[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Proposed Rules]
[Pages 45860-46843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14562]
[[Page 45859]]
Vol. 87
Friday,
No. 145
July 29, 2022
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 and Medicaid Programs; CY 2023 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment Policies;
Medicare Shared Savings Program Requirements; Medicare and Medicaid
Provider Enrollment Policies, Including for Skilled Nursing Facilities;
Conditions of Payment for Suppliers of Durable Medicaid Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing
Requirements for Manufacturers of Certain Single-Dose Container or
Single-Use Package Drugs To Provide Refunds With Respect To Discarded
Amounts; Proposed Rule
Federal Register / Vol. 87, No. 145 / Friday, July 29, 2022 /
Proposed Rules
[[Page 45860]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 423, 424, 425, and 455
[CMS-1770-P]
RIN 0938-AU81
Medicare and Medicaid Programs; CY 2023 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment
Policies; Medicare Shared Savings Program Requirements; Medicare and
Medicaid Provider Enrollment Policies, Including for Skilled Nursing
Facilities; Conditions of Payment for Suppliers of Durable Medicaid
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and
Implementing Requirements for Manufacturers of Certain Single-Dose
Container or Single-Use Package Drugs To Provide Refunds With Respect
to Discarded Amounts
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses: changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; Medicare Shared Savings Program requirements; updates to the
Quality Payment Program; Medicare coverage of opioid use disorder
services furnished by opioid treatment programs; updates to certain
Medicare and Medicaid provider enrollment policies, including for
skilled nursing facilities; updates to conditions of payment for DMEPOS
suppliers; HCPCS Level II coding and payment for wound care management
products; electronic prescribing for controlled substances for a
covered Part D drug under a prescription drug plan or an MA-PD plan
under the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment (SUPPORT) for Patients and Communities Act
(SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection
System; and provisions under the Infrastructure Investment and Jobs
Act.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 6,
2022.
ADDRESSES: In commenting, please refer to file code CMS-1770-P.
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-1770-P, P.O. Box 8016,
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-1770-
P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not
identified below. Please indicate the specific issue in the subject
line of the email.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and PFS specialty-specific
impacts.
Kris Corwin, (410) 786-8864, for issues related to the comment
solicitation on strategies for updates to practice expense data
collection and methodology.
Sarah Leipnik, (410) 786-3933, and Anne Blackfield, (410) 786-8518,
for issues related to the comment solicitation on strategies for
improving global surgical package valuation.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to telehealth services
and other services involving communications technology.
Regina Walker-Wren, (410) 786-9160, for issues related to nurse
practitioner and clinical nurse specialist certification by the Nurse
Portfolio Credentialing Center (NPCC).
Lindsey Baldwin, (410) 786-1694, or
[email protected], for issues related to PFS
payment for behavioral health services.
[email protected], for issues related to PFS
payment for evaluation and management services.
Geri Mondowney, (410) 786-1172, Morgan Kitzmiller, (410) 786-1623,
Julie Rauch, (410) 786-8932, and Tamika Brock, (312) 886-7904, for
issues related to malpractice RVUs and geographic practice cost indices
(GPCIs).
[email protected], for issues related to
non-face-to-face nonphysician services/remote therapeutic monitoring
services (RTM).
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to payment
of skin substitutes.
Pamela West, (410) 786-2302, for issues related to revisions to
regulations to allow audiologists to furnish diagnostic Tests, as
appropriate without a physician order.
Emily Forrest, (202) 205-1922, Laura Ashbaugh, (410) 786-1113, and
Erick Carrera, (410) 786-8949, for issues related to PFS payment for
dental services.
Heidi Oumarou, (410) 786-7942, for issues related to the rebasing
and revising of the Medicare Economic Index (MEI).
Laura Kennedy, (410) 786-3377, and Rachel Radzyner, (410) 786-8215,
for issues related to requiring manufacturers of certain single-dose
container or single-use package drugs payable under Medicare Part B to
provide refunds with respect to discarded amounts.
Laura Ashbaugh, (410) 786-1113, and Rasheeda Arthur, (410) 786-
3434, for issues related to Clinical Laboratory Fee Schedule.
Lisa Parker, (410) 786-4949, or [email protected], for issues
related to FQHCs.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHCs.
Daniel Feller, (410) 786-6913, and Elizabeth Truong (410) 786-6005,
for issues related to coverage of colorectal cancer screening.
Heather Hostetler, (410) 786-4515, for issues related to removal of
selected national coverage determinations.
Lindsey Baldwin, (410) 786-1694, for issues related to Medicare
coverage of opioid use disorder treatment services furnished by opioid
treatment programs.
Kathleen Johnson, (410) 786-3295, and Sabrina Ahmed, (410) 786-
7499, for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare
Shared
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Savings Program burden reduction proposal on OHCAs.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment, and financial methodology.
Naseem Tarmohamed, (410) 786-0814, or
[email protected], for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to vaccine administration services.
Katie Parker, (410) 786-0537, for issues related to medical
necessity and documentation requirements for nonemergency, scheduled,
repetitive ambulance services.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates (including for skilled nursing
facilities), State options for implementing Medicaid provider
enrollment affiliation provisions, and conditions of payment for DMEPOS
suppliers.
Mei Zhang, (410) 786-7837, and Daniel Standridge, (410) 786-2419,
for issues related to requirement for electronic prescribing for
controlled substances for a covered Part D drug under a prescription
drug plan or an MA-PD plan (section 2003 of the SUPPORT Act).
Amy Gruber, (410) 786-1542, or [email protected],
for issues related to the Medicare Ground Ambulance Data Collection
System.
Sundus Ashar, [email protected], for issues related to
HCPCS Level II Coding for skin substitutes.
Renee O'Neill, (410) 786-8821, or Kati Moore, (410) 786-5471, for
inquiries related to Merit-based Incentive Payment System (MIPS).
Richard Jensen, (410) 786-6126, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Addenda Available Only Through the internet on the CMS website: The
PFS Addenda along with other supporting documents and tables referenced
in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.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
2023 PFS proposed rule, refer to item CMS-1770-P. Readers with
questions related to accessing any of the Addenda or other supporting
documents referenced in this proposed rule and posted on the CMS
website identified above should contact
[email protected].
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this proposed rule, we use CPT codes and descriptions to refer to a
variety of services. We note that CPT codes and descriptions are a
copyright of 2020 American Medical Association (AMA); all rights
reserved; and CPT is a registered trademark of the AMA. Applicable
Federal Acquisition Regulations (FAR) and Defense Federal Acquisition
Regulations (DFAR) apply.
I. Executive Summary
This major annual rule proposes to revise payment polices under the
Medicare PFS and makes other policy changes, including proposals to
implement certain provisions of the Protecting Medicare and American
Farmers from Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, December 10,
2021), Infrastructure Investment and Jobs Act (Pub. L. 117-58, November
15, 2021), Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L.
116-260, December 27, 2020), Bipartisan Budget Act of 2018 (BBA of
2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment. In
addition, this major proposed rule includes proposals regarding other
Medicare payment policies described in sections III. and IV.
B. 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 each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major proposed rule, we are proposing to establish RVUs for
CY 2023 for the PFS 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 proposed rule also includes
discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this proposed rule addresses:
Determination of PE RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section II.C.)
Payment for Medicare Telehealth Services Under Section 1834(m)
of the Act (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Geographic Practice Cost Indices (GPCI) (section II.G.)
Determination of Malpractice Relative Value Units (RVUs)
(section II.H.)
Non-Face-to-Face/Remote Therapeutic Monitoring (RTM) Services
(section II.I.)
Payment for Skin Substitutes (section II.J.)
Proposal to Allow Audiologists to Furnish Certain Diagnostic
Tests Without a Physician Order (section II.K.)
Proposals and Request for Information on Medicare Parts A and
B Payment for Dental Services (section II.L.)
Rebasing and Revising the Medicare Economic Index (MEI)
(section II.M.)
Requiring Manufacturers of Certain Single-dose Container or
Single-use Package Drugs to Provide Refunds with Respect to Discarded
Amounts (Sec. Sec. 414.902 and 414.940) (section III.A.)
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Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions, and Proposals for Specimen
Collection Fees and Travel Allowance for Clinical Diagnostic Laboratory
Tests (section III.C.)
Expansion of Coverage for Colorectal Cancer Screening and
Reducing Barriers (section III.D.)
Removal of Selected National Coverage Determinations (section
III.E.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Medicare Part B Payment for Preventive Vaccine Administration
Services (section III.H.)
Medical Necessity and Documentation Requirements for
Nonemergency, Scheduled, Repetitive Ambulance Services (section III.I.)
Medicare Provider and Supplier Enrollment and Conditions of
DMEPOS Payment (section III.J.)
State Options for Implementing Medicaid Provider Enrollment
Affiliation Provision (section III.K.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.L.)
Medicare Ground Ambulance Data Collection System (GADCS)
(section III.M.)
Proposal to Revise HCPCS Level II Coding Procedures for Wound
Care Management Products (section III.N.)
Updates to the Quality Payment Program (section IV.)
Collection of Information Requirements (section V.)
Response to Comments (section VI.)
Regulatory Impact Analysis (section VII.)
3. Summary of Costs and Benefits
We have determined that this proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII., Regulatory Impact Analysis, of this proposed rule.
B. Determination of PE 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 malpractice (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 Physician Fee Schedule (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 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
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
[[Page 45863]]
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 titled ``CY 2023 PFS proposed rule PE/HR'' on the
CMS website under downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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 based on 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. 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.
Then, we incorporate 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.
(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 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 titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2023 PFS proposed 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 proposed 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.
[[Page 45864]]
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 an 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 use
the expected specialty that we identify on a list developed based on
medical review and input from expert interested parties. 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
interested parties 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 52983) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
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
titled ``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.
(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
[[Page 45865]]
neutrality (BN) adjustment. The final PE BN adjustment is calculated by
comparing the sum of steps 5 and 17 to the 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 BN. (See ``Specialties excluded from
ratesetting calculation'' later in this proposed 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).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP 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 1.
BILLING CODE 4120-01-P
[[Page 45866]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.000
BILLING CODE 4120-01-C
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
[[Page 45867]]
accordingly. Table 2 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TP29JY22.001
We also adjust 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.
Beginning in CY 2022, section 1834(v)(1) of the Act required that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We applied the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
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
proposed rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 +
interest rate)[caret] 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 below in this proposed 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 below 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.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different
[[Page 45868]]
types of equipment, the vast majority of which fall in the range of 5
to 10 years, and none of which are lower than 2 years in duration. We
believe that the updated editions of this reference material remain the
most accurate source for estimating the useful life of depreciable
medical equipment.
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
Maintenance: We finalized the 5 percent factor for annual
maintenance in the CY 1998 PFS final rule with comment period (62 FR
33164). As we previously stated in the CY 2016 PFS 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 noted that we 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 noted that we did not
believe 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 did not propose a variable maintenance factor for equipment
cost per minute pricing as we did not believe that we have sufficient
information at present. We noted that we would continue to investigate
potential avenues for determining equipment maintenance costs across a
broad range of equipment items.
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). The Interest rates are listed in Table 3.
[GRAPHIC] [TIFF OMITTED] TP29JY22.002
We are not proposing any changes to the equipment interest rates
for CY 2023.
3. Adjusting RVUs To Match PE Share of the Medicare Economic Index
(MEI)
For CY 2023, as explained in detail in section II.M. of this
proposed rule, we are proposing to rebase and revise the Medicare
Economic Index (MEI) to reflect more current market conditions faced by
physicians in furnishing physicians' services. The MEI is an index that
measures changes in the market price of the inputs used to furnish
physician services. This index measure was authorized by statute and is
developed by the CMS Office of the Actuary. We believe that the MEI is
the best measure available of the relative weights of the three
components in payments under the PFS--work, PE and malpractice.
Accordingly, we believe that to assure that the PFS payments reflect
the relative resources in each of these components as required by
section 1848(c)(3) of the Act, the RVUs used in developing rates should
reflect the same weights in each component as the MEI. In the past, we
have proposed (and subsequently, finalized) to accomplish this by
holding the work RVUs constant and adjusting the PE RVUs, the MP RVUs
and the CF to produce the appropriate balance in RVUs among the PFS
components and payment rates for individual services. The most recent
adjustments to reflect changes in the MEI weights were made for the CY
2014 RVUs, when the MEI was last updated. In the CY 2014 PFS proposed
rule (78 FR 43287 through 43288) and final rule (78 FR 74236 through
74237), we detailed the steps necessary to accomplish this result (see
steps 3, 10, and 18). The CY 2014 proposed and finalized adjustments
were consistent with our longstanding practice to make adjustments to
match the RVUs for the PFS components with the MEI cost share weights
for the components, including the adjustments described in the CY 1999
PFS final rule (63 FR 58829), CY 2004 PFS final rule (68 FR 63246 and
63247), and CY 2011 PFS final rule (75 FR 73275).
In the past when we have proposed a rebasing and/or revision of the
MEI, as we do in section II.M. of this proposed rule, we typically have
also proposed to modify steps 3 and 10 to adjust the aggregate pools of
PE costs (direct PE in step 3 and indirect PE in step 10) in proportion
to the change in the PE share in the rebased and revised MEI cost share
weights, as previously described in the CY 2014 PFS final rule (78 FR
74236 and 74237), and to recalibrate the relativity adjustment that we
apply in step 18 as described in the CY 2014 PFS final rule. Instead,
we are proposing to delay the adjustments to the PE pools in steps 3
and 10 and the recalibration of the relativity adjustment in step 18
until the public has an opportunity to comment on the proposed rebased
and revised MEI, as discussed in section II.M. of this proposed rule.
Because there are significant proposed methodological and data source
changes to the MEI for CY 2023 and significant time has elapsed since
the last rebasing and revision of the MEI, we believe it is important
to allow public comment and
[[Page 45869]]
finalization of the proposed MEI changes based on the review of public
comment before we incorporate the updated MEI into PFS ratesetting, and
we believe this is consistent with our efforts to balance payment
stability and predictability with incorporating new data through more
routine updates. We refer readers to the comment solicitation in
section II.B. of this proposed rule, where we discuss our ongoing
efforts to update data inputs for PE to aid stability, transparency,
efficiency, and data adequacy. Similarly, we are delaying the
implementation of the proposed rebased and revised MEI for use in the
PE geographic practice cost index (GPCI) and soliciting comment on
appropriate timing for implementation for potential future rulemaking,
discussed in detail in section II.G. and section VII. of this proposed
rule.
In light of the proposed delay in using the proposed update to the
MEI to make the adjustments to the PE pools in steps 3 and 10 and the
relativity adjustment in step 18, we are soliciting comment on when and
how to best incorporate the proposed rebased and revised MEI discussed
in section II.M. of this proposed rule into PFS ratesetting, and
whether it would be appropriate to consider a transition to full
implementation for potential future rulemaking. In section VII. of this
proposed rule, we present the impacts of implementing the proposed
rebased and revised MEI in PFS ratesetting through a 4-year transition
and through full immediate implementation, that is, with no transition
period. Given the significance of the impacts that result from a full
implementation and the interaction with other CY 2023 proposals, we did
not consider proposing to fully implement a rebased and revised MEI in
PFS ratesetting for CY 2023. We are seeking comment on other
implementation strategies for potential future rulemaking that are not
outlined in section VII. of this proposed rule.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2023 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2023 PFS
proposed 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 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 post service 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'' and ``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 a series of clinical labor tasks associated with
pathology services in the CY 2016 PFS final rule with comment period
(80 FR 70902). We do not believe these activities would be dependent on
number of blocks or batch size, and we believe that the finalized
standard values accurately reflect the typical time it takes to perform
these clinical labor tasks.
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. 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. Commenters explained
in response 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, and that a prior
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 was now divided into the
[[Page 45870]]
CA007 and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, 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, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, one
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
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 in previous calendar years, to facilitate
rulemaking for CY 2023, 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 crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2023 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. 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. Beginning in
CY 2019 and continuing through CY 2022, we conducted a market-based
supply and equipment pricing update, using information developed by our
contractor, StrategyGen, which updated pricing recommendations for
approximately 1300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
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. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2023, we are proposing to update the price of eight supplies
and two equipment items in response to the public submission of
invoices following the publication of the CY 2022 PFS final rule. The
eight supply and equipment items with proposed updated prices are
listed in the valuation of specific codes section of the preamble under
Table 15, CY 2023 Invoices Received for Existing Direct PE Inputs.
We are not proposing to update the price of another eight supplies
and two equipment items which were the subject of public submission of
invoices. Our rationale for not updating these prices is detailed
below:
Acetic acid 5% (SH001): We received an invoice submission
for an increase in price from 3 cents per ml to 9.5 cents per ml for
the SH001 supply. However, the invoice stated that this price was for
an ``Alcian Blue 1% in 3% Acetic Acid pH 2.5'' supply and it is not
clear that this represents the same supply as the ``Acetic acid 5%''
described by the SH001 supply item. We also do not believe that the
typical price for this supply has increased 200 percent in the 3 years
since StrategyGen researched its pricing, especially given that the
price for the SH001 supply previously increased from 1.2 cents in CY
2019 to its current price of 3 cents for CY 2022.
Cytology, lysing soln (CytoLyt) (SL039): We received an
invoice submission for an increase in price from 6 cents per ml to 80
cents per ml for the SL039 supply. We do not believe that the typical
price for this supply has increased 1200% in the 3 years since
StrategyGen researched its pricing, especially given that the price for
the SL039 supply previously increased from 3.4 cents in CY 2019 to its
current price of 6 cents for CY 2022.
Fixative (for tissue specimen) (SL068): We received an
invoice submission for an increase in price from 1.3 cents per ml to
$4.87 for the SL068 supply. We believe that this was the result of
confusion on the part of the interested party regarding the unit
quantity for the SL068 supply. This item is paid on a per ml basis and
not a per unit basis; there was not enough information on the submitted
invoice to determine the price for the SL068 supply on a per ml basis.
Ethanol, 100% (SL189): We received an invoice submission
for an increase in price from 0.33 cents per ml to 1.2 cents per ml for
the SL189 supply. However, we noted that the invoice was
[[Page 45871]]
based on the price for a single gallon of 100% ethanol which is
typically sold in much larger quantities than a single gallon. We found
that 100% ethanol was readily available for sale online in larger unit
sizes and the current price of 0.33 cents per ml (based on the past
StrategyGen market research) appears to be accurate based on online
bulk pricing. We also found that the submitted invoices for the
ethanol, 70% (SL190), ethanol, 95% (SL248), and stain, PAP OG-6 (SL491)
supplies were also based on pricing for a single gallon. Each of these
supply items was also available for purchase in larger unit quantities
which indicated that the current pricing remained typical for these
supplies. Therefore, we are not proposing to update the prices for the
SL189, SL190, SL248 or SL491 supply, as we do not believe that the
higher prices paid for smaller quantities of these supplies would be
typical.
Biohazard specimen transport bag (SM008): We received an
invoice submission for an increase in price from 8 cents to 45 cents
for the SM008 supply. However, it is not clear that the item described
on the invoice is the same item as the SM008 supply. The invoice states
only that the price is for ``Supplied Case Red Bags'' which was not
enough information to determine if this would be typical for the SM008
supply. We also do not believe that the typical price for this supply
has increased 460 percent in the 3 years since StrategyGen researched
its pricing, especially given that the price for the SM008 supply
previously increased from 3.5 cents in CY 2019 to its current price of
8 cents for CY 2022.
International Normalized Ratio (INR) analysis and
reporting system w-software (EQ312): We did not receive an invoice for
this equipment item, only a letter stating that the cost of the EQ312
equipment should be increased from the current price of $19,325 to
$1,600,000. We previously finalized a policy in the CY 2011 PFS final
rule (75 FR 73205) to update supply and equipment prices through an
invoice submission process. We require pricing data indicative of the
typical market price of the supply or equipment item in question to
update the price. It is not sufficient to state a different price
without providing information to support this new valuation. Since we
did not receive an invoice to support the higher costs asserted in the
letter, we are not proposing a new price for the EQ312 equipment item.
Interested parties are encouraged to submit invoices with their public
comments or, if outside the notice and comment rulemaking process, via
email at [email protected]. We also note that in order
to be considered a direct PE input, an equipment item must be
individually allocable to a particular patient for a particular
service. Costs associated with the implementation, maintenance, and
upgrade of equipment that is not individually allocable to a particular
patient for a particular service, or other costs associated with
running a practice, would typically be classified as forms of indirect
PE under our methodology.
The same interested parties that addressed the pricing of the EQ312
equipment item questioned the assignment of the General Practice
specialty crosswalk for indirect PE for home Prothrombin Time (PT)/INR
monitoring services. These individuals stated that the predominant code
used for PT/INR monitoring (HCPCS code G0249) will be significantly and
negatively impacted by the continuing implementation over a 4-year
period of changes in the clinical labor rates finalized in the CY 2022
PFS final rule (86 FR 65024). The individuals requested that CMS change
the crosswalk for home PT/INR monitoring services to All Physicians or
Pathology which would partially offset the reduction that HCPCS code
G0249 is facing due to changes in the clinical labor rates.
We note for these interested parties that we finalized a crosswalk
to the General Practice specialty for home PT/INR monitoring services
(HCPCS codes G0248, G0249, and G0250) in the CY 2021 PFS final rule (85
FR 84477 and 84478). The data submitted by the commenters at the time
indicated that the direct-to-indirect cost percentages to furnish home
PT/INR monitoring are in the range of 31:69, similar to the ratio
associated with the General Practice specialty. We disagree, as we did
in response to comments in the CY 2021 PFS final rule, that these home
PT/INR monitoring services should be reassigned to a different
specialty that is less reflective of the cost structure for these
services to offset reductions in payment for the services that result
from an unrelated policy proposal (the clinical labor pricing update).
We also note that we have not received any new information about PT/INR
monitoring services since CY 2021 to indicate that All Physicians or
Pathology would be more accurate choices for use in indirect PE
allocation but are open to receiving new relevant information that CMS
could consider in future rulemaking. As such, we are not proposing to
change the assigned specialty for PT/INR services; we direct interested
parties to the previous discussion of this topic in the CY 2021 PFS
final rule (85 FR 84477 and 84478) and again in the CY 2022 PFS final
rule (86 FR 65000). Interested parties are encouraged to submit new
information to support the most accurate specialty choice to use in
indirect PE allocation for PT/INR monitoring services distinct from
what has previously been reviewed during the last two rule cycles.
Remote musculoskeletal therapy system (EQ402): We received
an invoice submission for a price of $1,000 for the EQ402 equipment
item. Since this equipment already has a price of $1,000 we are not
proposing to make any changes in the pricing; we thank the interested
party for their invoice submission confirming the current price.
(1) 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. 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 will 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. Interested parties are encouraged to submit invoices with their
public comments or, if outside the notice and comment rulemaking
process, via email at [email protected].
c. Clinical Labor Pricing Update
Section 220(a) of the PAMA 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.
[[Page 45872]]
Beginning in CY 2019, we updated the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 was
the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Interested parties raised concerns that the long delay since
clinical labor pricing was last updated created a significant disparity
between CMS' clinical wage data and the market average for clinical
labor. In recent years, a number of interested parties suggested that
certain wage rates were inadequate because they did not reflect current
labor rate information. Some interested parties also stated that
updating the supply and equipment pricing without updating the clinical
labor pricing could create distortions in the allocation of direct PE.
They argued that since the pool of aggregated direct PE inputs is
budget neutral, if these rates are not routinely updated, clinical
labor may become undervalued over time relative to equipment and
supplies, especially since the supply and equipment prices are in the
process of being updated. There was considerable interest among
interested parties in updating the clinical labor rates, and when we
solicited comment on this topic in past rules, such as in the CY 2019
PFS final rule (83 FR 59480), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We believed it was
important to update the clinical labor pricing to maintain relativity
with the recent supply and equipment pricing updates. We proposed to
use the methodology outlined in the CY 2002 PFS final rule (66 FR
55257), which draws primarily from BLS wage data, to calculate updated
clinical labor pricing. As we stated in the CY 2002 PFS final rule, the
BLS' reputation for publishing valid estimates that are nationally
representative led to the choice to use the BLS data as the main
source. We believe that the BLS wage data continues to be the most
accurate source to use as a basis for clinical labor pricing and this
data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for our
CY 2022 clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we used the national salary data from the
Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at www.salaryexpert.com). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. We ultimately finalized the use of
median BLS wage data, as opposed to mean BLS wage data, in response to
comments in the CY 2022 PFS final rule. To account for the employers'
cost of providing fringe benefits, such as sick leave, we finalized the
use of a benefits multiplier of 1.296 based on a BLS release from June
17, 2021 (USDL-21-1094). As an example of this process, for the
Physical Therapy Aide (L023A) clinical labor type, the BLS data
reflected a median hourly wage rate of $12.98, which we multiplied by
the 1.296 benefits modifier and then divided by 60 minutes to arrive at
the finalized per-minute rate of $0.28.
After considering the comments on our CY 2022 proposals, we agreed
with commenters that the use of a multi-year transition would help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year
transition, as we have for several other broad-based updates or
methodological changes. While we recognized that using a 4-year
transition to implement the update means that we will continue to rely
in part on outdated data for clinical labor pricing until the change is
fully completed in CY 2025, we agreed with the commenters that these
significant updates to PE valuation should be implemented in the same
way, and for the same reasons, as for other major updates to pricing
such as the recent supply and equipment update. Therefore, we finalized
the implementation of the clinical labor pricing update over 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. An example of the
transition from the current to the fully-implemented new pricing that
we finalized in the CY 2022 PFS final rule is provided in Table 4.
BILLING CODE 4120-01-P
[[Page 45873]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.003
(1) CY 2023 Clinical Labor Pricing Update Proposals
For CY 2023, we received information from one interested party
regarding the pricing of the Histotechnologist (L037B) clinical labor
type. The interested party provided data from the 2019 Wage Survey of
Medical Laboratories which supported an increase in the per-minute rate
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This
rate of $0.64 for the L037B clinical labor type is a close match to the
online salary data that we had for the Histotechnologist and matches
the $0.64 rate that we initially proposed for L037B in the CY 2022 PFS
proposed rule. Based on the wage data provided by the commenter, we are
proposing this $0.64 rate for the L037B clinical labor type for CY
2023; we are also proposing a slight increase in the pricing for the
Lab Tech/Histotechnologist (L035A) clinical labor type from $0.55 to
$0.60 as it is a blend of the wage rate for the Lab Technician (L033A)
and Histotechnologist clinical labor types. We are also proposing the
same increase to $0.60 for the Angio Technician (L041A) clinical labor
type, as we previously established a policy in the CY 2022 PFS final
rule that the pricing for the L041A clinical labor type would match the
rate for the L035A clinical labor type (86 FR 65032). The proposed
pricing increase for these three clinical labor types is included in
Table 5; the CY 2023 pricing for all other clinical labor types would
remain unchanged from the pricing finalized in the CY 2022 PFS final
rule.
[[Page 45874]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.004
BILLING CODE 4120-01-C
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the course of
[[Page 45875]]
the 4-year transition period. We updated the pricing of a number of
clinical labor types in the CY 2022 PFS final rule in response to
information provided by commenters. We welcome additional feedback on
clinical labor pricing from commenters in response to this proposed
rule, especially any data that will continue to improve the accuracy of
our final pricing. For the full discussion of the clinical labor
pricing update, we direct readers to the CY 2022 PFS final rule (86 FR
65020 through 65037).
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
The PE inputs used in setting PFS rates, including both the
development of PE RVUs and, historically, the relative shares among
work, PE, and malpractice RVUs across the PFS, are central in
developing accurate rates and maintaining appropriate relativity among
PFS services and overall payment among the professionals and suppliers
paid under the PFS. Consequently, the underlying PE data inputs are a
consistent point of interest among interested parties. However, unlike
other payment systems with cost reporting systems, PFS data inputs are
primarily based on exogenous proprietary data that become available as
the data are collected. Specifically, we rely on historical survey data
(almost all of which is over a decade old), some publicly available
data collected for other purposes (for example, Bureau of Labor
Statistics (BLS) wage data), recommendations from the American Medical
Association and other provider groups, and annual Medicare claims data.
a. History of Updates to PE Inputs
Each year we continue to improve accuracy, predictability, and
sustainability of updates to the PE valuation methodology to reduce the
risks of possible misvaluation and other unintended outcomes. We have
continued to develop policies geared toward providing more consistent
updates to the direct PE inputs used in PFS ratesetting, including
supply/equipment pricing and clinical labor rates. These efforts to
develop these policies should contribute to improved standardization
and transparency for all PE inputs used to update the PFS. As we
continue our work to improve the information we use in our PE
methodology, we are issuing a general comment solicitation to better
understand how we might improve the collection of PE data inputs and
refine the PE methodology.
In recent years, we have refined specific PE data inputs using a
combination of market research and publicly available data (for
example, market research on medical supply and equipment items and BLS
data to update clinical labor wages) to update the direct PE data
inputs used in the PFS ratesetting process. Last year, we implemented a
final transition year for supply and equipment pricing updates and
started the first year of a 4-year phase-in update to the clinical
labor rates. However, the indirect PE data inputs remain tied to legacy
information that is well over a decade old. To build on much needed
progress, we now believe indirect PE would also benefit from a refresh
that implements similar standard and routine updates. We believe that a
data refresh, and use of data sources that receive routine refreshes,
would reduce the likelihood of unpredictable shifts in payment,
especially when such shifts could be driven by the age of data
available rather than comprehensive information about changes in actual
costs.
b. Data Collection, Analysis and Findings
In light of feedback from interested parties, CMS has prioritized
stability and predictability over ongoing updates, and has taken a
measured approach to updating PE data inputs. We have worked with
interested parties and CMS contractors over a period of years to study
the landscape and identify possible strategies to reshape the PE
portion of physician payments. The fundamental issues are clear, but
thought leaders and subject matter experts have advocated for more than
one tenable approach to updating our PE methodology. Thus, we must
balance the various interests of the public, and any path forward
should allow for ongoing and routine cycles of PE updates.
Of the various PE data inputs, we believe that indirect PE data
inputs, which reflect costs such as office rent, IT costs, and other
non-clinical expenses, present the opportunity to build consistency,
transparency, and predictability into our methodology to update PE data
inputs. The primary source for indirect PE information is the Physician
Practice Information Survey (PPIS), fielded by the AMA. The survey was
most recently conducted in 2007 and 2008 (reflecting 2006 data). The
survey respondents were self-employed physicians and selected
nonphysician practitioners.
In general, interested parties have expressed the following
concerns regarding CMS's approach to indirect PE allocation:
CMS seems to rely on increasingly out-of-date data
sources, and there is a dearth of mechanisms to update empirical
inputs.
The approach exacerbates payment differentials that
possibly create inappropriate variation of reimbursement across
ambulatory places of service (for example, significantly higher
payments for the same service provided in a hospital outpatient
department versus a physician office).
CMS's method of indirect PE allocation may not accurately
reflect variation in PE across different types of services, different
practice characteristics, or evolving business models.
Beyond these issues, we have also explored other concerns with our
indirect PE allocation method in depth in previous rulemaking. For
example, refer to our previous comment solicitation and discussion of
resource costs for services involving the use of innovative
technologies in our CY 2022 PFS proposed rule (86 FR 39125). PE data
inputs, and the methodological and evidence-based principles that shape
use of such information in the context of reimbursement, are discussed
in depth in a RAND Corporation (``RAND'') report prepared for CMS,
entitled Practice Expense Methodology and Data Collection Research and
Analysis, available at https://www.rand.org/pubs/research_reports/RR2166.html.\1\
---------------------------------------------------------------------------
\1\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
---------------------------------------------------------------------------
Various interested parties have taken issue with the use of certain
costs in our current PE allocation methodology that they do not believe
are associated with increased indirect PE. Some interested parties
argue that the costs of disposable supplies, especially expensive
supplies, and equipment are not relevant to allocating indirect PE; or
that similarly, work in the facility setting (for example, work RVUs
for surgical procedures) is not relevant to allocating indirect PE,
though they agree that work in the office setting may be relevant to
allocating indirect PE. \2\ However, we do not believe that there is
sufficient, if any,
[[Page 45876]]
data or peer-reviewed evidence available to definitively show that
shifting indirect PE allocations based on the setting of care, or based
on specialty, would result in improved allocations of PE that reflect
true costs. Further, varying indirect PE allocations based on setting
of care or based on specialty might create unintended consequences such
as reduced access to care for beneficiaries, or reduced competition and
autonomy of small group practices or individual clinicians whose
revenue is based in part on services furnished under contract in the
facility setting.
---------------------------------------------------------------------------
\2\ Kazungu, Jacob S., Edwine W. Barasa, Melvin Obadha, and Jane
Chuma. ``What Characteristics of Provider Payment Mechanisms
Influence Health Care Providers' Behaviour? A Literature Review.''
The International Journal of Health Planning and Management 33, no.
4 (October 2018): e892-905. https://doi.org/10.1002/hpm.2565.
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We believe it is necessary to establish a roadmap toward more
routine PE updates, especially because potentially improper or outdated
allocation of PE across services may affect access to certain services,
which could exacerbate disparities in care and outcomes. Establishing
payments that better reflect current practice costs would mitigate
possible unintended consequences, such as labor market distortions due
to indirect cost allocations that do not reflect the current evolution
of health care practice.\3\ Interested parties have reiterated their
desire for CMS to move away from the current PE allocation approach and
continued to raise concerns with CMS's methodology and the underlying
PE data inputs. In response to these and other concerns, we continue to
review the methodology we use to establish the PE RVUs and to identify
refinements. As part of this effort, we have contracted with RAND to
develop and assess potential improvements in the current methodology
used to allocate indirect practice costs in determining PE RVUs for a
service, model alternative methodologies for determining PE RVUs, and
identify and assess alternative data sources that CMS could use to
regularly update indirect practice cost estimates.\4\
---------------------------------------------------------------------------
\3\ Laugesen, Miriam J. ``Regarding `Committee Representation
and Medicare Reimbursements: An Examination of the Resource-Based
Relative Value Scale.' '' Health Services Research 53, no. 6
(December 2018): 4123-31. https://doi.org/10.1111/1475-6773.13084.
\4\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
---------------------------------------------------------------------------
In this proposed rule, we are signaling our intent to move to a
standardized and routine approach to valuation of indirect PE and we
welcome feedback from interested parties on what this might entail,
given our discussion above. We would propose the new approach to
valuation of indirect PE in future rulemaking.
We seek comment on the following topics related to identification
of the appropriate instrument, methods, and timing for updating
specialty-specific PE data:
Potential approaches to design, revision, and fielding of
a PE survey that foster transparency (for example, transparency in
terms of the methods of survey design, the content of the survey
instrument, and access to raw results for informing PFS ratesetting);
and
Mechanisms to ensure that data collection and response
sampling adequately represent physicians and non-physician
practitioners across various practice ownership types, specialties,
geographies, and affiliations.
We also seek comment on any alternatives to the above that would
result in more predictable results, increased efficiencies, or reduced
burdens. For example:
Use of statistical clustering or other methods that would
facilitate a shift away from specialty-specific inputs to inputs that
relate to homogenous groups of specialties without a large change in
valuation relative to the current PE allocations.
Avenues by which indirect PE can be moved for facility to
non-facility payments, based on data reflecting site of service cost
differences.
Methods to adjust PE to avoid the unintended effects of
undervaluing cognitive services due to low indirect PE.
A standardized mechanism and publicly available means to
track and submit structured data and supporting documentation that
informs pricing of supplies or equipment.
Sound methodological approaches to offset circularity
distortions, where variable costs are higher than necessary costs for
practices with higher revenue.
We also seek comment on the cadence, frequency, and phase-in of
adjustments for each major area of prices associated with direct PE
inputs (Clinical Labor, Supplies/Equipment). We ask that commenters
address the following:
Whether CMS should stagger updates year-to-year for each
update, or establish ``milestone'' years at regular intervals during
which all direct PE inputs would be updated in the same year.
The optimal method of phasing in the aggregate effect of
adjustments, such that the impacts of updates gradually ramp up to a
full 100 percent over the course of a few years (for example, 25
percent of the aggregate adjustment in Year 1, then 50 percent of the
aggregate adjustment in Year 2, etc.).
How often CMS should repeat the cycle to ensure that
direct PE inputs are based on the most up-to-date information,
considering the burden of data collection on both respondents and
researchers fielding instruments or maintaining datasets that generate
data.
c. Changes to Health Care Delivery and Practice Ownership Structures,
and Business Relationships Among Clinicians and Health Care
Organizations
Market consolidation, and shifts in workforce alignment, as well as
an evolution in the type of business entities predominant in health
care markets, all suggest significant transformation in the composition
and proportions of practice expenses required to furnish care. These
evolving conditions collectively highlight the need for a comprehensive
update to PE data inputs, and possibly the PE methodology as a
whole.\5\ Ideally, more comprehensive PE data inputs and a different PE
calculation methodology would better account for indirect/overhead
costs, current trends in the delivery of health care, the use of
machine learning technology, and EHRs, and the cost differentials in
independent versus facility-based practices.
---------------------------------------------------------------------------
\5\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara
O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al.
``Practice Expense Methodology and Data Collection Research and
Analysis.'' RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.
---------------------------------------------------------------------------
We seek comment on current and evolving trends in health care
business arrangements, use of technology, or similar topics that might
affect or factor into indirect PE calculations. We are interested in
learning whether any PE data inputs may be obsolete, unnecessary, or
misrepresentative of the actual costs involved in operating a medical
practice.
d. Unintended Consequences and Missing Information
We request comment on additional information that we may have not
considered or discussed above about updating and maintaining PE data
inputs, as well as any unintended impacts (or positive outcomes) that
could result from changes to the overall strategy. We are especially
interested in public comment on any concerns about beneficiaries'
access to care, possible consolidation of group practices, or burden on
small group or solo practitioners. We are also interested in public
comments on any collateral
[[Page 45877]]
program integrity or quality issues that could arise from potential
updates. We request that any respondents who provide feedback ensure
that the response includes discussion of any possible health equity
impacts.
6. Soliciting Public Comment on Strategies for Improving Global
Surgical Package Valuation
In preparation for future rulemaking, we are seeking public comment
on strategies to improve the accuracy of payment for the global
surgical packages (herein referred to as ``global packages') under the
PFS. Currently, there are over 4,000 physicians' services paid as
global packages under the PFS. Global packages generally include the
surgical procedure and any services typically provided during the pre-
and postoperative periods (including evaluation and management (E/M)
services and hospital discharge services). There are three types of
global packages:
The 0-day global package, which includes the procedure and
the preoperative and postoperative physicians' services on the day of
the procedure.
The 10-day global package, which includes services on the
day of, and 10 days after, the procedure.
The 90-day global package, which includes services
furnished one day prior to the procedure, and on the day of, and 90
days immediately following the day of the procedure.
More detail about how global packages are billed and what
activities are included may be found in Chapter 12, Section 40, of the
Medicare Claims Processing Manual (Pub. 100-04).
We have applied the concept of global payment for some procedures
since the inception of the PFS on January 1, 1992 (54 FR 59502).
However, in the past decade we have engaged with interested parties
regarding numerous concerns about the accuracy and validity of the
valuation of global packages, with particular attention paid to the E/M
visits included in the services. We have made previous requests for
public feedback on global packages, including solicitations for
information or data that could be used to help support more accurate
valuations. We now wish to expand on our conversations with the public,
considering the current status of a multi-year data collection and
analysis project, as well as ongoing changes we have made to payments
for other types of patient care that may impact the global packages.
a. History of Global Valuation Discussion
In the CY 2013 PFS proposed rule (77 FR 44737 through 44738), we
discussed two reports released by the HHS Office of the Inspector
General in 2005 and 2012 with findings that practitioners were
performing fewer E/M postoperative visits than had been included in the
valuation for these global packages, suggesting that Medicare was
paying for care that was not being delivered. In response to the
concerns raised by the OIG reports, we solicited public feedback on
methods of obtaining accurate and current data on E/M services
furnished as part of a global package. We summarized public comment in
the CY 2013 PFS final rule (77 FR 68911 through 68913).
In the CY 2015 PFS proposed rule (79 FR 40341), we delved into
barriers to accurate valuation of global packages, especially as
compared to other forms of bundled payments made under the inpatient or
outpatient prospective payment systems. In addition to the ongoing
concerns about whether E/M visits presumed to be furnished in
connection with global packages were actually being performed by the
physician receiving the global package payment, we noted issues such
as:
E/M services in the global period that occur post-
discharge are valued with practice expense values associated with
follow-up visits in the physician's office. Many of these follow-up
visits may occur in a hospital outpatient department where the
physician may not incur many PE costs.
The direct PE inputs often differ slightly between an E/M
service furnished in a global period and a stand-alone E/M service. For
example, follow-up visits for certain surgeries may include specialized
clinical labor such as an RN rather than a general nurse blend.
The types of physicians furnishing a specific service
dictate the direct and indirect percentages, as well as the indirect
practice cost index, in the PE methodology. Most surgical specialties
have a lower direct percentage mix, resulting in higher indirect costs
that extend to the E/M visits in the global periods.
Because the E/M visits embedded in the global package are
not reported separately and do not appear in claims data, it is
difficult to quantify the number and level of E/M services furnished in
connection with global packages under the fee-for-service system.
In some cases we have limited billing of the 10- and 90-
day global packages in conjunction with some of the payment policies
intended to encourage coordination of care through payments for non-
face-to-face services, such as transitional care management and chronic
care management, because of presumed overlap between these services.
To address these concerns, we solicited comment and finalized a
policy in the CY 2015 PFS final rule (79 FR 67586) intended to, over a
period of several years, transition all services with 10-day and 90-day
global periods to 0-day global periods. As stated in the CY 2015 PFS
final rule, we believed it would be more accurate to value the surgical
procedure-day services separately from postop E/M visits, and would
avoid potentially duplicative or unwarranted payments. For our full
discussion and rationale, refer to 79 FR 67586 through 67591.
Implementation of this policy, however, was halted by the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L.110-14).
Section 523(a) of the MACRA amended section 1848(c)(8) of the Act to
prohibit the Secretary from implementing the transition policy
finalized in the CY 2015 PFS final rule. The amendments to section
1848(c)(8) also require CMS to collect additional data on how best to
value global packages and to reassess every 4 years the continued need
for this data collection. Section 1848(c)(8) of the Act directs CMS to
use the information collected to improve the accuracy of valuation of
these services under the PFS starting in CY 2019. (Refer to the CY 2016
PFS final rule at 80 FR 70915 for additional discussion of these
requirements.)
In response to the statutory requirements as added by section
523(a) of the MACRA, we engaged in multiple discussions with interested
parties about methods of data collection and analysis, including
through public comment solicitation in the CY 2016 PFS proposed rule
(80 FR 41707) and CY 2017 PFS proposed rule (81 FR 46191), a national
listening session, and a town hall meeting. (Materials for the January
20, 2016 listening session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-01-20-MCRA-Presentation.pdf. The transcript of the town hall meeting held August
25, 2016 is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf.) In the CY 2017 PFS final rule (81 FR 80209 through
80213), we finalized a claims-based process to collect data from
practitioners on both
[[Page 45878]]
the number and level of postoperative visits furnished as part of the
10- and 90-day global packages. We also contracted with RAND to support
this data collection and analysis.
b. Data Collection, Analysis, and Findings
In 2019, RAND issued two reports based on its analysis of the data
collected through the data collection process we established. The
reports examined, using claims-based and survey-based data, the number
of postoperative visits furnished during the 10- and 90-day global
periods for certain high-volume procedures and the level of visits
furnished for certain procedures. (Complete details about the data
collected are discussed in the CY 2017 PFS final rule starting at 81 FR
80212, the CY 2020 PFS final rule at 84 FR 62857, and in the reports
themselves, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.)
Notably, RAND's analysis found that, according to claims-based data,
the reported number of E/M visits matched the expected number (included
for purposes of PFS valuation) for only 4 percent of reviewed 10-day
global packages and 38 percent of reviewed 90-day global packages.
Based on these analyses, RAND released a third report that analyzed the
current valuation of global packages based on the difference between
the number of postoperative E/M visits observed via the claims-based
data collection process and the expected number of such E/M visits. The
report modeled how valuation for global packages would change by
adjusting the work RVUs, physician time, and direct PE inputs to
reflect the observed number of E/M visits. The report provided
hypothetical valuations for the global packages based on these
adjustments. These three RAND reports were made available to the public
and are available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.
The RAND reports were shared with the public, and we received
public comment about these reports in the CY 2020 PFS final rule (84 FR
62866). Public commenters raised concerns about the findings in the
reports, including questions as to whether the E/M visit data were
collected from a true representative sample of practitioners, and
various other challenges to the validity of the RAND methodology. Other
members of the public, however, were supportive of our overall efforts
to collect and analyze the data, and supplied additional data similarly
suggesting that the 10- and 90-day global packages are overvalued. In
2021, RAND responded to the CY 2020 public comments that were critical
of the methodologies used in the three earlier reports in a separate
report entitled, ``Responses to Comments on RAND Global Services
Reports,'' which is available at https://www.rand.org/content/dam/rand/pubs/research_reports/RR4300/RR4314-1/RAND_RR4314-1.pdf/.
While some interested parties have challenged the methodology or
conclusions of the RAND reports, we have not yet received data
suggesting that postoperative E/M visits are being performed more
frequently than indicated by the data collected and analyzed in the
RAND reports. We continue to be concerned that our current valuations
of the global packages reflect certain E/M visits that are not
typically furnished in the global period, and thus, are not occurring.
We also believe that RAND has adequately responded to critiques of its
methodologies and findings. However, as part of our ongoing assessment
of our data collection process, we continue to welcome any comments
from the public on ideas for other sources of data that would help us
to assess global package valuation (including the typical number and
level of E/M services), as well as our data collection methodology and
the RAND report findings.
c. Changes to Health Care Delivery and Payment for E/M Services
Since the inception of the PFS 30 years ago, there have been
significant changes in health care, including improvements in medical
and information technology, new models of health care delivery and
coordination between multiple clinicians furnishing care to a single
patient, and an expanding beneficiary population. (For information on
Medicare service utilization, beneficiary demographics, provider
characteristics, and payment models, please visit the resources at
data.cms.gov.) We are interested in hearing from the public on whether
the postoperative health care landscape has changed in ways that impact
the relevance of the global packages.
We believe that changes to health care delivery may impact proper
valuation of global services. We are soliciting comment on whether
changes to health care delivery, including changes in coordination of
care and use of medical technology over the past 3 decades, as well as
during the recent PHE, have impacted: the number and level of
postoperative E/M visits needed to provide effective follow-up care to
patients; the timing of when postoperative care is being provided; and
who is providing the follow-up care. We have formed hypotheses that
some beneficiaries are not receiving the number of postoperative visits
that were contemplated when valuing the global surgical packages or are
not receiving any follow-up E/M visits at all during global periods
either because the physician who performed the surgical procedure has
determined they are unnecessary (perhaps due to improvements in medical
technology or evolution in standards of care) or as the result of more
comprehensive discharge planning. It has also been suggested by some
interested parties that physicians are, in fact, performing the number
of postoperative visits that were contemplated when valuing the global
surgical packages, but the visits may, for various reasons, be
scheduled outside the global period. Others have suggested that
physicians are, without formally transferring follow-up care to another
clinician, instructing patients to follow up with another physician or
NPP (such as the patient's primary care physician or other
practitioner), and that the other clinician then furnishes and bills
for E/M services furnished for postoperative care (whether the care is
performed during or after the global period). We would appreciate
comments on these ideas, and on other factors not mentioned here that
could affect the ways that postoperative E/M care is provided.
We are also soliciting comment on whether, or how, recent changes
in the coding and valuation of separately billable E/M services may
have impacted global packages. One change is the expansion of payment
for non-face-to-face care management services. Historically, an
advantage of global packages was that they compensated physicians for
non-face-to-face work related to the patient's transition from the
hospital to the community, or management of other health care needs
following a procedure or serious illness. Over the years, we have
implemented payment for many care management services to better reflect
non-face-to-face time spent by physicians and clinical staff on behalf
of patients with complex health care needs, including transitional care
management services in CY 2013 (77 FR 68978); chronic care management
in CY 2015 (78 FR 74414) and CY 2019 (83 FR 58577); complex chronic
care management in CY 2017 (81 FR 80244); and principal care management
in CY 2020 (84 FR 62962).
[[Page 45879]]
We solicit comment on whether global packages, and especially those
with 10- and 90-day global periods, continue to serve a purpose when
physicians could otherwise bill separately not only for the
postoperative E/M visits they furnish, but also for aspects of
postoperative care management they furnish for some patients. We also
would like to hear generally what, if any, components of preoperative
or postoperative care are currently only compensated as part of payment
for global packages.
We have also heard from some interested parties who believe that
recent changes to the coding and valuation of standalone office and
outpatient E/M visits finalized in the CY 2021 PFS final rule have
skewed the relativity between these visits and the E/M visits included
in the current global package valuations (which were not modified in
response to the coding and valuation changes). In the CY 2020 PFS final
rule (84 FR 62851 through 84 FR 62854), we finalized new--and generally
increased, RVUs for the CPT-revised office and outpatient E/M code set.
Some commenters encouraged us to increase the value of the E/M visits
included in the global surgical packages commensurate with the
increased RVUs for the standalone E/M visits. However, we declined to
do so, noting that at the time that it was unclear whether it would be
appropriate to treat the E/M visits reflected in global packages as
discrete components of the package (in other words, to use a building-
block approach to calculating the value of the service, versus valuing
the services using the more holistic magnitude estimation, or possibly
another approach.) Furthermore, we cited the uncertainty as to whether
the E/M services included in valuing the global packages are typically
furnished as part of global surgery services, reasoning that if the
number and level of E/M services for global packages is not
appropriate, adopting increases in the value of E/M services in global
surgery codes would exacerbate rather than ameliorate any potential
relativity issues. (Refer to the CY 2020 PFS final rule at 84 FR 62856
through 62860 for a complete summary of comments and our responses on
the topic of increasing the value of E/M visits included in the global
packages.) We welcome additional comments on the perceived misalignment
between the E/M visits included in global packages and separately
billable E/M services, including thoughts on how this current tension
reflects on global payment valuation and the appropriate methodology
for determining appropriate values for global packages.
d. Strategies To Address Global Package Valuation
Consistent with the discussion above, we continue to believe that:
(1) there is strong evidence suggesting that the current RVUs for
global packages are inaccurate; (2) many interested parties agree that
the current values for global packages should be reconsidered, whether
they believe the values are too low or too high; and (3) it is
necessary to take action to improve the valuation of the services
currently valued and paid under the PFS as global surgical packages.
We would like to re-engage with the public about whether the global
packages are indeed misvalued, and if so, what would be an appropriate
approach to valuation. We have previously sought assistance from the
public on possible methods of revaluation, such as in the CY 2015 PFS
rule (at 79 FR 67586).
As noted in the ``Data Collection, Analysis, and Findings'' section
above (section II.B.6.b.), RAND has provided a comprehensive roadmap
for a possible revaluation strategy. (See specifically the RAND report,
``Using Claims-Based Estimates of Postoperative Visits to Revalue
Procedures with 10- and 90-Day Global Periods,'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-) We are soliciting
additional input on the RAND methodology, including advantages and
drawbacks of applying the RAND methodology to revaluation (in addition
to previous feedback that was provided by the public in the CY 2020
final rule at 84 FR 62867). We also request input on specific
alternatives, including: (1) requesting the RUC to make recommendations
on new values; or (2) another method proposed by the public.
We solicit feedback from the public on possible strategies for a
revaluation process for global services. We believe that the available
information provided in the RAND reports (discussed in section
II.B.6.b. of this proposed rule and available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-) indicates that there is a mismatch between
the value of the global package and work being performed. In
particular, it appears that for some services, the number of
postoperative visits typically furnished by the billing physician is
much lower than what was reflected in the global package value, and
thus we believe it may be necessary to revalue those services. (As
noted in section II.B.6.b. of this proposed rule, RAND's analysis found
that the reported number of E/M visits matched the expected E/M visits
for only 4 percent of reviewed 10-day global packages and 38 percent of
reviewed 90-day global packages. We refer specifically to the RAND
report, ``Claims-Based Reporting of Postoperative Visits for Procedures
with 10- or 90-Day; Global Periods--Updated Results Using Calendar Year
2019 Data'' available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-).
Because there are a large number and volume of services paid as global
packages, we must consider the resources needed to revalue even a
subset of the global packages, as well as the impacts across the PFS
and healthcare delivery system in general if we were to change the
values of a significant number of services at one time. We are
considering various approaches we could pursue, such as: (1) revaluing
all 10- and 90-day global packages at one time (perhaps with staggered
implementation dates); (2) revaluing only the 10-day global packages
(because these appear to have the lowest rate of postoperative visit
performance, per RAND's analysis of claims data); (3) revaluing 10-day
global packages and some 90-day global packages (such as those with
demonstrated low postoperative visit performance rates as identified in
RAND's analysis of these services); or (4) relying on the Potentially
Misvalued Code process to identify and revalue misvalued global
packages over the course of many years. (We note that regardless of
whether we review particular global packages as part of a specific
revaluation strategy, the public may always nominate any global
packages to be reviewed through the Potentially Misvalued Code process;
refer to the description of the Potentially Misvalued Code process in
section II.C. of this proposed rule.) We solicit comment on any of the
strategies identified in this paragraph, as well as any additional
ideas members of the public may have that would address the concerns
described above about valuation of global packages. We also welcome
comment on ancillary considerations including timing considerations for
implementation of any future strategy (such as whether to have
staggered effective dates for new valuations and what criteria to use
if assigning staggered effective dates.)
We also solicit comment on additional considerations affecting
valuation of global services that may not have been thoroughly explored
in
[[Page 45880]]
previous public comment opportunities. For instance, we are aware that
some interested parties are concerned that not enough attention has
been paid to the value of preservice work bundled into the global
payment, which could affect accurate valuation of 10- and 90-day global
packages, as well as the value of the service if it is transitioned to
a 0-day global. We solicit additional information about this concern,
as well as any other concerns about valuation not otherwise mentioned
here.
e. Other Payment Structure Changes, Unintended Consequences, and
Missing Information
We solicit public comment on any other aspects of the global
payment structure (aside from the valuation of services) that
commenters believe are noteworthy. Much of the discussion over the
years has focused on whether global surgical packages are properly
valued and whether they are needed at all. We encourage commenters to
point out ways in which global surgical packages may continue to have a
positive impact on health care delivery (such as their potential to
support innovation). We also solicit suggestions on other ways that
global surgical package payments could be modified (aside from changing
their valuation) that could help improve accurate valuation or help
address other concerns about the payments (such as the lack of
transparency about what care is being provided as part of the package).
We also request comment on additional information that we may not
have considered or discussed above about proper valuation of the global
packages, as well as any unintended impacts (or positive outcomes) that
could result from changes to how we value global services. We are
especially interested in public comment on any concerns about
beneficiaries' access to care, continuity of care, cost sharing, or
program integrity.
C. 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 relative
value units (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.E. of this proposed rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), MedPAC, and other interested parties. 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 statute. 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 interested
parties. We conduct a review to assess the appropriate RVUs in the
context of contemporary medical practice. We note that section
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 costs decline.
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 costs rise.
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.
[[Page 45881]]
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 (76 FR 73026, 73058 through 73059),
other individuals and groups submit nominations for review of
potentially misvalued codes as well. Individuals and groups may submit
codes for review under the potentially misvalued codes initiative to
CMS in one of two ways. Nominations may be submitted to CMS via email
or through postal mail. Email submissions should be sent to the CMS
emailbox at [email protected], with the phrase
``Potentially Misvalued Codes'' and the referencing CPT code number(s)
and/or the CPT descriptor(s) in the subject line. Physical letters for
nominations should be sent via the U.S. Postal Service to the Centers
for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security
Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination
letters must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes.'' Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 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 same CY 2012 PFS final rule with comment period, 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 (77 FR 68892,
68896 through 68897) 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
the CY 2019 PFS proposed rule (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 of Work RVUs
proposed rule (76 FR 32410, 32419), 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
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). We continue each year to consider and
finalize a list of potentially misvalued codes that have or will be
reviewed and revised as appropriate in future rulemaking.
3. CY 2023 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 67548,
67606 through 67608), we modified this process whereby the public and
interested parties 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 demonstrate 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
[[Page 45882]]
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 each year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In each proposed rule, we seek nominations from the public and from
interested parties of codes that they believe we should consider as
potentially misvalued. We received public nominations for potentially
misvalued codes by February 10th and we displayed these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. Some submissions are for
specific, PE-related inputs for codes, and we refer readers to section
II.B. of this rule under Determination of PE RVUs for further
discussions on PE-related submissions. We summarize below this year's
submissions under the potentially misvalued code initiative.
An interested party nominated the home-based physician visit codes:
CPT code 99344 (Home visit for the evaluation and management of a new
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 presenting problem(s) are of high
severity. Typically, 60 minutes are spent face-to-face with the patient
and/or family), CPT code 99345 (Home visit for the evaluation and
management of a new 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 patient is
unstable or has developed a significant new problem requiring immediate
physician attention. Typically, 75 minutes are spent face-to-face with
the patient and/or family), CPT code 99349 (Home visit for the
evaluation and management of an established 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 presenting problem(s) are moderate to high
severity. Typically, 40 minutes are spent face-to-face with the patient
and/or family), and CPT code 99350 (Home visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A comprehensive interval history; A
comprehensive examination; Medical decision making of moderate to 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. The patient may be unstable or may have
developed a significant new problem requiring immediate physician
attention. Typically, 60 minutes are spent face-to-face with the
patient and/or family) as potentially misvalued.
In their submission, the nominator expressed concern that there is
no payment for transportation costs incurred when it is medically
necessary for a physician to drive to the home of the patient for a
face-to-face in-home E/M Visit, and that they are not compensated for
opportunity loss they incur by seeing fewer patients because they spend
time commuting to patients' homes, versus seeing more patients that
come to their offices. The nominator also argued that Medicare does not
compensate physicians for the work and time associated with assessing a
patient's home environment, which provides insight into a patient's
overall health and living conditions. The nominator collectively called
these non-medical factors that can affect a patient's overall health
the ``Social Determinants of Health'' (SDoH). The nominator requested
that we increase the overall RVUs for CPT codes 99344, 99345, 99349,
and 99350, by including the resources associated with: (1) the
physician's transportation costs to patients' homes; (2) lost income
opportunity for home versus in-office visits; and (3) in-home SDoH
assessment work. The nominator estimated that the adjustments to RVUs
to reflect transportation costs and opportunity costs would result in
Medicare payment that is 67 percent higher than the current Home-based
E/M Visits payment rates, and that adjustments to account for the
physician's SDoH assessment would add an additional 55 percent increase
to the payment rates for Home-based E/M Visits. In total, the nominator
suggests that if these resources were taken into account, the payment
rates for Home-based E/M CPT codes would increase by what the nominator
estimates as a 222 percent increase from their current amounts.
The nominator included references as evidence to support their
claim that the home-based E/M CPT codes are potentially misvalued, such
as the CMS ``Medicaid Non-Emergency Medical Transportation Booklet for
Providers'' (April 2016) 6 7 and a press release from the
Better Medicare Alliance entitled, ``Report Shows Dramatic Increase in
Medicare Advantage Activity to Address Social Determinants of Health,
But Barriers Remain''.\8\
---------------------------------------------------------------------------
\6\ https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/nemt-booklet.pdf.
\7\ https://storage.aanp.org/www/documents/NP-Infographic.pdf.
\8\ https://bettermedicarealliance.org/news/report-shows-
dramatic-increase-in-medicare-advantage-activity-to-address-social-
determinants-of-health-but-barriers-remain/
#:~:text=Social%20determinants%20of%20health%20are,to%20the%20World%2
0Health%20Organization.
---------------------------------------------------------------------------
We note that the nominator did not nominate the entire family of
home- based E/M visit codes.
When we establish values for codes or consider whether codes are
potentially misvalued under the PFS, we take into account the resources
involved in furnishing the specific service as described by the CPT
code. As such, historically, we do not take into account: (1) travel
costs incurred by the physician or other practitioner; (2) potential
opportunity costs to a physician or other practitioner when care is
delivered in one setting versus another; or (3) the physician or other
practitioner's work and time expended in performing activities that are
outside the scope of the specific service as described by the CPT code.
These are not considered to be resources involved in furnishing the
service, are not included in establishing payment rates under the PFS
in accordance with
[[Page 45883]]
section 1848 of the Act, and, as such, do not provide justification for
potential misvaluation of those payments. That said, in February 2021,
the AMA CPT Editorial Panel deleted the family of domiciliary codes,
CPT codes 99324 to 99340, and merged the services described by those
codes into the existing family of home-based E/M visits, CPT codes
99341 to 99350 (a range of codes that includes CPT codes 99344, 99345,
99349, and 99350). In addition, the AMA RUC has made recommendations
regarding the values for these home-based E/M codes in section II.E. of
this proposed rule. Since CMS has already received AMA RUC
recommendations for these home-based E/M visit codes for this year's
proposed rule, we refer readers to the discussion found in section
II.E. of this proposed rule, Valuation of Specific Codes, where we seek
additional public comments, recommendations, and independent analysis
as supporting evidence from all interested parties regarding the
valuations for the home-based E/M visits, including CPT codes 99344,
99345, 99349, and 99350. Because we address and are soliciting public
comment on the valuation of these codes in section II.E. of this
proposed rule, there is no need to consider these home-based E/M visits
here as potentially misvalued.
An interested party has nominated the following cataract surgery
codes, CPT codes 65820 (Goniotomy--Incision to improve eye fluid flow),
66174 (Transluminal dilation of aqueous outflow canal; without
retention of device or stent), 66982 (Complex Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification), 66984 (Extracapsular cataract
removal with insertion of intraocular lens prosthesis (one stage
procedure), manual or mechanical technique (e.g., irrigation and
aspiration or phacoemulsification)), 66989 (Complex Extracapsular
cataract removal w/IOL insertion, complex; with insertion of
intraocular (e.g., trabecular meshwork, supraciliary, suprachoroidal)
anterior segment aqueous drainage device, without extraocular
reservoir, internal approach, one or more), and 66991 (Extracapsular
cataract removal w/IOL insertion; with insertion of intraocular (e.g.,
trabecular meshwork, supraciliary, suprachoroidal) anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, one or more), as well as the following retinal procedure
codes, CPT codes 67015 (Aspiration or release of vitreous, subretinal
or choroidal fluid, pars plana approach (posterior sclerotomy)), 67036
(Vitrectomy, mechanical, pars plana approach), 67039 (Vitrectomy,
mechanical, pars plana approach; with focal endolaser
photocoagulation), 67040 (Vitrectomy, mechanical, pars plana approach;
with endolaser panretinal photocoagulation), 67041 (Vitrectomy,
mechanical, pars plana approach; with removal of preretinal cellular
membrane (e.g., macular pucker)), 67042 (Vitrectomy, mechanical, pars
plana approach; with removal of internal limiting membrane of retina
(e.g., for repair of macular hole, diabetic macular edema), includes,
if performed, intraocular tamponade (i.e., air, gas or silicone oil)),
67043 (Vitrectomy, mechanical, pars plana approach; with removal of
subretinal membrane (e.g., choroidal neovascularization), includes, if
performed, intraocular tamponade (i.e., air, gas or silicone oil) and
laser photocoagulation), 67108 (Repair of retinal detachment; with
vitrectomy, any method, including, when performed, air or gas
tamponade, focal endolaser photocoagulation, cryotherapy, drainage of
subretinal fluid, scleral buckling, and/or removal of lens by same
technique), and 67113 (Repair of complex retinal detachment (e.g.,
proliferative vitreoretinopathy, stage C-1 or greater, diabetic
traction retinal detachment, retinopathy of prematurity, retinal tear
of greater than 90 degrees), with vitrectomy and membrane peeling,
including, when performed, air, gas, or silicone oil tamponade,
cryotherapy, endolaser photocoagulation, drainage of subretinal fluid,
scleral buckling, and/or removal of lens), as potentially misvalued
because there is currently no established non-facility payment rate for
these global 090-day surgical procedures. These codes are complex
surgical eye procedures and they require dedicated spaces, similar to
facility-based spaces that are not typically found in an
ophthalmologist's office, such as a well-lighted and sterile surgical
theater, specific eye surgery equipment and possibly clinical staff and
other medical personnel trained to assist in these surgeries and the
patient's immediate post-surgery recovery, including anesthesia
services. In the past, with concerns for patient safety and given the
intricate and delicate nature of these surgeries, we understood that
these procedures would only be performed in a well-equipped and fully
staffed medical facility. This may still be the case, but this
nominator suggests that these cataract and retinal procedures can be
properly performed in the non-facility office, safely, effectively, and
perhaps more conveniently for patients and physicians; and thus
requests that we should establish non-facility RVUs under the PFS to
recognize the additional resources that would be expended in the non-
facility setting.
The nominator has included a list of practice expense items
involved in furnishing these services in the non-facility setting to
help us to consider establishing non-facility values for these codes.
They include the possible number and types of clinical staff and their
work time in minutes, and a list of various equipment and supplies
typically needed to furnish the services described by the nominated
codes.
The nominator also noted that there is projected backlog for these
cataract and retinal services that may have been building up due to the
COVID-19 restrictions from the past 2 years. We seek comment on the
merits of continuing to value these codes only in the facility setting,
as opposed to also establishing non-facility values for these cataract
and retinal surgery codes. We also seek comment on any appropriate
safety considerations for these codes in the non-facility setting and
whether these codes are potentially misvalued. We note that in last
year's CY 2022 PFS final rule with comment (86 FR 65096 through 65097),
we did review CPT codes 66982, 66984, 66987, 66988, 66989, 66991, and
0671T (Cataract Removal with Drainage Device Insertion) and did not
establish non-facility values for those services, but we did note a
potential rank order anomaly when considering minimally invasive
glaucoma surgeries (MIGS) and cataract surgeries together, and
suggested that the AMA RUC should consider re-surveying all of these.
An interested party has nominated add-on CPT code 20931 (Allograft,
structural, for spine surgery only (List separately in addition to code
for primary procedure)) as a potentially misvalued service with respect
to the physician's labor for spinal surgeries involving the use of
biomechanical synthetic cage devices versus the use of structural
allograft bone as it relates to a set of CPT codes related to anterior
cervical discectomy and fusion (ACDF). Ordinarily, interested parties
nominate a primary service code as potentially misvalued, or a primary
service code and its related add-on codes, but not an add-on code
alone. The valuation of an add-on code is typically developed with
reference to some portion of the work (or other resource inputs)
involved in furnishing the primary service code. For
[[Page 45884]]
example, the AMA CPT 2022 Professional Edition, page 147, states ``Use
code 20931 in conjunction with codes 22319, 22532-22533, 22548-22558,
22590-22612, 22630, 22633, 22634, 22800-22812''). The primary spinal
surgery codes and the add-on CPT code 20931 have not been recently
reconsidered or reviewed by the AMA RUC or CMS, and no new or
additional information has been included with this nomination to
persuade CMS that CPT code 20931 is individually potentially misvalued.
This nomination of an add-on code as potentially misvalued is similar
to the nomination we discussed in the CY 2022 PFS proposed rule (86 FR
65044) of CPT code 22551 (Arthrodesis, anterior interbody, including
disc space preparation, discectomy, osteophytectomy and decompression
of spinal cord and/or nerve roots; cervical below C2) and the
accompanying add-on codes.
The nominator refers to two different methods of vertebral fusion--
one using biomechanical synthetic cage devices, the other using
structural allograft bone; and describes a typical vertebral fusion
case that uses three units of one of these products. Both of these
methods of vertebral fusion are described by CPT code 22551 (includes a
90-day global period), which has a work RVU of 25.00. Both methods of
vertebral fusion also involve two units of CPT code 22552 (Arthrodesis,
anterior interbody, including disc space preparation, discectomy,
osteophytectomy and decompression of spinal cord and/or nerve roots;
cervical below C2, each additional interspace (List separately in
addition to code for primary procedure)), which have a total work RVU
of 13.00 (6.50 x 2), and 1 unit of CPT code 22846 (Anterior
instrumentation; 4 to 7 vertebral segments (List separately in addition
to code for primary procedure)), which has a work RVU of 12.40. The
vertebral fusion method employing three synthetic cage devices with
plate would involve three units of CPT code 22853 (Insertion of
interbody biomechanical device(s) (e.g., synthetic cage, mesh) with
integral anterior instrumentation for device anchoring (e.g., screws,
flanges), when performed, to intervertebral disc space in conjunction
with interbody arthrodesis, each interspace (List separately in
addition to code for primary procedure)) for a total work RVU of 12.75
(4.25 x 3), and one unit of CPT code 20930 (Allograft, morselized, or
placement of osteopromotive material, for spine surgery only (List
separately in addition to code for primary procedure)) with a work RVU
of 0.00 (because Medicare considers this code to be bundled into codes
for other services). The nominator states that the typical vertebral
fusion employing three synthetic cage devices with plate would total to
63.15 work RVUs.
In contrast, the nominator asserts that the vertebral fusion method
employing structural allograft bones with plate involves the same set
of services and codes (that is, one unit of CPT code 22551, two units
of CPT code 22552, and one unit of CPT code 22846), but the structural
allograft bone method includes CPT code 20931 (Allograft, structural,
for spine surgery only (List separately in addition to code for primary
procedure)), with a work RVU of 1.81, instead of CPT codes 22853 and
20930, for a total work RVU of 52.21. The nominator suggests that this
difference in total work RVUs for the two methods of vertebral fusion,
63.15 versus 52.21, is evidence that add-on CPT code 20931 is
potentially misvalued; however, we do not agree with this nominator's
method of aggregating and comparing sums of work RVUs for groups of
services that may be furnished together as being potentially misvalued,
nor consider CPT code 20931 as the source of misvaluation within this
grouping.
We understand that the nominator believes there should be an
equivalent total sum payment for all services involved in vertebral
fusion surgeries using either method, and that there should not be a
potential incentive for physicians to prefer the method that uses
synthetic cage devices because of the higher available payment amount.
The nominator asserts that the total sum payment for this kind of
spinal surgery using the structural allograft bone method is
undervalued as compared to the total sum payment for this kind of
spinal surgery using the synthetic cage method.
We note that CPT code 22853, which the commenter associates with
the synthetic cage device method of vertebral fusion, is a 45-minute
ZZZ-code (indicating an add-on code) with an IWPUT (intra-service work
(RVU) per unit of time) of 0.0944, whereas CPT code 20931, which the
commenter associates with the allograph method of vertebral fusion, is
a 20-minute ZZZ-code with an IWPUT of 0.0905. Given the much longer
intra-service time and greater IWPUT for CPT code 22853 than for CPT
code 20931, the allograph method of vertebral fusion would be expected
to have a lower total sum of work RVUs.
The nominator's description of why and how each vertebral fusion
method is potentially misvalued when compared to the other does not
present a situation that fits within our process for identifying
individual services that are potentially misvalued using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to individual
codes, or with the inter-code relativity between the RVUs assigned to
several individual codes found within a family of codes with
hierarchical relationships. CMS generally does not examine the summed
differences in total RVUs (as is the case presented here), based on
billing patterns for a combination of codes representing differing
physician work for different methods of performing a service, and then
comparing the total RVUs of each method as evidence of the potential
misvaluation of codes. We do not believe that the nominator has
provided sufficient evidence to demonstrate that CPT code 20931 itself
is misvalued, and therefore, we are not inclined to propose this code
as potentially misvalued; however, we seek additional comment and any
independent analysis and studies (see the supporting documentation
options listed above under ``CY 2023 Identification and Review of
Potentially Misvalued Services,'' particularly in regard to any changes
in the resources to providing a service) as supporting evidence from
commenters in agreement or disagreement with this nomination.
See Table 6 for the listing of nominated potentially misvalued
codes.
BILLING CODE 4120-01-P
[[Page 45885]]
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BILLING CODE 4120-01-C
D. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
a. Changes to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a regulatory process for adding services to or deleting
services from the Medicare Telehealth Services List in accordance with
section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
Telehealth Services List 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 Medicare Telehealth Services List. 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 Medicare Telehealth Services List. 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 other clinical benefits that we consider
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.
[[Page 45886]]
In the CY 2021 PFS final rule (85 FR 84507), we created a third
category of criteria for adding services to the Medicare Telehealth
Services List on a temporary basis following the end of the PHE for the
COVID-19 pandemic: Category 3. This new category describes services
that were added to the Medicare Telehealth Services List during the PHE
for which there is likely to be clinical benefit when furnished via
telehealth, but there is not yet sufficient evidence available to
consider the services for permanent addition under the Category 1 or
Category 2 criteria. Services added on a temporary, Category 3 basis
will ultimately need to meet the criteria under Category 1 or 2 in
order to be permanently added to the Medicare Telehealth Services List.
To add specific services on a Category 3 basis, we conducted a clinical
assessment to identify those services for which we could foresee a
reasonable potential likelihood of clinical benefit when furnished via
telehealth. We considered the following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns for patient safety if the service is furnished as a
telehealth service.
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns about whether the provision of the service via
telehealth is likely to jeopardize quality of care.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio-video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare Telehealth Services List using
the Category 3 criterion described above. We assessed codes that were
temporarily available on the list for the duration of the PHE to
determine their appropriateness for inclusion on the Medicare
Telehealth Services List on a Category 3 basis. We have reassessed the
services that are temporarily available via telehealth for the PHE,
based on both information provided by interested parties and our own
internal review. We have assessed whether or not these services can,
outside of the circumstances of the PHE, be furnished using the full
scope of service elements via two-way, audio-video communication
technology, without jeopardizing patient safety or quality of care, and
we now believe that there are additional services that would be
appropriate for addition to the Medicare Telehealth Services List on a
Category 3 basis that we did not identify in the CY 2021 rulemaking. In
this proposed rule, we are proposing to add these additional services
to the Medicare Telehealth Services List on a Category 3 basis, as
further discussed below.
The Medicare Telehealth Services List, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Beginning in CY 2019, we stated that 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
(83 FR 59491). For CY 2023, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2022. Each request to add a service to the Medicare
Telehealth Services List must have included 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 Medicare Telehealth Services List,
requesters are 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 in the future to add services to
the Medicare Telehealth Services List, including where to submit these
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2023
Under our current policy, we add services to the Medicare
Telehealth Services List on a Category 1 basis when we determine that
they are similar to services on the existing Medicare Telehealth
Services 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
criterion not only streamlines our review process for publicly
requested services that fall into this category, but also expedites our
ability to identify codes for the Medicare Telehealth Services List
that resemble those services already on the Medicare Telehealth
Services List. We add services on a Category 2 basis when the service
does not fall within Category 1, and based upon our assessment of
whether the services are accurately described by the corresponding code
when delivered via telehealth and whether the use of a
telecommunications system to deliver the service produces demonstrated
clinical benefit to the patient. We add services on a temporary
Category 3 basis when the services were temporarily included on the
Medicare Telehealth Services List during the PHE, and we find that
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition under the Category 1 or Category 2
criteria.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2023. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare Telehealth Services List. We also assessed the
appropriateness of adding these services to the Medicare Telehealth
Services List on a Category 3 basis instead.
We are not proposing changes to the length of time the services
that we temporarily included on a Category 3 basis will remain on the
Medicare Telehealth Services List; the services we temporarily included
on the Medicare Telehealth Services List on a Category 3 basis will
continue to be included through the end of CY 2023. In the event that
the PHE extends well into CY 2023, we may consider revising this
policy.
We are proposing to add some services to the Medicare Telehealth
Services List on a Category 3 basis through the end of 2023, some of
which we had not previously added to the Medicare Telehealth List
during the PHE, but will be added on a subregulatory basis as provided
in Sec. 410.78(f) of our regulations. For some of these services, we
have received information from interested parties suggesting potential
clinical benefit. For others, we continue to believe there is
sufficient evidence of potential clinical benefit to warrant allowing
additional time for interested parties to gather data to support their
possible inclusion on the Medicare Telehealth Services List on a
Category 1 or 2 basis. The Medicare Telehealth Services List requests
for CY 2023 are listed in Table 7.
Additionally, the Consolidated Appropriations Act, 2022 (CAA, 2022)
(Pub. L. 117-103, March 15, 2022) amended section 1834(m) of the Act to
extend a number of flexibilities that are in place during the PHE for
COVID-19 for 151 days after the end of the PHE. To align the
availability of these services with those flexibilities
[[Page 45887]]
extended under the Act, we are proposing to continue to allow certain
telehealth services that would otherwise not be available via
telehealth after the expiration of the PHE to remain on the Medicare
Telehealth Services List for 151 days after the expiration of the PHE.
BILLING CODE 4120-01-P
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[[Page 45888]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.007
[[Page 45889]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.008
BILLING CODE 4120-01-C
We remind interested parties that the criterion for adding services
to the Medicare Telehealth Services List under Category 1 is that the
requested services are similar to professional consultations, office
visits, and/or office psychiatry services that are currently on the
Medicare Telehealth Services List, and that the criterion for adding
services under Category 2 is that there is evidence of clinical benefit
if provided as telehealth. As explained below, we find that none of the
requested services listed in Table 7 met the Category 1 or 2 criteria.
We received a request to permanently add CPT code S9443 (Lactation
classes, non-physician provider, per session) to the Medicare
Telehealth Services List. This service has a status code of ``I,''
which means that it is not valid for Medicare billing purposes. We
understand that this is a temporary code established by a private payor
for private payor use, and thus, it is not valid for nor payable by
Medicare. As such, this code is not separately billable under the PFS.
We generally do not add services to the Medicare Telehealth Services
List unless they are separately billable under the PFS. Outside of the
circumstances of the PHE, the Medicare Telehealth Services List only
includes services that are covered if they are furnished without the
use of telecommunication technology in-person. Because CPT code S9443
is not billable under the PFS when furnished in-person, we do not
believe it would be appropriate to allow the service to be billed
separately when furnished as a Medicare telehealth service. As noted in
the CY 2018 PFS final rule (82 FR 53011), if a service does not
describe a service typically furnished in-person, it would not be
considered a telehealth service under the applicable provisions of the
statute. We are not proposing to add CPT code S9443 to the Medicare
Telehealth Services List.
(1) Therapy Services
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations: CPT codes
97161-97164; Therapy Personal Care services: CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services: CPT codes
97750, 97755, and 97763, to the Medicare Telehealth Services List on a
Category 1 basis.
In the CY 2022 PFS final rule (86 FR 65051), we determined that
these services did not meet the Category 1 criteria for addition to the
Medicare Telehealth Services List because they involve direct
observation and/or physical contact between the practitioner and the
patient and, in many instances, are therapeutic in nature, and that
they did not meet Category 2 criteria, because we thought
[[Page 45890]]
that the request did not provide sufficient detail to determine whether
all of the necessary elements of the service could be furnished
remotely. We continue to believe this is the case. We still do not have
sufficient information to determine whether these services meet the
Category 2 criteria. However, we note that some of these codes,
including codes 97110, 97112, 97116, 97150, 97530, 97161-97164, 97535,
97542, 97750, and 97755 have been added to the list on a temporary
basis for the duration of the PHE.
In assessing the evidence that was supplied by interested parties
in support of adding these services to the Medicare Telehealth Services
List on a Category 2 basis, we concluded that there was not sufficient
information to determine whether all of the necessary elements of these
services could be furnished remotely. Information regarding safety,
appropriateness, and that indicates that all elements of a given CPT
code can be furnished via telehealth is still needed to assess whether
these services meet the Category 2 criteria. However, we also believe
that the therapy services that are currently on the Medicare Telehealth
Services List on a temporary basis for the PHE (including CPT codes
97150, 97530, and 97542), but are not currently included on a Category
3 basis, may continue to be furnished safely via two-way, audio-video
communication technology outside of the circumstances of the PHE.
Therefore, we are proposing that CPT codes 97150, 97530, and 97542
(the set of therapy services that are currently on the Medicare
Telehealth Services List on a temporary basis for the PHE), should be
added to the Medicare Telehealth Services List through the end of CY
2023 on a temporary, Category 3 basis, to allow time to gather
additional data that could support their inclusion on the list on a
permanent basis. Therefore, we are proposing to add CPT codes 97150,
97530, and 97542 to the Medicare Telehealth Services List on a Category
3 basis. CPT codes 97110, 97112, 97116, 97161-97164, 97535, 97750, and
97755 will continue to be available on the Medicare Telehealth Services
List on a Category 3 basis. We anticipate that keeping these services
on the Medicare Telehealth Services List on a Category 3 basis, as
proposed, through the end of CY 2023 would preserve access to care and
promote health equity, and based on information provided by interested
parties and internal review, we believe that they may safely be
furnished as telehealth outside of the circumstances of the PHE through
the end of CY 2023. However, we remind readers that the practitioners
who primarily furnish these services, physical therapists, are not,
outside the circumstances of the PHE (and the 151 day period following
the expiration of the PHE), authorized to furnish Medicare telehealth
services. We note that if the PHE and the 151 day period following the
expiration of the PHE both end in CY 2023, the pre-PHE rules will take
effect, and these services could no longer be furnished by therapists
as Medicare telehealth services.
Certain other requested therapy services, namely CPT codes 97537,
97763, 90901, and 98960-98962 are not currently on the Medicare
Telehealth Services List; however, we are adding these services to the
Medicare Telehealth Services List on a temporary basis during the PHE,
in accordance with Sec. 410.78(f). As explained below in section
II.D.1.d. of this proposed rule, services included on the Medicare
Telehealth Services List on a temporary basis during the PHE that have
not been added to the list on a Category 3 basis will remain on the
list for 151 days following the end of the PHE. Furthermore, we are
proposing to add CPT codes 97537, 97763, 90901, and 98960-98962 to the
Medicare Telehealth Services List on a Category 3 basis through the end
of CY 2023. Our clinical analyses of these services indicate that they
can be furnished in full using two-way, audio and video technology
during the circumstances of the PHE, and information provided by
requestors indicates that there may be clinical benefit; however, there
is not yet sufficient evidence available to consider the services for
permanent addition to the Medicare Telehealth Services List under the
Category 1 or Category 2 criteria. Including these services on the
Medicare Telehealth Services List during the PHE and through CY 2023
would allow additional time for the development of evidence for CMS to
consider when evaluating these services for potential permanent
addition to the Medicare Telehealth Services List on a Category 1 or 2
basis. We continue to encourage commenters to supply additional
information in support of adding these services to the Medicare
Telehealth Services List on a permanent basis, including information
regarding the safety and appropriateness of furnishing these services
via telehealth.
(2) Telephone E/M Services
We have also received requests to temporarily add Telephone E/M
visit codes, CPT codes 99441, 99442, and 99443 to the Medicare
Telehealth Services List on a Category 3 basis. In the March 31, 2020
interim final rule with comment period (IFC), we established separate
payment for audio-only telephone E/M services (85 FR 19264 through
19266) for the duration of the PHE for the COVID-19 pandemic. Although
these services were previously considered non-covered under the PFS, in
the context of the PHE for COVID-19 and with the goal of reducing
exposure risks associated with COVID-19 (especially in situations when
two-way, audio and video technology is not available to furnish a
Medicare telehealth service), we believed there were circumstances
where prolonged, audio-only communication between the practitioner and
the patient could be clinically appropriate, yet not fully replace a
face-to-face visit. In the May 8, 2020 COVID-19 IFC, we noted that
interested parties had informed us that use of audio-only services was
more prevalent than we had previously considered, especially because
many beneficiaries were not using video-enabled communication
technology from their homes. In other words, there were many cases
where practitioners who would ordinarily furnish audio-video telehealth
or in-person visits to evaluate and manage patients' medical concerns
were instead using audio-only interactions to manage more complex care
(85 FR 27589 through 27590). While we had previously acknowledged the
likelihood that, under the circumstances of the PHE for COVID- 19, more
time would be spent interacting with the patient via audio-only
technology, we stated that the intensity of furnishing an audio-only
visit to a beneficiary during the unique circumstances of the PHE for
COVID-19 was not accurately captured by the valuation of these services
that we established in the March 31, 2020 IFC (85 FR 27590). This would
be particularly true to the extent that these audio-only services are
serving as a substitute for office/outpatient (O/O) Medicare telehealth
visits for beneficiaries not using video-enabled telecommunications
technology, which is contrary to the situation we anticipated when
establishing separate payment for them in the March 31, 2020 IFC. In
the May 8, 2020 COVID-19 IFC, we stated that, given our understanding
that these audio-only services were being furnished primarily as a
replacement for care that would otherwise be reported as an in-person
or telehealth visit using the O/O E/M codes, we established new RVUs
for the telephone E/M services based on crosswalks to the most
analogous O/O E/M codes, based on the time
[[Page 45891]]
requirements for the telephone codes and the times assumed for
valuation for purposes of the O/O E/M codes. Specifically, we
crosswalked the levels 2-4 O/O E/Ms for established patients, as
described by CPT codes 99212, 99213, and 99214, to CPT codes 99441,
99442, and 99443, respectively. Additionally, we stated that, given our
understanding that these audio-only services were being furnished as
substitutes for O/O E/M services, we recognized that they should be
considered as telehealth services, and added them to the Medicare
Telehealth Services List for the duration of the PHE for COVID-19 (85
FR 27590).
