide the patient high value care. The assigned
services for the STEMI with PCI and Elective Outpatient PCI measures
were developed with input from the Cardiovascular Disease Management
Clinical Subcommittee, with the goal of capturing complications of
Myocardial Infarction (MI) or Heart Failure (HF) admissions. Given this
clinical intent of the measure, we believe that MS-DRGs with MI or HF
in the measure (MS-DRGs 222-223: Defib with Cath with MI/HF) are
appropriate to include as assigned services. We agree, however, with
the comment about removing assignments of the MS-DRGs without MI or HF
(MS-DRGs 224-225: Defib with Cath without MI/HF and MS-DRGs 226-227:
Defib without Cath without MI/HF), as these are more likely to be
elective ICD placements. Given the scope of the measure, we believe it
is appropriate to assign services that are part of an admission for MI
or HF, while excluding services that are elective. To maintain a
consistent framework across all measures, we are implementing this
revision where relevant in STEMI with PCI, Elective Outpatient PCI, and
Revascularization for Lower Extremity Chronic Critical Limb Ischemia.
Comment: One commenter expressed concern with the possibility of
high cost variation for some episode-based measures depending on the
codes that trigger the episodes or the place of service in which an
episode is triggered. To account for this variation, the commenter
suggested incorporating a sub-group based on the triggering DRG code
for the Intracranial Hemorrhage or Cerebral Infarction measure and the
STEMI with PCI measure, a sub-group based on triggering procedure code
for the Elective Outpatient PCI measure, and a place of service sub-
group for the Revascularization for Lower Extremity Chronic Critical
Limb Ischemia measure and Screening/Surveillance Colonoscopy measure.
Response: The measure specifications, including the episode
triggers and the sub-groups for each measure, were determined with
significant clinical input from the Clinical Subcommittees that
developed each episode-based measure. To adjust for patient differences
outside attributed clinicians' influence, the Clinical Subcommittees
could choose to risk adjust for a specific patient factor or sub-group
by that factor. Risk adjustment ensures that a measure accounts for
average cost differences associated with the specific factor, while
sub-grouping involves estimating an entirely separate risk adjustment
model for patients with that factor. Sub-grouping is only appropriate
[[Page 59772]]
in cases where a sufficient number of episodes are present in the sub-
population to ensure a statistically meaningful model and where a
separate model for the sub-population is necessary. Balancing these
considerations, the Clinical Subcommittees addressed concerns raised by
the commenter by: Including indicators for MS-DRG in risk adjustment
models for the Intracranial Hemorrhage or Cerebral Infarction measure
and the STEMI with PCI measure to reflect the presence of Complication
or Comorbidity (CC) or Major Complication or Comorbidity (MCC); and
including place of service factors in risk adjustment models for the
Revascularization for Lower Extremity Chronic Critical Limb Ischemia
measure and the Screening/Surveillance Colonoscopy measure. For the
Elective Outpatient PCI measure, the current inclusion of other risk
adjustment factors is designed to control for factors outside of the
clinician's influence that may dictate the particular triggering
procedure used.
Comment: Several commenters expressed support for the episode-based
measure development process implemented by CMS that incorporates
significant stakeholder input as well as support for the measures. One
commenter commended CMS for convening the Clinical Subcommittees,
specifically noting that they believed members of the subcommittee that
developed the Screening/Surveillance Colonoscopy measure were part of a
successful and deliberative process. Two commenters also supported the
Routine Cataract with IOL Implantation measure, stating the measure
accurately reflected the costs of the procedure and will provide
actionable data to clinicians. Another commenter expressed appreciation
for the pace of the development process and urged CMS to continue this
level of engagement with stakeholders in other areas of the Quality
Payment Program.
Response: We recognize the importance of clinician input in
developing episode-based measures that provide actionable data and aim
to continue this level of engagement in the development of future
episode-based measures for MIPS.
Comment: One commenter supported the total per capita cost measure
and stated it is the best initial metric for assessing the cost-
effectiveness of primary care providers while fulfilling MACRA's
mandate to evaluate a primary care provider's cost performance.
Response: We agree that this measure is important as a measure of
the overall cost of care, even as we develop episode-based measures
which are also important measures of the cost of care.
Comment: Several commenters opposed the continued inclusion of the
total per capita cost measure and the MSPB measure in the cost
performance category. They stated that the measures included all
services provided to a patient, even those for which the attributed
clinician could not control. One commenter requested that these
measures only be applied to primary care clinicians and not to
specialists. Finally, one commenter expressed concerns with how total
per capita cost measure has not yet been endorsed by NQF, and MSPB
measure has only been endorsed at the facility-level.