In the CY 2022 PFS final rule (86 FR 65055), in response to
requests that these codes be added to the Medicare Telehealth Services
List on a Category 3 basis, we stated that we were finalizing a change
to the definition of ``telecommunications system'' to allow telehealth
services for the diagnosis, evaluation, and treatment of mental health
conditions to be furnished through audio-only technology in certain
circumstances after the end of the PHE. For example, the O/O E/M codes
are on the Medicare Telehealth Services List permanently and when used
to describe care for mental health conditions, will be reportable when
furnished via audio-only technology to patients in their homes. Since
audio-only telecommunications technology can be used to furnish mental
health telehealth services to patients in their homes, the addition of
these codes to the Medicare Telehealth Services List is unnecessary for
mental health telehealth services. For telehealth services other than
mental health care, we stated that we believe that two-way, audio-video
communications technology is the appropriate standard that will apply
for telehealth services after the PHE ends. Further, we note that
section 1834(m)(2)(A) of the Act requires that payment to a distant
site physician or practitioner that furnishes Medicare telehealth
services to an eligible telehealth individual be equal to the amount
that would have been paid under Medicare if such physician or
practitioner had furnished the service without a telecommunications
system. We believe that the statute requires that telehealth services
be so analogous to in-person care such that the telehealth service is
essentially a substitute for a face-to-face encounter. However, these
audio-only telephone E/M services are inherently non-face-to-face
services, since they are furnished exclusively through remote, audio-
only communications. Outside the circumstances of the PHE, the
telephone E/M services would not be analogous to in-person care; nor
would they be a substitute for a face-to-face encounter. Therefore, we
do not believe it would be appropriate for these codes to remain on the
Medicare Telehealth Services List after the end of the PHE and the 151-
day post-PHE extension period. Accordingly, we are not proposing to
keep these telephone E/M services on the Medicare Telehealth Services
List after that period on a Category 3 basis, because the codes
describe services that can only be furnished using audio-only
telecommunications technology, and outside of the circumstances of the
PHE, they do not describe services that are a substitute for an in-
person visit. While we acknowledge that audio-only technology can be
used to furnish mental health telehealth services to patients in their
homes under certain circumstances after the PHE ends, two-way, audio-
video communications technology continues to be the appropriate
standard that will apply for Medicare telehealth services after the PHE
and the 151-day extension period. As we noted in the CY 2021 PFS final
rule (85 FR 84535), we will assign these Telephone E/M visit codes (CPT
codes 99441, 99442, and 99443) a ``bundled'' status after the end of
the PHE and the 151-day extension period, and we will post the RUC-
recommended RVUs for these codes in accordance with our usual practice.
(3) GI Tract Imaging and Continuous Glucose Monitoring
We received requests to add CPT codes describing GI Tract Imaging,
CPT code 91110 (Gastrointestinal tract imaging, intraluminal (e.g.,
capsule endoscopy), esophagus through ileum, with interpretation and
report) and Ambulatory Continuous Glucose Monitoring, CPT code 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; analysis,
interpretation and report), to the Medicare Telehealth Services List on
a Category 3 basis. We believe these codes may describe services that
are inherently non-face-to-face services, (the patient need not be
present in order for the service to be furnished in its entirety), and
therefore, they do not describe services that are a substitute for an
in-person visit. As stated earlier, we believe that the statute
requires that telehealth services be so analogous to in-person care
such that the telehealth service is essentially a substitute for a
face-to-face encounter. For this and other reasons, we are not
proposing to add these services to the Medicare Telehealth Services
List on a Category 3 basis; we do not believe these CPT codes describe
services that are a substitute for an in-person visit, and we believe
that services that are not inherently face-to-face services are not
services that can be furnished as Medicare telehealth services. Even
so, we are interested in information that would help us to understand
whether these services would meet the criteria for inclusion on the
Medicare Telehealth Services List either for the PHE, as Category 3
services, or permanently on a Category 1 or 2 basis, given our
questions as to whether they are inherently non-face-to-face services,
and therefore, may not fit within the scope of services that could be
furnished as Medicare telehealth services. Therefore, we are also
seeking comment on whether these services would involve an in-person
service when furnished without the use of a telecommunications system.
(4) Neurostimulator Pulse Generator/Transmitter
We received requests to add codes describing the electronic
analysis of an implanted neurostimulator pulse generator/transmitter to
the Medicare Telehealth Services List. These included a request to add
CPT codes 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) and 95977
(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 complex
cranial nerve neurostimulator pulse generator/transmitter programming
by physician or other qualified health care professional) permanently
on a Category 1 basis, as well as a request to add CPT codes 95970
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group[s],
[[Page 45892]]
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), 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, 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 neurostimulator pulse
generator/transmitter programming, first 15 minutes face-to-face time
with physician or other qualified health care professional), and 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, 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
neurostimulator pulse generator/transmitter programming, each
additional 15 minutes face-to-face time with physician or other
qualified health care professional (List separately in addition to code
for primary procedure)) to the Medicare Telehealth Services List on a
temporary Category 3 basis.
The request to add CPT codes 95976 and 95977, which are codes that
describe analysis of cranial nerve neurostimulation, indicated that the
ability to fully furnish this service using two-way, audio-video
communication technology was forthcoming, but is currently unavailable.
Therefore, we are not proposing to add CPT codes 95976 and 95977 to the
Medicare Telehealth Services List, because the full scope of service
elements described by these codes cannot currently be furnished via
two-way, audio-video communication technology. However, we will
consider additional evidence regarding the ability to furnish these
services as telehealth services, such as information indicating that
current technology has evolved, as it becomes available for future
rulemaking. We are also not proposing to add them on a Category 1 basis
because they do not describe services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List.
With regard to CPT codes 95970, 95983, and 95984, which describe
general brain nerve neurostimulation, we have some concerns about
whether the full scope of service elements could be furnished via two-
way, audio-video communication technology, particularly since it is
unclear whether the connection between the implanted device and the
analysis/calibration equipment can be done remotely. Additionally, we
are concerned about the immediate safety of the patient if the
calibration of the neurostimulator were done incorrectly or if some
other problem occurred. However, we did include these services on the
Medicare Telehealth Services List on a temporary basis during the PHE,
and Medicare claims data suggest that these services are being provided
via telehealth. Based on this information, we believe there is some
possible clinical benefit for these services when furnished via
telehealth; however, there is not yet sufficient evidence available to
consider the services for permanent addition to the Medicare Telehealth
Services List under the Category 1 or Category 2 criteria. With that
said, CPT codes 95970, 95983, and 95984 do meet the criteria for
temporary inclusion on the Medicare Telehealth Services List on a
Category 3 basis. Therefore, we are proposing to add CPT codes 95970,
95983, and 95984 to the Medicare Telehealth Services List on a Category
3 basis, while soliciting comment on our concerns regarding patient
safety and whether these services are appropriate for inclusion on the
Medicare Telehealth Services List outside the circumstances of the PHE.
(5) Emotional/Behavior Assessment, Psychological, or Neuropsychological
Testing and Evaluation Services
We received requests to add a number of emotional/behavior
assessment, psychological, or neuropsychological testing and evaluation
services, described by CPT codes 97151 (Behavior identification
assessment, administered by a physician or other qualified health care
professional, each 15 minutes of the physician's or other qualified
health care professional's time face-to-face with patient and/or
guardian(s)/caregiver(s) administering assessments and discussing
findings and recommendations, and non-face-to-face analyzing past data,
scoring/interpreting the assessment, and preparing the report/treatment
plan), 97152 (Behavior identification-supporting assessment,
administered by one technician under the direction of a physician or
other qualified health care professional, face-to-face with the
patient, each 15 minutes), 97153 (Adaptive behavior treatment by
protocol, administered by technician under the direction of a physician
or other qualified health care professional, face-to-face with one
patient, each 15 minutes), 97154 (Group adaptive behavior treatment by
protocol, administered by technician under the direction of a physician
or other qualified health care professional, face-to-face with two or
more patients, each 15 minutes), 97155 (Adaptive behavior treatment
with protocol modification, administered by physician or other
qualified health care professional, which may include simultaneous
direction of technician, face-to-face with one patient, each 15
minutes), 97156 (Family adaptive behavior treatment guidance,
administered by physician or other qualified health care professional
(with or without the patient present), face-to-face with guardian(s)/
caregiver(s), each 15 minutes), 97157 (Multiple-family group adaptive
behavior treatment guidance, administered by physician or other
qualified health care professional (without the patient present), face-
to-face with multiple sets of guardians/caregivers, each 15 minutes),
97158 (Group adaptive behavior treatment with protocol modification,
administered by physician or other qualified health care professional,
face-to-face with multiple patients, each 15 minutes), 0362T (Behavior
identification supporting assessment, each 15 minutes of technicians'
time face-to-face with a patient, requiring the following components:
administration by the physician or other qualified health care
professional who is on site; with the assistance of two or more
technicians; for a patient who exhibits destructive behavior;
completion in an environment that is customized to the patient's
behavior.), and 0373T (Adaptive behavior treatment with protocol
modification, each 15 minutes of technicians' time face-to-face with a
patient, requiring the following components: administration by the
physician or other qualified health care professional who is on site;
with the assistance of two or more technicians; for a patient who
exhibits destructive behavior; completion in an environment that is
customized to the patient's behavior.) to the Medicare Telehealth
Services List permanently on a Category 2 basis. These services are
currently on
[[Page 45893]]
the Medicare Telehealth Services List temporarily for the duration of
the PHE. We believe that, for these services, there is likely to be
clinical benefit when furnished via telehealth, and therefore, they
meet the criteria for temporary inclusion on a Category 3 basis. We did
not identify these services during our initial assessment of services
that should be temporarily available on the Medicare Telehealth
Services List on a Category 3 basis in the CY 2021 rulemaking; however,
we are now proposing to include these services on the Medicare
Telehealth Services List on a Category 3 basis, in light of information
we received from the requestors describing the potential clinical
benefit of these services when furnished via telehealth. However, we do
have concerns regarding whether, outside the circumstances of the PHE,
the full scope of service elements can occur in a manner that does not
jeopardize quality of care, whether this patient population could be
fully assessed via interactive audio-video technology, and whether
these services could be conducted in a way that maintains the safety of
the beneficiary. This patient population often includes patients with
moderate to severe challenges in oral communication, and they may
require close observation of their movements within all of their
environmental cues, which include, for instance, smell, sound, and
colors around the room. We are concerned that two-way, audio and video
communications technology would not fully capture these behavioral
nuances. We believe more time may be necessary to develop evidence that
could support the decision to add these services to the Medicare
Telehealth Services List permanently on a Category 1 or Category 2
basis. We are soliciting comment on our patient safety concerns.
c. Other Services Proposed for Addition to the Medicare Telehealth
Services List
As discussed above, there are services that are included on the
Medicare Telehealth Services List temporarily during the PHE for which
there is likely to be clinical benefit when furnished via telehealth,
but there is not yet sufficient evidence available to consider the
services for permanent addition to the list under the Category 1 or
Category 2 criteria. In addition to the services discussed above that
we are proposing for addition to the Medicare Telehealth Services List
on a Category 3 basis in response to requests, we are also proposing to
add a number of services to the list on a Category 3 basis that are
currently included on the Medicare Telehealth Services List temporarily
during the PHE. These services would be included on the Medicare
Telehealth Services List through 2023 to allow us to evaluate data that
may support their permanent addition to the list on a Category 1 or
Category 2 basis.
The services we are proposing for inclusion to the Medicare
Telehealth Services List on a Category 3 basis include CPT codes 90875
(Individual psychophysiological therapy incorporating biofeedback
training by any modality (face-to-face with the patient), with
psychotherapy (e.g., insight oriented, behavior modifying or supportive
psychotherapy); 30 minutes), 92012 (Ophthalmological services: medical
examination and evaluation, with initiation or continuation of
diagnostic and treatment program; intermediate, established patient),
92014 (Ophthalmological services: medical examination and evaluation,
with initiation or continuation of diagnostic and treatment program;
comprehensive, established patient, 1 or more visits), 92507 (Treatment
of speech, language, voice, communication, and/or auditory processing
disorder; individual), 94005 (Home ventilator management care plan
oversight of a patient (patient not present) in home, domiciliary or
rest home (e.g., assisted living) requiring review of status, review of
laboratories and other studies and revision of orders and respiratory
care plan (as appropriate), within a calendar month, 30 minutes or
more), 96105 (Assessment of aphasia (includes assessment of expressive
and receptive speech and language function, language comprehension,
speech production ability, reading, spelling, writing, e.g., by Boston
Diagnostic Aphasia Examination) with interpretation and report, per
hour), 96110 (Developmental screening (e.g., developmental milestone
survey, speech and language delay screen), with scoring and
documentation, per standardized instrument), 96112 (Developmental test
administration (including assessment of fine and/or gross motor,
language, cognitive level, social, memory and/or executive functions by
standardized developmental instruments when performed), by physician or
other qualified health care professional, with interpretation and
report; first hour), 96113 (Developmental test administration
(including assessment of fine and/or gross motor, language, cognitive
level, social, memory and/or executive functions by standardized
developmental instruments when performed), by physician or other
qualified health care professional, with interpretation and report;
each additional 30 minutes (List separately in addition to code for
primary procedure)), 96127 (Brief emotional/behavioral assessment
(e.g., depression inventory, attention-deficit/hyperactivity disorder
[ADHD] scale), with scoring and documentation, per standardized
instrument), 96170 (Health behavior intervention, family (without the
patient present), face-to-face; initial 30 minutes), 96171 (Health
behavior intervention, family (without the patient present), face-to-
face; each additional 15 minutes (List separately in addition to code
for primary service)), 97129 (Therapeutic interventions that focus on
cognitive function (e.g., attention, memory, reasoning, executive
function, problem solving, and/or pragmatic functioning) and
compensatory strategies to manage the performance of an activity (e.g.,
managing time or schedules, initiating, organizing, and sequencing
tasks), direct (one-on-one) patient contact; initial 15 minutes), 97130
(Therapeutic interventions that focus on cognitive function (e.g.,
attention, memory, reasoning, executive function, problem solving, and/
or pragmatic functioning) and compensatory strategies to manage the
performance of an activity (e.g., managing time or schedules,
initiating, organizing, and sequencing tasks), direct (one-on-one)
patient contact; each additional 15 minutes (List separately in
addition to code for primary procedure)), and 99473 (Self-measured
blood pressure using a device validated for clinical accuracy; patient
education/training and device calibration). Our analyses of these
services indicate that there is some evidence of possible clinical
benefit associated with these services when furnished via telehealth.
We believe these services can safely be furnished via real-time, audio
and visual interactive telecommunications under the circumstances of
the PHE, but there is not yet sufficient evidence available to consider
the services for permanent addition to the Medicare Telehealth Services
List under the Category 1 or Category 2 criteria.
Some audiology testing services are currently temporarily available
on the Medicare Telehealth Services List for the duration of the PHE.
These are CPT codes 92550 (Tympanometry and reflex threshold
measurements), 92552 (Pure tone audiometry (threshold); air only),
92553 (Pure tone audiometry (threshold); air and bone), 92555 (Speech
audiometry threshold;), 92556 (Speech audiometry threshold; with speech
recognition), 92557 (Comprehensive audiometry threshold
[[Page 45894]]
evaluation and speech recognition (92553 and 92556 combined)), 92563
(Tone decay test), 92565 (Stenger test, pure tone), 92567 (Tympanometry
(impedance testing)), 92568 (Acoustic reflex testing, threshold), 92570
(Acoustic immittance testing, includes tympanometry (impedance
testing), acoustic reflex threshold testing, and acoustic reflex decay
testing), 92587 (Distortion product evoked otoacoustic emissions;
limited evaluation (to confirm the presence or absence of hearing
disorder, 3-6 frequencies) or transient evoked otoacoustic emissions,
with interpretation and report), 92588 (Distortion product evoked
otoacoustic emissions; comprehensive diagnostic evaluation
(quantitative analysis of outer hair cell function by cochlear mapping,
minimum of 12 frequencies), with interpretation and report), 92601
(Diagnostic analysis of cochlear implant, patient younger than 7 years
of age; with programming), 92625 (Assessment of tinnitus (includes
pitch, loudness matching, and masking)), 92626 (Evaluation of auditory
function for surgically implanted device(s) candidacy or postoperative
status of a surgically implanted device(s); first hour), 92627
(Evaluation of auditory function for surgically implanted device(s)
candidacy or postoperative status of a surgically implanted device(s);
each additional 15 minutes (List separately in addition to code for
primary procedure)). We have received information that, during the PHE,
certain practitioners have developed the capacity to perform these
services using remote technology including specialized equipment inside
an audiometric soundproof booth. We believe that, in circumstances in
which such equipment is available at the originating site, these
services can be furnished in a way in which all of the elements of the
services are met and that there is likely to be a clinical benefit when
these services are furnished via telehealth. Therefore, we are
proposing to add these services to the Medicare Telehealth Services
List on a Category 3 basis, which would allow these services to be
available via telehealth through the end of CY 2023. We are soliciting
comments regarding how widespread the availability of this remote
technology is, and whether interested parties believe these services
can be furnished in a way that does not jeopardize patient safety or
quality of care when these services are furnished remotely.
Additionally, as discussed in section II.F. of this proposed rule,
we are proposing to create HCPCS codes GXXX1 (Prolonged hospital
inpatient or observation care evaluation and management service(s)
beyond the total time for the primary service (when the primary service
has been selected using time on the date of the primary service); each
additional 15 minutes by the physician or qualified healthcare
professional, with or without direct patient contact (list separately
in addition to CPT codes 99223, 99233, and 99236 for hospital inpatient
or observation care evaluation and management services). (Do not report
GXXX1 on the same date of service as other prolonged services for
evaluation and management 99358, 99359, 993X0). (Do not report GXXX1
for any time unit less than 15 minutes)), GXXX2 (Prolonged nursing
facility evaluation and management service(s) beyond the total time for
the primary service (when the primary service has been selected using
time on the date of the primary service); each additional 15 minutes by
the physician or qualified healthcare professional, with or without
direct patient contact (list separately in addition to CPT codes 99306,
99310 for nursing facility evaluation and management services). (Do not
report GXXX2 on the same date of service as other prolonged services
for evaluation and management 99358, 99359, 993X0,). (Do not report
GXXX2 for any time unit less than 15 minutes)), and GXXX3 (Prolonged
home or residence evaluation and management service(s) beyond the total
time for the primary service (when the primary service has been
selected using time on the date of the primary service); each
additional 15 minutes by the physician or qualified healthcare
professional, with or without direct patient contact (list separately
in addition to CPT codes 99345, 99350 for home or residence evaluation
and management services). (Do not report GXXX3 on the same date of
service as other prolonged services for evaluation and management
99358, 99359, 99417). (Do not report GXXX3 for any time unit less than
15 minutes)) to describe prolonged services associated with certain
types of E/M services. These codes would be replacing existing codes
that describe prolonged services, specifically inpatient prolonged
services CPT codes 99356 (Prolonged service in the inpatient or
observation setting, requiring unit/floor time beyond the usual
service; first hour (List separately in addition to code for inpatient
or observation Evaluation and Management service)) and 99357 (Prolonged
service in the inpatient or observation setting, requiring unit/floor
time beyond the usual service; each additional 30 minutes (List
separately in addition to code for prolonged service)). These services
are similar to services currently on the Medicare Telehealth Services
List, such as CPT codes 99356 and 99357, which were added to the
Medicare Telehealth Services List on a Category 1 basis in the CY 2016
rule (80 FR 71060-71062), as well as O/O prolonged service HCPCS code
G2212 (Prolonged service in the inpatient or observation setting,
requiring unit/floor time beyond the usual service; each additional 30
minutes (List separately in addition to code for prolonged service)),
which was added to the Medicare Telehealth Services List on a Category
1 basis in the CY 2021 rule (85 FR 84506). Similarly, we believe that
these proposed HCPCS G codes would be sufficiently similar to
psychiatric diagnostic procedures or O/O visits currently on the
Medicare Telehealth Services List to qualify for inclusion on the list
on a Category 1 basis. Therefore, we are proposing to add proposed
HCPCS codes GXXX1, GXXX2, and GXXX3 to the Medicare Telehealth Services
List on a Category 1 basis.
Table 8 lists the services that we are proposing for addition to
the Medicare Telehealth Services List on a Category 3 basis. Table 9
lists the services we are proposing for permanent addition to the
Medicare Telehealth Services List on a Category 1 basis.
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d. Services Proposed for Removal From the Medicare Telehealth Services
List After 151 Days Following the End of the PHE
As we noted in the CY 2022 PFS final rule (86 FR 65054), at the
conclusion of the PHE for COVID-19, the associated waivers and interim
policies will expire, payment for Medicare telehealth services will
once again be limited by the requirements of section 1834(m) of the
Act, and we will return to the policies established through our regular
notice-and-comment rulemaking process, through which we established
Medicare Telehealth Services List. Services that have been added to the
Medicare Telehealth Services List on a Category 3 basis will remain on
the list through the end of CY 2023. Under our current policy, all
other services that were temporarily added to the Medicare Telehealth
Services List on an interim basis during the PHE and have not been
added to the Medicare Telehealth Services List on a Category 1, 2, or 3
basis will not remain on the list after the end of the PHE (85 FR
84506-84509). As explained in section II.D.1.e. of this proposed rule,
Division P, Title III, Subsection A of the Consolidated Appropriations
Act, 2022 (CAA, 2022), extends some of the flexibilities implemented
during the PHE for COVID-19 for an additional 151 days after the end of
the PHE, including Section 301(a) of Division P, Title III, Subtitle A
of the CAA, 2022, which specifies that, for services on the Medicare
Telehealth Services List as of the date of enactment (March 15, 2022)
furnished during 151 days after the end of the PHE, the originating
site for the telehealth service can be any site in the United States at
which the beneficiary is located when the service is furnished,
including the beneficiary's home. To give full effect to this
provision, we believe it is necessary to continue to include the
services on the Medicare Telehealth Services List through the 151-day
period after the end of the PHE that were temporarily added to the list
during the PHE but have not since been added on a Category 3 or other
basis, and which are currently set to be removed from the list at the
end of the PHE. As such, we are proposing to continue to include on the
Medicare Telehealth Services List the services that are currently set
to be removed from the list when the PHE ends (that is, those not
currently added to the list on a Category 1, 2, or 3 basis) for an
additional 151 days after the PHE ends. Table 10 lists those services
that are temporarily available for the PHE, which we are proposing to
retain on the Medicare Telehealth Services List for an additional 151
days following the end of the PHE. The services listed in Table 10 will
no longer be available on the Medicare Telehealth Services List on the
152nd day after the end of the PHE. On the 152nd day after the end of
the PHE, payment for Medicare telehealth services will once again be
limited by the requirements of section 1834(m) of the Act, as
aforementioned, and telehealth claims for these codes will be denied.
We are proposing to align those services that had been planned to stop
being available as Medicare telehealth at the end of the PHE with the
151-day extensions of flexibilities enacted in the CAA, 2022 in order
to simplify the process of when flexibilities will end and to minimize
possible errors.
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e. Implementation of Telehealth Provisions of the Consolidation
Appropriations Acts, 2021 and 2022
As discussed in the CY 2021 PFS final rule (85 FR 84506),
legislation enacted to address the PHE for COVID-19 provided the
Secretary with new authorities under section 1135(b)(8) of the Act, as
added by section 102 of the Coronavirus Preparedness and Response
Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020)
and subsequently amended by section 6010 of the Families First
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section
3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES
Act) (Pub. L. 116-136, March 27, 2020), to waive or modify Medicare
telehealth payment requirements during the PHE for COVID-19. We used
these authorities to establish several flexibilities to accommodate
changes in the delivery of care during the PHE. Through waiver
authority under section 1135(b)(8) of the Act, in response to the PHE
for COVID-19, we removed the geographic and site of service originating
site restrictions in section 1834(m)(4)(C) of the Act, as well as
restrictions in section 1834(m)(4)(E) of the Act on the types of
practitioners who may furnish telehealth services, for the duration of
the PHE for COVID-19. We also used waiver authority to allow certain
telehealth services to be furnished via audio-only communication
technology. At the end of the PHE for COVID-19, these waivers and
interim policies will expire, and payment for Medicare telehealth
services will once again be limited by the requirements of section
1834(m) of the Act.
Section 1834(m)(7) of the Act (as added by section 2001(a) of the
SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24,
2018)), removes the geographic restrictions under section
1834(m)(4)(C)(i) of the Act and authorizes the patient's home as a
permissible originating site, for telehealth services furnished for
purposes of treatment of a substance use disorder (SUD) or a co-
occurring mental health disorder, furnished on or after July 1, 2019,
to an individual with a SUD diagnosis. Section 123(a) of Division CC of
the Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260,
December 27, 2020) amended section 1834(m)(7)(A) of the Act to broaden
the scope of services for which the geographic restrictions under
section 1834(m)(4)(C)(i) of the Act do not apply and for which the
patient's home is a permissible originating site to include telehealth
services furnished for the purpose of diagnosis, evaluation, or
treatment of a mental health disorder, effective for services furnished
on or after the end of the PHE for COVID-19. Section 123(a) of the CAA,
2021 also added subparagraph (B) to section 1834(m)(7) of the Act to
prohibit payment for a telehealth service furnished in the patient's
home under paragraph (7), unless the physician or practitioner
furnishes an item or service in-person, without the use of telehealth,
within 6 months prior to the first time the physician or practitioner
furnishes a telehealth service to the beneficiary, and thereafter, at
such times as the Secretary determines appropriate. For a full
discussion of our implementation of section 123(a) of the CAA, 2021,
refer to our CY 2022 PFS final rule (86 FR 64996).
In this proposed rule, we are proposing to implement provisions of
section 1834(m) of the Act (including the amendments made by the CAA,
2021) and provisions of the CAA, 2022 that extend certain Medicare
telehealth flexibilities adopted during the PHE for 151 days after the
end of the PHE.
Sections 301, 302, 303, 304, and 305 of Division P, Title III,
Subtitle A of the CAA, 2022 amended section 1834(m) of the Act to
generally extend certain PHE-related telehealth policies for services
that are on the Medicare Telehealth Services List as of the date of
enactment (March 15, 2021). Specifically, section 301(a) of the CAA,
2022 amended section 1834(m)(4)(C) of the Act to add a new clause
(iii), which temporarily expands the scope of telehealth originating
sites for those services to include any site in the United States where
the beneficiary is located at the time of the telehealth service,
including an individual's home, for a 151-day period beginning on the
first day after the end of the PHE for COVID-19. Section 301(a) also
amended section 1834(m)(7)(A) of the Act to apply the expanded scope of
telehealth originating site policy to include any location in the
United States in new clause (iii) of section 1834(m)(4)(C) of the Act
during the 151-day period for telehealth services furnished for the
purposes of diagnosis, evaluation, or treatment of a mental health
disorder and to individuals with a SUD diagnosis for purposes of
treatment of the SUD or a co-occurring mental health disorder for this
151-day post-PHE extension period. In addition to this provision,
section 301(b) of the CAA, 2022 amended section 1834(m)(2)(B) of the
Act to add a new clause (iii) that allows payment of an originating
site facility fee to an originating site with respect to those
telehealth services furnished during the 151-day period only if the
originating site is one that meets the geographic requirements in
section 1834(m)(4)(C)(i) of the Act, and is a setting included on the
enumerated list of originating sites under section 1834(m)(4)(C)(ii) of
the Act (other than the patient's home).
Section 302 of the CAA, 2022 amended section 1834(m)(4)(E) of the
Act to temporarily expand the definition of eligible telehealth
practitioners for the 151-day period beginning on the first day after
the end of the PHE for COVID-19 to include qualified occupational
therapists, qualified physical therapists, qualified speech-language
pathologists, and qualified audiologists.
Section 303 of the CAA, 2022 amended section 1834(m)(8) of the Act
to temporarily continue payment for telehealth services furnished by
FQHCs and RHCs for the 151-day period beginning on the first day after
the end of the COVID-19 PHE using the methodology established for
telehealth services furnished by FQHCs and RHCs during the PHE, which,
in accordance with section 1834(m)(8)(B) of the Act, is based on
payment rates that are similar to the national average payment rates
for comparable telehealth services under the PFS.
Section 304(a) of the CAA, 2022 amended section 1834(m)(7)(B)(i) of
the Act to delay the requirement for an in-person visit with the
physician or practitioner within 6 months prior to the initial mental
health telehealth service, and again at subsequent intervals as the
Secretary determines appropriate. In light of this amendment, the in-
person requirements for telehealth services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder will
again be effective on the 152nd day after the PHE ends. In addition,
section 304(b) and (c) of the CAA, 2022 modified sections 1834(y) and
1834(o)(4) of the Act, respectively, to similarly delay in-person visit
requirements for mental health visits furnished by Rural Health Clinics
and Federally Qualified Health Centers via telecommunications
technology. Therefore, we are proposing to revise the regulatory text
at Sec. 410.78(b)(3)(xiv) to recognize the delay of the in-person
requirements for mental health visits furnished by RHCs and FQHCs
through telecommunication technology under Medicare until the 152nd day
after the PHE for COVID-19, to conform with the statute. See section
II.B.3. of this proposed rule for our proposal to implement similar
changes for RHC and FQHC mental health visits.
[[Page 45899]]
Finally, section 305 of the CAA, 2022 added a new paragraph (9) to
section 1834(m) of the Act to require the Secretary to continue to
provide for coverage and payment of telehealth services included on the
Medicare Telehealth Services List as of the March 15, 2022, date of
enactment that are furnished via an audio-only telecommunications
system during the 151-day period beginning on the first day after the
end of the PHE for COVID-19. The new paragraph applies only to
telehealth services specified on the Medicare Telehealth Services List
under section 1834(m)(4)(F)(i) of the Act that are designated to as
eligible to be furnished via audio-only technology as of the date of
enactment of the CAA, 2022 (that is, March 15, 2022). These are the
services for which CMS waived the requirements of section 1834(m)(1) of
the Act and the first sentence of Sec. 410.78(a)(3) for use of
interactive telecommunications systems to furnish telehealth services,
to the extent they require use of video technology, during the PHE.
Under this waiver, CMS permitted the audio-only telephone E/M services
and certain behavioral health counseling and educational services to be
furnished via audio-only equipment during the PHE for COVID-19. CMS is
proposing to continue to make payment for services included on the
Medicare Telehealth Services List as of March 15, 2022 that are
furnished via an audio-only telecommunications system for the 151-day
period beginning on the first day after the end of the PHE. We read
section 305 of the CAA, 2022 to require that we continue to make
payment for services furnished via audio-only telecommunications
systems (each described by a HCPCS code, including their successor
codes) for the 151-day period after the end of the PHE. These services
include certain behavioral health, counseling, and educational
services. A list of the services that involve audio-only interaction
but are included on the Medicare Telehealth Services List for the
duration of the PHE is available at the CMS website, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
Section 309 of Division P, Title III, Subtitle A of the CAA, 2022
authorizes the Secretary to implement the amendments described above
made by sections 301 through 305 through program instruction or
otherwise. Given that the end date of the PHE is not yet known and
could occur before the rulemaking process for the CY 2023 PFS is
complete, and that the changes made by these provisions are very
specific and concise, we are providing notice that we intend to issue
program instructions or other subregulatory guidance to effectuate the
changes described above, other than the proposed revisions to Sec.
410.78, in the near future. We believe this approach will serve to
ensure a smooth transition after the end of the PHE for COVID-19.
f. Use of Modifiers for Medicare Telehealth Services Following the End
of the PHE for COVID-19
Prior to CY 2017, Medicare telehealth services furnished via
interactive audio and video telecommunications systems were reported
using the GT modifier. In the CY 2017 PFS Final Rule, CMS finalized
creation of a new Place of Service (POS) code for Medicare telehealth,
POS ``02'' (81 FR 80199-80201). When a physician or practitioner
submits a claim for their services, including claims for telehealth
services, they include a place of service (POS) code that is used to
determine whether a service is paid using the facility or non-facility
rate. Under the PFS, there are two payment rates for many physicians'
services: the facility rate and the non-facility (or office) rate. The
PFS non-facility rate is the single amount paid to a physician or other
practitioner for services furnished in their office. The PFS facility
rate is the amount generally paid to a professional when a service is
furnished in a setting of care, like a hospital, where Medicare is
making a separate payment to a facility entity in addition to the
payment to the billing physician or practitioner. This separate
payment, often referred to as a ``facility fee,'' reflects the
facility's costs associated with the service (clinical staff, supplies,
and equipment) and is paid in addition to what is paid to the
professional under the PFS. POS ``02'' indicates payment at the
facility payment rate.
As discussed in the March 31, 2020 IFC, (refer to 85 FR 19230), we
stated that, as physician practices suddenly transitioned a potentially
significant portion of their services from in-person to telehealth
visits in the context of the PHE for the COVID-19 pandemic, the
relative resource costs of furnishing these services via telehealth may
not significantly differ from the resource costs involved when these
services are furnished in-person. Therefore, we instructed physicians
and practitioners who bill for Medicare telehealth services to report
the POS code that would have been reported had the service been
furnished in person. This would allow our systems to make appropriate
payment for services furnished via Medicare telehealth, which, if not
for the PHE for the COVID-19 pandemic, would have been furnished in-
person, at the same rate they would have been paid if the services were
furnished in-person. In order to effectuate this change, we finalized
on an interim basis (85 FR 19233) the use of the CPT telehealth
modifier, modifier ``95'', for the duration of the PHE for COVID-19,
which should be applied to claim lines that describe services furnished
via telehealth and that the practitioner should report the POS code
where the service would have occurred had it not been furnished via
telehealth.
We further noted that we are maintaining the facility payment rate
for services billed using the general telehealth POS code ``02'',
should practitioners choose to maintain their current billing practices
for Medicare telehealth during the PHE for the COVID-19 pandemic.
We propose that Medicare telehealth services furnished on or before
the 151st day after the end of the PHE, in alignment with the
extensions of telehealth-related flexibilities in the CAA, 2022, will
continue to be processed for payment as Medicare telehealth claims when
accompanied with the modifier ``95''. We further propose that
physicians and practitioners can continue to report the place of
service code that would have been reported had the service been
furnished in-person during the 151-day period after the end of the PHE,
as finalized on an interim basis in the March 31 IFC (85 FR 19233).
Medicare telehealth services performed with dates of service occurring
on or after the 152nd day after the end of the PHE will revert to pre-
PHE rules and will no longer require modifier ``95'' to be appended to
the claim, but the appropriate place of service (POS) indicator will
need to be included on the claim to be processed for payment as
Medicare telehealth claims in order to properly identify the place
where the service was furnished. For Medicare telehealth services
furnished on or after the 152nd day after the end of the PHE, the POS
indicators for Medicare telehealth will be:
POS ``02''--which would be redefined, if finalized, as
Telehealth Provided Other than in Patient's Home (Descriptor: The
location where health services and health related services are provided
or received, through telecommunication technology. Patient is not
located in their home when receiving health services or health related
services through telecommunication technology.); and
[[Page 45900]]
POS ``10''--Telehealth Provided in Patient's Home
(Descriptor: The location where health services and health related
services are provided or received through telecommunication technology.
Patient is located in their home (which is a location other than a
hospital or other facility where the patient receives care in a private
residence) when receiving health services or health related services
through telecommunication technology.).
We remind readers that we defined ``home'' in our CY 2022 PFS final
rule (86 FR 65059) as: ``both in general and for this purpose, a
beneficiary's home can include temporary lodging, such as hotels and
homeless shelters. We clarified that for circumstances where the
patient, for privacy or other personal reasons, chooses to travel a
short distance from the exact home location during a telehealth
service, the service is still considered to be furnished `in the home
of an individual' for purposes of section 1834(m)(4)(C)(ii)(X) of the
Act.''
Once the flexibilities for the geographic restrictions and the site
of service waivers for Medicare telehealth services expire (on the
152nd day after the end of the PHE, per the CAA, 2022), POS ``02'' will
once again be required for all Medicare telehealth claims. The
exceptions include claims for Medicare telehealth mental health
services, clinical assessments for patients with ESRD that are
receiving home dialysis, and Medicare telehealth mental health services
that are co-occurring with substance use treatment that are furnished
with the patient in their home (that is, the originating site is in a
private residence and not a hospital or other facility setting), in
which case POS ``10'' could be used by the billing practitioner. On or
after the 152nd day after the PHE has expired, payment for Medicare
telehealth services using either of the Medicare telehealth POS codes
will be made at the PFS facility payment rate, in accordance with
established policy outside the circumstances of the PHE. We propose to
align those telehealth services described as taking place in the
beneficiary's home, using POS ``10'' for Medicare telehealth, and those
services not provided in a patient's home, using POS ``02'' for
Medicare telehealth, to be made at the same facility payment amount. We
believe that the facility payment amount best reflects the practice
expenses, both direct and indirect, involved in furnishing services via
telehealth (please see section II.B. of this proposed rule for further
discussion regarding practice expense).
We further propose that, beginning January 1, 2023, a physician or
other qualified health care practitioner billing for telehealth
services furnished using audio-only communications technology shall
append CPT modifier ``93'' (Synchronous Telemedicine Service Rendered
Via Telephone or Other Real-Time Interactive Audio-Only
Telecommunications System: Synchronous telemedicine service is defined
as a real-time interaction between a physician or other qualified
health care professional and a patient who is located away at a distant
site from the physician or other qualified health care professional.
The totality of the communication of information exchanged between the
physician or other qualified health care professional and the patient
during the course of the synchronous telemedicine service must be of an
amount and nature that is sufficient to meet the key components and/or
requirements of the same service when rendered via a face-to-face
interaction) to Medicare telehealth claims (for those services for
which the use of audio-only technology is permitted under Sec.
410.78(a)(3)), to identify them as having been furnished using audio-
only technology. We note that CMS has instructed RHCs, FQHCs, and OTPs
to append Medicare modifier ``FQ'' (Medicare telehealth service was
furnished using audio-only communication technology) for allowable
audio-only services furnished in those settings; however, consistent
with our proposal for audio-only services furnished under the PFS, we
are also proposing to require RHCs, FQHCs, and OTPs to use modifier 93
when billing for eligible mental health services furnished via audio-
only telecommunications technology. We believe that using modifier
``93'', which is a CPT modifier, will simplify billing, as this
modifier is used by payers outside of Medicare. Currently, these
modifiers can only be applied to Medicare telehealth mental health
services and those telehealth services for the treatment of a SUD or a
co-occurring mental health disorder when the originating site is the
beneficiary's home.
Supervising practitioners continue to be required to append the
``FR'' modifier on any applicable telehealth claim when required to be
present through an interactive real-time, audio and video
telecommunications link, as reflected in each service's requirement.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
Under Medicare Part B, certain types of services, including
diagnostic tests, services incident to physicians' or practitioners'
professional services, and other services, are required to be furnished
under specific minimum levels of supervision by a physician or
practitioner.
For professional services furnished incident to the services of the
billing physician or practitioner (see Sec. 410.26) and many
diagnostic tests (see Sec. 410.32), direct supervision is required.
Additionally, for pulmonary rehabilitation services (see Sec. 410.47)
and for cardiac rehabilitation and intensive cardiac rehabilitation
services (see Sec. 410.49), statutory requirements for immediate
availability and accessibility of a physician are met if the physician
meets the requirements for direct supervision for physician office
services at Sec. 410.26 and for hospital outpatient services at Sec.
410.27. Outside the circumstances of the PHE, direct supervision
requires the immediate availability of the supervising physician or
other practitioner, but the professional need not be present in the
same room during the service. We have established this ``immediate
availability'' requirement to mean in-person, physical, not virtual,
availability (please see the April 6, 2020 IFC (85 FR 19245) and the CY
2022 PFS final rule (86 FR 65062)).
Through the March 31, 2020 COVID-19 IFC, we changed the definition
of ``direct supervision'' during the PHE for COVID-19 (85 FR 19245
through 19246) as it pertains to supervision of diagnostic tests,
physicians' services, and some hospital outpatient services, to allow
the supervising professional to be immediately available through
virtual presence using real-time audio/video technology, instead of
requiring their physical presence. In the CY 2021 PFS final rule (85 FR
84538 through 84540), we finalized continuation of this policy through
the later of the end of the calendar year in which the PHE for COVID-19
ends or December 31, 2021. In the March 31, 2020 IFC (85 FR 19246) and
in our CY 2022 PFS final rule (see 85 FR 65063), we also noted that the
temporary exception to allow immediate availability for direct
supervision through virtual presence facilitates the provision of
telehealth services by clinical staff of physicians and other
practitioners' incident to their own professional services. This is
especially
[[Page 45901]]
relevant for services such as physical therapy, occupational therapy,
and speech language pathology services, since those practitioners can
only bill Medicare for telehealth services under Medicare telehealth
waivers that are effective only during the PHE for COVID-19 (per the
emergency waiver authority established in section 1135(b)(8) of the
Act), and for 151 days after the final day of the PHE for COVID-19, as
mandated by the CAA, 2022. We note that sections 1834(m)(4)(D) and (E)
of the Act specify the types of clinicians who may furnish and bill for
Medicare telehealth service. Outside of the PHE and the 151-day period
after the PHE ends, such clinicians include only physicians as defined
in section 1861(r) of the Act and practitioners described in section
1842(b)(18)(C) of the Act. We remind readers that after December 31 of
the year in which the PHE ends, the pre-PHE rules for direct
supervision at Sec. 410.32(b)(3)(ii) would apply. As noted in the CY
2022 PFS final rule (86 FR 65062), this means the temporary exception
to allow immediate availability for direct supervision through virtual
presence facilitates the provision of telehealth services by clinical
staff of physicians and other practitioners incident to their own
professional services would no longer apply, so telehealth services can
no longer be performed by clinical staff incident to a physician's
professional service.
While we are not proposing to make the temporary exception to allow
immediate availability for direct supervision through virtual presence
permanent, as with last year's rulemaking (86 FR 39149-50), we continue
to seek information on whether the flexibility to meet the immediate
availability requirement for direct supervision through the use of
real-time, audio/video technology should potentially be made permanent.
We also seek comment regarding the possibility of permanently allowing
immediate availability for direct supervision through virtual presence
using real-time, audio/video technology for only a subset of services,
as we recognize that it may be inappropriate to allow direct
supervision without physical presence for some services due to
potential concerns over patient safety. As discussed in last year's
final rule (86 FR 65063), and based on gaps in the currently available
evidence, we are in need of more information as we consider whether to
make permanent a temporary exception to our direct supervision policy.
3. Telehealth Originating Site Facility Fee Update
Section 1834(m)(2)(B) of the Act established the initial Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00,
and specifies that 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 proposed MEI increase for CY 2023 is 3.7 percent and is based
on the most current forecast of the percentage increase of the 2006-
based MEI for the second quarter of 2022 (4.1 percent), and the most
recent estimate of the historical productivity adjustment for calendar
year 2021 (0.4 percent).
Therefore, for CY 2023, the proposed payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is $28.61. The final
Medicare telehealth originating site facility fee will be revised for
the final rule based on the historical data through the second quarter
2022 and the most recently available total factor productivity data.
The Medicare telehealth originating site facility fee and the MEI
increase by the applicable time period are shown in Table 11.
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E. 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, CY 2015, and CY 2020. 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.C. of this proposed 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 solicit 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 consider and responded
to public comments received on the interim final values, and typically
make any appropriate adjustments and finalize those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), 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 (81 FR 46162), 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 (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), 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.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature,
[[Page 45903]]
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. 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 proposed those values as
recommended. Additionally, we continually engage with interested
parties, 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 conduct a review that
includes 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 include, but have 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 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. 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 use in the building block approach may include
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 use 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 utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. Section 1848(c)(1)(A) of the
Act specifically defines the work component as the resources that
reflect time and intensity 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 refine 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 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 adjust 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 remove 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 remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do 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. We also include a summary of interested
party reactions to our approach when available. We note that many
commenters and interested parties have expressed concerns over the
years with our reviews of and updates to work RVUs based on changes in
the best available information 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 use to update
the RVUs 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
[[Page 45904]]
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 use 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 believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider 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 believe 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 interested parties, including the RUC, have expressed
general objections to our use of these methodologies to adjust for
reductions in time, suggesting that our adjustments to the RUC-
recommended work RVUs are inappropriate. Other interested parties have
expressed general concerns with our refinements to RUC-recommended
values. In the CY 2017 PFS proposed rule (81 FR 46162), 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. In the CY 2017 PFS final
rule (81 FR 80272 through 80277), we responded in detail to several
comments that we received regarding our approach to RUC-recommended
work times and RVUs. As described earlier in this section, crosswalks
to key reference or similar codes are 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.
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 the 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 section II.B. of this proposed rule, Determination
of PE RVUs, we address certain proposed refinements that would be
common across codes. We address refinements to particular codes in the
portions of section II.B. that focus on particular codes. We note that
for each refinement, we indicate the potential 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 $0.35 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 many of the refinements listed in Table 13 result in changes under
the $0.35 threshold and would be unlikely to result in a change to the
RVUs.
We note that the proposed direct PE inputs for CY 2023 are
displayed in the CY 2023 direct PE input files, available on the CMS
website under the downloads for the CY 2023 PFS proposed 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 proposed CY 2023 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
[[Page 45905]]
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 will 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 noted that we believe these same assumptions will
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 will 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 proposed rule,
Determination of 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. However, some recommendations 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 2023, we received invoices for several new supply and
equipment items. Tables 15 and 16 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this proposed rule, Determination of Practice Expense Relative
Value Units, we encourage interested parties 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
encourage interested parties 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 interested parties 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 15 and 16 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 interested parties 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 interested
parties 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 interested parties 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
[[Page 45906]]
proxy items, we might use existing items as proxies for the newly
recommended items. In other cases, we include 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 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 list of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the 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; are displayed in the public use files for the
PFS proposed and final rules for each year. The public use files for CY
2023 are available on the CMS website under downloads for the CY 2023
PFS proposed 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
through 74263).
Effective January 1, 2007, section 5102(b)(1) of the Deficit
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section
1848(b)(4) of the Act to require that, for imaging services, if-- (i)
The technical component (TC) (including the TC portion of a global fee)
of the service established for a year under the fee schedule without
application of the geographic adjustment factor, exceeds (ii) The
Medicare OPD fee schedule amount established under the prospective
payment system (PPS) for hospital outpatient (HOPD) services under
section 1833(t)(3)(D) of the Act for such service for such year,
determined without regard to geographic adjustment under paragraph
(t)(2)(D) of such section, the Secretary shall substitute the amount
described in clause (ii), adjusted by the geographic adjustment factor
[under the PFS], for the fee schedule amount for such TC for such year.
As required by the section 1848(b)(4)(A) of the Act, for imaging
services furnished on or after January 1, 2007, we cap the TC of the
PFS payment amount for the year (prior to geographic adjustment) by the
Outpatient Prospective Payment System (OPPS) payment amount for the
service (prior to geographic adjustment). We then apply the PFS
geographic adjustment to the capped payment amount. Section
1848(b)(4)(B) of the Act defines imaging services as imaging and
computer-assisted imaging services, including X-ray, ultrasound
(including echocardiography), nuclear medicine (including PET),
magnetic resonance imaging (MRI), computed tomography (CT), and
fluoroscopy, but excluding diagnostic and screening mammography. For
more information regarding the history of the cap on the TC of the PFS
payment amount under the DRA (the ``OPPS cap''), we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69659 through
69662).
For CY 2023, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined above
for purposes of this cap. Beginning for CY 2023, we propose to include
the following services on the list of codes to which the OPPS cap
applies: CPT codes 0493T (Contact near-infrared spectroscopy studies of
lower extremity wounds (e.g., for oxyhemoglobin measurement)), 0640T
(Noncontact near-infrared spectroscopy studies of flap or wound (e.g.,
for measurement of deoxyhemoglobin, oxyhemoglobin, and ratio of tissue
oxygenation [StO2]); image acquisition, interpretation and report, each
flap or wound), 0641T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); image acquisition only, each
flap or wound), 0642T (Noncontact near-infrared spectroscopy studies of
flap or wound (e.g., for measurement of deoxyhemoglobin, oxyhemoglobin,
and ratio of tissue oxygenation [StO2]); interpretation and report
only, each flap or wound), 0651T (Magnetically controlled capsule
endoscopy, esophagus through stomach, including intraprocedural
positioning of capsule, with interpretation and report), 0658T
(Electrical impedance spectroscopy of 1 or more skin lesions for
automated melanoma risk score), 0689T (Quantitative ultrasound tissue
characterization (non-elastographic), including interpretation and
report, obtained without diagnostic ultrasound examination of the same
anatomy (e.g., organ, gland, tissue, target structure)), 0690T
(Quantitative ultrasound tissue characterization (non-elastographic),
including interpretation and report, obtained with diagnostic
ultrasound examination of the same anatomy (e.g., organ, gland, tissue,
target structure) (List separately in addition to code for primary
procedure)), 0694T (3-dimensional volumetric imaging and reconstruction
of breast or axillary lymph node tissue, each excised specimen, 3-
dimensional automatic specimen reorientation, interpretation and
report, real-time intraoperative), 0700T (Molecular fluorescent imaging
of suspicious nevus; first lesion), 0701T (Molecular fluorescent
imaging of suspicious nevus; each additional lesion (List separately in
addition to code for primary procedure)), and 76XX0 (Ultrasound,
nerve(s) and accompanying structures throughout their entire anatomic
course in one extremity, comprehensive, including real-time cine
imaging with image documentation, per extremity).
4. Valuation of Specific Codes for CY 2023
(1) Anterior Abdominal Hernia Repair (CPT Codes 157X1, 49X01, 49X02,
49X03, 49X04, 49X05, 49X06, 49X07, 49X08, 49X09, 49X10, 49X11, 49X12,
49X13, 49X14, and 49X15)
In April 2021, the RUC reviewed an existing code that describes
hernia repair, CPT code 49565 (Repair recurrent incisional or ventral
hernia; reducible). CPT code 49565 was identified as being performed
less than 50 percent of the time in the inpatient setting and being
primarily performed in the outpatient setting. Interested parties
requested referral to CPT to update the code's descriptor. In response
to the disparate site of service and request to update the code's
descriptor, CPT created new codes with 000-day global periods to
describe this type of service. The codes within this family are
differentiated by 3 characteristics: whether the hernia is initial or
recurrent, whether it is reducible or strangulated, and the total
length of the hernia. CPT also created two new codes that describe
parastomal
[[Page 45907]]
hernia repair and an add-on code for removal of mesh.
The RUC recommendations differentiate the post-operative periods
for the codes within this family by whether there is a same-day
discharge, overnight stay with a visit on the same date, or whether the
patient is admitted to the hospital. We disagree with many of the RUC-
recommended work RVUs for the codes within this family that have a
post-operative overnight stay built into their valuation. More
specifically, we disagree with the RUC-recommended work RVUs for such
codes because the RUC did not completely apply the 23-hour policy
calculation (finalized in the CY 2011 PFS final rule (75 FR 73226)) in
formulating its recommendations. Additionally, we disagree with the
RUC-recommended work RVUs for the CPT codes in this family for which
the RUC considered the patient to be admitted during the post-operative
period because the RUC did not apply the 23-hour policy when
formulating its recommendations.
As we noted in the CY 2011 PFS final rule (75 FR 73226), the work
RVUs for services that are typically performed in the outpatient
setting and require a hospital stay of less than 24 hours may in some
cases involve multiple overnight stays while the patient is still
considered to be an outpatient for purposes of Medicare payment.
Because such services are typically furnished in the outpatient
setting, they should not be valued to include inpatient post-operative
E/M visits. The level of discharge day management services included in
the valuation of such services should similarly not reflect an
inpatient discharge and should therefore be reduced. And finally, as
discussed in CY 2011 rulemaking, the intraservice time from the
inpatient level E/M postoperative visit should be reallocated to the
immediate postservice time of the service. The 23-hour policy
calculation, when fully applied to the calculation of a work RVU, is
used to reduce the value of discharge day management services, remove
the inpatient E/M visits, and reallocate the intraservice time to the
immediate post-service period. See the CY 2011 PFS final rule (75 FR
73226) for additional in-depth explanation of the 23-hour policy.
For the codes with an overnight stay and an E/M visit on the same
date built into their valuation, we believe the RUC only partially
applied the 23-hour policy when it applied the policy to the immediate
post service times, but not to the calculation of the work RVUs.
Instead, we believe the 23-hour policy should be fully applied to the
codes in this family that describe outpatient services for which there
is an overnight stay during the post-operative period, regardless of
the number of nights that a patient stays in the hospital. The services
to which the 23-hour policy is usually applied would typically involve
a patient stay in a hospital for less than 24 hours, which often means
the patient may stay overnight in the hospital. On occasion, the
patient may stay in the hospital longer than a single night; however,
in both cases (one night or more than one night), the patient is
considered to be a hospital outpatient, not an inpatient, for Medicare
purposes. In short, we do not believe that the work that is typically
associated with an inpatient service should be included in the work
RVUs for the outpatient services to which the 23-hour policy applies.
The RUC recommended a work RVU of 8.0 for CPT code 157X1
(Implantation of absorbable mesh or other prosthesis for delayed
closure of defect(s) (ie, external genitalia, perineum, abdominal wall)
due to soft tissue infection or trauma). CPT code 157X1 was surveyed
with having one subsequent hospital visit, CPT code 99232 (subsequent
hospital care/day 25 minutes) and 25 minutes of immediate post service
time. For purposes of calculating the recommended work RVU of 8.0, the
RUC considered CPT code 157X1 to describe an inpatient service, while
we consider CPT code 157X1 to describe an outpatient service for
purposes of Medicare billing. As noted above, we do not believe that
work that is typically associated with an inpatient service should be
included in the work RVUs for the outpatient services to which the 23-
hour policy applies. Therefore, the valuation for this code should not
include inpatient work in the post-operative period. See the CY 2022
PFS final rule (86 FR 65090) for further discussion on the 23-hour
policy as it relates to outpatient billing. We believe the 23-hour
policy should be fully applied to CPT code 157X1, and we disagree with
the RUC-recommended work RVU of 8.0.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we are instead proposing a
work RVU of 7.05 for CPT code 157X1 and a reallocation of the time
associated with the intra-service portion of the inpatient hospital
visit to the immediate postservice time of CPT code 157X1.
The steps for the 23-hour policy calculation are as follows:
Step (1): CPT code 157X1 does not have a hospital
discharge day management service; therefore, we will skip this step *.
Step (2): 8.0-1.39 ** = 6.61.
Step (3): 6.61 + (20 minutes x 0.0224) *** = 7.05 RVUs.
* Value associated with \1/2\ hospital discharge day management
service
** Value associated with an inpatient hospital visit, CPT code
99232.
*** Value associated with the reallocated intraservice time
multiplied by the postservice intensity of the 23-hour stay code.
The following CPT codes have a post-operative period that is
considered an overnight stay with a visit on the same date: CPT codes
49X02 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
incarcerated or strangulated), 49X03 (Repair of anterior abdominal
hernia(s) (ie, epigastric, incisional, ventral, umbilical, spigelian),
any approach (ie, open, laparoscopic, robotic), initial, including
placement of mesh or other prosthesis, when performed, total length of
defect(s); 3 cm to 10 cm, reducible), 49X04 (Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), initial,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
49X05 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), initial, including placement of mesh or other
prosthesis, when performed, total length of defect(s); greater than 10
cm, reducible), 49X08 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s);
less than 3 cm, incarcerated or strangulated), and 49X09 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
recurrent, including placement of mesh or other prosthesis, when
performed, total length of defect(s); 3 cm to 10 cm, reducible). The
RUC recommended a work RVU of 9.0 for CPT code 49X02, 10.80 for CPT
code 49X03, 14.0 for CPT code 49X04, 14.88 for CPT code 49X05, 10.79
for CPT code 49X08, and 12.0 for CPT code 49X09. CPT codes 49X02,
49X03, 49X08, and 49X09 were surveyed with
[[Page 45908]]
one subsequent inpatient hospital visit at a level of CPT code 99231
(subsequent hospital care/day 15 minutes). The RUC applied the 10
minutes of intraservice time from CPT code 99231 to the immediate
postservice time of these codes, resulting in a total immediate
postservice time of 30 minutes for these codes. CPT codes 49X04 and
49X05 were surveyed with a subsequent inpatient hospital visit at a
level of CPT code 99232. The RUC applied the 20 minutes of intraservice
time from CPT code 99232 to the immediate postservice time of both
codes, resulting in a total immediate postservice time of 40 minutes.
Much like our concerns regarding the RUC-recommended work RVU for
CPT code 157X1, we do not believe that the RUC fully applied the 23-
hour policy calculation when calculating the work RVUs for these codes
and we disagree with the RUC-recommended RVUs. While the RUC removed
the 99231 and 99232 inpatient visits included in the post-operative
period for these codes, the RUC did not subtract the values of these
visits from the work RVUs before making their work RVU recommendations.
In the CY 2011 PFS final rule (75 FR 73226), we stated that we do not
believe that the post-procedure hospital visits for outpatient services
should be at the inpatient level since the typical case is an
outpatient who would be ready to be discharged from the hospital in 23
hours or less. However, we agree with the RUC that the intra-service
time of the inpatient hospital visit may be included in the valuation
for 23-hour stay codes. Therefore, we believe that step 2 of the 23-
hour hour policy calculation, which involves deducting the RVUs of the
inpatient hospital visits from the starting work RVU value and
subsequently reallocating the time associated with the intra-service
portion of the inpatient hospital visits to the immediate postservice
time of the 23-hour stay code, should be fully applied when calculating
the work RVUs for CPT codes 49X02, 49X03, 49X04, 49X05, 49X08, and
49X09.
Using the 23-hour policy calculation described above and in the CY
2011 PFS final rule, we are proposing work RVUs of 8.46 for CPT code
49X02, 10.26 for CPT code 49X03, 13.46 for CPT code 49X04, 13.94 for
CPT code 49X05, 10.25 for CPT code 49X08, and 11.46 for CPT code 49X09.
The following CPT codes have a post-operative period that the RUC
considers to be admitted to a hospital: CPT code 49X06 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49X10 (Repair of anterior abdominal hernia(s) (ie,
epigastric, incisional, ventral, umbilical, spigelian), any approach
(ie, open, laparoscopic, robotic), recurrent, including placement of
mesh or other prosthesis, when performed, total length of defect(s); 3
cm to 10 cm, incarcerated or strangulated), 49X11 (Repair of anterior
abdominal hernia(s) (ie, epigastric, incisional, ventral, umbilical,
spigelian), any approach (ie, open, laparoscopic, robotic), recurrent,
including placement of mesh or other prosthesis, when performed, total
length of defect(s); greater than 10 cm, reducible), 49X12 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
recurrent, including placement of mesh or other prosthesis, when
performed, total length of defect(s); greater than 10 cm, incarcerated
or strangulated), 49X13 (Repair of parastomal hernia, any approach (ie,
open, laparoscopic, robotic), initial or recurrent, including placement
of mesh or other prosthesis, when performed; reducible), and 49X14
(Repair of parastomal hernia, any approach (ie, open, laparoscopic,
robotic), initial or recurrent, including placement of mesh or other
prosthesis, when performed; incarcerated or strangulated). The RUC
recommended a work RVU of 18.67 for CPT code 49X06, 15.55 RVUs for CPT
code 49X10, 16.03 RVUs for CPT code 49X11, 22.67 RVUs for CPT code
49X12, 13.70 RVUs for CPT code 49X13, and 17.06 RVUs for CPT code
49X14. CPT codes 49X06 and 49X12 were surveyed and recommended with one
subsequent inpatient hospital visit at a level of CPT code 99233
(subsequent hospital care/day 35 minutes). The RUC recommendations
include an immediate postservice time of 25 minutes for CPT code 49X06
and 30 minutes for CPT code 49X12. CPT codes 49X10, 49X11, and 49X14
were surveyed and recommended with one subsequent inpatient hospital
visit at a level of CPT code 99232. The RUC recommendations include an
immediate postservice time of 25 minutes for 49X10, 28 minutes for CPT
code 49X11, and 25 minutes for CPT code 49X14. CPT code 49X13 was
surveyed and recommended with one subsequent inpatient hospital visit
at a level of CPT code 99231 and an immediate postservice time of 25
minutes.
For purposes of calculating the recommended work RVUs, the RUC
considered these CPT codes to describe an admitted inpatient service,
while we consider the CPT codes to describe outpatient services for
purposes of billing. Therefore, we believe that inpatient work in the
post-operative period should not be included in the valuation. We
believe the 23-hour policy should be applied to these codes. Using the
23-hour policy calculation described above and in the CY 2011 PFS final
rule, we are proposing a work RVU of 18.67 for CPT code 49X06, 15.55
RVUs for CPT code 49X10, 16.03 RVUs for CPT code 49X11, 22.67 RVUs for
CPT code 49X12, 13.70 RVUs for CPT code 49X13, and 17.06 RVUs for CPT
code 49X14. We are also proposing revised immediate postservice times
for the reallocation of the time associated with the intraservice
portion of the inpatient hospital visit. We are proposing immediate
post service times of 40 minutes for CPT code 49X06, 35 minutes for CPT
code 49X10, 38 minutes for CPT code 49X11, 45 minutes for CPT code
49X12, 30 minutes for CPT code 49X13, and 35 minutes for CPT code
49X14.
The following CPT codes have a post-operative period that the RUC
considers to be a same day discharge: CPT code 49X01 (Repair of
anterior abdominal hernia(s) (ie, epigastric, incisional, ventral,
umbilical, spigelian), any approach (ie, open, laparoscopic, robotic),
initial, including placement of mesh or other prosthesis, when
performed, total length of defect(s); less than 3 cm, reducible) and
49X07 (Repair of anterior abdominal hernia(s) (ie, epigastric,
incisional, ventral, umbilical, spigelian), any approach (ie, open,
laparoscopic, robotic), recurrent, including placement of mesh or other
prosthesis, when performed, total length of defect(s); less than 3 cm,
reducible). The RUC-recommended a work RVU of 6.27 for CPT code 49X01
and 7.75 for CPT code 49X07. We disagree with the RUC-recommended RVU
for CPT code 49X01 because it falls above the median value for codes
with similar times. We are proposing a work RVU of 5.96 RVUs based on
the intraservice time ratio, which is the ratio of 90 minutes of
intraservice time of a current hernia repair code--CPT code 49560
(Repair initial incisional or ventral hernia; reducible) and the 45
minutes of intraservice time for CPT code 49X01. The proposed work RVU
of 5.96 is also supported by reference CPT code 93453 (Combined right
and left heart catheterization including
[[Page 45909]]
intraprocedural injection(s) for left ventriculography, imaging
supervision and interpretation, when performed). CPT code 93453 has a
work RVU of 5.99, the same intraservice time as CPT code 49X01(45
minutes), and a slightly higher total time of 113 minutes.
For CPT code 49X07, we disagree with the RUC-recommended work RVU
of 7.75, as it is above the median range compared to codes with similar
times. We are proposing a work RVU of 7.42 RVUs for CPT code 49X07
based off of the intraservice time ratio of 100 minutes of intraservice
time for a current hernia repair code--CPT code 49565 (Repair recurrent
incisional or ventral hernia; reducible), compared to the 60 minutes of
intraservice time for CPT code 49X07. The proposed work RVU of 7.42 is
also supported by reference CPT code 52353 (Cystourethroscopy, with
ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral
catheterization is included)). CPT code 52353 has a work RVU of 7.50
with the same intraservice time of 60 minutes and a very similar total
time of 133 minutes.
CPT code 49X15 (Removal of total or near-total non-infected mesh or
other prosthesis at the time of initial or recurrent anterior abdominal
hernia repair or parastomal hernia repair, any approach (ie, open,
laparoscopic, robotic)) is an add-on code. The RUC recommended a work
RVU of 5.0 for CPT code 49X15. The RUC recommendation is higher than
the work RVUs for many other CPT add-on codes with similar times. We
are proposing a work RVU of 2.61 RVUs for CPT code 49X15, based on the
reverse building block methodology. The proposed work RVU of 2.61 is
also supported by reference CPT code 15774 (Grafting of autologous fat
harvested by liposuction technique to face, eyelids, mouth, neck, ears,
orbits, genitalia, hands, and/or feet; each additional 25 cc injectate,
or part thereof (List separately in addition to code for primary
procedure)), which has a work RVU of 2.50 and the same total time of 45
minutes.
We reviewed the RUC-recommended direct PE inputs for all of the
codes within this family. We disagree with the RUC's recommendations of
66 total minutes of clinical staff time for CPT codes 49X01 and 49X07,
60 total minutes of clinical staff time for CPT codes 49X02, 49X03,
49X04, 49X05, 49X06, 49X08, 49X09, 49X10, 49X11, 49X12, 49X13, and
49X14, and 20 total minutes of clinical staff time for CPT code 157X1.
We note that the RUC recommended 090-day pre-service times for all of
these codes despite surveying all of the services as 000-day services.
In the CY 2022 PFS final rule (86 FR 65090), we stated we continue to
believe that setting and maintaining clinical labor time and valuation
standards provides greater consistency among codes that share clinical
labor tasks and could improve relativity of values among codes.
Therefore, we believe that the standard clinical labor packages that
are in accordance with the surveyed global period continue to be the
most appropriate for purposes of clinical labor valuation.
The RUC recommendations for CPT codes 49X01 and 49X07, and CPT
codes 49X02, 49X03, 49X04, 49X05, 49X06, 49X08, 49X09, 49X10, 49X11,
49X12, 49X13, and 49X14, include the standard for 090-day preservice
times for clinical labor activities, which is 60 minutes. For 49X01 and
49X07 in particular, the RUC also recommended an additional 6 minutes
in the post service period to conduct patient communications. We
disagree with the RUC-recommended 090-day times as these CPT codes were
surveyed by the RUC as 000-day services and should have times
consistent with 000-day services. Therefore, we are proposing the
standard clinical labor times for a 000-day extensive package for a
total pre-service clinical staff time of 30 minutes for CPT codes 49X01
through 49X14 with an additional standard 3 minutes of post-service
patient communications for 49X01 and 49X07. CPT code 49X15 is an add-on
code and does not have RUC-recommended direct PE inputs.
For CPT code 157X1, the RUC recommendation is 20 minutes of
clinical staff activities, which is standard for an emergent procedure
package. We do not agree that the service described by CPT code 157X1
should be considered an emergent procedure. Therefore, we are proposing
the minimal clinical staff package minus pre-service education for CPT
code 157X1, for a total of 12 clinical staff time minutes.
(2) Removal of Sutures or Staples (CPT Codes 15851, 158X1, and 158X2)
In October 2021, the CPT Editorial Panel approved the deletion of
CPT code 15850 and revised CPT code 15851 (Removal of sutures or
staples requiring anesthesia (ie, general anesthesia, moderate
sedation)), and created two new related CPT add-on codes, 158X1 and
158X2, to describe Removal of sutures or staples requiring anesthesia
(i.e., general anesthesia, moderate sedation). The RUC reviewed the
three codes: 15851, 158X1 and 158X2 at the January 2022 RUC meeting.
After reviewing CPT code 15851, we are proposing the RUC-
recommended work RVU of 1.10. CPT code 158X1 (Removal of sutures OR
staples not requiring anesthesia (List separately in addition to E/M
code)), and 1581X2 (Removal of sutures OR staples not requiring
anesthesia (List separately in addition to E/M code), are valued by the
RUC as PE-only codes. The RUC did not recommend any work inputs for
these two add-on codes and we are not proposing any work RVU
refinements.
We are also proposing the RUC-recommended direct PE inputs for CPT
codes 15851, 158X1, and 158X2 without refinement.
(3) Arthrodesis Decompression (CPT Codes 22630, 22632, 22633, 22634,
63052, and 63053)
In October 2020, the CPT Editorial Panel approved the revision of
four codes describing arthrodesis and the addition of two new add-on
codes, CPT codes 63052 (Laminectomy, facetectomy, or foraminotomy
(unilateral or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]),
during posterior interbody arthrodesis, lumbar; single vertebral
segment (List separately in addition to code for primary procedure))
and 63053 (Laminectomy, facetectomy, or foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s] [eg, spinal or lateral recess stenosis]), during posterior
interbody arthrodesis, lumbar; each additional segment (List separately
in addition to code for primary procedure)), to report laminectomy,
facetectomy, or foraminotomy during posterior interbody arthrodesis,
lumbar to more appropriately identify the decompression that may be
separately reported. In January 2021, the RUC reviewed the survey
results for the two new codes and expressed concern that the four base
codes had not been surveyed along with the two new add-on codes. The
RUC recommended that the entire family be resurveyed and presented for
review at its April 2021 meeting. The RUC suggested that until new
values could be established, interim values be established for CPT
codes 63052 and 63053, which CMS revised for CY 2022 based on the
survey data and RUC review available to us at the time of the
development of the CY 2022 PFS proposed rule. We have noted in similar
circumstances, such as the minimally invasive glaucoma surgery (MIGS)
procedures with cataract surgery discussed in the CY 2022 PFS final
rule (86 FR 65097), that it is best for entire
[[Page 45910]]
code families to be surveyed at the same time. We also noted that we
finalized a policy in the CY 2015 PFS final rule (79 FR 67602 through
67609) to make all changes in the work and MP RVUs and the direct PE
inputs for new, revised, and potentially misvalued services under the
PFS by proposing and then finalizing such changes through notice and
comment rulemaking, as opposed to initially finalizing changes on an
interim final basis.
For CPT codes 22630 (Arthrodesis, posterior interbody technique,
including laminectomy and/or discectomy to prepare interspace (other
than for decompression), single interspace; lumbar), 22633
(Arthrodesis, combined posterior or posterolateral technique with
posterior interbody technique including laminectomy and/or discectomy
sufficient to prepare interspace (other than for decompression), single
interspace; lumbar), 22634 (Arthrodesis, combined posterior or
posterolateral technique with posterior interbody technique including
laminectomy and/or discectomy sufficient to prepare interspace (other
than for decompression), single interspace; each additional interspace
and segment (List separately in addition to code for primary
procedure)), 63052, and 63053, we disagree with the RUC-recommended
work RVUs of 22.09, 26.80, 7.96, 5.70, and 5.00, respectively, because
these values do not account for the surveyed changes in time, and we
are proposing a work RVU of 20.42 for CPT code 22630, a work RVU of
24.83 for CPT code 22633, a work RVU of 7.30 for CPT code 22634, the
current work RVU of 4.25 for CPT code 63052 and a work RVU of 3.78 for
CPT code 63053. For CPT code 22632 (Arthrodesis, posterior interbody
technique, including laminectomy and/or discectomy to prepare
interspace (other than for decompression), single interspace; each
additional interspace (List separately in addition to code for primary
procedure)), we agree with the RUC-recommended maintenance of the
current work RVU of 5.22, as there were no surveyed changes in time.
We are proposing a work RVU of 20.42 for CPT code 22630 based on
the reverse building block methodology to account for the surveyed 8-
minute decrease in total time, 10-minute decrease in pre-service time,
30-minute decrease in intraservice time, and 2-minute decrease in
immediate post-service time. We believe 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, it would be inappropriate to maintain the current work RVU
given the significant decrease in intraservice time without adequate
justification of increased intensity. There are currently three CPT
code 99231 (Subsequent hospital care/day 15 minutes) and four CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits bundled in
CPT code 22630's 090-day global period and valuation. The RUC
recommended that the post-operative period for CPT code 22630 change to
include two CPT code 99232 (subsequent hospital care/day 25 minutes),
one CPT code 99231, one CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter.), and two CPT code 99213 visits. The currently bundled post-
operative visits total to 6.16 work RVUs, whereas the RUC-recommended
changes to the post-operative visits total 6.98 work RVUs, resulting in
a 0.82 work RVU increase (if no other changes occurred to CPT code
22630). The proposed work RVU of 20.42 for CPT code 22630 maintains the
same IWPUT of 0.067 and maintains the 0.82 work RVU difference between
the current and RUC-recommended post-operative period. We believe this
proposed work RVU is more accurate than the RUC-recommended work RVU
because there was no obvious or explicitly stated rationale in the
RUC's recommendations for the change in intensity of intraservice time,
and there was a 30-minute decrease in intraservice time for CPT code
22630. We believe 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, it would be
inappropriate to propose the RUC-recommended work RVU for CPT code
22630.
Similarly, we are proposing a work RVU of 24.83 for CPT code 22633,
based on the reverse building block methodology, to account for the
surveyed 56-minute decrease in total time, 20-minute decrease in
intraservice time, and 33-minute decrease in post-operative time. The
reverse building block methodology accounts for the time and intensity
of post-operative work through long-established and agreed-upon times
and intensities for bundled post-operative visits, and accurately
adjusts for the changes occurring in the post-operative period. There
is currently one post-operative CPT code 99232, two CPT code 99233
(Subsequent hospital care/day 35 minutes), and three CPT code 99213
visits bundled in CPT code 22633's valuation. The RUC recommended that
the post-operative period for CPT code 22633 change to include two CPT
code 99232, one CPT code 99231, one CPT code 99214 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making. When using
time for code selection, 30-39 minutes of total time is spent on the
date of the encounter.), and two CPT code 99213 visits. The currently
bundled post-operative visits total to 8.30 work RVUs, whereas the RUC-
recommended changes to the post-operative visits total 6.98 work RVUs,
resulting in a 1.32 work RVU decrease (if no other changes occurred to
CPT code 22633). Using the reverse building block methodology, the
proposed work RVU of 24.83 maintains the same IWPUT of 0.080 and the
1.32 work RVU difference between the current and RUC-recommended post-
operative period. We believe this proposed work RVU is more accurate
than the RUC-recommended work RVU because there was no obvious or
explicitly stated rationale in the RUC's recommendations for the change
in intensity of intraservice time, and there was a 20-minute decrease
in intraservice time for CPT code 22633. We believe 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, it would be inappropriate to propose the RUC-
recommended work RVU decrease of 0.95, which is only about three-
quarters of the established decrease in work RVU of 1.32 and intensity
from the changes in the post-operative period alone. We also considered
the apparent decrease in intraservice time and the lack of an adequate
justification for increased intensity to arrive at our proposed work
RVU of 24.83 for CPT code 22633.
We are proposing a work RVU of 7.30 for CPT code 22634 based on a
comparison to its base code, CPT code 22633. We used the proposed work
RVU of 24.83 for the parent CPT code (22633) as the numerator and the
current work
[[Page 45911]]
RVU for CPT code 22633 of 27.75 as the denominator, and multiplied that
fraction by the current work RVU of 8.16 for CPT code 22634 to arrive
at a proportionate proposed work RVU of 7.30 for CPT code 22634
((24.83/27.75) * 8.16) = 7.30). The proposed work RVU accounts for the
decrease in intraservice time and is well bracketed by CPT code 34820
(Open iliac artery exposure for delivery of endovascular prosthesis or
iliac occlusion during endovascular therapy, by abdominal or
retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 7.00 work RVUs with an
intraservice time of 60 minutes, and CPT code 34833 (Open iliac artery
exposure with creation of conduit for delivery of endovascular
prosthesis or for establishment of cardiopulmonary bypass, by abdominal
or retroperitoneal incision, unilateral (List separately in addition to
code for primary procedure)), valued at 8.16 work RVUs with an
intraservice time of 72 minutes.
CPT codes 63052 and 63053 were new add-on codes to report
decompression when performed in conjunction with posterior interbody
arthrodesis at the same interspace for CY 2022. The proposed work RVU
for CPT code 63052 would maintain the current work RVU, despite a
surveyed change in time. In the CY 2022 PFS final rule, we finalized a
work RVU of 4.25 for CPT code 63052 for CY 2022 based on a crosswalk to
CPT code 22853 (Insertion of interbody biomechanical device(s) (e.g.,
synthetic cage, mesh) with integral anterior instrumentation for device
anchoring (e.g., screws, flanges), when performed, to intervertebral
disc space in conjunction with interbody arthrodesis, each interspace
(List separately in addition to code for primary procedure)), which has
a work RVU of 4.25 and an intraservice time of 45 minutes. Despite a
surveyed 5-minute intraservice time increase for CPT code 63052, we
believe the crosswalk to CPT code 22853 is still valid, given that only
3 months passed between the two surveys, as it now has the same
intraservice time as CPT code 63052, is a spinal procedure, and is an
add-on code to the same base codes as CPT code 63052. Commenters on the
CY 2022 PFS proposed rule supported the bracket of key reference
service CPT code 22552 (Arthrodesis, anterior interbody, including disc
space preparation, discectomy, osteophytectomy and decompression of
spinal cord and/or nerve roots; cervical below C2, each additional
interspace (List separately in addition to code for primary procedure))
and MPC CPT code 34812 (Open femoral artery exposure for delivery of
endovascular prosthesis, by groin incision, unilateral (List separately
in addition to code for primary procedure)), and therefore, we noted
that the final work RVU of 4.25 for CY 2022 was supported by the
commenters (86 FR 65092). CPT code 22552 has a work RVU of 6.50 and an
intraservice time of 45 minutes, and commenters noted that CPT code
22552 has a higher intensity as anticipated for a surgical procedure
and in comparison with a lumbar procedure. CPT code 34812 has a work
RVU of 4.13 and 40 minutes of intraservice time, and commenters noted
that this code involves open femoral artery exposure by groin incision
and closure of the wound, typically for separately reported delivery of
an endovascular prosthesis for an asymptomatic infrarenal abdominal
aortic aneurysm. In comparison, exposure and closure for CPT code 63052
are performed as part of the primary arthrodesis code and the
intraservice time includes higher intensity bony and soft tissue
resection, and therefore, although both codes require the same time,
the physician work and intensity of CPT code 63052 is greater than CPT
code 34812.
In the CY 2022 PFS final rule, we finalized a work RVU of 3.19 for
CPT code 63053 for CY 2022 based on an intraservice time ratio between
CPT codes 63052 and 63053 ((30 minutes/40 minutes) * 4.25 = 3.19). We
believe this intraservice time ratio between the two CPT codes is still
valid, given that only 3 months passed between the two surveys, and
therefore, we are proposing a work RVU of 3.78 based on the surveyed
time changes for CPT codes 63052 and 63053 ((40 minutes/45 minutes) *
4.25 = 3.78) in order to maintain consistency with previous analysis of
time and intensity of these two add-on codes. Due to the lack of an
obvious or explicitly stated rationale in the RUC's April
recommendations for the change in intensity between the January 2021
and April 2021 surveys, we relied on the changes in surveyed time to
calculate the proposed work RVUs for CPT codes 63052 and 63053.
We are proposing the RUC-recommended PE inputs for CPT codes 22630
and 22633.
(4) Total Disc Arthroplasty (CPT Codes 22857 and 228XX)
In September 2021, the CPT Editorial Panel created CPT Category I
code 228XX to describe Total disc arthroplasty (artificial disc),
anterior approach, including discectomy to prepare interspace (other
than for decompression); second interspace, lumbar (List separately in
addition to code for primary procedure) and replace CPT Category III
code 0163T (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression), each additional interspace, lumbar (List separately in
addition to code for primary procedure)), which prompted CPT codes
228XX and 22857 (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression); single interspace, lumbar) to be surveyed for the
January 2022 RUC meeting. At the January 2022 RUC meeting, the
specialty societies indicated, and the RUC agreed, that the survey
results for both CPT codes 22857 and 228XX were erroneous and that the
codes should be resurveyed for the April 2022 RUC meeting. Therefore,
we are proposing to maintain the RUC-recommended work RVU of 27.13 for
CPT code 22857 and contractor pricing for CPT code 228XX for CY 2023.
We will revisit the valuations of CPT codes 22857 and 228XX in future
rulemaking when we have received the April 2022 RUC recommendations,
based on our annual review process discussed in the Background section
of this proposed rule.
(5) Insertion of Spinal Stability Distractive Device (CPT Codes 22869
and 22870)
For CPT codes 22869 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without open decompression or fusion,
including image guidance when performed, lumbar; single level) and
22870 (Insertion of interlaminar/interspinous process stabilization/
distraction device, without open decompression or fusion, including
image guidance when performed, lumbar; second level (List separately in
addition to code for primary procedure)), we are proposing to maintain
the current work RVUs of 7.03 and 2.34, respectively. We are proposing
the RUC-recommended direct PE inputs for CPT code 22869 without
refinement.
(6) Knee Arthroplasty (CPT Codes 27446 and 27447)
CPT codes 27446 (Arthroplasty, knee, condyle and plateau; medial OR
lateral compartment) and 27447 (Arthroplasty, knee, condyle and
plateau; medial AND lateral compartments with or without patella
resurfacing (total knee arthroplasty)) were reviewed by the RUC in
April 2021. We previously reviewed CPT code 27447 in the CY
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2021 PFS final rule; (see 85 FR 84609 and 84610 for our previous
discussion). The RUC proposed a revised survey instrument to ask about
additional pre-operative time and resources spent on pre-optimization
patient work. The RUC agreed that the pre-service planning activities
are being performed routinely for the typical patient but the inclusion
of this work is not reflected in the 090-day global period structure.
The RUC indicated that separate planning codes may be developed, or
current codes such as the prolonged service codes may be reported for
these activities.
We are proposing the RUC-recommended work RVU of 17.13 for CPT code
27446. The survey 25th percentile actually showed an increase in work
RVU even though there was a decrease in total time. One post facility
visit, CPT code 99232 (Subsequent hospital care/day 25 minutes), was
removed and replaced with CPT code 99214 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using time for code
selection, 30-39 minutes of total time is spent on the date of the
encounter) a post-operative visit in the office. Given a decrease in
the total time spent and a lower level post-operative visit, it is
reasonable that the work RVU went down. There was no change in the
global period.
For CPT code 27447, the RUC reaffirmed the same valuation that it
recommended for the CY 2021 PFS rulemaking cycle. Since we did not
receive any new information regarding this code, we are not proposing
to change our previously finalized values (see 85 FR 84609 and 84610
for our previous discussion of this code in the CY 2021 PFS final
rule). We are proposing to maintain a work RVU of 19.60 for CPT code
27447, the value that we previously finalized through rulemaking. We
are proposing the RUC-recommended direct PE inputs for CPT code 27446
and we are proposing to maintain the direct PE inputs for CPT code
27447.
(7) Endovascular Pulmonary Arterial Revascularization (CPT Codes 338X3,
338X4, 338X5, 338X6, and 338X7)
At the February 2021 meeting of the CPT Editorial Panel, CPT
approved a new family of Category I CPT codes to describe percutaneous
endovascular repair of pulmonary artery stenosis (PAS) by stent
replacement. CPT codes 338X3 through 338X7 were surveyed by the RUC at
the October 2021 RUC meeting.
We disagree with the RUC-recommended work RVU of 14.0 for CPT code
338X3 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We are proposing the survey 25th percentile
work RVU of 11.03 for CPT code 338X3. A work RVU of 11.03 is supported
by a bracket of reference CPT codes, including CPT code 61650 and CPT
code 61640. CPT code 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) has a work RVU of 10.0
and the same intraservice time of 90 minutes and the same total time of
206 minutes. CPT code 61640 (Balloon dilatation of intracranial
vasospasm, percutaneous; initial vessel) has a work RVU of 12.32 and an
intraservice time of 90 minutes and a higher total time of 233 minutes.
There are no direct PE inputs for CPT Code 338X3.
We disagree with the RUC-recommended work RVU of 18.0 for CPT code
338X4 (Percutaneous pulmonary artery revascularization by stent
placement, initial; normal native connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We are proposing the survey 25th percentile
work RVU of 14.50. A work RVU of 14.50 is supported by a reference CPT
code--CPT code 11005. CPT code 11005 (Debridement of skin, subcutaneous
tissue, muscle and fascia for necrotizing soft tissue infection;
abdominal wall, with or without fascial closure) has a work RVU of
14.24 and the same intraservice time of 120 minutes and nearly the same
total time of 235 minutes.
There are no direct PE inputs for CPT Code 338X4.
We disagree with the RUC-recommended work RVU of 17.33 for CPT code
338X5 (Percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, unilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We are proposing the survey 25th percentile
work RVU of 14.0. A work RVU of 14.0 is supported by a reference CPT
code--CPT code 61640. CPT code 61640 (Balloon dilatation of
intracranial vasospasm, percutaneous; initial vessel) has a work RVU of
12.32 and the same intraservice time of 90 minutes and a higher total
time of 233 minutes.
There are no direct PE inputs for CPT Code 338X5.
We disagree with the RUC-recommended work RVU 20.0 for CPT code
338X6 (percutaneous pulmonary artery revascularization by stent
placement, initial; abnormal connections, bilateral). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. Although we disagree with the RUC-recommended
work RVU, we concur that the relative difference in work between CPT
codes 338X4 and 338X6 is equivalent to the RUC-recommended interval of
2.0 RVUs. Therefore, we are proposing a work RVU of 16.50 for CPT code
338X6, based on the recommended interval of 2.0 additional RVUs above
our proposed work RVU of 14.50 for CPT code 338X4. A work RVU of 16.50
is also supported by a reference code--CPT code 11005. CPT code 11005
(Debridement of skin, subcutaneous tissue, muscle and fascia for
necrotizing soft tissue infection; abdominal wall, with or without
fascial closure) has a work RVU of 14.24 and the same intraservice time
of 120 minutes and a higher total time of 265 minutes.
There are no direct PE inputs for CPT Code 338X6.
We disagree with the RUC-recommended RVU of 7.27 for CPT code 338X7
(Percutaneous pulmonary artery revascularization by stent placement,
each additional vessel or separate lesion, normal or abnormal
connections (list separately in addition to code for primary procedure)
(use 338X7 in conjunction with 338X3, 338X4, 338X5, 338X6)). The RUC
recommendation is the survey median and appears to be high compared to
codes with similar times. We are proposing the survey 25th percentile
work RVU of 5.53. A work RVU of 5.53 is supported by a reference code--
CPT code 57267. CPT code 57267 (Insertion of mesh or other prosthesis
for repair of pelvic floor defect, each site (anterior, posterior
compartment), vaginal approach (List separately in addition to code for
primary procedure) has a work RVU of 4.88 and the same time of 45
minutes.
There are no direct PE inputs for CPT code 338X7.
(8) Percutaneous Arteriovenous Fistula Creation (CPT Codes 368X1 and
368X2)
In October 2021, the CPT Editorial Panel created CPT codes 368X1
(Percutaneous arteriovenous fistula creation, upper extremity, single
access of both the peripheral artery and
[[Page 45913]]
peripheral vein, including fistula maturation procedures (e.g.,
transluminal balloon angioplasty, coil embolization) when performed,
including all vascular access, imaging guidance and radiologic
supervision and interpretation) and 368X2 (Percutaneous arteriovenous
fistula creation, upper extremity, separate access sites of the
peripheral artery and peripheral vein, including fistula maturation
procedures (e.g., transluminal balloon angioplasty, coil embolization)
when performed, including all vascular access, imaging guidance and
radiologic supervision and interpretation) to describe the creation of
an arteriovenous fistula in an upper extremity via a percutaneous
approach. Previously, CPT coding did not account for percutaneous
arteriovenous access creation, as current the CPT codes only describe
an open surgical approach. Given that new technologies have been
developed that allow for less invasive approaches that utilize
percutaneous image-guided methods to approximate a target artery and
vein using magnets or mechanical capture, we created HCPCS codes G2170
(Percutaneous arteriovenous fistula creation (avf), direct, any site,
by tissue approximation using thermal resistance energy, and secondary
procedures to redirect blood flow (e.g., transluminal balloon
angioplasty, coil embolization) when performed, and includes all
imaging and radiologic guidance, supervision and interpretation, when
performed) and G2171 (Percutaneous arteriovenous fistula creation
(avf), direct, any site, using magnetic-guided arterial and venous
catheters and radiofrequency energy, including flow-directing
procedures (e.g., vascular coil embolization with radiologic
supervision and interpretation, when performed) and fistulogram(s),
angiography, venography, and/or ultrasound, with radiologic supervision
and interpretation, when performed) in July 2020 that describe two
approaches to percutaneous arteriovenous access creation. The RUC
intends for CPT codes 368X1 and 368X2, which represent two percutaneous
approaches to creating arteriovenous access for End-Stage Renal Disease
(ERSD) patients during hemodialysis, to replace HCPCS codes G2170 and
G2171, and has requested both G2170 and G2171 be deleted. For CY 2023,
the RUC recommended a work RVU of 7.50 for CPT code 368X1, and a work
RVU of 9.60 for CPT code 368X2.
We disagree with the RUC-recommended RVUs for CPT codes 368X1 and
368X2. We found that the recommended work RVUs were high when compared
to other codes with similar time values. The RUC-recommended RVU of
7.50 for 368X1 is the second highest RVU for codes with 55 to 65
minutes of intraservice time and 94 to 114 minutes of total time, with
RVUs ranging from 2.45 to 8.84. Similarly, the RUC-recommended RVU of
9.60 for 368X2 is the third highest RVU for codes with 65 to 85 minutes
of intraservice time and 109 to 129 minutes of total time, with RVUs
ranging from 4.69 to 10.95. Therefore, we are proposing a work RVU of
7.20 for CPT code 368X1, and a work RVU of 9.30 for CPT code 368X2.
We disagree with the RUC-recommended work RVU of 7.50 for CPT code
368X1 and are proposing an RVU of 7.20 that is based on the intra-
service time ratio calculation using the second reference code from the
RUC survey, CPT code 36905 (Percutaneous transluminal mechanical
thrombectomy and/or infusion for thrombolysis, dialysis circuit, any
method, including all imaging and radiological supervision and
interpretation, diagnostic angiography, fluoroscopic guidance, catheter
placement(s), and intraprocedural pharmacological thrombolytic
injection(s); with transluminal balloon angioplasty, peripheral
dialysis segment, including all imaging and radiological supervision
and interpretation necessary to perform the angioplasty). The proposed
RVU of 7.20 is based on the intra-service time ratio using the RUC-
recommended 60 minutes intra-service time for CPT code 368X1 divided by
75 minutes of intra-service time for CPT code 36905, then multiplying
by the RVU of 9.00 for CPT code 36905 ((60/75) x 9.00 = 7.20). We chose
to use the second reference code from the RUC survey, CPT code 36905,
in this calculation because its intra-service time and total time
values were closer to the time values proposed by the RUC for CPT code
368X1. We note that the RUC-recommended RVU of 7.50 is one of the
highest values within the range of reference codes we reviewed with the
same intra-service time and similar total time. The proposed work RVU
of 7.20 is supported by the reference CPT codes we compared to CPT code
368X1 with the same 60 minutes of intra-service time and similar total
time as CPT code 368X1; reference CPT code 47541 (Placement of access
through the biliary tree and into small bowel to assist with an
endoscopic biliary procedure (e.g., rendezvous procedure),
percutaneous, including diagnostic cholangiography when performed,
imaging guidance (e.g., ultrasound and/or fluoroscopy), and all
associated radiological supervision and interpretation, new access) has
a work RVU of 6.75, and reference CPT code 33991 (Insertion of
ventricular assist device, percutaneous, including radiological
supervision and interpretation; left heart, both arterial and venous
access, with transseptal puncture) has a work RVU of 8.84. Again, we
believe 7.20 is a more appropriate value overall than 7.50 when
compared to the range of codes with the same intra-service time and
similar total time.
Although we disagree with the RUC-recommended work RVU of 9.60 for
CPT code 368X2, we concur that the relative difference in work between
CPT codes 368X1 and 368X2 is equivalent to the RUC-recommended interval
of 2.10 RVUs. We believe the use of an incremental difference between
these CPT codes is a valid methodology for setting values, especially
in valuing services within a family of codes where it is important to
maintain an appropriate intra-family relativity. Therefore, we are
proposing a work RVU of 9.30 for CPT code 368X2, based on the RUC-
recommended interval of 2.10 RVUs above our proposed work RVU of 7.20
for CPT code 368X1.
For the direct PE inputs, we are seeking additional information on
two equipment items and four supply items. For two of those four supply
items, we are requesting a justification for their inclusion as direct
PE inputs. The RUC submitted invoices for two new equipment inputs; one
for a Wavelinq EndoAVF generator (EQ403) used for CPT code 368X2, and
the other for an Ellipsys EndoAVF generator (EQ404) used for CPT code
368X1. We are seeking comments and requesting information that may
inform us why the Wavelinq generator (EQ403) is so much more expensive
on its invoice as compared with the Ellipsys generator (EQ404) since
the former costs $18,580 and the latter costs $3,000.
In addition, the RUC included supply items SD149 (catheter, balloon
inflation device) and SD152 (catheter, balloon, PTA) as direct PE
inputs for CPT codes 368X1 and 368X2. We are seeking comments and
requesting information that may inform us if supply items SD149 and
SD152 are typical, and how often they are used, for CPT codes 368X1 and
368X2. Also, the RUC included supply items SF056 (detachable coil) and
SF057 (non-detachable embolization coil) as direct PE inputs for CPT
code 368X2 (one each for SF056 and two each for SF057). We are seeking
comments and requesting information that may provide us with a
[[Page 45914]]
justification for keeping supply items SF056 and SF057 as direct PE
inputs for CPT code 368X2. We need to know if both of these supply
items are typical and how often they are used for CPT code 368X2. If
these supply inputs are not typical for these procedures, we believe
that they should be removed from the direct PE inputs.
We are proposing to delete HCPCS codes G2170 and G2171 and replace
them with CPT codes 368X1 and 368X2 as recommended by the RUC.
(9) Energy Based Repair of Nasal Valve Collapse (CPT Codes 37X01 and
30468)
In September 2021, the CPT Editorial Panel created CPT code 37X01
(Repair of nasal valve collapse with low energy, temperature-controlled
(i.e., radiofrequency) subcutaneous/submucosal remodeling) which is
currently reported with an unlisted code. For the January 2022 RUC
meeting, both CPT code 37X01 and CPT code 30468 (Repair of nasal valve
collapse with subcutaneous/submucosal lateral wall implant(s)) were
reviewed. For CY 2023, the RUC recommended a work RVU of 2.70 for CPT
code 37X01, and no change to the current work RVU of 2.80 for CPT code
30468.
The RUC reviewed the specialty society request to affirm the recent
RUC valuations for CPT code 30468, which was surveyed and valued by the
RUC in January 2020 for CY 2021. The RUC agreed, so for CY 2023, the
RUC is not recommending any change to the current work RVU of 2.80 for
CPT code 30468. In addition, the PE Subcommittee reviewed the direct
practice expense inputs and made modifications to the pre-service
clinical staff time to CPT code 30468 in accordance with current
standards. There was a previous oversight in valuing the direct PE
inputs for CPT code 30468. Therefore, 3 minutes of clinical staff time
has been added to CPT code 30468 for clinical activity CA005 (complete
pre-procedure phone calls and prescription).
We are proposing to maintain the current work RVU of 2.80 for CPT
code 30468 as recommended by the RUC. We are also proposing the RUC-
recommended direct PE inputs for CPT code 30468, which now includes
clinical activity code CA005, without refinement.
For CPT code 37X01, the RUC recommended a work RVU of 2.70 based on
a direct work RVU crosswalk from CPT code 31295 (Nasal/sinus endoscopy,
surgical, with dilation (e.g., balloon dilation); maxillary sinus
ostium, transnasal or via canine fossa). We disagree with the RUC-
recommended work RVU of 2.70. Therefore, we are proposing a work RVU of
2.44 for CPT code 37X01, which is the same RVU as CPT code 31297
(Nasal/sinus endoscopy, surgical, with dilation (e.g., balloon
dilation); sphenoid sinus ostium) and has the same 20 minutes of intra-
service time and similar total time. We note that CPT code 31295, which
the RUC used as a direct crosswalk for the work RVU for CPT code 37X01,
has the same 20 minutes of intra-service time and 56 minutes of total
time as CPT code 31297. We believe the RUC should have used CPT code
31297 as the crosswalk for CPT code 37X01. Both CPT codes 31295 and
31297 were reviewed in 2017 and are in the same code family. The
proposed work RVU of 2.44 is supported by the reference CPT codes we
compared to CPT code 37X01 with the same 20 minutes of intra-service
time and similar total time as CPT code 37X01; reference CPT code 31233
(Nasal/sinus endoscopy, diagnostic; with maxillary sinusoscopy (via
inferior meatus or canine fossa puncture)) with an RVU of 2.18, and CPT
code 31295 with an RVU of 2.70. Again, we believe 2.44 is a more
appropriate value overall than 2.70 when compared to the range of codes
with the same intra-service time and similar total time.
We are proposing the RUC-recommended direct PE inputs for CPT code
37X01 without refinement.
(10) Drug Induced Sleep Endoscopy (DISE) (CPT Code 42975)
In October 2020, the CPT Editorial Panel created CPT code 42975
(Drug-induced sleep endoscopy, with dynamic evaluation of velum,
pharynx, tongue base, and larynx for evaluation of sleep-disordered
breathing, flexible, diagnostic) to report drug induced sleep endoscopy
(DISE) flexible, diagnostic. At the January 2021 RUC Meeting, the RUC
requested that this service be resurveyed for the April 2021 RUC
Meeting using a standard 000-day survey template. For CY 2023, the RUC
recommended a work RVU of 1.95 for CPT code 42975.
We disagree with the RUC-recommended work RVU of 1.95 for CPT code
42975 and are proposing a work RVU of 1.58. We believe the RVU should
be lower than the RUC recommendation of 1.95 to reflect the decrease in
total time from 68 minutes to 50 minutes. The proposed RVU of 1.58 is
based on the total time ratio calculation using the RUC-recommended 50
minutes total time for CPT code 42975 divided by the 48 minutes of
total time for CPT code 43197 (Esophagoscopy, flexible, transnasal;
diagnostic, including collection of specimen(s) by brushing or washing,
when performed (separate procedure)), then multiplying by the RVU of
1.52 for CPT code 43197 ((50/48) x 1.52 = 1.58). We found that CPT code
43197 has the same intra-service time and similar total time as CPT
code 42975. Also, CPT code 43197 is a similar endoscopic procedure as
CPT codes 42975 and 31579 (Laryngoscopy, flexible or rigid telescopic,
with stroboscopy). We note that CPT code 31579 is the first key
reference code in the RUC survey. The proposed work RVU of 1.58 is
supported by the reference CPT codes we compared to CPT code 42975 with
the same 15 minutes of intra-service time and similar total time as CPT
code 42975; reference CPT code 43200 (Esophagoscopy, flexible,
transoral; diagnostic, including collection of specimen(s) by brushing
or washing, when performed (separate procedure)) with an RVU of 1.42,
and CPT code 62272 (Spinal puncture, therapeutic, for drainage of
cerebrospinal fluid (by needle or catheter)) with an RVU of 1.58.
Again, we believe the proposed RVU of 1.58 is a more appropriate value
overall than 1.95 when compared to the range of codes with the same
intra-service time and similar total time.
We are proposing the RUC-recommended direct PE inputs for CPT code
42975 without refinement.
(11) Endoscopic Bariatric Device Procedures (CPT Codes 43235, 43X21,
and 43X22)
In February 2021, the CPT Editorial Panel created CPT codes 43X21
(Esophagogastroduodenoscopy, flexible, transoral; with deployment of
intragastric bariatric balloon) and 43X22 (Esophagogastroduodenoscopy,
flexible, transoral; with removal of intragastric bariatric balloon(s))
for endoscopic bariatric device procedures to the
esophagogastroduodenoscopy (EGD) code family. CPT code 43235
(Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing, when performed
(separate procedure)) is the base code for the EGD family and was
surveyed with the new endoscopic bariatric device procedures, 43X21 and
43X22. All three of these CPT codes were reviewed at the April 2021 RUC
meeting. For CY 2023, the RUC recommended an RVU of 3.11 for CPT code
43X21, an RVU of 2.80 for CPT code 43X22, and maintaining the current
work RVU of 2.09 for CPT code 43235.
We are proposing the RUC-recommended work RVU of 3.11 for
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CPT code 43X21, the RUC-recommended work RVU of 2.80 for CPT code
43X22, and maintaining the current work RVU of 2.09 for CPT code 43235
for this code family.
We are proposing the direct PE inputs for CPT code 43235 without
refinement. However, we are proposing refinements to the direct PE
inputs for CPT codes 43X21 and 43X22.
For CPT code 43X21, we are proposing refinements to the direct PE
inputs for clinical labor activity codes CA001 (complete pre-service
diagnostic and referral forms) and CA011 (provide education/obtain
consent). We are proposing to refine CA001 from 5 minutes to the
standard 3 minutes since no explanation was provided to support 5
minutes for this clinical labor activity. We are proposing to refine
CA011 from 15 minutes to 10 minutes since it was not clear why this
much time for education is needed, and we do not believe that the
recommended 15 minutes would be typical for the procedure. Also, when
we looked at other procedures with clinical labor activity code CA011
we did not find many procedures with more than 12 minutes for this
activity. Therefore, we are proposing to refine the clinical labor
activity times for CA001 and CA011 for CPT code 43X21 as described
above, and to accept the remaining RUC-recommended direct PE inputs
without refinement.
For CPT code 43X22, we are proposing a refinement to the direct PE
input for clinical labor activity code CA016 (prepare, set-up and start
IV, initial positioning and monitoring of patient) from 10 minutes to
the standard 2 minutes. In the PE Summary of Recommendations for non-
facility direct PE inputs provided by the RUC, the RUC recommended 8
minutes above the standard 2 minutes for CA016 and stated this clinical
labor activity was identical to the 10 minutes for positioning the
patient as CPT code 43260 (Endoscopic retrograde
cholangiopancreatography (ERCP); diagnostic, including collection of
specimen(s) by brushing or washing, when performed (separate
procedure)). However, our study of this code family could not find 10
minutes of non-facility direct PE inputs for clinical labor activity
CA016. Also, CPT code 43260 is only performed in a facility and does
not have any non-facility clinical labor times. Therefore, we are
proposing to refine the clinical labor activity time for CA016 for CPT
code 43X22 as described above, and to accept the remaining RUC-
recommended direct PE inputs without refinement. This proposed
reduction of 8 minutes to the CA016 clinical labor activity also
carries over to the equipment times for the suction machine (Gomco)
(EQ235), the scope video system (monitor, processor, digital capture,
cart, printer, LED light) (ES031), and the multi-channeled flexible
digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087)
which we are proposing to reduce by the same 8 minutes.
(12) Delayed Creation Exit Site From Embedded Catheter (CPT Code 49436)
CPT code 49436 (Delayed creation of exit site from embedded
subcutaneous segment of intraperitoneal cannula or catheter) was
finalized as potentially misvalued in the CY 2022 PFS final rule (86 FR
64996) and the code was found to be appropriate to value for the non-
facility/office setting. The RUC only reviewed the PE inputs for this
service at the January 2022 meeting. The RUC recommended 5 minutes for
Clinical Activity Code CA013, line 34 in the non-facility/office
setting on the RUC-recommended PE spreadsheet. We disagree with the
RUC-recommended time, and are proposing the standard time of 2 minutes,
as an adequate rationale was not provided for the additional time in
the global space. This proposed reduction of 3 minutes to the CA013
clinical labor activity also carries over to the equipment times, which
we are proposing to reduce by the same 3 minutes. Otherwise, we agreed
with the RUC-recommended clinical labor times for activity codes CA011
and CA018, and we are proposing the remaining refinements as
recommended.
The RUC did not recommend any work inputs for this code and we are
not proposing any work RVU refinements.
(13) Percutaneous Nephrolithotomy (CPT Codes 50080, 50081)
In September 2021, the CPT Editorial Panel revised the descriptors
to CPT codes 50080 (Percutaneous nephrolithotomy or pyelolithotomy,
lithotripsy stone extraction, antegrade ureteroscopy, antegrade stent
placement and nephrostomy tube placement, when performed, including
imaging guidance; simple (e.g., stone[s] up to 2 cm in a single
location of kidney or renal pelvis, nonbranching stones)) and 50081
(Percutaneous nephrolithotomy or pyelolithotomy, lithotripsy stone
extraction, antegrade ureteroscopy, antegrade stent placement and
nephrostomy tube placement, when performed, including imaging guidance;
complex (e.g., stone[s] 2 cm, branching stones, stones in
multiple locations, ureter stones, complicated anatomy)), that in
recent claims data were identified via the site of service anomaly
screen, to be performed less than 50 percent of the time in the
inpatient setting, but both codes have 090 day global periods, which
include post-op inpatient hospital E/M services as a component of their
value, typical of major surgery codes. The revised code descriptors
also include image guidance and nephrostomy tube placement, which were
not present in the old descriptors, and were reported as procedures
that were separate from CPT codes 50081 and 50082. These codes have not
been reviewed for nearly 30 years.
CPT code 50080 currently has a work RVU of 15.74 with 117 minutes
of intra-service time and 359.5 minutes of total time. The RUC
recommended a work RVU of 13.50, 90 minutes of intra-service time, and
244 minutes of total time for CPT code 50080, which represents a
reduction from the current values. However, the recommended intra-
service times dropped by 76.9 percent from the current intra-service
time and the RUC recommended work RVU is reduced only by 85.9 percent.
Therefore, we disagree with the RUC recommended work RVU and we are
proposing a work RVU of 12.11 for CPT code 50080 with the RUC
recommended 90 minutes of intra-service time and 244 minutes of total
time. We note that our proposed work RVU for CPT code 50080 falls
between CPT code 36830 (Creation of arteriovenous fistula by other than
direct arteriovenous anastomosis (separate procedure); nonautogenous
graft (e.g., biological collagen, thermoplastic graft)), with a work
RVU of 12.03 and the same intra-service time of 90 minutes, and CPT
code 36818 (Arteriovenous anastomosis, open; by upper arm cephalic vein
transposition), with a work RVU of 12.39 and the same intra-service
time of 90 minutes (and both with similar total times to CPT code
50080).
CPT code 50081 currently has a work RVU of 23.50 with 42 minutes of
pre-service evaluation time, 0 minutes of pre-service positioning time,
25 minutes of pre-service scrub/dress/wait time, 195 minutes of intra-
service time, 27 minutes of immediate post-service time, and 507.5
minutes of total time. The RUC recommended 22.00 work RVUs with 40
minutes of pre-service evaluation time, 3 minutes positioning time, 10
minutes scrub/dress/wait time, 140 minutes of intra-service time, 44
minutes of immediate post-service time, for a sum of 302 minutes of
total time. The RUC-recommended intra-service time and total time for
CPT code 50081 are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs.
[[Page 45916]]
Though the RUC recommended a work RVU of 22.00 that is less than the
current 23.50 work RVU, a substantial reduction in time should be
better reflected in the work RVU.
The RUC recommended 13.50 work RVUs for CPT code 50800 and 22.00
for CPT code 50081, with an incremental difference between the two
codes of 8.50 work RVUs (22.00-13.50 = 8.50). We are proposing a work
RVU of 20.61 for CPT code 50081, based on the proposed CPT code 50080's
work RVU of 12.11 plus the RUC-recommended incremental difference 8.50
work RVUs between CPT code 50080 and CPT code 50081 (12.11 + 8.50 =
20.61).
We are proposing the direct PE inputs as recommended by the RUC for
both codes in the family.
(14) Laparoscopic Simple Prostatectomy (CPT Codes 55821, 55831, 55866,
and 558XX)
In October 2021, the CPT Editorial Panel added CPT placeholder code
558XX (Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) and prompted this family of
Laparoscopic Simple Prostatectomy codes for survey and review for the
January 2022 RUC meeting.
The RUC recommends a work RVU of 15.18 for CPT code 55821
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); suprapubic, subtotal, 1 or 2 stages) with 33 minutes of
pre-service evaluation time, 3 minutes positioning time, 10 minutes
scrub/dress/wait time, 120 minutes of intra-service time, and 25
minutes of immediate post-service time, for a sum of 329 minutes of
total time. CPT code 55821 currently has a work RVU value of 15.76 with
102.0 minutes of intra-service time and 399.5 minutes of total time.
After reviewing this code and relative similar codes in the PFS, we are
proposing the RUC-recommended work RVU of 15.18 with 315 minutes of
total time.
The RUC recommends a work RVU of 15.60 for CPT code 55831
(Prostatectomy (including control of postoperative bleeding, vasectomy,
meatotomy, urethral calibration and/or dilation, and internal
urethrotomy); retropubic, subtotal), with 40 minutes of pre-service
evaluation time, 3 minutes positioning time, 10 minutes scrub/dress/
wait time, 120 minutes of intra-service time, 25 minutes of immediate
post-service time, for a sum of 329 minutes of total time. CPT code
55831 currently has a work RVU value of 17.19 with 114.0 minutes of
intra-service time and 422.5 minutes of total time. The RUC notes an
additional degree of difficulty with this retropubic incision approach
(behind the pubis) compared to the suprapubic approach. After reviewing
this code and relative similar codes in the PFS, we are proposing the
RUC recommended work RVU of 15.60 with 322 minutes of total time.
The RUC recommends a work RVU of 22.46 for CPT code 55866
(Laparoscopy, surgical prostatectomy, retropubic radical, including
nerve sparing, includes robotic assistance, when performed) with 40
minutes of pre-service evaluation time, 15 minutes positioning time, 12
minutes scrub/dress/wait time, 180 minutes of intra-service time, 50
minutes of immediate post-service time, for a sum of 362 minutes of
total time. CPT code 55866 currently has a work RVU value of 26.80 with
180 minutes of intra-service time and 422 minutes of total time. The
RUC notes that this procedure removes the entire prostate with robotic
assistance, and the complexity of nerve sparing when operating with a
cancerous prostate, increases the medical complexity and intensity of
this procedure. After reviewing this code and relative similar codes in
the PFS, we are proposing the RUC recommended work RVU of 22.46 with
362 minutes of total time to CPT code 55866.
The RUC recommends a work RVU of 19.53 for CPT code 558XX
(Laparoscopy, surgical prostatectomy, simple subtotal (including
control of postoperative bleeding, vasectomy, meatotomy, urethral
calibration and/or dilation, and internal urethrotomy), includes
robotic assistance, when performed) with 40 minutes of pre-service
evaluation time, 8 minutes positioning time, 11 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 50 minutes of immediate
post-service time, for a sum of 354 minutes of total time. The RUC
offers CPT code 42420 (Excision of parotid tumor or parotid gland;
total, with dissection and preservation of facial nerve) with a work
RVU of 19.53, 180 minutes of intra-service time and 383 minutes of
total time)) as a crosswalk to CPT code 558XX. After reviewing this
code and relative similar codes in the PFS, we are proposing the RUC-
recommended work RVU of 19.53 with 354 minutes of total time to CPT
code 558XX.
We are proposing the RUC-recommended direct PE inputs for CPT codes
55821, 55831, 55866, and 558XX without refinement.
(15) Lumbar Laminotomy With Decompression (CPT Codes 63020, 63030, and
63035)
In October 2018, CPT code 63030 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, lumbar) was identified by the AMA as having an anomalous
site of service when compared to Medicare utilization data. The
Medicare data from 2014 through 2017 indicated that CPT code 63030 was
performed less than 50 percent of the time in the inpatient setting,
yet included inpatient hospital evaluation and management (E/M)
services within its global period. In January 2019, the RUC recommended
that this code be reviewed in 2 years (January 2021) to determine if
previous changes to differentiate percutaneous, endoscopic, and open
spine procedures were effective to correct reporting of this service.
In December 2020, the Relativity Assessment Workgroup noted that CPT
code 63030 continues to be primarily reported in the outpatient
setting, but still includes inpatient hospital visits in its valuation.
The specialty society indicated that there is still confusion about
this code, and therefore, the RUC recommended that CPT code 63030 be
referred to the CPT Editorial Panel to revise the descriptor to
mitigate the incorrect reporting in the outpatient setting, but the CPT
Editorial Panel did not accept the code change application to
differentiate inpatient (63030) versus outpatient (630X0) at the
September 2021 CPT meeting. Since this is a site of service issue, CPT
code 63030 was surveyed with the code family for the January 2022 RUC
meeting.
For CPT codes 63020 (Laminotomy (hemilaminectomy), with
decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; 1
interspace, cervical), 63030, and 63035 (Laminotomy (hemilaminectomy),
with decompression of nerve root(s), including partial facetectomy,
foraminotomy and/or excision of herniated intervertebral disc; each
additional interspace, cervical or lumbar (List separately in addition
to code for primary procedure)), we disagree with the RUC's recommended
work RVUs of 15.95, 13.18, and 4.00, respectively, because they do not
account for the surveyed changes in time for CPT codes 63020, 63030,
and
[[Page 45917]]
63035, and the full application of the 23-hour policy to CPT code
63030. We are proposing a work RVU of 14.91 for CPT code 63020, a work
RVU of 12.00 for CPT code 63030, and a work RVU of 3.86 for CPT code
63035.
The RUC recommends 40 minutes pre-service evaluation, 20 minutes
pre-service positioning, 15 minutes pre-service scrub/dress/wait time,
90 minutes intraservice time, 30 minutes immediate post-service time,
and one CPT code 99232 (subsequent hospital care/day 25 minutes), one
CPT code 99231 (Subsequent hospital care/day 15 minutes), one CPT code
99238 (Hospital discharge day management; 30 minutes or less), one CPT
code 99214 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using time for code selection, 30-39 minutes of
total time is spent on the date of the encounter.), and two CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter.) visits in the post-
operative period. This results in a 15-minute decrease in the pre-
service period, a 30-minute decrease in intraservice time, a 5-minute
decrease in immediate post-service time, and a 17-minute increase in
the post-operative period. The proposed work RVU of 14.91 is based on
the total time ratio calculation using the RUC-recommended 379 minutes
of total time divided by the current total time of 412 minutes for CPT
code 63020, then multiplying by the current work RVU of 16.20 for CPT
code 63020 ((379 minutes/412 minutes) * 16.20 = 14.90). We note that
this is a direct crosswalk to CPT code 27057 (Decompression
fasciotomy(ies), pelvic (buttock) compartment(s) (e.g., gluteus medius-
minimus, gluteus maximus, iliopsoas, and/or tensor fascia lata muscle)
with debridement of nonviable muscle, unilateral), which has a work RVU
of 14.91, identical intraservice and immediate post-service time of 90
minutes and 30 minutes, respectively, and only 10 more minutes of total
time. We believe this work RVU more adequately accounts for the
decrease in total and intraservice time than the RUC recommended work
RVU, and we note that we considered the reverse building block
methodology, which would result in a work RVU of 14.30, but we felt
that it decreased the valuation of CPT code 63020 too much, considering
the shift in post-operative work to include a longer, more intense
office/outpatient visit (CPT code 99214).
We disagree with the RUC-recommended work RVU for CPT code 63030.
More specifically, we disagree with the RUC recommended work RVU for
CPT code 63030 because the RUC did not completely apply the 23-hour
policy calculation (finalized in the CY 2011 PFS final rule (75 FR
73226)) in formulating its recommendations. Additionally, we disagree
with the RUC recommended work RVU for this code for which the RUC
considered the patient to be admitted during the post-operative period
because the RUC did not fully apply the 23-hour policy when formulating
their recommendations. As we noted in the CY 2011 PFS final rule (75 FR
73226), and as we discuss earlier in this section of this proposed rule
(``(1) Anterior Abdominal Hernia Repair (CPT codes 157X1, 49X01, 49X02,
49X03, 49X04, 49X05, 49X06, 49X07, 49X08, 49X09, 49X10, 49X11, 49X12,
49X13, 49X14, and 49X15''), the work RVUs for services that are
typically performed in the outpatient setting and require a hospital
stay of less than 24 hours may in some cases involve multiple overnight
stays while the patient is still considered to be an outpatient for
purposes of Medicare payment. Because such services are typically
furnished in the outpatient setting, they should not be valued to
include inpatient post-operative E/M visits. The level of discharge day
management services included in the valuation of such services should
similarly not reflect an inpatient discharge and should therefore be
reduced. And finally, as discussed in CY 2011 rulemaking, the
intraservice time from the inpatient level E/M postoperative visit
should be reallocated to the immediate postservice time of the service.
The 23-hour policy calculation, when fully applied to the calculation
of a work RVU, is used to reduce the value of discharge day management
services, remove the inpatient E/M visits, and reallocate the
intraservice time to the immediate post-service period. We refer
readers to the 2011 PFS final rule (75 FR 73226) for an in-depth
explanation of the 23-hour policy.
For CPT code 63030, we believe the RUC only partially applied the
23-hour policy when it applied the policy to the immediate post service
time, but not to the calculation of the work RVU. Instead, we believe
the 23-hour policy should be fully applied to this code that describes
outpatient services for which there is an overnight stay during the
post-operative period, regardless of the number of nights that a
patient stays in the hospital. The services to which the 23-hour policy
is usually applied would typically involve a patient stay in a hospital
for less than 24 hours, which often means the patient may stay
overnight in the hospital. On occasion, the patient may stay in the
hospital longer than a single night; however, in both cases (one night
or more than one night), the patient is considered to be a hospital
outpatient, not an inpatient, for Medicare purposes. In short, we do
not believe that the work that is typically associated with an
inpatient service should be included in the work RVUs for the
outpatient services to which the 23-hour policy applies, especially
considering the previously discussed site of service anomaly for CPT
code 63030.
In accordance with the 23-hour policy valuation methodology we
established in the CY 2011 PFS final rule, we are instead proposing a
work RVU of 12.00 for CPT code 63030.The steps are as follows:
Step (1): 13.18 - 0.64* = 12.54.
Step (2): 12.54 - 0.76** = 11.78.
Step (3): 11.78 + (10 minutes x 0.0224)*** = 12.00 RVUs.
*Value associated with \1/2\ hospital discharge day management
service
**Value associated with an inpatient hospital visit, CPT code
99231.
***Value associated with the reallocated intraservice time
multiplied by the post-service intensity of the 23-hour stay code.
The RUC recommends the maintenance of the current work RVU of 13.18
because there was no change in intraservice time and the 37-minute
decrease in total time is largely due to the change in immediate post-
service time and post-operative period from the application of the 23-
hour policy. We note that the proposed work RVU of 12.00 is higher than
the other valuations that we considered, including the total time ratio
work RVU of 11.75 ((305 minutes/342 minutes) * 13.18 = 11.75) and the
reverse building block work RVU of 11.45. We note that the proposed
work RVU of 12.00 is well-bracketed by two 90-minute intraservice timed
090-day CPT codes 28725 (Arthrodesis; subtalar), with a work RVU of
11.22, and 58720 (Salpingo-oophorectomy, complete or partial,
unilateral or bilateral (separate procedure)), with a work RVU of
12.16.
We note that, in the summary of recommendations (SOR) submitted to
CMS by the RUC, the specialty societies assert that the surveyed total
time would be the same as the current total
[[Page 45918]]
time if the 23-hour policy was not fully applied to the immediate post-
service time and post-operative period, with only a shift of work from
facility to office, but we note that this is not true. The surveyed
total time is 339 minutes, but the RUC recommended 40 minutes for the
pre-service evaluation time rather than the specialty societies'
surveyed 45 minutes. If the RUC had recommended the survey times, with
the pre-service evaluation refinement, the reverse building block work
RVU would be 12.62, still less than the RUC-recommended work RVU of
13.18, effectively accounting for the shift from facility to office
post-operative visits.
For CPT code 63035, we are proposing a work RVU of 3.86 based on
the reverse building block methodology to account for the 11-minute
increase in intraservice time. We note that this proposed value is
between the surveyed 25th percentile value of 3.50 and the RUC-
recommended work RVU of 4.00. We note that the proposed work RVU is
well-bracketed by two 60-minute add-on CPT codes--CPT code 50706 and
63231. CPT code 50706 (Balloon dilation, ureteral stricture, including
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all
associated radiological supervision and interpretation (List separately
in addition to code for primary procedure)), has a work RVU of 3.80,
and CPT code 63621 (Stereotactic radiosurgery (particle beam, gamma
ray, or linear accelerator); each additional spinal lesion (List
separately in addition to code for primary procedure)), has a work RVU
of 4.00.
For the direct PE inputs, we are proposing to remove the 125
minutes of equipment time for EQ168 (light, exam) for CPT codes 63020
and 63030 because the RUC contested the typicality of its use to assess
the wound and remove staples. Because it is a standard piece of
equipment in a neurosurgeon and orthopedic exam room, and the RUC
questioned its typicality, we are proposing 0 minutes for EQ168 for CPT
codes 63020 and 63030.
(16) Somatic Nerve Injections (CPT Codes 64415, 64416, 64417, 64445,
64446, 64447, 64448, 76942, 77002, and 77003)
In May 2021, the CPT Editorial Panel revised the descriptors and
billing instructions for CPT codes 64415 (Injection(s), anesthetic
agent(s) and/or steroid; brachial plexus, including imaging guidance,
when performed), 64416 (Injection(s), anesthetic agent(s) and/or
steroid; brachial plexus, continuous infusion by catheter (including
catheter placement), including imaging guidance, when performed), 64417
(Injection(s), anesthetic agent(s) and/or steroid; axillary nerve,
including imaging guidance, when performed), 64445 (Injection(s),
anesthetic agent(s) and/or steroid; sciatic nerve, including imaging
guidance, when performed), 64446 (Injection(s), anesthetic agent(s)
and/or steroid; sciatic nerve, continuous infusion by catheter
(including catheter placement), including imaging guidance, when
performed), 64447 (Injection(s), anesthetic agent(s); femoral nerve,
including imaging guidance, when performed), 64448 (Injection(s),
anesthetic agent(s) and/or steroid; femoral nerve, continuous infusion
by catheter (including catheter placement), including imaging guidance,
when performed), 77002 (Fluoroscopic guidance for needle placement),
77003 (Fluoroscopic guidance and localization of needle or catheter tip
for spine or paraspinous diagnostic or therapeutic injection procedures
(epidural or subarachnoid)) and 76942 (Ultrasonic guidance for needle
placement, imaging supervision and interpretation). These codes were
then surveyed by the RUC in October 2021.
We last finalized values for CPT codes 64415, 64416, 64417, 64445,
64446, 64447, and 64448 in the CY 2020 PFS final rule (84 FR 62744
through 62745). In May 2018, the CPT Editorial Panel approved the
revision of descriptors and guidelines for codes in the somatic nerve
injection family. At its October 2018 meeting, the RUC recommended work
RVU and PE inputs for a number of somatic nerve injection codes,
including CPT codes 64415, 64416, 64417, 64445, 64446, 64447, and
64448. (Note that in 2018, the codes did not include ``including
imaging guidance, when performed'' in their descriptors.) During the
October 2018 RUC presentation for this family of services, the
specialty societies stated that CPT codes 64415, 64416, 64417, 64446,
66447, and 64448 were reported with the imaging code CPT code 76942
more than 50 percent of the time. In reviewing this family of services
in the CY 2020 PFS final rule, our finalized work and PE values for the
codes did not consider the simultaneous performance of injection and
imaging (84 FR 62744). In May 2021, the CPT Editorial Panel revised the
codes to include ``with imaging, when performed'' in the descriptors.
When presenting its CY 2023 valuation recommendations, the RUC
pointed out that the current values and times for CPT codes 64415,
64416, 64417, 64445, 64446, 64447, and 6448 reflect only the work and
time of the injection. The revised codes, however, include both
injection and imaging. In order to make an equitable comparison between
the RUC recommendations and the current values, the RUC suggested we
compare the RUC recommendations to values that combined the current
work and estimated time of the injection codes and the imaging code
with which they are being bundled, CPT code 76942. We agreed with this
approach and thank the RUC for providing combined work RVUs and
estimated combined times, which we considered as part of the RUC's
recommendations.
As part of its recommendations, the RUC reaffirmed its prior
recommendations for a number of codes that were previously reviewed or
reaffirmed in the CY 2020 PFS final rule, including: CPT codes 64400
(Injection(s), anesthetic agent(s); trigeminal nerve, each branch
(i.e., ophthalmic, maxillary, mandibular)), 64408 (Injection(s),
anesthetic agent(s), and/or steroid; vagus nerve), 64420 (Injection(s),
anesthetic agent(s) and/or steroid; intercostal nerve, single level),
64421 (Injection(s), anesthetic agent(s) and/or steroid; intercostal
nerves, each additional level (List separately in addition to code for
primary procedure)), 64425 (Injection(s), anesthetic agent(s) and/or
steroid; ilioinguinal, iliohypogastric nerves), 64430 (Injection(s),
anesthetic agent(s) and/or steroid; pudendal nerve), 64435
(Injection(s), anesthetic agent(s) and/or steroid; paracervical
(uterine) nerve), 64449 (Injection(s), anesthetic agent(s) and/or
steroid; lumbar plexus, posterior approach, continuous infusion by
catheter (including catheter placement)), and 64450 (Injection(s),
anesthetic agent(s); other peripheral nerve or branch) (84 FR 62744
through 62745); CPT code 64451 (Injection(s), anesthetic agent(s) and/
or steroid; nerves innervating the sacroiliac joint, with image
guidance (ie, fluoroscopy or computed tomography) (84 FR 62740); and
CPT code 64454 (Injection(s), anesthetic agent(s) and/or steroid;
genicular nerve branches including imaging guidance, when performed)
(84 FR 62749). The RUC also reaffirmed its recommendation for CPT code
64455 (Injection(s), anesthetic agent(s) and/or steroid; plantar common
digital nerve(s) (e.g., Morton's neuroma)), which was reviewed and
valued in the CY 2019 PFS final rule (83 FR 58542). The codes the RUC
wishes to reaffirm for CY 2023 have not been revised by the CPT
Editorial Panel and were not resurveyed by the RUC since their prior
valuation. Since we have not received new
[[Page 45919]]
information regarding these codes, we acknowledge the RUC's
reaffirmation but are not reviewing the values of these codes at this
time. We also note that the RUC-reaffirmed values for CPT codes 64435
(work RVU of 0.75), 64450 (work RVU of 0.75), 64451 (work RVU of 1.52),
and 64454 (work RVU of 1.52) are the same as the current work RVUs that
we finalized in the CY 2020 PFS final rule. The RUC reaffirmed work RVU
of 0.94 for CPT code 64405 is the current work RVU, which was finalized
in the CY 2019 PFS final rule (83 FR 59542) and reaffirmed in the CY
2020 final rule, and the RUC-reaffirmed work RVU of 1.10 for CPT code
64418 is the current work RVU value finalized in the CY 2018 PFS final
rule (82 FR 53054) and reaffirmed in the CY 2020 PFS final rule. The
RUC reaffirmed a work RVU of 0.75 for CPT code 64455 which is the
current work RVU we finalized in the CY 2019 PFS final rule (83 FR
58542).
For CY 2023, we are proposing the RUC-recommended work RVUs for CPT
codes 64417 (work RVU of 1.31), 64447 (work RVU of 1.34), 64448 (work
RVU of 1.68), 77002 (work RVU of 0.54), 77003 (work RVU of 0.60), and
76942 (work RVU of 0.67).
For CPT code 64415, we disagree with the RUC-recommended work RVU
of 1.50 and are proposing a work RVU of 1.35, based on the intraservice
time ratio calculated using the ``combined'' values for CPT code 64415
and the imaging CPT code 76942 provided by the RUC. (The combined work
RVU the RUC offered for comparison was 2.02 (the sum of the work RVUs
for both codes: CPT code 64415 is 1.35 and CPT code 76942 is 0.67), and
an estimated intraservice time of 15 minutes and total time of 43
minutes.) This proposed work RVU of 1.35 for CPT code 64415 is
supported by a crosswalk to CPT code 11982 (Removal, non-biodegradable
drug delivery implant), which has a work RVU of 1.34, an identical
service time, and a total time that is two minutes lower than CPT code
64415. This value is further supported by a bracket of CPT codes: CPT
code 64486 and CPT code 33285. CPT code 64486 (Transversus abdominis
plane (TAP) block (abdominal plane block, rectus sheath block)
unilateral; by injection(s) (includes imaging guidance, when
performed)) has a work RVU of 1.27 and identical intraservice and total
time values to CPT code 64415, and CPT code 33285 (insertion,
subcutaneous cardiac rhythm monitor, including programming) has a work
RVU of 1.53, an intraservice time of 10 minutes and a total time of 40
minutes.
We note that when compared to the current time file for CPT code
64415, the RUC-recommended intraservice time decreased from 12 to 10
minutes (16.7 percent reduction) and RUC-recommended total time
decreased from 40 to 35 minutes (12.5 percent reduction). However, the
RUC-recommended work RVU increased by 0.15 which is an 11.1 percent
increase. Although we do not imply that the decrease in time as
reflected in survey values must always 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, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, significant decreases in time should not be
met with significant increases to work RVUs without adequate
justification. Additionally, while we do acknowledge that adding
imaging does bundle some additional work into the code, we do not
believe that the recoding of the services in this family has resulted
in a significant increase in their intensity, only a change in the way
in which they will be reported, and through the bundling of some of
these frequently reported services, it is reasonable to expect that the
new coding system will achieve efficiencies via elimination of
duplicative assumptions of the resources involved in furnishing
particular services. We believe 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. If the addition of imaging guidance had made the new CPT
codes significantly more intense to perform, we believe that this would
have been reflected in the surveyed work times, which in the case of
CPT code 64415 actually decreased from the predecessor code. Thus, we
are disinclined to ignore the impact of decreased times on the work
RVU. We believe our proposed value of 1.35 appropriately reflects both
the additional work and the decrease of time.
We considered proposing a work RVU of 1.27 for CPT code 64415,
using CPT code 64486 as a comparison code, since it has the same
intraservice and total times as the revised CPT code 64415. However,
CPT code 64486, with a work RVU of 1.27, has a lower work RVU than the
current work RVU of 64415 (1.35.) We are in general agreement with the
RUC that it is important to acknowledge that there is some additional
work that comes with adding imaging to this procedure.
For CPT code 64416, we disagree with the RUC-recommended work RVU
of 1.80 and are proposing a work RVU of 1.65. While we disagree with
the RUC's recommended work RVU, we did agree with the RUC's proposed
increment of +0.30 between CPT codes 64415 and 64416. (The RUC
recommendation for CPT code 64415 was 1.50, and the recommendation for
CPT code 64416 was 1.80.) We found persuasive the RUC's observation
that the current increment between CPT codes 64415 and 64416 is
unusually small when compared to other sets of related codes in the
family. Typically, the codes that add catheter placement in addition to
the injection are 0.30-0.36 work RVUs higher than the codes for an
injection in the same nerve group or region. Retaining such a narrow
interval of 0.15 between CPT codes 64415 and 64416 would create a rank
order anomaly within the family in light of adjustments to some of the
other codes' work RVUs. Our proposed work RVU of 1.65 for CPT code
64416 is supported by a bracket of CPT codes: CPT code 64448 and CPT
code 36573. CPT code 64448 (Transversus abdominis plane (TAP) block
(abdominal plane block, rectus sheath block) bilateral; by injections
(includes imaging guidance, when performed)) has a work RVU of 1.60, 15
minutes intraservice time and 40 minutes total time, and 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)
has a work RVU of 1.70, 15 minutes intraservice time and 40 minutes
total time.
We note that, when compared to the current time file, the RUC-
recommended intraservice time for CPT code 64416 decreased from 20 to
15 minutes (25 percent reduction) and the RUC-recommended total time
decreased from 49 to 44 minutes (10.2 percent reduction). However, the
RUC recommended a 0.32 increase in the work RVU, which is a 21.6
percent increase. We note that the RUC-recommended work RVU of 1.80
would give CPT code 64416 the highest work RVU of the surveyed codes,
and would make it among the highest valued codes in the family. We do
not believe the RUC-recommended work RVU appropriately accounts for the
reductions in the surveyed total time for the procedure, and did not
receive specific information explaining why, despite the decrease in
time, the value should receive such a significant
[[Page 45920]]
increase relative to the other surveyed codes. As stated previously,
absent an obvious or explicitly stated rationale for why the relative
intensity of a given procedure has increased significantly, decreases
in time should be reflected in the revised work RVUs. As noted in our
discussion of CPT code 64415 above, if the addition of imaging guidance
had made the new CPT codes significantly more intense to perform, we
believe that this would have been reflected in the surveyed work times,
which in the case of CPT code 64416, are now actually lower. We believe
our proposed work RVU of 1.65 corrects the increment between CPT code
64415 and 64416, while also acknowledging that, the addition of imaging
notwithstanding, the times for CPT code 64416 have noticeably
decreased.
For CPT code 64445, we disagree with the RUC-recommended work RVU
of 1.39 and are proposing a work RVU of 1.28, based on the intraservice
time ratio calculated using the. ``combined'' values for CPT code 64445
and the imaging CPT code 76942 provided by the RUC. (The combined work
RVU the RUC offered for comparison was 1.67 (the sum of the work RVUs
for both codes: CPT code 64445 is 1.00 and CPT code 76942 is 0.67), and
an estimated intraservice time of 13 minutes and total time of 27
minutes.) This proposed value of 1.28 is supported by a comparison to
CPT code 64486 (Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) unilateral; by injection(s) (includes
imaging guidance, when performed)), which has a work RVU of 1.27 and
intraservice time of 10 minutes and total time of 35 minutes. The value
is also supported by a low bracket of CPT code 58100 (Endometrial
sampling (biopsy) with or without endocervical sampling (biopsy),
without cervical dilation, any method (separate procedure)), with a
work RVU of 1.21, identical intraservice time and almost identical
total time, and a high bracket of CPT code 11982 (Removal, non-
biodegradable drug delivery implant), with a work RVU of 1.34,
identical intraservice time and a higher total time of 33 minutes.
We note that the RUC-recommended intraservice time and total time
for CPT code 64445 are identical to the current intraservice and total
times in the time file for CPT code 64445. However, the RUC recommended
a 0.39 increase to the work RVU. We do not imply that the lack of
change to the intraservice and total times means that the work RVU
cannot be increased. We believe 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, the RUC-proposed increase in the work RVU does not seem
justified. As noted in our discussion of CPT code 64415 above, if the
addition of imaging guidance had made the new CPT codes significantly
more intense to perform, we believe that this would have been reflected
in the surveyed work times, which in the case of CPT code 64445, are
the same as the predecessor code.
We considered proposing a work RVU of 1.10 for CPT code 64445,
using CPT code 30901 (Control nasal hemorrhage, anterior, simple
(limited cautery and/or packing) any method) as a comparison code, with
a work RVU of 1.10 and identical intraservice and total times as CPT
code 64445. However, we believed this would cause a rank order anomaly
within the family. For example, CPT code 64418 (Injection(s),
anesthetic agent(s) and/or steroid; suprascapular nerve) also has a
work RVU of 1.10, but does not include imaging. Again, we generally
agree with the RUC that it is important to acknowledge the additional
work that comes with adding imaging to this procedure, and to ensure
that this additional work is reflected within the relative values of
the family, but we are still proposing a work RVU of 1.28 for CPT code
64445.
For CPT code 64446, we disagree with the RUC-recommended work RVU
of 1.75 and are proposing a work RVU of 1.64. This recommended work RVU
is 0.36 higher than the proposed work RVU for CPT code 64445 (1.28). We
note that the current increment between the current values of 64445 and
64446 (1.00 and 1.36, respectively) is 0.36. The RUC recommendations
for these codes (1.39 and 1.75) preserved this increment. Since the
same imaging activity is being added to both codes, we agree with
preserving the relationship between the values of CPT codes 64445 and
64446. Our proposed work RVU of 1.64 for CPT code 64446 is supported by
a bracket of CPT codes: CPT code 64448 and 36573. CPT code 64448
(Transversus abdominis plane (TAP) block (abdominal plane block, rectus
sheath block) bilateral; by injections (includes imaging guidance, when
performed)) has a work RVU of 1.60, 15 minutes intraservice time and 40
minutes total time, and 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) has a work RVU of 1.70, 15
minutes intraservice time and 40 minutes total time. (We note that this
is the same bracket we suggested to support the proposed value for CPT
code 64416. As revised, the intraservice and total times for CPT codes
64416 and 64446 are the same.)
We note that, compared to the time file for CPT code 64446, the
RUC-recommended intraservice time stayed the same (15 minutes) and the
total time increased from 40 to 44 minutes (10 percent increase). The
RUC-recommended work RVU for CPT code 64446, is 0.39 higher than the
current RVU, a 28.7 percent increase. We believe the RUC-recommended
work RVU increase is disproportionate to the change in time.
Additionally, we note that the RUC-recommended times result in CPT code
64416 and CPT code 64446 having identical intraservice and total times.
We believe it best preserves rank order within the family to assign CPT
code 64416 and CPT code 64446 similar work RVUs.
We are proposing the direct PE inputs as recommended by the RUC for
all of the codes in the Somatic Nerve Injections family.
(17) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714,
69716, 69717, 69719, 69726, 69727, 69XX0, 69XX1, and 69XX2)
In October 2020, the CPT Editorial Panel deleted two codes used for
mastoidectomy and replaced them with four new codes for magnetic
transcutaneous attachment to external speech processor. The CPT
Editorial Panel made additional revisions to differentiate
implantation, removal, and replacement of the implants. The RUC
submitted interim recommendations to CMS for six codes in this family
following the January 2021 RUC meeting, and CMS proposed and finalized
the recommended work RVU for all six of these codes in the CY 2022 PFS
final rule (86 FR 65099 through 65100). For CY 2023, the CPT Editorial
Panel established three additional new codes and the coding structure
of the family was changed to describe the different techniques more
appropriately for transcutaneous passive implant procedures that vary
in time and intensity depending on the indication for the procedure,
device chosen, and patient anatomy. The nine codes in the family were
surveyed again for the January 2022 RUC meeting and new recommendations
were submitted to CMS.
We are proposing the RUC-recommended work RVU for six of the nine
codes in the Transcutaneous Passive Implant-Temporal Bone family.
[[Page 45921]]
We are proposing a work RVU of 9.03 for CPT code 69716 (Implantation,
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor within the mastoid and/or resulting in
removal of less than 100 mm2 surface area of bone deep to the outer
cranial cortex), a work RVU of 9.97 for CPT code 69XX0 (Implantation,
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor, outside of the mastoid and resulting in
removal of greater than or equal to 100 mm2 surface area of bone deep
to the outer cranial cortex), a work RVU of 9.46 for CPT code 69719
(Revision/replacement (including removal of existing device),
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor, within the mastoid and/or involving a
bony defect less than 100 mm2 surface area of bone deep to the outer
cranial cortex), a work RVU of 10.25 for CPT code 69XX1 (Revision/
replacement (including removal of existing device), osseointegrated
implant, skull; with magnetic transcutaneous attachment to external
speech processor, outside the mastoid and involving a bony defect
greater than or equal to 100 mm2 surface area of bone deep to the outer
cranial cortex), a work RVU of 7.38 for CPT code 69727 (Removal, entire
osseointegrated implant, skull; with magnetic transcutaneous attachment
to external speech processor, within the mastoid and/or involving a
bony defect less than 100 mm2 surface area of bone deep to the outer
cranial cortex), and a work RVU of 8.50 for CPT code 69XX2 (Removal,
entire osseointegrated implant, skull; with magnetic transcutaneous
attachment to external speech processor, outside the mastoid and
involving a bony defect greater than or equal to 100 mm2 surface area
of bone deep to the outer cranial cortex).
We disagree with the RUC's recommended work RVU for the other three
codes in the family for the procedures describing percutaneous
attachment to external speech processor. We disagree with the RUC's
recommended work RVU of 8.00 for CPT code 69714 (Implantation,
osseointegrated implant, skull; with percutaneous attachment to
external speech processor) and we are instead proposing a work RVU of
6.68 based on a crosswalk to CPT code 38305 (Drainage of lymph node
abscess or lymphadenitis; extensive). In reviewing CPT code 69714, we
noted that the recommended intraservice time is decreasing from 40
minutes to 30 minutes (25 percent reduction), and the recommended total
time is decreasing from 182 minutes to 146 minutes (20 percent
reduction); however, the RUC-recommended work RVU is only decreasing
from 8.69 to 8.00, which is a reduction of just over 8 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 69714, we believe that it is more accurate to propose a work RVU
of 6.68 based on a crosswalk to CPT code 38305 to account for these
decreases in the surveyed work time.
We also disagree with the recommended work RVU of 8.00 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family. At the recommended work RVU of 8.00, the
intensity of CPT code 69714 is increasing by nearly 50 percent as
compared with the survey conducted last year, and the resulting
intensity of the service would be significantly higher than any of the
other codes in the family. We do not agree that this intensity would be
typical given that the percutaneous form of implant described by CPT
code 69714 should have the lowest intensity of the three types
described in this code family. The implantation procedure described by
this code should also typically have lower intensity than the revision/
replacement procedures elsewhere in the family. We believe that the
intensity of CPT code 69714 is more accurately described at our
proposed work RVU of 6.68 based on a crosswalk to CPT code 38305. This
code shares the same intraservice time of 30 minutes as CPT code 69714
and has a higher total time of 186 minutes; we agree that CPT code
69714 is more intense than CPT code 38305 which is offset by our
crosswalk code having an additional office visit in its global period.
We disagree with the RUC's recommended work RVU of 8.48 for CPT
code 69717 (Revision/replacement (including removal of existing
device), osseointegrated implant, skull; with percutaneous attachment
to external speech processor) and we are instead proposing a work RVU
of 7.91 based on a crosswalk to CPT code 46262 (Hemorrhoidectomy,
internal and external, 2 or more columns/groups; with fistulectomy,
including fissurectomy, when performed). In reviewing CPT code 69717,
we noted that although the intraservice time remains essentially
unchanged (decreasing from 45 minutes to 44 minutes), the recommended
total time is decreasing from 187 minutes to 159 minutes (15 percent
reduction). However, the RUC-recommended work RVU is only decreasing
from 8.80 to 8.48, which is a reduction of less than 4 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 69717, we believe that it is more accurate to propose a work RVU
of 7.91 based on a crosswalk to CPT code 46262 to account for these
decreases in the surveyed work time.
We also disagree with the recommended work RVU of 8.48 because it
results in a higher intensity than the other two revision/replacement
codes (CPT codes 69719 and 69XX1) in this family. CPT code 69717
describes the percutaneous form of implant which should have the lowest
intensity of the three revision/replacement codes in this family,
however at the recommended work RVU of 8.48 it would have the highest
intensity of this group. While the intensity at the recommended work
RVU for CPT code 69717 is nowhere near the anomalous nature of the
intensity at the recommended work RVU for CPT code 69714, we still
believe that the intensity would be more typical at the proposed work
RVU of 7.91. This proposed valuation restores the relationship between
the three revision/replacement codes by placing the intensity of CPT
code 69717 slightly lower than CPT codes 69719 and 69XX1. Therefore, we
believe that the intensity of CPT code 69717 is more accurately
described at our proposed work RVU of 7.91 based on a crosswalk to CPT
code 46262. This code has nearly the same intraservice time of 45
minutes as CPT code 69717 and has a higher total time of 179 minutes;
we agree that CPT code 69717 is more intense than CPT code 46262 which
is offset by our crosswalk code having an additional office visit in
its global period.
We disagree with the RUC's recommended work RVU of 7.50 for CPT
code 69726 (Removal, entire osseointegrated implant, skull; with
percutaneous attachment to external speech processor) and we are
instead proposing a work RVU of 6.36 based on a crosswalk to CPT code
67912 (Correction of lagophthalmos, with implantation of upper eyelid
lid load
[[Page 45922]]
(e.g., gold weight)). In reviewing CPT code 69726, we noted that the
recommended intraservice time is increasing from 30 minutes to 35
minutes (17 percent increase), and the recommended total time is
increasing from 148 minutes to 150 minutes (1 percent increase);
however, the RUC-recommended work RVU is increasing from 5.93 to 7.50,
which is an increase of just over 26 percent. 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,
modest increases in time should be appropriately reflected in modest
increases to work RVUs. In the case of CPT code 69726, we believe that
it is more accurate to propose a work RVU of 6.36 based on a crosswalk
to CPT code 67912 to account for these increases in the surveyed work
time.
We also disagree with the recommended work RVU of 7.50 because it
results in an intensity which is anomalously high in relationship to
the rest of the code family and creates a rank order anomaly within the
work RVUs. CPT code 69726 describes the percutaneous form of the
removal procedure which should have the lowest intensity of all nine
codes in this family. However, the intensity of CPT code 69726 at the
recommended work RVU of 7.50 would be the second-highest in the family,
even higher than CPT code 69XX1 which describes the revision/
replacement procedure with magnetic transcutaneous attachment resulting
in removal of greater than or equal to 100 square mm surface area of
bone. We do not agree that this would be typical and we believe that
the intensity would be more accurate at our proposed work RVU of 6.36.
We also note that the recommended work RVU of 7.50 for CPT code 69726
creates a rank order anomaly within the family as it would be higher
than the recommended work RVU of 7.38 for CPT code 69727 which
describes a more complex procedure and has higher surveyed work times.
We therefore believe that the work and intensity of CPT code 69726 are
more accurately described at our proposed work RVU of 6.36 based on a
crosswalk to CPT code 67912. This code has nearly the same intraservice
time of 40 minutes as CPT code 69726 and has a higher total time of 166
minutes; we agree that CPT code 69726 is more intense than CPT code
69726 which is offset by our crosswalk code having an additional office
visit in its global period.
We are proposing the direct PE inputs as recommended by the RUC for
all nine codes in the Transcutaneous Passive Implant-Temporal Bone
family.
(18) Contrast X-Ray of Knee Joint (CPT Code 73580)
CPT code 73580 (Radiologic examination, knee, arthrography,
radiological supervision and interpretation) was first identified via
the high-volume growth screen in 2008. In 2021, the Relativity
Assessment Workgroup (RAW) noted that code 73580 was never surveyed and
remains CMS/Other sourced, and recommended that it be surveyed. CPT
code 73580 was then surveyed. We are proposing the RUC-recommended work
RVU of 0.59. We are also proposing the RUC-recommended direct PE inputs
without refinement.
(19) 3D Rendering With Interpretation and Report (CPT Code 76377)
We nominated this code in the CY 2020 PFS final rule as potentially
misvalued, stating that we believe it is of the same family as CPT code
76376 (3D rendering with interpretation and reporting of computed
tomography, magnetic resonance imaging, ultrasound, or other
tomographic modality with image postprocessing under concurrent
supervision; not requiring image postprocessing on an independent
workstation), which was reviewed at the April 2018 RUC meeting. CMS
requested that CPT code 76377 also be reviewed to maintain relativity
within the code family (84 FR 62625). The specialty societies maintain
that these services are more accurately viewed as separate code
families. Furthermore, the RUC cites changes in technique and patient
population as compelling evidence to maintain a physician work RVU of
0.79 despite a 5-minute recommended reduction in physician total time
compared to the current physician time.
We are proposing the RUC recommended work RVU of 0.79 for CPT code
76377; however, we reiterate that we continue to believe that CPT code
76376 and 76377 would be more appropriately viewed as belonging to the
same code family and we request that they be surveyed together.
We are proposing the RUC-recommended direct PE inputs without
refinement.
(20) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76XX0)
Since their creation in 2011, CPT codes 76881 (Ultrasound, complete
joint (ie, joint space and peri-articular soft-tissue structures),
real-time with image documentation) and 76882 (Ultrasound, limited,
joint or other nonvascular extremity structure(s) (e.g., joint space,
peri-articular tendon[s], muscle[s], nerve[s], other soft-tissue
structure[s], or soft-tissue mass[es]), real-time with image
documentation) have been reviewed numerous times as New Technology/New
Services by the Relativity Assessment Workgroup (RAW). In October 2016,
the RAW reviewed these codes and agreed with the specialty societies
that the dominant specialties providing the complete (CPT code 76881)
versus the limited (CPT code 76882) ultrasound of extremity services
were different than originally thought, causing variation in the
typical practice expense inputs. The RAW recommended referral to the
Practice Expense Subcommittee for review of the direct practice expense
inputs and the CPT Editorial Panel to clarify the introductory language
regarding the reference to one joint in the complete ultrasound. The PE
Subcommittee reviewed the direct practice expense inputs for CPT codes
76881 and 76882 and adjusted the clinical staff time at the January
2017 RUC meeting, and the CPT Editorial Panel editorially revised CPT
codes 76881 and 76882 to clarify the distinction between complete and
limited studies and revised the introductory guidelines to clarify
reference to one joint in the complete ultrasound procedure in June
2017. In October 2021, the CPT Editorial Panel approved the addition of
CPT code 76XX0 for reporting real-time, complete neuromuscular
ultrasound of nerves and accompanying structures throughout their
anatomic course, per extremity, and the revision of CPT code 76882 to
add focal evaluation. CPT codes 76881 and 76882 were identified as part
of the neuromuscular ultrasound code family with CPT code 76XX0 and
surveyed for the January 2022 RUC meeting.
For CPT codes 76881, 76882, and 76XX0, we disagree with the RUC-
recommended work RVUs of 0.90, 0.69, and 1.21, respectively, as they do
not account for the surveyed time changes or appropriate comparisons
for the new add-on code, CPT code 76XX0, and are proposing a work RVU
of 0.54 for CPT code 76881, a work RVU of 0.59 for CPT code 76882, and
a work RVU of 0.99 for CPT code 76XX0.
CPT code 76881 represents a complete evaluation of a specific joint
in an extremity. This service requires ultrasound examination of all
the following joint elements: joint space (for example, effusion),
peri-articular soft-tissue structures that surround the joint (that is,
muscles, tendons, other soft-tissue structures), and any identifiable
abnormality. In some circumstances, additional evaluations such as
dynamic
[[Page 45923]]
imaging or stress maneuvers may be performed as part of the complete
evaluation. The RUC recommended 5 minutes of pre-service time, 20
minutes of intraservice time, and 5 minutes of post-service time, based
on the survey. The RUC discussed the 5-minute increase in intraservice
time and determined that the increase relates to the change in the
dominant specialty provider since the creation of the code, as
previously there was 15 minutes of intraservice time for the
radiologist to scan and/or review the sonographer-obtained images. Now,
the rheumatologist is performing the scanning and it takes 20 minutes
for the typical patient. For rheumatology, physicians typically scan
the patients with portable ultrasound devices rather than utilizing
sonographers as originally described in the 2010 survey. The RUC noted
that this code is reported with an office E/M visit 58.9 percent and a
non-facility office E/M visit 66.3 percent of the time; the RUC stated
that CPT code 76881 is imaging-specific so the physician work described
would not overlap with the E/M service, but we disagree, as the
descriptions of pre-service and post-service work directly overlap. The
description of pre-service work for CPT code 76881 states ``Review
pertinent clinical information. Review any prior applicable imaging
studies.'' Pre-service work for CPT code 99214 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making. When using
time for code selection, 30-39 minutes of total time is spent on the
date of the encounter.), the most common E/M code reported with CPT
code 76811, includes ``Review interval correspondence, referral notes,
medical records, and diagnostic data generated since the last visit.''
Post-service work of CPT code 76881 is described as ``Discuss
significant findings with the referring physician. Review and sign
final report,'' whereas the post-service work for CPT code 99214
includes ``Arrange diagnostic testing and referral if necessary.
Document the encounter in the medical record, spending time to further
refine the differential diagnosis, workup, or treatment plan as
necessary. Coordinate care by discussing the case with other physicians
and members of the health care team and write letters of referral if
necessary. Perform electronic data capture and reporting to comply with
quality payment program and other electronic mandates. Review and
analyze interval testing results and refine the differential diagnosis,
workup, and treatment plan based on these results. Order additional
testing based on these results. Communicate results and plan
modifications with patient and/or family.'' We believe there is
distinct overlap in pre-service and post-service work between the E/M
visit and CPT code 76881, and therefore, we are proposing 0 minutes for
the pre-service and post-service time rather than the RUC-recommended 5
minutes of pre-service and post-service time. The proposed work RVU of
0.54 is the reverse building block valuation based on the removal of
the 5 minutes of pre-service and post-service time, with a long-
standing intensity of 0.0224 (10 minutes * 0.0224 work/minute = 0.224
work RVUs). The proposed work RVU accounts for the 0.224 work RVU
decrease as a result of the removal of pre-service and post-service
time, and the increase of 5 minutes of intraservice time, while
maintaining the same IWPUT of 0.027, as there was no discussed change
in intensity. The specialty societies and the RUC asserted that there
was an increase of 5 minutes as a result of the intraservice work
changing due to a change in dominant specialty providing the service
(from radiology to rheumatology), but did not present a change in
intensity. We note that the specialty societies used CPT code 76700
(Ultrasound, abdominal, real time with image documentation; complete)
with a work RVU = 0.81, 11 minutes of intra-service time, and 21
minutes total time, as a reference code because it has identical pre-
and post-service time but less intra-service time than the surveyed
code and is a clinically similar ultrasound code. We note that this is
not an appropriate reference code as it is billed alone 72.8 percent of
the time, and therefore, the valuation of CPT code 76700 accounts for
pre- and post-service work that would not overlap with an E/M visit
like the pre- and post-service work does for CPT code 76881.
CPT code 76882 represents a limited evaluation of a joint or focal
evaluation of a structure(s) in an extremity other than a joint (for
example, soft-tissue mass, fluid collection, or nerve[s]). This
evaluation includes assessment of a specific anatomic structure(s) (for
example, joint space only [effusion] or tendon, muscle, and/or other
soft-tissue structure[s] that surround the joint) that does not assess
all the elements included in CPT code 76881, although it does include
all surrounding anatomy and any associated pathology or contralateral
comparison as indicated. The RUC discussed the four-minute increase in
intraservice time and determined that the increase relates to the
change in dominant supplier of this service since the creation of the
code, as there is currently 11 minutes of intraservice time that
included scanning performed only by the podiatrist, and now the
radiologist works with the sonographer to obtain and interpret the
images in addition to the physician performing additional scanning as
needed. Because radiologists no longer use portable ultrasound devices
as originally described in the 2010 survey or in the 2017 PE update,
the RUC and specialty societies assert that the physician work (time)
has changed due to supervision of the sonographer in addition to the
radiologist performing the scanning. The specialty societies and RUC
also note that ultrasound technology has evolved immensely since 2010,
including proliferation of high-frequency ultrasound probes dedicated
to musculoskeletal imaging, as well as producing images with higher
fidelity and more detail, whereby the number and quality of images that
can be reviewed and the pathology to evaluate have greatly increased
since 2010. Therefore, the typical patient requires 15 minutes of
intraservice time. While we agree with the RUC that 15 minutes of
intraservice time is warranted for CPT code 76882, we note there was no
information indicating a change in intensity, and therefore, for CPT
code 76882, we are proposing the reverse building block work RVU of
0.59 to account for the 4-minute increase in intraservice time and the
maintenance of the current IWPUT of 0.024.
We note that commenters may raise concern about a potential rank
order anomaly with the proposed work RVUs of 0.54 and 0.59 for CPT
codes 76881 and 76882, respectively, but we note that the IWPUT of each
code adequately reflects the increased intensity of intraservice work
for the complete ultrasound (CPT code 76881; IWPUT = 0.027) versus the
limited/focal ultrasound (CPT code 76882; IWPUT = 0.024), and the
lesser work RVU of 0.54 for CPT code 76881 stems from the removal of
the overlapping pre- and post-service time with the E/M visits that are
typically performed. The RUC noted that consistency of intensity
measures is demonstrated across the range of codes ascending from the
limited code (CPT code 76881) to the new, most complex code (CPT code
76XX0). By proposing work RVUs that maintain the current IWPUTs, we
maintain relativity both among the neuromuscular ultrasound family, as
well as the larger family of ultrasound
[[Page 45924]]
imaging codes. We also note that the difference between the RUC-
recommend IWPUTs and our proposed IWPUTs for CPT codes 76881 and 76882
is the same, where CPT code 76882 has an IWPUT that is 0.003 less than
the IWPUT of CPT code 76881.
CPT code 76XX0 will be available for CY 2023 to report real-time,
complete neuromuscular ultrasound of nerves and accompanying structures
throughout their anatomic course, per extremity. This code will examine
a nerve throughout its length, within one extremity, including
evaluation of multiple areas for potential nerve compression,
measurement of cross-sectional areas, evaluation of echogenicity,
vascularity, mobility including dynamic maneuvers when indicated,
evaluation for any associated muscular denervation, with comparison to
unaffected muscles or nerves within that extremity as needed. CPT code
76XX0 also requires permanently recorded images and cine loop and a
written report containing a description of each of the elements
evaluated. The RUC recommended 7 minutes of pre-service time, 25
minutes of intra-service time and 7 minutes of post-service time as
supported by the survey. The RUC clarified that this service would not
typically be reported with an office E/M visit. The RUC arrived at a
recommended work RVU of 1.21 by comparing the pre-, intra-, and post-
service times to those of CPT code 76881, which CMS is proposing to
modify due to overlapping work in the pre- and post-service time with
E/M visits. When we compared the proposed times of 0 minutes of pre-
service time, 20 minutes of intraservice time, and 0 minutes of post-
service time, and a work RVU of 0.54 for CPT code 76881, and the
proposed times of 7 minutes of pre-service time, 25 minutes of
intraservice time, and 7 minutes of post-service time for CPT code
76XX0, we arrived at a reverse building block work RVU of 0.99.
For the direct PE inputs, we are proposing to remove the 2 minutes
of clinical labor time for CA006 (Confirm availability of prior images/
studies), the 1 minute of clinical labor time for the CA007 (Review
patient clinical extant information and questionnaire), and the 2
minutes for CA011 (Provide education/obtain consent) for CPT code 76881
because these RUC recommendations describe clinical labor activities
that overlap with the E/M visit that is typically billed with CPT code
76881. We are proposing the direct PE inputs as recommended by the RUC
for CPT codes 76882 and 76XX0.
(21) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472,
90473, and 90474)
Especially in the context of the current PHE for COVID-19, it is
evident that consistent beneficiary access to vaccinations is vital to
public health. As discussed in the CY 2021 PFS proposed rule (85 CFR
50162), many interested parties raised concerns about the reductions in
payment rates for the preventive vaccine administration services that
had occurred over the past several years. The codes for immunization
administration services include CPT codes 90460, 90471, and 90473, as
well as the three Healthcare Common Procedural Coding System (HCPCS)
codes that describe the services to administer the Part B preventive
vaccinations other than the COVID-19 vaccine: G0008 (influenza), G0009
(pneumococcal), and G0010 (HBV). Until CY 2019, we generally had
established payment rates for these immunization administration
services based on a direct crosswalk to the PFS payment rate for CPT
code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular). Because we proposed
and finalized reductions in valuation for the crosswalk code for CY
2018, and because the reductions in overall valuation for that code
have been subject to the multi-year phase-in of significant reductions
in RVUs, the payment rate for these vaccine administration codes has
been concurrently reduced. Further, because the reduction in RVUs for
the crosswalk code, CPT code 96372, was significant enough to be
required to be phased in over several years under section 1848(c)(7) of
the Act, the reductions in overall valuation for the vaccine
administration codes were likewise subject to reductions over several
years. As we noted in Table 21 of the CY 2022 PFS proposed rule (86 FR
39222), the national payment rate for administering these preventive
vaccines has declined more than 30 percent since 2015.
We have attempted to address the reduction in payment rates for the
Part B preventive vaccine administration HCPCS G-codes in the last
three PFS rulemaking cycles. In the CY 2020 PFS final rule, we
acknowledged that it is in the public interest to ensure appropriate
resource costs are reflected in the valuation of the immunization
administration services that are used to deliver these vaccines, and
noted that we planned to review the valuations for these services in
future rulemaking. For CY 2020, we maintained the CY 2019 national
payment amount for immunization administration services described by
HCPCS codes G0008, G0009 and G0010 (84 FR 62798).
In the CY 2021 PFS proposed rule, we proposed to crosswalk CPT
codes 90460, 90471, and 90473, as well as HCPCS codes G0008, G0009 and
G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein)
(85 FR 50163). In the proposed rule, we noted that CPT code 36000 is a
service with a similar clinical vignette, and that the additional
clinical labor, supply, and equipment resources associated with
furnishing CPT code 36000 were similar to costs associated with these
vaccine administration codes. We also noted that this crosswalk would
have resulted in a payment rate for vaccine administration services
that is approximately the same as the CY 2017 rate that was in place
prior to the revaluation of CPT code 96372 (the original crosswalk
code). In the CY 2021 PFS final rule, we did not finalize the proposed
policy, and instead finalized a policy to maintain the CY 2019 payment
amount for CPT codes 90460-90474, as well as HCPCS codes G0008, G0009
and G0010 (85 FR 84628). In the final rule, we also noted that we
continued to seek additional information that specifically identifies
the resource costs and inputs that should be considered to establish
payment for vaccine administration services on a long-term basis.
For the CY 2022 rulemaking cycle, we requested feedback from
interested parties that would support the development of an accurate
and stable payment rate for administration of the preventive vaccines
described in section 1861(s)(10) of the Act (influenza, pneumococcal,
HBV, and COVID-19) for physicians, NPPs, mass immunizers and certain
other providers and suppliers. We invited commenters to submit their
detailed feedback to a series of questions and requests that we
believed would assist us in establishing payment rates for these
services that could be appropriate for use on a long-term basis; we
direct readers to the full discussion of this topic in the CY 2022 PFS
final rule (86 FR 65179 through 65193). For CY 2022, we finalized a
uniform payment rate of $30 for the administration of an influenza,
pneumococcal or HBV vaccine covered under the Medicare Part B
preventive vaccine benefit at section 1861(s)(10) of the Act. We
explained that since the administration of the preventive vaccines
described under section 1861(s)(10) of the Act is not included within
the statutory definition of physicians' services, the payment rates we
established for these services in the
[[Page 45925]]
CY 2022 PFS final rule are independent of the PFS, and will be updated
as necessary independently of the valuation of any specific codes under
the PFS (86 FR 65186). We discuss the current payment policy for
administration of preventive vaccines and our proposals for CY 2023 in
section III.H. of this proposed rule.
We note that as we consider payment policies to ensure adequate
access to the Part B preventive vaccines, including consideration of
resource costs, the RUC surveyed and reviewed CPT codes 90460-90474 at
the April 2021 meeting and submitted recommendations to CMS for our
consideration in the CY 2023 rulemaking cycle.
We are proposing the RUC-recommended work RVU for all six codes in
the Immunization Administration family. We are proposing a work RVU of
0.24 for CPT code 90460 (Immunization administration through 18 years
of age via any route of administration, with counseling by physician or
other qualified health care professional; first or only component of
each vaccine or toxoid administered), a work RVU of 0.18 for CPT code
90461 (Immunization administration through 18 years of age via any
route of administration, with counseling by physician or other
qualified health care professional; each additional vaccine or toxoid
component administered), a work RVU of 0.17 for CPT code 90471
(Immunization administration (includes percutaneous, intradermal,
subcutaneous, or intramuscular injections); 1 vaccine (single or
combination vaccine/toxoid)), a work RVU of 0.15 for CPT code 90472
(Immunization administration (includes percutaneous, intradermal,
subcutaneous, or intramuscular injections); each additional vaccine
(single or combination vaccine/toxoid)), a work RVU of 0.17 for CPT
code 90473 (Immunization administration by intranasal or oral route; 1
vaccine (single or combination vaccine/toxoid)), and a work RVU of 0.15
for CPT code 90474 (Immunization administration by intranasal or oral
route; each additional vaccine (single or combination vaccine/toxoid)).
For the direct PE inputs, we are proposing to remove 1 minute of
clinical labor time for the CA008 (Perform regulatory mandated quality
assurance activity (pre-service)) activity for CPT codes 90460 and
90471-90474. The RUC recommendations describe these activities as
``Checking historical and current temperatures for vaccine
refrigerator; recording temperatures; reporting temperatures; vaccine
inventorying; ordering vaccines; completing required Vaccines for
Children (VFC) paperwork; receiving vaccines; inspecting/logging
vaccines and putting them in the vaccine refrigerator; creating lot
numbers in HER.'' Checking refrigerator temperatures, vaccine
inventorying, and filling out vaccine paperwork are administrative
tasks which are not individually allocable to a particular patient for
a particular service. We are removing this 1 minute of clinical labor
time as these administrative tasks are forms of indirect PE. We are
also refining the equipment times for CPT codes 90460 and 90471-90474
to conform to our established policies for non-highly technical
equipment.
In consideration of the information provided in the recommendation
for these services, we are proposing the RUC's recommended work RVUs
and direct PE inputs (with minor refinements) for these vaccine
administration services. However, we continue to seek additional
information from commenters that specifically identifies the resource
costs and inputs that should be considered to establish payment for
these vaccine administration services on a long-term basis, consistent
with our policy objectives for ensuring maximum access to immunization
services.
(22) Orthoptic Training (CPT Codes 92065 and 920XX)
In October 2019, the RUC identified CPT code 92065 (Orthoptic and/
or pleoptic training, with continuing medical direction and evaluation;
performed by a physician or other qualified health care professional)
as needing review because it was Harvard Valued (that is, the value of
the code had not been reviewed since the implementation of the
Resource-Based Relative Value Scale (RBRVS)) and its utilization
surpassed 30,000 in each of several recent years. At its January 2020
meeting, during review of CPT code 92065, the RUC noted that the use of
``and/or'' in the descriptor defined different patient populations and
treatment techniques and recommended that the code be reviewed by the
CPT Editorial Panel (CPT) in order to create two separate codes.
Additionally, based upon review and analysis of survey data, specialty
societies decided to submit a new code change application for the
February 2021 CPT meeting.
During the February 2021 meeting, CPT noted that the services of
CPT code 92065 are delivered in two different ways: directly by the
practitioner and by a technician under the supervision of the
practitioner. In response to this observation, CPT suggested that two
codes be created to identify who furnishes the orthoptic service.
Identifying in the code descriptor who furnishes the services would
ensure more accurate valuation of both the work and the practice
expense associated with the service. The CPT formally revised code
92065 and created new CPT code 920XX to describe orthoptic services
furnished under the supervision of a physician or qualified health care
professional.
During its April 2021 meeting, the RUC revalued the work associated
with the services of CPT code 92065 (Orthoptic training; performed by a
physician or other qualified health care professional) and valued the
PE inputs for new CPT code 920XX (Orthoptic training; performed by a
physician or other qualified health care professional under supervision
of a physician or other qualified health care professional). CPT code
920XX is valued as a PE-only code.
After reviewing CPT code 92065, we are proposing to accept the RUC-
recommended work RVU of 0.71. We also are proposing to accept the RUC-
recommended direct PE inputs for CPT code 92065. We are proposing to
accept the RUC-recommended direct PE inputs for CPT code 920XX as well.
(23) Dark Adaptation Eye Exam (CPT Code 92284)
CPT code 92284 (Dark adaptation examination with interpretation and
report) was identified in July 2020 as Harvard Valued with a
utilization of over 30,000 claims. In January 2021, the RUC recommended
that the code be surveyed for the April 2021 RUC meeting. The RUC
reviewed the survey results for the procedure and noted that the 25th
percentile work value of 0.45 was greater than the code's current
value. The RUC recommended a work RVU of 0.14, based on a direct work
RVU crosswalk from CPT code 76514 (Ophthalmic ultrasound, diagnostic;
corneal pachymetry, unilateral or bilateral (determination of corneal
thickness)). We disagree with the RUC-recommended work RVU of 0.14 for
CPT code 92284. We found that the recommended work RVU did not
adequately reflect reductions in physician time, since this diagnostic
screening is usually completed during an E/M visit and largely consists
of interpreting machine generated results. Instead, we are proposing a
work RVU of 0.00 for CPT code 92284, which is comparable to other
ophthalmic screening tests; such as 99172 (Visual function screening,
automated or semi-automated bilateral quantitative determination of
visual acuity, ocular
[[Page 45926]]
alignment, color vision by pseudoisochromatic plates, and field of
vision (may include all or some screening of the determination[s] for
contrast sensitivity, vision under glare)) and 99173 (Screening test of
visual acuity, quantitative, bilateral). Alternatively, we considered
using a total-time methodology with a work RVU of 0.03 and a reverse
building block methodology with a work RVU of 0.06. We are seeking
comments and requesting information that may inform why CPT code 92284
should include additional valuation as this procedure is included in an
E/M visit.
For the direct PE inputs, we are proposing to refine the equipment
time for the lens set (EQ165) from 24 minutes to 15 minutes and
motorized table (EF030) from 24 minutes to 15 minutes. The reduction in
time for both equipment types is proposed to match the RUC-recommended
15 minutes in Clinical Activity Code CA021. We are seeking public
comment to provide further rationale for the additional 9 minutes
recommended.
(24) Anterior Segment Imaging (CPT Code 92287)
For CPT code 99287 (Anterior segment imaging with interpretation
and report; with fluorescein angiography), we are proposing the RUC-
recommended work RVU of 0.40.
We are proposing the RUC-recommended direct PE inputs for CPT code
92287 without refinement.
(25) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243,
93244, 93245, 93246, 93247, and 93248)
In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to
adopt the RUC's work RVU recommendations for CPT codes 93241 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation), 93242 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93243 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93244 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation),
93245 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; includes
recording, scanning analysis with report, review and interpretation),
93246 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; recording
(includes connection and initial recording)), 93247 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; scanning analysis with
report), and 93248 (External electrocardiographic recording for more
than 7 days up to 15 days by continuous rhythm recording and storage;
review and interpretation).
We noted that the recommendations for this family of codes
contained one new supply item, the ``extended external ECG patch,
medical magnetic tape recorder'' (SD339). We did not receive a
traditional invoice to establish a price for this supply item. Instead,
we received pricing information from two sources: a weighted median of
claims data with the cost of the other direct PE inputs removed, and a
top-down approach calculating the cost of the supply per service based
on summing the total costs of the health care provider and dividing by
the total number of tests furnished. The former methodology yielded a
supply price of approximately $440 while the latter methodology
produced an estimated supply price of $416.85. Interested parties also
submitted a series of invoices from the clinical study marketplace with
a price of $595, which we rejected as we typically require an invoice
representative of commercial market pricing to establish a national
price for a new supply or equipment item.
After consideration of the information, we proposed to employ a
crosswalk to an existing supply for use as a proxy price until we
received pricing information to use for the ``extended external ECG
patch, medical magnetic tape recorder'' item. We proposed to use the
``kit, percutaneous neuro test stimulation'' (SA022) supply as our
proxy item at a price of $413.24. We believed the kit to be the closest
match from a pricing perspective to employ as a proxy until we would be
able to arrive at an invoice that is representative of commercial
market pricing. We welcomed the submission of invoices or other
additional information for use in pricing the ``extended external ECG
patch, medical magnetic tape recorder'' supply. In response to our
proposal, we received conflicting information from commenters and in
the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized
contractor pricing for CY 2021 for the four codes that included this
supply input (CPT codes 93241, 93243, 93245, and 93247) to allow
additional time to receive more pricing information.