Response: While we appreciate the interest in the total per capita
cost and MSPB measures' NQF endorsement status, we continue to believe
that these measures are tested and reliable for Medicare populations
and provide an important measurement of clinician cost performance (82
FR 53644) while we continue to develop episode-based measures that
precisely identify services that are part of an episode that could be
considered directly under the control of a clinician. Versions of the
total per capita cost and MSPB measures were included in the QRURs and
used in the VM for many years before the implementation in MIPS. These
measures have an important place in cost measurement given that the
episode-based measures will only apply to a subset of clinicians at
this time.
The total per capita cost measure uses a primary care attribution
method in which a specialist would not be attributed a patient unless
that patient did not see a primary care clinician (based on the
Medicare specialty) during the year. For some patients who do not see a
primary care clinician in a year, a specialist may serve as a primary
care clinician due to an underlying disease or condition which the
specialist focuses on. For the MSPB measure, we do not believe it is
appropriate to limit attribution to primary care clinicians as
specialists may perform procedures or manage patients in the hospital
and can have a significant influence on the overall spending during the
hospitalization.
Both the total per capita cost and MSPB measures are being refined
as part of the measure maintenance and re-evaluation process,
incorporating substantial stakeholder input. We are completing an
extensive outreach initiative in the fall of 2018 to share performance
information with clinicians as part of field testing, a part of measure
re-evaluation. After considering the stakeholder feedback on these
refinements, we may propose the re-evaluated measures for use in MIPS
to replace the current versions of the measures in the program.
Comment: Several commenters expressed concern about the risk and
specialty adjustment methods used in the measures that are part of the
cost performance category. In particular, several commenters stated
that measures do not appropriately account for sociodemographic status,
which can drive differences in average episode costs. Additionally,
commenters noted that measures did not take into account the risks
associated with complex or dual-eligible patients or patients seen by
certain specialists. Another noted the lack of risk-adjustment for
cancer treatment. One commenter also expressed concern about the
differences in case-mix across specialties for a given measure,
specifically STEMI with PCI. The commenter stated that under this
measure, hospitalists may be attributed episodes that include more
medically complex patients who require post-ICU care on a general
medicine floor, making these hospitalists appear to be costlier than
other clinicians.
Response: We understand stakeholders' concerns regarding risk
adjustment for social risk factors and dual eligible status. As we have
previously stated, we are concerned about holding clinicians to
different standards for the outcomes of their patients with social risk
factors, because we do not want to mask potential disparities. We
believe that the path forward should incentivize improvements in health
outcomes for disadvantaged populations while ensuring that
beneficiaries have adequate access to excellent care. We thank
commenters for this important feedback and will continue to consider
options to account for social risk factors that would allow us to view
disparities and potentially incentivize improvement in care for
patients and beneficiaries. We recognize the concern regarding risk
adjusting for complex patients, including those with cancer treatment,
and regarding the variation in case-mix across specialties for a given
episode. Our risk adjustment methodology, which employs a common
starting point of the CMS-HCC model across episode groups and can
include the use of risk factors specifically adapted for each episode
group is designed to account for patient comorbidities that predict a
complex hospitalization and lead to higher costs that are outside the
influence of attributed clinicians, regardless of
[[Page 59773]]
which specialty designations those clinicians choose to identify.
Comment: Several commenters requested that certain clinicians be
excluded or included in the cost performance category on the basis of
their type of practice, particularly non-patient facing clinicians.
Response: We have established a policy to assign a zero percent
weight to the cost performance category if there are not sufficient
measures applicable and available to a MIPS eligible clinician (see,
for example, 81 FR 77322 through 77325). We believe it is possible that
a clinician may not have sufficient cost measures applicable or
available to them based on their specialty or type of practice,
including clinicians who are non-patient facing. We continue to work to
expand the reach of the cost performance category to as many clinicians
as possible, including non-patient facing clinicians in accordance with
section 1848(q)(2)(C)(iv) of the Act.
After consideration of the public comments, we are finalizing our
proposal to include the 8 episode-based measures listed in Table 36 in
the cost performance category beginning with the 2019 MIPS performance
period with a modification to the STEMI with PCI, Elective Outpatient
PCI, and Revascularization for Lower Extremity Chronic Critical Limb
Ischemia episode-based measures to remove assignments of the MS-DRGs
without MI or HF (MS-DRGs 224-225: Defib with Cath without MI/HF and
MS-DRGs 226-227: Defib without Cath without MI/HF).
(iii) Reliability
In the CY 2017 Quality Payment Program final rule (81 FR 77169
through 77170), we finalized a reliability threshold of 0.4 for
measures in the cost performance category. We seek to ensure that MIPS
eligible clinicians are measured reliably. In the CY 2017 Quality
Payment Program final rule, we finalized a case minimum of 20 for the
episode-based measures specified for the 2017 MIPS performance period
(81 FR 77175). We examined the reliability of the proposed 8 episode-
based measures listed in Table 36 at various case minimums and found
that all of these measures meet the reliability threshold of 0.4 for
the majority of clinicians and groups at a case minimum of 10 episodes
for procedural episode-based measures and 20 episodes for acute
inpatient medical condition episode-based measures. Furthermore, these
case minimums would balance the goal of increased reliability with the
goal of adopting cost measures that are applicable to a larger set of
clinicians and clinician groups. Our analysis indicated that the case
minimum for procedural episode-based measures could be lower than that
of acute inpatient medical condition episode-based measures while still
ensuring reliable measures.