We noted that interested parties have continued to engage with CMS
and the MACs on payment for this service. We remained concerned that we
continued to hear that the supply costs as initially considered in our
CY 2021 PFS proposal were much higher than they should be. At the same
time, we also heard that the resource costs, as reflected in the
contractor-based payments, do not adequately cover the incurred cost
for the SD339 supply that is used to furnish these services. In
consideration of continued access to these services for Medicare
beneficiaries, we once again solicited public comments and information
in the CY 2022 PFS proposed rule (86 FR 39179) to support CMS' future
rulemaking to establish a uniform national payment that appropriately
reflects the PE inputs that are used to furnish these services. During
the comment period, we received invoices and additional information for
use in pricing the SD339 supply from the commenters.
Based on this information, we finalized an updated price of $200.15
for the extended external ECG patch, medical magnetic tape recorder''
(SD339) supply in the CY 2022 PFS final rule based on the average of
the ten invoices we received (86 FR 65125). We believed that the
invoice data for this supply item, which ranged from a minimum price of
$179.80 to a maximum price of $241.99, suggested that our updated price
of $200.15 was more accurate than the suggested crosswalk to the SD214
supply at a price of $325.98. We believed that considering a potential
impact to payment for other services under the PFS, a proposal to
establish national payment for these services based on this new pricing
information should take into account broader feedback from interested
parties. Therefore, we did not finalize national pricing at this time
and finalized our proposal to maintain contractor pricing for CPT codes
93241, 93243, 93245, and 93247 for CY 2022.
For CY 2023, we received a series of additional invoices for the
SD339 supply from two impacted parties. Each of the invoices priced the
supply item at either $265.00 or $226.38; we are therefore proposing to
average together these prices and establish a proposed price of $245.69
for the SD339 supply. We believe that this represents the most typical
price for the supply based on the invoice data that has been provided
over the past 2 years. We are also proposing
[[Page 45927]]
national pricing for CPT codes 93241, 93243, 93245, and 93247 for CY
2023 now that the SD339 supply has an established price. The proposed
CY 2023 RVUs for these CPT codes are displayed in Addendum B on the CMS
website under downloads for the CY 2023 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
(26) Cardiac Ablation (CPT Codes 93653, 93654, 93655, 93656, and 93657)
The technologies and clinical practices associated with Cardiac
Ablation Services have changed enough over the past decade (since 2011
when they were first developed) that the specialty societies
recommended referring theses codes to the CPT Editorial Panel to have
the code descriptors for Cardiac Ablation Services updated to create
new and more complete descriptors reflecting the fact that many of
these services are commonly performed together and should be
incorporated and bundled. From the survey results presented to CMS last
year, the RUC advisory committee believes that many of the survey
respondents may not have realized that the code descriptors had been
substantially revised and that they may not have read the updated code
descriptors thoroughly enough to understand that services that are
separately billed, were now combined into the existing codes (since CPT
did not issue new codes for the revised descriptors). Since then, the
RUC has re-surveyed these Cardiac Ablation codes in April 2021 for re-
review. In the interim, the work RVUs for the newly bundled CPT codes
were maintained at their current values until the new recommendations
were presented for CY 2023.
The RUC re-surveyed and reviewed CPT code 93653 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; treatment of
supraventricular tachycardia by ablation of fast or slow
atrioventricular pathway, accessory atrioventricular connection, cavo-
tricuspid isthmus or other single atrial focus or source of atrial re-
entry), and recommends a work RVU of 15.00 with 31 minutes of pre-
service evaluation time, 3 minutes positioning time, 15 minutes scrub/
dress/wait time, 120 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 199 minutes of total time.
CPT code 93653 currently has a work RVU value of 14.75 with 23 minutes
of pre-service evaluation time, 1 minutes positioning time, 5 minutes
scrub/dress/wait time, 180 minutes of intra-service time, 30 minutes of
immediate post-service time, for a sum of 239 minutes of total time.
The time and the physician's work of CPT add-on code 93613
(Intracardiac electrophysiologic 3-dimensional mapping (List separately
in addition to code for primary procedure) with a work RVU of 5.23 and
90 minutes of total time, and CPT add-on code 93621 (Comprehensive
electrophysiologic evaluation including insertion and repositioning of
multiple electrode catheters with induction or attempted induction of
arrhythmia; with left atrial pacing and recording from coronary sinus
or left atrium (List separately in addition to code for primary
procedure)) with a work RVU of 1.50 and 20 minutes of total time are
bundled within CPT code 93653. When all three codes are separately
considered, they currently sum up to 21.48 work RVUs, much greater than
the 15.00 work RVUs that the RUC has recommended. These codes also add
up to much more physician total time than the RUC-recommended 199
minutes.
After reviewing this code and relative similar codes in the PFS, we
propose a comparator CPT code 37229 (Revascularization, endovascular,
open or percutaneous, tibial, peroneal artery, unilateral, initial
vessel; with atherectomy, includes angioplasty within the same vessel,
when performed) with a work RVU of 13.80 and a similar intra-service
time of 120 minutes and similar pre-service evaluation, pre-service
positioning, pre-service scrub/dress/wait times, and immediate post-
service times, for a sum of 188 minutes of total time for a 000 day
global period, compared to the RUC-recommended 199 minutes of total
time for CPT code 93653. We propose a work RVU of 13.80 for the bundled
CPT code 93563.
The RUC re-surveyed and reviewed CPT code 93654 (Comprehensive
electrophysiologic evaluation with insertion and repositioning of
multiple electrode catheters, induction or attempted induction of an
arrhythmia with right atrial pacing and recording, and catheter
ablation of arrhythmogenic focus, including intracardiac
electrophysiologic 3-dimensional mapping, right ventricular pacing and
recording, left atrial pacing and recording from coronary sinus or left
atrium, and His bundle recording, when performed; with treatment of
ventricular tachycardia or focus of ventricular ectopy including left
ventricular pacing and recording, when performed), and recommends a
work RVU of 18.10 with 40 minutes of pre-service evaluation time, 3
minutes positioning time, 15 minutes scrub/dress/wait time, 200 minutes
of intra-service time, 33 minutes of immediate post-service time, for a
sum of 291 minutes of total time. CPT code 93654 currently has a work
RVU value of 19.75 with 23 minutes of pre-service evaluation time, 1
minutes positioning time, 5 minutes scrub/dress/wait time, 240 minutes
of intra-service time, 40 minutes of immediate post-service time, for a
sum of 309 minutes of total time. CPT code 93654 is currently and
continues to be a bundled code. The RUC recommended intra-service times
and total times for CPT code 93654 are less than the current times for
this code, and the RUC-recommended work RVUs are also less than the
current work RVUs. Though the RUC recommended a work RVU of 18.10, it
is still a relatively high value compared to the existing 19.75 value.
The RUC recommended a work RVU of 15.00 for CPT code 93653, and 18.10
for CPT code 93654, with a relative increment between them of 3.10 work
RVUs. We are proposing to maintain the relative increment RVU
difference of 3.10 between CPT code 93653 and CPT code 93654, so
because we are proposing a work RVU of 13.80 for CPT code 93653, we are
proposing a work RVU of 16.90 (13.80 plus 3.10) for CPT code 93654,
with 200 minutes of intra-service time and 291 minutes of total time.
CPT add-on code 93655 (Intracardiac catheter ablation of a discrete
mechanism of arrhythmia which is distinct from the primary ablated
mechanism, including repeat diagnostic maneuvers, to treat a
spontaneous or induced arrhythmia (List separately in addition to code
for primary procedure)) has a current work RVU of 5.50 with a physician
intra-service time of 60 minutes as finalized last year, from a
previous value of 7.50 work RVUs with 90 minutes of physician intra-
service time. The RUC recommended the re-surveyed intraservice time of
60 minutes and 7.00 work RVUs. The primary change to CPT code 93655 is
the reduction of the intraservice time of about 67 percent, which we
use as a guide to determine a work RVU. We compare CPT add-on code
22854
[[Page 45928]]
(Insertion of intervertebral biomechanical device(s) (e.g., synthetic
cage, mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to vertebral corpectomy(ies)
(vertebral body resection, partial or complete) defect, in conjunction
with interbody arthrodesis, each contiguous defect (List separately in
addition to code for primary procedure)), also with 60 minutes of
intraservice and total time and a work RVU of 5.50 to CPT add-on code
93655 and we believe that this is a more accurate valuation than the
RUC's work RVU comparison to CPT add-on code 93592 (Percutaneous
transcatheter closure of paravalvular leak; each additional occlusion
device (List separately in addition to code for primary procedure))
with a work RVU of 8.00 and an intra-service and total time of 60
minutes, and to CPT add-on code 34820 (Open iliac artery exposure for
delivery of endovascular prosthesis or iliac occlusion during
endovascular therapy, by abdominal or retroperitoneal incision,
unilateral (List separately in addition to code for primary procedure))
with a work RVU of 7.00 and an intra-service and total time of 60
minutes. After reviewing this code and relative similar codes in the
PFS, we propose to maintain the current work RVU for CPT code 93655 of
5.50 with a physician intra-service time of 60 minutes, as finalized
last year (86 FR 65108).
The RUC re-surveyed and reviewed CPT code 93656 (Comprehensive
electrophysiologic evaluation including transseptal catheterizations,
insertion and repositioning of multiple electrode catheters with
intracardiac catheter ablation of atrial fibrillation by pulmonary vein
isolation, including intracardiac electrophysiologic 3-dimensional
mapping, intracardiac echocardiography including imaging supervision
and interpretation, induction or attempted induction of an arrhythmia
including left or right atrial pacing/recording, right ventricular
pacing/recording, and His bundle recording, when performed), and
recommends a work RVU of 17.00 with 35 minutes of pre-service
evaluation time, 3 minutes positioning time, 15 minutes scrub/dress/
wait time, 180 minutes of intra-service time, 30 minutes of immediate
post-service time, for a sum of 263 minutes of total time. CPT code
93656 currently has a work RVU of 19.77 with 23 minutes of pre-service
evaluation time, 1 minute positioning time, 5 minutes scrub/dress/wait
time, 240 minutes of intra-service time, 40 minutes of immediate post-
service time, for a sum of 309 minutes of total time. CPT code 93656
has bundled within it, the time and the physician's work of CPT add-on
code 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List
separately in addition to code for primary procedure) with a work RVU
of 5.23 and 90 minutes of total time and CPT add-on code 93662
(Intracardiac echocardiography during therapeutic/diagnostic
intervention, including imaging supervision and interpretation (List
separately in addition to code for primary procedure)) with a work RVU
of 1.44 and 25 minutes of total time. When all three codes are
separately considered, they sum up to 26.44 work RVUs, which is much
greater than the 17.00 work RVUs that is recommended and has much more
physician total time than the RUC recommended 263 total time minutes.
The RUC recommended intra-service times and total times for CPT
code 93656 that are less than the current times for this code and we
expect the work RVUs to also be less than the current work RVUs. Though
the RUC recommended a work RVU of 17.00, it is still a high value
compared to the existing 19.77. The RUC recommended the work RVU for
CPT code 93653 as 15.00, and for CPT code 93656 as 17.00, with a
relative increment between them of 2.00 work RVUs. As a better
valuation for CPT code 93656, CMS proposes the proposed CPT code
93653's 13.80 work RVU plus the relative increment RVU difference of
2.00 that the RUC is maintaining between CPT code 93653 and CPT code
93656 (15.00 subtracted from 17.00 equals 2.00). This would value CPT
code 93656 at 15.80 (13.80 plus 2.00) work RVUs for 180 minutes of
intra-service time and 263 minutes of total time, which we propose for
CY 2023.
CPT add-on code 93657 (Additional linear or focal intracardiac
catheter ablation of the left or right atrium for treatment of atrial
fibrillation remaining after completion of pulmonary vein isolation
(List separately in addition to code for primary procedure)) has a
current work RVU of 5.50 with a physician intra-service time of 60
minutes as finalized last year (86 FR 65108). The previous work RVU was
7.50 with 90 minutes of physician intraservice time. The RUC
recommended the re-surveyed intra-service time of 60 minutes and 7.00
work RVUs. The primary change to CPT add-on code 93657 is the reduction
of the intra-service time from before the re-survey and the current
RUC-recommended time, from 90 minutes to 60 minutes, which is a
reduction of about 67 percent, and which we used as a guide to
determine an appropriate work RVU. We compare CPT add-on code 22854
(Insertion of intervertebral biomechanical device(s) (e.g., synthetic
cage, mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to vertebral corpectomy(ies)
(vertebral body resection, partial or complete) defect, in conjunction
with interbody arthrodesis, each contiguous defect (List separately in
addition to code for primary procedure)), also with 60 minutes of
intra-service and total time, and a work RVU of 5.50, to CPT add-on
code 93657, and believe that this is a more accurate comparison for
valuation than the RUC's work RVU comparison to CPT add-on code 93592
(Percutaneous transcatheter closure of paravalvular leak; each
additional occlusion device (List separately in addition to code for
primary procedure)) with a work RVU of 8.00 and an intra-service and
total time of 60 minutes, and to CPT add-on code 34820 (Open iliac
artery exposure for delivery of endovascular prosthesis or iliac
occlusion during endovascular therapy, by abdominal or retroperitoneal
incision, unilateral (List separately in addition to code for primary
procedure)) with a work RVU of 7.00 and an intra-service and total time
of 60 minutes. After reviewing this code and relative similar codes in
the PFS, we are proposing to re-affirm the current work RVU of 5.50
with a physician intraservice time of 60 minutes for CPT add-on code
93657, as finalized last year (86 FR 65108).
The RUC did not recommend, and we are not proposing, direct PE
inputs for CPT codes 93653-93657.
(27) Pulmonary Angiography (CPT Codes 93XX0, 93XX1, 93XX2, 93XX3,
93563, 93564, 93565, 93566, 93567, and 93568)
In May 2021, the CPT Editorial Panel revised CPT code 93568
(Injection procedure during cardiac catheterization including imaging
supervision, interpretation, and report; for nonselective pulmonary
arterial angiography (List separately in addition to code for primary
procedure) which resulted in the creation of four new related CPT add-
on codes. CPT add-on codes 93563 to 93567 were surveyed with the four
new codes, as part of the same code family.
The RUC surveyed and reviewed CPT code 93563 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective coronary angiography during
congenital heart
[[Page 45929]]
catheterization (List separately in addition to code for primary
procedure)), and recommends a work RVU of 1.11 for 15 minutes of intra-
service and total time for this add-on service. The current work RVU is
1.11 for 25 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64494
(Injection(s), diagnostic or therapeutic agent, paravertebral facet
(zygapophyseal) joint (or nerves innervating that joint) with image
guidance (fluoroscopy or CT), lumbar or sacral; second level (List
separately in addition to code for primary procedure)), with a work RVU
of 1.00 for 15 minutes of intra-service and total time. CPT code 64494
is a good comparator in terms of both the new physician time and due to
the proportional work RVU, as compared to CPT code 93563. Therefore, we
are proposing a work RVU of 1.00 and 15 minutes of intra-service and
total time for add-on CPT code 93563.
The RUC surveyed and reviewed CPT code 93564 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective opacification of
aortocoronary venous or arterial bypass graft(s) (e.g., aortocoronary
saphenous vein, free radial artery, or free mammary artery graft) to
one or more coronary arteries and in situ arterial conduits (e.g.,
internal mammary), whether native or used for bypass to one or more
coronary arteries during congenital heart catheterization (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 1.13 for 18 minutes of intra-service and total time for
this add-on service. The current work RVU is 1.13 for 25 minutes of
intra-service and total time, so there is a reduction of 7 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 31632 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
transbronchial lung biopsy(s), each additional lobe (List separately in
addition to code for primary procedure)) with a work RVU of 1.03 for 18
minutes of intra-service and total time. CPT code 31632 is a good
comparator in terms of both the new physician time and due to the
proportional work RVU, as compared to CPT code 93564. Therefore, we are
proposing a work RVU of 1.03 and 18 minutes of intra-service and total
time for add-on CPT code 93564.
The RUC surveyed and reviewed CPT code 93565 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective left ventricular or left
atrial angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU as compared
to CPT code 93565. Therefore, we are proposing a work RVU of 0.50 and
10 minutes of intra-service and total time for add-on CPT code 93565.
The RUC surveyed and reviewed CPT code 93566 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for selective right ventricular or right
atrial angiography (List separately in addition to code for primary
procedure)) and recommends a work RVU of 0.86 for 10 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.86 for 20 minutes of intra-service and total time, so there is a
reduction of 10 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we believe a better comparator add-on code would be CPT code 64421
(Injection(s), anesthetic agent(s) and/or steroid; intercostal nerve,
each additional level (List separately in addition to code for primary
procedure)) with a work RVU of 0.50 for 10 minutes of intra-service and
total time. CPT code 64421 is a good comparator code in terms of both
the new physician time and due to the proportional work RVU, as
compared to CPT code 93566. Therefore, we are proposing a work RVU of
0.50 and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93567 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for supravalvular aortography (List
separately in addition to code for primary procedure)), and recommends
a work RVU of 0.97 for 10 minutes of intra-service and total time for
this add-on service. The current work RVU is 0.97 for 15 minutes of
intra-service and total time, so there is a reduction of 5 minutes in
physician time. With the reduction of physician time, it is typical
that there would be some reduction in the work RVUs. After reviewing
this code and relative similar codes in the PFS, we believe a better
comparator add-on code would be CPT code 74248 (Radiologic small
intestine follow-through study, including multiple serial images (List
separately in addition to code for primary procedure for upper GI
radiologic examination)) with a work RVU of 0.70 for 10 minutes of
intra-service and total time. CPT code 74248 is a good comparator code
in terms of both the new physician time and due to the proportional
work RVU, as compared to CPT code 93567. Therefore, we are proposing a
work RVU of 0.70 and 10 minutes of intra-service and total time.
The RUC surveyed and reviewed CPT code 93568 (Injection procedure
during cardiac catheterization including imaging supervision,
interpretation, and report; for nonselective pulmonary arterial
angiography (List separately in addition to code for primary
procedure)), and recommends a work RVU of 0.88 for 13 minutes of intra-
service and total time for this add-on service. The current work RVU is
0.88 for 20 minutes of intra-service and total time, so there is a
reduction of 7 minutes in physician time. With the reduction of
physician time, it is typical that there would be some reduction in the
work RVUs. After reviewing this code and relative similar codes in the
PFS, we agree with the RUC recommendation and are proposing a work RVU
of 0.88 with 13 minutes of intra-service and total time for add-on CPT
code 93568.
For the first of the related four new add-on codes to this family,
temporarily designated as CPT placeholder code 93XX0 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for selective pulmonary arterial
angiography, unilateral (List separately
[[Page 45930]]
in addition to code for primary procedure)), the RUC recommends a work
RVU of 1.05 for 11 minutes of intra-service and total time for this
add-on service. The RUC noted that the typical patient for this service
is pediatric. After reviewing this code and relative similar codes in
the PFS, we believe a better comparator add-on code would be CPT code
78434 (Absolute quantitation of myocardial blood flow (AQMBF), positron
emission tomography (PET), rest and pharmacologic stress (List
separately in addition to code for primary procedure)) with a work RVU
of 0.63 for 11 minutes of intra-service and total time. CPT code 78434
is a good comparator code in terms of both the physician time, and due
to the proportional work RVU, as compared to CPT code 93XX0. Therefore,
we are proposing a work RVU of 0.63 and 11 minutes of intra-service and
total time for add-on CPT code 93XX0.
For the second of the related four new add-on codes to this family,
temporarily designated as CPT placeholder code 93XX1 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for selective pulmonary arterial
angiography, bilateral (List separately in addition to code for primary
procedure)), the RUC recommends a work RVU of 1.75 for 18 minutes of
intra-service and total time for this add-on service. The RUC noted
that the typical patient for this service is pediatric and that this
service is bilateral. After reviewing this code and relative similar
codes in the PFS, we believe a better comparator add-on code would be
HCPCS code G0289 (Arthroscopy, knee, surgical, for removal of loose
body, foreign body, debridement/shaving of articular cartilage
(chondroplasty) at the time of other surgical knee arthroscopy in a
different compartment of the same knee (List separately in addition to
code for primary procedure)) with a work RVU of 1.48 for 20.5 minutes
of intra-service and total time and that this service is bilateral.
G0289 has 2.5 minutes of additional physician intra-service time, so we
adjust the comparator work RVU from 1.48 to 1.30. Therefore, we are
proposing 1.30 work RVUs for 18 minutes of intra-service and total time
for add-on CPT code 93XX1.
For the third of the related four new add-on codes to this family,
temporarily designated as CPT placeholder code 93XX2 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for selective pulmonary venous angiography
of each distinct pulmonary vein during cardiac catheterization. (List
separately in addition to code for primary procedure)), the RUC
recommends a work RVU of 1.84 for 20 minutes of intra-service and total
time for this add-on service. The RUC noted that the typical patient
for this service is pediatric. After reviewing this code and relative
similar codes in the PFS, we believe a better comparator add-on code
would be CPT code 93598 (Measurement of output of blood from heart,
performed during cardiac catheterization for evaluation of congenital
heart defects (List separately in addition to code for primary
procedure)) with a work RVU of 1.44 for 20 minutes of intra-service and
total time. CPT code 93598 is a good comparator code in terms of both
the physician time, and due to the proportional work RVU, as compared
to CPT code 93XX2.
Therefore, we are proposing 1.44 work RVUs for 20 minutes of intra-
service and total time for add-on CPT code 93XX2.
For the last of the related four new add-on codes to this family,
temporarily designated as CPT placeholder code 93XX3 (Injection
procedure during cardiac catheterization including imaging supervision,
interpretation, and report; for selective pulmonary angiography of
major aortopulmonary collateral arteries (MAPCAs) arising off the aorta
or its systemic branches, each distinct vessel)), the RUC recommends a
work RVU of 1.92 for 20 minutes of intra-service and total time for
this add-on service. The RUC describes this service and the physician's
work as very time-intensive and complicated, and the typical patient
for this service is pediatric. We agree with the RUC recommendations
and are proposing a work RVU of 1.92 with 20 minutes of intra-service
and total time for add-on CPT code 93XX3.
The RUC did not recommend, and we are not proposing, direct PE
inputs for CPT codes 93563-93XX3.
(28) Quantitative Pupillometry Services (CPT Code 959XX)
The CPT Editorial Panel approved a new Category I CPT code to
replace the sunset Category III (CPT code 0341T Quantitative
pupillometry with interpretation and report, unilateral or bilateral)
and 92499 (Unlisted ophthalmological service or procedure for reporting
this service).
We are not proposing the RUC-recommended work RVU of 0.25 for CPT
code 959XX, as we believe this is an overestimation based on a
comparison to other codes with similar time values, particularly the
key reference code CPT code 92081 (Visual field examination, unilateral
or bilateral, with interpretation and report; limited examination
(e.g., tangent screen, Autoplot, arc perimeter, or single stimulus
level automated test, such as Octopus 3 or 7 equivalent). In the
interest of maintaining relativity with similarly timed codes, we are
instead proposing a work RVU of 0.18 with a crosswalk to CPT code 92504
(Binocular microscopy (separate diagnostic procedure)). We note that
this value falls between the work RVUs of 0.17 for CPT code 94010
(Spirometry, including graphic record, total and timed vital capacity,
expiratory flow rate measurement(s), with or without maximal voluntary
ventilation) and 0.20 for CPT code 77081 (Dual-energy X-ray
absorptiometry (DXA), bone density study, 1 or more sites; appendicular
skeleton (peripheral) (e.g., radius, wrist, heel)); both codes have
identical intraservice times and similar total times.
We are proposing the RUC-recommended direct PE inputs without
refinement.
(29) Caregiver Behavior Management Training (CPT Codes 96X70 and 96X71)
CPT code 96X70 (Multiple-family group behavior management/
modification training for guardians/caregivers of patients with a
mental or physical health diagnosis, administered by physician or other
qualified health care professional (without the patient present), face-
to-face with multiple sets of guardians/caregivers; initial 60 minutes)
and its add-on code, CPT code 96X71 (Multiple-family group behavior
management/modification training for guardians/caregivers of patients
with a mental or physical health diagnosis, administered by physician
or other qualified health care professional (without the patient
present), face-to-face with multiple sets of guardians/caregivers; each
additional 15 minutes (List separately in addition to code for primary
service)), are new codes created by the CPT Editorial Panel during its
February 2021 meeting. The two codes are to be used to report the total
duration of face-to-face time spent by the physician or other qualified
health professional providing group training to guardians or caregivers
of patients. Although the patient does not attend the group trainings,
the goals and outcomes of the sessions focus on interventions aimed at
improving the patient's daily life. According to the CPT Summary of
Recommendations, during the face-to-face time service time, caregivers
are taught how to structure the patient's environment to support and
reinforce
[[Page 45931]]
desired patient behaviors, to reduce the negative impacts of the
patient's diagnosis on patient's daily life, and to develop highly
structured technical skills to manage patient behavior.
As a means of identifying work values for CPT codes 96X70 and
96X71, three specialty societies sent surveys to a random sample of a
subset of their members. Based upon survey results and after
discussion, the RUC recommended a work RVU of 0.43 per identified
patient service for CPT code 96X70. The RUC noted that this
recommendation is based upon a median group size of six caregivers and
includes 10 minutes pre-time, 60 minutes intra-time, and 20 minutes
post-time for a total time of 90 minutes. For CPT code 96X71, the 15-
minute add-on code, the RUC recommended a work RVU of 0.12, which is
also based upon a median group size of six.
After reviewing the caregiver training codes, we have determined
that CPT codes 96X70 and 96X71 are not payable under the PFS. Under
section 1862(a)(1)(A) of the Act, Medicare payment is generally limited
to those items and services that are reasonable and necessary for the
diagnosis or treatment of illness or injury or that improve the
functioning of a malformed body member. In past rulemaking, we have
explained that we read section 1862(a)(1)(A) of the Act to limit
Medicare coverage and payment to items and services that are reasonable
and necessary for the diagnosis and treatment of an individual Medicare
beneficiary's illness or injury or that improve the functioning of an
individual Medicare beneficiary's malformed body member. For example,
in the CY 2013 PFS final rule (77 FR 68979), when discussing payment
for the non-face-to-face care management services that are part of E/M
services, we stated that Medicare does not pay for services that are
furnished to parties other than the beneficiary. We listed as an
example, communication with caregivers. Because the codes for caregiver
behavior management training describe services furnished exclusively to
caregivers rather than to the individual Medicare beneficiary, we did
not review the RUC-recommended valuation of these codes for purposes of
PFS payment. However, recognizing our focus on ensuring equitable
access to reasonable and necessary medical services, we are seeking
comment about the services described by these two codes. First, we are
seeking comment on the ways in which a patient may benefit when a
caregiver learns strategies to modify the patient's behavior. We are
also seeking comment on how current Medicare policies regarding these
caregiver training services may impact Medicare beneficiary health.
Finally, we are seeking comment about how the services described by
these codes might be bundled into Medicare covered services as incident
to services or as practitioner work that is part of some care
management codes.
(30) Cognitive Behavioral Therapy Monitoring (CPT Code 989X6).
See the Remote Therapeutic Monitoring (RTM) section II.I. of this
proposed rule for a review of new device code, CPT code 989X6.
(31) Code Descriptor Changes for Annual Alcohol Misuse and Annual
Depression Screenings (HCPCS Codes G0442 and G0444)
Interested parties have raised concerns with the portion of the
code descriptors that require a certain number of minutes to bill for
the HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and
G0444 (Annual depression screening, 15 minutes). Over the past several
years, AAFP and the ACP have requested that CMS revise the code
descriptors to state ``up to 15 minutes'' instead of the current ``15
minutes,'' allowing practitioners to efficiently furnish the service.
As currently described, claims for the service are said to be denied by
MACs in instances where records suggest that a full 15 minutes was not
reached by the practitioner when furnishing the service. Both codes are
high in volume for 2019 and 2020, with over 700,000 reported services
in our Medicare claims data.
Medicare Part B coverage for such screenings originated from a
national coverage determination (NCD) from 2011 and 2012. We believe
that these screenings may not require a full 15 minutes to perform for
the typical patient, so we believe that it would be appropriate to
propose to revise the descriptors to specify that screening times of 5
to 15 minutes would be the typical range to furnish these services.
This will establish a lower time limit for both HCPCS codes G0442 and
G0444. Therefore, we propose to modify the descriptor for HCPCS code
G0442 to read ``Annual alcohol misuse screening, 5 to 15 minutes'' and
for HCPCS code G0444 to read ``Annual depression screening, 5 to 15
minutes.''
(32) Insertion, and Removal and Insertion of New 180-Day Implantable
Interstitial Glucose Sensor System (HCPCS Codes G0308 and G0309)
For the CY 2021 PFS final rule (85 FR 84645), we established
national pricing for 3 Category III CPT codes that describe continuous
glucose monitoring. Category III CPT codes 0446T (Creation of
subcutaneous pocket with insertion of implantable interstitial glucose
sensor, including system activation and patient training), 0447T
(removal of implantable interstitial glucose sensor from subcutaneous
pocket via incision), and 0448T (removal of implantable interstitial
glucose sensor with creation of subcutaneous pocket at different
anatomic site and insertion of new implantable sensor, including system
activation) describe the services related to the insertion, removal,
and removal and insertion of an implantable interstitial glucose sensor
from a subcutaneous pocket. The implantable interstitial glucose
sensors are part of systems that can allow real-time glucose
monitoring, provide glucose trend information, and signal alerts for
detection and prediction of episodes of low blood glucose
(hypoglycemia) and high blood glucose (hyperglycemia). The direct PE
inputs for CPT code 0446T include a 90-day supply item, SD334
(implantable interstitial glucose sensor), and a 90-day smart
transmitter proxy equipment item, EQ392 (heart failure patient
physiologic monitoring equipment package). The direct PE inputs for CPT
code 0448T include only the 90-day SD334 interstitial glucose sensor.
For CY 2022, based on requests from interested parties for CMS to
allow beneficiaries critical access to a newly approved 180-day
continuous glucose monitoring system, CMS established two new HCPCS
codes to describe the new 180-day monitoring service. Specifically, CMS
established HCPCS code G0308 (Creation of subcutaneous pocket with
insertion of 180-day implantable interstitial glucose sensor, including
system activation and patient training) and G0309 (removal of
implantable interstitial glucose sensor with creation of subcutaneous
pocket at different anatomic site and insertion of new 180-day
implantable sensor, including system activation). The newly approved
180-day continuous glucose monitoring system extends the monitoring
period from the previous 90 days to allow for a longer monitoring
period between replacement of the sensor. We believe it is important
for beneficiaries to have continued access to this service during the
transition from a 90- to 180-day monitoring period where the 90-day
sensor may become obsolete. Therefore, HCPCS codes G0308 and G0309 are
contractor priced and effective July 1, 2022. We are seeking
information and invoices from
[[Page 45932]]
interested parties on the costs of the 180-day interstitial glucose
supply and 180-day smart transmitter equipment direct PE inputs for
HCPCS codes G0308 and G0309 to ensure proper payment for these
physician's services, for consideration of national payment amounts for
CY 2023. We note that the 90-day supply item, SD334, is currently
priced at $1,500 based on information we received from interested
parties. The 90-day smart transmitter, EQ392, is currently priced at
$1,000 and assigned a time value of 25,290 minutes derived from 60
minutes per hour times 24 hours per day times 90 days per billing
quarter divided by 1 minute of equipment use of every 5 minutes of
time. HCPCS code G0308 includes the smart transmitter and interstitial
glucose sensor and HCPCS code G0309 includes the interstitial glucose
sensor only.
(33) Chronic Pain Management and Treatment (CPM) Bundles (HCPCS GYYY1,
and GYYY2)
(a) Background and Proposal
In the CY 2022 PFS proposed rule (86 FR 39104, 39179-39181), we
explored refinements to the PFS that would appropriately value chronic
pain management and treatment (CPM) by soliciting comment on CPM for
the purpose of future rulemaking. In our solicitation, we described
Federal efforts for more than a decade to effectively address pain
management as a response to the nation's overdose crisis,\9\ such as
the National Pain Strategy \10\ and the HHS Pain Management Best
Practices Inter-Agency Task Force (PMTF) Report.\11\ As we noted in our
CY 2022 comment solicitation, several sections of the Support for
Patients and Communities Act of 2018 \12\ (SUPPORT Act) describe
actions the Department of Health and Human Services has been directed
to take to improve pain care, such as section 2003, which amended
Medicare's Annual Wellness Visit \13\ to include a review of factors
for evaluation related to pain for patients using opioid medications;
section 6086, the Dr. Todd Graham Pain Management Study; \14\ and
section 6032, which required CMS to furnish a Report to Congress and
develop a related Action Plan to review coverage and payment policies
in Medicare and Medicaid related to the treatment of opioid use
disorder and for non-opioid therapies to help manage acute and chronic
pain.\15\ In the section 6032 Report and the Action Plan, CMS included
a recommendation to explore the possibility of establishing a new
bundled payment under the Medicare Physician Fee Schedule for
integrated multimodal pain care that could include certain elements
such as diagnosis, a person-centered plan of care, care coordination,
medication management, and other aspects of pain care.
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\9\ https://www.hhs.gov/overdose-prevention/.
\10\ https://www.iprcc.nih.gov/sites/default/files/documents/NationalPainStrategy_508C.pdf.
\11\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
\12\ https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf.
\13\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
\14\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\15\ https://www.cms.gov/sites/default/files/2022-4/SUPPORT%206032%20Action%20Plan_Final_061521_Clean.pdf.
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As described in Goal 3 of CMS's 2022 Behavioral Health Strategy
\16\ (Strategy), CMS intends to improve the care experience for
individuals with acute and chronic pain, expand access to evidence-
based treatments for acute and chronic pain, and increase coordination
between primary and specialty care through payment episodes,
incentives, and payment models. In late 2019, the CMS Office of Burden
Reduction & Health Informatics launched the ``Chronic Pain Stakeholder
Engagement'', which focused on understanding access to covered
treatment and services for people living with pain.\17\ CMS recently
released information gathered from interested parties through this
Engagement using qualitative research methods and the human-centered
design process, to uncover provider burden, and identify opportunities
to improve access to covered services by illustrating the experiences
of people living with, and treating, chronic pain. The intent of this
project was to highlight the most prominent barriers people with pain
face in accessing care, and the factors influencing clinicians that can
affect people with chronic pain, the quality of their care, and their
quality of life.
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\16\ https://www.cms.gov/cms-behavioral-health-strategy.
\17\ https://www.cms.gov/About-CMS/OBRHI.
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In the context of the Biden-Harris' Administration's commitment to
equity,\18\ and the inclusion of equity as a pillar of CMS's Strategic
Vision,\19\ disparities exist in pain treatment due to bias in
treatment, language barriers, and socioeconomic status. We are also
aware that pain is a factor in suicidality and suicide, prioritized in
the Surgeon General's Call to Action to Implement the National Strategy
for Suicide Prevention \20\ and in HHS's work to implement ``988,\21\''
the new national dialing code for suicide and crisis assistance to be
implemented nationally this year.
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\18\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
\19\ https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
\20\ https://www.hhs.gov/sites/default/files/sprc-call-to-action.pdf.
\21\ https://www.samhsa.gov/find-help/988.
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In coordination with all of these initiatives, we also have
continued to explore refinements to the PFS that would appropriately
value CPM. In the CY 2022 PFS proposed rule, we sought comment on
whether we should approach CPM through a standalone code or E/M add-on
coding, and about the specific activities that are involved in CPM, how
we might value such a code or service, the settings where this care is
provided, the types of practitioners that furnish this care, and
whether the service or any components of it could or should be
furnished as ``incident to'' \22\ services under the direction of the
billing practitioner by other members of the care team (86 FR 39182).
We received just under two thousand comments on this comment
solicitation, including comments from national health care
organizations including provider associations, federations, and
societies that represent health care professionals; organizations that
educate, connect, and advocate for people with pain; State-based health
care organizations, medical societies and associations; cancer care
centers; health care companies; device manufacturers; pain care
providers; and people living with pain. Almost all commenters were
supportive of our efforts to carefully consider an approach to coding
and payment for care for CPM. Many commenters supported the creation of
separate coding and payment for CPM under the PFS. We summarized these
comments, expressed appreciation for the commenters' attention to
informing our approach to payment and coding for comprehensive CPM
services, and thanked the commenters for their comments in the CY 2022
PFS final rule (86 FR 65129).
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\22\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se0441.pdf.
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Generally, commenters agreed that efforts are needed to effectively
support the complex needs of beneficiaries with chronic pain.
Commenters emphasized that there are numerous conditions giving rise to
chronic pain and that people presenting with chronic pain respond
variably to various treatment modalities, and often require longer
office visit times, and longer follow-up coordinating care with social
workers
[[Page 45933]]
and case managers, mental and behavioral health support, communications
with emergency department physicians and nurses, and numerous
medication adjustments. One commenter stated that beneficiaries with
complex chronic pain conditions may require a lot of time for correct
dosing of medications and counseling, and that such time is not
captured effectively using existing E/M codes. This commenter also
believed that separate coding and payment for chronic pain management
could help with better understanding of the treatment of chronic pain
than when the service is reported with existing visit codes and would
allow for valuation based on the resources involved in furnishing these
specific services to people with chronic pain, enhancing the likelihood
of appropriate payment, especially for non-face-to-face time involved
with the service.
A few commenters expressed preference for using existing E/M codes
and the creation of codes to be used in conjunction with E/M codes. One
commenter suggested that CMS either clarify or modify existing codes so
they can support services for patients with chronic pain or significant
acute pain, as well as beneficiaries with a chronic disease and a
behavioral health condition, stating that using the existing codes
would avoid any concerns about overpayment for patients with both a
chronic disease and pain, while also making it more feasible for small
practices to employ care management staff and provide customized care
management services for all the patients who need them.
One commenter who was agreeable with various approaches to payment
suggested that the guidelines for Cognitive Assessment and Care Plan
Services code 99483 include ``chronic pain syndromes'' in the
``assessment of factors that could be contributing to cognitive
impairment'' and that these codes could be reported by physicians who
consult with a pain specialist about their patient's pain. This
commenter also suggested that Transitional Care Management could also
potentially include pain management following inpatient care to help
prevent acute pain from progressing to chronic pain. Other commenters
also likened CPM services to chronic care management services. We
believe that chronic care management codes, which, except for Principal
Care Management, specify that the chronic condition being managed is
expected to last at least one year or until death, would not properly
describe the condition of many beneficiaries with chronic pain. For
example, the 11th revision of the World Health Organization's
International Classification of Diseases and Related Health Problems
define chronic pain as persistent or recurring pain lasting longer than
three months.\23\
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\23\ https://icd.who.int/en.
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Commenters included feedback about other specific activities
involved in the management of patients with chronic pain in addition to
those we specified in the comment solicitation. Commenters also
identified codes that CMS might examine as models for payment, either
as stand-alone timed codes or monthly bundles. Commenters suggested
which practitioners should be able to bill such CPM codes, which
practitioners should be able to furnish CPM services incident to the
services of a physician or other practitioner, and expressed views on
adding CPM services to the Medicare Telehealth Services List and
obtaining beneficiary consent for CPM services.
We agree with commenters who believe that E/M codes may not reflect
all the services and resources required to furnish comprehensive,
chronic pain management to beneficiaries living with pain. While we
agree in principle that it might be appropriate to establish bundled
all-inclusive coding with monthly payment for a broader set of CPM
services, we do not have data at the present time on the full scope of
services and resource inputs involved in care for patients with chronic
pain to support development of a proposed monthly bundled all-inclusive
rate. We do believe that E/M codes do not appropriately reflect the
time and other potential resources involved in furnishing comprehensive
CPM for beneficiaries with chronic pain. Beginning in the CY 2014 PFS
final rule (78 FR 74414 through 74427), we recognized that the
resources involved in furnishing comprehensive care to patients with
multiple chronic conditions are greater than those required to support
care in a typical E/M service. In response, we finalized a separately
payable HCPCS code GXXX1 (Chronic Care Management (CCM) services
furnished to patients with multiple (2 or more) chronic condition
expected to last at least 12 months, or until the death of the patient;
20 minutes or more per in 30 days of chronic care management services
provided by clinical staff and directed by a physician or other
qualified health care practitioner). The following year, in the CY 2015
PFS final rule (79 FR 67715 through 67730), we refined aspects of the
existing CCM policies and adopted separate payment for CCM services
under CPT code 99490 (Chronic care management services (CCM), at least
20 minutes of clinical staff time directed by a physician or other
qualified health 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 the CY 2017
PFS final rule (81 FR 80244), we adopted CPT codes 99487 (Complex
chronic care management (CCCM) 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, comprehensive care plan
established, implemented, revised, or monitored, moderate or high
complexity medical decision making; first 60 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month) and 99489 (CCCM 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, comprehensive
care plan established, implemented, revised, or monitored, moderate or
high complexity medical decision making; each additional 30 minutes of
clinical staff time directed by a physician or other qualified health
care professional, per calendar month (List separately in addition to
code for primary procedure)). Then, in the CY 2019 PFS final rule (83
FR 59577), we adopted a new CPT code, 99491 (CCM 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 at least
30 minutes of CCM services performed personally by a
[[Page 45934]]
physician or NPP. In the CY 2020 PFS final rule (84 FR 62690), we
established payment for an add-on code to CPT code 99490 by creating
HCPCS code G2058 (CCM services, each additional 20 minutes of clinical
staff time directed by a physician or other qualified healthcare
professional, per calendar month). We also created two new HCPCS G
codes, G2064 and G2065 (84 FR 62692 through 62694), representing
comprehensive services for a single high-risk disease (that is,
principal care management). In the CY 2021 PFS final rule (85 FR
84639), we finalized a RUC-recommended replacement code for HCPCS code
G2058 with the identical descriptor, CPT code 99439, and assigned the
same valuation as for G2058. For CY 2022, the RUC resurveyed the CCM
code family, including CCCM and Principal Care Management (PCM), and
added five new CPT codes: 99437 (CCM services each additional 30
minutes by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure)), 99424 (PCM services for a single high-risk disease first
30 minutes provided personally by a physician or other qualified health
care professional, per calendar month), 99425 (PCM services for a
single high risk disease each additional 30 minutes provided personally
by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure), 99426 (PCM, for a single high-risk disease first 30 minutes
of clinical staff time directed by physician or other qualified health
care professional, per calendar month), and 99427 (PCM services, for a
single high-risk disease each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure)).
The CCM/CCCM/PCM code family now includes five sets of codes, each
set with a base code and an add-on code. The sets vary by the degree of
complexity of care (that is, CCM, CCCM, or PCM), who directly performs
the services (that is, clinical staff, or the physician or NPP), and
the time spent furnishing the services. The RUC-recommended values for
work RVUs and direct PE inputs for these codes in CY 2022 were derived
from a recent RUC specialty society survey. We proposed to accept the
RUC-recommended values, considered public comments, and finalized the
proposed values for the 10 CCM/CCCM/PCM codes.
In consideration of the supportive comments we received last year
in response to our comment solicitation, clinical expertise within CMS,
and internal input from CMS staff and from our HHS operating division
partners, we are proposing to create separate coding and payment for
CPM services beginning January 1, 2023. We recognize that there is
currently no existing CPT code that specifically describes the work of
the clinician who performs comprehensive, holistic CPM. We also believe
the resources involved in furnishing CPM services to beneficiaries with
chronic pain are not appropriately recognized under current coding and
payment mechanisms. As noted above, we do not believe that E/M codes
and values appropriately reflect time involved in furnishing CPM for
beneficiaries with chronic pain. CMS has authority under section 1848
of the Act to establish codes that describe services furnished by
clinicians and suppliers that bill for physicians' services, and to
establish payment amounts for those services that reflect the relative
value of the resources involved in furnishing them. We also expect that
creating separate coding and payment for CPM will help facilitate the
development of data regarding the prevalence and impact of chronic pain
in the Medicare population, where conditions including osteoarthritis,
cancer, and other similar conditions that cause pain over extended
periods of time are common.\24\ Such information can assist us in
identifying potential coding and valuation refinements to ensure
appropriate payment for these services. We also believe that the
comprehensive care management involved in CPM services may potentially
prevent or reduce the need for acute services, such as those due to
falls \25\ and emergency department care \26\ associated with chronic
pain, and also have the potential to reduce the need for treatment for
concurrent behavioral health disorders, including substance use
disorders. There is some evidence that addressing chronic pain early in
its course may result in averting the development of ``high-impact''
chronic pain \27\ in some individuals; these people report more severe
pain, more difficulty with self-care, and higher health care use than
others with chronic pain.
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\24\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CC_Main.
\25\ https://www.cdc.gov/falls/facts.html.
\26\ https://effectivehealthcare.ahrq.gov/products/improving-pain-management/rapid-evidence.
\27\ https://www.sciencedirect.com/science/article/pii/S1526590018303584?via%3Dihub.
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There are various definitions for chronic pain from, for example,
the Centers for Disease Control and Prevention \28\ and the National
Institutes of Health,\29\ and in the Institute of Medicine's (IOM)
``Relieving Pain in America: A Blueprint for Transforming Prevention,
Care, Education, and Research'',\30\ and in the World Health
Organization International Classification of Disease Edition 11,--most
define chronic pain consistently, with some variation, as pain that
persists longer than three months. The CDC, for example, has defined
chronic pain within its 2016 opioid prescribing Guideline as ``pain
that typically lasts >3 months or past the time of normal tissue
healing, and can be the result of an underlying medical disease or
condition, injury, medical treatment, inflammation, or an unknown
cause.'' For clarity and operational use, we propose to define chronic
pain as ``persistent or recurrent pain lasting longer than three
months.'' We welcome comments from the public regarding whether this is
an appropriate definition of chronic pain, or whether we should
consider some other interval or description to define chronic pain. We
are also interested in hearing from commenters about how the chronic
nature of the person's pain should be documented in the medical record.
---------------------------------------------------------------------------
\28\ https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf.
\29\ https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.
\30\ https://www.ncbi.nlm.nih.gov/books/NBK92525/#ch1.s3.
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A monthly payment approach may also be more financially
straightforward from the standpoint of beneficiaries receiving
treatment for chronic pain, particularly with respect to applicable
coinsurance, which is generally 20 percent of the payment amount, after
the annual Part B deductible amount is met.\31\
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\31\ https://www.medicare.gov/what-medicare-covers/what-part-b-covers.
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Beginning for CY 2023, we are proposing to create two HCPCS G-codes
to describe monthly CPM services. The codes and descriptors for the
proposed G-codes are:
HCPCS code GYYY1: Chronic pain management and treatment,
monthly bundle including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and maintenance of a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes;
[[Page 45935]]
overall treatment management; facilitation and coordination of any
necessary behavioral health treatment; medication management; pain and
health literacy counseling; any necessary chronic pain related crisis
care; and ongoing communication and care coordination between relevant
practitioners furnishing care (e.g., physical therapy and occupational
therapy, and community-based care), as appropriate. Required initial
face-to-face visit at least 30 minutes provided by a physician or other
qualified health professional; first 30 minutes personally provided by
physician or other qualified health care professional, per calendar
month. (When using GYYY1, 30 minutes must be met or exceeded.)
HCPCS code GYYY2: Each additional 15 minutes of chronic
pain management and treatment by a physician or other qualified health
care professional, per calendar month (List separately in addition to
code for GYYY1). (When using GYYY2, 15 minutes must be met or
exceeded.)
We are interested in hearing from commenters regarding our proposed
inclusion of ``administration of a validated pain assessment rating
scale or tool,'' as an element of the proposed CPM services, and
including it within the descriptor of the proposed HCPCS code GYYY1. We
also solicit comment on whether a repository or list of such tools
would be helpful to practitioners delivering CPM services.
We are proposing to include, as an element of the CPM codes, the
development of and/or revisions to a person-centered care plan that
includes goals, clinical needs, and desired outcomes, as outlined above
and maintained by the practitioner furnishing CPM services.
We are proposing to include health literacy counseling as an
element of the CPM codes because we believe it will enable
beneficiaries with chronic pain to make well-informed decisions about
their care, increases pain knowledge, and strengthens self-management
skills. Health literacy is the degree to which individuals have the
ability to find, understand, and use information and services to inform
health-related decisions and actions for themselves and others.\32\
Adequate health literacy may improve the person's capability to take
responsibility for their health, including pain-related health issues
such as adherence to treatment regimens and medication administration,
and have a positive influence on health outcomes, and health
disparities. CMS' Network of Quality Improvement and Innovation
Contractors have used health literacy counseling to improve health
counseling,\33\ and health literacy counseling has been used to treat
arthritis.\34\ We are interested in hearing from commenters about how
pain and health literacy counseling is or may be effectively used as a
service element to help beneficiaries with chronic pain make well-
informed decisions about their own care, weigh risks and benefits, make
decisions, and take actions that are best for them and their health.
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\32\ https://health.gov/healthypeople/priority-areas/health-
literacy-healthy-people-
2030#:~:text=Health%20literacy%20is%20a%20central,well-
being%20of%20all.%E2%80%9D.
\33\ https://qi.ipro.org/health-equity/health-literacy/.
\34\ https://www.ahrq.gov/health-literacy/improve/precautions/1stedition/tool3.html.
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For HCPCS code GYYY1, we propose to include an initial face-to-face
visit of at least 30 minutes, provided by a physician or other
qualified health professional, to a beneficiary who has chronic pain,
as defined above, or is being diagnosed with chronic pain that has
lasted more than 3 months at the time of the initial visit. After
consultation with our medical officers, we believe the management of a
new patient with chronic pain would involve an initial face-to-face
visit of at least 30 minutes due to the complexity involved with the
initial assessment. We believe follow-up or subsequent visits could be
non-face to face. HCPCS code GYYY2 describes an additional 15 minutes
of CPM and treatment by a physician or other qualified health care
professional, per calendar month (listed separately in addition to
GYYY1). We are seeking comment on the appropriateness of the proposed
30-minute duration per calendar month for GYYY1, and also on the
proposed duration and frequency for GYYY2. We are also seeking comment
on whether we should consider specifying a longer duration of time for
GYYY1 (for example, one hour--or 45 minutes). Similarly, we seek
comment on whether we should consider specifying a longer duration of
time for GYYY2 (for example, 20-minute increments). We also welcome
comment on our proposal to permit billing of CPM services for
beneficiaries who have already been diagnosed with chronic pain, and
for those who are being diagnosed with chronic pain during the visit.
We welcome comments regarding how best the initial visit and
subsequent visits should be conducted (for example, in-person, via
telehealth, or the use of a telecommunications system, and any
implications for additional or different coding). We will also consider
whether to add the CPM codes to the Medicare Telehealth Services List,
based on our review of any information provided through the public
comments and our analysis of how these new services may be
appropriately furnished to Medicare beneficiaries. We are also asking
for comment regarding whether there are components of the proposed CPM
services that do not necessarily require face-to-face interaction with
the billing practitioner, such as care that could be provided by
auxiliary staff incident to the billing practitioner's services. For
any components that could be furnished incident to the services of the
billing practitioner, we request comment on whether these could be
appropriately furnished under the general supervision of the billing
physician or non-physician practitioner (NPP), for example,
administration of a pain rating scale or tool, or elements of care
coordination, as we have provided for certain care management services.
We believe that most CPM services would be billed by primary care
practitioners who are focused on long-term management of their patients
with chronic pain. As calls for improved pain management have increased
in recent years, this has resulted in better education and training of
primary care practitioners and heightened awareness of the need for
pain care nationally. We believe the codes we are proposing for CPM
services will create appropriate payment for physicians and other
practitioners (beyond primary care practitioners) that reflects the
time and resources involved in attending comprehensively to the needs
of beneficiaries with chronic pain. As the IOM ``Blueprint'' report
noted, even people who need consultation with a pain specialist should
benefit from the sustained involvement of a primary care practitioner
who is able to help coordinate care across the full spectrum of health
care providers, as such coordination ``helps prevent people from
seeking relief from multiple providers and treatment approaches that
may leave them frustrated and angry and worse off both physically and
mentally, and from falling into a downward spiral of disability,
withdrawal, and hopelessness.'' \35\ The Blueprint stated that this
type of fragmentation hinders the development of a strong, mutually
trusting relationship with a single health professional who takes
responsibility, and that this established relationship is one of the
keys to successful pain treatment. We anticipate that if these
[[Page 45936]]
proposed codes are finalized, primary care practitioners will employ a
variety of person-centered pain management strategies, such as those
suggested in the PMTF Report and illustrated in CMS' CPM graphic \36\
including medications, therapies, exercise, behavioral health
approaches, complementary and integrative health, and community-based
care based on the complexity, goals, and characteristics of each person
they serve with chronic pain and according to the person-centered plan
of care. It is also important to note that, in many parts of the
country, people have access only to their primary care practitioner for
chronic pain care.\37\ We understand, however, the need or desire that
some individuals with chronic pain have to be seen on an ongoing basis
for CPM by a pain specialist who has received special training and/or
certification to meet the needs of the most complex and challenging
patients with chronic pain.
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\35\ https://www.ncbi.nlm.nih.gov/books/NBK91497/.
\36\ PLACEHOLDER FOR OBRHI GRAPHIC.
\37\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
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Therefore, we are proposing to permit billing by another
practitioner after HCPCS code GYYY1 has already been billed in the same
calendar month by a different practitioner. In these situations, we
anticipate that there could be occasional instances where care of an
individual with chronic pain is transferred to a pain specialist or
other specialist during the same month they received the CPM services
from a primary care practitioner, for ongoing care. In these or other
situations (such as when the beneficiary elects to choose a different
physician or practitioner to furnish CPM services), we would anticipate
GYYY1 and potentially GYYY2 could be billed by another practitioner
during the same month, for the same beneficiary. We believe that it
would be unlikely for GYYY1 to be billed more than twice per month
under such circumstances and are proposing placing a limit on the
number of times the code could be billed per beneficiary per calendar
month, at a maximum of twice per calendar month. We seek comment on our
proposal to permit billing by another practitioner after the GYYY1 has
already been billed in the same month by a different practitioner, and
on the number of times the code could be appropriately billed per
month, per beneficiary.
We propose to require that the beneficiary's verbal consent to
receive CPM services at the initiating visit be documented in the
beneficiary's medical record, as not all Medicare beneficiaries with
chronic pain eligible to receive these separately billable CPM services
may understand or want to receive these services, and the beneficiary
should be aware that they are receiving them. At the initial visit, the
beneficiary with chronic pain should be educated regarding what the CPM
services are, how often they may generally expect to receive the
services, and have an explanation of any cost sharing that may apply in
their particular situation. Practitioners have informed us that
beneficiary cost sharing is a significant barrier to provision of
similar care management services, such as CCM services, and we are
seeking comment on how best to effectively educate both practitioners
and beneficiaries with chronic pain about the existence of, and the
benefits and value of, the proposed CPM services. We are seeking
comment regarding whether the initiating visit is the appropriate time
for billing practitioners to obtain beneficiary verbal consent, if
consent should be given at each visit, and also if beneficiary consent
should be sought by the practitioners with whom CPM billing
practitioners coordinate other Medicare services under the CPM plan of
care, or even more broadly.
We believe there might be some potential for duplicative payment
for services allocated to the same patient concurrent with certain
other Medicare care management services, such as CCM or behavioral
health integration (BHI) services; however, we believe the proposed CPM
codes have features that would mitigate such circumstances, such as the
elements of the service that specifically address the beneficiary's
pain--for example, the administration of a validated pain rating scale
or tool. We welcome comments regarding what, if any, Medicare services
we should consider that could not be billed by the same practitioner
for the same patient concurrent with any other Medicare services, to
avoid duplication of payment, and help limit financial burden to the
Medicare beneficiary with chronic pain. We note that we would expect to
refine these codes as needed through future rulemaking as we receive
more information how the codes are being used, and how they are
implemented in practice.
To the extent that components of the proposed CPM codes are also
components of other care management services, we reiterate our policy
against double-counting time and require that the time used in
reporting CPM services may not represent time spent in any other
reported service. We propose that the CPM codes could be billed in the
same month as a care management service, such as CCM, or BHI. We
believe there are circumstances in which it is reasonable and necessary
to provide both services in a given month, based on the needs of the
Medicare beneficiary with chronic pain, for example, when the
beneficiary has both chronic pain, and a mental disorder(s), or
multiple chronic conditions. We are also proposing that the CPM codes
would be able to be billed for the same Medicare patient in the same
month as another bundled service such as HCPCS Codes G2086-G2088, which
describe bundled payments under the PFS for opioid use disorders. We
note that patient consent would need to be obtained for both of the
bundled services such as, for example, CPM and BHI, and all other
requirements to report CPM and to report the other service or services
would need to be met. We invite comments on these billing proposals and
their appropriateness in the context of CPM.
Finally, we are asking commenters whether we should consider
creating additional coding and payment to address acute pain. We are
interested in information regarding a definition for acute pain,
standalone or E/M coding, the specific activities that could be
furnished, how we might value and price such a code or service, the
settings where care should be provided, the types of practitioners that
should furnish acute pain care, if the service or any components should
be furnished as ``incident to'' services under the direction of the
billing practitioner or by other members of the care team, and other
information that might help us in proposing such a code or codes.
(b) Valuation of Chronic Pain Management Services
Consistent with the valuation methodology for other services under
the PFS, proposed HCPCS codes GYYY1 and GYYY2 would be valued based on
what we believe to be a typical case, and we understand that, based on
variability in patient needs, some patients will require more
resources, and some fewer. The proposed CPM codes would separately pay
for a specified set of CPM elements furnished during a month, including
the administration of validated rating scales, establishment and review
of a person-centered care plan that includes goals, clinical needs, and
desired outcomes, and other elements as described in the proposed code
descriptors. To value CPM, we compared the proposed services to codes
that involve care management. In doing so, we concluded that the CPM
services were similar in work (time and intensity) to that of PCM in
that both the
[[Page 45937]]
PCM codes and proposed CPM codes reflect services that have similar
complexities, possible comorbidities, require cognitive time on the
part of the practitioner, and may involve coordination of care across
multiple practitioners.
For HCPCS code GYYY1, we developed proposed inputs using a
crosswalk to CPT code 99424 (Principal care management services, for a
single high-risk disease, with the following required elements: One
complex chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/decompensation, functional decline, or death; the
condition requires development, monitoring, or revision of disease-
specific care plan; the condition requires frequent adjustments in the
medication regimen and/or the management of the condition is unusually
complex due to comorbidities; ongoing communication and care
coordination between relevant practitioners furnishing care; first 30
minutes provided personally by a physician or other qualified health
care professional, per calendar month.), which is assigned a work RVU
of 1.45. Additionally, for GYYY1 we are proposing to use a crosswalk to
the direct PE inputs associated with CPT code 99424. We believe that
the work and practice expense described by this crosswalk code is
analogous to the services described in GYYY1, because GYYY1 includes
similar care plan, medication management, unusually complex clinical
management; care coordination between relevant practitioners furnishing
care; and time for care provided personally by a physician or other
qualified health care professional, as described in CPT code 99424.
We are proposing to value GYYY2 at a work RVU of 0.50, using a
crosswalk to CPT code 99425 (each additional 30 minutes provided
personally by a physician or other qualified health care professional,
per calendar month) (List separately in addition to code for GYYY1),
which is assigned a work RVU of 1.00. However, the required minimum
number of minutes described in GYYY2 is half of the number of minutes
in CPT code 99425. For HCPCS code GYYY2, we are proposing to use a
crosswalk to half of the direct PE inputs associated with CPT code
99425. We believe that the work and practice expense described by this
crosswalk code is analogous to the services described in GYYY2, because
GYYY2 includes similar activities as described in CPT code 99425.
We are proposing that GYYY1 can only be billed when the full 30
minutes of service time has been met or exceeded. Additionally, we are
proposing that the add-on code (GYYY2) can only be billed when the full
15 minutes of service time is met or exceeded.
Our proposed valuation of CPM services includes services that are
personally performed by a physician (or other appropriate billing
practitioner, such as a nurse practitioner (NP) or physician assistant
(PA)) described by certain E/M visit codes that apply to a new patient
in various settings. Accordingly, we are proposing that GYYY1/GYYY2
must be furnished by the physician (or other appropriate billing
practitioner) and could not be billed on the same date of service as
CPT codes 99202-99215 (Office/outpatient visits new), since these codes
reflect face-to-face services furnished by the physician or other
billing practitioner for related, separately billable services that are
being furnished to a patient the practitioner has not previously seen.
We believe it would be unlikely the practitioner is prepared to address
the complex pain needs of a new patient on the same day he or she is
seen for a general visit, or a visit where the person is being seen for
some other illness or condition. We do not believe that the services
included in GYYY1/GYYY2 would significantly overlap with CCM services;
Transitional Care Management (TCM) services; or BHI services, which
have various clinical purposes separate from CPM. We do believe there
is likely overlap in the Medicare beneficiary population eligible to
receive CCM, TCM, BHI, and the proposed CPM services, but we believe
there are distinctions in the nature and extent of the assessments,
care coordination, medication management, and care planning for CPM to
allow concurrent billing for services that are medically reasonable and
necessary, and that it is particularly important to allow for the
provision of needed services, including behavioral health services to
beneficiaries with chronic pain. We are soliciting comment on whether
we have appropriately identified the codes Medicare should not pay if
furnished during the same day as the proposed CPM codes, and if there
are circumstances where multiple care planning codes could be furnished
without overlap or other situations, such as where the practitioner is
seeing a new patient.
We note that the proposed CPM codes would be limited to
beneficiaries in office or other outpatient or domiciliary settings. We
will consider for future rulemaking separately identifying and paying
for CPM services furnished to beneficiaries in any appropriate setting
of care, in recognition of the prevalence and burden of pain across all
settings of care, and the associated time and service complexity to
provide care for chronic pain. We appreciate comments on other settings
where CPM services could be provided.
(c) Request for Comment
We believe there could be circumstances in which a beneficiary
receiving CPM services needs referrals or recommendations, based on a
clinician's assessment, for services or interventions that are not
included as elements of the CPM services, such as for community-based
care or physical and occupational therapy. We welcome comments on the
care coordination that may occur between relevant practitioners
furnishing services, such as complementary and integrative care, and on
the community-based care element included in the descriptors for
proposed GYYY1 and GYYY2.
Commenters may also wish to weigh in on how documentation of the
performance of the elements of CPM services might best be addressed in
medical recordkeeping. We are seeking general comment on whether there
are any elements of CPM services outlined in this proposal that the
public and interested parties believe are not typically furnished in
connection with comprehensive chronic pain management, or any proposed
elements of the CPM services that should be removed or altered. We also
seek comment on whether there are elements of CPM services that we have
not identified and should be added to the code descriptors.
Additionally, we are seeking comment on which, if any, CPM elements
could be furnished as ``incident to'' services, and whether to add
GYYY1 and GYYY2 to the list of services for which we allow general
supervision as described in our regulation at Sec. 410.26(b)(5). We
welcome comments from the public for future rulemaking regarding what
elements of the CPM services could be furnished under general
supervision, or direct supervision. For example, facilitation and
coordination of any necessary behavioral health treatment, chronic pain
related crisis care, and ongoing communication and care coordination
between relevant practitioners furnishing care might be appropriate
activities to be considered under general supervision.
The proposed CPM codes may involve arrangements where the physician
or
[[Page 45938]]
other health professional might work in collaboration with other health
care providers or members of a care team, such as a psychologist,
dental practitioner, or social worker, where these individuals might
furnish certain elements of the service bundle under the direction of
the physician or qualified health practitioner, such as assessments,
person-centered care planning, referrals to community-based care, and
other activities, as appropriate. We are requesting comments on if, and
how, we should structure the proposed CPM code and payment for these
services to account for these types of arrangements that could include
team-based care.
(34) Proposed Revisions to the ``Incident to'' Physicians' Services
Regulation for Behavioral Health Services
In the CY 2014 PFS final rule with comment period (78 FR 74425
through 74427), we created an exception to our ``incident to''
regulation at Sec. 410.26(b)(5) under which ``incident to'' services
generally must be furnished under direct supervision. Specifically, we
finalized a policy to require general, rather than direct, supervision
when chronic care management services are furnished incident to the
billing physician's or NPP's services outside of the practice's normal
business hours by clinical staff. In the CY 2017 PFS final rule (81 FR
80255), we finalized a revision to our regulation under Sec.
410.26(b)(5) to require a general, rather than direct, level of
supervision for designated care management services, and established
that we would designate care management services through notice and
comment rulemaking.
We understand that circumstances related to the PHE for COVID-19
have likely contributed to an increase in the demand for behavioral
health services while also exacerbating existing barriers to
beneficiaries' access to needed behavioral health services. For
example, the American Psychological Association (APA) conducted a
survey in 2020 and a follow-up survey in 2021 to better understand the
impact of the COVID-19 pandemic on mental health treatment and the work
of practicing psychologists. In the 2021 follow-up survey, many
psychologists reported increases in the demand for treatment of anxiety
and depression. They reported the greatest increases in treating
anxiety disorders (84 percent, up from 74 percent), depressive
disorders (72 percent, up from 60 percent), and trauma- and stress-
related disorders (62 percent, up from 50 percent). Other diagnoses
with large increases included sleep-wake disorders, obsessive-
compulsive and related disorders, and substance-related and addictive
disorders.\38\
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\38\ https://www.apa.org/pubs/reports/practitioner/covid-19-2021.
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Additionally, according to HRSA's National Center for Health
Workforce Analysis, by 2025, shortages are projected nationally for a
variety of behavioral health practitioners, including psychiatrists;
clinical, counseling, and school psychologists; mental health and
substance use social workers; school counselors; and marriage and
family therapists.\39\ Currently, there is no separate benefit category
under the statute that recognizes the professional services of licensed
professional counselors (LPCs) and Licensed Marriage and Family
Therapists (LMFTs). Therefore, payment for the services of LPCs and
LMFTs can only be made under the PFS indirectly when an LPC or LMFT
performs services as auxiliary personnel incident to, the services, and
under the direct supervision, of the billing physician or other
practitioner. According to the American Counseling Association, there
are more than 140,000 licensed professional counselors (LPCs) in the
U.S., and the Medicare program's reimbursement for mental health
treatment services delivered by this professional group could address
provider shortages.\40\ Additionally, according to the U.S. Bureau of
Labor Statistics, there were approximately 54,800 Marriage and Family
Therapists (MFTs) as of May 2021.\41\
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\39\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\40\ https://www.counseling.org/government-affairs/federal-issues/medicare-reimbursement.
\41\ https://www.bls.gov/oes/current/oes211013.htm.
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In the 2022 CMS Behavioral Health Strategy,\42\ CMS included a goal
to improve access to and quality of mental health care services. In
light of the current needs among Medicare beneficiaries for improved
access to behavioral health services, and the existing workforce
shortages impeding access to needed treatment for behavioral health, we
have considered regulatory revisions that may help to reduce existing
barriers and make greater use of the services of LPCs and LMFTs. We
note that CMS does not have authority to create a statutory benefit
category for practitioner types. Therefore, we are proposing to amend
the direct supervision requirement under our ``incident to'' regulation
at Sec. 410.26 to allow behavioral health services to be furnished
under the general supervision of a physician or NPP when these services
or supplies are provided by auxiliary personnel incident to the
services of a physician or NPP. We are limiting the scope of this
proposal to behavioral health services at this time due to increased
needs for behavioral health treatment and workforce shortages in this
field. We believe that this proposed change will facilitate utilization
and extend the reach of behavioral health services. We believe that any
risk associated with this proposed change would be minimal, since the
auxiliary personnel providing the services would need to meet all of
the applicable requirements to provide incident to services, including
any applicable licensure requirements imposed by the State in which the
services are being furnished, as described in Sec. 410.26(a)(1).
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\42\ https://www.cms.gov/cms-behavioral-health-strategy.
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(35) New Coding and Payment for General Behavioral Health Integration
(BHI) Billed by Clinical Psychologists (CPs) and Clinical Social
Workers (CSWs)
In the CY 2017 PFS final rule (81 FR 80230), we established G-codes
to describe monthly services furnished using the Psychiatric
Collaborative Care Model (CoCM), an evidence-based approach to
behavioral health integration that enhances ``usual'' primary care by
adding care management support and regular psychiatric inter-specialty
consultation. These G-codes were replaced by CPT codes 99492-99494,
which we established for payment under the PFS in the CY 2018 PFS final
rule (82 FR 53077 through 53078). Additionally, we created a fourth G-
code to describe services furnished using other models of BHI in the
primary care setting, which was replaced by CPT code 99484 in the CY
2018 PFS final rule (82 FR 53077 through 53078).
We stated in the CY 2017 PFS final rule (81 FR 80236) that we
recognized that the psychiatric CoCM is prescriptive and that much of
its demonstrated success may be attributable to adherence to a set of
elements and guidelines of care. We finalized a code set to pay
accurately for care furnished using this specific model of care, given
its widespread adoption and recognized effectiveness. However, we
stated we recognized that there are primary care practices that are
incurring, or may incur, resource costs inherent to treatment of
patients with similar conditions based on BHI models of care other than
the psychiatric CoCM that may benefit beneficiaries with behavioral
health conditions, and
[[Page 45939]]
therefore finalized a General BHI code which may be used to report a
range of models of BHI services, and that we expected this code to be
refined over time as we receive more information about other BHI models
in use.
In the CY 2018 PFS final rule (82 FR 53078), we stated that we had
received inquiries from interested parties about whether professionals
who were not eligible to report the approved initiating visit codes for
BHI services to Medicare might nonetheless serve as a primary hub for
BHI services. For example, interested parties have suggested that a CP
might serve as the primary practitioner that integrates medical care
and psychiatric expertise. For purposes of future rulemaking, we sought
comment on the circumstances under which this model of care is
happening and whether additional coding would be needed to accurately
describe and value other models of care. A few commenters suggested
that CMS create separate codes to describe behavioral health care
management services that could be billed by CPs and NPPs who are not
authorized to bill Medicare for E/M services. One commenter suggested
that CMS include psychiatric diagnostic evaluation services that can be
furnished and billed by CPs as eligible initiating visits. Commenters
also described other models of care that are in use, including the
STAR-VA model and a model used in outpatient health care settings where
a clinical social worker (CSW) not only furnishes psychiatric care but
also assists with psychosocial aspects of medical care.
In the CY 2017 PFS final rule (81 FR 80239), we stated that we had
received a few comments suggesting that in addition to the qualifying
E/M services (or an AWV or IPPE), the initiating visit services for BHI
should include in-depth psychological evaluations delivered by a CP
including CPT codes 90791, 96116 or 96118, which include care plan
development. In this final rule, we established that the same services
that qualify as the initiating visit for CCM would also qualify as
initiating services for BHI, which do not include in-depth
psychological evaluation by a CP and which were not, in their entirety,
within the scope of CPs' practice, and therefore, CPs would not be able
to report the General BHI code directly (although a psychiatrist may be
able to do so) (81 FR 80239).
In the 2022 CMS Behavioral Health Strategy,\43\ CMS included a goal
to improve access to and quality of mental health care services, and
included an objective to ``increase detection, effective management
and/or recovery of mental health conditions through coordination and
integration between primary and specialty care providers.'' As
previously noted in this proposed rule, we understand that
circumstances related to the COVID-19 PHE have likely contributed to an
increase in the demand for behavioral health services while also
exacerbating existing barriers in beneficiaries' access to needed
behavioral health services. In light of the feedback we have received
and considering the increased needs for mental health services, we are
proposing to create a new G code describing General BHI performed by
CPs or CSWs to account for monthly care integration where the mental
health services furnished by a CP or CSW are serving as the focal point
of care integration. The proposed new code is GBHI1 (Care management
services for behavioral health conditions, at least 20 minutes of
clinical psychologist or clinical social worker time, per calendar
month, with the following required elements: initial assessment or
follow-up monitoring, including the use of applicable validated rating
scales; behavioral health care planning in relation to behavioral/
psychiatric health problems, including revision for patients who are
not progressing or whose status changes; facilitating and coordinating
treatment such as psychotherapy, coordination with and/or referral to
physicians and practitioners who are authorized by Medicare law to
prescribe medications and furnish E/M services, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.) We are proposing to value this service under
the proposed HCPCS code GBHI1 based on a direct crosswalk to the work
values and direct PE inputs for CPT code 99484 (Care management
services for behavioral health conditions, 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: initial assessment or follow-up monitoring, including the use
of applicable validated rating scales; behavioral health care planning
in relation to behavioral/psychiatric health problems, including
revision for patients who are not progressing or whose status changes;
facilitating and coordinating treatment such as psychotherapy,
pharmacotherapy, counseling and/or psychiatric consultation; and
continuity of care with a designated member of the care team), because
the services described by GBHI1 closely mirror those described by CPT
code 99484. Therefore, we believe that this crosswalk is an appropriate
valuation of the level, time, and intensity of the proposed service
described by HCPCS code GBHI1. CPs are authorized under their statutory
benefit category at section 1861(ii) of the Act to furnish ``qualified
psychologist services'' to include ``such services and such services
and supplies furnished as an incident to his service furnished by a
clinical psychologist (as defined by the Secretary) which the
psychologist is legally authorized to perform under State law (or the
State regulatory mechanism provided by State law) as would otherwise be
covered if furnished by a physician or as an incident to a physician's
service.'' Additionally, the statutory benefit category for CSWs at
Section 1861(hh)(2) of the Act defines ``clinical social worker
services'' as ``services performed by a clinical social worker (as
defined in paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a hospital
and other than services furnished to an inpatient of a skilled nursing
facility which the facility is required to provide as a requirement for
participation) which the clinical social worker is legally authorized
to perform under State law (or the State regulatory mechanism provided
by State law) of the State in which such services are performed as
would otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.'' Based on the
authorizations under the CP and CSW statutory benefit categories, CPs
are authorized to furnish and bill for services that are provided by
clinical staff incident to their professional services when the
``incident to'' requirements specified in Sec. 410.26 of our
regulations are met, and would be authorized to do the same when
furnishing services described by proposed HCPCS code GBHI1, whereas
CSWs would only be able to bill Medicare for services they furnish
directly and personally. The proposed work value for HCPCS code GBHI1
is 0.61 (based on a direct crosswalk to CPT code 99484). We are seeking
comment on whether this proposed value accurately reflects the resource
costs involved in furnishing these models of care, or whether
additional coding may be needed, for example, separate coding for CPs
and CSWs. We are also seeking comment on the proposed requirements for
billing GBHI1, including any applicable ``incident to'' requirements,
[[Page 45940]]
and the role and responsibilities of CSWs and CPs.
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\43\ https://www.cms.gov/cms-behavioral-health-strategy.
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In the CY 2017 PFS final rule (81 FR 80239), we finalized the
requirement of an initiating visit for the BHI codes for new patients
or beneficiaries not seen within a year of commencement of BHI
services. We stated that the initiating visit would establish the
beneficiary's relationship with the billing practitioner (most aspects
of the BHI services would be furnished incident to the billing
practitioner's professional services), ensure the billing practitioner
assesses the beneficiary prior to initiating care management processes,
and provide an opportunity to obtain beneficiary consent. We noted that
the existing eligible initiating visit codes are not, in their
entirety, within the scope of the CP's practice. Given that, we are
proposing to allow a psychiatric diagnostic evaluation (CPT code 90791)
to serve as the initiating visit for GBHI1. We welcome comment on
whether we should consider additional codes to qualify as the
initiating visit.
In the CY 2017 PFS final rule (81 FR 80235), we established that
CCM and BHI services could be billed during the same month for the same
beneficiary if all the requirements to bill each service are separately
met. We are also proposing that HCPCS code GBHI1 could be billed during
the same month as CCM and TCM services, provided that all requirements
to report each service are met and time and effort are not counted more
than once. The patient consent requirements would apply to each service
independently.
In the CY 2017 PFS final rule (81 FR 80235), we established that
the BHI services may be furnished incident to the billing
professional's services under general supervision because we do not
believe it is clinically necessary that the professionals on the team
who provide services other than the treating practitioner (namely, the
behavioral health care manager and the psychiatric consultant) to have
the billing practitioner immediately available to them at all times, as
would be required under a higher level of supervision. We believe this
is also the case for the service described by GBHI1. Therefore,
consistent with other care management codes paid under the PFS, we are
proposing to add HCPCS code GBHI1 to the list of designated care
management services for which we allow general supervision.
(36) Request for Information: Medicare Part B Payment for Services
Involving Community Health Workers (CHWs)
The American Public Health Association (APHA) defines a community
health worker as a ``frontline public health worker who is a trusted
member of and/or has an unusually close understanding of the community
served. This trusting relationship enables the worker to serve as a
liaison/link/intermediary between health/social services and the
community to facilitate access to services and improve the quality and
cultural competence of service delivery.'' Community Health Workers are
classified as a workforce category by the Department of Labor. The
Community Health Worker Core Consensus Project (C3) lists the following
ten roles of CHWs: \44\
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\44\ St John, J.A., Mayfield-Johnson, S.L., & Hern[aacute]ndez-
Gordon, W.D. (2021). Introduction: Why Community Health Workers
(CHWs)? In Promoting the Health of the Community (pp. 3-10).
Springer, Cham.
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Cultural mediation among individuals, communities, and
health and social service systems.
Providing culturally appropriate health education and
information.
Care coordination, case management, and system navigation.
Providing coaching and social support.
Advocating for individuals and communities.
Building individual and community capacity.
Providing direct service.
Implementing individual and community assessments.
Conducting outreach.
Participating in evaluation and research.
Findings from randomized controlled trials indicate that particular
CHW interventions reduce chronic disease disparities in low income,
racial and ethnic minority communities, such as type 2 diabetes,
hypertension, HIV/AIDS, and obesity.45 46 47 48 49 CMS is
also interested in better addressing the social needs of beneficiaries;
for example, in the FY 2023 IPPS/LTCH NPRM, CMS proposed new measures
under the Hospital Inpatient Quality Reporting Program pertaining to
assessing social determinants of health. The CHW skillset may position
this workforce to address these social needs. In light of the
significant benefits that services involving CHWs can potentially offer
the health of Medicare beneficiaries, including a reduction in health
disparities, CMS is interested in learning more about how services
involving CHWs are furnished in association with the specific Medicare
benefits established by the statute.
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\45\ Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA.
Community Health Worker Support for Disadvantaged Patients With
Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public
Health. 2017;107(10):1660-1667. doi:10.2105/AJPH.2017.303985.
\46\ Cooper L.A., Roter D.L., Carson K.A., et al. A randomized
trial to improve patient-centered care and hypertension control in
underserved primary care patients. J Gen Intern Med.
2011;26(11):1297-1304.
\47\ Spencer MS, Rosland AM, Kieffer EC, Sinco BR, Valerio M,
Palmisano G, et al. Effectiveness of a community health worker
intervention among African American and Latino adults with type 2
diabetes: a randomized controlled trial. Am J Public Health. 2011
Dec;101(12):2253-60.
\48\ Brown LD, Vasquez D, Lopez DI, Portillo EM. Addressing
Hispanic Obesity Disparities Using a Community Health Worker Model
Grounded in Motivational Interviewing. Am J Health Promot.
2022;36(2):259-268.
\49\ Kenya, S., Jones, J., Arheart, K. et al. Using Community
Health Workers to Improve Clinical Outcomes Among People Living with
HIV: A Randomized Controlled Trial. AIDS Behav 17, 2927-2934 (2013).
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Over the past several years, we have worked to develop payment
mechanisms under the PFS to improve the accuracy of valuation and
payment for the services furnished by physicians and other health care
professionals, especially in the context of evolving models of care.
For example, physicians and other eligible practitioners are able to
report care management services and behavioral health integration
services based on tasks personally provided by clinical staff under
their supervision. Some of the elements of the comprehensive care plans
referenced in the description of care management services include
medication management, community/social services ordered, and
coordination with other agencies, which are also some of the services
personally provided by CHWs.
Section 1862(a)(1)(A) of the Act generally excludes from coverage
services that are not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member. We are interested in learning whether and how
CHWs, as auxiliary personnel of physicians and hospitals, may provide
reasonable and necessary services to Medicare beneficiaries under the
appropriate supervision of health care professionals that are
responsible more broadly for medical care, including behavioral health
care. We are also looking to understand whether and how services
involving CHWs are accounted for under the existing CCM codes or other
care management or behavioral health integration services, including
whether the employment and supervision arrangements ordinarily adopted
within the industry would meet the requirements that allow for billing
by supervising professionals or providers, including RHCs and FQHCs.
For example, do CHWs tend to be
[[Page 45941]]
employees of physicians or of the same entities that employ physicians?
Are physicians or other medical professionals supervising their
interaction with patients in a manner consistent with direct
supervision--for example, immediate availability in the same location?
We note that CHWs are employed in a number of sectors, including
local government, community-based organizations, and social services
sectors. Therefore, the health care providers working with CHWs may
have established nontraditional relationships with these organizations
outside of the health sector. We are interested in learning how
payments between health care provider organizations, and community-
based organizations, local governments, and social service
organizations, account for the costs of services provided by CHWs, and
how health care provider organizations ensure that the funding amount
is sufficient to cover the costs of the full range of CHW services. We
are also seeking comment on whether and to what extent CHW services are
provided in association with preventive services, including those
covered by Medicare.
Physicians and certain other health care practitioners are
authorized to bill Medicare for services furnished incident to their
professional services by auxiliary personnel. Our regulation at Sec.
410.26 requires that auxiliary personnel who perform services incident
to the services of the billing physician or other practitioner must be
acting under the supervision of the billing practitioner, and must meet
any applicable requirements, including licensure, imposed by the State
in which the services are furnished. We understand that there is wide
variation in State standards for CHWs. In addition, the training that
CHWs receive is typically provided by employers but varies widely in
terms of its breadth and scope.\50\ We are trying to understand how
CHWs might also be recognized as auxiliary personnel in the Medicare
context, and are therefore interested in learning how States may have
determined whether and under what circumstances CHWs have the necessary
qualifications to perform services that would improve the health of
Medicare beneficiaries and others being treated by supervising
professionals or providers.
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\50\ Fasting, D., Mayfield-Johnson, S.L., St. John, J.A., &
Hern[aacute]ndez-Gordon, W.D. (2021). In Promoting the Health of the
Community (pp. 43-52). Springer, Cham.
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(37) Proposed Recognition of the Nurse Portfolio Credentialing
Commission (NPCC)
The Medicare program established qualifications under regulations
at Sec. 410.75 for NPs and, under 42 CFR 410.76 for clinical nurse
specialists (CNS). Both the NP and CNS qualification regulations
require that NPs and CNSs be certified as a NP or a CNS by a recognized
national certifying body that has established standards for NPs and/or
CNSs, and that a listed certifying body must be approved by the
Secretary. An identical list of Medicare recognized and approved
national certifying bodies for NPs and CNSs is included under Chapter
15, section 200 and 210 of the Medicare Benefit Policy Manual, pub.
100-02.
The organizations listed under program manual instructions as
recognized national certifying bodies for NPs and CNSs are as follows:
American Academy of Nurse Practitioners;
American Nurses Credentialing Center;
National Certification Corporation for Obstetric,
Gynecologic and Neonatal Nursing Specialties;
Pediatric Nursing Certification Board (previously named
the National Certification Board of Pediatric Nurse Practitioners and
Nurses);
Oncology Nurses Certification Corporation;
AACN Certification Corporation; and
National Board on Certification of Hospice and Palliative
Nurses.
The Nurse Portfolio Credentialing Center (NPCC) has requested to
have its organization added to the lists of recognized national
certifying bodies for NPs and CNSs who specialize in clinical genetics/
genomics and are awarded the Advanced Clinical Genomics Nurse (ACGN)
credential. The NPCC's request to CMS describes the NPCC as a non-
profit organization, established in 2018 by genetics/genomics nurse
leaders as the only organization that now offers new credentials to
advanced practice registered nurses (APRNs) who specialize in genetics/
genomics, a nursing specialty recognized by the American Nurses
Association.
Additionally, the NPCC's letter states that its organization
evolved directly from the American Nurses Credentialing Center (a
listed, CMS-recognized national certifying body) and the Genetic
Nursing Credentialing Commission, which are the organizations that
awarded new genetics/genomics nursing credentials from 2001 to 2018.
However, as of 2019, the American Nurses Credentialing Center (ANCC)
stopped offering new credentialing to genetics nurses and instead
offers only renewal credentialing to nurses who specialize in genetics.
Since 2019, the NPCC has awarded the ACGN credential to 32 APRNs from
17 States.
Now, with the NPCC being the only organization that offers new
credentialing to nurses in genetics, the NPCC is concerned that the
absence of its organization from the current list of recognized
national certifying bodies appropriate for NPs and CNSs presents a
barrier and a disadvantage for newly credentialed APRNs. Specifically,
the NPCC is concerned that newly NPCC credentialed NPs and CNSs seeking
enrollment under Medicare would be denied on the basis that they do not
meet Medicare's certification requirement unless the NPCC is listed as
a recognized national certifying body appropriate for NPs and CNSs who
specialize in genetics/genomics. The website for the NPCC is available
at https://www.nurseportfolio.org.
When considering previous requests to add other organizations to
the list of recognized national certifying bodies for NPs and CNSs, we
stated that it is not our intention to be overly restrictive in our
program requirements and consequently prevent qualified NPs and CNSs
who specialize in areas of medicine other than those certified by the
ANCC from participating in the Medicare program as NPs or CNSs and from
rendering care to patients in need of specialized services (see 71 FR
69707). Accordingly, we are proposing to add the NPCC organization to
the list of recognized national certifying bodies in manual
instructions for NPs at section 200 and CNSs at section 210 of the
Medicare Benefit Policy Manual, pub. 100-02. We request public comments
on this proposal.
(38) Request for Information: Medicare Potentially Underutilized
Services
Medicare provides payment for many kinds of services that support
beneficiaries in promoting health and well-being and that may also, in
some cases, reduce unnecessary spending within the health care system
by decreasing the need for more expensive kinds of care. Some examples
of these services may include patient educational services, like
Diabetes Self-Management Training or preventive services, like the
Annual Wellness Visit.
We are seeking comments on ways to identify specific services and
to recognize possible barriers to improved access to these kinds of
high value, potentially underutilized services by
[[Page 45942]]
Medicare beneficiaries. We are also seeking comment regarding how we
might best mitigate some of these obstacles, including for example,
through examining conditions of payment or payment rates for these
services or by prioritizing beneficiary and provider education
investments.
``High value'' health services have been described as those
``services that provide the best possible health outcomes at the lowest
possible cost.'' \51\ The American College of Physicians states that
high value services seek ``to improve health, avoid harms, and
eliminate wasteful practices.'' \52\ However, we believe that some high
value Medicare services may be potentially underutilized by
beneficiaries. In some cases, limited use of these kinds of services
occurs disproportionately in underserved communities.
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\51\ ``Michigan Program on Value Enhancement.'' Institute for
Healthcare Policy & Innovation (28 Apr. 2022). https://ihpi.umich.edu/featured-work/michigan-program-value-enhancement.
\52\ High value care. ACP. (n.d.). (May 9, 2022). https://www.acponline.org/clinical-information/high-value-care.
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Disparities in health and healthcare persist despite decades of
research and widespread efforts to improve health outcomes in the
United States.\53\ Certain populations, including groups experiencing
racial disparity, people with disabilities, individuals dually eligible
for Medicare and Medicaid, and those living in rural and underserved
areas are more likely to experience challenges accessing healthcare
services, lower quality of care, and below average health outcomes when
compared to the general population.54 55 56 Many known
factors impede efficient and equitable healthcare, including workforce
challenges, transportation issues, healthcare costs, language barriers,
a lack of health literacy, and confusion about health insurance
coverage and processes.\57\ Additional factors include social
determinants of health and community-level burdens that contribute to
the exacerbation of health disparities. For example, disparities in
cancer screening and treatment across racial and ethnic groups have
been well documented. Research demonstrates that minority populations
are less likely to receive cancer screening tests than their white
counterparts and, consequently, are more likely to be diagnosed with
late-stage cancer.\58\ Additionally, racial and ethnic minorities with
positive test results are more likely to experience delays in receiving
the diagnostic tests that would serve to confirm cancer diagnoses.\59\
CMS is committed to building solutions that will help close gaps in
healthcare quality, access, and outcomes.\60\
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\53\ Office of Minority Health. (2021, January, page 3). Paving
the Way to Equity: A Progress Report. Centers for Medicaid and
Medicare Services. https://www.cms.gov/files/document/paving-way-equity-cms-omh-progress-report.pdf.
\54\ Agency for Health Care Research and Quality (AHRQ). (2021,
June). 2019 National Healthcare Quality and Disparities Report.
AHRQ. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr19/index.html.
\55\ Executive Order No. 13985, 86 FR 7009 (2021, January 20).
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/. For the
purposes of this RFI, we are using the definitions of equity and
underserved communities established in Executive Order 13985, ``The
term `equity' means the consistent and systematic fair, just, and
impartial treatment of all individuals, including individuals who
belong to underserved communities that have been denied such
treatment, such as Black, Latino, and Indigenous and Native American
persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) persons; persons with disabilities;
persons who live in rural areas; and persons otherwise adversely
affected by persistent poverty or inequality.'' The term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life.
\56\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health & Human. Services. Second
Report to Congress on Social Risk Factors and Performance in
Medicare's Value-Based. Purchasing Program. 2020. https://aspe.hhs.gov/reports/second-report-congress-social-risk-medicares-value-based-purchasing-programs.
\57\ Lahr, M., Henning-Smith, C., Rahman, A., Hernandez, A.
(2021, January). Barriers to Health Care Access for Rural Medicare
Beneficiaries: Recommendations from Rural Health Clinics. University
of Minnesota Rural Health Research Center. https://rhrc.umn.edu/wp-content/uploads/2021/01/UMN-RHC-Access-to-Care-PB_1.20.pdf.
\58\ Agency for Healthcare Research and Quality [AHRQ], 2004;
National Institutes of Health/National Cancer Institute [NIH/NCI],
2001). Racial and ethnic minorities with positive test results are
more likely to experience delays in receiving the diagnostic tests
needed to confirm cancer diagnoses (Battaglia et al., 2007; Ries et
al., 2003.
\59\ Battaglia et al., 2007; Ries et al., 2003.
\60\ Office of Minority Health. (2021, January). Paving the Way
to Equity: A Progress Report. Centers for Medicaid and Medicare
Services. https://www.cms.gov/files/document/paving-way-equity-cms-omh-progress-report.pdf.
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We are working to advance health equity by designing, implementing,
and operationalizing policies and programs that support health for all
the people served by our programs, eliminating avoidable differences in
health outcomes experienced by people who are disadvantaged or
underserved, and providing the care and support that our beneficiaries
need to thrive.\61\ Health equity as defined by CMS \62\ means the
attainment of the highest level of health for all people, where
everyone has a fair and just opportunity to attain their optimal health
regardless of race, ethnicity, disability, sexual orientation, gender
identity, socioeconomic status, geography, preferred language, or other
factors that affect access to care and health outcomes. More
information regarding CMS's Strategic Plan for health equity is
available in the CMS Strategic Plan Pillar: Health Equity Fact Sheet:
https://www.cms.gov/sites/default/files/2022-04/Health%20Equity%20Pillar%20Fact%20Sheet_1.pdf.
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\61\ https://www.cms.gov/pillar/health-equity.
\62\ https://www.cms.gov/sites/default/files/2022-04/Health%20Equity%20Pillar%20Fact%20Sheet_1.pdf.
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In light of the concerns regarding the potential underutilization
of high value health services, particularly among potentially
underserved communities, we are committed to promoting these high value
services within the Medicare program. In concert with the CMS strategy
to advance health equity in addressing health disparities that underlie
our health system, we seek to engage with interested parties and
solicit comment regarding ways to identify and improve access to high
value, potentially underutilized services by Medicare beneficiaries.
We are seeking comment on how to best define and identify high
value, potentially underutilized health services. We are also looking
to understand what existing services within current Medicare benefits
may represent high value, potentially underutilized services, such as:
Preventive Services;
Annual Wellness Visits;
Diabetes Management Training;
Screening for Diabetes;
Referral to appropriate education/prevention/training
services
Immunizations/vaccinations
Cancer screenings
Cardiac rehabilitation services
Intensive Behavioral Therapy for obesity
Opioid treatment programs
Complex/Chronic Care Management
Cognitive Assessment & Care
Behavioral Health Integration Services
Other examples of Medicare preventive services are available at the
following website: https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html.
We invite the public to submit information about specific obstacles
to
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accessing these services and how specific potential policy, payment or
procedural changes could reduce potential obstacles and facilitate
better access to high value health services. Specifically, we are
soliciting new and innovative ideas that may help broaden perspectives
about potential solutions. Ideas may include, but are not limited to:
Educational or marketing strategies (informed by
beneficiary input) to promote awareness of available programs and
resources that advance the utilization of ``high value'' services;
Aligning of Medicare and other payer coding, payment and
documentation requirements, and processes related to ``high value''
services;
Recommendations from States and other interested parties
regarding how to best raise awareness of underutilized services, with
special consideration for the dual-eligible population;
Enabling of operational flexibility, feedback mechanisms,
and data sharing that would enhance the utilization of ``high value''
services; and
New recommendations regarding when and how CMS issues
regulations and policies related to ``high value'' services and how CMS
can advance rules and policies for beneficiaries, clinicians, and
providers.
We are interested in learning about how CMS might best promote high
value care and health equity, address concerns regarding health
disparities, and increase access to high value services, which could
improve the health of Medicare beneficiaries. Comments received in
response to this RFI may be used to identify potential opportunities
for improvement to and refinement of existing Medicare FFS and MA
programs.
(39) Change in Procedure Status for Family Psychotherapy
The CPT codes that describe family psychotherapy are payable under
Medicare, but are currently assigned a restricted status indicator in
the Medicare Physician Fee Schedule payment files. The codes describing
family psychotherapy with the patient present are CPT code 90847
(Family psychotherapy (conjoint psychotherapy) (with patient present),
50 minutes) and CPT code 90849 (Multiple-family group psychotherapy).
We note that CPT code 90846 (Family psychotherapy (without the patient
present), 50 minutes) describes family psychotherapy without the
patient present. In past rulemaking, we have discussed that Medicare
coverage is limited to items and services that are for the diagnosis
and treatment of the individual beneficiary. For example, in the CY
2013 PFS final rule (77 FR 68979), we stated that Medicare does not pay
for services that are furnished to parties other than the beneficiary
and which Medicare does not cover, for example, communication with
caregivers.
During the COVID-19 pandemic, the number of adults reporting
adverse behavioral health conditions has increased sharply, with higher
rates of depression, substance use, and self-reported suicidal thoughts
observed in racial and ethnic minority groups.\63\ We are seeking to
ensure that appropriate care is furnished to Medicare beneficiaries and
note that CPT codes 90847 and 90849 are payable under Medicare.
Accordingly, we are proposing to update our payment files to remove the
restricted (``R'') procedure status indicator for CPT codes 90847 and
90849 and assigning these codes an active (``A'') procedure status
indicator.
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\63\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm.
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We note that there are national coverage determinations (NCDs)
addressing family psychotherapy described by CPT codes 90847 and 90849
describing the settings of care in which these services are covered,
documentation requirements and other guidelines.\64\ The Medicare
National Coverage Determinations (NCD) Manual, Pub. 100-03, section
70.1, titled ``Consultations with a Beneficiary's Family and
Associates'' states that ``family counseling services are covered only
where the primary purpose of such counseling is the treatment of the
patient's condition.'' \65\ The change to the ``A'' status indicator
for these subject CPT codes does not alter the policy under the
applicable coverage determinations for these codes.
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\64\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57065&ver=10&keyword=&keywordType=starts&areaId=all&docType=6,3,5,1,F,P&contractOption=all&hcpcsOption=code&hcpcsStartCode=90847&hcpcsEndCode=90847&sortBy=title&bc=1.
\65\ https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=16&ncdver=1.
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(40) Comment Solicitation on Intensive Outpatient Mental Health
Treatment, Including Substance Use Disorder (SUD) Treatment, Furnished
by Intensive Outpatient Programs (IOPs)
There are a range of services described by existing coding under
the PFS that can be billed for treatment of mental health conditions,
including SUDs, such as individual, group, and family psychotherapy.
Over the past several years, in collaboration with interested parties
and the public, we have increased the coding and payment mechanisms for
substance use treatment services paid under the PFS. For example, in
the CY 2020 PFS final rule (84 FR 62673), we finalized the creation of
new coding and payment describing a bundled episode of care for the
treatment of Opioid Use Disorder (OUD) (HCPCS codes G2086-G2088). In
the CY 2021 PFS final rule, we finalized expanding the bundled payments
described by HCPCS codes G2086-G2088 to be inclusive of all SUDs (85 FR
84642 through 84643).
Additionally, in the CY 2020 PFS final rule (84 FR 62630 through
62677), we implemented coverage requirements and established new codes
describing bundled payments for episodes of care for the treatment of
OUD furnished by Opioid Treatment Programs (OTPs). Medicare also covers
services furnished by inpatient psychiatric facilities and partial
hospitalization programs (PHP). PHP services can be furnished by a
hospital outpatient department or a Medicare-certified Community Mental
Health Center (CMHC). PHPs are structured to provide intensive
psychiatric care through active treatment that utilizes a combination
of the clinically recognized items and services described in Sec.
1861(ff) of the Social Security Act (the Act). According to the
Medicare Benefit Policy Manual, Chapter 6, Section 70.3, the treatment
program of a PHP closely resembles that of a highly structured, short-
term hospital inpatient program and is at a level more intense than
outpatient day treatment or psychosocial rehabilitation. PHPs work best
as part of a community continuum of mental health services which range
from the most restrictive inpatient hospital setting to less
restrictive outpatient care and support.
We understand that in some cases, people that do not require a
level of care for mental health needs that meets the standards for PHP
services, nonetheless require intensive services on an outpatient
basis. We are interested in whether or not the current coding and
payment mechanisms under the PFS adequately account for intensive
outpatient services that are part of a continuum of care in the
treatment. For example, according to SAMHSA's Advisory on Clinical
Issues in Intensive Outpatient Treatment for Substance Use Disorders,
IOP programs for substance use disorders (SUDs) offer services to
clients seeking primary treatment; step-down care from inpatient,
residential, and withdrawal management settings; or step-up treatment
from individual or group outpatient treatment. IOP treatment includes a
prearranged schedule of core services for example,
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individual counseling, group therapy, family psychoeducation, and case
management) for a minimum of 9 hours per week for adults or 6 hours per
week for adolescents. The 2019 National Survey of Substance Abuse
Treatment Services reports that 46 percent of SUD treatment facilities
offer IOP treatment.\66\
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\66\ https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep20-02-01-021.pdf.
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We are seeking comment on whether there is a gap in coding under
the PFS or other Medicare payment systems that may be limiting access
to needed levels of care for treatment of mental health or substance
use disorder treatment, including and especially SUDs, for Medicare
beneficiaries. We are particularly interested in the extent to which
any potential gaps would best be addressed by the creation of new
codes, revision of particular billing rules for some kinds of care in
specific settings, or whether the valuation of particular codes
(existing or new) needs to be addressed in order to better reflect the
relative resource costs involved in furnishing intensive outpatient
mental health services. We are also interested in additional, detailed
information about IOP services, such as the settings of care in which
these programs typically furnish services, the range of services
typically offered, the range of practitioner types that typically
furnish those services, and any other relevant information, especially
to the extent it would inform our ability to ensure that Medicare
beneficiaries have access to this care.
(41) Comment Solicitation on Payment for Behavioral Health Services
Under the PFS
As discussed throughout this proposed rule, CMS is committed to
ensuring that beneficiaries have access to needed services for mental
and behavioral health. Through the CMS Behavioral Health Strategy, CMS
seeks to remove barriers to care and services, and to adopt a data-
informed approach to evaluate our behavioral health programs and
policies. CMS strives to support a person's whole emotional and mental
well-being and promote person-centered behavioral health care.\67\
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\67\ https://www.cms.gov/cms-behavioral-health-strategy.
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As part of our review of our payment policies and systems, we
understand that the PFS ratesetting methodology and application of
budget neutrality may impact certain services more significantly than
others based on factors such as how frequently codes are revalued and
the ratio of physician work to practice expense (PE). In the CY 2018
PFS final rule (82 FR 52999), we discussed that some interested parties
had suggested that for codes in which direct PE inputs for a service
are very low, the methodology for allocating indirect PE does not allow
for a site of service differential that accurately reflects the
relative indirect costs involved in furnishing services in non-facility
settings. We stated that primary therapy and counseling services
available to Medicare beneficiaries for treatment of behavioral health
conditions, including substance use disorders, are among the services
most affected by our methodology.
We are soliciting comment on how we can best ensure beneficiary
access to behavioral health services, including any potential
adjustments to the PFS ratesetting methodology, for example, any
adjustments to systematically address the impact on behavioral health
services paid under the PFS.
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F. Evaluation and Management (E/M) Visits
1. Background
Over the past several years, CMS has engaged in a multi-year effort
with the American Medical Association (AMA) and other interested
parties to update coding and payment for evaluation and management (E/
M) visits, so that they better reflect the current practice of
medicine, are less administratively complex, and are paid more
accurately under the PFS. This work is critical to help reduce
practitioner burnout in general, especially in light of the COVID-19
pandemic. In a step-wise approach, the AMA CPT Editorial Panel revised
the office/outpatient (O/O) E/M visit code family first. Effective
January 1, 2021, the CPT Editorial Panel redefined the O/O E/M visits,
such that visit level is selected based on the amount of practitioner
time spent performing the visit or the level of medical decision-making
(MDM) as redefined in the CPT E/M Guidelines. Additionally, effective
January 1, 2021, history of present illness (History) and a physical
exam are no longer required elements of these services or used to
select the O/O E/M visit level. (See 85 FR 84549). Also, effective
January 1, 2021, the CPT Editorial Panel revised the O/O E/M visit
descriptor times and the CPT E/M Guidelines.
We generally adopted these revised codes and changes in CPT code
selection and documentation guidance for payment purposes under the PFS
effective January 1, 2021 (84 FR 62844 through 62859). While we
accepted the revised CPT codes and approach for the O/O E/M visits, we
did not accept the revisions for prolonged O/O services, because we
were concerned that they could have resulted in overpayment, were
administratively complex, and would have impacted our ability to tell
how much total time was spent with the
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patient (see 84 FR 62849 through 62850). We created G2212 for reporting
of prolonged O/O E/M services. Finally, the AMA RUC resurveyed the O/O
E/M visits, and we generally accepted the RUC recommendations, which
reflected increased service times (84 FR 62851 through 62854). This
resulted in increased values for the O/O E/M codes beginning in CY
2021. Also, we created add-on code G2211 (office/outpatient E/M visit
complexity) that can be reported in conjunction with O/O E/M visits to
better account for resources associated with primary care or care
services that are part of ongoing care related to a patient's single,
serious, or complex chronic condition(s). (84 FR 62854 through 62856).
The Consolidated Appropriations Act, 2021 imposed a moratorium on
Medicare payment for these services by prohibiting CMS from making
payment under the physician fee schedule for HCPCS code G2211 before
January 1, 2024. See our fact sheet available at Physician Fee Schedule
(PFS) Payment for Office/Outpatient Evaluation and Management (E/M)
Visits--Fact Sheet \68\ (cms.gov).
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\68\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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For CY 2023, the AMA CPT Editorial Panel has revised the rest of
the E/M visit code families (except critical care services) to match
the general framework of the O/O E/M visits, including inpatient and
observation visits, emergency department (ED) visits, nursing facility
visits, domiciliary or rest home visits, home visits, and cognitive
impairment assessment. Hereafter in this proposed rule, we refer to
these other E/M visit code families as ``Other E/M'' visits or CPT
codes, as relevant. Effective January 1, 2023, the CPT Editorial Panel
has redefined the Other E/M visits so that they parallel the O/O E/M
visits, where visit level will be selected based on the amount of
practitioner time spent with the patient or the level of MDM as
redefined in the CPT E/M Guidelines. History and physical exam will
only be considered when and to the extent that they are medically
appropriate, and will no longer impact the Other E/M visit level. The
CPT Editorial Panel also revised the service times within the
descriptors, the associated prolonged service codes, and the CPT E/M
Guidelines for the Other E/M CPT codes. We note that the CPT Editorial
Panel also consolidated a considerable number of the Other E/M CPT
codes, with inpatient and observation visits being combined into a
single code set, and home and domiciliary visits being combined into a
single code set. Currently there are approximately 75 Other E/M CPT
codes, and in 2023 there will be approximately 50 Other E/M CPT codes.
The CPT Editorial Panel created one new CPT code for prolonged
inpatient services by physicians and other qualified healthcare
professionals on the date of the E/M visit. Finally, the RUC has
resurveyed the Other E/M visits and associated prolonged service codes,
and provided revaluation recommendations to CMS.
In total, E/M visits comprise approximately 40 percent of all
allowed charges under the PFS. The subset of Other E/M visits comprises
approximately 20 percent of all allowed charges. Accordingly, our final
policies for the Other E/M visits will have a significant impact on
relative resource valuation under the PFS, which could potentially
impact patient care more broadly. In this section of our proposed rule,
we propose policies addressing coding and revaluation of Other E/M
visits beginning for CY 2023. We also propose a technical correction to
the placement of our regulation text for split (or shared) visits, and,
as we further consider feedback from interested parties, we propose to
delay implementation of our policy to define the substantive portion of
a split (or shared) visit at Sec. 415.140 based on the amount of time
spent by the billing practitioner until January 1, 2024. Finally, we
provide clarification and propose a technical correction regarding how
time is reported for split (or shared) critical care visits.
2. Overview of Policy Proposals
We are proposing to generally adopt the revised CPT E/M Guidelines
for Other E/M visits, which are available online at www.ama-assn.org/cpt-evaluation-management. We propose to adopt the general CPT
framework for Other E/M visits, such that practitioner time or MDM
would be used to select the E/M visit level. This includes the listing
of qualifying activities by the physician or NPP that count toward the
time spent when time is used required to select the visit level.
History and physical exam would be considered, as medically
appropriate, and would no longer be used to select visit level. We
would not adopt the general CPT rule \69\ where a billable unit of time
is considered to have been attained when the midpoint is passed (for
example, we would not consider a service with a time descriptor of 30
minutes to have been satisfied if only 15 minutes of time had been
spent furnishing that service). We similarly interpreted this rule for
O/O E/M visits, when time is used to select visit level. For example,
we required the full time within the CPT code descriptors to be met in
order to select an O/O E/M visit level using time, rather than half of
the descriptor time (84 FR 62848 through 62851). Also, we do not
interpret the CPT E/M Guidelines as adopting this general CPT rule
regarding the midpoint of time.
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\69\ Introduction to 2022 CPT Codebook, p.xviii.
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We are proposing to adopt the revised CPT codes and descriptors for
Other E/M visits, except where specified otherwise. Under our proposed
policies, we would adopt the new CPT codes and descriptors for Other E/
M visits except for prolonged services, for which we propose Medicare-
specific coding. For administrative simplicity and payment accuracy
purposes, and to enable us to determine how much time was spent with
the patient using claims data, prolonged Other E/M services would be
reported under one of three proposed G codes (one for each family for
which prolonged services apply, namely inpatient/observation visits,
nursing facility visits, and home or residence visits). This would be
consistent with our previously finalized approach to prolonged O/O E/M
services.
We are proposing to adopt the CPT E/M Guidelines regarding MDM for
E/M services. The CPT Editorial Panel revised the CPT E/M guidelines
for levels of MDM, and we are proposing to adopt them as revised.
In addition, as we note in the Medicare Claims Processing Manual
((pub 100-04) chapter 26, section 10.8), our longstanding taxonomy for
PFS services will continue to apply, where, for payment purposes,
physicians and NPPs are not classified as having the same specialty,
and the PFS does not recognize subspecialties. However, we are
continuing to consider whether we could better align this payment
taxonomy with clinical practice, where we might consider NPPs as
working in the same specialty as the physicians with whom they work,
and/or recognize subspecialties.
Regarding valuation of the Other E/M CPT codes, the RUC recommended
direct work RVU comparisons for many Other E/M CPT codes to those
currently assigned to O/O E/M CPT codes. In some cases, there were
assumptions that patient needs were inherently more complex or work was
more intense for E/M visits furnished in non-office settings (for
example, inpatient, ED, and home settings) when compared to the office
settings. This direct comparison to the O/O visit codes may not be
appropriate or accurate, given that
[[Page 45988]]
practitioners furnishing visits in the office setting face particular
uncertainties in their estimates of illness and treatment courses, and
the office settings have fewer resources close at hand. For example,
compared to fully-staffed institutional settings, office settings
generally have smaller, ancillary staff complements (such as
pharmacists, registered nurses, social workers, and other
paraprofessionals) who provide specialized advice and services, spend
time coordinating with other practitioners for review and evaluation of
medical records and test results, educate patients, manage medications,
and assess and help address social determinants of health.
Additionally, those practicing in institutional settings generally have
ready availability of diagnostic equipment (for example, imaging and
other advanced services), allowing for more immediate access to
clinical information and reducing the amount of time needed to manage a
given case. This access is critical for positive health outcomes, to
treat or prevent acute exacerbations of chronic conditions and timely
manage patients to prevent deterioration and improve outcomes. The
challenge of coordinating and gathering these types of care and
information in the office setting may add additional time and
complexity to the case management. Further, some of the Other E/M CPT
code families are being merged into lower complexity settings, such as
CPT codes for observation services migrating into the inpatient visit
CPT codes.
The values we established for the revised O/O E/M CPT codes in the
CY 2021 PFS final rule were finalized in concert with a policy that
would have provided separate payment for the new add-on code G2211.
This add-on code describes the complexity inherent to E/M visits
associated with primary care and other similar types of care
(specifically, E/M visits associated with medical care services that
serve as the continuing focal point for all needed health care services
and/or with medical care services that are part of ongoing care related
to a patient's single, serious condition or a complex condition,
regardless of the specialty of the billing professional) (see 85 FR
84569 through 84572). Section 113 of the Consolidated Appropriations
Act, 2021 delayed Medicare payment for G2211 until at least January 1,
2024 (see the following Fact Sheet available on our website at
Physician Fee Schedule \70\ (PFS) Payment for Office/Outpatient
Evaluation and Management (E/M) Visits--Fact Sheet (cms.gov). To the
extent we are proposing to adopt the RUC-recommended values for Other
E/M visits beginning for CY 2023, we do not agree with the RUC that the
current visit payment structure among and between care settings fully
accounts for the complexity of certain kinds of visits, especially for
those in the office setting, nor do they fully reflect appropriate
relative values, since separate payment is not yet made for G2211.
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\70\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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3. Hospital Inpatient or Observation Care (CPT Codes 99218-99236)
a. Coding Changes and Visit Selection for Hospital Inpatient or
Observation Care Services
The CPT Editorial Panel deleted seven observation care codes and
revised nine codes effective January 1, 2023, to create a single set of
codes for inpatient and observation care. (Note that the CPT Editorial
Panel also made changes to codes for inpatient and observation
discharge, which will be discussed in section II.F.4. of this proposed
rule.) The CPT Editorial Panel also changed the code descriptors to
allow level of service to be based on total time or MDM, as well as
updating documentation requirements.
The CPT Editorial Panel deleted the six codes that were used to
report observation care visits: three initial observation care codes,
CPT codes 99218 (Initial observation care, per day, for the evaluation
and 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 to
outpatient hospital ``observation status'' are of low severity.
Typically, 30 minutes are spent at the bedside and on the patient's
hospital floor or unit), 99219 (Initial observation 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 to outpatient hospital ``observation
status'' are of moderate severity. Typically, 50 minutes are spent at
the bedside and on the patient's hospital floor or unit), and 99220
(Initial observation 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 to
outpatient hospital ``observation status'' are of high severity.
Typically, 70 minutes are spent at the bedside and on the patient's
hospital floor or unit); and three subsequent observation care codes,
CPT codes 99224 (Subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: Problem focused interval history; 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), 99225 (Subsequent observation 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), and 99226 (Subsequent observation
care, per day, for the evaluation and management of a patient, which
requires at least 2 of
[[Page 45989]]
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).
The CPT Editorial Panel also revised the six hospital inpatient
care codes. The revisions allow these codes to be reported for hospital
inpatient or observation care services and allow the codes to be
selected by the billing practitioner based on either MDM or time. In
addition, the CPT Editorial Panel changed the name of the ``Hospital
Inpatient Care'' code family to ``Hospital and Observation Care,'' and
the new code family includes three initial hospital or observation care
codes: CPT codes 99221 (Initial hospital inpatient or observation care,
per day, for the evaluation and management of a patient, which requires
a medically appropriate history and/or examination and straightforward
or low-level medical decision-making. When using total time on the date
of the encounter for code selection, 40 minutes must be met or
exceeded), 99222 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
encounter for code selection, 55 minutes must be met or exceeded), and
99223 (Initial hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making When using total time on the date of the encounter for
code selection, 75 minutes must be met or exceeded); and three
subsequent inpatient or observation care codes, CPT codes 99231
(Subsequent hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and straightforward or low level
of medical decision making. When using total time on the date of the
encounter for code selection, 25 minutes must be met or exceeded),
99232 (Subsequent hospital inpatient or observation care, per day, for
the evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using total time on the date of the encounter for
code selection, 35 minutes must be met or exceeded), and 99233
(Subsequent hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using total time on the date of the encounter for
code selection, 50 minutes must be met or exceeded).
The CPT Editorial Panel also revised the three codes under
``Observation or Inpatient Care Services (including Admission and
Discharge)'' (frequently referred to as ``same-day discharge'' codes).
Billing practitioners could already use these codes to bill for
patients in inpatient or observation status, but the CPT Editorial
Panel revised the codes to allow the billing practitioner to select the
code level based either on MDM or time. The same-day discharge codes
were renamed as ``Hospital Inpatient or Observation Care (Admission and
Discharge)'': CPT codes 99234 (Hospital inpatient or observation care,
for the evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and straightforward or low level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded), 99235 (Hospital
inpatient or observation care, for the evaluation and management of a
patient including admission and discharge on the same date, which
requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using total time on the
date of the encounter for code selection, 70 minutes must be met or
exceeded), and 99236 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using total time on the date of the encounter for code selection,
85 minutes must be met or exceeded).
We propose to adopt the revised CPT codes 99221 through 99223 and
99231 through 99236. We highlight that the CPT code descriptors specify
that, when selecting the code level based on time, the indicated
increment of time must be ``met or exceeded.'' We propose that, when a
physician or practitioner selects CPT codes 99221 through 99223 and
99231 through 99236 based on time, the number of minutes specified in
the descriptor for the relevant CPT code must be ``met or exceeded.''
We note that we are not proposing to adopt the CPT Codebook
instructions regarding the application of prolonged codes to CPT codes
99223, 99233, and 99236; refer to additional discussion under
``Prolonged Codes for Hospital Inpatient or Observation Care'' in this
section.
We also note that the descriptors for CPT codes 99221 through 99223
and 99231 through 99236 specify that the time counted toward the code
is ``per day.'' We propose to adopt the 2023 CPT Codebook instruction
that ``per day,'' also referred to as ``date of encounter,'' means the
``calendar date.'' (2023 CPT Codebook citation forthcoming.) We also
propose to adopt the 2023 CPT Codebook instruction that when using MDM
or time for code selection, a continuous service that spans the
transition of 2 calendar dates is a single service and is reported on
one date, which is the date the encounter begins. If the service is
continuous before and through midnight, all the time may be applied to
the reported date of the service, that is, the calendar date the
encounter began. (2023 CPT Codebook citation forthcoming.) We note that
nothing in this proposal is intended to conflict with our proposed
retention of the ``8 to 24 hour rule,'' discussed in the next section.
Finally, we propose to retain our policy that a billing
practitioner shall bill only one of the hospital inpatient or
observation care codes for an initial visit, a subsequent visit, or
inpatient or observation care (including admission and discharge), as
appropriate, once per calendar date. We propose that the practitioner
would select a code that reflects all of the practitioner's services
provided during the date of the service, as provided in the Medicare
Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.9.B. We discuss
additional policies relating to a single billing practitioner providing
services to a single beneficiary on the same day in section II.F.3.d.
of this proposed rule.
b. Proposed ``8 to 24 Hour Rule'' for Hospital Inpatient or Observation
Care
We propose to retain what is known as the ``8 to 24-hour rule''
regarding payment of discharge CPT codes 99238 (Hospital inpatient or
observation discharge day management; 30 minutes or less) and 99239
(more than 30 minutes). (CPT codes 99238 and 99239 are discussed in
further detail in section
[[Page 45990]]
II.F.4. of this proposed rule.) The ``8 to 24 hour rule'' is described
in further detail in the Medicare Claims Processing Manual (IOM 100-04,
Chapter 12, 30.6.8.B and 30.6.9.1.C.). As we discussed in the CY 2001
PFS final rule (65 FR 65376), the ``8 to 24 hour rule'' was designed to
avoid unintended incentives to keep a patient in the hospital past
midnight during a stay lasting less than 24 hours. When this policy was
memorialized in the CY 2001 PFS final rule, it was applied to both the
initial inpatient hospital care codes (CPT codes 99221 through 99223)
and the initial observation care codes (CPT codes 99218 through 99220)
which CPT has deleted for 2023. The policy we propose to retain is as
follows:
If the beneficiary receives less than 8 hours of hospital
inpatient or observation services, the practitioner may not bill for
hospital inpatient and observation discharge day management services
(to be described by CPT codes 99238 and 99239). If a patient receives
less than 8 hours of hospital inpatient or observation services, we
propose that the practitioner would bill only initial inpatient or
observation care (described by CPT codes 99221, 99222, or 99223, as
appropriate).
If a beneficiary receives hospital inpatient or
observation services for a minimum of 8 hours but less than 24 hours,
we propose that the practitioner would bill CPT codes 99234, 99235, or
99236, as appropriate. (These codes, commonly referred to as ``same-day
discharge'' codes, describe hospital inpatient or observation care that
includes both admission and discharge as part of a single service.)
If a beneficiary is admitted for hospital inpatient or
observation care and is then discharged after more than 24 hours, we
propose that the practitioner would bill an initial hospital inpatient
or observation care code (CPT codes 99221 through 99223) for the date
of admission, and a hospital discharge day management service (CPT code
99238 or 99239) on the date of discharge.
We believe it remains necessary to retain our 8 to 24 hour policy
to avoid overpayments or create incentives to unnecessarily extend
beneficiaries' hospital stays past midnight. Hospital inpatient and
observation care codes (CPT codes 99221 through 99223 and 99234 through
99239) are billed ``per day,'' and have been valued to account for all
services a practitioner furnishes during the day-long billing period.
In an environment such as a hospital, where admissions can occur 24
hours a day, relying solely on the calendar date of an admission or
observation stay, to determine a billing day can be misleading, which
is why we propose to retain the existing 8 to 24 hour policy.
For example, Patient A was admitted by Physician A at 11:00 p.m. on
April 1st and discharged at 6:00 a.m. on April 2nd. Patient B was
admitted by Physician B at 8:00 a.m. on April 1st and discharged at
9:00 p.m. on April 2nd. Both Patient A and Patient B were in the
hospital on the same two calendar dates (April 1 and April 2), but
Patient A's stay was only 7 hours and Patient B's stay was 25 hours.
Allowing both Physician A and Physician B to bill similarly (that is,
both an initial hospital visit for April 1 and a discharge day
management code for April 2nd) would be inappropriate. Both initial
hospital visits and discharge day management codes are billed ``per
day'' (and are valued as being ``per day''). Allowing a physician to
bill for two ``per day'' services, delivered to the same patient in the
same setting in less than an 8-hour period results in duplicative
payment. This also may create an incentive for patients to be kept in
the hospital past midnight, just to get to a second calendar date in
which a practitioner is able to bill for two services rather than one.
We also note that CPT codes 99234, 99235, and 99236 are valued to
include physician time spent admitting, caring for, and discharging the
patient. These codes are billed for stays longer than 8 hours to
acknowledge the increased resources inherent to caring for a patient
during a longer hospital stay.
For another illustration of why relying solely on the calendar date
of admission to determine the billing date is misguided, Patient A is
admitted at 11 a.m. on April 1st and discharged at 11 p.m. on April
1st. Patient B is admitted at 11 p.m. on April 1st and discharged at 11
a.m. on April 2nd. Both patients are in the hospital for 12 hours. The
practitioner treating Patient A would bill for a same-day discharge
service, CPT code 99234 through 99236. It would not be appropriate to
allow the practitioner treating Patient B to bill separately for an
initial visit (CPT codes 99221 through 99223) and a separate discharge
day management service (CPT codes 99238 or 99239) simply because
Patient B's visit happened to span two calendar days and Patient A's
did not. Under the proposed 8 to 24-hour rule, the practitioner
treating Patient B would also bill for a same-day discharge service,
CPT code 99234 through 99236.
We believe that by tying billing to the length of hospital stay
rather than the calendar date, the 8 to 24-hour rule avoids confusion
and the potential for overpayment of multiple E/M visits improperly
billed for the same period of service.
c. Proposed Definition of Initial and Subsequent Hospital Inpatient or
Observation Visit
According to the 2023 CPT Codebook (citation forthcoming), an
``initial'' service may be reported when ``the patient has not received
any professional services from the physician or other qualified health
care professional or another physician or other qualified health care
professional of the exact same specialty and subspecialty who belongs
to the same group practice during the stay. When advanced practice
nurses and physician assistants are working with physicians they are in
the exact same specialty and subspecialty as the physician.'' The
revised CPT codes 99231 through 99233 describe subsequent hospital
inpatient or observation care services similarly. According to the 2023
CPT Codebook (citation forthcoming), a ``subsequent'' service is
reported when the patient has received any professional services from
the physician or other qualified health care professional or another
physician or other qualified health care professional of the exact same
specialty and subspecialty who belongs to the same group practice
during the stay.
As we do not recognize subspecialties, we propose slightly amended
definitions of ``initial'' and ``subsequent'' service:
An initial service would be defined as one that occurs
when the patient has not received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the same
specialty who belongs to the same group practice during the stay.
A subsequent service would be defined as one that occurs
when the patient has received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the same
specialty who belongs to the same group practice during the stay.
These are the same definitions that we propose for ``initial'' and
``subsequent'' in the context of nursing facility visits below. We are
also proposing that for both initial and subsequent visits, when
advanced practice nurses and physician assistants are working with
physicians, they are always classified in a different specialty than
the physician (see section II.F.2. of this proposed rule).
[[Page 45991]]
d. Transitions Between Settings of Care and Multiple Same-Day Visits
for Hospital Patients Furnished by a Single Practitioner
We propose to retain our current policy that for the purposes of
reporting an initial hospital inpatient or observation care service, a
transition from observation status to inpatient status does not
constitute a new stay. (Refer to Medicare Claims Processing Manual, IOM
100-04, Chapter 12, 30.6.8.D.) For instance, if a practitioner places a
beneficiary in observation status on one date of service (and bills an
initial observation visit to be described under CPT code 99221 through
99223), and then determines later in the stay that the beneficiary
should be admitted to the hospital as an inpatient, the practitioner
would not bill a second initial visit for the hospital inpatient stay.
Rather, the practitioner would bill the work done on the inpatient
admission day as a subsequent visit (CPT codes 99231, 99232, or 99233).
This policy aligns with language in the 2023 CPT Codebook instructions
(citation forthcoming.)
We also propose to retain our policy that if a patient is seen in a
physician's office on one date and receives care at a hospital (for
inpatient or observation care) on the next date from the same
physician, both visits are payable to that physician, even if less than
24 hours has elapsed between the visit and the hospital inpatient or
observation care. (Refer to Medicare Claims Processing Manual, IOM 100-
04, Chapter 12, 30.6.9.1.B.) We also propose, however, to retain our
current policy that when a patient is admitted to outpatient
observation or as a hospital inpatient via another site of service
(such as, hospital ED, physician's office, nursing facility), all
services provided by the physician in conjunction with that admission
are considered part of the initial hospital inpatient or observation
care when performed on the same date as the admission. (Refer to the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.9.1.A.)
This policy differs somewhat from the instructions provided in the 2023
CPT Codebook (citation forthcoming.)
We believe it is important to retain both policies, as they promote
appropriate payment in situations in which the beneficiary visits the
practitioner in a non-hospital setting before the practitioner
determines that hospital admission is necessary. The codes for initial
hospital inpatient or observation visits (CPT codes 99221 through
99223) are billed ``per day'' and include all work furnished by the
practitioner on the day of admission. The initial hospital inpatient
and observation care codes do not include work furnished by the
practitioner prior to the date of admission. Thus, under our proposal,
for example, if a practitioner sees a beneficiary in an office setting
at 5 p.m. on April 1st and the practitioner then oversees the
beneficiary's admission to the hospital at 7 a.m. on April 2nd, these
would be separately billable payments because initial hospital
inpatient or observation care codes (CPT code 99221 through 99223)
billed for April 2nd would not retroactively cover the work furnished
on April 1st. However, if the practitioner sees the beneficiary in the
office setting at 7 a.m. on April 1st and then oversees the
beneficiary's admission at 9 p.m. on April 1st, all time the
practitioner spent furnishing services to that beneficiary would be
reportable under the initial hospital inpatient or observation care
code (CPT code 99221 through 99223).
We also propose to retain our current billing policy in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.1.A.
that a physician may bill only for an initial hospital or observation
care service if the physician sees a patient in the ED and decides to
either place the patient in observation status or admit the patient as
a hospital inpatient. For discussion of additional policy proposals
regarding patients seen in both the ED and the hospital, refer to the
next section, ``Emergency Department Services.''
We propose to preserve our current billing policies for patients in
swing beds, which are as follows: If the inpatient care is being billed
by the hospital as inpatient hospital care, the hospital care codes
(CPT codes 99221 through 99223 and 99231 through 99239) apply. (Refer
to Medicare Claims Processing Manual, IOM 100-04, Chapter 12,
30.6.9.D.) If the inpatient care is being billed by the hospital as
nursing facility care, then the nursing facility codes (CPT codes 99304
through 99316) apply. Refer to the section below on Nursing Facility
Care Services for additional discussion of billing hospital inpatient
or observation care and nursing facility care.
e. Impact of Changes to Hospital Inpatient or Observation Codes on
Billing and Claims Processing Policies
We propose that starting in CY 2023, hospital inpatient and
observation care by physicians will be billed using the same CPT codes,
CPT codes 99221 through 99223, 99231 through 99233, and 99238 and
99239. (We note that currently, both hospital inpatient and observation
care are already billed under CPT codes 99234 through 99236 for same-
day discharge.) Therefore, though the current observation care codes
(CPT codes 99218 through 99220 and 99224 through 99226) are being
deleted, practitioners will still be able to furnish and bill for
observation services. We solicit feedback from the public on potential
challenges to billing or claims processing policies for hospital
inpatient or observation care as reflected in the Medicare Claims
Processing Manual (Medicare Claims Processing Manual, IOM 100-04,
Chapter 12), including possible impact on: billing for patients during
a global period (Medicare Claims Processing Manual, IOM 100-04, Chapter
12, Sections 30.6.8.E and 30.6.9.2.A.); documentation requirements
(Medicare Claims Processing Manual, IOM 100-04, Chapter 12, Sections
30.6.8.C and 30.6.9.1.D.); modifiers associated with hospital inpatient
or observation care claims (Medicare Claims Processing Manual, IOM 100-
04, Chapter 12, Section 30.6.9.1.F); and any other issues not otherwise
discussed in this proposed rule that may need to be addressed through
additional guidance.
f. Prolonged Services for Hospital Inpatient or Observation Care
As part of its E/M revisions, the CPT Editorial Panel made several
changes to prolonged codes that previously could be billed with
inpatient or observation codes. In February 2021, the CPT Editorial
Panel deleted Prolonged Service with Direct Patient Contact (Except
with Office or Other Outpatient Services), including CPT code 99356
(Prolonged service in the inpatient or observation setting, requiring
unit/floor time beyond the usual service; first hour; List separately
in addition to code for inpatient or observation Evaluation and
Management service) and CPT code 99357 (each additional 30 minutes),
effective January 1, 2023. Prior CPT Codebook instructions indicated
that CPT codes 99356 and 99357 could be applied to hospital inpatient
or observation care (CPT codes 99218 through 99236). (Refer, for
example, to instructions on pages 41-42 of the 2022 CPT Codebook.)
To replace deleted CPT codes 99356 and 99357, the CPT Editorial
Panel created CPT code 993X0 (Prolonged inpatient or observation
evaluation and management service(s) time with or without direct
patient contact beyond the required time of the primary service when
the primary service level has been selected using total time, each 15
minutes of total time.) (List separately in addition to the code of the
inpatient and
[[Page 45992]]
observation Evaluation and Management services). Additional guidance
from the 2023 CPT Codebook states, ``Code 993X0 is used to report
prolonged total time (that is, combined time with and without direct
patient contact) provided by the physician or other qualified health
care professional on the date of an inpatient service (that is, 99223,
99233, 99236, 99255, 99306, 99310). Prolonged total time is time that
is 15 minutes beyond the time required to report the highest-level
primary service.'' (2023 CPT Codebook citation forthcoming.)
We do not propose to adopt CPT code 993X0, as we believe that the
billing instructions for CPT code 993X0 will lead to administrative
complexity, potentially duplicative payments, and limit our ability to
determine how much time was spent with the patient using claims data;
these reasons are discussed in further detail below. We are instead
proposing to create a single G-code that describes a prolonged service,
and that applies to CPT codes 99223, 99233, and 99236. This G-code
would be GXXX1:
GXXX1 Prolonged hospital inpatient or observation care
evaluation and management service(s) beyond the total time for the
primary service (when the primary service has been selected using time
on the date of the primary service); each additional 15 minutes by the
physician or qualified healthcare professional, with or without direct
patient contact (list separately in addition to CPT codes 99223, 99233,
and 99236 for hospital inpatient or observation care evaluation and
management services). (Do not report GXXX1 on the same date of service
as other prolonged services for evaluation and management 99358, 99359,
993X0, 99415, 99416). (Do not report GXXX1 for any time unit less than
15 minutes).
We are proposing that the GXXX1 prolonged code can only be applied
to the highest-level hospital inpatient or observation care visit codes
(CPT codes 99223, 99233, and 99236), and can only be used when
selecting the E/M visit level based on time. In other words, we propose
that a prolonged code would only be applied once the greatest amount of
time for initial, subsequent, or same-day discharge visits has been
exceeded. We note that this proposed policy mirrors the policy the CPT
Editorial Panel will apply to CPT code 993X0 (although we are not
proposing to use CPT code 993X0).
We are proposing to use GXXX1 instead of CPT code 993X0 because we
disagree with the CPT instructions regarding the point in time at which
the prolonged code should apply. According to the 2023 CPT Codebook,
CPT code 993X0, which represents a 15-minute interval, would apply to:
CPT code 99223 when a practitioner reaches 90 minutes; CPT code 99233
when 65 minutes is reached; and CPT code 99236 when 100 minutes is
reached. Each of these times represent only 15 minutes more than the
codes' descriptor times. We disagree with this instruction, and we
believe that a prolonged code is only applicable after both the total
time described in the base E/M code descriptor is complete and the full
15-minutes described by the prolonged code are complete as well. We do
not believe that the CPT instructions for CPT code 993X0 align with our
payment policy.
Additionally, we note that CPT code 99236, per the RUC-recommended
times, includes not only 85 minutes of intraservice time (performed on
the date of encounter) but an additional 12 minutes of post-service
time. The RUC based this recommendation on a survey timeframe which was
within 3 days of the date of encounter. We are concerned that the CPT
instructions for CPT code 993X0, as it applies to CPT code 99236, would
result in duplicative payment, since the 12-minute post-service time
was factored into the proposed valuation of CPT code 99236. It would be
inappropriate to pay for a prolonged code based on post-service time
that is already accounted for in the base code. We believe that the
instruction for when to apply CPT code 993X0 to base code CPT code
99236 does not accurately account for this post-service time.
We propose that the prolonged service period described by GXXX1 can
begin 15 minutes after the total times (as established in the Physician
Time File) for CPT codes 99223, 99233, and 99236 have been met.
Additionally, we propose that the proposed GXXX1 prolonged code would
be for a 15-minute increment, and the entire 15-minute increment must
be completed in order to bill GXXX1. Note that for administrative
simplicity, we propose to round the time when the prolonged service
period begins to the nearest 5 minutes. For the times below, CPT code
99223, which has a RUC-proposed total time of 74 minutes, would be
treated as though it has 75 total minutes. CPT code 99233, which has a
RUC-proposed total time of 52 minutes, would be treated as though it
has 50 total minutes; and CPT code 99236, which has a RUC-proposed
total time of 97 minutes will be treated as though it has 95 total
minutes. The rounding here is solely for the purpose of calculating a
proposed prolonged period, and would not affect the total times for
these CPT codes in the Time File.
Thus, a practitioner could bill GXXX1 for base code CPT code 99223
when 105 minutes is reached for an initial visit on the date of
encounter. For the purposes of applying the proposed prolonged code,
the CPT code 99223 total time is rounded to 75 minutes on the date of
encounter. The prolonged service period would begin at 90 minutes, 15
minutes beyond 75 minutes. A practitioner would bill GXXX1 once the 15-
minute increment for GXXX1 is completed, at minute 105.
A practitioner could bill GXXX1 for the base code CPT code 99233
when 80 minutes is reached for a subsequent visit on the date of
encounter. For the purposes of applying the prolonged code, the CPT
code 99233 total time is rounded to 50 minutes on the date of
encounter. The prolonged service period would begin at 65 minutes, 15
minutes beyond 50 minutes. A practitioner would bill GXXX1 once the 15-
mimute increment for GXXX1 is completed, at minute 80.
A practitioner could bill GXXX1 for base code CPT code 99236 at 125
minutes for same-day discharge. For the purposes of applying the
prolonged code, the CPT code 99236 total time is rounded to 95 minutes
completed within 3 calendar days of the encounter. The prolonged
service period would begin at 110 minutes, 15 minutes beyond 95
minutes. A practitioner could bill GXXX1 once the 15-minute increment
for GXXX1 is completed, at minute 125.
Refer to summary Table 18 in the section ``Prolonged Services
Valuation'' (section II.F.11.e. of this proposed rule) for a chart
showing the proposed billing timeframe for GXXX1.
We are also proposing that the proposed GXXX1 would apply to both
face-to-face and non-face-to-face time spent on the patient's care
within the survey timeframe. For CPT codes 99223 and 99233, this would
be time spent on the date of encounter. For CPT code 99236, this would
be time spent within 3 calendar days of the encounter. Because we are
proposing that prolonged services without direct patient contact would
be reportable under GXXX1, we are also proposing that CPT codes 99358
(Prolonged evaluation and management services before and/or after
direct patient care, first hour) and 99359 (each additional 30 minutes)
cannot be billed for base codes CPT codes 99221 through 99223 and 99231
through 99236. Direct patient care, as currently described by CPT codes
99358 and 99359, will be reportable under GXXX1. Allowing both GXXX1
and CPT codes 99358 and 99359 would cause confusion and invite
[[Page 45993]]
duplicative billing for prolonged direct patient care. This is
consistent with our final policy for O/O E/M visits, which requires the
use of prolonged code G2212 (Prolonged office or other outpatient
evaluation and management service(s) beyond the maximum required time
of the primary procedure which has been selected using total time on
the date of the primary service; each additional 15 minutes by the
physician or qualified healthcare professional, with or without direct
patient contact) for prolonged O/O E/M services. We continue to be
concerned about program integrity, duplicative payments for time
counted in both E/M base codes and prolonged E/M services codes, the
administrative complexity of having multiple prolonged service codes,
and our ability to tell how much time was spent with the patient using
claims data (see our previous discussion of these issues in our CY 2020
PFS final rule at 84 FR 62849 through 62850). If we proposed to adopt
the CPT codes for prolonged inpatient and observation E/M visits, we
would not be able to identify the time spent with patients in the
claims data alone, because we might not know which primary service is
the companion code to the prolonged service code(s) due to the wide
service timespan (for prolonged services without direct patient
contact) and non-specific care settings within the prolonged CPT code
descriptors.
g. Valuation of Hospital Inpatient or Observation Care Services
The revised hospital inpatient or observation care codes (CPT codes
99221 through 99223 and 99231 through 99236) were surveyed for the
October 2021 RUC meeting. The survey times captured the total time on
the date of encounter by calendar date. In October 2021, the RUC
referred these services to be resurveyed because the survey did not
include a request for distinct time before and after floor/unit time,
and therefore could not be compared to previous RUC surveys of these
services. The RUC reviewed the resurveyed inpatient and observation
services for the January 2022 RUC meeting.
We propose to accept the RUC recommendations for work RVUs and
times for CPT codes 99221 (work RVU 1.63, intraservice time 40 minutes,
total time 40 minutes); 99222 (work RVU 2.60, intraservice time 55
minutes, total time 55 minutes); 99223 (work RVU of 3.50, intraservice
time 74 minutes, total time 74 minutes); 99231 (work RVU 1.00,
intraservice time 25 minutes, total time 25 minutes), 99232 (work RVU
1.59, intraservice time 36 minutes, total time 36 minutes); 99233 (work
RVU 2.40, intraservice time 52 minutes, total time 52 minutes); 99234
(work RVU 2.00, intraservice time 45 minutes, total time 50 minutes);
99235 (work RVU 3.24, intraservice time 68 minutes, total time 76
minutes); and 99236 (work RVU 4.30, intraservice time 85 minutes, total
time 97 minutes).
There are no PE inputs for these codes.
4. Hospital or Observation Discharge Day Management (CPT Codes 99217,
99238 and 99239)
a. Coding Changes to Hospital Inpatient or Observation Discharge Day
Management Services
Effective January 1, 2023, the CPT Editorial Panel deleted the
observation discharge code, CPT code 99217 (Observation care discharge
day management) and revised the two hospital discharge day management
codes, CPT codes 99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less) and CPT code 99239 (more than 30
minutes) so that CPT codes 99238 and 99239 may be billable for
discharge of hospital inpatient or observation patients.
We propose to adopt the revised CPT codes 99238 and 99239. We also
propose to retain our current hospital inpatient policy outlined in the
Medicare Claims Processing Manual, Chapter 12, 30.6.9.2.A and
30.6.9.2.E, and expand it to include observation care. Specifically, we
are proposing that CPT codes 99238 and 99239 are to be billed by the
practitioner who is personally responsible for discharge service (or,
in the case of the death of the patient, the physician who personally
performs the death pronouncement); services furnished by other
practitioners, including: instructions to the patient, communication
with the family/caregiver, and coordination of post discharge services
would be reported as subsequent hospital inpatient or observation care
with CPT codes 99231, 99232, and 99233. (Refer to the Medicare Claims
Processing Manual, IOM 100-04, Chapter 12, Manual, IOM 100-04, Chapter
12, 30.6.9.2.A and 30.6.9.2.E.) This policy aligns with instructions in
the 2023 CPT Codebook (citation forthcoming).
We propose to retain our related policy that the same physician may
not bill a hospital discharge CPT code 99238 or 99239 on the same day
as a subsequent visit CPT codes 99231 through 99233. (Refer to Medicare
Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.9.2.C.)
b. Prolonged Services and Hospital Inpatient or Observation Discharge
Day Management
As we discussed in section II.F.3. of this proposed rule, as part
of its E/M revisions, effective January 1, 2023, the CPT Editorial
Panel deleted CPT code 99356 (Prolonged service in the inpatient or
observation setting, requiring unit/floor time beyond the usual
service; first hour) and CPT code 99357 (each additional 30 minutes)
and replaced them with CPT code 993X0 (Prolonged inpatient or
observation evaluation and management service(s) time with or without
direct patient contact beyond the required time of the primary service
when the primary service level has been selected using total time, each
15 minutes of total time). CPT codes 99356 and 99357 were not
previously billable with discharge day management CPT codes 99238 or
99239. (Refer to, for example, instructions on pages 41-42 of the 2022
CPT Codebook.) Additionally, according to 2023 CPT Codebook
instructions, the CPT code 993X0 is not billable with CPT codes 99238
and 99239. (2023 CPT Codebook citation forthcoming.)
We propose that a practitioner would not be able to bill prolonged
services for hospital discharge (CPT code 99238 or 99239). This means
that CPT codes 993X0, 99358 (Prolonged evaluation and management
services before and/or after direct patient care, first hour) and 99359
(each additional 30 minutes), and the proposed GXXX1 code (discussed in
section II.F.3. of this proposed rule) would not be payable where the
discharge day management code is CPT codes 99238 or 99239. We believe
the code descriptors for CPT codes 99238 and 99239 do not allow for
additional payment of prolonged services. The descriptor for CPT code
99238 provides for hospital discharge day management, ``30 minutes or
less.'' If a practitioner spends more than 30 minutes on a hospital
discharge service for a patient, the practitioner would be able to bill
CPT code 99239, which is defined in the code descriptor as ``30 minutes
or more.'' Thus, a prolonged code (including CPT codes 993X0, 99358,
99359, and our proposed GXXX1) would not be appropriate for CPT code
99238, because CPT code 99239 accounts for services that exceed 30
minutes.
The descriptor for CPT code 99239 states that the code is for ``30
minutes or more'' of hospital discharge day management services. When
the RUC surveyed this code, the surveyed timeframe was within 3
calendar days of the encounter. In other words, the
[[Page 45994]]
descriptor time is 30 minutes or more, completed within 3 calendar days
of the encounter. Neither the descriptor nor the CPT billing
instructions provide an upper limit on how many minutes can be reported
within the 3-day timeframe for CPT code 99239. All face-to-face and
non-face-to-face activities performed by the practitioner during the
date of encounter and within 3 calendar days from the date of encounter
may be counted toward CPT code 99239, as applicable. Prolonged codes
CPT codes 993X0, 99358, 99359 and our proposed GXXX1 code are intended
to pay for time not included in the base E/M codes during the surveyed
timeframe; as it appears that CPT code 99239 already includes all
services furnished during the surveyed timeframe, we do not believe it
is appropriate to allow any prolonged codes to be billed with CPT code
99239 as a base code.
c. Valuation of Hospital Inpatient or Observation Discharge Day
Management
The revised discharge day management codes (CPT codes 99238 through
99239) were surveyed for the January 2022 RUC meeting. We propose to
accept the RUC recommendations for CPT codes 99238 (work RVU 1.50,
intraservice time 28 minutes, total time 38 minutes); and 99239 (work
RVU 2.15, intraservice time 45 minutes, 64 minutes total time).
We are proposing the RUC-recommended direct PE inputs for CPT codes
99238 and 99239 without refinement.
5. Emergency Department Visits (CPT Codes 99281-99285)
a. Coding
We have revalued the ED visit codes under the PFS four times: in
1997, 2007, 2020, and most recently in 2021 as part of the update for
O/O E/M visits. In the past, consistent with AMA RUC recommendations,
we revalued these services such that the values of levels 1 through 3
of the ED visits were equal to levels 1 through 3 new patient O/O E/M
visits, and the levels 4 and 5 ED visits were valued higher than the
levels 4 and 5 new patient O/O E/M visits to reflect higher typical
intensity. In addition, in the CY 2018 PFS final rule (82 FR 53018), we
finalized a proposal to nominate all five ED visit codes as potentially
misvalued, based on information suggesting that the work RVUs for ED
visits may not appropriately reflect the full resources involved in
furnishing these services. Specifically, some impacted parties
expressed concerns that the work RVUs for these services have been
undervalued given the increased acuity of the patient population and
the heterogeneity of the sites, such as freestanding and off-campus
EDs, where ED visits are furnished. Accordingly, the RUC resurveyed and
reviewed these five codes for the April 2018 RUC meeting, and provided
a recommendation to CMS for consideration in CY 2020 rulemaking. In the
CY 2020 PFS final rule (84 FR 62796), we finalized the RUC-recommended
increases to the work RVUs of 0.48 for CPT code 99281, a work RVU of
0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of
2.60 for 99284, and a work RVU of 3.80 for CPT code 99285. The RUC did
not recommend, and we did not finalize, any change in direct PE inputs
for the codes in this family. We note that the RUC submitted these
recommended values to CMS prior to the submission of the RUC-
recommended revaluation of the O/O E/M visit code family.
In response to our finalizing of the RUC-recommended values for the
ED visits, and to our comment solicitation in the CY 2020 PFS proposed
rule regarding whether we should revalue certain services commensurate
with increases to the O/O E/M visits (84 FR 62859 through 62860), a
commenter submitted a public comment stating that relativity between
the ED visits and O/O E/M visits should be maintained, and submitted a
specific recommendation for CPT codes 99283-99285 that was higher than
the RUC-recommended values. The commenter stated we should preserve the
relationship between the ED and O/O E/M visit code sets that was
established in prior years and that they believe would have likely been
maintained had the O/O E/M visits been reviewed prior to the ED visits.
In order to avoid the rank order anomaly whereby an ED visit would be
valued lower than the analogous O/O E/M visit, we proposed and
eventually finalized the values recommended by this commenter in the CY
2021 PFS final rule (85 FR 84562). This final policy increased the work
RVU from 1.42 to 1.60 for CPT code 99283, from 2.60 to 2.74 for CPT
code 99284, and from 3.80 to 4.00 for CPT code 99285.
Following the implementation of the revisions to the O/O E/M visits
for the CPT 2021 code set, the CPT/RUC Workgroup on E/M standardized
the rest of the E/M sections in the CPT code set. In February 2021, the
CPT Editorial Panel revised the five ED visit codes to align with the
principles included in the E/M office visit services by documenting and
selecting level of service based on medical decision making, effective
January 1, 2023. The descriptor for CPT code 99281 was revised such
that the code may not require the presence of a physician or other
qualified health care professional. The CPT Editorial Panel also
revised the MDM level in the descriptor for CPT code 99282 from ``low''
to ``straightforward'' complexity, and from ``moderate'' to ``low''
complexity for CPT code 99283. These five codes were resurveyed and
reviewed at the April 2021 RUC meeting with recommendations submitted
to CMS for the CY 2023 PFS rulemaking cycle.
b. Sites of Service and Multiple Same-Day E/M Visits for Emergency
Department Patients
As we discussed in the previous section (Hospital Inpatient or
Observation Care (CPT codes 99218-99236)) the CPT Editorial Panel has
revised CPT codes 99221 through 99223 to include both inpatient
hospital and observation care services. (Note our proposal in that
section regarding billing policy for transitions between ED and
hospital inpatient or observation care.) We also propose to modify our
policy regarding when to bill ED codes CPT codes or hospital inpatient
care (CPT codes 99221 through 99223), as further described in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.11.E.,
to clarify that these policies apply to observation care billed under
CPT codes 99221 through 99223 as well. We are proposing that if a
physician advises their own patient to go to an ED of a hospital for
inpatient care or observation and the physician subsequently is asked
by the ED physician to come to the hospital to evaluate the patient and
to advise the ED physician as to whether the patient should be admitted
to the hospital, placed in observation status, or sent home, the
physicians should bill as follows:
If the patient is admitted to the hospital or placed in
observation status by the patient's personal physician, then the
patient's personal physician should bill only the appropriate level of
the initial hospital inpatient or observation care (CPT codes 99221-
99223), because all E/M services provided by that physician in
conjunction with that admission are considered part of the initial
hospital inpatient or observation care when performed on the same date
as the admission. The ED physician who saw the patient in the ED should
bill the appropriate level of the ED codes.
If the ED physician, based on the advice of the patient's
personal physician who came to the ED to see the patient, sends the
patient home, then the ED physician shall bill the
[[Page 45995]]
appropriate level of ED service. The patient's personal physician shall
also bill the level of ED code that describes the service they provided
in the ED. If the patient's personal physician does not come to the
hospital to see the patient, but only advises the ED physician by
telephone, then the patient's personal physician may not bill the ED
codes.
Similarly, we propose that if the ED physician requests that
another physician evaluate a given patient, the other physician should
bill an ED visit code. We are also proposing that if the patient is
admitted by the second physician performing the evaluation, that
physician shall bill an initial hospital inpatient or observation care
code (CPT codes 99221 through 99223, as appropriate), and not an ED
visit code. This policy appears in the Medicare Claims Processing
Manual, (Pub. 100-04) Chapter 12, 30.6.11.F., and we are clarifying
that this policy applies to both hospital inpatient and observation
care billed under CPT codes 99221 through 99223.
Finally, we note that the 2023 CPT Codebook provides instructions
that critical care and ED services may be billed on the same day under
certain circumstances. We refer readers to the CY 2022 PFS final rule
(86 FR 65163), where we finalized our policy that critical care and ED
visits may be billed on the same day if performed by the same
physician, or by physicians in the same group and specialty if there is
documentation that the E/M service was provided prior to the critical
care service at a time when the patient did not require critical care,
that the service is medically necessary, and that the service is
separate and distinct, with no duplicative elements from the critical
care service provided later in the day, and that practitioners may bill
for both services. Practitioners must use modifier -25 on the claim
when reporting these critical care services. This policy is also in the
Medicare Claims Processing Manual, IOM 100-04, Chapter 12, 30.6.12.6.
Refer to the next section, ``Nursing Facility Services'' for
discussion of policies regarding patients seen in the ED and the
nursing facility on the same day.
c. Valuation
We are proposing the RUC-recommended work RVU for four of the five
codes in the ED Visits family. We are proposing a work RVU of 0.25 for
CPT code 99281 (Emergency department visit for the evaluation and
management of a patient, that may not require the presence of a
physician or other qualified health care professional), a work RVU of
0.93 for CPT code 99282 (Emergency department visit for the evaluation
and management of a patient, which requires a medically appropriate
history and/or examination and straightforward medical decision
making), a work RVU of 1.60 for CPT code 99283 (Emergency department
visit for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and low level of
medical decision making), and a work RVU of 4.00 for CPT code 99285
(Emergency department visit for the evaluation and management of a
patient, which requires a medically appropriate history and/or
examination and high level of medical decision making).
We disagree with the RUC-recommended work RVU of 2.60 for CPT code
99284 (Emergency department visit for the evaluation and management of
a patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making) and we are
proposing to maintain the current work RVU of 2.74. The survey
conducted for CPT code 99284 maintained unchanged a work time of 40
minutes, and the level of medical decision making in the code's
descriptor also remains unchanged at ``moderate'' complexity.
Therefore, we continue to believe that the levels 4 and 5 ED visits are
more accurately valued higher than the levels 4 and 5 new patient O/O
E/M visits to reflect their higher typical intensity. This has been the
historic relationship between these codes, and we previously finalized
a proposal in the CY 2021 PFS final rule, increasing the work RVU from
2.60 to 2.74 for CPT code 99284. Given that there has been no change in
the surveyed work time or level of MDM for this service, we continue to
believe that the work RVU of 2.74 that we finalized in the CY 2021 rule
cycle remains the most accurate valuation for CPT code 99284 (85 FR
84562).
The RUC did not recommend and we are not proposing any direct PE
inputs for these five ED visit codes.
d. Prolonged Services
We are proposing that the prolonged services described by HCPCS
codes GXXX1-GXXX3 would not be reportable in conjunction with ED visit
codes, because the ED visit codes are not reported based on the amount
of time spent with the patient. This proposal is reflected in summary
Table 18 in section II.F.11.e. of this proposed rule.
6. Nursing Facility Visits (CPT Codes 99304-99318)
a. Coding Overview
The codes in the Nursing Facility (NF) services family are used to
report E/M services primarily to patients in nursing facilities and
skilled nursing facilities. Following the implementation of the
revisions to the O/O E/M visits (CPT codes 99201 through 99215) for the
CPT 2021 code set, the CPT/RUC Workgroup on E/M met to standardize the
rest of the E/M sections in the CPT code set. We have received
valuation recommendations from the AMA RUC for the Nursing Facility
Visit codes (CPT codes 99304 through 99318) following completion of its
survey and revaluation process for these codes. In April 2021, the RUC
provided us the results of its review, and recommendations for work
RVUs, practice expense inputs, and physician time (number of minutes)
for the revised Nursing Facility Visits E/M code set. Therefore, we are
proposing changes in coding and values for the revised Nursing Facility
Visits E/M code set. This code set is effective beginning in CY 2023,
and the proposed values, if finalized, would go into effect with those
codes as of January 1, 2023. In February 2021, the CPT Editorial Panel
deleted CPT code 99318, the annual nursing facility assessment code and
revised the remaining nursing facility code to better align with the
principles included in the E/M office visit services by documenting and
selecting level of service based on total time or MDM. The remaining
codes, initial and subsequent daily visits and nursing facility
discharge day management codes were revised. Similar to what was done
for the office visit codes, for CY 2023, we are proposing when total
time on the date of encounter is used to select the appropriate level
of a nursing facility visit service code, both the face-to-face and
non-face-to-face time personally spent by the physician (or other
qualified health care professional that is reporting the office visit)
assessing and managing the patient are summed to select the appropriate
code to bill. Additionally, the codes have new descriptor times,
assigned for when time is used to select visit level. (We note that we
are not adopting the CPT Codebook instructions regarding the
application of prolonged codes to CPT codes 99306 and 99310; see
additional discussion under the subsection ``Prolonged Codes for NF
Care'' in this section.) Initial nursing facility care (CPT codes 99304
through 99306) may be used once per admission, per practitioner,
regardless of the length of
[[Page 45996]]
stay in the SNF/NF. (2023 CPT Codebook citation forthcoming.)
These nursing facility visits are noted by the RUC to be typically
performed in the skilled nursing facility which requires a higher level
of care than the nursing facility. The survey time captured includes
pre-service time 1 day before the date of encounter, intra-service time
is all the time on the date of encounter, and post-service time is 3
days after the date of encounter. The RUC's recommendations for this
code family are consistent with the 25th percentile of the survey
results and is based on a comparison of the survey codes with the
selected the O/O CPT codes as a crosswalk to the key reference
services.
While we have thoroughly reviewed the times and descriptors for all
the codes in this family, and we are proposing to accept the RUC
recommendations as explained below, we would like to note our concerns
regarding instances of inconsistencies and errors where the time
described in certain CPT code descriptors does not correctly relate to
the time that would be used to select visit level for the Nursing
Facility visit, for example CPT code 99306 and 99310 have the same
times noted in the descriptors where one is an initial visit and one is
a subsequent visit. In general, the specialty societies and the RUC
have advocated for increasing the work RVUs for the Nursing Facility
visits, as compared to their previous values, regardless of some of the
survey times, on the basis that values for these Nursing Facility visit
codes should be valued the same as the values for the comparable O/O E/
M visits. We considered the survey results, especially reductions in
pre, intra, and post service time and note that the comparison to O/O
E/M visits is not accurate. These code families are incomparable for a
few reasons, including, but not limited to: (1) the two families have a
different number/stratification of levels for the visits, thus a one-
to-one crosswalk is not possible; (2) times in the code descriptors
detailing the typical time spent at the patient's bedside or hospital
unit vary significantly; and (3) the patient populations differ
substantially when considering typical patients who require nursing
facility services versus those in the general beneficiary community.
Additional reasons are laid out in our overview section above. We do
not believe that a comparison of these two code families can
technically be made on a code-by-code basis. However, given the recent
changes to the O/O E/M visit values that we finalized in the CY 2020
PFS final rule (84 FR 62846), and our interest in maintaining
continuity in the overall code set, we are proposing to accept the RUC
recommendations for the work time values and work RVUs for these
Nursing Facility visit codes and are seeking public comment on our
concerns for some of the codes as noted below in this section.
We are proposing to adopt a number of billing policies reflected in
our current Medicare Claims Processing Manual, Chapter 12, section
30.6.13:
We are proposing that the initial comprehensive assessment
required under 42 CFR 483.30(c)(4) shall be billed as an initial NF
care visit (CPT code 99304 through 99306). We propose that a
practitioner may bill the most appropriate initial nursing facility
care code (CPT codes 99304 through 99306) or subsequent nursing
facility care code (CPT codes 99307 through 99310), if the practitioner
furnishes services that meet the code descriptor requirements, even if
the service is furnished prior to the initial comprehensive assessment
required under Sec. 483.30.
A practitioner who bills an initial NF visit (CPT codes 99304
through 99306) for the initial comprehensive assessment required under
Sec. 483.30(c)(4) may bill subsequent NF visits (CPT codes 99307
through 99310), if the practitioner furnishes medically necessary face-
to-face and non-face-to-face care that meets the requirements in the NF
services code descriptors (CPT codes 99307 through 99310) to the
beneficiary prior to the completion of the initial comprehensive
assessment required under Sec. 483.30. We are proposing to allow for
an initial or subsequent NF visit to be furnished and billed by the
appropriate practitioner (physician, physician assistant, nurse
practitioner, or clinical nurse specialist as specified in Sec. 483.30
for the type of visit furnished) regardless of whether the initial
comprehensive assessment was performed.
We propose to retain our policy to not pay a physician for
an ED visit or an office visit and a comprehensive nursing facility
assessment on the same calendar day, because it would be duplicative
care. If the practitioner saw the patient in the nursing facility once
on a given date, they have performed a lot of the work that is included
in the other visit E/M visits, for example an ED visit. The services
furnished on the same date and provided in sites other than the nursing
facility are already bundled into the initial nursing facility care
code when performed on the same date as the nursing facility admission
by the same physician.
We note that the Medicare Claims Processing Manual also states that
ED visits provided on the same day as a comprehensive nursing facility
assessment are not paid, regardless of whether the ED and nursing
facility visits are by the same or different practitioners. We are
proposing to retain this policy as well. We note that the 2023 CPT
Codebook does not limit the number of visits that can be billed
(citation forthcoming.) We are proposing that more than one ED and
nursing facility visit could not be billed if both visits are furnished
by the same practitioner on the same date of service.
We propose to adopt the 2023 CPT Codebook guidance that,
for reporting initial nursing facility care, transitions between
skilled nursing facility level of care and nursing facility level of
care do not constitute a new stay. (2023 CPT Codebook citation
forthcoming.)
We propose that an initial service is one that occurs when
the patient has not received any professional services from the
physician or other qualified health care professional or another
physician or other qualified health care professional of the exact same
specialty who belongs to the same group during the stay. We propose
that a subsequent service is one that occurs when the patient has
received any professional services from the physician or other
qualified health care professional or another physician or other
qualified health care professional of the exact same specialty who
belongs to the same group during the stay. This is the same definition
that we propose for ``initial'' and ``subsequent'' in the context of
inpatient and observation services above. According to CPT
instructions, an ``initial'' service may be reported when the patient
has not received any professional services from the physician or other
qualified health care professional or another physician or other
qualified health care professional of the exact same specialty and
subspecialty who belongs to the same group practice during the stay. As
we do not recognize subspecialties, we propose to apply these slightly
amended definitions of ``initial'' and ``subsequent'' service.
b. Valuation
For CPT codes 99304 through 99310, we are proposing to adopt the
RUC-recommended work RVUs for all of the nursing facility codes given
the new times surveyed by the RUC and specialty societies.
Specifically, we are proposing a work RVU of 1.50 for CPT code 99304
(Initial nursing facility care, per day, for the evaluation and
management of a patient, which
[[Page 45997]]
requires a medically appropriate history and/or examination and
straightforward or low level of medical decision making. When using
total time on the date of the encounter for code selection, 25 minutes
must be met or exceeded.), a work RVU of 2.50 for CPT code 99305
(Initial nursing facility care, per day, for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and moderate level of medical decision making. When
using total time on the date of the encounter for code selection, 35
minutes must be met or exceeded.), a work RVU of 3.50 for CPT code
99306 (Initial nursing facility care, per day, for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and high level of medical decision making. When
using total time on the date of the encounter for code selection, 45
minutes must be met or exceeded.), a work RVU of 0.70 for CPT code
99307 (Subsequent nursing facility care, per day, for the evaluation
and management of a patient, which requires a medically appropriate
history and/or examination and straightforward medical decision making.
When using total time on the date of the encounter for code selection,
10 minutes must be met or exceeded.), a work RVU of 1.30 for CPT code
99308 (Subsequent nursing facility care, per day, for the evaluation
and management of a patient, which requires a medically appropriate
history and/or examination and low level of medical decision making.
When using total time on the date of the encounter for code selection,
15 minutes must be met or exceeded.), a work RVU of 1.92 for CPT code
99309 (Subsequent nursing facility care, per day, for the evaluation
and management of a patient, which requires a medically appropriate
history and/or examination and moderate level of medical decision
making. When using total time on the date of the encounter for code
selection, 30 minutes must be met or exceeded.), and a work RVU of 2.80
for CPT code 99310 (Subsequent nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.). We are proposing
the RUC-recommended direct PE inputs for all the codes in the family,
CPT codes 99305 through 99310.
While we are proposing to accept the RUC recommendations for CPT
code 99306, we considered maintaining the current work RVU of 3.06,
since there was no change in the overall time. To support their
recommendation, the RUC cited the survey key reference service, CPT
code 99205 (Office or other outpatient visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using time for code selection, 60-74 minutes of total time is
spent on the date of the encounter), which has a much higher time noted
in the descriptor and does not seem to be a valid comparison or support
the increase in value to the RUC survey 25th percentile. There was no
change in time for this service, and the code the RUC used for
comparison has a higher total time. Therefore, we request comment on
the accuracy of the time noted in the descriptor for CPT code 99306. We
note that it is not clear to us why CPT code 99306 would have the same
descriptor time and medical decision making as CPT code 99310, which is
a subsequent visit, thus appearing like they are the same service. We
are seeking clarification, especially with regard to the vast
similarities of these two descriptors noted for these services.
For CPT code 99308, we are proposing to accept the RUC
recommendations; however, we considered maintaining the current work
RVU of 1.16 given there was a decrease in the total time for the
service and no change in the descriptor time. We are soliciting comment
regarding the RUC recommendations that the total time be rounded down
to 15 minutes instead of rounding up to twenty minutes, when using
total time on the date of the encounter for code selection (minutes
must be met or exceeded), and are seeking clarification on this
difference. In light of the changes made to the O/O E/M visits,
however, we are proposing the RUC-recommended work RVU of 1.30 for CPT
code 99308, but would appreciate comments regarding rounding.
For CPT code 99309, we are proposing a work RVU of 1.92. When
compared to CPT code 99214 (Office or other outpatient visit for the
evaluation and management of an established patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using time for code selection, 30-39
minutes of total time is spent on the date of the encounter), we are
acknowledging the increase in time required to bill CPT code 99309. We
note that the descriptor time for CPT code 99309 went up since these
codes were last revalued. We are focusing on the time in the
descriptor, and if there is a change in the level of MDM. In light of
recent changes made to the O/O E/M visits, however, we are proposing
the RUC-recommended work RVU of 1.92 for CPT code 99309.
Although we are proposing to adopt all the RUC-recommended work
RVUs and times for this code family as explained above, we are seeking
comment regarding the discrepancies in times, which have implications
both for valuation of individual codes (and for PFS ratesetting in
general), since the intraservice times and total times are used as
references for valuing many other services under the PFS. After
reviewing the RUC recommendations, in conjunction with the revised code
descriptors and documentation guidelines for CPT codes 99304 through
99310, we are proposing to accept the RUC-recommended work and time
values for the revised nursing facility visit codes with the PE
refinements noted by the RUC for CY 2023.
c. Prolonged Services
We are proposing that prolonged nursing facility services by a
physician or NPP would be reportable under GXXX2, which would be used
when the total time (in the time file) is exceeded by 15 or more
minutes to account for the additional time spent. The long descriptor
would be GXXX2 (Prolonged nursing facility evaluation and management
service(s) beyond the total time for the primary service (when the
primary service has been selected using time on the date of the primary
service); each additional 15 minutes by the physician or qualified
healthcare professional, with or without direct patient contact (list
separately in addition to CPT codes 99306, 99310 for nursing facility
evaluation and management services). (Do not report GXXX2 on the same
date of service as other prolonged services for evaluation and
management 99358, 99359, 993X0). (Do not report GXXX2 for any time unit
less than 15 minutes)). We propose that the practitioner would include
any prolonged service time spent within the surveyed timeframe, which
includes the day before the visit, the day of the visit, and up to and
including 3 days after the visit (please see summary Table 18 in
section II.F.11.e. of this proposed rule). We are proposing that
prolonged physician or NPP NF services would be reportable when the
total time (in the physician time file) is exceeded by 15 or more
minutes which would be once 95 minutes are spent for initial NF visits,
and once 85 minutes are spent for subsequent NF visits, and for each
additional 15 minutes furnished thereafter. Consistent with CPT coding
[[Page 45998]]
guidance as indicated below, there would not be any frequency
limitation; therefore, we are proposing that physicians and NPPs would
be able to bill GXXX2 for each additional 15-minute increment of time
beyond the total time for CPT codes 99306 and 99310.
Since GXXX2 includes time without direct patient contact, there
would no longer be a need to use CPT codes 99358 and 99359 (prolonged
E/M visit without direct patient contact) in conjunction with NF
visits. Therefore, we are proposing to change the payment status for
CPT codes 99358 and 99359 to ``I'' (Not valid for Medicare purposes.
Medicare uses another code for reporting of, and payment for, these
services). This is consistent with our final policy for O/O E/M visits,
where prolonged time can no longer be reported using CPT codes 99358
and 99359. We continue to be concerned about program integrity,
counting time that was not included in the surveyed timeframe, and the
administrative complexity of having multiple prolonged service codes
associated with a given primary service (see our previous discussion of
these issues in our CY 2020 PFS final rule at 84 FR 62849 through
62850). As we stated in that rule, many other codes are available to
report prolonged E/M work associated with an E/M visits that occurs
outside of the timeframe included in the visit, such as CCM, TCM, PCM,
behavioral health integration (BHI), and other care management service
codes. We designed these codes to be used to report time spent outside
the direct patient contact (but still in management/consideration of
that given patient's case) on dates other than the E/M visit. While
these care management codes are not identical to the prolonged visit
codes, they can be used to report a number of similar activities.
Additional information about those codes can be found on our PFS Care
Management website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management. We also direct the
reader to section II.E of this proposed rule, where we propose
additional care management service codes for pain management and BHI.
When prolonged nursing facility services are furnished by a
physician or NPP, they would be reportable under GXXX2. We believe that
allowing practitioners to report CPT code 993X0 after the minimum time
requirement for the highest level subsequent visit is met and then
exceeded by at least 15 minutes would result in double counting time.
As a specific example, CPT code 99310 requires that 45 minutes must be
met or exceeded up to 60 minutes. If the reporting practitioner spent
55 minutes of time, those 55 minutes would be billed and are included
in the services described by CPT code 99310. After 60 minutes has been
met, any additional time should be counted toward the 15 minutes
required to report the add on CPT code for the prolonged service.
Similar to the policy we finalized in the CY 2020 PFS final rule for
the O/O E/M visits (84 FR 62849), which states that when the time of
the reporting physician or NPP is used to select O/O E/M visit level,
HCPCS code G2212 could be reported when the maximum time for the level
5 O/O E/M visit is exceeded by at least 15 minutes on the date of
service.
In addition, we note that the CPT code descriptor for CPT code
993X0 does not include nursing facility. Further, the timeframes do not
align for CPT codes 993X0, 99358, and 99359. The survey time for CPT
code 993X0 is for time on the date of service, and when the nursing
facility visit codes were resurveyed by the RUC, the survey time
included the day before, the day of, and up to and including 3 days
post the date of service. We are proposing Medicare-specific coding in
order to avoid duplicative counting of time, administratively simplify
prolonged service coding, and better enable us to determine how much
total time was spent with the patient. If we proposed to merely accept
the CPT prolonged service coding changes, we would not be able to
identify the time spent with patients in the claims data alone. This is
because we might not know which primary service is the companion code
to the prolonged service code(s) due to the wide service timespan (for
prolonged services without direct patient contact) and non-specific
care settings within the prolonged CPT code descriptors. Consistent
with CPT's approach, we are proposing that practitioners and NPPs would
only be able to report the prolonged services code for NF (GXXX2) in
conjunction with the highest level codes in the family (CPT code 99306
and 99310). This would also be consistent with our policy for O/O E/M
visits (see (84 FR 62849).
7. Nursing Facility Discharge Management (CPT Codes 99315-99316)
a. Coding
CPT codes 99315 (Nursing facility discharge day management; 30
minutes or less) and 99316 (Nursing facility discharge day management;
more than 30 minutes) were identified for RUC review in October 2021
and were then postponed so that they could be reviewed at the same time
as the inpatient hospital and observation care codes, in January 2022.
Due to changes in physician work, changes in technology, patient
population, and length of stay, the RUC determined that the nursing
facility discharge services could be reviewed separately from the
inpatient hospital discharge day services.
The nursing facility discharge day management codes are used to
report the total duration of time spent by a physician or other
qualified health care professional for the final nursing facility
discharge of a patient. The codes include, as appropriate, final
examination of the patient and discussion of the NF stay, even if the
time spent on that date is not continuous. Instructions are given for
continuing care to all relevant caregivers, as well as for preparation
of discharge records, prescriptions, and referral forms. These services
require a face-to-face encounter, which may be performed on a calendar
date prior to the actual discharge date. The time of the face-to-face
encounter performed on a date prior to the discharge date is counted
toward CPT code 99315 and CPT code 99316 and not reported separately.
We propose to retain our policy that CPT codes 99315 and 99316 (as
appropriate) shall be reported for a face-to-face visit with the
patient provided by the physician or the qualified NPP, which is
required in order to report the SNF/NF discharge day management
service. The NF discharge day management visit shall be reported for
the date of the actual visit by the physician or qualified NPP, even if
the patient is discharged from the facility on a different calendar
date. (Refer to Medicare Claims Processing Manual, IOM 100-04, Chapter
12, 30.6.13.I.) Additionally, we are proposing that a physician or
qualified NPP may report CPT codes 99315 or 99316 for a patient who has
expired only if the physician or qualified NPP personally performed the
death pronouncement.
b. Valuation
We are proposing the RUC-recommended work RVU of 1.50 for CPT code
99315. We considered maintaining the current work RVU of 1.28 for CPT
code 99315, based on the total time ratio between the current time of
40 minutes and the recommended time established by the survey of 40
minutes. Utilizing our total time ratio methodology this ratio equals
100 percent, and 100 percent of the current
[[Page 45999]]
work RVU of 1.28, which indicates there is no change to the physician
service and no change in the physician total time. 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
this case, there was no change in total time. However, maintaining CPT
code 99315 at the current value of a work RVU of 1.28 would cause a
rank order anomaly with CPT code 99308. Also, given the remaining NF
codes were revised to align with the principles included in the O/O E/M
visit services by documenting and selecting level of service based on
total time or MDM, we concluded that the increase of the work RVU to
1.50 for CPT code 99315 would be appropriate.