Table 37 presents the percentage of TINs and TIN/NPIs with 0.4 or
higher reliability, as well as the mean reliability for the subset of
TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for
procedural episode-based measures and 20 episodes for acute inpatient
medical condition episode-based measures for each of the proposed
episode-based measures. Each row in Table 37 provides the percentage of
TINs and TIN/NPIs who had reliability of 0.4 or higher among all the
TINs and TIN/NPIs who met the case minimum for that measure during the
study period (6/1/2016 to 5/31/2017).
Table 37--Percentage of TINs and TIN/NPIs With 0.4 or Higher Reliability From June 1, 2016 to May 31, 2017 at
Proposed Case Minimums
----------------------------------------------------------------------------------------------------------------
Percentage Percentage TIN/
TINs with 0.4 Mean NPIs with 0.4 Mean
Measure name or higher reliability or higher reliability
reliability for TINs reliability for TIN/NPIs
(%) (%)
----------------------------------------------------------------------------------------------------------------
Elective Outpatient Percutaneous Coronary 100.0 0.73 84.1 0.53
Intervention (PCI).............................
Knee Arthroplasty............................... 100.0 0.87 100.0 0.81
Revascularization for Lower Extremity Chronic 100.0 0.74 100.0 0.64
Critical Limb Ischemia.........................
Routine Cataract Removal with Intraocular Lens 100.0 0.95 100.0 0.94
(IOL) Implantation.............................
Screening/Surveillance Colonoscopy.............. 100.0 0.96 100.0 0.93
Intracranial Hemorrhage or Cerebral Infarction.. 100.0 0.70 74.9 0.48
Simple Pneumonia with Hospitalization........... 100.0 0.64 31.8 0.40
ST-Elevation Myocardial Infarction (STEMI) with 100.0 0.59 100.0 0.59
PCI............................................
----------------------------------------------------------------------------------------------------------------
Based on this analysis, we proposed at Sec. 414.1350(c)(4) and (5)
a case minimum of 10 episodes for the procedural episode-based measures
and 20 episodes for the acute inpatient medical condition episode-based
measures beginning with the 2019 MIPS performance period (83 FR 35904).
We stated that these case minimums would ensure that the measures meet
the reliability threshold for groups and individual clinicians. We
stated that we believe that the proposed case minimums for these
procedural and acute inpatient medical condition episode-based measures
would achieve a balance between several important considerations. In
order to help clinicians become familiar with the episode-based
measures as a robust and clinician-focused form of cost measurement, we
want to provide as many clinicians as possible the opportunity to
receive information about their performance on reliable measures. This
is consistent with the stakeholder feedback that we have received
throughout the measure development process. We stated that we believe
that calculating episode-based measures with these case minimums would
accurately and reliably measure the performance of a large number of
clinicians and clinician group practices.
We stated that we recognize that the percentage of TIN/NPIs with
0.4 or greater reliability for the Simple Pneumonia with
Hospitalization measure, while still meeting our reliability threshold,
is somewhat lower than that of the other proposed acute inpatient
medical condition episode-based measures, as well as all of the
proposed procedural episode-based measures. For this reason, we
considered an alternative case minimum of 30 for both TIN/NPIs and TINs
for this measure. At this case minimum, 100 percent of TIN/NPIs would
have 0.4 or greater reliability and the mean reliability would increase
to 0.49 for TIN/NPIs and 0.70 for TINs. However, the number of TINs and
TIN/NPIs that would meet the case minimum for this important measure
would decrease by 29 percent for TINs and by 84 percent for TIN/NPIs.
We invited comments on
[[Page 59774]]
this alternative case minimum for TIN/NPIs and TINs for the Simple
Pneumonia with Hospitalization episode-based measure.
We previously finalized a case minimum of 35 for the MSPB measure
(81 FR 77171), 20 for the total per capita cost measure (81 FR 77170),
and 20 for the episode-based measures specified for the 2017 MIPS
performance period (81 FR 77175). We proposed to codify these final
policies under Sec. 414.1350(c) (83 FR 35904).