We are proposing the RUC-recommended work RVU of 2.50 for CPT code
99316. We considered proposing a work RVU of 2.22 based on the total
time ratio between the current time of 54 minutes and the recommended
time established by the survey of 63 minutes. When we reviewed CPT code
99316, 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 code would have an anomalously high intensity. As
we stated earlier, in light of changes made to the O/O E/M visits and
the changes to include documenting and selecting level of service based
on total time or MDM, we are proposing the RUC-recommended work RVU of
2.50 for CPT code 99316. We are proposing the RUC-recommended direct PE
inputs for CPT code 99315 and the RUC-recommended direct PE inputs for
CPT code 99316.
c. Prolonged Services
CPT code 99315 and CPT code 99316, the two codes for nursing
facility discharge management, are set up as a base code with an add-on
code with no ceiling of time. Since time on any day can be included
when billing CPT code 99315 or 99316, there is no need for a prolonged
service code for either of these two codes. Allowing for a prolonged
service code for either of these two codes could result in double
counting a physician or NPP's time spent during a nursing facility
discharge, which would not be appropriate. Additionally, CPT code 993X0
does not include Nursing Facility in the descriptor. Therefore, we are
proposing that prolonged services would not be reportable in
conjunction with CPT codes 99315 and 99316 (NF discharge day
management).
8. Annual Nursing Facility Assessment (CPT Code 99318)
a. Coding
CPT code 99318 (Evaluation and management of a patient involving an
annual nursing facility assessment, which requires these 3 key
components: A detailed interval history; A comprehensive examination;
and Medical decision making that is of low to 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 stable, recovering, or
improving. Typically, 30 minutes are spent at the bedside and on the
patient's facility floor or unit) was recommended for deletion by CPT
for 2023. In February 2021, the CPT Editorial Panel deleted CPT code
99318 and revised seven nursing facility codes to align with the
principles included in the O/O E/M visits by documenting and selecting
level of service based on total time or MDM.
We are proposing to accept CPT's deletion of CPT code 99318. Our
longstanding manual guidance states that an annual nursing facility
assessment visit code may substitute as meeting one of the required
physician visits, as specified in 42 CFR 483.30 (c)(1), if the code
requirements for CPT code 99318 are fully met (Medicare Claims
Processing Manual (Pub. 100-04) chapter 12, section 30.6.13 (B)). Due
to the longstanding nature of the manual section, we believe some
provisions may be outdated, and it is possible to satisfy this
requirement through other codes. We are seeking comment on whether
there is a need to keep this code for Medicare purposes. As we consider
accepting the CPT's deletion of CPT code 99318, we are concerned that
the absence of a similar code could cause an unwarranted increase in
valuation of other services under the PFS, and CMS would not have a
means of tracking how often these visits are occurring. While CPT code
99308, CPT code 99309, and CPT code 99310 could be used to report the
required annual visit, if we were to accept deletion of CPT code 99318,
we believe most of the utilization for that former code would instead
be reported under CPT code 99309, with a RUC-recommended work RVU of
1.92 which is described in the valuation section below.
b. Valuation
After considering the utilization and the need for the service
described by CPT code 99318, we are proposing to accept the CPT's
deletion of CPT code 99318. Given the proposed deletion for CPT code
99318, the RUC recommends that 10 percent of the CPT code 99318
utilization would go to CPT code 99308, with a work RVU of 1.16; 85
percent of the utilization would go to CPT code 99309, with a work RVU
of 1.55; and 5 percent of the utilization would go to CPT code 99310,
with a work RVU of 2.35.
9. Home or Residence Services (CPT Codes 99341, 99342, 99344, 99345,
99347-99350)
a. Coding
In February 2021, the CPT Editorial Panel deleted the nine CPT
codes in the Domiciliary, Rest Home (for example, Boarding Home), or
Custodial Care Services code family (CPT codes 99324-99328, and 99334-
99337), and one CPT code in the Home Services family (CPT code 99343),
to merge these services with the eight remaining home visit services.
The eight remaining home services CPT codes (99341, 99342, 99344,
99345, and 99347-99350) were revised to describe Home or Residence
Services to align with the principles of the O/O E/M visit codes by
allowing physicians and NPPs to document and select the level of
service based on total practitioner time or MDM level. For CY 2023, the
home and domiciliary E/M code family will be revised by the CPT to
include services provided in assisted living facilities, group homes,
custodial care facilities, and residential substance abuse treatment
facilities, as well as a patient's home. These changes include
combining the domiciliary and rest home CPT codes with the home visit
CPT codes, resulting in a single family of CPT codes that describe
these types of services. In addition, CPT revised the descriptors to
allow reporting that is based on time or MDM level--in alignment with
the O/O E/M visit CPT codes. The RUC survey time includes pre-service
time 3 days before the date of encounter, intraservice time on the date
of encounter, and post-service time that includes 7 days after the date
of encounter. These eight CPT codes were reviewed at the October 2021
RUC meeting with recommendations submitted to CMS for the CY 2023 rule
cycle. The RUC recommended the survey 25th percentile value for all CPT
codes in the Home or Residence Services code family, except for CPT
code 99350, for which the RUC recommended the median value.
[[Page 46000]]
b. Valuation
We are proposing the RUC-recommended work RVU for all eight CPT
codes in the Home or Residence Services CPT code family. We are
proposing a work RVU of 1.00 for CPT code 99341 (Home or residence
visit for the evaluation and management of a new patient, which
requires a medically appropriate history and/or examination and
straightforward medical decision making), a work RVU of 1.65 for CPT
code 99342 (Home or residence visit for the evaluation and management
of a new patient, which requires a medically appropriate history and/or
examination and low level of medical decision making), a work RVU of
2.87 for CPT code 99344 (Home or residence visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and moderate level of medical decision
making), a work RVU of 3.88 for CPT code 99345 (Home or residence visit
for the evaluation and management of a new patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making), a work RVU of 0.90 for CPT code 99347 (Home
or residence visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination straightforward medical decision making), a work RVU of
1.50 for CPT code 99348 (Home or residence visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making), a work RVU of 2.44 for CPT code 99349 (Home or
residence visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and moderate level of medical decision making), and a work
RVU of 3.60 for CPT code 99350 (Home or residence visit for the
evaluation and management of an established patient, which requires a
medically appropriate history and/or examination and high level of
medical decision making).
We are proposing the RUC-recommended direct PE inputs for CPT codes
99345, and 99347-99350 without refinement. For CPT codes 99341 and
99342, we are refining the direct PE inputs by removing supply item
SK062 (patient education booklet). For CPT code 99344, we are refining
the direct PE inputs by removing supply items SK062 (patient education
booklet), SJ053 (swab-pad, alcohol), and SJ061 (tongue depressor). Per
the PE Summary of Recommendations provided by the RUC, CPT codes 99341,
99342, 99344, and 99347 would typically have procedures performed on
the same date of service. For those CPT codes, the RUC stated that they
removed supplies that would be duplicative, such as gloves, alcohol
wipes, booklet, and tongue depressor. However, we found that not all of
these duplicative supplies had been removed from CPT codes 99341,
99342, and 99344 by the RUC. Therefore, we are proposing to remove
these duplicative supplies from CPT codes 99341, 99342, and 99344, and
accept the remaining RUC-recommended direct PE inputs without
refinement.
c. Prolonged Services for Home or Residence Services
We are proposing that prolonged home or residence services by a
physician or NPP would be reportable under GXXX3 (Prolonged home or
residence evaluation and management service(s) beyond the total time
for the primary service (when the primary service has been selected
using time on the date of the primary service); each additional 15
minutes by the physician or qualified healthcare professional, with or
without direct patient contact (list separately in addition to CPT
codes 99345, 99350 for home or residence evaluation and management
services). (Do not report GXXX3 on the same date of service as other
prolonged services for evaluation and management 99358, 99359, 99417).
(Do not report GXXX3 for any time unit less than 15 minutes)). Code
GXXX3 would be reportable when the total time (in the time file) is
exceeded by 15 or more minutes. Prolonged services (whether on the same
date or another date within the surveyed timeframe) would be reportable
as an add-on code to CPT codes 99345 or 99350 once the practitioner
spends 15+ minutes beyond the total time finalized for the primary
service (in time file). We would allow the physician or NPP to include
any prolonged service time spent within the surveyed timeframe for the
home or residence services code family, which includes pre-service time
3 days before the date of encounter, intraservice time on the date of
encounter, and post-service time that includes 7 days after the date of
encounter. This means that for CPT code 99345, assuming we finalize the
RUC-recommended total time of 126 minutes, prolonged services would be
reportable once 141 or more minutes are spent by a physician or NPP
providing home or residence services. Likewise, for CPT code 99350,
assuming we finalize the RUC-recommended total time of 97 minutes,
prolonged services would be reportable once 112 or more minutes are
spent by a physician or NPP providing home or residence services. See
Table 18 in section II.F.11.e. of this proposed rule for a table
summarizing this information.
Since we are proposing that prolonged services with or without
direct patient contact would be reportable under GXXX3, we are also
proposing that CPT codes 99358 (Prolonged evaluation and management
service before and/or after direct patient care; first hour), 99359
(Prolonged evaluation and management service before and/or after direct
patient care; each additional 30 minutes (List separately in addition
to code for prolonged service)), and 99417 (Prolonged outpatient
evaluation and management service(s) time with or without direct
patient contact beyond the required time of the primary service when
the primary service level has been selected using total time, each 15
minutes of total time (List separately in addition to the code of the
outpatient Evaluation and Management services)) cannot be billed for
CPT codes 99345 and 99350. We are proposing to change the status
indicator for CPT codes 99358 and 99359 to ``I,'' which indicates that
these codes are not valid for Medicare purposes, and that Medicare uses
another code for reporting of, and payment for, these services.
We continue to be concerned about program integrity, duplicative
time, counting time that was not included in the surveyed timeframe,
the administrative complexity of having multiple prolonged service
codes, and our ability to determine how much time was spent with the
patient using claims data. If we proposed to merely accept the CPT
coding for prolonged home or residence E/M visits, we would not be able
to identify the time spent with patients in the claims data alone. This
is because we might not know which primary service is the companion
code to the prolonged service code(s) due to the wide service timespan
(for prolonged services without direct patient contact) and non-
specific care settings within the prolonged CPT code descriptors. See
our previous discussion of these issues in our CY 2020 PFS final rule
at 84 FR 62849 through 62850. As we stated in that rule, many other
codes are available to report prolonged E/M work associated with an E/M
visits that occurs outside of the timeframe included in the visit, such
as CCM, TCM, PCM, behavioral health integration (BHI), and other care
management service codes. We designed these codes to be used to report
time spent outside the direct patient contact on dates other than the
E/M visit. While
[[Page 46001]]
these care management codes are not identical to the prolonged visit
codes, they can be used to report a number of similar activities.
Additional information about those codes can be found on our PFS Care
Management web page on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management. We
also direct the reader to section II.E. of this proposed rule where we
propose additional care management service codes for pain management
and BHI.
10. Cognitive Assessment and Care Planning (CPT Code 99483)
a. Coding and Valuation
In February 2021, the CPT Editorial Panel revised CPT code 99483 to
replace ``50 minutes'' from its descriptor with a revised time value
determined by the RUC survey to align with the principles underlying
the O/O E/M CPT codes. The 2023 descriptor time for CPT code 99483 will
be 60 minutes typical time instead of 50 minutes typical time.
Due to the increase in the valuation for O/O E/M visits in the CY
2021 PFS final rule (85 FR 84556), we finalized a proposal to increase
the value of CPT code 99483 from 3.44 to 3.80 work RVUs as a service
that is analogous to the O/O E/M visits, because CPT code 99483
includes a high-level O/O E/M visit. We stated that 99483 includes an
evaluation of a patient's cognitive functioning and requires collecting
pertinent history and current cognitive status, all of which require
MDM of moderate or high complexity. To not create a rank order anomaly
with CPT code 99205 (Office or other outpatient visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. When using time for code selection, 60-74 minutes of
total time is spent on the date of the encounter) we increased 99483 by
using the ratio of the increase between the CY 2020 and CY 2021 values
for 99205 to commensurate with the increase to CPT code 99205.
We are not proposing the RUC-recommended work RVU of 3.50, because
we continue to believe that this service is appropriately valued more
highly than the analogous O/O E/M visit code, CPT code 99205. Given
what we view as the appropriate rank order among these services, we do
not believe a reduction in work RVU, especially with a ten-minute
increase in physician time, is warranted. In the interest of supporting
access to this service, we are instead proposing a slight increase from
the current 3.80 to 3.84 to account for the increase in physician time
with use of a total time ratio: we divide the RUC-recommended total
time of 86 by the current total time of 85 and then multiply the
product by the current work RVU of 3.80 to arrive at 3.84. We are
proposing the RUC-recommended PE inputs without refinement.
b. Prolonged Services
We are proposing that prolonged services would not be reportable in
conjunction with CPT code 99483, because it has a typical time in its
descriptor, which is not necessarily the actual time spent.
Accordingly, we would not know when the prolonged services exceeded the
service time.
11. Prolonged Services Valuation
a. Prolonged Services With Direct Patient Contact (CPT Codes 99354-
99357)
The CPT Editorial Panel is deleting CPT codes 99354-99357
(prolonged services with direct patient contact (except with office or
other outpatient services)). These codes are currently used to report
prolonged E/M visit time involving direct patient contact, by
physicians or NPPs, beyond the usual service, in settings other than O/
O settings. We are proposing to accept this deletion, since this work
would be reported instead under the Medicare-specific codes that we are
proposing for prolonged physician/NPP time, discussed in each family's
section above.
b. Prolonged Services on a Different Date Than the E/M (CPT Codes
99358-99359)
We note that the RUC resurveyed and provided recommendations to
revalue these codes. However, we are proposing to assign an inactive
status to these codes for purposes of PFS payment as discussed above.
c. Prolonged Services Clinical Staff Services (CPT Codes 99415 and
99416)
CPT code 99415 was created to describe the first hour of prolonged
clinical staff services provided in addition to an office E/M visit,
while CPT code 99416 was created to describe each additional 30 minutes
beyond that first hour of prolonged clinical staff service time that
was provided in addition to the O/O E/M visit. For these codes, we are
proposing the RUC-recommended direct PE inputs without refinement.
d. Valuation of Prolonged Other E/M Services (HCPCS Codes GXXX1, GXXX2
and GXXX3)
As discussed above in the Overview section, we do not agree that
there is inherently greater complexity of patient need or intensity of
work for E/M visits furnished in non-office settings (for example,
inpatient, ED, and home settings) compared to the office settings.
Therefore, we believe it would be more accurate to make payment based
on the same time increment of physician work in these various settings.
We are proposing that the three prolonged visit HCPCS G codes GXXX1-
GXXX3 (discussed above under each applicable family) be valued
identically across settings, based on the RUC recommended value for CPT
code 99417. Therefore, we are proposing a work RVU of 0.61 for these
codes with a crosswalk to CPT code 99417. We are likewise proposing
direct PE inputs for these three codes that are identical to the RUC-
recommended PE inputs for CPT code 99417. For the purposes of
ratesetting, our utilization for these services will include the
assumption that one third of the services currently reported with 99356
will be reported with each of HCPCS codes GXXX1, GXXX2, and GXXX3, and
one third of the services currently reported with 99357 will be
reported with each of HCPCS codes GXXX1, GXXX2, and GXXX3. We will
continue to use HCPCS code G2212 previously finalized in lieu of CPT
code 99417.
e. Summary of Proposed Time Thresholds To Report Other E/M Prolonged
Services
Table 18 summarizes the proposed rules for reporting Other E/M
prolonged services by physicians or NPPs (See each family section above
for detailed proposal information).
[[Page 46002]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.055
12. Consultations (CPT Codes 99241-99255)
The RUC revised code descriptors, deleted two codes, and revalued
the RVUs of the consultation codes during its October 2021 and January
2022 RUC meetings. We did not review the RUC recommendations for the
eight revised consultation codes (CPT codes 99242, 99243, 99244, 99245,
99252, 99253, 99254, and 99255). We note that CMS stopped paying for
the consultation codes beginning in CY 2010. We refer readers to 74 FR
61767 through 61775 where we discuss our payment policy for these
services.
13. Payment for Multiple Same-Day Visits
Our manuals include many longstanding policies regarding when more
than one Other E/M visit can be billed by the same practitioner for the
same patient on the same date of service, particularly when a patient
is being transferred among multiple care settings (see the Medicare
Claims Processing Manual (Pub. 100-04), Chapter 12, which is available
on our website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). In contrast, CPT reporting
instructions do not place any limitations on the number of visits that
can be billed. We are proposing our longstanding manual policies for
same-day visits (at Pub. 100-04, chapter 12, et al, per topic section),
and refer the reader to the sections above regarding its application to
each individual Other E/M family.
14. Split (or Shared) Services
The split (or shared) ``substantive portion'' policy for services
furnished in facility settings was reflected in subregulatory guidance
until it was withdrawn in May of 2021, in response to a petition under
the Good Guidance regulation. In the CY 2022 PFS final rule (86 FR
65150 through 65159) we finalized a policy for E/M visits furnished in
a facility setting, to allow payment to a physician for a split (or
shared) visit (including prolonged visits), where a physician and NPP
provide the service together (not necessarily concurrently) and the
billing physician personally performs a substantive portion of the
visit. Commenters were generally supportive of our proposals with some
divide with regard to our proposed definition of substantive portion.
Some commenters preferred the use of MDM or one of the three key visit
components as opposed to time for purposes of defining what is the
substantive portion of the service.
a. Background
A split (or shared) visit refers to an E/M visit performed by both
a physician and an NPP in the same group practice. In the non-facility
(for example, office) setting, the rules for ``incident to'' billing
apply under this circumstance. However, ``incident to'' services are
not available for services furnished in a facility setting.
Longstanding CMS policy has been that, for split (or shared) visits in
the facility (for example, hospital) setting, the physician can bill
for the services if they perform a substantive portion of the
encounter. Section 1833(a)(1)(N) of the Act specifies that payment is
made for services furnished and billed by a physician at 100 percent of
the PFS rate, while under section 1833(a)(1)(O)(i) of the Act, NPPs are
paid for the services they furnish and bill for at a reduced PFS rate
(85 percent of the PFS).
We defined substantive portion in the CY 2022 PFS final rule (86 FR
65152 through 65156) and provided for billing of split (or shared)
visits in certain settings (86 FR 65156 through 65157) and for certain
patient types (new and established) (86 FR 65156). After consideration
of the public comments on the CY 2022 PFS proposed rule, we finalized a
phased in approach to this policy (86 FR 65153). For CY 2022, we
finalized the definition substantive portion as one of the following:
history, or exam, or MDM, or more than half of total time. In the CY
2022 PFS final rule (86 FR 65152 and 65153), we finalized
[[Page 46003]]
that for CY 2023, the definition of substantive portion as being more
than half of total time.
As part of our ongoing engagement with interested parties, we are
hearing continued concern about the implementation of our phased in
approach with regard to using only more than half of the total time to
define the substantive portion of the visit, and continue to receive
requests that we continue to recognize MDM as the substantive portion.
Many of these concerns relate to practice patterns where the physician
does not spend half or more of the time with the patient, as well as
possible adjustments needed to the practice's internal processes or
information systems to track visits based on time, rather than MDM.
After consideration, we are proposing to delay implementation of our
definition of the substantive portion as more than half of the total
time until January 1, 2024. We continue to believe it is appropriate to
define the substantive portion of a split (or shared) service as more
than half of the total time, and propose that this policy will be
effective beginning January 1, 2024. While we continue to believe that
the definition of substantive portion we finalized in the CY 2022 PFS
final rule is appropriate, delaying implementation of this aspect of
our policy would also allow for the changes in the coding and payment
policies for Other E/M visits to take effect for CY 2023, and allows
for a one-year transition for providers to get accustomed to the new
changes and adopt their workflow in practice. Additionally, this delay
allows interested parties another opportunity to comment on this
policy, and gives us time to consider more recent feedback and evaluate
whether there is a need for additional rulemaking on this aspect of our
policy. To reflect the proposed delay, we are proposing to amend our
regulations text at 42 CFR 415.140 to revise the definition of
substantive portion, and note the current definition of substantive
portion applies for visits other than critical care visits furnished in
CY 2022 and CY 2023.
We are amending Sec. 415.140 by adding to paragraph (a) ``and
2023'' after the phrase ``For visits other than critical care visits
furnished in calendar year 2022''. Therefore, the proposed paragraph
would specify, for visits other than critical care visits furnished in
calendar year 2022 and 2023, substantive portion means one of the three
key components (history, exam or MDM) or more than half of the total
time spent by the physician and NPP performing the split (or shared)
visit.
15. Technical Correction to the Conditions for Payment: Split (or
Shared) Visits
In the CY 2022 PFS final rule (86 FR 64996), we finalized our
definition of split (or shared) visits as proposed, and codified it in
a new section of our regulations at Sec. 415.140. We established
regulation text for this definition of split (or shared) visits. We
subsequently discovered an inadvertent typographical error in the
instructions we used to codify the new regulation at Sec. 415.140.
Specifically, we added the regulation text for Sec. 415.140 under
Subpart D, Physician Services in Teaching Settings, rather than Subpart
C, Part B Carrier Payments for Physician Services to Beneficiaries in
Providers. Because this regulation was inadvertently included with
policies relating to teaching physician services, and is more
appropriately placed with other policies relating to payment for
physicians' services to beneficiaries in providers, we propose to
revise our regulation to correct this error. As such, we propose to
amend part 415 subpart D by removing the regulation at Sec. 415.140
and relocating that section to subpart C, such that subpart D will then
begin at Sec. 415.150.
16. Technical Correction for Split (or Shared) Critical Care Services
In the CY 2022 PFS final rule, starting at 86 FR 65159, we
finalized a number of billing policies for critical care CPT codes
99291 (Critical care, evaluation and management of the critically ill
or critically injured patient; first 30-74 minutes) and 99292 (each
additional 30 minutes). At 86 FR 65162, we stated in error, ``Similar
to our proposal for split (or shared) prolonged visits, the billing
practitioner would first report CPT code 99291 and, if 75 or more
cumulative total minutes were spent providing critical care, the
billing practitioner could report one or more units of CPT code
99292.'' We intended to state that CPT code 99292 could be billed after
104, not 75, or more cumulative total minutes were spent providing
critical care. As correctly stated elsewhere in the CY 2022 PFS final
rule (regarding critical care furnished by single physicians at 86 FR
65160, and regarding concurrent care furnished by multiple
practitioners in the same group and the same specialty to the same
patient at 86 FR 65162), our policy is that CPT code 99291 is
reportable for the first 30-74 minutes of critical care services
furnished to a patient on a given date. CPT code 99292 is reportable
for additional, complete 30-minute time increments furnished to the
same patient (74 + 30 = 104 minutes). We clarify that our policy is the
same for critical care whether the patient is receiving care from one
physician, multiple practitioners in the same group and specialty who
are providing concurrent care, or physicians and NPPs who are billing
critical care as a split (or shared) visit.
G. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, practice expense
(PE), and malpractice (MP)). We discuss the localities established
under the PFS below in this section. Although the statute requires that
the PE and MP GPCIs reflect full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
one-quarter of the relative cost differences compared to the national
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
1.5 work GPCI floor for services furnished in Alaska beginning January
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
GPCI floor for services furnished in Frontier States (as defined in
section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
Additionally, section 1848(e)(1)(E) of the Act provides for a 1.0 floor
for the work GPCIs, which has been extended by many successive
amendments to the statute. The 1.0 floor for the work GPCI under
section 1848(e)(1)(E) of the Act was most recently extended by section
101 of the Consolidated Appropriations Act of 2021 (Pub. L. 116-260,
enacted December 27, 2020) through CY 2023 (that is, for services
furnished no later than December 31, 2023). Therefore, the proposed CY
2023 work GPCIs and summarized GAFs reflect the 1.0 work floor.
Additionally, as required by sections 1848(e)(1)(G) and (I) of the Act,
the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for
Frontier States are permanent, and therefore, reflected in the CY 2023
proposed GPCIs.
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)(C) of the Act requires that, if more than 1 year has elapsed
since the date of the last previous GPCI adjustment, the adjustment to
be applied in the first year of the next
[[Page 46004]]
adjustment shall be \1/2\ of the adjustment that otherwise would be
made. Therefore, since more than 1 year has passed since the previous
GPCI update was implemented in CY 2020 and 2021, we are proposing to
phase in \1/2\ of the proposed GPCI adjustment in CY 2023 and the
remaining \1/2\ of the adjustment for CY 2024.
We have completed our review of the GPCIs and are proposing new
GPCIs beginning for CY 2023 in this proposed rule. We also calculate a
geographic adjustment factor (GAF) for each PFS locality. The GAFs are
a weighted composite of each PFS locality's proposed work, PE and MP
expense GPCIs using the national GPCI cost share weights. While we do
not actually use GAFs in computing the fee schedule payment for a
specific service, they are a useful metric for purposes of comparing
overall costs and payments across fee schedule areas. The actual effect
of GPCIs on payment for any actual service would deviate from the GAF
to the extent that the proportions of work, PE and MP RVUs for the
service differ from those reflected in the GAF.
As noted above, section 101 of the Consolidated Appropriations Act
of 2021 extended the 1.0 work GPCI floor for services furnished through
December 31, 2023. Therefore, the proposed CY 2023 work GPCIs and
summarized GAFs reflect the 1.0 work floor. Additionally, as required
by sections 1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor
for Alaska and the 1.0 PE GPCI floor for Frontier States are permanent,
and therefore, reflected in the CY 2023 proposed GPCIs. See Addenda D
and E to this proposed rule for the CY 2023 proposed GPCIs and
summarized GAFs. These Addenda are available on the CMS website under
the supporting documents section of the CY 2023 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Payment Locality Background
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments under this system largely
reflected the charging patterns of physicians, which resulted in large
differences in payment for physicians' services among types of
services, physician specialties and geographic payment areas.
Local Medicare carriers initially established 210 payment
localities, to reflect local physician charging patterns and economic
conditions. These localities changed little between the inception of
Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we
undertook a study that culminated in a comprehensive locality revision
(based on locality resource cost differences as reflected by the GPCIs)
that we implemented in 1997. The development of the current locality
structure is described in detail in the CY 1997 PFS final rule (61 FR
34615) and the subsequent final rule with comment period (61 FR 59494).
The revised locality structure reduced the number of localities from
210 to 89, and increased the number of Statewide localities from 22 to
34.
Section 220(h) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, enacted April 1, 2014) required modifications to the
payment localities in California for payment purposes beginning with
2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through
80268) we established 23 additional localities, increasing the total
number of PFS localities from 89 to 112. The current 112 payment
localities include 34 Statewide areas (that is, only one locality for
the entire State) and 75 localities in the other 16 States, with 10
States having two localities, two States having three localities, one
State having four localities, and three States having five or more
localities. The remainder of the 112 PFS payment localities are
comprised as follows: the combined District of Columbia, Maryland, and
Virginia suburbs; Puerto Rico; and the Virgin Islands. We note that the
localities generally represent a grouping of one or more constituent
counties.
The current 112 fee schedule areas, also referred to as payment
localities, are defined alternatively by State boundaries (Statewide
areas for example, Wisconsin), metropolitan areas (for example,
Metropolitan St. Louis, MO), portions of a metropolitan area (for
example, Manhattan), or rest-of-State areas that exclude metropolitan
areas (for example, Rest of Missouri). This locality configuration is
used to calculate the GPCIs that are in turn used to calculate
geographically adjusted payments for physicians' services under the
PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a State. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. We refer readers to the
CY 2014 PFS final rule with comment period (78 FR 74384 through 74386)
for further discussion regarding additional information about locality
configuration considerations.
3. GPCI Update
As required by the statute, we developed GPCIs to measure relative
cost differences among payment localities compared to the national
average for each of the three fee schedule components (that is, work,
PE, and MP). The changes to the proposed CY 2023 GPCIs for each
locality reflect the updated resource cost data in each area to better
adjust PFS payments for geographic cost differences compared to
national average costs. We note that the changes in the proposed GPCIs
reflect the statutory floors and limitations on variation discussed
above that may advantage some rural localities. We describe the data
sources and methodologies we use to calculate each of the three GPCIs
below in this section. Additional information on the CY 2023 GPCI
update is available in an interim report, ``Interim Report for the CY
2023 Update of GPCIs and MP RVUs for the Medicare PFS,'' on our website
located under the supporting documents section for the CY 2023 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
The work GPCIs are designed to reflect the relative cost of
physician labor by Medicare PFS locality. As required by statute, the
work GPCI reflects one quarter of the relative wage differences for
each locality compared to the national average.
To calculate the work GPCIs, we use wage data for seven
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to
the national average, as a proxy for physicians' wages. Physicians'
wages are not included in the occupation categories used in calculating
the work GPCI because Medicare payments are a key determinant of
physicians' earnings. Including physician wage data in calculating the
work GPCIs would potentially introduce some circularity to the
adjustment since Medicare payments typically contribute to or influence
physician wages. That is, including physicians' wages in the physician
work GPCIs would, in effect, make the indices, to some extent,
dependent upon Medicare payments.
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more
[[Page 46005]]
recent Census because the ``long form'' was discontinued. Therefore, we
used the median hourly earnings from the 2006 through 2008 Bureau of
Labor Statistics (BLS) Occupational Employment Statistics (OES) wage
data as a replacement for the 2000 Census data. The BLS OES data meet
several criteria that we consider to be important for selecting a data
source for purposes of calculating the GPCIs. For example, the BLS OES
wage and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OES is updated regularly, and includes a
comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OES data (2009 through 2011) as a replacement for the 2006
through 2008 data to compute the work GPCIs; for the CY 2017 GPCI
update, we used updated BLS OES data (2011 through 2014) as a
replacement for the 2009 through 2011 data to compute the work GPCIs;
and for the CY 2020 GPCI update, we used updated BLS data (2014 through
2017) as a replacement for the 2011 through 2014 data to compute the
work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OES data continue to be the most
appropriate source of wage and employment data for use in calculating
the work GPCIs (and as discussed below, the employee wage component and
purchased services component of the PE GPCI). Therefore, for the CY
2023 GPCI update, we used updated BLS OES data (2017 through 2020) as a
replacement for the 2014 through 2017 data to compute the proposed work
GPCIs.
b. Practice Expense (PE) GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising PEs (not including MP
expenses) among the PFS localities as compared to the national average
of these costs. Whereas the physician work GPCIs (and as discussed
later in this section, the MP GPCIs) are comprised of a single index,
the PE GPCIs are comprised of four component indices (employee wages;
purchased services; office rent; and equipment, supplies and other
miscellaneous expenses). The employee wage index component measures
geographic variation in the cost of the kinds of skilled and unskilled
labor that would be directly employed by a physician practice. Although
the employee wage index adjusts for geographic variation in the cost of
labor employed directly by physician practices, it does not account for
geographic variation in the cost of services that typically would be
purchased from other entities, such as law firms, accounting firms,
information technology consultants, building service managers, or any
other third-party vendor. The purchased services index component of the
PE GPCI (which is a separate index from employee wages) measures
geographic variation in the cost of contracted services that physician
practices would typically buy. For more information on the development
of the purchased service index, we refer readers to the CY 2012 PFS
final rule with comment period (76 FR 73084 through 73085). The office
rent index component of the PE GPCI measures relative geographic
variation in the cost of typical physician office rents. For the
medical equipment, supplies, and miscellaneous expenses component, we
believe there is a national market for these items such that there is
not significant geographic variation in costs. Therefore, the
equipment, supplies and other miscellaneous expense cost index
component of the PE GPCI is given a value of 1.000 for each PFS
locality.
For the previous update to the GPCIs (implemented in CY 2020), we
used 2014 through 2017 BLS OES data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed previously in
this section, because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OES is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the proposed CY 2023 GPCI update, we used
updated BLS OES data (2017 through 2020) as a replacement for the 2014
through 2017 data for purposes of calculating the employee wage
component and purchased service index component of the PE GPCI.
In calculating the proposed CY 2023 GPCI update for the office rent
index component of the PE GPCI, we used the 2015 through 2019 American
Community Survey (ACS) 5-year estimates as a replacement for the 2013
through 2017 ACS data. The 2016 through 2020 5-year estimates were
supposed to be released in December 2021, but the release date was
delayed to March 17, 2022. Therefore, the recent 2015 through 2019 5-
year estimates, which preceded any COVID-19 impacts, were used in the
CY 2023 GPCI update, rather than the 2016 through 2020 ACS data, which
were not publicly released in time for the development of this proposed
rule. The Census Bureau noted that COVID-19 impacted data collection
for the 2020 ACS, and the resulting challenges have the potential to
affect the quality of the data. In particular, the Census Bureau noted
that there were lower response rates, and nonresponse bias was found in
the data collected for 2020.\71\ We will analyze the ACS data collected
in 2020 and subsequent years that occurred during the COVID-19
pandemic, and consider using those data for the next GPCI update after
we better understand their integrity and validity for our purposes.
Because the office rent index is based on 5-year estimates, we expect
minimal impact from the non-response bias in the CY 2020 data on the
next GPCI update, but we will examine the subsequent years' ACS data
that could be similarly impacted by conditions during the COVID-19
pandemic. Because the 2020 ACS data were not released in time for us to
use them in the development of this proposed rule, and the public would
not have an opportunity to comment on the use of those data if we were
to adjust our proposed GPCIs in the final rule to reflect the 2020 ACS
data, we will not consider using the 2020 ACS data for the CY 2023
final GPCIs.
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\71\ https://www.census.gov/library/working-papers/2021/acs/2021_CensusBureau_01.html.
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c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
To ensure that premium data are homogenous and comparable across
geographic areas, data were collected for policies with uniform
coverage limits of $1 million per occurrence and $3 million aggregate
($1 million/$3 million). The MP GPCIs are calculated based on insurer
rate filings of premium data for $1 million/$3 million mature claims-
made policies (policies for claims made rather than losses occurring
during the policy term). For the CY 2020 GPCI update, we used premium
data presumed in effect as of December 10, 2017. The proposed CY 2023
MP GPCI update reflects premium data presumed in effect no later than
December 31, 2020. We note that we finalized a few technical
refinements to the MP GPCI methodology in CY 2017, and refer readers to
the CY 2017 PFS final rule (81 FR 80270) for additional discussion of
those.
d. GPCI Cost Share Weights
For the CY 2023 GPCIs, we are proposing to continue to use the
current 2006-based MEI cost share weights for
[[Page 46006]]
determining the proposed PE GPCI values. Specifically, we use the cost
share weights to weight the four components of the PE GPCI: employee
compensation, office rent, purchased services, and medical equipment,
supplies, and other miscellaneous expenses, as shown in Table 22. We
refer readers to the CY 2014 PFS final rule with comment period (78 FR
74382 through 74383), for further discussion regarding the 2006-based
MEI cost share weights revised in CY 2014 that we also finalized for
use in the CY 2017 and CY 2020 GPCI updates.
We note that we are proposing to rebase and revise the MEI cost
share weights for CY 2023, and we refer readers to the detailed
discussion in section II.M. of this proposed rule, but we are proposing
to maintain the use of the current 2006-based MEI cost share weights
for the CY 2023 GPCIs, thus delaying the implementation of the rebased
and revised MEI cost share weights for this purpose. We refer readers
to our discussion about using the proposed rebased and revised MEI cost
share weights for purposes of proportioning the work, PE, and MP RVU
pools in PFS ratesetting and for the purposes of updating the GPCIs for
CY 2023 in sections II.B. and VII. of this proposed rule. In those
sections, we discuss our considerations for updating the MEI cost share
weights for the RVUs and the GPCIs and the potential redistributive
impact that making such a change would have on PFS payments. We have
historically updated the GPCI cost share weights to make them
consistent with the most recent update to the MEI, which was most
recently done for CY 2014 (78 FR 74382 through 74383). However, in
light of the overall impacts of making this change and in the interest
of maintaining stability in payments, we are proposing to maintain the
use of the current 2006-based MEI cost share weights for the CY 2023
proposed PE GPCIs. We believe that doing so will allow interested
parties the opportunity to review and comment on the proposed rebased
and revised MEI cost share weights discussed in section II.M. of this
proposed rule and their potential impacts before we actually use such
rebased and revised MEI cost share weights for purposes of
proportioning the work, PE, and MP RVU pools in PFS ratesetting and
updating the GPCIs. This approach would maintain consistency in the
data used to update both the GPCI and PFS ratesetting inputs for CY
2023; delaying implementation of the rebased and revised MEI cost share
weights is consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. We refer readers to section VII. of this proposed rule for
additional discussion on this issue and impacts as it relates to PFS
ratesetting and the GPCI update for CY 2023. We also refer readers to
the comment solicitation in section II.B. of this proposed rule, where
we discuss our ongoing efforts to update data inputs for PE to aid
stability, transparency, efficiency, and data adequacy. In addition, we
direct readers to the CY 2011 PFS final rule (75 FR 73256) where we
similarly delayed implementation of updated MEI cost share weights in
response to commenters' concerns about ongoing analysis that would
inform future GPCI changes and the reallocation of labor-related costs
from the medical equipment and supplies and miscellaneous component to
the employee compensation component of the PE GPCI.
In the CY 2011 PFS final rule (75 FR 73256), we acknowledged that
we typically update the GPCI cost share weights concurrently with the
most recent MEI rebasing and revision, but in consideration of the
commenters' concerns in response to the proposed rule, we did not use
the revised cost share weights for the CY 2011 GPCIs and instead
finalized the implementation of the rebased and revised MEI cost share
weights through subsequent rulemaking. We invite comments on the delay
in implementation of the MEI cost share weights for purposes of the CY
2023 GPCIs and PFS ratesetting, given the impacts discussed in section
VII. of this proposed rule. We are also soliciting comments on how best
to proceed with implementation of the rebased and revised MEI cost
share weights in the future. More specifically, we are seeking comment
on how best to incorporate the MEI cost share weights into the PE GPCI
if we were to implement them outside the statutorily required triennial
update in which we phase in all aspects of the GPCI update through the
previously discussed 2-year (\1/2\ in each year) phase-in required by
section 1848(e)(1)(C) of the Act. Section 1848(e)(1)(C) of the Act
requires that, if more than one year has elapsed since the date of the
last GPCI adjustment, the adjustment to be applied in the first year of
the next adjustment shall be \1/2\ of the adjustment that otherwise
would be made. Therefore, specifically, we are soliciting comment on
potentially incorporating the rebased and revised MEI cost share
weights into the CY 2024 GPCIs. Notably, we would not be required by
statute to phase in the adjustment over 2 years as specified in section
1848(e)(1)(C) of the Act because, in CY 2024, no more than one year
would have elapsed since the last GPCI adjustment. Therefore, we are
also seeking comment on whether it would be appropriate to use a multi-
year transition to incorporate the rebased and revised MEI cost share
weights for purposes of the PE GPCI and PFS ratesetting as we have done
in the past when incorporating other new data into the PFS payment
methodology (for example, the clinical labor update), or if, because
the MEI cost share weights only impact the composition of the PE GPCI,
such a transition would not be warranted. If we were to instead apply
the rebased and revised MEI cost share weights for purposes of the PE
GPCI and PFS ratesetting for CY 2025 or later, we would be required
under section 1848(e)(1)(C) of the Act to phase in the GPCI adjustments
over 2 years. We are seeking comments on whether, in that case, it
would be appropriate to similarly apply a transition to implement the
MEI cost share weights for purposes of PFS ratesetting as well, and
refer readers to section II.B and VII. of this proposed rule for more
discussion regarding the alternatives considered and impacts of a
phase-in of the rebased and revised MEI cost share weights in PFS
ratesetting. The proposed CY 2023 GPCI cost share weights are displayed
in Table 19. We note that the proposed rebased and revised cost share
weights discussed in detail in section II.M. of this proposed rule are
also displayed in Table 19 for awareness and for comment solicitations
regarding potential future rulemaking and GPCI updates.
[[Page 46007]]
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e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in Frontier States
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in States determined to be Frontier
States. In general, a Frontier State is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
have a population per square mile of less than 6. For more information
on the criteria used to define a Frontier State, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the States identified
as Frontier States for the CY 2023 PFS proposed rule. The qualifying
States are: Montana; Wyoming; North Dakota; South Dakota; and Nevada.
In accordance with statute, we will apply a 1.0 PE GPCI floor for these
States in CY 2023.
f. Methodology for Calculating GPCIs in the U.S. Territories
Prior to CY 2017, for all the island territories other than Puerto
Rico, the lack of comprehensive data about unique costs for island
territories had minimal impact on GPCIs because we used either the
Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and
Northern Mariana Islands) or used the unadjusted national averages (for
the Virgin Islands). In an effort to provide greater consistency in the
calculation of GPCIs given the lack of comprehensive data regarding the
validity of applying the proxy data used in the States in accurately
accounting for variability of costs for these island territories, in
the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a
policy to treat the Caribbean Island territories (the Virgin Islands
and Puerto Rico) in a consistent manner. We do so by assigning the
national average of 1.0 to each GPCI index for both Puerto Rico and the
Virgin Islands. We refer readers to the CY 2017 PFS final rule for a
comprehensive discussion of this policy.
g. California Update to the Fee Schedule Areas Used for Payment Under
Section 220(h) of the Protecting Access to Medicare Act
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act that modified the fee schedule areas used for payment purposes in
California beginning in CY 2017. Prior to CY 2017, the fee schedule
areas used for payment in California were based on the revised locality
structure that was implemented in 1997 as previously discussed.
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that
the fee schedule areas used for payment in California must be
Metropolitan Statistical Areas (MSAs) as defined by the Office of
Management and Budget (OMB) as of December 31 of the previous year; and
section 1848(e)(6)(A)(ii) of the Act required that all areas not
located in an MSA must be treated as a single rest-of-State fee
schedule area. The resulting modifications to California's locality
structure increased its number of fee schedule areas from 9 under the
current locality structure to 27 under the MSA-based locality
structure; although for the purposes of payment, the actual number of
fee schedule areas under the MSA-based locality structure is 32. We
refer readers to the CY 2017 PFS final rule (81 FR 80267) for a
detailed discussion of this operational decision.
Section 1848(e)(6)(D) of the Act defined transition areas as the
counties in fee schedule areas for 2013 that were in the rest-of-State
locality, and locality 3, which was comprised of Marin County, Napa
County, and Solano County. Section 1848(e)(6)(B) of the Act specified
that the GPCI values used for payment in a transition area are to be
phased in over 6 years, from 2017 through 2022, using a weighted sum of
the GPCIs calculated under the new MSA-based locality structure and the
GPCIs calculated under the PFS locality structure that was in place
prior to CY 2017. That is, the GPCI values applicable for these areas
during this transition period were a blend of what the GPCI values
would have been for California under the locality structure that was in
place prior to CY 2017, and what the GPCI values would be for
California under the MSA-based locality structure. For example, in CY
2020, which represented the fourth year of the transition period, the
applicable GPCI values for counties that were previously in the rest-
of-State locality or locality 3 and are now in MSAs were a blend of \2/
3\ of the GPCI value calculated for the year under the MSA-based
locality structure, and \1/3\ of the GPCI value calculated for the year
under the locality structure that was in place prior to CY 2017. The
proportions continued to shift by \1/6\ in each subsequent year so
that, by CY 2021, the applicable GPCI values for counties within
transition areas were a blend of \5/6\ of the GPCI value for the year
under the MSA-based locality structure, and \1/6\ of the GPCI value for
the year under the locality structure that was in place prior to CY
2017. Beginning in CY 2022, the applicable GPCI values for counties in
transition areas were the values calculated solely under the new MSA-
based locality structure; therefore, the phase-in for
[[Page 46008]]
transition areas is complete. Additionally, section 1848(e)(6)(C) of
the Act establishes a hold harmless requirement for transition areas
beginning with CY 2017; whereby, the applicable GPCI values for a year
under the new MSA-based locality structure may not be less than what
they would have been for the year under the locality structure that was
in place prior to CY 2017. There are 58 counties in California, 50 of
which were in transition areas as defined in section 1848(e)(6)(D) of
the Act. The eight counties that were not within transition areas are:
Orange; Los Angeles; Alameda; Contra Costa; San Francisco; San Mateo;
Santa Clara; and Ventura counties. We note that while the phase-in for
transition areas is no longer applicable, the hold harmless requirement
is not time-limited, and therefore, is still in effect.
For the purposes of calculating budget neutrality and consistent
with the PFS budget neutrality requirements as specified under section
1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by
calculating the national GPCIs as if the fee schedule areas that were
in place prior to CY 2017 are still applicable nationwide; then, for
the purposes of payment in California, we override the GPCI values with
the values that are applicable for California consistent with the
requirements of section 1848(e)(6) of the Act. This approach to
applying the hold harmless requirement is consistent with the
implementation of the GPCI floor provisions that have previously been
implemented--that is, as an after-the-fact adjustment that is made for
purposes of payment after both the GPCIs and PFS budget neutrality have
already been calculated.
Additionally, section 1848(e)(1)(C) of the Act requires that, if
more than 1 year has elapsed since the date of the last GPCI
adjustment, the adjustment to be applied in the first year of the next
adjustment shall be \1/2\ of the adjustment that otherwise would be
made. For a comprehensive discussion of this provision, transition
areas, and operational considerations, we refer readers to the CY 2017
PFS final rule (81 FR 80265 through 80268).
(1) Proposed refinement to number of unique fee schedule areas in
California.
In the CY 2020 final rule (84 FR 62622), a commenter indicated that
some of the distinct fee schedule areas that were used during the
period between CY 2017 and CY 2018 are no longer necessary.
Specifically, with regard to the Los Angeles-Long Beach-Anaheim MSA,
which contains 2 counties (across two unique locality numbers, 18 and
26) that are not transition areas, we acknowledge that we only needed
more than one unique locality number for that MSA for payment purposes
in CY 2017, which was the first year of the implementation of the MSA-
based payment locality structure. Neither of the counties in the Los
Angeles-Long Beach-Anaheim MSA (Orange County and Los Angeles County)
are transition areas under section 1848(e)(6)(D) of the Act. Therefore,
the counties were not subject to the aforementioned GPCI value
incremental phase-in (which is no longer applicable) or the hold-
harmless provision at section 1848(e)(6)(C) of the Act. Similarly, the
San Francisco-Oakland-Berkeley MSA contains four counties--San
Francisco, San Mateo, Alameda, and Contra Costa counties--across three
unique locality numbers, 05, 06, and 07. These counties are not
transition areas and will receive the same GPCI values, for payment
purposes, going forward. In response to the comment, we acknowledged
that we did not propose any changes to the number of fee schedule areas
in California, but would consider the feasibility of a technical
refinement to consolidate into fewer unique locality numbers, and if we
determined that consolidation was operationally feasible, we would
propose the technical refinement in future rulemaking. This refinement
would ultimately change the number of distinct fee schedule areas for
payment purposes in California from 32 to 29. In light of the
foregoing, for CY 2023 we are proposing to identify the Los Angeles-
Long Beach-Anaheim MSA, containing Orange County and Los Angeles
County, by one unique locality number, 18, as opposed to two, thus
retiring locality number 26, as it is no longer needed. Similarly, we
are proposing to identify the San Francisco-Oakland-Berkeley MSA
containing San Francisco, San Mateo, Alameda, and Contra Costa counties
by one unique locality number, 05, as opposed to four, thus retiring
locality numbers 06 and 07, as they are no longer needed. Additionally,
we would modify the MSA names as follows: the San Francisco-Oakland-
Berkeley (San Francisco Cnty) locality (locality 05) would become San
Francisco-Oakland-Berkeley (San Francisco/San Mateo/Alameda/Contra
Costa Cnty), and Los Angeles-Long Beach-Anaheim (Los Angeles Cnty)
locality (locality 18) would become Los Angeles-Long Beach-Anaheim (Los
Angeles/Orange Cnty). We note that because Marin County is in a
transition area and subject to the hold harmless provision at section
1848(e)(6)(C) of the Act, we need to retain a unique locality number
for San Francisco-Oakland-Berkeley (Marin Cnty), locality 52. We are
seeking comment on the proposed technical refinements to consolidate
unique fee schedule areas and their locality numbers in California
where the unique localities are not operationally necessary. We note
that these changes, if finalized, would not have any payment
implications under the PFS.
h. Refinements to the GPCI Methodology
In the process of calculating GPCIs for the purposes of this
proposed rule, we identified four technical refinements to the
methodology that we are proposing because they would yield improvements
over the current method; these refinements are applicable to the work
and MP GPCIs, the employee wage index component of the PE GPCI, and the
GAFs.
We conducted a thorough review of the BLS OES occupation codes
within each of the seven occupation groups used in past updates to
track and document the changes over time. As new BLS OES data are
released, the availability of specific occupation codes is subject to
change, and it is possible that new codes can be added, changed, or
removed over time; therefore, we believe it is important to
periodically review and update the occupation groups and codes based on
our review during the GPCI updates. We reviewed the occupation codes
and groups used to capture geographic variation in professional wages
to assess other potential codes and groups that could be used in
addition to the current selections to calculate the work GPCI, with
significant consideration given to the extent to which the data exist
in the file (data existence) and how well the occupation codes are
represented in the data (data sufficiency). Based on our review, we are
proposing the addition of two new occupation groups (and their
corresponding occupation codes), Management Occupations and Business
and Financial Operation Occupations, to the preexisting seven
occupation groups for CY 2023, as shown in Table 20.
BILLING CODE 4120-01-P
[[Page 46009]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.057
We are also proposing to add four occupation codes to the Computer,
Mathematical, Life, and Physical Science group, and three occupation
codes to the Social Science, Community and Social Service, and Legal
group, for
[[Page 46010]]
CY 2023, as shown in Table 21. The practical effect of the proposed
inclusion of these occupation groups and codes on the work GPCI would
be minimal because the statute at section 1848(e)(1)(A)(iii) of the Act
requires that the work GPCI reflect only one quarter of cost
differences, but their inclusion adds meaningful data regarding the
geographic variation in professional wages for CY 2023.
[GRAPHIC] [TIFF OMITTED] TP29JY22.058
BILLING CODE 4120-01-C
We are proposing to modify the list of occupation codes used within
the first PE GPCI component, Employee Wages, to conform more closely to
the clinical labor categories used in PFS ratesetting. Specifically,
six occupation codes listed as sources for clinical labor rates used to
establish practice expense RVUs in PFS ratesetting that were previously
inadvertently excluded in the Employee Wage Index calculation are now
included in the proposed CY 2023 Employee Wage Index (29-1126, 29-1124,
19-3031, 29-1031, 29-1181, 29-1127). Lastly, we are proposing a
technical refinement to the method used to calculate each locality's
GAF. The GAFs are calculated as the weighted average of the three GPCIs
(work, PE, and MP), essentially representing the net geographic
adjustment that would be made to a theoretical standard service.
Instead of the 2006-based MEI cost share weights, which were used to
calculate GAFs in previous updates to the GPCIs, we calculated the CY
2023 GAFs using weights that reflect the share of total RVUs that each
component (work, PE, and MP) accounts for, based on Medicare
utilization data from CY 2020. The GAFs are not used for payment under
the PFS but are a useful measure to illustrate the overall effect of
geographic adjustments under the PFS across Medicare fee schedule
areas. We believe that using the share of RVUs reflected in recent
Medicare utilization data as weights when calculating the CY 2023 GAFs
results in GAFs that more accurately reflect the composite effect of
geographic adjustment on payment, year over year, as compared to the
GAFs calculated using the 2006-based MEI cost share weights. This
change also allows the use of current Medicare utilization data that
are available each year as opposed to the MEI cost share weights that
are not updated as frequently. The proposed weights used to calculate
the CY 2023 GAFs are displayed in Table 22.
[GRAPHIC] [TIFF OMITTED] TP29JY22.059
These four proposed methodological refinements, including changes
to: (1) the occupation group; (2) occupation codes; (3) occupation
codes used for the Employee Wage Index; and (4) the GAF weighting
adjustment, will yield improved mathematical precision in the proposed
CY 2023 GPCIs and GAFs by providing for a more accurate, full
[[Page 46011]]
landscape of occupations that should be accounted for in the work and
PE GPCIs, and by aligning the GAF equation weights to use routinely
available data Additional information on the GPCI methodology and the
proposed refinements are available in the interim report, ``Interim
Report for the CY 2023 Update of GPCIs and MP RVUs for the Medicare
PFS'' on our website located under the supporting documents section of
the CY 2023 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
i. Alternatives Considered Related to the Use of the American Community
Survey (ACS) Data for Office Rent Index
Commenters often express concern about the use of residential rents
as a proxy for physician office space costs for purposes of updating
the PE GPCIs, and state that CMS should collect commercial rent data
and use it either as the basis for measuring geographic differences in
physician office rents, or if this is not feasible, use it to validate
the residential rents as a proxy for physician office rents. In the
past, commenters have requested that CMS provide a specific explanation
of the barriers to obtaining better commercial rent data and that we
reevaluate existing databases to find or develop a nationwide measure
of commercial office rents for use in calculating PE GPCIs. For each
GPCI update, we have noted that our efforts are ongoing to identify a
publicly-available, robust, nationally representative commercial rent
data source that could be made available to CMS for this purpose. We
have welcomed opportunities to discuss such data sources with impacted
parties and to incorporate such data, as appropriate in the GPCI
calculation process, through our annual rulemaking process.
Because Medicare is a national program, and section 1848(e)(1)(A)
of the Act requires us to establish GPCIs to measure relative cost
differences among localities compared to the national average, we
believe it is important to use the best data source that is available
on a nationwide basis, that is regularly updated, and retains
consistency area-to-area, year-to-year. The ACS is administered by the
United States Census Bureau, which is a leading source of national,
robust, high quality, publicly available data. We agree that a data
source for commercial office rents that provided for adequate
representation of urban and rural areas nationally would be preferable
to a residential rent data source as a proxy for commercial rents. We
have previously discussed in the CY 2005, CY 2008, CY 2011, and CY 2017
(69 FR 66262, 72 FR 66376, 75 FR 73257, and 81 FR 80265, respectively)
final rules that we recognize that apartment rents may not be a perfect
proxy for physician office rent.
We have conducted searches for commercial rent data sources for
consideration as an alternative to the ACS data in the past and have
not found or received public comments with suggestions of reliable data
sources that meet our needs. For CY 2023, we have conducted another
search for reliable commercial rent data sources that are publicly
available for the CY 2023 update and did not find any reliable data
sources that would meet our needs. The principal characteristic of any
substitute data source for the ACS data would be that it captures
geographic variation in the office space cost for physician practices.
We primarily investigated sources that report data on commercial real
estate, but we also considered a few residential rent data sources and
one data source that reports on a type of property that would be unable
to house a physician practice--U.S. Post Office (P.O.) box rentals.
Because the underlying property in which the P.O. boxes are located is
commercial in nature, the rental rates may reflect the underlying
geographic variation in facility cost. Because this source has other
features that are important for creating a geographic index, we have
included it for consideration. Although impacted parties may prefer a
database focused on the types of properties that physicians would use
for offices (that is, a commercial rent database), the identified
potential data alternatives discussed below failed to meet one or more
of five criteria that we believe are critical to the creation of an
appropriate geographic index.
We used the following five criteria to analyze the potential data
sources for this search: (1) applicability to planned use; (2)
standardization of the measure; (3) potential bias; (4) geographic
scope, distribution, and granularity of the data; and (5) availability,
continuity, and price of the data. Our review revealed challenges with
the commercial real estate market data in several of these criteria.
Under the first criterion, there are two sub-criteria that present
problems with the type of real estate data reported when we considered
their use for creating a geographic index: (1A) leases versus sales of
commercial real estate, and (1B) comparables versus listings versus
assessments of commercial real estate. For the first sub-criterion, the
commercial and residential real estate markets can be subdivided into
markets for leases and sales. Terms for commercial leased properties
are often varied and not readily available. Commercial sales,
especially of office condominiums, may be more readily available and
require less adjustment for use in a geographic index. The availability
of different arrangements--leasing versus owning--may vary
geographically, affecting the underlying stability and
representativeness of an index based on either. Under the second sub-
criterion, an important distinction is whether the data in the
alternative data source represents closed transactions (known as
``comparables'' or ``comps'') or asking prices (known as ``listings''),
regardless of whether the source is reporting data for leased or sales
of commercial property. Because asking prices are often aspirational,
professional real estate appraisers rely on comparable transactions in
order to estimate a price for sale or lease. Therefore, comparables
provide the most reliable substitute dataset for consideration for use
in creating a geographic index. Assessments are the estimated values of
real property set by the tax assessors in each State, which are
generally intended to reflect full cash value of the property, though
there may be State-specific laws and regulations that interfere (that
is, by limiting the percentage increase in a property from year to year
if it has not been transferred). Assessments for commercial properties
often rely heavily on the ``income method'' of valuation, which
capitalizes the net income the property does or could receive if
rented. The advantage of assessments for use in creation of a
geographic index is their existence for every property in the United
States.
The second criterion is that appropriate adjustments need to be
made to reduce variation for other factors, or the standardization of
the data reported by a considered alternative data source. The primary
data adjustment is to standardize the size of the property. For
commercial space, conversion to a price per square foot (price/SF)
value allows for direct comparison between properties. There are other
factors involved in standardizing commercial rents and sale prices. The
Building Owners and Managers Association (BOMA) groups buildings into
three property classes:
Class A: Most prestigious buildings competing for premiere
office users with rents above market average for the area. These
buildings have high quality standard finishes, state of the art
building systems and amenities,
[[Page 46012]]
exceptional accessibility, and a definite market presence.
Class B: Buildings competing for a wide range of users
with rents in the average range for the market. Buildings finishes are
good to fair for the area, and systems are adequate but the building
does not compete with Class A at the same price.
Class C: Buildings competing for tenants requiring
functional space at rents below average for the market.\72\
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\72\ https://www.boma.org/BOMA/Research-Resources/Industry_Resources/BuildingClassDefinitions.aspx.
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A dataset of commercial rentals or sales must include the building
class information so properties can be appropriately compared to each
other, similar to the way that CMS currently only compares ACS rent
data for two-bedroom apartments. For leases, the dataset would also
need to specify lease type (Single Net, Double Net, Triple Net,
Bondable Net, Full Service Gross, Modified Gross, and or
Percentage).\73\ The same property rented under a type of Net lease
would be expected to have a lower rent than if it were rented under a
Full-Service lease because the lessee would pay some amount towards
operating expenses. Although a dataset may contain an indication of the
type of lease, it may not include the amount of operating expenses paid
by the lessee that would be necessary to standardize the rent or other
terms that affected the final transaction price. There are often
considerable privacy considerations with respect to commercial
transactions in order to maintain competitive advantage, so accurate
information is often difficult to obtain. Typically, the sale price for
a leased property, assuming an arms-length transaction, accounts for
the detailed lease terms applicable to the property and likely would
not require adjustment for this factor. Another consideration is the
effective date of the transaction. Market prices for leases and sales
can change rapidly or slowly, and even transactions occurring within
the same calendar year may or may not require adjustment in order to be
reflective of the market at the intended point in time, and therefore,
the transaction date is critical for professional appraisals. Markets
are also localized, so even data reported for areas in relatively close
proximity may not experience the same price fluctuations.
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\73\ https://www.reonomy.com/blog/post/commercial-lease-types.
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The third criterion is that potential bias is limited in a
considered alternative data source. Our search to date was unable to
locate any scientifically designed national survey of commercial
property costs. Many of the data sources are intended to facilitate the
sale of commercial property and provide listings, rather than
comparables. They also may only contain a fraction of the listings on
the market and have been selected by brokers to advertise for sale,
rather than to represent the entire market, resulting in substantial
bias. Even the most comprehensive and detailed data sources for
verified transactions are designed to support valuation of individual
properties. These databases reflect the mix of properties that are
either currently available or have been sold or leased during a defined
period. The aggregate data are not intended to produce an unbiased
estimate of the average cost per square foot in a particular geographic
area, whereas, the ACS is a scientifically designed and implemented
national housing survey created by the U.S. Census Bureau that has been
designed to reduce bias in the statistics it creates.
The fourth criterion is that the alternate data source would need
to be national in scope and sufficiently granular to capture the
characteristics of highly localized real estate markets. The ACS data
have been consistently available in each year for the majority of
counties in the nation. Although some of the commercial data sources
may range nationwide and provide property-level data, there may be a
much higher proportion of areas with missing data. An important
consideration for the office rent index is that it sufficiently
captures data in both urban and rural areas. Rural areas may have a
less active commercial real estate market than urban areas, in which
case there may be few transactions to use in a geographic index.
Lastly, the fifth criterion is that the data source be publicly
available, consistently available for CMS' GPCI update years, and/or
reasonably priced in order to facilitate transparency and
administrative efficiency. Proprietary databases can only be accessed
by those who sign up for the service, and use of the data is governed
by Terms of Service (TOS) that may preclude its use in derivative
works, such as the creation of a geographic index, or dissemination of
the data. Public databases are more likely to be accessible and able to
be used for derivative work, such as the creation of the GPCIs. Any
change in the data source we use in the creation of the index is likely
to cause changes in index values, and possibly invoke critique if the
resulting changes are significant. If CMS were to consider a change in
data source, the change would need to be sustainable over time, and
therefore, the data must be consistently accessible for subsequent GPCI
updates, and data sources must maintain consistency over time in order
to avoid any potential dramatic changes and/or the need to refine the
adjustments to a dataset each update year, which would introduce
unnecessary variation in the index. If the data source changes or
discontinues the dataset, CMS would need to find a replacement data
source, possibly within a short time period. This would likely
introduce the possibility of dramatic changes and variation in the
index that does not reflect the real geographic changes between update
years--stemming from the use of different data sources. Additionally,
the price to obtain and make necessary adjustments to the data
discussed above may be prohibitive for use in the GPCIs.
The Federal Government already paid for the construction of the
ACS, the ACS provides the data in a very usable form, CMS can
consistently and freely access the data, and relatively minor
processing is required to turn it into an index. Every proprietary
database is likely to charge substantial amounts to access the data as
it is currently provided, which will be geared to uses very different
from the creation of an office rent index. There may be substantial
work required to gather and process the data and TOS conditions imposed
by the database owners may not allow even free data to be used for the
intended purpose. In all cases, it is likely that CMS would need to
negotiate the terms for utilizing any proprietary sources.
We identified eight data sources for analysis as potential
alternatives to the ACS, but all failed to meet one or more of the five
key criteria discussed above that would allow us to better reflect
geographic cost variation for the office rent component of the PE GPCI
that is currently measured using the ACS. We specifically identified
the following potential data sources: (1) REIS[supreg] Real Estate
Solutions by Moody's Analytics[supreg]; (2) CompStak; (3)
CoStarTM; (4) Zillow[supreg] Assessor and Real Estate
Database (ZTRAX); (5) U.S. Postal Service (USPS[supreg]) P.O. Box
Rental; (6) GSA[supreg] Lease Inventory; (7) Reonomy[supreg]; and (8)
SMR Research. Three of the eight data sources had substantial costs
associated with obtaining the data, and we were unable to obtain
pricing information for an additional two of the eight without
extensive discussions with a sales representative. Two of the eight
sources lacked necessary building class information, and many of the
eight sources presented challenges with TOS restrictions,
representativeness of rural
[[Page 46013]]
areas, small or undisclosed sample sizes, sample sizes that differed
from year to year, and/or a large number of geographic areas with
missing data.
While we determined that none of these data sources are appropriate
substitutes for the ACS data we currently use, based on their failure
to meet one or more of the five key criteria discussed above, some of
the sources possess useful qualities that allowed for further
preliminary research into the correlation between commercial and
residential rent that fell within the confines of our contractual
restrictions. To investigate whether the use of ASC residential rents
captures geographic variation in office rents, as discussed above, we
identified a few data alternatives above for further research and
examined their correlation with the ACS residential rent data in effort
to evaluate the validity of the ACS data as a proxy for determining
geographic variation in office rents. Overall, our ongoing analysis
shows that the ACS residential rent data are highly correlated with
commercial rents across areas. Therefore, we have concluded that the
continued use of the ACS data for the office rent component of the PE
GPCI is appropriate. We considered the use of USPS P.O. Box Rental data
for preliminary analysis, as it is free, publicly available, and
national in scope (in all zip codes where P.O. Boxes are available),
but resource and time constraints limited us from considering this for
the CY 2023 update. P.O. Box rent data is available online, but it is
not formatted in an easy-to-use dataset that we could readily analyze
without conducting resource-intensive data extraction and preparation.
Considering that the P.O. Box rent data would have required significant
resources, and that expending such resources was not feasible for the
CY 2023 proposed rule, we identified the GSA Lease Inventory data
source as the next best alternative data source to use to evaluate the
correlation between residential and commercial rents because it is
publicly available, free, and accessible in an easy-to-use format that
required limited adjustments to allow analysis. To get a comparative
sense of the rents per square foot that would be suggested for a
specific geographic area, we chose to compare the GSA Lease Inventory
data and the ACS data for available counties in the State of Maryland.
As shown in Table 23, the GSA Lease Inventory data are missing for
approximately half of the counties in Maryland. For those counties with
available GSA data, the rent per square foot of the GSA leased
facilities is shown in Table 23 and can be compared to the
corresponding ACS residential rent data for that county.
[GRAPHIC] [TIFF OMITTED] TP29JY22.060
[[Page 46014]]
Figure 1 shows a rank order test for the counties in Maryland where
both GSA Lease Inventory data and ACS data are available. Allegany
County has the lowest rent per square foot in the GSA Lease Inventory
data and the lowest residential rent in the ACS data. Anne Arundel
County has the highest residential rent data and the second highest GSA
Lease Inventory data. Analysis shows that the rank order of the
available counties in the GSA Lease Inventory data follow a relatively
similar pattern (positive, linear relationship) to the same counties in
the ACS data.
[GRAPHIC] [TIFF OMITTED] TP29JY22.061
We expanded the comparison of the GSA Lease Inventory data with the
ACS residential rent data from available counties in Maryland to all
available counties nationwide by creating a rent per square foot
measure for all GSA Lease Inventory records using the January 2017 GSA
Leased Inventory data. The comparison was done by condensing the GSA
Lease data to the county level, merging it with the ACS data (for
counties where GSA data were available), and aggregating it to the
Medicare locality level, weighting by county population. We performed
two rank order tests for both ACS (median two-bedroom rent) and GSA
(rent per SF) measures in all available localities where at least 50
percent, and 75 percent, subsequently, of the locality population was
represented in the county-level GSA data file. Similar to our findings
from the initial analysis of Maryland counties, the expanded
comparisons generally show a positive, linear relationship between rank
of ACS (median two-bedroom rent) and rank of GSA (rent per SF)
measures. Because the GSA Lease Inventory data are not geographically
complete, our analyses were limited. GSA Lease Inventory data are
sparse or nonexistent in some counties, therefore, we calculated the
percent of the locality population and only included localities in our
analysis with county-level data where at least 50 percent (and 75
percent for the second analysis) of the locality population was
represented in the county-level GSA data file. For example, Locality A
includes county 1 and county 2. If the GSA data includes county 1 (with
a population of 1,000), but not county 2 (population of 50), we
included Locality A in the analysis, as it met the 50 percent and 75
percent thresholds. In contrast, if the GSA data includes county 2
(population of 50), but not county 1 (population of 1,000), we did not
perform analysis on Locality A. The January 2017 GSA data file includes
information on approximately 8,200 GSA leases across the country, which
were then aggregated to the county level, and then to the Medicare
locality level for our analysis. After these two aggregations, we had
enough GSA Lease Inventory data to perform two rank order tests on 52
Medicare localities, one rank order test for counties where at least 50
percent of the locality population was represented and a second rank
order test for counties where 75 percent of the locality population was
represented. We further analyzed the outlier localities (where the ACS
rank differs from the GSA rank by 30 ranks) and found that
when the population threshold increased from 50 percent to 75 percent,
we see a reduction in outliers from 13 to only two localities,
indicating that more
[[Page 46015]]
complete data (that is, 75 percent of the locality population
represented in GSA lease data) yields higher correlation between the
median two-bedroom rent in the ACS data and the rent per square foot in
the GSA data. This correlative effect supports the continued use of ACS
data in the GPCI update for CY 2023, as it indicates that GSA lease
data (a commercial rent data source) and ACS residential rents varied
similarly across geographic areas.
It is important to note that we use the ACS data to create an index
to measure cost differences, and not as a direct proxy for commercial
office rents. Rather, the ACS data are used to measure geographic
variation in residential rents, which is used as a proxy for the
geographic variation in commercial office rent. Based on our limited
analyses comparing the GSA and ACS data, which showed that commercial
and residential rents varied similarly across geographic areas, and the
lack of any identified alternative data source that meets all five of
the criteria discussed above, we believe that it is appropriate to
continue use of the ACS data.
With regard to the suggestion that CMS should collect commercial
rent data, we note that we discussed this issue in the CY 2012 PFS
final rule with comment period (76 FR 73088) and stated that the
development and implementation of a survey could take several years if
CMS were to survey physicians directly to gather data to compute the
office rent index. Additionally, we have historically not sought direct
survey data from physicians related to the GPCI to avoid issues of
circularity and self-reporting bias. In the CY 2011 PFS final rule with
comment period (75 FR 73259), we solicited public comments regarding
the benefits of utilizing physician cost reports to potentially achieve
greater precision in measuring the relative cost difference among
Medicare localities. We also asked for comments regarding the
administrative burden of requiring physicians to routinely complete
these cost reports and whether this should be mandatory for physicians'
practices. We did not receive any feedback related to that comment
solicitation during the open public comment period for the CY 2011 PFS
final rule with comment period.
We reiterate that the GPCIs are not an absolute measure of practice
costs. Rather they are a measure of the relative cost differences for
each of the three GPCI components. The U.S. Census Bureau is a Federal
agency that specializes in data collection, accuracy, and reliability,
and we continue to believe that where such a publicly available
resource exists that can provide useful data to assess geographic cost
differences in office rent, even though it is a proxy for the exact
data we seek, that we should utilize that available resource. In
addition to reviewing alternative data sources, we also explored
whether there are alternative ways of using the ACS data that could
improve geographic representation or improve impacted parties'
confidence in it as a reasonable way to capture geographic variation in
office rent, including consideration of alternative ways to handle
counties where we are missing ACS data, as well as using alternative
variables within the ACS data to assess whether there are other similar
variables that have more complete data than median gross rent for two-
bedroom residences. Our research indicates that using alternatives
within the ACS would likely result in minimal changes to the resulting
index and would likely not address commenters' concerns regarding use
of residential rent data as a proxy for office rent. Our research also
suggests that the variation captured by the two-bedroom measure is
highly correlated with the geographic variation in one-bedroom and
three-bedroom units. The high correlation coefficient strengthens the
support for using the ACS two-bedroom measure to capture office rent
variation across areas. We explored the continued use of the ACS data
to see if there are other available variables that have a lower count
of missing observations. The data includes variables on the median
gross rent for no bedrooms, one bedroom, two bedrooms, three bedrooms,
four bedrooms, five or more bedrooms, and the total median gross rent.
Table 24 shows the number of observations that are missing for each of
the median gross rent variables in the 2017 5-year ACS data.
[GRAPHIC] [TIFF OMITTED] TP29JY22.062
Based on the 2017 5-year ACS data, total median gross rent and
median gross rent for three bedrooms are two available alternative
variables that have fewer missing county-level ACS data than the
currently used median gross rent for two bedrooms. However, it is
important to note that the number of missing observations for each
variable could change over time. While the median gross rent for two
bedrooms has a relatively low count for missing observations, it could
be substituted with the total median gross rent, which has the smallest
count of missing observations. In future years of ACS data, there could
be more or fewer missing observations for this list of variables.
Moving to use of the median gross rent for three bedrooms would result
in slightly fewer missing observations in the 2017 ACS 5-Year
Estimates, but this may not be the case for all update years.
There are also alternative ways of handling counties that are
missing data. In the CY 2020 update, we imputed county-level rent
estimates using the average value for a given county's MSA. Other
options include using the average value for contiguous counties, using
an average value for the county's State or removing the missing
observation from
[[Page 46016]]
the calculation. However, we note that the current method of handling
counties that are missing data is a reasonable approach and any
alternative would not likely affect the calculation materially.
Additionally, since there are so few counties that are missing data
(less than one percent), these alternatives (even if we had reason to
prefer one of them) would likely have no impact on the resulting index.
Table 25 shows the correlation coefficients between the available
residential rent variables in the ACS. The variation captured by the
two-bedroom measure is highly correlated with the geographic variation
in one-bedroom and three-bedroom units (approximately 0.9). This
relationship is similar, but not quite as prominent for the other
residential measures. The correlation coefficient between three-bedroom
and four-bedroom rent measures is also approximately 0.9. Based on our
research, the geographic variation in residential rents is consistent
regardless of specific measure used, and therefore, a change in the ACS
variable used or a change in the way of handling counties that are
missing data would likely result in minimal changes to the resulting
index.
[GRAPHIC] [TIFF OMITTED] TP29JY22.063
Given its national representation, reliability, high response rate
and frequent updates, and based on the rank order comparison of GSA and
ACS data and high correlation coefficients for the ASC residential rent
variables discussed above, we continue to believe the ACS residential
rent data is the most appropriate data source available at this time
for the purposes of calculating the rent index of the PE GPCI. We
undertook a comprehensive analysis of alternatives to the ACS data and
concluded that there is still no acceptable national data source
available for physician office or other comparable commercial rents,
and therefore, we propose to continue to use county-level residential
rent data from the ACS as a proxy for the relative cost differences in
commercial office rents for the proposed CY 2023 update, and have done
so in calculating the CY 2023 proposed GPCIs.
j. Proposed GPCI Update Summary
As explained in the Background section above, section 1848(e)(1)(C)
of the Act mandates the periodic review and adjustment of GPCIs. For
each periodic review and adjustment, we publish the proposed GPCIs in
the PFS proposed rule to provide an opportunity for public notice and
comment, and allow us to consider whether any revisions in response to
comments are warranted prior to implementation. The CY 2023 updated
GPCIs that we propose for the first and second year of the 2-year
phase-in, along with the GAFs, are displayed in Addenda D and E to this
proposed rule available on our website under the supporting documents
section of the CY 2023 PFS proposed rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
H. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that valuations for each
service under the PFS be composed of three components: work, practice
expense (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 (79 FR 67591
through 67596), 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). In the CY
2018 PFS proposed rule (82 FR 33965 through 33970), we proposed to
update the specialty-level risk factors, used in the calculation of MP
RVUs, prior to the next required 5-year update (CY 2020), using the
updated MP premium data that were used in the eighth Geographic
Practice Cost Index (GPCI) update for CY 2017; however, the proposal
was ultimately not finalized for CY 2018.
We consider the following factors when we determine MP RVUs for
individual PFS services: (1) specialty-level risk factors derived from
data on specialty-specific MP premiums incurred 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 portion of the direct PE RVU. Prior to CY 2016, MP RVUs
were only updated once every 5 years, except in the case of new and
revised codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjusted (or scaled) the
MP RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code was 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach, the same risk factor
(RF) was
[[Page 46017]]
applied for the new/revised code and source code, but the work RVU for
the new/revised code was used to adjust the MP RVUs for risk.
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
for 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-level risk factor to individual codes based on the same
utilization assumptions we make regarding 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-level 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.
Section 1848(e)(1)(C) of the Act requires us to review, and if
necessary, adjust the GPCIs at least every 3 years. In the CY 2020 PFS
final rule with comment period, we implemented the fourth review and
update of MP RVUs, and we also conducted the statutorily required 3-
year review of the GPCIs. For a comprehensive discussion of the fourth
review and update of MP RVUs, see the CY 2020 PFS proposed rule (84 FR
40504 through 40510) and final rule with comment period (84 FR 62606
through 62615). The MP premium data used to update the MP GPCIs are the
same data used to determine the specialty-level risk factors, which are
used in the calculation of MP RVUs. Therefore, for the CY 2020 update
of MP RVUs we finalized a policy to align the update of MP premium data
with the update to the MP GPCIs to increase efficiency. Effective
beginning in CY 2020, our policy is to review, and if necessary update,
the MP RVUs at least every 3 years, similar to our review and update of
the GPCIs.
2. Methodology for the Proposed Revision of Resource-Based Malpractice
(MP) RVUs
a. General Discussion
We calculated the MP RVUs that we are proposing for CY 2023 using
updated MP premium data obtained from State insurance rate filings. We
used a calculation methodology for the CY 2023 review and update of
resource-based MP RVUs that largely parallels the process used in the
CY 2020 update; however, we are proposing to incorporate some
methodological refinements, which are described below. The MP RVU
calculation requires us to obtain information on specialty-specific MP
premiums that are linked to specific services, and using this
information, we derive relative risk factors (RFs) for the various
specialties that furnish a particular service. Because MP premiums vary
by State and specialty, the MP premium information must be weighted
geographically and by specialty. The MP RVUs that we are proposing were
calculated using four data sources:
MP premium data presumed to be in effect as of December
31, 2020;
CY 2020 Medicare payment and utilization data;
Higher of the CY 2022 final work RVUs or the clinical
labor portion of the direct PE RVUs; and
CY 2022 MP GPCIs.
We used the higher of the CY 2022 final work RVUs or clinical labor
portion of the direct PE RVUs in our calculation to develop the CY 2023
proposed MP RVUs while maintaining overall PFS budget neutrality.
Similar to the CY 2020 update, the proposed MP RVUs were calculated
using specialty-specific MP premium data because they represent the
expense incurred by practitioners to obtain MP insurance as reported by
insurers. For CY 2023, the most current MP premium data available, with
a presumed effective date of no later than December 31, 2020, were
obtained from insurers with the largest market share in each State. We
identified insurers with the largest market share using the National
Association of Insurance Commissioners (NAIC) market share report. This
annual report provides State-level market share for entities that
provide premium liability insurance (PLI) in a State. Premium data were
downloaded from the System for Electronic Rates & Forms Filing Access
Interface (SERFF) (accessed from the NAIC website) for participating
States. For non-SERFF States, data were downloaded from the State-
specific website (if available online) or obtained directly from the
State's alternate access to filings. For SERFF States and non-SERFF
States with online access to filings, the 2020 market share report was
used to select companies. These were the most current data available
during the data collection and acquisition process.
MP insurance premium data were collected from all 50 States, and
the District of Columbia. Efforts were made to collect filings from
Puerto Rico; however, no recent filings were submitted at the time of
data collection, and therefore, filings from the previous update were
used. Consistent with the CY 2020 update, no filings were collected for
the other U.S. territories: American Samoa; Guam; Virgin Islands; or
Northern Mariana Islands. MP premiums were collected for coverage
limits of $1 million/$3 million, mature, claims-made policies (policies
covering claims made, rather than those covering losses occurring,
during the policy term). A $1 million/$3 million liability limit policy
means that the most that would be paid on any claim is $1 million and
the most that the policy would pay for claims over the timeframe of the
policy is $3 million. Adjustments were made to the premium data to
reflect mandatory surcharges for patient compensation funds (PCF, funds
used to pay for any claim beyond the State's statutory amount, thereby
limiting an individual physician's liability in cases of a large suit)
in States where participation in such funds is mandatory.
Premium data were included for all physician and nonphysician
practitioner (NPP) specialties, and all risk classifications available
in the collected rate filings. Although premium data were collected
from all States, the District of Columbia, and previous filings for
Puerto Rico were utilized, not all specialties had distinct premium
data in the rate filings from all States. In the CY 2020 PFS final rule
(84 FR 62607 through 62610), we finalized methodological improvements
that expanded the specialties and amount of filings data used to
develop the proposed risk factors, which are used to develop the
proposed MP RVUs.
b. Proposed Methodological Refinements
For the CY 2023 update, we are proposing the following
methodological improvements to the development of MP premium data:
(1) Improving our current imputation strategy to develop a more
comprehensive data set when CMS specialty names are not distinctly
identified in the insurer filings, which
[[Page 46018]]
sometimes use unique specialty names or do not include all CMS
specialties.
In instances where insurers report data for some (but not all)
specialties that explicitly corresponded to a CMS specialty, where
those data were missing, we finalized in the CY 2020 final rule (84 FR
62607 through 62610) to use partial imputation based on available data
to establish what the premiums would likely have been had that
specialty been delineated in the filing. In instances where there were
no data corresponding to a CMS specialty in the filing, we finalized a
policy to use total imputation to establish premiums for that
specialty. We are proposing to further refine our strategy for imputing
risk factor values for specialties that have incomplete data during the
data collection process by using rates mapped from the more commonly
reported specialty within risk class as opposed to excluding
underrepresented filing data.
For example, Hospice and Palliative Care is typically assigned the
same risk class as Internal medicine. Rather than excluding Hospice and
Palliative Care because there is insufficient filing data, we would use
Internal Medicine rates in filings that did not explicitly report
Hospice and Palliative Care. For the CY 2020 update, commenters
requested that we continue to improve our data collection process to
ensure that as much specialty-specific data as possible are used to
calculate risk factors. Therefore, we are proposing to utilize this
small improvement for collecting risk value input data in the future,
as this retains as much data as possible and maps specialties more
intentionally.
(2) Creation of a risk index for the calculation of MP RVUs.
We are proposing to utilize a true MP risk index as opposed to
derived risk factors when calculating MP RVUs. Historically, we have
used risk factors, which is a ratio of a specialty's national average
premium to a single referent specialty's national average premium. This
denominator has typically been based on the national average premium
for the Allergy/Immunology specialty, which has had the lowest average
premium for 2017 and 2020. The proposed risk index would be calculated
as a ratio of the specialty's national average premium to the volume-
weighted national average premium across all specialties. We believe
this change will increase consistency with the calculation of MP RVUs,
so that changes in the MP risk index reflect changes in payment, as
opposed to changes relative only to the specialty with the lowest
national average premium. We believe that this definitional change to
risk index does not impact the pricing of services in the PFS since it
does not change relative risk across specialties, and MP RVUs are
rescaled for purposes of budget neutrality to be equal to the overall
pool of MP RVUs. Readers can refer to the section of this proposed rule
entitled, ``Application of BN to Adjustments of RVUs'' for a discussion
of our budget neutrality process.
c. Steps for Calculating Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 PFS final rule with
comment period (79 FR 67591), along with the above proposed
methodological improvements. The specialty-weighted approach bases the
MP RVUs for a given service on a weighted average of the risk index of
all specialties furnishing the service. This approach ensures that all
specialties furnishing a given service are reflected in the calculation
of the MP RVUs. The steps for calculating the proposed MP RVUs are
described below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area MP premiums for each specialty are mapped to
the county level. The specialty premium for each county is then
multiplied by its share of the total U.S. population (from the U.S.
Census Bureau's 2015-2019 American Community Survey (ACS) 5-year
estimates). This is in contrast to the method used for creating
national average premiums for each specialty in the 2015 update; in
that update, specialty premiums were weighted by the total RVU per
county, rather than by the county share of the total U.S. population.
We refer readers to the CY 2016 PFS final rule with comment period (80
FR 70909) for a discussion of why we have adopted a weighting method
based on share of total U.S. population. This calculation is then
divided by the average MP GPCI across all counties for each specialty
to yield a normalized national average premium for each specialty. The
specialty premiums are normalized for geographic variation so that the
locality cost differences (as reflected by the 2022 GPCIs) would not be
counted twice. Without the geographic variation adjustment, the cost
differences among fee schedule areas would be reflected once under the
methodology used to calculate the MP RVUs and again when computing the
service specific payment amount for a given fee schedule area.
Step (2): Determine which premium service risk groups to use within
each specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. These premium classes are
designed to reflect differences in risk of professional liability and
the cost of MP claims if they occur. To account for the presence of
different classes in the MP premium data and the task of mapping these
premiums to procedures, we calculated a distinct risk index for
surgical, surgical with obstetrics, and nonsurgical procedures where
applicable. However, the availability of data by surgery and non-
surgery varied across specialties. Historically, no single approach
accurately addressed the variability in premium class among
specialties, and we previously employed several methods for calculating
average premiums by specialty. These methods are discussed below.
Developing Distinct Service Risk Groups: We determined that there
were sufficient data for surgery and non-surgery premiums, as well as
sufficient differences in rates between classes for 17 specialties
(there were 15 such specialties in the CY 2020 update). These
specialties are listed in Table 26. The CY 2023 update uses the same
structure of specialty/service risk group as the previous update except
that Unknown Physician Specialty (99) is now divided into surgery and
non-surgery groups. We were able to collect an expanded amount of
premium data for this specialty relative to the previous update, and
this service risk group structure change is reflective of the patterns
observed in the most current premium data. For all other specialties
(those that are not listed in Table 26) that typically do not
distinguish premiums as described above, a single risk index value was
calculated, and that specialty risk index value was applied to all
services performed by those specialties. For further discussion of the
information contained in Table 26, refer to ``Interim Report for the CY
2023 Update of GPCIs and MP RVUs for the Medicare Physician Fee
Schedule'' Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
[[Page 46019]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.064
Step (3): Calculate a risk index for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty-level risk
index. These risk index values are calculated by dividing the national
average premium for each specialty by the volume-weighted national
average premium across all specialties. For specialties with sufficient
surgical and non-surgical premium data, we calculated both a surgical
and non-surgical risk index value. Similarly, for specialties with rate
filings that distinguished surgical premiums with obstetrics, we
recognized that service-risk subgroup of the specialty and calculated a
separate surgical with obstetrics risk index value.
Table 27 shows the risk index values by specialty type and service
risk group.
BILLING CODE 4120-01-P
[[Page 46020]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.065
[[Page 46021]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.066
BILLING CODE 4120-01-C
Step (4): Calculate MP RVUs for each CPT/HCPCS code.
Resource-based MP RVUs were calculated for each CPT/HCPCS code that
has work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective CPT/HCPCS
code. This percentage was then multiplied by each respective
specialty's risk index value as calculated in Step 3. The products for
all specialties for the CPT/HCPCS code were then added together,
yielding a specialty-weighted service specific risk
[[Page 46022]]
index reflecting the weighted MP costs across all specialties
furnishing that procedure. The service specific risk index was
multiplied by the greater of the work RVU or clinical labor portion of
the direct PE RVU for that service, to reflect differences in the
complexity and risk-of-service between services.
Impacts of expanded data collection: As we discussed previously in
this proposed rule, we are proposing important methodological
improvements to our process for calculating MP RVUs. These improvements
are in response to comments from interested parties suggesting that we
continue to improve data collection to ensure that we use as much
specialty-specific data as possible to reflect the most accurate trends
in malpractice premiums. When we do not have sufficient premium data
for a specialty, our practice has been to use the data from the
specialty with the lowest premium. We now have specialty-specific data
for many more specialties. However, although the newly captured
specialty-specific premium data are more accurate, the new data produce
premiums and risk index values that are significantly lower for some
specialties than the ones we applied in the absence of sufficient
specialty-specific data.
We acknowledge that this reduction in premiums and risk index value
is expected to negatively impact payment for services furnished by
those specialties that are affected by the improved data collection
process. Based on our analyses of the new risk index data, we
identified an impact threshold to guide how we could integrate the new
information into our calculations and minimize the impact on affected
specialties. Specifically, we identified a reduction of approximately
\1/3\ to the risk index calculated for specialties based on the new
specialty-specific premium data compared to the information we had
previously used. To mitigate the negative impact on affected
specialties, promote payment stability, and prevent potential
reductions in access to services for beneficiaries, for specialties for
which the use of newly available premium data would result in a 30
percent or greater reduction in the risk index for CY 2023 as compared
to the current risk index value for CY 2022, we are proposing to phase
in the reduction in MP RVUs over the 3 years that precedes the next
update, by \1/3\ of the change in MP RVUs for those specialties in each
year that have a 30 percent or more threshold reduction in risk index
value as a result of the update. For a detailed explanation of how the
phase-in will be applied per specialty, a file is available on our
website under downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This proposed
phase-in is similar to the 2-year phase-in required under section
1848(e)(1)(C) of the Act for changes to the GPCIs when it has been more
than one year since the last changes. We propose to phase in the
reduction in MP RVUs over 3 years rather than 2 years because the MP
risk index values are updated every 3 years. The list of specialties
that would be subject to the phase-in under this proposed policy, and
the corresponding risk index values for each specialty is available on
our website under downloads for the CY 2023 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Low volume service codes: As we discuss above in this proposed
rule, for low volume service codes, we use the list of expected
specialties who may perform a service instead of the claims-based
specialty mix when calculating MP RVUs. We finalized this approach in
the CY 2018 PFS final rule to address concerns from interested parties
about the year-to-year variability in PE and MP RVUs for low volume
services (which also includes no volume services). (82 FR 53000 through
53006). Low volume codes are codes that have 100 or fewer allowed
services for a year. These service-level overrides are used to
determine the expected specialty for low volume procedures for both PE
and MP.
In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also
finalized our proposal to eliminate general use of an MP-specific
specialty-mix crosswalk for new and revised codes. However, we
indicated that we would continue to consider, in conjunction with
annual recommendations, specific recommendations regarding specialty
mix assignments for new and revised codes, particularly in cases where
coding changes are expected to result in differential reporting of
services by specialty, or where the new or revised code is expected to
be low-volume. Absent such information, the specialty mix assumption
for a new or revised code would derive from the analytic crosswalk in
the first year, followed by the introduction of actual claims data,
which is consistent with our approach for developing PE RVUs.
For CY 2023, we are soliciting public comment on the list of
expected specialties. The proposed list of codes and expected
specialties is available on our website under downloads for the CY 2023
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. Thus, the last step is to adjust for relativity by
rescaling the proposed MP RVUs so that the total proposed resource-
based MP RVUs are equal to the total current resource-based MP RVUs
scaled by the ratio of the pools of the proposed and current MP and
work RVUs. This scaling is necessary to maintain the work RVUs for
individual services from year to year while also maintaining the
overall relationship among work, PE, and MP RVUs.
Specialties Excluded from Ratesetting Calculation: In section II.B.
of this proposed rule, Determination of Practice Expense Relative Value
Units, we discuss specialties that are excluded from ratesetting for
the purposes of calculating PE RVUs. We are proposing to treat those
excluded specialties in a consistent manner for the purposes of
calculating MP RVUs. We note that all specialties are included for
purposes of calculating the final BN adjustment. The list of
specialties excluded from the ratesetting calculation for the purpose
of calculating the PE RVUs that we proposed to also exclude for the
purpose of calculating MP RVUs is available in section II.B. of this
final rule, Determination of Practice Expense Relative Value Units. The
resource-based MP RVUs are shown in Addendum B, which is available on
the CMS website under the downloads section of the CY 2023 PFS rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Because a different share of the resources involved in furnishing
PFS services is reflected in each of the three fee schedule components,
implementation of the resource-based MP RVU update will have much
smaller payment effects than implementing updates of resource-based
work RVUs and resource-based PE RVUs. On average, work represents about
50.9 percent of payment for a service under the fee schedule, PE about
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change
in PE RVUs or work RVUs for a service would result in a change in
payment of about 11 to 13 percent. In contrast, a corresponding 25
percent change in MP values for a service would yield a change in
payment of only about 1 percent.
[[Page 46023]]
Estimates of the effects on payment by specialty type is detailed in
section VII. of this proposed rule, the Regulatory Impact Analysis.
Additional information on our methodology for updating the MP RVUs
is available in the ``Interim Report for the CY 2023 Update of GPCIs
and MP RVUs for the Medicare Physician Fee Schedule,'' which is
available on the CMS website under the downloads section of the CY 2023
PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
I. Non-Face-to-Face Services/Remote Therapeutic Monitoring (RTM)
Services
Remote Therapeutic Monitoring (RTM) is a family of five codes
created by the CPT Editorial Panel in October 2020, valued by the RUC
at its January 2021 meeting, and finalized for Medicare payment in the
CY 2022 PFS final rule (86 FR 65114 through 65117). The RTM codes
include three PE-only codes and two professional work, treatment
management codes.
In the CY 2022 PFS final rule, we finalized refinements to payment
for the three PE-only RTM codes: CPT code 98975 (Remote therapeutic
monitoring (e.g., respiratory system status, musculoskeletal system
status, therapy adherence, therapy response); initial set-up and
patient education on use of equipment); CPT code 98976 (Remote
therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, therapy adherence, therapy response);
device(s) supply with scheduled (e.g., daily) recording(s) and/or
programmed alert(s) transmission to monitor respiratory system, each 30
days); and CPT code 98977 (Remote therapeutic monitoring (e.g.,
respiratory system status, musculoskeletal system status, therapy
adherence, therapy response); device(s) supply with scheduled (e.g.,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days). We valued the three PE-only
codes by: (1) cross-walking CPT code 98975 to the PE RVU value of 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); and by (2)
cross-walking CPT codes 98976 and 98977 to the PE RVU of comparable 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), a code that includes payment for
the medical device used to collect and transmit data.
For the two RTM treatment management codes, we finalized the RUC-
recommended work RVU of 0.62 for CPT code 98980 (Remote therapeutic
monitoring treatment management services, physician/other qualified
health care professional time in a calendar month requiring at least
one interactive communication with the patient/caregiver during the
calendar month; first 20 minutes) and the RUC-recommended work RVU of
0.61 for its add-on code, CPT code 98981 (Remote therapeutic monitoring
treatment management services, physician/other qualified health care
professional time in a calendar month requiring at least one
interactive communication with the patient/caregiver during the
calendar month; each additional 20 minutes (List separately in addition
to code for primary procedure)).
We also finalized the RUC-recommended direct PE inputs for the two
treatment management codes without refinement. The direct PE for these
two codes includes clinical labor. According to the supporting
materials in the RUC recommendations that we accepted, CPT code 98980
includes 40 minutes of activities performed by clinical staff while CPT
code 98981 includes 20 minutes of activities performed by clinical
staff as direct practice expenses (PE). The RUC materials describe the
activities of clinical staff who perform the clinical labor involved in
each of these codes as including: communicating with the patient
throughout the month, resolving technology or data transmission
concerns, reviewing data with the billing practitioner, updating and
modifying care plans, and addressing lack of patient improvement. These
activities performed by clinical staff of the billing practitioner
would be considered services provided incident to the services of the
billing practitioner. For more information about ``incident to''
services, see Sec. 410.26.
We expressed concern in the CY 2022 PFS final rule (86 FR 65116)
about the treatment management codes as described by the CPT and RUC.
In particular, we expressed concern about the inclusion of clinical
labor in codes that could be billed by qualified nonphysician
healthcare professionals because Medicare Part B does not include a
benefit for services furnished ``incident to'' the services of some
types of qualified nonphysician healthcare professionals including
CSWs, CRNAs, PTs, OTs, and SLPs. Commenters on the CY 2022 PFS proposed
rule (86 FR 65116) agreed with our assessment and suggested that we
consider developing new coding to resolve the issue. In the CY 2022 PFS
final rule, we finalized a policy that permitted therapists and other
qualified healthcare practitioners to bill the RTM codes. We stated
that where the practitioner's Medicare benefit does not include
services furnished incident to their professional services, the
services described by the codes must be furnished directly by the
billing practitioner or, in the case of a PT or OT, by a therapy
assistant under the billing PT's or OT's supervision.
The commenters also expressed concern about another issue with the
RTM coding that also relates to the clinical labor in the direct PE for
the two treatment management codes (86 FR 65116). The commenters
acknowledged that the clinical labor involved in these codes, that is,
the portion of these services performed by clinical staff incident to
the services of the billing clinician, requires direct supervision by
the billing practitioner. The commenters stated that direct supervision
of clinical staff performing these activities was burdensome, and
suggested that physicians and nonphysician practitioners who can bill
for ``incident to'' services would be unlikely to use the codes if
direct supervision were required. The commenters suggested that we
designate CPT codes 98980 and 98981 as care management services or
alternatively, that we develop HCPCS G codes that would allow the
``incident to'' clinical labor portions of the services to be furnished
under general supervision of the billing physician or nonphysician
practitioner.
Since the CY 2022 PFS final rule was issued, we have remained in
communication with interested parties. Conversations continue to
revolve around the two concerns detailed above related to the clinical
labor in the direct PE for the two RTM treatment management codes, CPT
codes 98980 and 98981. Thus, for CY 2023 we are proposing to create
four new HCPCS G codes with one pair of codes aimed at increasing
patient access to remote therapeutic monitoring services and the second
pair aimed at reducing physician and NPP supervisory burden.
We note that we also considered requests from interested parties to
develop a generic device code for RTM. We have decided to wait to
develop a generic RTM device code and instead will seek comment to
inform any new coding relating to devices. Thus, we are seeking comment
about RTM devices that are used to deliver services that meet the
``reasonable and necessary'' standard under section 1862(a)(1)(A) of
[[Page 46024]]
the Act. We seek information related to the types of data collected
using RTM devices, how the data that are collected solve specific
health conditions and what those health conditions are, the costs
associated with RTM devices that are available to collect RTM data, how
long the typical episode of care by condition type might last, and the
potential number of beneficiaries for whom an RTM device might be used
by the health condition type.
Proposal to develop two HCPCS G codes that allow certain qualified
nonphysician healthcare professionals to furnish RTM services. In our
ongoing dialogue with interested parties, we have heard that a primary
reason for developing the RTM codes was to increase beneficiary access
to remote monitoring services by allowing the services to be furnished
by a broad array of qualified nonphysician healthcare professionals.
However, concerns with the CPT coding structure related to the
inclusion of clinical labor integral to the professional services have
complicated the achievement of those goals. In the CY 2022 PFS final
rule, we finalized a policy that permitted therapists and other
qualified healthcare practitioners to bill the RTM codes, though we
expressed some concerns about the ability of therapists to bill for
these codes because the Medicare benefit does not include services
provided incident to the services of a therapist (86 FR 65116). We
stated that where the practitioner's Medicare benefit does not include
services furnished incident to their professional services, the
services described by the codes must be furnished directly by the
billing practitioner or, in the case of a PT or OT, by a therapy
assistant under the billing PT's or OT's supervision. We said that
these practitioners could bill CPT codes 98980 and 98981 even when the
practitioner's Medicare benefit category did not include services
furnished incident to their professional services as long as the
services were furnished directly by the billing practitioner.
For CY 2023, as a means of increasing beneficiary access to RTM
services, as well as more clearly defining the services of RTM for
qualified nonphysician healthcare practitioners whose Medicare benefit
category does not include services provided incident to their own
services, we are proposing two codes that would expressly facilitate
RTM services furnished by qualified nonphysician healthcare
professionals who cannot bill under Medicare Part B for services
furnished incident to their professional services. These codes would
not include ``incident to'' activities in the PE. Neither of the two
proposed new codes include clinical labor inputs in the direct PE. We
are proposing to make the current CPT codes 98980 and 98981 codes non-
payable by Medicare.
The two proposed HCPCS G codes are:
GRTM3 (Remote therapeutic monitoring treatment assessment
services, first 20 minutes furnished personally/directly by a
nonphysician qualified health care professional over a calendar month
requiring at least one interactive communication with the patient/
caregiver during the month).
GRTM4 (Remote therapeutic monitoring treatment assessment
services, additional 20 minutes furnished personally/directly by a
nonphysician qualified health care professional over a calendar month
requiring at least one interactive communication with the patient/
caregiver during the calendar month (List separately in addition to
code for primary procedure)).
For CY 2023, we are proposing a work RVU of 0.62 for the base code,
HCPCS code GRTM3, which is the RUC-recommended work RVU we established
for CPT code 98980 in the CY 2022 PFS final rule. Similarly, for the
add-on code, HCPCS code GRTM4, we are proposing a work RVU of 0.61,
which is the RUC-recommended value we established for CPT code 98981.
We are proposing to remove the clinical labor inputs in the direct PE
for both codes, which will facilitate the use of these codes by
qualified nonphysician healthcare practitioners who cannot bill under
Medicare Part B for services furnished incident to their professional
services. See Table 28: Summary of Proposed HCPCS G Codes for Remote
Therapeutic Monitoring Services for more detailed information about the
codes.
Additionally, we note that all the RTM codes including proposed
HCPCS codes GRTM3 and GRTM4 would be designated as ``sometimes
therapy'' codes, which means that the services could be billed outside
a therapy plan of care by physicians and certain NPPs. When the
services described by proposed HCPCS codes GRTM3 and GRTM4 are
furnished by PTs, OTs, or SLPs, the services would always need to be
furnished under a therapy plan of care. We remind readers that RTM
services that relate to devices specific to therapy services should
always be furnished under a therapy plan of care regardless of who
provides them. See the Medicare Benefit Policy Manual Chapter 15,
Section 230 for more information about the practice of PT, OT, and SLP.
Proposal to develop two HCPCS G codes allowing general supervision
of auxiliary personnel. As we described previously in this proposed
rule, since the CY 2022 PFS final rule was published, we have continued
to hear concerns from interested parties that, as for most ``incident
to'' services, the clinical labor activities described in the direct PE
of CPT codes 98980 and 98981 must be furnished under the direct
supervision of the billing practitioner, which imposes burden on
physicians and NPPs who are delivering services to other patients.
Thus, for CY 2023, we are proposing to create two HCPCS G codes, one
base code and one add-on code, that include clinical labor activities
(that is, incident to services such as communicating with the patient,
resolving technology concerns, reviewing data, updating and modifying
care plans, and addressing lack of patient improvement) that can be
furnished by auxiliary personnel under general supervision. These two
new G codes, GRTM1 and GRTM2, will include physician work and direct PE
inputs as currently described in CPT codes 98980 and 98981 but will
allow general supervision of the clinical labor found in the direct PE
inputs. See Table 28: Summary of Proposed HCPCS G Codes for Remote
Therapeutic Monitoring Services for more detailed information about the
codes and use of the codes.
The two proposed HCPCS G codes are described as follows:
HCPCS code GRTM1 (Remote therapeutic monitoring treatment
management services, physician or NPP professional time over a calendar
month requiring at least one interactive communication with the
patient/caregiver during the calendar month; first 20 minutes of
evaluation and management services).
HCPCS code GRTM2 (Remote therapeutic monitoring treatment
management services, physician or NPP professional time over a calendar
month requiring at least one interactive communication with the
patient/caregiver over a calendar month; each additional 20 minutes of
evaluation and management services during the calendar month (List
separately in additional to code for primary procedure).
For CY 2023, we are proposing a work RVU of 0.62 for HCPCS code
GRTM1, which reflects the work RVU for CPT code 98980 that we finalized
in the CY 2022 PFS final rule. For HCPCS code GRTM2, we are proposing a
work RVU of 0.61, which is the RUC-recommended
[[Page 46025]]
value we finalized for the similar CPT code 98981. We are proposing the
direct PE inputs associated with CPT codes 98980 and 98981 without
refinement for HCPCS codes GRTM1 and GRTM2, respectively. As stated
previously, we are proposing to make the current CPT codes 98980 and
98981 codes non-payable by Medicare.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP29JY22.067
[[Page 46026]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.068
BILLING CODE 4120-01-C
Review of New RTM Device Code: Cognitive Behavioral Therapy Monitoring
(CPT Code 989X6)
During its October 2021 meeting, the CPT Editorial Panel replaced
two Category III codes: 0702T (Remote therapeutic monitoring of a
standardized online digital cognitive behavioral therapy program
ordered by a physician or other qualified health care professional;
supply and technical support, per 30 days) and 0703T (Remote
therapeutic monitoring of a standardized online digital cognitive
behavioral therapy program ordered by a physician or other qualified
health care professional; management services by physician or other
qualified health care professional per calendar month) (e.g.,
respiratory system status, musculoskeletal system status, cognitive
behavioral therapy, therapy adherence, therapy response) with the
Category 1 CPT code 989X6, Cognitive Behavioral Therapy Monitoring
(Remote therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, cognitive behavioral therapy, therapy
adherence, therapy response); initial set-up and patient education on
use of equipment; device(s) supply with scheduled (e.g., daily)
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days). The CPT Editorial Panel
created 989X6 for CY 2023 and deleted Codes 0702T and 0703T.
Also, during the October 2021 meeting, the CPT Editorial Panel
revised the code descriptors for the PE-only RTM codes (that is, CPT
codes 98975, 98976, and 98977) that CMS finalized in the CY 2022 PFS
final rule (86 FR 65114 through 65117) to include ``cognitive
behavioral therapy'' as another example of the type of service
described by the coding. The RUC indicated that it considered this
revision to be editorial.
During the January 2022 RUC review, the definition of new CPT code
989X6 was further refined to read Remote therapeutic monitoring (e.g.,
therapy adherence, therapy response); device(s) supply with scheduled
(e.g., daily)
[[Page 46027]]
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavior therapy, each 30 days). During the RUC review of CPT
code 989X6, specialty societies indicated that the technologies for
this service are still evolving. As a result, there were no invoices
for devices specific to the cognitive behavioral therapy monitoring
services described by the code that could be shared. In response, the
RUC recommended that CPT code 989X6 be contractor priced.
Given the anticipatory nature of this code, we agree with the RUC
recommendation that this new code should be contractor priced until we
learn more about the devices being used to furnish the service. Thus,
we are proposing to accept the RUC recommendation to contractor price
CPT code 989X6, a PE-only device code. There is no professional work
associated with the code. We will work with our Medicare Administrative
Contractors (MACs) to better understand the kinds of devices and device
costs they are encountering as they review claims for payment for the
new cognitive behavioral monitoring code, CPT code 989X6.
We thank last year's commenters and the many others who have
contacted us with their questions and ideas. We appreciate the
continuing dialogue about the remote monitoring codes and welcome
comments including any additional information that the medical
community and other members of the public believe may provide further
clarity on how remote patient monitoring services are used in clinical
practice, and how they would be most appropriately coded, billed and
valued under the Medicare PFS.
J. Payment for Skin Substitutes
1. Background
In the CY 2022 PFS final rule, we finalized an approach for payment
of synthetic skin substitutes in the physician office setting. We also
announced that we had established a unique HCPCS code for each of ten
products for which we had received a HCPCS Level II coding application,
and we finalized that those products would be payable in the physician
office setting as contractor priced products that are billed separately
from the procedure to apply them. The ten products are as follows:
NovoSorb[supreg] SynPathTM, Restrata[supreg] Wound Matrix,
SymphonyTM, InnovaMatrixTM AC, Mirragen[supreg]
Advanced Wound Matrix, bio-ConneKt[supreg] Wound Matrix,
TheraGenesis[supreg], XCelliStem[supreg], Microlyte[supreg] Matrix, and
Apis[supreg] (86 FR 65121). After, the CY 2022 PFS Final rule was
released, we deleted the ``A'' code that was established for bio-
ConneKt Wound Matrix after subsequent determination that a HCPCS Level
II code was already established for this product. We note that since we
issued the CY 2022 PFS final rule, we have received additional HCPCS
Level II coding applications for similarly situated 510(k) cleared
wound care management products. Those products have been issued unique
HCPCS ``A'' codes and are also payable in the physician office setting
as contractor priced products that are billed separately from the
procedure to apply them.
We also received several comments in response to our finalized
policies expressing concern about potential inconsistencies in our
policies for synthetic and non-synthetic skin substitutes. We indicated
we would take these concerns into future consideration.
2. Key Objectives/Roadmap for Consistent Treatment of Skin Substitutes
We believe outlining our HCPCS Level II coding and payment policy
objectives in this proposed rule will be beneficial for interested
parties, as we work to create a consistent approach for treatment of
the suite of products we have referred to as skin substitutes. We have
a number of objectives related to refining our Medicare policies in
this area, including: (1) ensuring a consistent payment approach for
skin substitute products across the physician office and hospital
outpatient department setting; (2) ensuring that all skin substitute
products are assigned an appropriate HCPCS code; (3) using a uniform
benefit category across products within the physician office setting,
regardless of whether the product is synthetic or comprised of human or
animal based material, so we can incorporate payment methodologies that
are more consistent; and (4) maintaining clarity for interested parties
on CMS skin substitutes policies and procedures. Interested parties
have asked CMS to address what they have described as inconsistencies
in our payment and coding policies, indicating that treating clinically
similar products (for example, animal-based and synthetic skin
products) differently for purposes of payment is confusing and
problematic for healthcare providers and patients. These concerns exist
specifically within the physician office setting; however, interested
parties have also indicated that further alignment of our policies
across the physician office and hospital outpatient department settings
would reduce confusion.
Interested parties have suggested that all skin substitutes,
regardless of the inclusion of human, animal or synthetic material in
the product should be treated as drugs and biological products.
Furthermore, they believe all skin substitute products should receive
product-specific ``Q'' codes and receive separate payment under the
ASP+6 methodology. They have expressed confusion regarding our
assignment of HCPCS Level II ``A'' codes to the 10 skin substitute
products in accordance the policy finalized in the CY 2022 PFS final
rule, which we typically assign to identify ambulance services and
medical supplies, instead of ``Q'' codes, which we typically assign to
identify drugs, biologicals, and medical equipment or services not
identified by national HCPCS Level II codes. They have indicated that
the use of ``A'' HCPCS codes has caused confusion, not only for
interested parties, but also for the A/B MACs, who the interested
parties assert, have inconsistently processed submitted claims, in part
because they are assigned HCPCS ``A'' codes that are treated as
supplies which are subject to contractor pricing under the PFS.
Additionally, interested parties have expressed concern that physicians
and practitioners are hesitant to use the products associated with
``A'' codes because they are unsure if they will be paid appropriately
for using those products. When considering potential changes to
policies involving skin substitutes, we believe it would be appropriate
to take a phased approach over the next 1 to 5 years, that allows CMS
sufficient time to consider input from interested parties on coding and
policy changes primarily through our rulemaking process, and to account
for FDA's regulation of these products, with the goal of avoiding
unintended impacts on access to medically necessary care involving the
use of these products.
We welcome comment on our policy objectives for creating a
consistent approach for treatment of the suite of products we have
referred to as skin substitutes. Additionally, we welcome feedback on
our phased approach and associated timeline. To achieve our objective
of creating a consistent approach for paying for skin substitutes
across the physician office and hospital outpatient department setting,
we are including similar proposed changes in the CY 2023 OPPS proposed
rule, which will be issued near the time this proposed rule is issued.
[[Page 46028]]
3. Changing the Terminology of Skin Substitutes
As we work to clarify our policies for these products, we believe
that the existing terminology of ``skin substitutes'' is problematic as
it is an overly broad misnomer. In the CY 2021 OPPS/ASC final rule with
comment period, we revised our description of skin substitutes to refer
to a category of biological and synthetic products that are most
commonly used in outpatient settings for the treatment of diabetic foot
ulcers and venous leg ulcers (85 FR 80605). We noted that skin
substitute products are not a substitute for a skin graft as they do
not actually function like human skin that is grafted onto a wound.
Instead, these products are applied to wounds to aid wound healing and
through various mechanisms of action they stimulate the host to
regenerate lost tissue. We also clarified that our definition of skin
substitutes does not include bandages or standard dressings, and that
within the hospital outpatient department, these items cannot be
assigned to either the high cost or low-cost skin substitute groups or
be reported with either CPT codes 15271 through 15278 or HCPCS codes
C5271 through C5278. (85 FR 86066).
While this definition has been updated to provide clarity that
synthetic products are considered to be skin substitutes, there is
still confusion with the usage of the term skin substitutes because as
noted above in the definition, these skin substitute products are
technically not a substitute for skin, but rather, a wound covering
that is used to promote healing. We have used the current term ``skin
substitutes'' to describe the suite of products that are currently
referred to as skin substitutes. Additionally, the term ``skin
substitutes'' is used within the Current Procedural Terminology
(CPT[supreg]) code series 15271-8 as maintained by American Medical
Association. Also, skin substitute products are generally regulated by
the FDA as medical devices under section 510(k) of the Federal Food,
Drug and Cosmetic (FD&C) Act and implementing regulations per 21 CFR
part 807, or as HCT/Ps solely under section 361 of the PHS Act and the
FDA regulations in 21 CFR part 1271.
We believe that improving how we reference these products by using
a more accurate and meaningful term will help address confusion among
interested parties about how we describe these products, and further,
how we pay for them. We are proposing to replace the term ``skin
substitutes'' with the term ``wound care management'' or ``wound care
management products.'' We believe this new term more accurately
describes the suite of products that are currently referred to as skin
substitutes while providing enough specificity to not include bandages
or standard dressings, which as noted above, are not considered skin
substitutes. We understand that our proposed terms contain the words
``care management'' which could be construed to implicate the care
management series of AMA CPT codes (for example, 99424-99427, 99437,
99439, 99487, 99489, 99490-99491) that are commonly used by healthcare
professionals. We also understand that the use of the word
``management'' in our proposed terms might be construed by some to
implicate AMA CPT Evaluation or Assessment and Management (E/M) codes.
We would like to clarify that the proposed terms ``wound care
management'' and ``wound care management products'' would not implicate
the care management series of AMA CPT codes (for example, 99424-99427,
99437, 99439, 99487, 99489, 99490-99491), or our own G-codes that
describe care management services. Nor would our proposed terms relate
to the AMA CPT E/M codes. Unlike ``care management'' or ``evaluation
and management'' codes and services, the proposed terms would describe
a category of items or products, not a type of services. Lastly, we
also considered alternate terms such as wound coverings, wound
dressings, wound care products, skin coverings and cellular and/or
tissue-based products for skin wounds but believe the proposed terms
are more technically accurate and descriptive for how these products
are used than the alternative's considered.
We solicit feedback on our proposal to change the terminology we
use for the suite of products referred to as ``skin substitutes'' to
instead use the term ``wound care management'' or ``wound care
management products,'' and on the alternative terms we considered
including wound coverings, wound dressings, wound care products, skin
coverings and cellular and/or tissue-based products for skin wounds. We
are particularly interested in how these products are referenced in
current CPT coding and would appreciate feedback from the CPT Editorial
Panel and other interested parties on how to address the challenges we
discuss above. We also are interested in feedback on other possible
terms that could be used to more meaningfully and accurately describe
the suite of products currently referred to as skin substitutes.
4. Revising Payment for Skin Substitutes
In 2003, the Medicare Modernization Act established the Average
Sales Price (ASP) approach for drugs and biologicals as described under
section 1847A of the Act. We generally considered skin substitute
products to be biologicals in our initial implementation of the ASP
methodology. However, with the introduction of synthetic skin
substitutes products over the last several years, we are reviewing our
categorization of these products, especially as we work to establish
payment policies for these products across the various care settings.
As explained above, we announced in the CY 2022 PFS final rule the
establishment of product specific HCPCS Level II codes for certain
products for which we had received a HCPCS Level II coding application.
We also finalized that these products would be payable in the physician
office setting as contractor priced products that are billed separately
from the procedure to apply them (86 FR 65120). After we issued the CY
2022 PFS final rule, we assigned nine HCPCS ``A'' codes for the
synthetic skin substitute products that were addressed in the rule.
In the CY 2022 PFS final rule, we stated that we recognized there
was no payment mechanism for synthetic skin substitute products within
the PFS, and we acknowledged the need to reconcile the gap in payment
for synthetic products in the physician office setting without delay
(86 FR 65121). Additionally, as we described in the CY 2022 PFS final
rule, a commenter stated that skin substitutes are a heterogenous group
and there is an increasing intersection between biological,
bioengineered, and synthetic components. This highlights that the
current categorization of skin substitutes as either synthetic or non-
synthetic is not mutually exclusive given the expansion of skin
substitute products that may contain both biological and synthetic
elements. The increasing overlap of both synthetic and non-synthetic
skin substitute products emphasizes the importance of treating all skin
substitute products in a similar manner in terms of coding and payment
After further review, we agree with interested party
recommendations that the suite of products referred to as skin
substitutes should be treated in a uniform manner across different
outpatient care settings. In terms of payment for these products within
the office setting, we acknowledge the current variation between
contractor
[[Page 46029]]
pricing for synthetic skin substitute products and payment based on
ASP+6% for non-synthetic skin substitute products; and also the
challenges to the clear categorization of products as synthetic or non-
synthetic. As a result, we believe establishing a consistent framework
for how these products are treated within the physician office and
hospital outpatient settings will help ensure equitable access and
appropriate payment for these services. As referenced in section
II.J.3. of this proposed rule, we believe the term skin substitutes is
not all-inclusive or particularly technically accurate, and therefore,
we propose to replace the term skin substitutes with `wound care
management products.' Additionally, the term `wound care management
products' accurately reflects our belief that these products are more
appropriately considered as supplies incident to a physician service.
In order to ensure we treat skin substitutes consistently in terms
of coverage, coding, and payment, we are proposing that skin substitute
products that are commonly furnished in the physician office setting be
considered as incident to supplies in accordance with section
1861(s)(2)(A) of the Act, effective January 1, 2024. ``Incident to
supplies'' refers to supplies that are furnished as an integral,
although incidental, part of the physician's personal professional
services in the course of diagnosis or treatment of an injury or
illness (Sec. 410.26). Under our proposal, in the office setting, we
would no longer pay separately for skin substitute products under the
ASP+6% payment methodology.
By categorizing skin substitute products that are furnished in the
office setting as incident to supplies, we would consider the cost of
the supply used in furnishing a physicians' service through the
physician fee schedule practice expense (PE) methodology. Treating
these products as incident to supplies would mean that the resource
costs for these products would be included in establishing PE relative
value units (RVUs) for the associated physicians' service with which
they would be furnished. For example, for CPT Code 15271 (application
of skin substitute graft, leg or ankle), we establish the PE RVU by
considering three separate categories of PE resource costs involved in
furnishing the service: clinical labor, supplies, and equipment.
Together, these costs are the total direct PE resource inputs. When
considering these skin substitute products as a supply, we would add
their associated cost to the direct PE inputs for the service with
which the product is furnished. For a more detailed description of the
PE RVU methodology, please refer to section II.B. of this proposed
rule, Determination of Practice Expense Relative Value Units in the
rule.
We acknowledge that this proposed change to consider skin
substitute products furnished in the office setting as incident to
supplies would not be implemented immediately in CY 2023. Rather, we
would need to transition toward consistent coding and payment for these
products. Please refer to section III.O. of this proposed rule for our
proposed changes to our process for assigning HCPCS Level II codes to
wound care management products. In that section, we are proposing a
deadline of 12 months after the effective date of the CY 2023 PFS final
rule for applicants to submit HCPCS Level II applications for HCT/Ps .
In order to move forward with the proposed changes toward uniform
coding, we anticipate that the Q codes for all skin substitute products
will be discontinued at the end of CY 2023. We further propose to
establish ``A'' codes for all skin substitute products meeting the
criteria for a HCPCS Level II code, and propose to contractor price
these codes effective January 1, 2024. For CY 2023, skin substitute
products that were previously assigned Q codes will continue to be paid
under the current ASP+6 payment methodology.
We believe it is necessary to establish an effective date of
January 1, 2024, for the proposed payment of skin substitutes in the
non-facility setting as incident to supplies in order to align with the
HCPCS Level II coding proposals for wound care management products as
described in section III.O., to ensure all interested parties have the
same opportunity to effectively transition toward the coding and
payment changes. Additionally, we intend to engage with interested
parties via an open-door forum/listening session to receive feedback on
this proposal.
To summarize, we propose to treat skin substitutes (including
synthetic skin substitutes) as incident to supplies as described under
section 1861(s)(2)(A) of the Act when furnished in non-facility
settings and to include the costs of these products as resource inputs
in establishing practice expense RVUs for associated physician's
services effective January 1, 2024. This proposal would mean skin
substitutes are treated in the same manner for purposes of payment when
furnished in non-facility settings, and would be consistently
contractor priced through CY 2024. Given these significant changes, we
believe maintaining the current treatment of these products for
purposes of payment during CY 2023 will aid interested parties through
the transition. We also propose to discontinue the use of the term skin
substitutes beginning January 1, 2024 and to instead refer to this
suite of products as ``wound care management products.'' We solicit
feedback on our proposals.
K. Proposal To Allow Audiologists To Furnish Certain Diagnostic Tests
Without a Physician Order
Audiologists are recognized under Medicare Part B to provide
certain diagnostic audiology services as defined at section 1861(ll)(3)
of the Act. Specifically, the statute describes audiology services that
include such hearing and balance assessment services as the audiologist
is legally authorized to perform under State law, as would otherwise be
covered if the services were furnished by a physician. The definition
of qualified audiologist appears at section 1861(ll)(4)(B) of the Act.
Currently, the only other provision in the Medicare statute that
relates to audiology services is found at section 1862(a)(7) of the
Act, which excludes payment for hearing aids and related examinations.
This exclusion is codified at Sec. 411.15(d)(1) which precludes
payment for hearing aids or examinations for the purpose of
prescription, fitting, and changing hearing aids. There are no other
Medicare statutory provisions addressing audiologists or audiology
services. Diagnostic tests are included as a Medicare Part B benefit
under section 1861(s)(3) of the Act.
For many diagnostic testing services, payment under the PFS can be
made in two separate components of the service when parts of the
services are furnished by two different physicians, practitioners, or
other suppliers: the technical component (TC) and the professional
component (PC). The TC is the portion of the service that involves the
collection of information from the patient--for example, a radiological
image, sample, specimen, or interrogatory study. When the TC is
furnished separately, the ``TC'' modifier is used with the relevant
HCPCS code to bill for the service under the PFS. The PC of a
diagnostic test is the portion of the service involving the
interpretation of the collected information by a physician or other
practitioner. When the PC is furnished separately, the service is coded
with modifier ``26''. When the same physician or practitioner furnishes
both the TC and PC of the service, the relevant HCPCS code (known as
the ``global'') is billed
[[Page 46030]]
without a modifier. We have established general requirements for
furnishing and billing diagnostic tests at Sec. 410.32.
In the CY 1997 PFS final rule, we established in regulations at
Sec. 410.32(a), based on long-standing manual provisions, that all
diagnostic tests, including audiology tests, must be ordered by the
physician who is treating the beneficiary who will use the results to
manage the beneficiary's care. We believed this requirement was
necessary to ensure that the physician had a relationship with the
beneficiary, and would ensure the tests were reasonable and medically
necessary, as well as prevent patterns of abuse. At the same time, we
finalized a regulatory provision at Sec. 410.32(c) (later redesignated
to Sec. 410.32(a)(2)) to recognize as the treating practitioner for
the purpose of ordering diagnostic tests certain nonphysician
practitioners (NPPs) who are authorized under the statute to provide
services that would be physician services if furnished by a physician
when they are operating within the scope of their State license. The
NPPs who can serve as the treating practitioner for purposes of
ordering diagnostic tests include physician assistants (PAs), nurse
practitioners (NPs), and clinical nurse specialists (CNSs) (defined in
sections 1861(s)(2)(K)(i) and (ii) of the Act, respectively), certified
nurse-midwives (defined in section 1861(gg) of the Act), qualified
psychologists (defined in section 1861(ii) of the Act), and social
workers (defined in section 1861(hh) of the Act)) (61 FR 59497 through
59498). We note that all of these NPPs are included as practitioners
who must accept Medicare payment on an assignment-related-basis under
section 1842(b)(18)(C) of the Act. As such, these NPPs can only collect
any applicable cost-sharing from the patient, and cannot balance bill
the patient for additional amounts above the Medicare payment amount.
The regulation reflecting the ordering requirements for diagnostic
tests has not been substantively amended since that time, except to add
an exception to the treating practitioner ordering requirement for
screening mammography and, in response to the PHE for COVID-19 to add a
limited exception for a single, otherwise-covered COVID-19 diagnostic
test (and one otherwise covered diagnostic laboratory test for flu or
similar respiratory condition needed to diagnose COVID-19) per patient
per year during the PHE.
In the CY 1998 final rule (62 FR 59057 through 59070), we also
amended Sec. 410.32(a) to clarify that the ordering requirement is
based on the exclusion in section 1862(a)(1)(A) of the Act and
contained in Sec. 411.15(k)(1); that is, diagnostic testing services
that do not meet the ordering requirements in Sec. 410.32(a) are
considered not reasonable and necessary for the diagnosis and treatment
of illness or injury or to improve the functioning of a malformed body
member. We explained that we found tests not demonstrably reasonable
and medically necessary if they are not ordered by the beneficiary's
treating physician or practitioner who will use the test results to
manage the beneficiary's condition or symptom. Also in the CY 1998 PFS
final rule, while we continued to require physician supervision for
most diagnostic tests, we amended our regulation to except diagnostic
tests personally furnished by audiologists (as well as psychologists
and certain physical therapists board-certified in electrophysiology)
from the physician supervision requirement.
As explained above, all of the NPPs that we recognize as treating
practitioners in Sec. 410.32(a)(2) for purposes of the diagnostic test
order requirement who must accept Medicare payment on an assignment-
related basis can only collect any applicable cost-sharing from the
patient and cannot balance bill the patient for additional amounts.
Audiologists are not NPPs as defined by the statute (that is, they are
not listed at section 1842(b)(18)(C) of the Act). However, beginning in
2008, we allowed audiologists to enroll in the Medicare program so that
they could independently bill for their audiology services rather than
relying on physicians or other enrolled practitioners to bill on their
behalf. As such, audiologists are not required to accept payment on an
assignment-related basis.
Over the past several years, interested parties have requested that
CMS eliminate the treating physician or other practitioner order
requirement for the hearing and balance assessment services furnished
by audiologists. They have suggested that CMS has the administrative
authority to eliminate the order requirement for audiology services via
notice and comment rulemaking, and that doing so would enable greater
access to these important services. The interested parties believe that
an order from the treating physician or practitioner is not required by
the statute, and that audiology services are covered unless they are
otherwise excluded, such as because they are not reasonable and
necessary in a particular circumstance. To support their points, these
interested parties shared with us a report prepared in 2020 by a
consultant concluding that removal of the treating physician or
practitioner ordering requirement for audiology hearing and balance
assessment services would result in an estimated savings to Medicare
over a 10-year period of approximately $108 million, which includes a
savings of $36 million in beneficiary copayments. These savings
estimates are based on projected Medicare payments and beneficiary
copayments that would not occur if Medicare beneficiaries directly
accessed the audiology hearing and balance services furnished by an
audiologist without the order of a treating physician or other
practitioner. In addition, we have heard from interested parties that
an order is not required for audiology services by certain other public
or private health insurers including Medicare Advantage plans,
Medicaid, plans under the Federal Health Benefit Program, and the
Veterans Administration. We do not know the scope of services that are
covered by these plans or insurers when furnished by audiologists,
including whether these health insurers cover only hearing and balance
assessment services (as the Medicare program does in accordance with
the statute) or also hearing aid examinations for the prescription,
fitting, and programming of hearing aids or other services excluded
from payment under Medicare Part B and/or whether only some or all of
the plans allow payment directly to audiologists for some or all of the
covered services without a physician/NPP order. Additionally, we note
that some of these health insurance programs involve closed systems
with greater levels of interprofessional communication and control (for
example, within certain accountable care organizations (ACOs), managed
care plan networks, or through various Veterans Affairs medical
centers). In contrast, the physicians and practitioners furnishing care
under the fee-for-service Medicare Part B program often practice
independently from each other, which can pose barriers to communication
and coordination of care between health care professionals such as
audiologists and the treating physicians or other practitioners.
In addition, the nature of audiology services personally furnished
by audiologists is such that these services are often billed based on
the audiologist's reassignment of billing rights by an entity other
than the furnishing audiologist, so we are currently unable to
determine the number of audiologists furnishing these services or the
full scope of beneficiary
[[Page 46031]]
utilization of these services in those settings.
While we believe that CMS has the administrative authority to
remove the treating physician or practitioner order requirement for
audiology hearing and balance assessment services via notice and
comment rulemaking, we do not agree with the suggestions of interested
parties that audiologists should be considered in the same way as the
NPPs we recognized as treating practitioners for purposes of the order
requirement under Sec. 410.32(a)(2). Specifically, we allowed the NPPs
(including PAs, NPs, and CNSs) to order diagnostic tests for the
beneficiaries they treat, and we continued to require that the results
of the tests be used in the management of the patient's specific
medical problem. In these cases, the relationship of the patient to the
NPP who orders diagnostic tests and uses the results in managing the
beneficiary's medical condition serves to provide assurance that the
services are medically necessary. In contrast, audiologists are not
recognized under Medicare Part B to treat or manage patients. We
consider audiologists' services to be more specialized that those of
other physicians and NPPs who provide diagnostic services. That is,
their diagnostic tests are more limited and focused in scope than
others furnishing services under the Medicare Part B benefit for
diagnostic tests at section 1861(s)(3) of the Act. Unlike PAs, NPs or
CNSs who may bill for E/M services, and for whom Medicare Part B covers
services and supplies incident to their own professional services as
provided in the regulation at Sec. 410.26, the scope of audiology
services under the Medicare Part B statute includes only diagnostic
hearing and balance assessment services. We are concerned that removal
of the order requirement for hearing and balance services furnished by
audiologists could lead to the furnishing and payment of services that
are not used by a treating physician or practitioner in the management
of the patient's medical condition, and thus, not medically necessary.
We are also concerned about patient safety if Medicare beneficiaries
seek hearing and balance services directly from audiologists without
the involvement of a treating physician or practitioner. For example,
the beneficiary could have an acute condition or symptom such as acute
sensorineural hearing loss resulting from a viral neuronitis that needs
to be diagnosed and treated by a physician or practitioner on an
emergent basis, and that care could be delayed if the beneficiary first
sought care directly from an audiologist. As an additional example,
disequilibrium has many possible causes, including potentially life
threatening cardiologic (for example, arrythmias, heart attack or
cardiac ischemia) and neurologic etiologies (for example, migraines,
TIAs (transient ischemic attacks), strokes). The wide variety of
possible causes of disequilibrium with some of these in both categories
being potentially life threatening (for example, stroke, heart attack,
arrythmias) speaks to the importance of a physician or NPP being
involved in the initial patient assessment. Such an assessment would
include a careful history, a physical examination, and immediate
office-based testing (for example, EKG) to look for some of the more
critical possible causes of disequilibrium, and the physician or NPP
would determine the plan for the progression of the outpatient workup.
That is to say, the physician or NPP would decide, given the history
and clinical exam, whether the evaluation should continue along
cardiologic, neurologic, or vestibular perspectives--the latter of
which could possibly result in an order/referral to an audiologist for
balance assessments using the vestibular dysfunction testing codes. For
these reasons, we believe patients with disequilibrium would be best
served by seeing a physician or NPP before being referred to an
audiologist as appropriate. Furthermore, as previously noted,
audiologists are not required to accept Medicare payment on an
assignment-related basis, and therefore, can balance bill the
beneficiary. We are concerned that the removal of the treating
physician or practitioner ordering requirement, and potentially
increased volume of audiology services, could lead to unnecessary costs
to beneficiaries. In addition, in the absence of a required order of
the treating physician or practitioner, we are concerned that the
direct access to audiologists might incentivize changes in behavior and
practice patterns among audiologists that could lead to overutilization
of audiology services.
We have carefully considered the interested parties' requests to
remove the treating physician or practitioner order requirement for
diagnostic audiology hearing and balance assessment services. We
believe it would be appropriate to provide a limited exception to the
order requirement for diagnostic hearing testing services furnished by
audiologists in order to broaden patient access to these services. In
response to the requests of interested parties, we are proposing to
amend our regulation by adding a paragraph at Sec. 410.32(a)(4) to
remove the order requirement under certain circumstances for certain
audiology services furnished personally by an audiologist for non-acute
hearing conditions. These non-acute hearing conditions would not
include balance assessments that are used for patients with
disequilibrium, because as we explained above, the physician/NPP needs
to first evaluate the patient clinically due to the many serious
medical conditions the beneficiary might have, and ensure the patient
is cleared medically before setting them on track to receive vestibular
function tests, possibly from an audiologist. The list of audiology
services for which Medicare payment can be made when an audiologist
personally performs them on the order of the treating physician or NPP
can be found on the Medicare physician fee schedule web page under the
link titled ``Audiology Services'' at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched. We propose to
permit the services described by the codes listed in Table 29 to be
furnished under the proposed exception without the order of the
treating physician or NPP. We note that Table 29 does not include the
codes for vestibular function tests in the code ranges of 92517-92519
and 92537-92549 because, as discussed above, we believe it is in the
clinical interest of the beneficiary to be assessed by a treating
physician or NPP for potentially serious medical implications of
disequilibrium symptoms, including cardiologic and neurologic
etiologies before they can be cleared and referred for vestibular
function tests.
BILLING CODE 4120-01-P
[[Page 46032]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.069
BILLING CODE 4120-01-C
We are proposing to create HCPCS code GAUDX (Audiology service(s)
furnished personally by an audiologist without a physician/NPP order
for non-acute hearing assessment unrelated to disequilibrium, or
hearing aids or examinations for the purpose of prescribing, fitting,
or changing hearing aids; (service may be performed once every 12
months) to describe these audiology services furnished personally by an
audiologist without the order of the treating physician or other
practitioner. We believe that limiting the audiology services that can
be furnished without an order to include only hearing conditions that
are non-acute in onset and balance services (patients with
disequilibrium symptoms) by removing the CPT codes for vestibular
dysfunction would be appropriate to address our patient safety
concerns. We also propose to specify in the code descriptor for HCPCS
code GAUDX that the audiology services can be performed only once every
12 months. We believe this limitation is appropriate to avoid potential
program integrity issues, such as audiologists billing for GAUDX with a
greater frequency, or providing services that are not reasonable and
necessary for the treatment of the patient's illness or injury. We
selected once every 12 months, rather than every 6 months, for two
reasons. The first is because 6 months did not seem long enough for a
new, non-acute hearing condition to arise, and if an acute hearing
condition were to onset, it would necessitate an evaluation with a
physician/NPP. The second reason is that, at any time, the beneficiary
may always elect to see their physician/NPP for any hearing
conditions--acute or non-acute--or for conditions with disequilibrium
symptoms.
Under this proposal, an audiologist would be able to bill code
GAUDX once every 12 months for a beneficiary. The GAUDX code would
include and be used to bill for any number of audiology services
furnished in that particular
[[Page 46033]]
encounter with the beneficiary. Since the proposed GAUDX code is
generic, the tests provided could include those that are split into PC/
TC and those that are not. As with all services, the actual tests
provided and their results would need to be documented in the medical
record, for purposes of medical review. Further, we propose that no
more than one unit of code GAUDX could be billed--that means ``1'' is
inserted in the ``days or units'' block 24G on the CMS 1500
professional claim form. We are also concerned that beneficiaries may
receive services billed as code GAUDX from more than one audiologist in
the 12-month period and/or be mistaken or misled into thinking that
code GAUDX represents a screening/preventive service which Medicare
does not cover. To avoid the potential for inappropriate use of HCPCS
code GAUDX, we plan to establish system edits through our usual change
management process to ensure that GAUDX is only paid once every 12
months, per each beneficiary. We note that the code descriptor proposed
for GAUDX could be billed for patients seeking care for non-acute
hearing conditions, and that the furnished audiology services would
still have to be medically necessary. Under our proposal, after
receiving audiology services from an audiologist accessed directly
without the order of a treating physician or practitioner, the
beneficiary would have to wait a full 12 months before receiving
additional diagnostic tests from an audiologist without a physician/NPP
order. The beneficiary would remain free to seek care from a treating
physician (or/NPP) if needed, and that care could potentially include a
referral with an order for further diagnostic testing furnished by an
audiologist.
To value HCPCS code GAUDX, we propose to use the combined values of
CPT codes 92557 (Comprehensive audiometry threshold evaluation and
speech recognition (92553 and 92556 combined)) and 92567 (Tympanometry
(impedance testing)), which we believe would represent a typical
service provided by audiologists. We chose CPT Codes 92557 and 92567 as
typical because they make up 72 percent of all billings for
audiologists; and, when all physician and practitioner specialties are
considered, including audiologists, code 92557 is billed with code
92567 over 60 percent of the time and code 92567 is billed with code
92557 over 83 percent of the time in the same clinical encounter,
according to Medicare claims data.
Thus, we propose a total work RVU of 0.8 for GAUDX, calculated by
combining the 0.60 work RVU for CPT code 92557 and 0.20 work RVU for
CPT code 92567. We are proposing to establish the PE value for GAUDX by
combining the unduplicated PE of CPT codes 92557 and 92567.
Specifically, we propose to include the following direct practice
expense (PE) inputs for supply items: two SD046 (Ear tip, tympanometry
probe), two SJ053 (Swab pad, alcohol), one SM0251 (Specula tips,
otoscope), one (SK059) sheet of recording paper, and two SD047 (Ear tip
insert with sound tube); and the following direct PE inputs for
equipment: EQ054 (Audiometric soundproof booth (exam and control room))
for 20 minutes, EQ053 (Audiometer, clinical, diagnostic) for 20
minutes, and EQ244 (Tympanometer with printer) for 4 minutes. We also
propose to apply the same provisions for code GAUDX as those set for
92557 and 92567 (for example, PC/TC indicator, bilateral indicator,
physician supervision indicator, etc.), as they now appear in the PFS
Relative Value file found at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.
We believe that proposed HCPCS code GAUDX, if finalized, will allow
us to better understand the scope of beneficiary access to these
services with or without the order requirement. We also believe that
proposed HCPCS code GAUDX, if finalized, will allow us to better assess
possible burdens to the beneficiary when attempting to access these
services. Given the makeup and intended use of proposed code GAUDX, we
would like to increase our understanding about how and where these
audiology services would be provided without the order of a treating
physician or practitioner. We are also requesting comments from
interested parties about what settings might represent the typical
places of service and which institutional providers might bill for
HCPCS code GAUDX.
L. Proposals and Request for Information on Medicare Parts A and B
Payment for Dental Services
1. Background on Medicare Payment for Dental Services
Section 1862(a)(12) of the Act generally precludes payment under
Medicare Parts A or B for any expenses incurred for services in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth. (Collectively here,
we will refer to ``the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth'' as
``dental services.'') That section of the statute also includes an
exception to allow payment to be made under Medicare Part A for
inpatient hospital services in connection with the provision of such
dental services if the individual, because of their underlying medical
condition and clinical status or because of the severity of the dental
procedure, requires hospitalization in connection with the provision of
such services. Our regulation at 42 CFR 411.15(i) similarly excludes
payment for dental services except for inpatient hospital services in
connection with dental services when hospitalization is required
because of: (1) the individual's underlying medical condition and
clinical status; or (2) the severity of the dental procedure.
However, under our current policy, we make payment under both
Medicare Part A and Part B for certain dental services in circumstances
where the services are not considered to be in connection with dental
services within the meaning of section 1862(a)(12) of the Act or our
regulation at Sec. 411.15(i). We make payment when a doctor of dental
medicine or dental surgery (hereinafter referred to as a ``dentist'')
furnishes dental services that are an integral part of the covered
primary procedure or service furnished by another physician treating
the primary medical illness. In these limited circumstances, Medicare
payment can be made for dental services such as, but not limited to,
the wiring of teeth when done in connection with a reduction of a jaw
fracture, the extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease, and/or an oral or dental examination
on an inpatient basis performed as part of a comprehensive workup prior
to renal transplant surgery. (See Medicare Benefit Policy Manual (IOM
Pub 100-02, Chapter 15, section 150); and Medicare National Coverage
Determinations Manual Chapter 1, Part 4 (IOM Pub 100-03, Chapter 1,
Part 4, section 260.6)). Medicare Administrative Contractors (MACs)
make claim-by-claim determinations as to whether a patient's
circumstances do or do not fit within the terms of the preclusion and
exception specified in section 1862(a)(12) of the Act and Sec.
411.15(i) of our regulations, and in accordance with the CMS manual
provisions.
We have received feedback from interested parties suggesting that
our interpretation of section 1862(a)(12) of the Act is unnecessarily
restrictive, which may contribute to inequitable distribution of dental
services for Medicare beneficiaries. Additionally, a recent report from
the National
[[Page 46034]]
Institutes of Health, ``Oral Health in America Advances and
Challenges,'' discusses how unequal distribution of dental services and
prohibitive costs, particularly for older adults who are at the highest
risk for poor oral health, can lead to and further complicate the
treatment of other medical conditions (for more information, see
https://directorsblog.nih.gov/2022/06/14/using-science-to-solve-oral-health-inequities/). The interested parties also suggest that there are
instances where dental services are directly related to the clinical
success of an otherwise covered medical service under Medicare Parts A
and B, and that the regulation at Sec. 411.15(i) should be amended to
reflect that Medicare payment is available in these circumstances.
Recognizing that there may be instances where medical services
necessary to diagnose and treat the individual's underlying medical
condition and clinical status may require the performance of certain
dental services, we believe that there are instances where dental
services are so integral to other medically necessary services that
they are not in connection with the care, treatment, filling, removal,
or replacement of teeth or structures directly supporting teeth within
the meaning of section 1862(a)(12) of the Act. Rather, such dental
services are inextricably linked to the clinical success of an
otherwise covered medical service, and therefore, are instead
substantially related and integral to that primary medical service. We
also believe that there are circumstances where the dental services are
in direct connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, and are
not inextricably linked to the clinical success of a covered medical
service. In these instances, we continue to believe that Medicare
payment is precluded by section 1862(a)(12) of the Act except when, due
to the patient's underlying medical condition and clinical status, or
the severity of the dental procedure, hospitalization is required; and
that in those instances, the Medicare Part A exception provided under
section 1862(a)(12) of the Act would apply.
To provide greater clarity to our current policies and respond to
issues raised by interested parties, as described in section II.L.2 of
this proposed rule, we are: (1) proposing to clarify our interpretation
of section 1862(a)(12) of the Act and codify certain of our current
Medicare FFS payment policies for medically necessary dental services;
(2) proposing and seeking comment on payment for other dental services,
such as dental examinations, including necessary treatment, performed
as part of a comprehensive workup prior to organ transplant surgery, or
prior to cardiac valve replacement or valvuloplasty procedures, that
are similarly inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services; (3) requesting comments on other types of clinical scenarios
where the dental services may be inextricably linked to, and
substantially related and integral to the clinical success of, other
covered medical services; (4) requesting comments on the potential
establishment of a process to identify for our consideration and review
submissions of additional dental services that are inextricably linked
and substantially related and integral to the clinical success of other
covered medical services; (5) requesting comment on other potentially
impacted policies; and (6) requesting comment on potential future
payment models for dental and oral health care services. We welcome
public comments on these areas.
2. Proposals To Clarify the Interpretation of Section 1862(a)(12) of
the Act and Codify Current Payment Policies for Certain Dental Services
and Request for Comment
a. Proposed Payment for Inpatient Hospital Dental Services and Request
for Comment
As explained above, under our interpretation of the statute and our
current regulation, and as reflected in our regulation and manuals,
items and services furnished in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting the teeth generally are not covered, and no payment may be
made for them under either Medicare Part A or Part B. Section
1862(a)(12) of the Act and our regulation at Sec. 411.15(i) includes
an exception to allow Medicare Part A payment to be made for inpatient
hospital services in connection with the provision of dental services
if the individual, because of their underlying medical condition and
clinical status or because of the severity of the dental procedure,
requires hospitalization in connection with the provision of such
services. We believe that there are instances in which a Medicare
beneficiary may require dental services that are in direct connection
with the care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth such that the application of the
Medicare Part A payment exception would apply when hospitalization is
required because of: (1) a patient's underlying medical condition and
clinical status; or (2) the severity of the dental procedure. Under
these circumstances, we would continue to apply the exception under
section 1862(a)(12) of the Act, and make payment for inpatient hospital
services. We are interested in receiving public comments on what
professional services, including, but not limited to dental services,
may occur during and prior to the patient's hospitalization or
procedure requiring hospitalization under this exception. We may
consider finalizing, based on our review of public comments, additional
payment policies in this area.
b. Proposal To Clarify the Interpretation of Section 1862(a)(12) of the
Act and Codify Current Payment Policies for Certain Dental Services
As explained above, Medicare payment can be made for inpatient
hospital services associated with dental services that fall within the
statutory exception under section 1862(a)(12) of the Act. However,
under our current policy, if a dental service and other related
services (for example, anesthesia or imaging services) are performed as
incident to and as an integral part of a covered procedure or service
performed by a dentist, the total service performed by the dentist is
covered, and payment can be made under Medicare Parts A and B as
appropriate. This policy is based on the idea that some dental services
that would ordinarily be excluded by statute from payment are
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services. When that
is the case, then we believe those dental services are not in
connection with dental services within the meaning of section
1862(a)(12) of the Act, but are instead inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services. As such, we propose to interpret the
statute under section 1862(a)(12) of the Act to permit Medicare payment
under Parts A and B for dental services where the dental service is
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services and allow
payment to be made, regardless of whether the services are furnished in
an inpatient or outpatient setting. Under these circumstances, we
propose that the exclusion under section 1862(a)(12) of the Act would
not apply, because the service is not in connection with the
[[Page 46035]]
care, treatment, filling, removal, or replacement of the teeth or
structures supporting the teeth, but instead is inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services.
As described in section II.L.1. of this proposed rule, in a limited
number of circumstances, Medicare Part B currently pays for dental
services under the PFS when a dentist furnishes a service(s) that is
integral to the covered primary procedure or service rendered when
treating the primary medical illness. Our current payment policies for
dental services are contained in manual provisions (The Medicare
Benefit Policy Manual Chapter 15 (IOM Pub 100-02, Chapter 15, section
150) and Medicare National Coverage Determinations Manual Chapter 1,
Part 4 (IOM Pub 100-03, Chapter 1, Part 4, section 260.6)) that reflect
the proposed interpretation of section 1862(a)(12) of the Act discussed
above.
Our payment policy contained in Medicare National Coverage
Determinations Manual Chapter 1, Part 4 (IOM Pub 100-03, Chapter 1,
Part 4, section 260.6) \74\ (herein ``the NCD Manual'') provides for
payment of an oral or dental examination performed on an inpatient
basis as part of a comprehensive workup prior to renal transplant
surgery. We believe Medicare payment is permitted under this manual
provision for such a dental or oral examination prior to renal
transplant surgery, because the examination is inextricably linked to,
and substantially related and integral to the clinical success of, the
renal transplant procedure. As such, we believe such services are not
subject to the payment preclusion under section 1862(a)(12) of the Act.
However, we believe that comprehensive workups prior to renal
transplant surgery, including related dental examinations, can occur in
either the inpatient and outpatient setting. As such, we are proposing
to provide Medicare payment for oral or dental examinations performed
as part of a comprehensive workup prior to renal transplant surgery
when these services occur in either the inpatient or outpatient
setting, and revise our regulation at Sec. 411.15(i) accordingly.
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\74\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
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The NCD Manual goes on to state that, when performing a dental or
oral examination, a dentist is not recognized as a physician under
section 1861(r) of the Act. We believe this statement is based on an
unnecessarily narrow reading of section 1861(r) of the Act, and is also
not consistent with other manual provisions. The statutory definition
of physician includes a doctor of dental surgery or of dental medicine
in section 1861(r)(2) of the Act, and a similar definition of physician
is included in our IOM Pub 100-1, Section 70.2 \75\ when dental or oral
examinations, and specific treatments, are within the State scope of
practice for the dentist. As such, we are proposing to amend Sec.
411.15(i) to clarify that Medicare Part B coverage and payment can be
made for such a dental or oral examination prior to renal transplant
surgery when performed by a doctor of dental surgery or dental medicine
as defined in section 1861(r)(2) of the Act.
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\75\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS050111.
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The Medicare Benefit Policy Manual Chapter 15 (IOM Pub 100-02,
Chapter 15, section 150) (herein ``the MBP Manual'') states that if an
otherwise noncovered procedure or service is performed by a dentist as
incident to and as an integral part of a covered procedure or service
performed by the dentist, the total service performed by the dentist on
such an occasion is covered.\76\ The MBP Manual continues by providing
several specific examples where CMS would pay for dental services:
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The reconstruction of a ridge when it is performed as a
result of and at the same time as the surgical removal of a tumor
(other than for dental purposes).
The wiring of teeth when done in connection with the
reduction of a jaw fracture.
The extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease.
The dental splint when performed in conjunction with
treatment that is determined to be a covered medical condition.
Specifically, in the MBP Manual, we describe that the
reconstruction of a ridge performed primarily to prepare the mouth for
dentures is a noncovered procedure and therefore would not generally be
eligible for payment. However, when the reconstruction of a ridge is
performed as a result of and at the same time as the surgical removal
of a tumor (for other than dental purposes), the totality of surgical
procedures is a covered service. In the case of the procedure of ridge
reconstruction occurring in conjunction with the surgical removal of a
tumor, we believe that the dental services are inextricably linked to,
and substantially related and integral to the clinical success of, the
other covered medical services, that is, the removal of a tumor; and
therefore, Medicare Part A and Part B payment could be made.
Additionally, the MBP Manual explains that Medicare makes payment for
the wiring of teeth when this is done in connection with the reduction
of a jaw fracture. Once again, we believe that the dental services of
wiring of the teeth are inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services, which in this case is the reduction of a jaw
fracture, and therefore, Medicare Part A and Part B payment could be
made. Likewise, the MBP Manual states that the extraction of teeth to
prepare the jaw for radiation treatment of neoplastic disease is also
currently covered. We continue to believe that in this clinical
scenario the dental services related to teeth extraction are
inextricably linked to, and substantially related and integral to the
clinical success of, the radiation treatment of neoplastic disease; and
therefore, Medicare Part A and Part B payment could be made. The Manual
also describes a specific situation in which certain dental services
may be considered a covered service, depending on whether the
underlying medical condition is deemed to be covered. The Manual
explains that dental splints used to treat a dental condition are
generally excluded from coverage under section 1862(a)(12) of the Act,
but if the treatment is determined to be a covered medical condition
(that is, dislocated upper/lower jaw joints), then the splint can be
covered. We believe that dental splint services could be covered and
paid, because the dental services could be inextricably linked to, and
substantially related and integral to the clinical success of, a
covered medical service, such as treatment of a dislocated jaw.
Therefore, we are proposing to clarify and modify the regulations text
at Sec. 411.15(i) to include this scenario of dental splints used in
the treatment of a covered medical condition. We seek comments on this
aspect of the proposal.
Therefore, we are proposing to codify and clarify in the regulation
at Sec. 411.15(i) that payment can be made under Medicare Part A and
Part B for dental services that are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services, including (1) reconstruction of a ridge
when it is performed as a result of and
[[Page 46036]]
at the same time as the surgical removal of a tumor; (2) the wiring or
immobilization of teeth when done in connection with the reduction of a
jaw fracture; (3) the extraction of teeth to prepare the jaw for
radiation treatment of neoplastic disease; and (4) a dental splint only
when used in conjunction with covered treatment of a medical condition.
This proposal would constitute a clarification to existing policy, as
we are codifying in regulation existing manual provisions.
The MBP Manual states that payment can be made under Medicare Parts
A and B for a covered dental procedure regardless of where the service
is performed, noting that the hospitalization or non-hospitalization of
a patient has no direct bearing on the coverage, payment, or exclusion
of a given dental procedure in specific circumstances. As such, dental
services that are not excluded from Medicare payment under section
1862(a)(12) of the Act could be appropriately furnished in inpatient or
outpatient settings. We propose to clarify in the regulation at Sec.
411.15(i) that payment for dental services that do not fall within the
scope of section 1862(a)(12) of the Act, and that are inextricably
linked to, and substantially related and integral to the clinical
success of, certain other covered medical services, could be made
regardless of whether the services are furnished on an inpatient or
outpatient basis. We seek comments on whether it is clinically
appropriate for these services to be furnished in inpatient or
outpatient settings.
The MBP Manual further states that the coverage of services such as
the administration of anesthesia, diagnostic x-rays, and other related
procedures depends upon whether the primary procedure being performed
by the dentist is itself covered. The MBP Manual explains that an x-ray
taken in connection with the reduction of a fracture of the jaw or
facial bone is covered, while a single x-ray or x-ray survey taken in
connection with the care or treatment of teeth or the periodontium is
not covered. In order to clarify and codify this current policy, we
propose to amend our regulation at Sec. 411.15(i) to provide that
payment can be made for dental services provided in conjunction with
medical services that are inextricably linked to, and substantially
related and integral to the clinical success of, covered medical
services, such as X-rays, administration of anesthesia, and use of the
operating room.
The MBP Manual also specifies that payment can be made for services
and supplies furnished incident to other dental services for which
Medicare payment can be made, for example, services furnished incident
to the dentist's professional services by a dental technician or
registered nurse under the dentist's direct supervision. Medicare
payment policy for services furnished incident to the services of the
billing practitioner are contained in Sec. 410.26 of our regulations.
Additionally, the MBP Manual provides that when an excluded service
is the primary procedure involved, dental services are not covered,
regardless of complexity or difficulty. The MBP Manual describes an
example of the extraction of an impacted tooth as not covered, and goes
on to state that certain procedures, including an alveoplasty (the
surgical improvement of the shape and condition of the alveolar
process) and a frenectomy, are excluded from coverage when either of
these procedures is performed in connection with an excluded service,
for example, the preparation of the mouth for dentures. Additionally,
the MBP Manual states that the removal of a torus palatinus (a bony
protuberance of the hard palate) may be a covered service, but notes
that it is often provided in connection with an excluded service (that
is, the preparation of the mouth for dentures), and in that event,
Medicare does not pay for this procedure.
We are not proposing to modify this policy. No payment is made for
dental services when an excluded service is the primary procedure
involved. Our interpretation of section 1862(a)(12) of the Act allows
for Medicare payment when dental services are inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services. Therefore, no payment is made
when dental services are related to medical services that are not
covered, even if the dental services are inextricably linked to, and
substantially related and integral to the clinical success of, the non-
covered services. The proposed amendment to Sec. 411.15(i) would
specify that, in order for Medicare payment to be made, the dental
services must be inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services.
Under our proposal to clarify and codify our current payment policy
for dental services, section 1862(a)(12) of the Act does not apply only
when dental services are inextricably linked to, and substantially
related and integral to the clinical success of, certain other covered
medical services, such that the standard of care for that medical
service would be compromised or require the dental services to be
performed in conjunction with the covered medical services. When such
medically necessary dental services are furnished by a physician or
practitioner, including a dentist, Medicare Part A or B payment can be
made for the dental services and other services integral or incident to
those dental services. Specifically, such services include:
The wiring of teeth when done in connection with an
otherwise covered medical service,
The reduction of a jaw fracture (such as services
described by CPT code sets 21440-21490),
The extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease (such as services described by Current
Dental Terminology (CDT) \77\ codes D7140 and D7210 for ICD-10 C41.1
Malignant neoplasm of mandible),
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\77\ https://www.ada.org/publications/cdt.
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Dental splints only when used in conjunction with covered
treatment of a medical condition (such as dislocated upper/lower jaw
joints), or
An oral or dental examination performed as part of a
comprehensive workup prior to renal transplant surgery (such as
services described by ICD-10 Z94.0, and codes D0150, D0180, or D0160).
We propose that Medicare Part A and B payment for these dental
services can be made, because the services are inextricably linked to,
and substantially related and integral to the clinical success of, the
other covered medical services. We further seek comment on whether,
given current clinical advances, the descriptions of these dental
services are clinically accurate and appropriate. For example, we are
interested in whether the phrase ``wiring of the teeth'' is still
clinically accurate or if other terminology would be more appropriate.
Given that such dental services would not be subject to the
preclusion on payment under section 1862(a)(12) of the Act, Medicare
would make payment to the furnishing dentist or another physician or
practitioner for the professional dental services. As described in the
MBP Manual, payment may also be made for services and supplies
furnished incident to those dental services furnished by the dentist or
other physician or practitioner, and for other ancillary services
integral to the dental services. For example, Medicare payment could be
made for services furnished incident to the professional dental
services by auxiliary personnel, such as a dental hygienist,
[[Page 46037]]
dental therapist, or registered nurse who is under the direct
supervision of the furnishing dentist or other physician or
practitioner, if they meet the requirements for ``incident to''
services as described in Sec. 410.26 of our regulations. When such
dental services are furnished in a facility setting, such as an
inpatient acute care hospital or hospital outpatient department,
payment for the facility or ancillary services would be made under the
applicable payment system.
In summary, we are proposing to amend Sec. 411.15(i) to codify
that payment can be made under Medicare Part A and Part B for dental
services that are inextricably linked to, and substantially related and
integral to the clinical success of, an otherwise covered medical
service. We further propose to amend Sec. 411.15(i) to include
examples of services for which payment can be made under Medicare Parts
A and B on that basis. Specifically, we propose to include as examples
the following dental services for which payment is permitted under our
current policy: (1) dental or oral examination as part of a
comprehensive workup prior to a renal organ transplant surgery; (2)
reconstruction of a dental ridge performed as a result of and at the
same time as the surgical removal of a tumor; (3) wiring or
immobilization of teeth in connection with the reduction of a jaw
fracture; (4) extraction of teeth to prepare the jaw for radiation
treatment of neoplastic disease; and (5) dental splints only when used
in conjunction with medically necessary treatment of a medical
condition. We further propose that Medicare payment would be made for
these dental services regardless of whether the services are furnished
in an inpatient or outpatient setting, and we propose that payment can
also be made for services that are ancillary to these dental services,
such as x-rays, administration of anesthesia, use of an operating room,
other facility services.
We seek comment on all aspects of this proposal. If finalized, we
note that we will make conforming changes to the MBP Manual to reflect
changes or clarifications, and to remove any text that is no longer
applicable. We will also make conforming changes to other Manual
provisions or National Coverage Decision policies as necessary.
As discussed, MACs may determine on a claim-by-claim basis whether
a patient's circumstances do or do not fit within the terms of the
preclusion or exception specified in section 1862(a)(12) of the Act and
Sec. 411.15(i). The proposed policies outlined in this section of this
proposed rule would not prevent a MAC from making a determination that
payment can be made for dental services in other circumstances not
specifically addressed within this proposed rule and the proposed
amendments to Sec. 411.15(i).
c. Proposed Update to Current Payment Policies for Dental Services
As discussed in section II.L.2 of this proposed rule, we are
proposing that payment can be made under Medicare Parts A and B for
dental services such as the reconstruction of a dental ridge performed
as a result of and at the same time as the surgical removal of a tumor,
the wiring or immobilization of the teeth when done in connection with
a reduction of a jaw fracture, the extraction of teeth to prepare the
jaw for radiation treatment of neoplastic disease, dental splints only
when used in conjunction with covered treatment of a medical condition,
and an oral or dental examination performed as part of a comprehensive
workup prior to renal transplant surgery. We believe, after further
review of current medical practice, through consultations with
interested parties and our medical officers, that there are additional
circumstances that are clinically similar to these examples, and where
Medicare payment for the service could be made, because the dental
services are inextricably linked to, and substantially related and
integral to the clinical success of, the other covered medical
service(s).
For example, after further review, we believe that if a patient
requiring an organ transplant has an oral infection, the success of
that transplant could be compromised if the infection is not properly
diagnosed and treated prior to the transplant surgery. Without an oral
or dental examination to identify such an infection, and the necessary
treatment, such as restorative dental services, to eradicate it prior
to the transplant procedure, the patient's ability to accept the organ
transplant could be seriously complicated or compromised. Examples of
restorative dental services to eradicate infection could include:
extractions (removal of the entire infection, such as pulling of
teeth--for example, CDT D7140, D7210), restorations (removal of the
infection from tooth/actual structure, such as fillings--for example,
CDT D2000-2999), periodontal therapy (removal of the infection that is
surrounding the tooth, such as scaling and root planning--for example,
CDT D4000-4999, more specifically D4341, D4342, D4335 and D4910), or
endodontic therapy (removal of infection from the inside of the tooth
and surrounding structures, such as root canal--for example, CDT D3000-
3999). If such an infection is not treated prior to transplant, and
immunosuppressant therapy is initiated to preserve the transplant, then
there is an increased likelihood for morbidity and mortality resulting
from spreading of the local infection to sepsis. Similarly, without a
dental or oral exam and necessary diagnosis and treatment of any
presenting infection of the mouth prior to a cardiac valve replacement
\78\ or valvuloplasty procedures, an undetected, non-eradicated oral or
dental infection could lead to bacteria seeding the valves, seeding
surrounding cardiac muscle tissues involved with the surgical site, and
conceivably leading to systemic infection or sepsis, all of which
increase the likelihood of unnecessary and preventable acute and
chronic complications for the patient. Because an oral or dental
infection can present substantial risk to the success of these
procedures, such that the standard of care would be to not proceed with
the procedure when there is a known oral or dental infection present,
we believe dental services furnished to identify, diagnose, and treat
oral or dental infections prior to organ transplant, cardiac valve
replacement, or valvuloplasty procedures are not in connection with the
care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth, but instead are inextricably
linked to, and substantially related and integral to the clinical
success of, these other covered medical services. We note that, in
these circumstances, the necessary treatment to eradicate an infection
may not be the totality of recommended dental services for a given
patient. For example, if an infected tooth is identified in a patient
requiring an organ transplant, cardiac valve replacement, or
valvuloplasty procedure, the necessary treatment would be to eradicate
the infection, which could result in the tooth being extracted.
Additional dental services, such as a dental implant or crown, may not
be considered immediately necessary to eliminate or eradicate the
infection or its source prior to surgery. Therefore, such additional
services would not be inextricably linked to, and substantially related
and integral to the clinical success of, the organ transplant, cardiac
valve replacement, or valvuloplasty services. As such, no Medicare
payment would be made for
[[Page 46038]]
the additional services that are not immediately necessary prior to
surgery to eliminate or eradicate the infection.
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\78\ Knox, K.W., & Hunter, N. (1991). The role of oral bacteria
in the pathogenesis of infective endocarditis. Australian dental
journal, 36(4), 286-292. https://doi.org/10.1111/j.1834-7819.1991.tb00724.x.
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As discussed, we believe that there are circumstances where the
clinical success of medical or surgical services required for a
successful organ transplantation, cardiac valve replacement, and
valvuloplasty procedure may require the performance of certain dental
services. As such, we propose to amend our regulation at Sec.
411.15(i)(3) to provide that dental services that are inextricably
linked to, and substantially related and integral to the clinical
success of, a certain covered medical service are not subject to the
exclusion under section 1862(a)(12) of the Act; and that payment can be
made under Medicare Parts A and B for such dental services. We are
proposing to amend Sec. 411.15(i) to include examples of payable
services under Medicare Parts A and B, as: (1) the dental or oral
examination as part of a comprehensive workup prior to an organ
transplant, cardiac valve replacement, or valvuloplasty procedure; and
(2) the necessary dental treatments and diagnostics to eliminate the
oral or dental infections found during a dental or oral examination as
part of a comprehensive workup prior to an organ transplant, cardiac
valve replacement, or valvuloplasty procedure. We believe that clinical
practice is such that these services can occur within the inpatient
hospital or outpatient setting, and we further propose that Medicare
Parts A and B would make payment for these dental services, as
applicable, regardless of whether the services are furnished in an
inpatient or outpatient setting. Furthermore, we propose that payment
under the applicable payment system could also be made for services
that are ancillary to these dental services, such as x-rays,
administration of anesthesia, and use of the operating room.
We seek comment on this proposed policy and our proposed amendments
to Sec. 411.15(i)(3) to specify that payment under Medicare Parts A
and B can be made for an oral or dental examination, and medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection, prior to an organ transplant, cardiac valve
replacement, or valvuloplasty procedure. We propose to continue to
contractor price the dental services for which payment is made
currently, and for the dental services that can be made under the
proposed amendments to Sec. 411.15(i)(3) for CY 2023, or until we have
further data to establish prospective payment rates. We also seek
public comment on the expected utilization of these services.
We solicit comment on these proposals.
i. Other Clinical Scenarios for Dental Services Integral to Other
Covered Medical Services
In addition to the examples of dental services for which payment is
made under our current policy, and dental services to avoid risk of an
oral or dental infection prior to organ transplant, cardiac valve
replacement, or valvuloplasty procedures, we believe there may be other
clinical scenarios where dental services may not be in connection with
the care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth, but instead are inextricably
linked to, and substantially related and integral to the clinical
success of, certain other covered medical services. These could include
certain dental exams and medically necessary diagnostic and treatment
services prior to treatments for head and neck cancers, such as
radiation therapy with or without chemotherapy, or the initiation of
immunosuppressant therapy, such as those used during cancer treatments,
where the standard of care is such that it is clinically advisable to
eliminate the source of infection prior to proceeding with the
necessary medical care, or the standard of care for the primary medical
condition would be significantly materially compromised if the dental
services are not performed. As with any assessment of patient health
prior to initiating immunosuppressant therapy, it may be necessary to
eradicate all sites of infection, including oral infections, prior to
suppressing the immune system, regardless of the reason for prescribing
an immunosuppressant. We also note some medications may have an
immunosuppressant effect, even though they are not prescribed
principally to suppress the immune system. We believe, in these
circumstances, eradicating oral or dental infection prior to beginning
a medication that has been found to have a suppressant effect on that
part of the immune system required to eradicate infectious agents could
be necessary to the clinical success of the medication therapy.
Similarly, in joint replacement surgery (such as total hip and knee
arthroplasty surgery) we believe there may be risks to the outcome of
the procedure if an oral infection is not treated. There is evidence
that some joint replacement patients have significant dental pathology
found before their surgery.\79\ Given the incidence of dental pathology
in joint replacement patients, there may be some joint replacement
patients who would experience a clinically significant benefit from a
pre-operative dental exam and medically necessary treatment of oral
pathology(ies). As in transplant surgery, patients having joint
replacement surgery are at risk for surgical site infection, and there
may be an increased risk for those patients with significant dental
pathology. The presence of an overlooked oral infection may increase
the risk for acute and chronic surgical site infection.\80\ \81\
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\79\ https://www.aaos.org/aaosnow/2011/feb/clinical/clinical2/.
\80\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4919067/.
\81\ https://www.nebh.org/blog/why-its-a-good-idea-to-see-a-dentist-before-your-joint- replacement/.
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We acknowledge there is other clinical evidence that does not
support the need for a dental exam and necessary treatment prior to
total joint replacement surgery, specifically total hip and knee
arthroplasty.82 83 Rather, there is evidence that further
study is needed to determine whether pre-operative dental exams and
treatments are necessary and clinically beneficial.\84\ Therefore, we
are interested in public comment providing systematic clinical evidence
as to whether there is an inextricable link between dental service(s)
and joint replacement surgery such that the dental services are
substantially related and integral to the clinical success of the
surgical procedures. We note that if we receive compelling clinical
evidence, we may finalize in this final rule additional clinical
scenarios, such as dental services prior to joint replacement surgery
(for example, total hip and knee arthroplasty surgery), where payment
could be made under Medicare Part A or Part B. We are seeking comment
on whether there is a significant quality-of-care detriment if certain
dental services are not provided prior to joint replacement surgery
(such as total hip and knee arthroplasty surgery), and if so, we
request a description of that systematic evidence. Specifically, we are
looking for medical evidence that
[[Page 46039]]
the provision of certain dental services leads to improved healing,
improved quality of surgery, and the reduced likelihood of readmission
and/or surgical revisions, because an infection has interfered with the
integration of the implant and interfered with the implant to the
skeletal structure. Evidence needs to be clinically meaningful and
represent a material difference that results in some level of
persistence in the clinical success of the procedure to support that
pre-operative dental services are similarly inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered medical services, and therefore in connection with, and
substantially related and integral to that primary covered medical
service. If commenters are able to provide us with compelling evidence
to support that a dental exam and necessary treatment prior to joint
replacement procedures such as total hip and knee arthroplasty surgery
would result in clinically significant improvements in quality and
safety outcomes, for example, fewer revisions, fewer readmissions, more
rapid healing, quicker discharge, quicker rehabilitation for the
patient, then we would consider whether such dental services may be
inextricably linked to, and substantially related and integral to the
clinical success of, the joint replacement surgery.
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\82\ Barrere S, Reina N, Peters OA, Rapp L, Vergnes JN, Maret D.
Dental assessment prior to orthopedic surgery: A systematic review.
Orthop Traumatol Surg Res. 2019 Jun;105(4):761-772. doi: 10.1016/
j.otsr.2019.02.024. Epub 2019 May 3. PMID: 31060914.
\83\ Young, H., Hirsh, J., Hammerberg, E.M., & Price, C.S.
(2014). Dental disease and periprosthetic joint infection. The
Journal of bone and joint surgery. American volume, 96(2), 162-168.
https://doi.org/10.2106/JBJS.L.01379.
\84\ https://www.sciencedirect.com/science/article/pii/S1877056819301318.
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We also believe there may be other clinical scenarios involving
dental services that we have not yet considered, where certain dental
services may be similarly inextricably linked to, and substantially
related and integral to the clinical success of, certain otherwise
covered medical service such that the exclusion under section
1862(a)(12) of the Act would not apply. For example, we are proposing
to codify current policy that Medicare payment can be made for the
wiring of teeth when done in connection with the reduction of a jaw
fracture. We request comment on whether there are other dental services
associated with stabilizing and/or repairing the jaw after accidental
injury or trauma and similarly that similarly would not be subject to
the exclusion under section 1862(a)(12) of the Act, and for which we
should consider providing Medicare payment.
We solicit comment on our current approach to payment for dental
services that we have already identified under our current and proposed
policies as inextricably linked to, and substantially related and
integral to the clinical success of, certain covered services, as well
as those services we may yet identify, and other operational topics we
should consider further. We acknowledge that there may be other
clinical circumstances we have not yet identified where dental services
may not be in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, and
instead are similarly inextricably linked to, and substantially related
and integral to the clinical success of, certain other covered medical
services. There may be other clinical scenarios involving physiologic
or anatomic conditions in which dental services could be a medically
critical precondition to the clinical success of other services, such
as certain surgical procedures or cancer treatments. For these reasons,
we solicit comment on whether there are other clinical scenarios for
medical or surgical services where the standard of care is such that
the performance of certain dental services (for example, an exam, and
certain diagnostic and treatment services) is considered to be a
critical clinical precondition to proceeding with the primary medical
procedure and/or treatment, and therefore may be similarly inextricably
linked to, and substantially related and integral to the clinical
success of, a certain covered service, and therefore, not subject to
the exclusion under section 1862(a)(12) of the Act. If we were to
finalize our proposed policies as discussed under sections II.L.2.a.
and II.L.2.b. of this proposed rule, we may consider finalizing, based
on our review of public comments, these additional examples of dental
services that may not be subject to the payment exclusion under section
1862(a)(12) of the Act because they are similarly inextricably linked
to, and substantially related and integral to the clinical success of,
covered medical services. If we were to finalize such additional
examples of dental services, we would list those services as examples
under the regulation at Sec. 411.15(i)(3), as discussed in section
II.L.2.c. of this proposed rule. Lastly, as discussed above, we
recognize that the dental services we have identified for which
Medicare payment could be made under our proposed policies would occur
either prior to, or contemporaneously with, the covered medical
service. We are also interested in comments on whether, on the same
basis, there are clinical circumstances under which Medicare payment
could be made for dental services furnished after the covered medical
procedure or treatment.
ii. Establishment of a Process To Consider Additional Clinical
Scenarios for Future Updates
As discussed, we believe there may be clinical scenarios where
dental services are not in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting teeth, and instead are inextricably linked to, and
substantially related and integral to the clinical success of, certain
covered medical services. We believe there may be additional clinical
scenarios we have not yet identified under which Medicare payment could
be made for certain dental services on this basis. To ensure we are
appropriately considering other potential clinical scenarios that may
involve such dental services, we believe it may be appropriate to
establish a process whereby interested parties can share
recommendations for our consideration, review and analysis for
potential inclusion on the list of dental services for which payment
can be made under Sec. 411.15(i)(3) through future rulemaking. If an
interested party believes that there is a clinical scenario in which
certain dental services are similarly inextricably linked to, and
substantially related and integral to the clinical success of, certain
covered medical services, we invite interested parties to submit
information about the clinical scenario and the medical evidence to
support that the standard of care for the medical service is such that
one would not proceed with the medical procedure or service without
performing the dental services, because the covered medical services
would or could be significantly and materially compromised, or where
dental services are a clinical prerequisite to proceeding with the
primary medical procedure and/or treatment. The interested party should
explain why the particular dental services should not be subject to the
general preclusion on payment for dental services under section
1862(a)(12) of the Act, because they are inextricably linked to, and
substantially related and integral to the clinical success of, covered
medical services, and provide the medical evidence to support that
conclusion.