In general, higher case minimums increase reliability, but also
decrease the number of clinicians who are measured. We aim to measure
as many clinicians as possible in the cost performance category. Some
clinicians or smaller groups may never see enough patients in a single
year to meet the case minimum for a specific episode-based measure. For
this reason, we solicited comment on whether we should consider
expanding the performance period for the cost performance category
measures from a single year to 2 or more years in future rulemaking. We
believe this would allow us to more reliably measure a larger number of
clinicians. However, we are also concerned that expanding the
performance period would increase the time between the measurement of
performance and the application of the MIPS payment adjustment. In
addition, it would take a longer period of time for us to introduce new
cost measures as we would expect to adopt them through rulemaking prior
to the beginning of the performance period.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Many commenters expressed concern with the reliability
thresholds that we use to inform the determination of case minimums in
the cost performance category. Several of these commenters suggested
that measures should have case minimums that would reflect 0.8
reliability for all TINs and TIN/NPI combinations. One commenter stated
that using a low reliability threshold would result in measuring the
acuity of patients as opposed to the performance of a clinician.
Another commenter suggested that we consider whether a standard case
minimum for all episode group should continue to be set or case
minimums should be set accordingly for each individual measure. One
commenter also suggested increasing to a 20 episode case minimum for
procedural episode-based measures.
Response: Because we aim to balance the need for consistent program
standards with ensuring that measures are reliable, we proposed to set
a different case minimum for the procedural and acute inpatient medical
condition episode-based measures. We aim to measure cost for as many
clinicians as possible, and limiting measures to reliability of 0.7 or
0.8 would result in few individual clinicians with attributed cost
measures. In addition, a 0.4 reliability threshold ensures moderate
reliability for most MIPS eligible clinicians and group practices that
are being measured on cost. Under the proposed case minimum of 10
episodes for the procedural episode-based measures, the reliability of
the measures already exceeds the 0.4 reliability threshold we have
previously established, with most having higher than 0.7 reliability.
Using a 20 episode case minimum, while having a slight increase in
reliability, will reduce clinician coverage. Therefore, retaining the
proposed case minimum of 10 episodes for the procedural measures allows
us to maximize the number of clinicians covered by these measures,
while still exceeding the 0.4 moderate reliability threshold. We will
continue to evaluate reliability as we develop new measures and propose
them for inclusion in MIPS in future rulemaking.
Comment: Several commenters supported our alternative proposal for
a case minimum of 30 for the Simple Pneumonia with Hospitalization
measure. The commenters stated that using a more reliable measure would
be preferred over measuring more clinicians.
Response: We agree that our proposed alternative case minimum of 30
episodes for the Simple Pneumonia with Hospitalization measure would
have slightly higher reliability, but we also believe that maintaining
a consistent case minimum across all acute inpatient medical condition
episode-based measures would accurately and reliably assess cost
measure performance for a large number of clinicians and clinician
groups. We believe it is in the interests of MIPS participants,
particularly specialists who treat patients for this condition, to have
this new episode-based measure available to them. A consistent case
minimum for acute inpatient medical condition episode-based measures
would also make it easier for clinicians to understand because it
establishes cohesiveness across the different measures as stakeholders
are still becoming familiar with these new measures. The mean
reliability of the Simple Pneumonia with Hospitalization measure at 20
episodes exceeds the 0.4 reliability threshold (indicating moderate
reliability) for TINs and meets that threshold for TIN/NPIs.
Comment: One commenter stated that small practices are less
reliably measured by cost measures and that it will be difficult for
small practices to analyze cost data in order to improve.
Response: While we have not examined the issue of practice size in
relation to the reliability of the cost measures, we have examined the
issue of case size in relation to the reliability of cost measures. The
results of the analysis of episode-based cost measures can be found in
our National Summary Data Report on Eight Wave 1 Episode-Based Cost
Measures at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Updated-2017-National-Summary-Data-Report.pdf. To some degree, the size
of a practice correlates with the case size for cost measures, as an
individual clinician can only see so many patients. We believe that
establishing case minimums that are based on moderate reliability allow
us to measure all clinicians and groups that meet those case minimums.
We note that the scores on the measures in the cost performance
category are only a component of the MIPS final score, which also
includes a small practice bonus available within the quality
performance category to accommodate the issues that may be faced by
small practices.
After consideration of the public comments, we are finalizing our
proposed case minimum of 10 episodes for the procedural episode-based
measures and 20 episodes for the acute inpatient medical condition
episode-based measures beginning with the 2019 MIPS performance period
at Sec. 414.1350(c)(4) and (5) as proposed. We are also finalizing our
proposal to codify our previously finalized case minimum of 35 for the
MSPB measure, 20 for the total per capita cost measure, and 20 for the
episode-based measures specified for the 2017 MIPS performance period
at Sec. 414.1350(c) as proposed. We will take the comments we received
on expanding the performance period for measures in the cost
performance category into account for future rulemaking.
(iv) Attribution
(A) Attribution Methodology for Cost Measures
In the CY 2017 Quality Payment Program final rule (81 FR 77168
through 77169; 77174 through 77176), we adopted final policies
concerning the attribution methodologies for the total
[[Page 59775]]
per capita cost measure, the MSPB measure, and the episode-based
measures specified for the 2017 MIPS performance period in addition to
an attribution methodology for individual clinicians and groups. We
proposed to codify these final policies under Sec. 414.1350(b).
The following is a summary of the public comments received on these
proposals and our responses:
Comment: Several commenters expressed concern with the attribution
methods finalized in the 2017 Quality Payment Program final rule (81 FR
77168 through 77169), which we proposed to codify. These commenters
stated that it was unclear to clinicians which patients would be
attributed to them. They recommended a number of methods to improve
this process, such as offering feedback on the patients that may be
attributed to a clinician at some time during the performance period or
allowing clinicians to define attribution with the use of patient
relationship codes.
Response: We will continue to look at ways to facilitate the
engagement of clinicians in the measures in the cost performance
category and will look into offering as much information as is feasible
to clinicians.
Comment: Several commenters expressed concern with the attribution
methodology for the total per capita cost measure that we finalized in
the CY 2017 Quality Payment Program final rule (81 FR 77168 through
77169), which we proposed to codify. In particular, they expressed
concerns with the identification of clinicians such as nurse
practitioners and physician assistants as primary care clinicians under
this methodology, because many of them work in specialist practices.
Response: We believe that attribution methods that include nurse
practitioners (NP) and physician assistants (PA) as primary care
clinicians best represents the role they play in clinical care. Under
the attribution methodology for the total per capita cost measure, a
patient who saw a primary care physician more often than an NP or PA in
a specialty practice would be attributed to that primary care
physician. As we have observed in rulemaking for the Value Modifier (79
FR 67961), including NPs and PAs in the first step of attribution in
the total per capita care cost measure did not significantly affect the
attribution of patients.
Comment: Several commenters expressed concern with the attribution
methods used for the MSPB measure for which we finalized policy in the
CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169)
and which we proposed to add to regulatory text. Many of the commenters
expressed concern that the method of attribution was assigning patients
to non-patient facing specialists such as pathologists and radiologists
because they may provide expensive services, but do not provide overall
care management for the patient. A few commenters requested that non-
patient facing clinicians not be attributed this measure.
Response: We believe that the MSPB measure continues to be an
important measure of the overall cost of care for a patient and the
clinician who provides the plurality of care. We believe that a
clinician who provides the plurality of care in a hospital has
opportunities to affect the cost of care for that patient. In some
cases that may be a non-patient facing clinician, who in order to
provide the plurality of care, would have provided a significant amount
of service to a hospitalized patient.
After consideration of the public comments, we are finalizing our
proposal to codify the previously adopted final policies at Sec.
414.1350(b) as proposed.
(B) Attribution Rules for the Episode-Based Measures
In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized 8
episode-based measures for the cost performance category for the 2019
MIPS performance period and future performance periods, which can be
categorized into two types of episode groups: Acute inpatient medical
condition episode groups, and procedural episode groups. These measures
only include items and services that are related to the episode of care
for a clinical condition or procedure (as defined by procedure and
diagnosis codes), as opposed to including all services that are
provided to a patient over a given period of time. The attribution
methodology will be the same for all of the measures within each type
of episode groups--acute inpatient medical condition episode groups and
procedural episode groups. Our approach to attribution will ensure that
the episode-based measures reflect the roles of the individuals and
groups in providing care to patients.
For acute inpatient medical condition episode groups specified
beginning in the 2019 performance period, we proposed at Sec.
414.1350(b)(6) to attribute episodes to each MIPS eligible clinician
who bills inpatient evaluation and management (E&M) claim lines during
a trigger inpatient hospitalization under a TIN that renders at least
30 percent of the inpatient E&M claim lines in that hospitalization (83
FR 35905). We stated that a trigger inpatient hospitalization is a
hospitalization with a particular MS-DRG identifying the episode group.
These MS-DRGs, and any supplementary trigger rules, are identified in
the measure specifications posted at qpp.cms.gov. The measure score for
an individual clinician (TIN/NPI) is based on all of the episodes
attributed to the individual. The measure score for a group (TIN) is
based on all of the episodes attributed to a TIN/NPI in the given TIN.
If a single episode is attributed to multiple TIN/NPIs in a single TIN,
the episode is only counted once in the TIN's measure score. We stated
that we believe that establishing a 30 percent threshold for the TIN
would ensure that the clinician group is collectively measured across
all of its clinicians who are likely responsible for the oversight of
care for the patient during the trigger hospitalization.
This proposed attribution approach differs from the attribution
approach previously established for episode-based measures for acute
inpatient medical conditions specified for the 2017 performance period
in the CY 2017 Quality Payment Program final rule (81 FR 77174 through
77175). The previous approach attributed episodes to TIN/NPIs who
individually exceed the 30 percent E&M threshold, while excluding all
episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout
the measure development process, stakeholders have discussed the team-
based nature of acute care, in which multiple clinicians share
management of a patient during a hospital stay. The previous approach
outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174
through 77175) does not capture patients' episodes when a group
collaborates to manage a patient but no individual clinician exceeds
the 30 percent threshold. Based upon stakeholder feedback, our proposed
approach emphasizes team-based care and expands the measures' coverage
of clinicians, patients, and cost.
We provided an example to illustrate the proposed attribution rules
for acute inpatient medical condition episode groups in the proposed
rule (83 FR 35905).
For procedural episode groups specified beginning in the 2019 MIPS
performance period, we proposed at Sec. 414.1350(b)(7) to attribute
episodes to each MIPS eligible clinician who renders a trigger service
as identified by HCPCS/CPT procedure codes (83 FR 35905). These trigger
services are identified in the measure specifications posted at
qpp.cms.gov. We stated that the measure score for an individual
[[Page 59776]]
clinician (TIN/NPI) is based on all of the episodes attributed to the
individual. The measure score for a group (TIN) is based on all of the
episodes attributed to a TIN/NPI in the given TIN. If a single episode
is attributed to multiple TIN/NPIs in a single TIN, the episode is only
counted once in the TIN's measure score. We stated that we believe this
approach best identifies the clinician(s) responsible for the patient's
care. This attribution method is similar to that used for procedural
episode-based measures in the 2017 MIPS performance period but more
clearly defines that the services must be provided during the episode
and how we would address instances in which two NPIs in the same TIN
provided a trigger service.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: One commenter supported our proposed attribution methods
for the procedural and acute inpatient medical condition episode-based
measures.
Response: We appreciate the support of the commenter.
Comment: A few commenters agreed with the importance of shared
accountability in attribution, with one commenter noting that they
believed the proposed methodology represented a novel approach to this
shared accountability. However, a few commenters opposed our proposed
attribution methodology for acute inpatient medical condition episode-
based measures. A few commenters recommended that the required
percentage be increased. A few commenters expressed concern that a
single patient could be attributed to many clinicians in a practice if
they participated in MIPS as individuals under this proposed
attribution method. This commenter stated that a clinician billing for
a single service during a hospitalization could not be expected to have
a significant effect on costs. A few commenters stated that this change
in attribution methodology had been made following the episode-based
measure field testing and could undercut the viability of measures
established with clinical input.
Response: We appreciate the support for the emphasis on team-based
care and shared accountability in the attribution methodology. We also
appreciate the interest in increasing the E&M threshold percentage as
part of the attribution methodology for the acute inpatient medical
condition episode-based measures. While there is interest in increasing
the E&M threshold and concern about the impact of the proposed
attribution methodology on clinicians participating in MIPS as
individuals, we believe that the methodology as proposed appropriately
balances the interest in team-based care and enabling as many
clinicians as possible to be attributed to these new acute inpatient
medical condition episode-based measures. Specifically, we believe that
an E&M threshold requirement of 30 percent reflects stakeholder input
throughout the measure development process to reasonably reflect the
nature of care in an inpatient setting, and it is in the interests of a
large number of clinicians and clinician groups to be able to access
these episode-based measures. We disagree that the proposed methodology
undercuts the viability of the episode-based measures. Each component
of the measures reflects feedback that the measure development
contractor has gathered from clinical subcommittees, a technical expert
panel, and public comments, including during field testing in 2017. We
believe that the changes made to the attribution methodology after
field testing reflect the purpose of such testing--which we believe
goes beyond the typical testing associated with many performance
measures--to reveal issues and to gather stakeholder feedback to inform
potential measure refinements. This included feedback on the importance
of incorporating considerations of care coordination into the
attribution methodology. We believe that a clinician participating as
an individual who bills one E&M claim within a TIN that has 30 percent
of the total E&Ms for that trigger inpatient stay does not necessarily
have limited influence on episode costs due to the nature of inpatient
care involving teams. In addition, we seek to incentivize clinicians to
engage in greater care coordination throughout a patient's trajectory.
The case minimum of 20 for acute inpatient medical condition episode-
based measures as finalized above ensures that clinicians are reliably
measured in providing care to beneficiaries with those specific
conditions. We note that the mean reliability for the measures meets or
exceeds the established 0.4 reliability threshold under this
attribution methodology for TINs and TIN/NPIs.
Comment: Some commenters expressed concern with our procedural
episode groups proposal to attribute episodes to each MIPS eligible
clinician who renders a trigger service as identified by HCPCS/CPT
procedure codes. One commenter suggested that a clinician should be
required to bill at least two service codes in order to be attributed a
procedural episode in order to increase the reliability of the measure.
One commenter recommended that a single clinician should not be solely
attributed the costs for a patient based on the provision of a trigger
service, but that the responsibility should be shared among all
clinicians who treated the patient during the episode. One commenter
stated that the same patient would be attributed twice if a two-stage
procedure were performed.
Response: We believe that in the case of a procedural episode, the
clinician who performs the service has a significant influence on the
costs of care that are part of the episode that follows the provision
of that service. These clinicians perform significant therapeutic and
diagnostic services, and the episode-based measures are intended to
limit costs to those which the clinician can affect, such as by
avoiding complications or better managing the patient during the
episode. In many cases, it would not be practical to require more than
a single service, such as in cases of surgical services which may
encompass much of the period of the episode.
After consideration of the public comments, we are finalizing as
proposed our proposal at Sec. 414.1350(b)(6) for acute inpatient
medical condition episode groups specified beginning in the 2019
performance period, to attribute episodes to each MIPS eligible
clinician who bills inpatient evaluation and management (E&M) claim
lines during a trigger inpatient hospitalization under a TIN that
renders at least 30 percent of the inpatient E&M claim lines in that
hospitalization. Additionally, we also finalizing as proposed our
proposal at Sec. 414.1350(b)(7) for procedural episode groups
specified beginning in the 2019 MIPS performance period, to attribute
episodes to each MIPS eligible clinician who renders a trigger service
as identified by HCPCS/CPT procedure codes.
(4) Improvement Activities Performance Category
(a) Background
In CY 2017 Quality Payment Program final rule (81 FR 77179 through
77180), we codified at Sec. 414.1355 that the improvement activities
performance category would account for 15 percent of the final score.
We refer readers to section III.I.3.i.(1)(e) of this final rule where
we proposed to modify Sec. 414.1355 to provide further technical
clarifications. In addition, in the CY 2018 Quality Payment Program
final
[[Page 59777]]
rule (82 FR 53649), we codified at Sec. 414.1380(b)(3)(iv) that the
term recognized be accepted as equivalent to the term certified when
referring to the requirements for a patient-centered medical home to
receive full credit for the improvement activities performance category
for MIPS. We also finalized at Sec. 414.1380(b)(3)(x) that for the
2020 MIPS payment year and future years, to receive full credit as a
certified or recognized patient-centered medical home or comparable
specialty practice, at least 50 percent of the practice sites within
the TIN must be recognized as a patient-centered medical home or
comparable specialty practice (82 FR 53655). We refer readers to
section III.I.3.i.(1)(e)(i)(D) of this final rule for details on our
proposals regarding patient-centered medical homes.
In the CY 2017 Quality Payment Program final rule (81 FR 77539), we
codified the definition of improvement activities at Sec. 414.1305 to
mean an activity that relevant MIPS eligible clinicians, organizations,
and other relevant stakeholders identify as improving clinical practice
or care delivery and that the Secretary determines, when effectively
executed, is likely to result in improved outcomes. Further, in that
final rule (81 FR 77190), we codified at Sec. 414.1365 that the
improvement activities performance category would include the
subcategories of activities provided at section 1848(q)(2)(B)(iii) of
the Act. We also codified subcategories for improvement activities at
Sec. 414.1365 (81 FR 77190).
We also previously codified in the CY 2017 and CY 2018 Quality
Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively)
data submission criteria for the improvement activities performance
category at Sec. 414.1360(a)(1). In addition, we established
exceptions for: Small practices; practices located in rural areas;
practices located in geographic HPSAs; non-patient facing individual
MIPS eligible clinicians or groups; and individual MIPS eligible
clinicians and groups that participate in a MIPS APM or a patient-
centered medical home submitting in MIPS (81 FR 77185, 77188).
Specifically, we codified at Sec. 414.1380(b)(3)(vii) that non-patient
facing MIPS eligible clinicians and groups, small practices, and
practices located in rural areas and geographic HPSAs receive full
credit for the improvement activities performance category by selecting
one high-weighted improvement activity or two medium-weighted
improvement activities; such practices receive half credit for the
improvement activities performance category by selecting one medium-
weighted improvement activity (81 FR 77185). We refer readers to
section III.I.3.i.(1)(e)(i)(B) of this final rule for our proposals
related to that provision. In addition, we specified at Sec. 414.1305
that rural areas refers to ZIP codes designated as rural, using the
most recent HRSA Area Health Resource File data set available (81 FR
77188, 82 FR 53582). Lastly, we finalized the meaning of Health
Professional Shortage Areas (HPSA) at Sec. 414.1305 to mean areas as
designated under section 332(a)(1)(A) of the Public Health Service Act
(81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR
53581), we modified the definition of small practices at Sec. 414.1305
to mean practices consisting of 15 or fewer eligible clinicians.
In the CY 2019 PFS proposed rule (83 FR 35906 through 35912), we
requested comments on our proposals to: (1) Revise Sec. 414.1360(a)(1)
to more accurately describe the data submission criteria; (2) delete
Sec. 414.1365 and move improvement activities subcategories to Sec.
414.1355(c); (3) update the criteria considered for nominating new
improvement activities; (4) modify the Annual Call for Activities
timeline for the CY 2019 performance period and future years; (5) add 6
new improvement activities for the CY 2019 performance period and
future years; (6) modify 5 existing improvement activities for the CY
2019 performance period and future years; and (7) remove 1 existing
improvement activity for the CY 2019 performance period and future
years. In addition, we also requested comments on our proposals with
respect to the CMS Study on Factors Associated with Reporting Quality
Measures for the CY 2019 performance period and future years the
following proposals: (1) Change the title of the study to CMS Study on
Factors Associated with Reporting Quality Measures; (2) increase the
sample size to a minimum of 200 participants; (3) limit the focus group
requirement to a subset of the 200 participants; and (4) require that
at least one of the minimum of three required measures be a high
priority measure. We are also making clarifications to: (1)
Considerations for selecting improvement activities for the CY 2019
performance period and future years; and (2) the weighting of
improvement activities.
These topics are discussed in more detail below.
(b) Submission Criteria
We refer readers to the CY 2017 Quality Payment Program final rule
(81 FR 77181) for submission mechanism policies we finalized and
codified for the transition year of MIPS. In the CY 2018 Quality
Payment Program final rule (82 FR 53651), we continued these policies
for future years. Specifically, we finalized that for MIPS Year 2 and
future years, MIPS eligible clinicians or groups must submit data on
MIPS improvement activities in one of the following manners: Qualified
registries; EHR submission mechanisms; QCDR; CMS Web Interface; or
attestation. Additionally, we finalized that for activities that are
performed for at least a continuous 90-days during the performance
period, MIPS eligible clinicians must submit a yes response for
activities within the improvement activities inventory. In addition, in
the case where an individual MIPS eligible clinician or group is using
a health IT vendor, QCDR, or qualified registry for their data
submission, we finalized that the MIPS eligible clinician or group must
certify all improvement activities were performed and the health IT
vendor, QCDR, or qualified registry would submit on their behalf (82 FR
53650 through 53651). We also updated Sec. 414.1360 to reflect those
changes (82 FR 53651). We refer readers to section III.I.3.h.(1) of
this final rule, MIPS Performance Category Measures and Activities,
where we discuss our finalized policies to update the data submission
process for MIPS eligible clinicians, groups and third party
intermediaries, by updating our terminology. We also refer readers to
changes to Sec. 414.1325 for data submission requirements. In the CY
2019 PFS proposed rule (83 FR 35906), we proposed those changes to more
closely align with the actual submission experience users have.
In alignment with those proposals, we also proposed to revise Sec.
414.1360(a)(1) to more accurately reflect the data submission process
for the improvement activities performance category. In particular, in
the CY 2019 PFS proposed rule (83 FR 35906), we proposed that instead
of ``via qualified registries; EHR submission mechanisms; QCDR, CMS Web
Interface; or attestation,'' as currently stated, we revised the first
sentence to state that data would be submitted ``via direct, login and
upload, and login and attest'' as discussed in section III.I.3.h.(1)(b)
of this final rule. In addition, we proposed to add further additions
to Sec. 414.1360(a)(1) to specify, submit a yes response for each
improvement activity that is performed for at least a continuous 90-day
period during the applicable performance period.
We did not receive any comments on these proposals. Therefore, we
are
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finalizing our proposals, as proposed, to revise the first sentence of
Sec. 414.1360(a)(1) to state that data must be submitted via direct,
login and upload, and login and attest. In addition, we are finalizing
our proposal, as proposed, to update Sec. 414.1360(a)(1) to specify:
Submit a yes response for each improvement activity that is performed
for at least a continuous 90-day period during the applicable
performance period.
(c) Subcategories
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we
finalized at Sec. 414.1365 that the improvement activities performance
category includes the subcategories of activities provided at section
1848(q)(2)(B)(iii) of the Act. It has since come to our attention that
it is unnecessary to have a separate regulation text included under
Sec. 414.1365 since the subcategories are not a component of the
scoring calculations. Therefore, in the CY 2019 PFS proposed rule (83
FR 35906 through 35907), we proposed to delete Sec. 414.1365 and move
the same improvement activities subcategories to Sec. 414.1355(c). We
reiterate that we did not propose any changes to the subcategories
themselves. These subcategories are:
Expanded practice access, such as same day appointments
for urgent needs and after-hours access to clinician advice.
Population management, such as monitoring health
conditions of individuals to provide timely health care interventions
or participation in a QCDR.
Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients or other
clinicians, and use of remote monitoring or telehealth.
Beneficiary engagement, such as the establishment of care
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision making
mechanisms.
Patient safety and practice assessment, such as through
the use of clinical or surgical checklists and practice assessments
related to maintaining certification.