To ensure a thorough review can occur, we encourage interested
parties to include relevant medical literature, clinical guidelines or
generally accepted standards of care, and other supporting
documentation to support our review and consideration of the clinical
scenario involving dental services. To facilitate our consideration of
interested parties' recommendations within an annual rulemaking cycle,
we would
[[Page 46040]]
request that interested parties submit this information by February
10th of that year at [email protected].
Submissions received outside of the public comment period for a PFS
proposed rule will be considered for possible inclusion in future
notice and comment rulemaking cycles. Recommendations received by
February, 10th of a calendar year would be reviewed for consideration
and potential inclusion within the PFS proposed rule for the subsequent
calendar year. For example, information received by February 10, 2024
would be reviewed for consideration and potential inclusion within the
CY 2025 PFS proposed rule. We encourage interested parties to engage
with us and provide medical evidence to support their recommendations
for additional clinical scenarios where dental services may not fall
within the scope of the payment preclusion under section 1862(a)(12) of
the Act.
As discussed previously, we may consider finalizing a change, after
reviewing public comments, in the CY 2023 PFS final rule to revise the
list of examples of dental services for which Medicare payment can be
made. Furthermore, we solicit feedback on: (1) whether there are
additional clinical circumstances we should consider where dental
services are inextricably linked to, and substantially related and
integral to the clinical success of, covered medical services; and (2)
the establishment of a process to review additional clinical scenarios
identified by the public, which we may consider finalizing, after
review of public comments received, in this final rule.
iii. Request for Comment on Dental Services Integral to Covered Medical
Services Which Can Result in Improved Patient Outcomes
As described in section II.L.2 of this proposed rule, we believe
there are clinical scenarios where the standard of care is such that
there is an immediate need for certain dental services as the necessary
clinical prerequisite to an otherwise covered medical service. We
believe there may be other clinical scenarios, however, where the
ongoing disease management of the patient receiving the medically
necessary procedure may have an improved outcome or see a clinical
benefit from the performance of dental services, but that the dental
service may not be inextricably linked to, or substantially related and
integral to the clinical success of, the otherwise covered medical
service.
For example, we believe there may be certain circumstances where
the clinical benefit of medical care or treatment of a diabetic patient
could be improved if certain dental services are furnished. We are
interested in public feedback on whether certain dental services (for
example, a dental exam, necessary treatment of a dental condition such
as the extraction of an infected and mobile tooth) should be considered
so integral to the standard of care for an otherwise covered medical
service that the preclusion on Medicare payment under section
1862(a)(12) of the Act does not apply.
Additionally, we are interested in comments on whether the success
of a given surgery is dependent upon eradication of dental or oral
infection. As noted in section II.L.2.c., we believe surgeries dealing
with organ transplants, cardiac valve replacement, or valvuloplasty
procedures may require a dental exam and treatment prior to the surgery
because the services to identify and eradicate dental or oral infection
are inextricably linked to, and substantially related and integral to
the success of, these otherwise covered medical services. However, we
are interested in feedback on whether there are other types of surgery
for which certain dental services would meet this threshold. We invite
public comment on whether there are other clinical scenarios involving
acute or chronic conditions that would have an improved patient outcome
if dental services are furnished, and if so, whether we should consider
these services as inextricably linked to, and substantially related and
integral to the clinical success of, certain covered medical services.
3. Request for Comment on Other Potentially Impacted Policies
As discussed in section II.L.2.a-b of this proposed rule, we are
proposing to codify and clarify our current payment policies for dental
services. We recognize that under these policies there may be instances
where multiple health care providers may need to coordinate the
performance of certain medical and dental services based on the
patients' chronic conditions and/or serious illnesses. We continue to
consider improvements to our payment policies for care management
services as health care delivery models evolve. As such, we seek
comment on whether our current policies for care management services
make clear that time spent by physicians or non-physician practitioners
coordinating care with dentists regarding the performance and outcomes
of services as proposed under section II.L.2 of this proposed rule, may
be counted for purposes of applicable care management codes. We are
also interested in whether existing care management codes adequately
describe and account for time spent coordinating with dentists and
their clinical staff. We are also interested in comments regarding the
impact of changes in how health care is delivered, and whether an
increased integration and coordination of care among health care
providers should also be taken into account in considering dental
services that may be inextricably linked to, and substantially related
and integral to the clinical success of, a primary medical service.
Additionally, we are interested in whether, and to what extent, the
proposed policies as described in section II.L.2 of this proposed rule
would address any inequitable distribution of dental services for
Medicare beneficiaries.
Finally, we recognize that many Medicare beneficiaries have
separate or supplemental dental coverage, such as through a Medigap
plan or other plan offering. If we were to finalize in the CY 2023 PFS
final rule our proposed policies as described further in section II.L.2
of this proposed rule, we seek comment on how current coordination of
dental benefits operates, and where improvements could be provided.
Additionally, we seek comment on what aspects of coordinating benefits
among supplemental dental providers we should consider if we were to
finalize the proposed policies as specified under section II.L.2 of
this proposed rule.
4. Request for Comment on Potential Future Payment Models for Dental
and Oral Health Care Services
Our waiver authority under section 1115A(d)(1) of the Act provides
broad authority for the Secretary to waive such requirements of title
XVIII of the Act, which pertain to Medicare, as may be necessary solely
for purposes of carrying out section 1115A of the Act with respect to
testing models described in section 1115A(b) of the Act.
In 2014, the Health Care Innovation Awards (HCIA) Round 2, a
limited time grant initiative, included awards with the goal to improve
the health of populations through activities focused on engaging
beneficiaries, prevention, wellness, and comprehensive care that
extended beyond the clinical service delivery setting. Several
participants used their HCIA Round 2 funds to test models of clinical
care that included payment for dental and oral care services. For
further information regarding the success of these awards as applied to
dental and oral care services please review the HCIA Round 2 Final
[[Page 46041]]
Awardee Evaluation Report (2014-2018).\85\
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\85\ https://innovation.cms.gov/data-and-reports/2020/hcia2-fg-finalevalrpt.
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We are seeking comment on additional ways to integrate the payment
for dental and oral health care services within existing and future
payment models using the Innovation Center's waiver authority in
existing or future service delivery models, including models focused on
equity, care coordination, total cost of care and specific disease
conditions.
M. Rebasing and Revising the Medicare Economic Index (MEI)
1. Background
The Medicare Economic Index (MEI) is authorized under section
1842(b)(3) of the Act, which relates to the reasonable charge-based
payment methodology that was in place for physicians' services prior to
the PFS. That section states that prevailing charge levels beginning
after June 30, 1973 may not exceed the level from the previous year
except to the extent that the Secretary finds, on the basis of
appropriate economic index data, that such higher level is justified by
year-to-year economic changes. CMS began calculating the MEI for this
purpose on July 1, 1975, and continues to do so today for several
statutory and other purposes. The MEI reflects the weighted-average
annual price change for various inputs involved in furnishing
physicians' services.
The MEI is a fixed-weight input price index comprised of two broad
categories: (1) Physicians' own time (compensation); and (2)
physicians' practice expense (PE). Additionally, it includes an
adjustment for the change in economy-wide, private nonfarm business
total factor productivity (previously referred to as multifactor
productivity).\86\ The U.S. Department of Labor's Bureau of Labor
Statistics (BLS) publishes the official measures of productivity for
the U.S. economy. We note that previously the productivity measure
referenced in section 1886(b)(3)(B)(xi)(II) of the Act was published by
BLS as private nonfarm business multifactor productivity. Beginning
with the November 18, 2021 release of productivity data, BLS replaced
the term multifactor productivity (MFP) with total factor productivity
(TFP). BLS noted that this is a change in terminology only and will not
affect the data or methodology.
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\86\ https://www.bls.gov/news.release/prod5.nr0.htm.
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The current form of the MEI was described in the November 25, 1992
Federal Register (57 FR 55896) and was based in part on the
recommendations of a Congressionally-mandated meeting of experts held
in March 1987. Since that time, the MEI has been updated or revised on
five instances. First, the MEI was rebased in 1998 (63 FR 58845), which
moved the cost structure of the index from 1992 data to 1996 data.
Second, the methodology for the productivity adjustment was revised in
the CY 2003 PFS final rule with comment period (67 FR 80019) to reflect
the percentage change in the 10-year moving average of economy-wide
private nonfarm business total factor (multifactor) productivity.
Third, the MEI was rebased in the CY 2004 PFS final rule with comment
period (68 FR 63239), which moved the cost structure of the index from
1996 data to 2000 data. Fourth, the MEI was rebased in 2011 (75 FR
73262), which moved the cost structure of the index from 2000 data to
2006 data. Subsequently, in the CY 2014 PFS final rule with comment
period (78 FR 74264), the MEI cost share weights were revised based on
recommendations from the MEI technical advisory panel (MEI-TAP). From
May 2012 through September 2012, the MEI Technical Advisory Panel
conducted a technical review of the MEI, including analyses of the
inputs, input weights, price-measurement proxies, and productivity
adjustment. Details regarding the Panel's work and documents such as
transcripts, meeting summaries, presentations, and the final report
with recommendations to the Secretary of Health and Human Services are
available at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEITAP and in the FY 2014 PFS proposed rule (78 FR 43311) which
provides details related to how the MEI TAP panel recommendations were
implemented into the revised 2006-based MEI. The current 2006-based MEI
relies on data collected from the American Medical Association (AMA)
for self-employed physicians from the Physician Practice Information
Survey (PPIS). The AMA has not fielded another survey since that 2006
data collection effort and so the MEI has continued to be based on
2006-based costs. In its August 28, 2012 report, the MEI-TAP expressed
concern regarding the representativeness and availability of data to
support the MEI, and provided two recommendations regarding the data
sources to update the MEI in the future. Recommendation 2.1 stated that
CMS should research whether using self-employed physician data for the
MEI cost weights continues to be the most appropriate approach given
the trend toward larger, physician-owned practices, as well as movement
from physician-owned practices toward hospital-owned practices.
Recommendation 2.2 stated that CMS should scan for and research
additional data sources that may allow for more frequent updates to the
MEI's cost categories and their respective weights.\87\
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\87\ The MEI-TAP's final report, including all findings and
recommendations, are available at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEITAP.
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Updates to the PFS conversion factor (CF) were previously
calculated based on a prescribed statutory formula that used a
combination of the MEI and a ``sustainable growth rate''; for details
about this formula, we refer readers to the CY 2015 PFS final rule with
comment period (79 FR 67741 through 67742). Section 101 of the Medicare
Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 115-05,
April 16, 2015) repealed the previous statutory update formula and
specified the update adjustment factors for calendar years 2015 and
beyond. Therefore, effective beginning for CY 2015, the MEI was no
longer used in calculating the annual update to the PFS CF. The annual
growth in the MEI continues to be used to update the following: the
Medicare telehealth originating site facility fee under section
1834(m)(2)(B)(i) of the Act, the KX Modifier Thresholds (formerly the
therapy caps) under section 1833(g)(2) of the Act, targeted medical
review (MR) threshold amounts (beginning in 2029) under section
1833(g)(7)(B)(ii) of the Act, Rural Health Clinic Payment Limits under
section 1833(f)(2) of the Act, and the annual update to the non-drug
portion of the Opioid Treatment Program payment as finalized in the CY
2020 PFS final rule (84 FR 62668 and 62669).
While the MEI annual percentage change increase is not directly
used in determining the update to the PFS CF, the MEI cost weights have
historically been used to update the GPCI cost share weights to weigh
the four components of the practice expense GPCI (employee
compensation, the office rent, purchased services, and medical
equipment, supplies, and other miscellaneous expenses), as discussed in
detail in section II.G. of this proposed rule, and to recalibrate the
relativity adjustment to ensure that the total pool of aggregate PE
RVUs remains relative to the pool of work and MP RVUs, as discussed in
section II.B. and section VII. of this proposed rule. The most recent
recalibration was done for the CY 2014 RVUs, when the MEI was last
[[Page 46042]]
updated. As described in the CY 2014 PFS final rule (78 FR 74236
through 74237, and 74241), in steps 3 and 10, we adjusted the aggregate
pool of PE costs in proportion to the change in the PE share in the
revised MEI cost share weights. These adjustments were consistent with
our longstanding practice to make adjustments to match the RVUs for the
PFS components with the MEI cost share weights for the components,
including the adjustments described in the CY 1999 PFS final rule (63
FR 58829), CY 2004 PFS final rule (68 FR 63246 and 63247), and CY 2011
PFS final rule (75 FR 73275). Therefore, we believe that the MEI cost
weights need to be updated to reflect more current market conditions
faced by physicians in furnishing physicians' services, but note that
we are proposing to delay the implementation of the proposed rebased
and revised MEI cost weights for both PFS ratesetting and the proposed
CY 2023 GPCIs. We believe that doing so will allow interested parties
the opportunity to review and comment on the proposed rebased and
revised MEI cost share weights discussed in section II.M. of this
proposed rule and their potential impacts before we use such rebased
and revised MEI cost share weights for purposes of proportioning the
work, PE, and MP RVU pools in PFS ratesetting and updating the GPCIs.
We refer readers to our discussion about using the proposed rebased and
revised MEI cost share weights for purposes of proportioning the work,
PE, and MP RVU pools in PFS ratesetting and for the purposes of
updating the GPCIs for CY 2023 in sections II.B. and VII. of this
proposed rule. In those sections, we discuss our considerations for
updating the MEI cost share weights for the RVUs and the GPCIs and the
potential redistributive impact that making such a change would have on
PFS payments. We are soliciting comments on the proposed delay and
potential use of the proposed updated MEI cost weights in future years
to recalibrate the RVU shares and to update the GPCI cost share
weights, which were last realigned to the revised MEI weights in the CY
2014 PFS final rule (78 FR 74380 through 74391).
The terms ``rebasing'' and ``revising,'' while often used
interchangeably, actually denote different activities. Rebasing refers
to moving the base year for the structure of costs of an input price
index, while revising relates to other types of changes such as using
different data sources, cost categories, or price proxies in the input
price index. Effective with this CY 2023 PFS rulemaking cycle, we are
proposing to rebase and revise the MEI based on a methodology that uses
publicly available data sources for input costs that represent all
types of physician practice ownership; that is, not limited to only
self-employed physicians. In the following sections of this proposed
rule, we detail our proposals regarding derivation of the cost
categories and associated cost share weights, selection of the price
proxies in the MEI, and the results of the proposed 2017-based MEI as
compared to the current 2006-based MEI.
2. Developing the Cost Weights for Use in the MEI
The 2006-based MEI was last rebased in the CY 2011 PFS final rule
with comment period (75 FR 73262 through 73275) and subsequently
revised in the CY 2014 PFS final rule with comment period (78 FR 74264
through 74278). The proposed 2017-based MEI cost weights are derived
predominantly from the annual expense data from the U.S. Census
Bureau's Services Annual Survey (SAS, https://www.census.gov/programs-surveys/sas.html). Other data sources that were considered and analyzed
as potential sources of expense data for Physician Offices included the
BEA Benchmark Input-Output data, the Internal Revenue Services (IRS)
Statistics of Income data for sole proprietors, and Medical Group
Management Association (MGMA) cost and revenue data. While each of
these data sources provided information on physician input price
expenses, we found the SAS data to be the most technically appropriate
data source available based on various factors including public
availability, level of detail of expense categories, and sample
representativeness of the universe. The SAS data are publicly available
data that provide annual receipts estimates for the service industries.
Collected data include sources of revenue and expenses by type for
selected industries and selected industry-specific items. Specifically,
we propose to use the 2017 SAS data from Table 5, Estimated Selected
Expenses for Employer Firms for NAICS 6211 (Office of Physicians). The
survey data collection in 2018 and 2019 were scaled back and therefore,
data by expense category was limited. For example, the SAS expense data
for lease and rental payments, professional and technical services,
repair and maintenance services, and detailed utility cost were
unavailable in 2018 and 2019. The 2020 data included a return to the
more comprehensive collection of expense data; however, the presence of
the PHE for COVID-19 raised questions regarding the representativeness
and stability of the data given impacts on the utilization of
physicians' services and associated expenses. Therefore, we propose to
use the 2017 SAS data for the proposed 2017-based MEI because it is the
most recently available and complete data.
We are proposing to supplement the 2017 SAS expense data by using
several data sources for further disaggregation of compensation costs
and all other residual costs, including: the 2017 Bureau of Labor
Statistics (BLS) Occupational Employment and Wage Statistics (OEWS),
the 2012 Bureau of Economic Analysis (BEA) Benchmark Input-Output data
(I/O), the 2006 AMA PPIS, and the 2020 AMA Physician Practice Benchmark
Survey. Table 30 lists the set of mutually exclusive and exhaustive
cost categories and weights for the proposed 2017-based MEI compared to
the 2006-based MEI.
BILLING CODE 4120-01-P
[[Page 46043]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.070
BILLING CODE 4120-01-C
Total costs equal the sum of the costs for Physician Compensation
and Practice Expenses. The development of the cost weights for each
cost category in the proposed 2017-based MEI is described, in detail,
as follows.
a. Physician's Compensation
The component of the MEI that reflects physician work is
represented by the estimated portion of compensation expenses
attributable to physicians. The proposed 2017 cost weight associated
with the physician's work (otherwise referred to as the Physician
Compensation cost weight) is based on the estimated share of 2017 SAS
expenses for total compensation associated with physician compensation.
Since the compensation expense in the SAS data is only reported as an
aggregate for all employees, we propose to split the compensation
expenses between physicians (including nonphysician practitioners that
can bill independently such as nurse practitioners (NPs), physician
assistants (PAs), and other clinical personnel) and all other workers
using the following process.
Step 1: Total compensation costs are calculated by summing the
reported expenses in the SAS for gross annual payroll, employer costs
for fringe benefits (including health insurance, defined benefit and
defined contribution plans, payroll taxes, employer paid insurance
premiums, and all other benefits), and temporary staff and leased
employees as reported in the 2017 SAS data for NAICS 6211 (Office of
Physicians).
Step 2: Determine the ratio of physician (including nonphysician
practitioners that can bill independently such as NPs, PAs, and other
clinical personnel) wage costs to total wage costs. This ratio is
calculated using data from the Bureau of Labor Statistics (BLS)
Occupational Employment and Wage Statistics (OEWS) May 2017 National
Industry-Specific Occupational Employment and Wage Estimates for
Offices of Physicians (NAICS 6211). This data reports the number of
employees by occupational category based on the Standard Occupational
Classification System (SOC) and the mean hourly wage for each
occupation. For each occupation, we multiply the number of employees by
the mean hourly wage to estimate the total mean hourly wage expense.
The sum of each occupation category represents total mean hourly wage
expenses for all occupations in NAICS 6211. Then to derive the total
mean hourly wage expenses for physicians (including nonphysician
practitioners that can bill independently such as NPs, PAs, and other
clinical personnel) we sum the following occupations: Physicians and
Surgeons (29-1060); Chiropractor (29-1011); Optometrist (29-1041);
Podiatrist (29-1081); Physical Therapist (29-
[[Page 46044]]
1123); Dieticians & Nutritionists (29-1031); Physician Assistants (29-
1071); Nurse Practitioners (29-1171); and All Other Diagnosing &
Treating Occupations (29-11XX) to estimate OEWS expenses for
physicians. The ratio of physician total mean hourly wage costs to
total mean hourly wage costs is 63.2 percent.
Step 3: We multiply the total compensation expenses from Step 1 by
the ratio determined in Step 2 to derive estimated Employed Physician
Compensation Expenses, which in 2017 are estimated to account for 42.4
percent of total costs.
Next, since the expenses estimated above reflect only employed
physician compensation, we propose to add an estimate of compensation
costs to account for physician practice owners that are not classified
as employees but instead would be included in the net income of the
practice. The net income physician compensation costs are estimated by
the following methodology. This amount is determined in three steps:
Step 1: Subtract total expenses from total revenue as reported in
the 2017 SAS data for NAICS 6211.
Step 2: Estimate the share of owners versus employees of physician
practices for 2017 based on the average share of ``owners'' for 2016
and 2018 as reported in Exhibit 1 of the 2020 AMA Physician Practice
Benchmark Survey. This estimated share for 2017 is 46.5 percent (and
reflects the average of the share for 2016 and 2018).
Step 3: Multiply the share determined in step 2 by the amount
determined in step 1, which represents the estimated expenses for net
income for owners of physician practices and are 4.845 percent of total
costs in 2017.
The proposed aggregate 2017-based Physician Compensation cost
weight is the sum of Employed Physician Compensation cost weight
(42.416 percent) and Estimated Net Income for Physician Practice Owners
cost weight (4.845 percent), or 47.261 percent. By comparison, the
2006-based Physician Compensation cost weight is 50.866 percent and
reflects the net income for self-employed physicians and the expenses
for nonphysician clinical staff that can bill Medicare independently.
The proposed 2017-based MEI cost weight for Physician Compensation is
3.6 percentage points lower than the 2006-based MEI cost weight. This
difference is due to two key factors: (1) any changes that occurred in
the cost to provide physician services between 2006 and 2017, and (2)
the SAS data reflects relative costs for all physician ownership
practices while the 2006 AMA PPIS data reflected relative costs only
for self-employed physician practices.
We propose to split the Physician Compensation cost weight into two
cost categories: Physician Wages and Salaries, and Physician Benefits.
The Physician Wages and Salaries cost weight is calculated by
multiplying the total Physician Compensation weight by the ratio of the
gross payroll to the sum of gross payroll and employer's cost for
fringe benefits in the 2017 SAS data, which is 83 percent. The
Physician Benefits cost weight is calculated by multiplying the total
physician compensation weight by the ratio of the employee benefits to
the sum of gross payroll and employer's cost for fringe benefits in the
2017 SAS data, which is 17 percent. As a result, the proposed Physician
Wages and Salaries cost weight is 39.226 percent and the proposed
Physician Benefits cost weight is 8.034 percent in the 2017-based MEI.
b. Practice Expenses
The Practice Expenses cost weight reflects all remaining operating
costs other than physician compensation. We propose to determine the
remaining Practice Expense cost weights in the 2017-based MEI using the
2017 SAS Expense data for NAICS 6211 expressed as a percentage of total
costs. The explanations for the derivation of the individual cost
weights under Practice Expenses are detailed below.
(1) Non-Physician Compensation
We propose to estimate the cost weight for Non-physician
Compensation using the 2017 SAS data for these expenses. As mentioned
previously, since the compensation expenses in the SAS data are only
reported as an aggregate for all employees, we are proposing to
multiply the 2017 SAS total compensation expenses for NAICS 6211 by
36.8 percent, which is the residual of the 63.2-percent share
determined for physicians (including nonphysician practitioners that
can bill independently such as NPs, PAs, and other clinical personnel).
Then, we multiply the total compensation expenses by the ratio of
nonphysician compensation expenses to total compensation expenses. This
results in the proposed Non-physician Compensation cost weight of
24.716 percent in the proposed 2017-based MEI.
Next, we propose to split the Non-physician Compensation cost
weight into two cost categories: Non-physician Wages and Salaries, and
Non-physician Benefits. The Non-physician Wages and Salaries cost
weight is calculated by multiplying the total Non-physician
Compensation cost weight by ratio of the gross payroll to the sum of
gross payroll and employer's expense for fringe benefits in the 2017
SAS data, which is 83 percent. The Non-physician Benefits cost weight
is calculated by multiplying the total Non-physician Compensation
weight by the ratio of the employee benefits to the sum of gross
payroll and employer's expenses for fringe benefits in the 2017 SAS
data, which is 17 percent. As a result, the proposed Non-physician
Wages and Salaries cost weight is 20.514 percent in the proposed 2017-
based MEI and the proposed Non-physician Benefits cost weight is 4.202
percent. For comparison purposes, the 2006-based MEI cost weights are
11.885 percent and 4.668 percent, respectively. We are also proposing
to disaggregate the Non-physician Wages and Salaries cost weight into
two categories: (1) Health-related, non-physician and (2) Nonhealth,
non-physician Wages and Salaries.
Of the 36.8 percent of total SAS compensation costs associated with
non-physicians, 14.7 percent points are determined to be associated
with The Health-related, non-physician Wages and salaries. This
percentage reflects the mean hourly wages to total mean hourly wages
from the 2017 OEWS data for the following occupations: Health
Technologists and Technicians (29-2000); Other Healthcare Practitioners
and Technical (29-9000); and Healthcare Support (31-0000). Applying
this share (40 percent) to the Non-physician wages cost weight results
in a proposed weight of 8.208 percent for the health-related, non-
physician Wages and Salaries cost weight for the proposed 2017-based
MEI.
The remaining approximately 60 percent are associated with
Nonhealth, non-physician Wages and salaries (Salary 22.1 percentage
points of the 36.8 percent). This percentage reflects the mean hourly
wages to total mean hourly wages from the 2017 OEWS data for the
following occupations: Management (11-0000); Business and Financial
Operations (13-0000); Computer and Mathematical (15-0000); Architecture
and Engineering (17-0000); Life, Physical, and Social Science (19-
0000); Community and Social Service (21-0000); Legal (23-0000);
Education, Training, and Library (25-0000); Arts, Design,
Entertainment, Sports, and Media (27-0000); Protective Service (33-
0000); Food Preparation and Serving Related (35-0000); Building and
Grounds Cleaning and Maintenance (37-0000); Personal Care and Service
(39-0000); Sales and Related (41-0000);
[[Page 46045]]
Office and Administrative Support (43-0000); Construction and
Extraction (47-0000); Installation, Maintenance, and Repair (49-0000);
Production (51-0000); and Transportation and Material Moving (53-0000).
Applying this share (60 percent) to the non-physician wages cost weight
results in a proposed weight of 12.306 percent for the Nonhealth, non-
physician Wages and Salaries cost weight for the proposed 2017-based
MEI.
Next, since the non-health, non-physician wages represent various
types of occupations that may experience different wage inflation
pressures, we propose to disaggregate the Non-health, non-physician
Wages and Salaries cost weight of 12.306 percent into four occupational
subcategories. To arrive at a distribution for these separate
occupational categories (Professional Related (PR) workers, Managers,
Clerical workers, and Service workers), we determined an estimate of
annual earnings for each using the Standard Occupational Classification
(SOC) system. The professional and related wages salaries consist of
the following occupational categories: Business and Financial
Operations (13-0000); Computer and Mathematical (15-0000); Architecture
and Engineering (17-0000); and Life, Physical, and Social Science (19-
0000). The Clerical wages salaries consist of the occupational category
Office Administrative Support (43-0000). The Services wages salaries
consist of the following occupational categories: Community and Social
Service (21-0000); Arts, Design, Entertainment, Sports, and Media (25-
0000); Protective Service (33-0000); Food Preparation and Serving
Related (35-0000); Building and Grounds Cleaning and Maintenance (37-
0000); Personal Care and Service (39-0000); Sales and Related (41-
0000); Construction and Extraction (47-0000); Installation,
Maintenance, and Repair (49-0000); Production (51-0000); and
Transportation and Material Moving (53-0000).
The Non-health, non-physician Wages and Salaries cost weight of
12.306 percent is multiplied by the relative share of each category to
arrive at the detailed distribution. The occupational distribution in
the proposed 2017-based MEI, as well as the distribution for the 2006-
based MEI is presented in Table 31.
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(2) Other Practice Expenses
We propose that the remaining aggregate Other Practice Expenses
would be derived using the 2017 NAICS 6211 SAS expense data and
calculated as the sum of the expenses for the detailed categories
expressed as a percentage of total expenses. The aggregate Other
Practice Expenses include all SAS expenses other than gross annual
payroll, fringe benefits, and temporary staff and leased employee
expenses. Additionally, we propose to remove the estimated expenses for
drugs and separately billable supplies (which are paid outside of the
PFS system) from total expenses in order to be consistent with the PFS.
The Other Practice Expenses share of total costs in the proposed 2017-
based MEI is 28.023 percent compared to a cost weight of 32.582 percent
in the 2006-based MEI.
We further propose to use the 2017 SAS data for NAICS 6211 to
disaggregate the Other Practice Expenses into the following ten cost
categories: Utilities; All Other Products; Telephone; Administrative
Support & Waste Services; All Other Services; Professional, Scientific,
and Technical; Fixed Capital; Moveable Capital; Professional Liability
Insurance; and Medical Supplies. Table 32 shows the 10 detailed cost
weights for the Other Practice Expenses for the 2017-based MEI, which
is 6 fewer categories than the 2006-based MEI. The major differences
are: (1) we propose to have one cost category for All Other Products in
the proposed 2017-based MEI instead of having separate cost categories
for Chemicals, Paper, Rubber and Plastics, and Other Miscellaneous
Products as done for the 2006-based MEI, (2) we propose to eliminate
the separate cost category for Postage as the cost weight was small
(less than 0.2 percentage point) and include the expenses for postage
in the proposed All Other Products cost weight, and (3) we propose to
eliminate the cost category for Medical Equipment as the cost weight
for the Moveable Capital in the proposed 2017-based MEI includes the
expenses for all types of machinery and equipment, including medical
equipment; we do not have a data source available to split the expenses
between Medical Equipment and All Other Equipment in the SAS or I/O
data.
[[Page 46046]]
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As previously mentioned, we are proposing to make one adjustment to
the medical supplies expenses as reported on the SAS data to exclude
estimated expenses associated with drugs and separately billable
supplies. We propose to make this adjustment in order to exclude the
expenses that are paid outside of the PFS and to be consistent with the
expenses that were also excluded in the 2006-based MEI. Finally, we
propose to use the BEA 2012--Benchmark I/O data aged to 2017 to
determine the split between All Other Products and All Other Services
that are captured in the residual ``all other expenses'' line in the
2017 SAS data. The BEA 2012--Benchmark I/O data can be accessed at
https://www.bea.gov/industry/input-output-accounts-data#supplemental-estimate-tables. We note that this method of splitting residual
expenses is similar to the methodology used in the 2006-based MEI where
the 2002 Benchmark I/O data was aged to 2006 to further disaggregate
the residual expense from the AMA PPIS.
The following is a description of the types of expenses included in
each of the detailed categories under Other Practice Expenses:
(a) Utilities
The proposed weight for Utilities was calculated using the 2017 SAS
expense data expressed as a percentage of total expenses. Utilities
expenses are calculated as the sum of the expenses from SAS for: (1)
purchased electricity, (2) purchased fuels (except motor fuels), and
(3) water, sewer, refuse removal, and other utility payments. The SAS
survey questionnaire defines the purchased electricity expenses as
costs paid for electricity. The SAS survey questionnaire defines the
purchased fuels (except motor fuels) as the costs for fuel for heating,
power, or generating electricity (e.g., natural gas, propane, oil,
coal). The SAS survey questionnaire defines the water, sewer, refuse
removal, and other utility payments as the costs for hazardous waste
removal. If the utility payments for any of these expenses are included
with lease and rental payments then they are captured in the SAS
question for lease and rental payments for land, building, structures,
storage spaces, or offices. The proposed cost weight for Utilities in
the 2017-based MEI is 0.366 percent.
(b) Telephone Services
The Telephone cost weight in the proposed 2017-based MEI includes
2017 SAS expenses reported for purchased communication services. The
SAS survey questionnaire defines purchased communication services as
telephone, cellular, and fax services; computer-related communications
(for example, internet, connectivity, online), and other wired and
wireless communication services. The proposed cost weight for Telephone
Services is 0.471 percent.
(c) All Other Products
The proposed cost weight for All Other Products for the proposed
2017-based MEI was calculated in two steps. First, all other operating
expenses are calculated as a percentage of total expenses from the 2017
SAS, which was 9.158 percent. The SAS survey questionnaire defines the
All other operating expenses as operating expenses not reported or
captured by any other survey expense question or specifically excluded
in the general instructions. These expenses specifically excluded in
the general instructions are: transfers made within the company,
capitalized expenses, interest, bad debt, impairment, and income tax.
Second, All Other Products expenses are calculated as the estimated
percentage of expenses from SAS for all other operating expenses using
Benchmark I/O data. In order to split the aggregate all other operating
expenses, which reflects both products and services, we propose to rely
on the 2012 Benchmark I/O data for NAICS 6211, Offices of Physicians
aged to 2017 for the NAICS categories that align with expenses in the
SAS all other operating expenses. The process for doing this is
explained step by step as follows:
Step 1: We crosswalked the NAICS categories in the 2012 Benchmark
I/O data to the expense questions in the 2017 SAS data. This process
allowed for all Benchmark I/O costs to be grouped into similar buckets
as the SAS Expenses as closely as possible
Step 2: We aged the 2012 Benchmark I/O costs to 2017 for each of
the following major buckets of expenses: Physician Compensation, Non-
Physician Compensation, Capital-related expenses (fixed and moveable),
PLI, Professional Services, Other Products, Other Services, Utilities,
and Medical Supplies using the growth of
[[Page 46047]]
the various price proxies used for these cost categories in the 2006-
based MEI.
Step 3: The share of each of the aged 2012 I/O expenses were
calculated as a percentage of the total aged 2012 I/O expenses. The
aged 2012 I/O categories of other products and other services were
estimated to account for about 9.6 percent of total costs. This share
is similar to the SAS residual cost share weight of 9.158 percent
The following Table 33 shows the Benchmark I/O NAICS categories
that were crosswalked to the SAS all other operating expenses for all
other product expenses.
BILLING CODE 4120-01-P
[[Page 46048]]
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BILLING CODE 4120-01-C
[[Page 46049]]
Step 4: The share of expenses for the aged 2012 Benchmark I/O all
other products to the aged total all other operating expenses in the
Benchmark I/O were calculated. This resulted in products accounting for
22.4 percent and services accounting for 77.6 percent of the I/O
expenses classified as all other costs. We then multiplied the SAS all
other operating expenses (9.158 percent) by 22.4 percent to estimate
expenses for the all other products .
Step 5: Lastly, we divided the estimated all other products SAS
expenses by the total SAS expenses and the resulting proposed 2017-
based MEI cost weight for All Other Products is 2.055 percent.
(d) Administrative Support and Waste Services
The proposed weight for Administrative Support and Waste for the
proposed 2017-based MEI is based on a portion of the 2017 SAS all other
operating expenses (Residual). Similar to the methodology to calculate
the All Other Products cost weight we follow a similar process for the
Administrative Support Waste Services cost weight and the All Other
Services cost weight discussed in the next section. First, we estimated
the total SAS residual expenses associated with other services by
multiplying the SAS all other operating expenses by 77.6 percent, or a
cost weight of 7.103 percent accounting for the SAS residual expenses
associated with services rather than products.
Next, we carved out a portion of these all other services expenses
that we identified as Administrative Support and Waste Services from
the I/O categories as shown in Table 34 below. These categories
accounted for about 26 percent of All other operating expenses.
Finally, we divided the estimated Administrative Support and Waste
Services expenses by the Total SAS Expenses and the resulting proposed
2017-based MEI cost weight for Administrative Support and Waste
Services is 2.341 percent.
[GRAPHIC] [TIFF OMITTED] TP29JY22.074
(e) All Other Services
The proposed weight for All Other Services for the proposed 2017-
based MEI was determined in two steps. First, as was done for other
products, we identified I/O categories (as shown in Table 35)
associated with other services that would crosswalk to the 2017 SAS
data for all other operating expenses. Next, we carved out a portion of
these all other services expenses that were not assigned to
Administrative Support and Waste Services from the I/O categories, the
categories assigned to all other services are shown in Table 35. Using
this information, we determined that All Other Services accounted for
52 percent of the SAS expenses for other operating expenses, or a
weight of 4.762 percent.
[[Page 46050]]
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Second, we also propose to include the expenses directly reported
on the SAS survey for purchased repairs and maintenance to machinery
and equipment in the other services category. The SAS survey
questionnaire defines these expenses to include expensed repair and
maintenance services to machinery, vehicles, equipment, and computer
hardware. These expenses accounted for 0.461 percent of total expenses,
and when added to the 4.762 percent calculated above, results in a
proposed 2017-based MEI cost weight for All Other Services of 5.223
percent.
(f) Professional, Scientific, and Technical Services
The Professional, Scientific and Technical Services cost weight
includes the sum of the 2017 SAS expenses for three categories: (1)
data processing and other purchased computer services, (2) purchased
advertising and promotional services, and (3) purchased professional
and technical services. The SAS survey questionnaire defines data
processing and other purchased computer services to include expenses
for web hosting, computer facilities management services, computer
input preparation, data storage, computer time rental, optical scanning
services, and other computer-related advice and services (including
training). The SAS survey questionnaire defines purchased advertising
and promotional services to include marketing and public relations
services. The SAS survey questionnaire defines purchased professional
and technical services to include management consulting, accounting,
auditing, bookkeeping, legal, actuarial, payroll processing,
architectural, engineering, and other professional services. The cost
weight for Professional, Scientific, and Technical Services is 6.350
percent in the proposed 2017-based MEI.
(g) Fixed Capital
The Fixed Capital cost weight includes the sum of the 2017 SAS
expenses for four categories: (1) purchased repairs and maintenance to
buildings, structures, and offices, (2) lease and rental payments for
land, buildings, structures, store spaces, and offices, (3) an
estimated portion of depreciation and amortization charges, and (4)
governmental taxes and license fees. The SAS survey questionnaire
defines purchased repairs and maintenance to buildings, structures, and
offices as repair and maintenance to integral parts of buildings (for
example, elevators, heating systems). The SAS survey questionnaire
defines lease and rental payments for land, buildings, structures,
store spaces, and offices to include the rental or lease expenses paid
for these items including any penalties incurred for broken leases. The
SAS survey questionnaire defines depreciation and amortization charges
to include depreciation charges taken against tangible assets owned and
used by this firm, tangible assets owned and used by this firm within
leaseholds, tangible assets obtained through capital lease agreements,
and amortization charges against intangible assets (patents,
copyrights). We propose to include the share of the depreciation
expenses applicable to only the structures by multiplying the total
[[Page 46051]]
depreciation expenses by the share of total lease and rental payments
that were associated with land, buildings, structures, store spaces,
and offices as reported on the SAS, which is 89 percent. The SAS survey
question defines governmental taxes and license fees as payments to
government agencies for taxes and licenses including business and
property taxes. The proposed cost weight for Fixed Capital for the
proposed 2017-based MEI is 5.527 percent.
(h) Moveable Capital
The Moveable Capital cost weight includes the sum of the 2017 SAS
expenses for five categories: (1) expensed equipment, (2) expensed
purchases of other materials, parts, and supplies, (3) expensed
purchases of software, (4) an estimated portion of depreciation and
amortization charges, and (5) lease and rental payments for machinery,
equipment, and other tangible items. The SAS survey questionnaire
defines expensed equipment as expensed computer hardware and other
equipment (for example, copiers, fax machines, phones, shop and lab
equipment, CPUs, monitors). The SAS survey questionnaire defines
depreciation and amortization charges to include depreciation charges
taken against tangible assets owned and used by this firm, tangible
assets owned and used by this firm within leaseholds, tangible assets
obtained through capital lease agreements, and amortization charges
against intangible assets (patents, copyrights). We propose to include
the share of the depreciation expenses applicable to only the machinery
equipment by multiplying the total depreciation expenses by the share
of total lease and rental payments associated with machinery equipment
as reported on the SAS, which is 11 percent. The SAS survey question
defines lease and rental payments for machinery, equipment, and other
tangible items as lease and rental of transportation equipment without
operators including penalties incurred for broken lease agreements. The
proposed cost weight for Moveable Capital for the proposed 2017-based
MEI is 2.221 percent.
(i) Professional Liability Insurance (PLI)
The Professional Liability Insurance (PLI) cost weight includes
2017 SAS expenses reported for professional liability insurance. The
SAS survey questionnaire defines professional liability insurance as
the premiums paid for professional liability insurance and the amounts
set aside for self-insurance. The proposed cost weight for PLI is 1.398
percent in the proposed 2017-based MEI.
(j) Medical Supplies
The Medical Supplies cost weight includes 2017 SAS expenses
reported for Medical supplies with an adjustment to remove the
estimated expenses for drugs and separately billable medical supplies.
The SAS survey questionnaire defines medical supplies as the materials
and supplies used to provide medical services to others (except for
medical equipment). Since the reported expenses in the SAS would
include the expenses for drugs and biologicals, as well as the expenses
for supplies that generally are paid separately under Medicare we
propose to remove the expenses for these two items from the SAS
expenses reported using the following methodology:
Step 1: To remove the separately billable drug expenses, we rely on
the reported expenses for separately billable drugs from the 2006 AMA
PPIS data. We inflate the reported AMA PPIS expenses for separately
billable drugs to 2017 using the growth in Medicare Part B physician-
administered drug spending. Using this method, we inflate the 2006 AMA
PPIS expenses for separately billable drugs to 2017 by an increase
factor of 1.784 (or 78.4 percent).
Step 2: To remove the non-separately billable drug expenses, we
rely on a similar method where we start with the reported expenses for
non-separately billable drugs from the 2006 AMA PPIS data. We inflate
the reported AMA PPIS expenses for non-separately billable drugs to
2017 using the growth in the PPI for prescription drugs. Using this
method, we inflate the 2006 AMA PPIS expenses for non-separately
billable drugs to 2017 by an increase factor of 2.122 (or 112.2
percent).
Step 3: To remove the non-separately billable supply expenses, we
start with the reported expenses for non-separately billable supplies
from the 2006 AMA PPIS data. We inflate the reported AMA PPIS expenses
for non-separately billable supplies to 2017 using the growth in the
Medical supplies price proxy in the 2006-based MEI (a 50/50 blend of
the PPI--Commodity--Medical and surgical appliances and supplies and
the CPI--Medical equipment and supplies). Using this method, we inflate
the 2006 AMA PPIS expenses for non-separately billable supplies to 2017
by an increase factor of 1.048 (or 4.8 percent).
Step 4: We then calculate the share of estimated 2017 expenses for
all drugs and separately billable supplies from steps 1-3 as a
percentage of total drugs and medical supplies expenses from the 2017
SAS for NAICS 6211. This share is 80 percent.
Step 5: We multiply the SAS 2017 total medical supplies expenses by
a factor of 0.2 (or 1-0.8) in order to estimate the 2017 SAS expenses
for non-separately billable medical supplies only.
Taking the 2017 estimated expenses for non-separately billable
medical supplies as a ratio of total expenses as reported on the 2017
SAS for NAICS 6211 results in a proposed Medical Supplies cost weight
of 2.071 percent in the proposed 2017-based MEI.
3. Selection of Price Proxies for Use in the MEI
To select prices proxies for the proposed 2017-based MEI cost
categories, most of the proxy measures we considered are based on BLS
data and are grouped into one of the following four categories:
Producer Price Indices (PPIs): PPIs measure the average
change over time in the selling prices received by domestic producers
for their output. The prices included in the PPI are from the first
commercial transaction for many products and some services (https://www.bls.gov/ppi/).
Consumer Price Indices (CPIs): CPIs measure the average
change over time in the prices paid by urban consumers for a market
basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs
are only used when the purchases are similar to those of retail
consumers rather than purchases at the producer level, or if no
appropriate PPIs are available or if the particular expenditure
category is likely to contain purchases made at the final point of
sale.
Employment Cost Indices (ECIs): ECIs measure the rate of
change in employee wage rates and employer costs for employee benefits
per hour worked. These indexes are fixed-weight indexes and strictly
measure the change in wage rates and employee benefits per hour. ECIs
are superior to Average Hourly Earnings (AHE) as price proxies for
input price indexes because they are not affected by shifts in
occupation or industry mix, and because they measure pure price change
and are available by both occupational group and by industry. The
industry ECIs are based on the NAICS and the occupational ECIs are
based on the Standard Occupational Classification System (SOC). We
evaluated the price proxies using the criteria of reliability,
timeliness, availability, and relevance:
Reliability: Reliability indicates that the index is based
on valid statistical
[[Page 46052]]
methods and has low sampling variability. Widely accepted statistical
methods ensure that the data were collected and aggregated in a way
that can be replicated. Low sampling variability is desirable because
it indicates that the sample reflects the typical members of the
population. (Sampling variability is variation that occurs by chance
because only a sample was surveyed rather than the entire population.)
Timeliness: Timeliness implies that the proxy is published
regularly, preferably at least once a quarter. The market basket levels
are updated quarterly, and therefore, it is important for the
underlying price proxies to be up-to-date, reflecting the most recent
data available. We believe that using proxies that are published
regularly (at least quarterly, whenever possible) helps to ensure that
we are using the most recent data available to update the market
basket. We strive to use publications that are disseminated frequently,
because we believe that this is an optimal way to stay abreast of the
most current data available.
Availability: Availability means that the proxy is
publicly available. We prefer that our proxies are publicly available
because this will help ensure that our market basket updates are as
transparent to the public as possible. In addition, this enables the
public to be able to obtain the price proxy data on a regular basis.
Relevance means that the proxy is applicable and
representative of the cost category weight to which it is applied. We
believe the proposed PPIs, CPIs, and ECIs selected meet these criteria.
Therefore, we believe that they continue to be the best measure of
price changes for the cost categories to which they would be applied.
In this rule, we present a detailed explanation of the price proxies
that we are proposing for each cost category weight. We note that many
of the proxies that we are proposing to use for the proposed 2017-based
MEI (as shown in Table 36) are the same as those used in the 2006-based
MEI except as noted below.
a. Physician Compensation
(1) Physician Wages and Salaries
We propose to continue to use the ECI for Wages and Salaries for
Professional and Related Occupations (Private Industry) (BLS series
code CIU2020000120000I) to measure price growth of this category in the
proposed 2017-based MEI. We believe this price proxy reflects the wage
pressures faced by physicians in that it captures wage trends in labor
markets of skilled professional workers without being directly affected
by trends in physician income that may be influenced by the ownership
structure of physician practices. This price proxy also follows the
recommendation of the MEI-TAP that the price proxy would maintain
consistency with the guidance provided in the 1972 Senate Finance
Committee report titled ``Social Security Amendments of 1972,'' which
stated that the index should reflect changes in practice expenses and
``general earnings''. This is the same proxy used in the 2006-based
MEI.
(2) Physician Benefits
We propose to continue to use the ECI for Benefits for Professional
and Related Occupations (Private Industry) to measure price growth of
this category in the proposed 2017-based MEI. The ECI for Benefits for
Professional and Related Occupations is derived using BLS's Total
Compensation for Professional and Related Occupations (BLS series ID
CIU2010000120000I) and the relative importance of wages and salaries
within total compensation. We believe this series is technically
appropriate because it better reflects the benefit trends for
professionals requiring advanced training. This is the same proxy used
in the 2006-based MEI.
b. Practice Expense
(1) Non-Physician, Non-Health-Related Wages and Salaries
Professional and Related: We propose to continue using the
ECI for Wages and Salaries for Professional and Related Occupation
(Private Industry) (BLS series code CIU2020000120000I) to measure the
price growth of this cost category. This is the same proxy used in the
2006-based MEI.
Management: We propose to continue using the ECI for Wages
and Salaries for Management, Business, and Financial (Private Industry)
(BLS series code CIU2020000110000I) to measure the price growth of this
cost category. This is the same proxy used in the 2006-based MEI.
Clerical: We propose to continue using the ECI for Wages
and Salaries for Office and Administrative Support (Private Industry)
(BLS series code CIU2020000220000I) to measure the price growth of this
cost category. This is the same proxy used in the 2006-based MEI.
Services: We propose to continue using the ECI for Wages
and Salaries for Service Occupations (Private Industry) (BLS series
code CIU2020000300000I) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(2) Non-Physician, Health-Related Wages and Salaries
We propose to continue to use the ECI for Wages and Salaries for
Hospital Workers (Private Industry) (BLS series code CIU2026220000000I)
to measure the price growth of this cost category in the proposed 2017-
based MEI. The ECI for Hospital workers has an occupational mix that
approximates that of physicians' offices. This is the same proxy used
in the 2006-based MEI.
(3) Non-Physician Benefits
We propose to continue using a composite ECI for non-physician
employee benefits in the proposed 2017-based MEI. The weights and price
proxies for the composite benefits index are shown in Table 36, which
lists the five ECI series and corresponding weights used to construct
the proposed composite benefit index for nonphysician employees in the
proposed 2017-based MEI. We note the ECI benefits series are derived
based on BLS published data from the applicable Total Compensation ECI
and Wages & Salaries ECI as BLS does not publish the ECI Benefit
Indexes directly.
[[Page 46053]]
[GRAPHIC] [TIFF OMITTED] TP29JY22.076
(4) Other Practice Expense
(a) Utilities
We propose to continue using the CPI for Fuel and Utilities (BLS
series code CUUR0000SAH2) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(b) All Other Products
We propose to use the PPI--Final demand--Finished goods less foods
and energy (BLS series code WPUFD413) as the price proxy for this
category. We believe that the expenses that physician purchase for use
in providing physicians services are better reflected by purchases at
the wholesale or producer level rather than at the consumer level and
the growth in overall prices less food and energy provides a good
approximation for the inflation pressures experienced for these
expenses. The 2006-based MEI used several PPI and CPI series to proxy
the price growth for the products reflected in this category.
(c) Telephone
We propose to continue using the CPI for Telephone Services (BLS
series code CUUR0000SEED) to measure the price growth of this cost
category in the proposed 2017-based MEI. This is the same proxy used in
the 2006-based MEI.
(d) Professional, Scientific, and Technical Services
We propose to continue to use the ECI for Total Compensation for
Professional, Scientific, and Technical Services (Private Industry)
(BLS series code CIU2015400000000I) to measure the price growth of this
cost category in the proposed 2017-based MEI. This is the same proxy
used in the 2006-based MEI.
(e) Administrative and Support Services
We propose to continue to use the ECI for Total Compensation for
Administrative, Support, Waste Management, and Remediation Services
(Private Industry) (BLS series code CIU2015600000000I) to measure the
price growth of this cost category in the 2017-based MEI. This is the
same proxy used in the 2006-based MEI.
(f) All Other Services
We are proposing to continue to use the ECI for Compensation for
Service Occupations (Private Industry) (BLS series code
CIU2010000300000I) to measure the price growth of this cost category.
(g) Fixed Capital
We propose to continue to use the PPI for Lessors of Nonresidential
Buildings (BLS series code PCU531120531120) to measure the price growth
of this cost category in the proposed 2017-based MEI. This is the same
proxy used in the 2006-based MEI.
(h) Moveable Capital
We propose to continue to use the PPI for Machinery and Equipment
(series code WPU11) to measure the price growth of this cost category
in the proposed 2017-based MEI. This is the same proxy used in the
2006-based MEI.
(i) Professional Liability Insurance
Unlike the other price proxies based on data from BLS and other
public sources, the proxy for PLI is based on data collected directly
by CMS from a sample of commercial insurance carriers. The MEI-TAP
discussed the methodology of the CMS PLI index, as well as considered
alternative data sources for the PLI price proxy, including information
available from BLS and through State insurance commissioners. As
detailed in the CY 2014 PFS final rule (78 FR 74271), the MEI-TAP
``believes the current index appropriately reflects the price changes
in premiums throughout the industry.'' Accordingly, we propose to
continue using the CMS Physician PLI index to measure the price growth
of this cost category in the proposed 2017-based MEI. This is the same
proxy used in the 2006-based MEI.
(j) Medical Supplies
We propose to continue using a blended index comprised of 50/50
blend of the PPI for Surgical Appliances (BLS series code WPU156301)
and the CPI-U for Medical Equipment and Supplies (BLS series code
CUUR0000SEMG). This is the same proxy used in the 2006-based MEI.
Table 37 shows the proposed 2017-based MEI cost categories, weights
and price proxies.
BILLING CODE 4120-01-P
[[Page 46054]]
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BILLING CODE 4120-01-C
4. Productivity Adjustment to the MEI
The MEI has been adjusted for changes in productivity since its
inception. In the CY 2003 PFS final rule with comment period (67 FR
80019), we implemented a change in the way the MEI was adjusted to
account for changes in productivity. The MEI used for the 2003
physician payment update incorporated changes in the 10-year moving
average of private nonfarm business (economy-wide) total factor
productivity (previously referred to as multifactor productivity) that
were applied to the entire index. Previously, the index incorporated
changes in productivity by adjusting the labor portions of the index by
the 10-year moving average of economy-wide private nonfarm business
labor productivity.
The MEI-TAP's Finding 5.1 states that, ``[t]he Panel reviewed the
basis for the current economy-wide multifactor productivity adjustment
(Private
[[Page 46055]]
Nonfarm Business Multifactor Productivity) in the MEI and finds such an
adjustment continues to be appropriate. This adjustment prevents
``double counting'' of the effects of productivity improvements, which
would otherwise be reflected in both (i) the increase in compensation
and other input price proxies underlying the MEI, and (ii) the growth
in the number of physician services performed per unit of input
resources, which results from advances in productivity by individual
physician practices.''
We propose to continue to use the current method of applying a
productivity adjustment to the full MEI increase factor in the proposed
2017-based MEI. As described in the CY 2003 PFS final rule with comment
period, we believe this adjustment is appropriate because it explicitly
reflects the productivity gains associated with all inputs (both labor
and non-labor). We believe that using the 10-year moving average
percent change in economy-wide total factor productivity is appropriate
for deriving a stable measure that helps alleviate the influence that
the peak (or a trough) of a business cycle may have on the measure. The
adjustment will be based on the latest available historical economy-
wide nonfarm business total factor productivity data as measured and
published by BLS.
5. Results of Proposed Rebasing and Revising of the MEI
Table 38 illustrates the results of the proposed update to the MEI
cost weights for Physician Compensation, Practice Expenses (excluding
PLI), and PLI from a 2006-based cost distribution to the proposed 2017-
based cost distribution, including all the proposals as specified.
[GRAPHIC] [TIFF OMITTED] TP29JY22.078
Table 39 shows the average calendar year percent change for CY
2016 to CY 2023 for both the 2006-based MEI and proposed 2017-based
MEI. The proposed 2017-based MEI annual percent changes differ from the
2006-based MEI annual percent changes by 0.1 to 0.2 percentage point
for any given year.
[GRAPHIC] [TIFF OMITTED] TP29JY22.079
As shown in Table 39, the percent change of the proposed 2017-based
MEI for the CY 2023 is an increase of 3.8 percent, one tenth of a
percentage point higher than the 2006-based MEI for the same period
based on the current expectation from the IGI 2022Q1 forecast with
historical data through 2021Q4. The CY 2023 MEI increase factors for
the 2006-based MEI and the proposed 2017-based MEI will be updated to
reflect historical data available (through 2022Q2) for the CY 2023 PFS
final rule.
III. Other Provisions of the Proposed Rule
A. Requiring Manufacturers of Certain Single-Dose Container or Single-
Use Package Drugs To Provide Refunds With Respect to Discarded Amounts
Sec. Sec. 414.902 and 414.940)
1. Background
Drugs and biologicals payable under Medicare Part B fall into three
general categories: those furnished incident to a physician's service
(hereinafter referred to as ``incident to'') (section 1861(s)(2) of the
Act), those administered via a covered item of durable medical
equipment (DME) (section 1861(s)(6) of the Act), and others as
specified by statute (for example, certain vaccines described in
sections 1861(s)(10)(A) and (B) of the Act). Payment limit amounts for
most drugs and biologicals separately payable under Medicare Part B are
determined using the methodology
[[Page 46056]]
in section 1847A of the Act, and in many cases, payment is based on the
average sales price (ASP) plus a statutorily mandated 6 percent add-on.
Most drugs payable under Part B are covered under the ``incident to''
benefit under section 1861(s)(2) of the Act, which includes drugs and
biologicals not usually self-administered by the patient.
Many drugs and biologicals (hereafter referred to as a drugs)
payable under Medicare Part B are dosed in a variable manner such that
the entire amount identified on the vial or package is not administered
to the patient. For example, many drugs are dosed based on the
patient's body weight or body surface area (BSA). Often times, these
drugs are available only in single-dose containers. As stated in U.S.
Food and Drug Administration (FDA) guidance for industry,\88\ a single-
dose container is designed for use with a single patient as a single
injection or infusion. The FDA-approved labeling for a drug packaged in
a single-dose container typically states that any extra amount of the
drug remaining after the dose is administered must be discarded. When a
provider must discard the amount of drug that was unused (that is, the
discarded amount) from a single-dose container or other single-use
package of a drug after administering a dose to a Medicare beneficiary,
the program provides payment for the unused and discarded amount as
well as the dose administered, up to the amount of the drug indicated
on the vial or package labeling. On a Medicare Part B claim, the JW
modifier (Drug amount discarded/not administered to any patient) is a
Healthcare Common Procedure Coding System (HCPCS) Level II modifier
used to report the amount of a drug that is discarded and eligible for
payment.
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\88\ https://www.fda.gov/media/117883/download.
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Beginning on January 1, 2017, CMS revised the JW modifier policy to
require the uniform use of the modifier for all claims for separately
payable drugs with discarded drug amounts from single use vials or
single use packages payable under Part B in order to more effectively
identify and monitor billing and payment for discarded amounts of
drugs.89 90 The policy does not apply to drugs that are not
separately payable, such as packaged hospital outpatient prospective
payment system (OPPS) drugs or those administered in the Federally
qualified health centers (FQHC) or rural health clinics (RHC) setting.
Additional details about this policy can be found in Chapter 17 of the
Medicare Claims Processing Manual \91\ and in the JW modifier
frequently asked questions (FAQ) document.\92\
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\89\ CF6603: https://www.cms/gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3538CP.pdf.
\90\ MLN Matters[supreg] Number MM9603: https://www.cms/gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf.
\91\ https://www.cms/gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf.
\92\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-PAQs.pdf.
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Medicare Part B data for discarded amounts of drug (based on the JW
modifier) have been published on the CMS website annually for calendar
years beginning in 2017.\93\ Data for 2020 shows that Medicare paid
nearly $720 million for discarded amounts of drugs from a single-dose
container or single-use package (hereafter referred to as single-dose
container) paid under Part B with claims identifying the discarded
amounts with the JW modifier. JW modifier data from 2020 is the most
recent available at the time of this analysis. This data is comparable
to 2017-2019 with regards to percentage of discarded amounts and total
Medicare spending for discarded drugs each year, which ranged from
approximately $700-750 million each year during that time. More than
half of Medicare spending for discarded amounts in 2020 represents
about 40 billing and payment codes (that is, HCPCS codes), for which 10
percent or more of the total charges for the drug were for discarded
units. A large proportion of single source drugs with 10 percent or
more discarded units are dosed based on patient's body weight or BSA.
We note that the JW modifier data published on the CMS website is
limited to only billing and payment codes that are published on the ASP
Drug Pricing File.\94\ There are likely additional billing and payment
codes payable under Medicare Part B available in single-dose containers
that would be subject to the JW modifier policy and are not reflected
in the data discussed above.
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\93\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
\94\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice.
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When the calculated dose (based on weight or BSA) is drawn from one
or more vials and any remaining amount of the drug is discarded. For
example, if labeled dose of a drug is 20 mg/m\2\, the dose for a
patient with a BSA of 1.9 m\2\ (the approximate average BSA of an adult
male) would be 38 mg. If the drug is available in single-dose 60-mg
vials, then 38 mg would be administered to the patient and 22 mg (36.67
percent) would be discarded. If the ASP payment limit amount
(typically, ASP plus 6 percent) for this drug for a given quarter is
$190 per 1 mg, the total payment for the amount of drug that was
administered to the beneficiary would be $7,220 and for the amount of
drug that was discarded would be $4,180. Both the amount of drug
administered and the amount discarded (consistent with the discarded
drug policy) are subject to the deductible and coinsurance. For a
beneficiary who has already met the deductible, the coinsurance for the
entire 60-mg vial would be $2280. Since the vial in this example
contains enough drug to provide a 20 mg/m\2\ dose to an individual with
a BSA of 3 m\2\, the full amount of drug labeled on the vial would be
used in a small subset of patients.
Section 90004 of the Infrastructure Investment and Jobs Act (Pub.
L. 117-9, November 15, 2021) (hereinafter is referred to as ``the
Infrastructure Act'') amended section 1847A of the Act to redesignate
subsection (h) as subsection (i) and insert a new subsection (h), which
requires manufacturers to provide a refund to CMS for certain discarded
amounts from a refundable single-dose container or single-use package
drug. The refund amount is the amount of discarded drug that exceeds an
applicable percentage, which is required to be at least 10 percent, of
total charges for the drug in a given calendar quarter. A refundable
single-dose container or single-use package drug does not include a
radiopharmaceutical or imaging agent, certain drugs requiring
filtration, and certain new drugs. We are proposing implementation of
section 90004 of the Infrastructure Act below including: how discarded
amounts of drugs are determined; a definition of which drugs are
subject to refunds (and exclusions); when and how often CMS will notify
manufacturers of refunds; when and how often payment of refunds from
manufacturers to CMS is required; refund calculation methodology
(including applicable percentages); a dispute resolution process; and
enforcement provisions.
We are proposing regulatory changes to implement new section
1847A(h) of the Act at 42 CFR part 414, subpart K.
2. Discarded Amounts
The JW modifier has existed since 2003, and since 2017 its use has
been required on claims for separately payable Part B drugs that
include discarded amounts of single use vials or
[[Page 46057]]
single use packages. Currently, there are no other modifiers to measure
discarded units of Part B drugs. On the claim form, the amount of drug
administered is billed on one line (reflected as billing units in the
unit field); discarded amounts are billed on a separate line with the
JW modifier (reflected as billing units in the unit field). The term
``billing unit'' is defined in section 1847A(b)(6)(B) of the Act as the
identifiable quantity associated with a billing and payment code, as
established by the Secretary. For example, in a circumstance where a
single-dose container is labeled to contain 200 mg and the established
billing unit for the billing and payment code is 2 mg, then there are
100 billing units in the vial. If 95 billing units (190 mg) are
administered to the patient and 5 billing units (10 mg) are discarded,
the 95 billing units are billed on one line, and the discarded 5
billing units are billed on another line using the JW modifier. Both
line items are processed for payment.
The JW modifier must not be used to report discarded amounts of
overfill, which is any amount of drug greater than the amount
identified on FDA-approved labeling. Additional information on the
overfill policy is available in the Physician Fee Schedule Final Rule
published in the November 29, 2010 Federal Register (75 FR 73466
through 70). Contents of a vial or package that are considered overfill
are not included in the total billing units contained in the vial or
package and also do not count toward the number of billing units that
are discarded.
Section 1847A(h) of the Act specifies that discarded amounts of
refundable single-dose container or single-use package drugs are to be
determined using a mechanism such as the JW modifier used as of the
date of enactment of the Infrastructure Act or any successor modifier
that includes such data as determined appropriate by the Secretary. For
consistency with our current billing procedures and to minimize burden,
we propose to use the JW modifier or any successor modifier that
includes the same data to determine the total number of billing units
of a billing and payment code (that is, the identifiable quantity
associated with a billing and payment code, as established by CMS) of a
refundable single-dose container or single-use package drug (defined in
the next section), if any, that were discarded for dates of service
during such quarter. We propose to use the JW modifier (or any
successor modifier that includes the same data) to identify discarded
billing units of a billing and payment code for the purpose of
calculating the refund amount as described in section 1847A(h)(3) of
the Act.
Currently, under the Outpatient Prospective Payment System (OPPS)
and Ambulatory Surgical Center (ASC) Payment System, hospital
outpatient departments (HOPDs) and ASCs use the JW modifier to identify
all separately payable drugs and biologicals for which there is an
unused or discarded amount. For consistency with our current billing
procedures we propose that HOPDs would be required to report the JW
modifier or any successor modifier to identify discarded amounts of
refundable single-dose container or single-use package drugs described
by HCPCS codes that are assigned status indicator ``K'' (Nonpass-
Through Drugs and Nonimplantable Biologicals, Including Therapeutic
Radiopharmaceuticals) or status indicator ``G'' (Pass-Through Drugs and
Biologicals) under the OPPS. Specifically, we propose that the JW
modifier would be used to determine the total number of billing units
of the HCPCS code (that is, the identifiable quantity associated with a
HCPCS code, as established by CMS) of a refundable single-dose
container or single-use package drug (defined in the next section), if
any, assigned status indicator ``K'' or ``G'' that were discarded for
dates of service during such quarter for the purpose of calculating the
refund amount described in section 1847A(h)(3) of the Act. Similarly,
we propose that ASCs would be required to report the JW modifier or any
successor modifier to identify discarded amounts of refundable single-
dose container or single-use package drugs described by HCPCS codes
assigned payment indicator ``K2'' (`Drugs and biologicals paid
separately when provided integral to a surgical procedure on ASC list;
payment based on OPPS rate) under the ASC payment system. Specifically,
we propose that ASCs would be required to report the JW modifier or any
successor modifier that includes the same data to determine the total
number of billing units of the HCPCS code (that is, the identifiable
quantity associated with a HCPCS code, as established by CMS) of a
refundable single-dose container or single-use package drug (defined in
the next section), if any, assigned status indicator ``K2'' that were
discarded for dates of service during such quarter.
Consistent with section 1847A(h)(1)(C) of the Act, which excludes
units that are packaged into the payment amount for an item or service
and not separately payable, as well as current HOPD and ASC use of the
JW modifier, we propose that the JW modifier would not be required to
identify discarded amounts of drugs that are not separately payable,
such as drugs for which payment is packaged under the OPPS or ASC
payment system or drugs administered in the FQHC or RHC setting.
Specifically, in HOPD setting and the ASC setting, the JW modifier does
not apply to drugs that are described by HCPCS codes assigned status
indicator ``N'' (Items and Services Packaged into APC Rates) under the
OPPS or assigned to a payment indicator of ``N1'' (Packaged service/
item; no separate payment made) under the ASC payment system.
Similarly, we propose to exclude from the refund amount those units
of drugs for which payment is packaged into payment for a comprehensive
ambulatory payment classification (C-APC) service under the OPPS. We
propose to exclude such drugs when payment is packaged into a C-APC
service which is assigned to an OPPS status indicator of ``J1''
(Hospital Part B Services Paid Through a Comprehensive APC) or ``J2''
(Hospital Part B Services That May Be Paid Through a Comprehensive
APC). For example, if a drug under the OPPS is assigned to status
indicator ``K'', reports the JW or similar modifier, but is then
packaged into a C-APC service assigned to a status indicator of ``J1''
or ``J2'', we would exclude from the refund those units associated with
the packaged drug. For a complete list of all proposed OPPS status
indicator and ASC payment indicator descriptors, please see the
addendum D1 and addendum DD1 to the CY 2023 OPPS/ASC proposed rule,
which we expect to issue at around the same time as this proposed rule.
As described in the section III.A.1 of this proposed rule
(Background) and also in section III.A.6 of this proposed rule, section
1847A(h) of the Act requires manufacturers to provide refunds for
discarded amounts of refundable single-dose container or single-use
package drugs for which payment is made under Part B exceeding an
applicable percentage of 10 percent of the estimated total allowed
charges for such a drug (less the amount paid for packaged drugs)
during the quarter. Under our current discarded drug policy, no
modifier is required when there are no discarded amounts from a single
use vial or single use package drug. However, we are aware that the JW
modifier is often omitted on claims, and it is unclear whether the
absence of the JW modifier on a claim for a single-dose container drug
indicates that there were no discarded amounts or that the modifier was
incorrectly omitted from the claim. This
[[Page 46058]]
has led to incomplete data describing quantities of discarded amounts
and the associated Medicare payments. There are a number of possible
reasons why the modifier might be incorrectly omitted on the claim
form, including provider burden for documentation or lack of awareness
of the policy. In addition, there may not be strong incentive for
appropriate JW modifier use because Medicare pays for administered and
discarded amounts of the drug. For instance, if a provider administers
a portion and discards a portion of a single-use vial, but bills for
the entire vial as administered (incorrectly omitting the JW modifier),
the provider payment and beneficiary coinsurance amounts would be the
same as if the provider had correctly billed for the administered
amounts and the discarded amounts (using the JW modifier). The JW
modifier FAQs state that claims that do not use the modifier correctly
may be subject to review, but we do not have quantifiable numbers
regarding how often the modifier is omitted or how many discarded units
are not accounted for because of such omissions. Because JW modifier
data is incomplete and because refund amounts would rely on this data,
we propose that for dates of service on or after January 1, 2023, the
JW modifier be required on claims for all single-dose container or
single use drugs for which any amount is discarded (as reflected in our
current policy and proposed above), and a separate modifier be required
on claims for these drugs when there are no discarded amounts.
Specifically, we propose to require the use of a separate modifier, the
JZ modifier, to attest that there were no discarded amounts. To align
with the JW modifier policy, the JZ modifier would be required when
there are no discarded amounts from single use vials or single use
packages payable under Part B for which the JW modifier would be
required if there were discarded amounts. So, on all claims for single
use vials or single use packages payable under Part B, either the JW
modifier would be used (on a separate line) to identify any discarded
amounts or the JZ modifier (on the claim line with the administered
amount) would be present to attest that there were no discarded
amounts. We believe the proposed JZ modifier requirement would not
increase burden on the provider because under the current JW modifier
policy, the provider already needs to determine whether or not there
are any discarded units from a single use vial or package, record
discarded amounts in the patient medical record, and specify
administered and discarded amounts on the claim form.
We welcome comments on these proposals.
3. Refundable Single-Dose Container or Single-Use Package Drug
Section 90004 of the Infrastructure Act added section 1847A(h)(8)
of the Act, which defines in subparagraph (A) of such section the term
``refundable single-dose container or single-use package drug'' as a
single source drug or biological (as defined in section 1847A(c)(6)(D)
of the Act) or a biosimilar biological product (as defined in section
1847A(c)(6)(H) of the Act) for which payment is made under Part B and
that is furnished from a single-dose container or single-use package.
For the purposes of section 1847A(h) of the Act, we propose that
the definition of ``refundable single-dose container or single-use
package drug'' would apply to drugs paid under Medicare Part B (that
is, under any payment methodology) that are described as being supplied
in a ``single-dose'' container or ``single-use'' package based on FDA-
approved labeling or product information. This definition also includes
drugs described in FDA-approved labeling as a ``kit'' that is intended
for a single dose or single use. As discussed above in the background,
we note that the JW modifier data published on the CMS website is
limited to only billing and payment codes that are published on the ASP
Drug Pricing File. Therefore, there are likely billing and payment
codes payable under Medicare Part B that would meet the proposed
definition of refundable single-dose container or single-use package
drug that are not found on the ASP drug pricing file or the JW modifier
data published on the CMS website.
In our analysis of drugs that meet this definition, there may be a
need to revise existing billing and payment codes or establish a new
billing and payment codes for the purposes of implementing these
provisions because estimated total number of units discarded and total
allowed charges must be determined at the billing and payment code
level for the purpose of calculating refund amounts (described below in
section III.A.6. of this proposed rule). For example, if there is a
drug that meets the definition of refundable single-dose container or
single-use package drug that does not have a unique billing and payment
code, a new code may be needed for the purposes of estimating the total
number of units that were discarded during such quarter and the total
allowed charges.
There may be drugs for which there are national drug codes (NDCs)
of single-dose containers and NDCs of multiple-dose containers under
the same FDA approval, and these NDCs are assigned to the same billing
and payment code. We propose that for a drug to meet the definition of
``refundable single-dose container or single-use package drug,'' all
NDCs assigned to the drug's billing and payment code must be single-
dose containers or single-use packages, as described in each product's
labeling.
Section 1847A(h)(8)(B) of the Act specifies that the term
``refundable single-dose container or single-use package drug''
excludes drugs that are either radiopharmaceuticals or imaging agents,
drugs that require filtration during the drug preparation process, and
drugs approved on or after the date of enactment of the Infrastructure
Act (that is, November 15, 2021) for which payment under Part B has
been made for fewer than 18 months. Our proposals for implementing this
definition and its exclusions are discussed below.
a. Exclusions for Radiopharmaceuticals and Imaging Agents
Section 1847A(h)(8)(B)(i) of the Act excludes a drug or biological
that is either a radiopharmaceutical or an imaging agent. We propose to
identify radiopharmaceuticals (including therapeutic or diagnostic
radiopharmaceuticals) and imaging agents (including contrast agents
\95\) for purposes of the exception at section 1847A(h)(8)(B)(i) of the
Act by language describing them as such in FDA-approved labeling.
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\95\ https://www.fda.gov/media/72295/download.
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We propose to codify the exclusion of radiopharmaceuticals and
imaging agents from the definition of ``refundable single-dose
container or single-use package drug'' at Sec. 414.902.
b. Exclusions for Drugs Requiring Filtration
Section 1847A(h)(8)(B)(ii) of the Act excludes from the definition
of refundable single-dose container or single-use package a drug
approved by FDA for which dosage and administration instructions
included in the labeling require filtration during the drug preparation
process, prior to dilution and administration, and require that any
unused portion of such drug after the filtration process be discarded
after the completion of such filtration process. As the statute states,
for the purposes of this exclusion, the filtration must occur prior to
dilution and administration. Therefore, for example,
[[Page 46059]]
the definition excludes those drugs requiring filtration in order to
remove the product from a vial, such as drugs contained within ampules
or certain liposomal products that require filtration when removing the
product from the manufacturer's vial consistent with FDA labeling.
However, drugs that require in-line filters only as part of the drug
administration process would not meet this exclusion. We propose that,
consistent with section 1847A(h)(8)(B)(ii) of the Act, requirement for
filtration must be present on FDA labeling in order for the drug to be
excluded.
Additionally, consistent with our longstanding interpretation of
the distinction between multiple source drugs and single source drugs
(see program instructions available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), we are
proposing if there is any NDC under a single New Drug Application (NDA)
or Biologics License Application (BLA) that requires filtration as
described in section 1847A(h)(8)(B)(ii) of the Act, then all NDCs of
such drug or biological (that is, any billing and payment code to which
any such NDCs are assigned) would be excluded from the definition of
refundable single-dose container or single-use package drug, even if
other products under the relevant approval and assigned to that billing
and payment code do not require such filtration. We believe this is
appropriate because drugs and biologicals payable under Medicare Part B
are billed at the level of the billing and payment code (not with the
NDC of the individual product). If some products that require
filtration and some products that do not require filtration are
assigned to the same billing and payment code, we would not be able to
distinguish (based on JW modifier data) which discarded amounts were
from the filtered product and which were from the non-filtered product.
c. Exclusions for Drugs for Which Payment Under Medicare Part B Has
Been Made for Fewer Than 18 Months
Section 1847A(h)(8)(B)(iii) of the Act excludes from the definition
of refundable single-dose container or single-use package drugs
approved by FDA on or after November 15, 2021 and for which payment has
been made under Part B for fewer than 18 months. Typically, if their
use is reasonable and necessary and all other coverage requirements are
met, FDA-approved drugs become payable under Medicare Part B on the
date which they are marketed in the United States. However, we are not
able to reliably determine the exact date on which the first Part B
claim was paid for a particular new drug because they are usually first
billed using an unclassified drug or biological billing and payment
code. Therefore, our ability to accurately determine when payment for a
new drug has been made under Part B for 18 months is exceedingly
limited. Because of the operational challenges with identifying the
date of when the first Part B claim was paid for a new drug and because
this exclusion would be operationally difficult to implement if the 18-
month period ends in the middle of a calendar quarter, we believe it is
appropriate to measure the 18-month period using the first day of the
calendar quarter following the date of first sale as reported to CMS,
which is a required field for reporting ASP data.\96\ That is, for
purposes of this exclusion, we propose to consider the 18-month period
to begin on the first day of the calendar quarter following the date of
first sale as reported to CMS for the drug. Because 18 months is the
equivalent of six calendar quarters, under our proposed approach,
refundable single-dose container or single-use package drugs approved
or licensed by FDA on or after November 15, 2021 would be excluded from
the definition of refundable single-dose container or single-use
package, and thus, not subject to a refund, for the first 6 full
calendar quarters following the date of first sale for any NDCs of such
drug. Thereafter, that is, beginning with dates of service after the
last day of the sixth full sales quarter, the drug would no longer be
excluded from the definition of refundable single-dose container or
single-use package drug. For example, if a drug that would otherwise
meet the definition of refundable single-dose container or single-use
package drug is approved by FDA in June 2023 and the first date of sale
is June 20, 2023, the first day of the calendar quarter following the
date of first sale for such drug would be sales occurring in the third
calendar quarter of 2023 (July 1, 2023 through September 30, 2023), and
we would consider the drug to be excluded from the definition for the
next six quarters (that is, through December 31, 2024). As of January
1, 2025, the drug would no longer be excluded from the definition of
refundable single-dose container or single-use package drug and would
be subject to applicable refunds.
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\96\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Downloads/ASP_Data_Collection_Validation_Macro_User_Guide.pdf.
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We propose that exclusion would apply only once for a drug. That
is, it would apply for the first NDC of such drug assigned to a billing
and payment code and paid under Medicare Part B. If additional NDCs in
the same billing and payment code, such as a new vial size or ready-to-
use syringe, were subsequently approved under the same FDA approved
application (for example, under the same approved NDA or BLA number),
marketed, and paid under Part B, these subsequent NDCs would not start
a new 18-month exception period. We believe this proposed approach is
appropriate to prevent a drug from periodic or continual exemption from
reports and refunds due to new NDCs that are marketed under the same
FDA-approval.
We propose to add a new definition at Sec. 414.902 of ``refundable
single-dose container or single-use package drug,'' which would be
defined to mean a single source drug or biological or a biosimilar
biological product for which payment is made under this part and that
is furnished from a single-dose container or single-use package based
on FDA-approved labeling or product information, except as otherwise
specified. We welcome comment on the proposed implementation of these
statutory exclusions.
4. Provision of Information to Manufacturers
Section 1847A(h)(1) of the Act requires the Secretary to provide
each manufacturer of a refundable single-dose container or single-use
package drug (as defined in section 1847A(h)(8) of the Act) with a
report, for each calendar quarter beginning on or after January 1,
2023, that includes the following information:
The total number of units of the billing and payment code
of such drug, if any, that were discarded during such quarter, as
determined using a mechanism such as the JW modifier used as of the
date of enactment of this subsection (or any such successor modifier
that includes such data as determined appropriate by the Secretary).
The refund amount that the manufacturer is liable for
pursuant to section 1847A(h)(3) of the Act.
We propose to use the definition of manufacturer at section
1847A(c)(6)(A) of the Act, which is codified at Sec. 414.802 and
defines manufacturer as any entity that is engaged in the following
(this term does not include a wholesale distributor of drugs or a
retail pharmacy licensed under State law):
[[Page 46060]]
(1) Production, preparation, propagation, compounding, conversion
or processing of prescription drug products, either directly or
indirectly by extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis.
(2) The packaging, repackaging, labeling, relabeling, or
distribution of prescription drug products.
We propose to identify the manufacturer responsible for the
provision of refunds by the labeler code of the refundable single-dose
container or single-use package drug. If such product does not have an
NDC, we propose to use manufacturer information included on the ASP
data submission for the product.
We propose that there be a lag between the date of service quarter
and the date we send reports to manufacturers to allow for claims
maturity from the date of service. To operationalize reports to
manufacturers, we must consider the timing with regards to the
availability of JW modifier data. Providers and suppliers have a 12-
month period to submit Medicare Part B claims, including claims for
drugs payable under Part B, so a lag exists between the date of service
when a drug is administered and when the claim is submitted and
adjudicated. Because of this lag in finalized claims, there may also be
a lag in available JW modifier data for any given date of service
quarter. An evaluation of July 2010 Medicare Part B claims in the
Physician/Supplier-Carrier setting showed that 91.68, 96.84, and 98.32,
and 99.13 percent of claims were final at 3, 6, 9, and 12 months,
respectively, following the date of service. At 24 and 48 months, 99.83
and 100 percent of the claims, respectively, were considered to be
final.
Section 1847A(h)(1) of the Act does not specify the interval by
which reports for each calendar quarter must be sent to manufacturers.
We propose that CMS provide an annual report to manufacturers with
information for each calendar quarter. Sending reports (with
information for each calendar quarter) annually would reduce the
operational resources needed to implement this provision and would
streamline the dispute resolution process as described in section
III.A.7 of this proposed rule. We propose to send reports to
manufacturers no later than October 1 of each year. We propose that the
report reflect claims data that is finalized by the end of the second
calendar quarter (that is, June 30) of the year in which the report is
sent. This will allow time for CMS to analyze the data and calculate
refund amounts (as discussed in section III.A.5 of this proposed rule)
to provide reports to manufacturers no later than October 1. In
addition, we propose that annual reports would include any additional
lagged claims data not included for the quarters first reflected in the
prior year's report.
In an effort to implement this provision in a timely manner, we
propose to send the first report to manufacturers no later than October
1, 2023. Under our proposal, this first report would contain
information only for the first calendar quarter of 2023, because that
would be the only quarter for which we would have a substantial amount
of claims data that is finalized by the end of the second calendar
quarter of the year in which the report is sent. We propose to send the
second annual report no later than October 1, 2024, and this report
would include information for the second, third, and fourth quarters of
2023 and the first calendar quarter of 2024. It also would include any
additional lagged claims for dates of service in the first calendar
quarter of 2023 that were not included in the first report. Subsequent
annual reports would be done in this manner, meaning that they would
provide the information required under section 1847A(h)(1) of the Act
for the last 3 quarters of the prior year, the first quarter of the
current year, and lagged claims data not reflected for the last three
quarters of the year that is two years prior and the first quarter of
the prior year (that is, the quarters first reflected in the previous
year's report). This means that reports (except for those in 2023 and
2024) would include information for eight calendar quarters: four new
calendar quarters and four quarters with additional information for
claims that were not yet finalized for those dates of service in the
previous year's report. In this proposed approach, we would expect to
capture JW modifier data and total allowed charges from over 99 percent
of claims for dates of service in a given quarter. For example, the
report sent to manufacturers in 2025 would include information for
dates of service in the second, third, and fourth quarters of 2024 and
the first quarter of 2025 plus additional lagged claims that were not
included in the report sent in 2024 (that is, information for dates of
service in the second, third, and fourth quarters of 2023 and the first
quarter of 2024).
When lagged claims data is evaluated, any changes in the refund
amount owed for those quarters and not already accounted for in the
previous year's report would be calculated as described below in
section III.A.6. of this proposed rule.
5. Manufacturer Provision of Refund
Section 1847A(h)(2) of the Act states that for each calendar
quarter beginning on or after January 1, 2023, the manufacturer of a
refundable single-dose container or single-use package drug shall, for
such drug, provide to the Secretary a refund for such quarter. As
described in the previous section, we propose to issue reports for each
calendar quarter on an annual basis. Section 1847A(h)(4) of the Act
states that refunds under section 1847A(h)(2) of the Act must be paid
in regular intervals as determined appropriate by the Secretary. We
propose that refunds be paid in 12-month intervals (that is, annually)
to align with our proposal to issue reports for each calendar quarter
on an annual basis. Additionally, we believe requiring refunds to be
paid on an annual basis is operationally optimal because it allows for
some claims runout while administering reports in a timely manner
following the date of service and leaves more time for dispute
resolution (discussed below in section III.A.6. of this proposed rule),
which we believe will be important for refund calculation accuracy.
Including lagged claims data from the previous year's report allows
more time for claims to be finalized for a given calendar quarter,
subsequently represent a more accurate estimate of discarded units, and
result in a more accurate refund calculation. Therefore, we propose to
specify that the regular interval for the payment of refunds is annual
and that refund amounts for the quarters reported in an annual report
must be paid no later than December 31 of the year in which the report
was sent to the manufacturer except in circumstances where a dispute is
pending. In the case of a dispute, payment of the refund is due no
later than 30 days after the resolution of the dispute. As discussed in
more detail in the next section, we believe December 31 is an
appropriate deadline because it would allow manufacturers to review
their annual reports and initiate dispute resolution if needed. We
propose to require manufacturers owing refunds to transmit payment in a
form and manner specified by CMS.
We propose to reflect these provisions at Sec. 414.940.
6. Refund Amount
Section 1847A(h)(3) of the Act provides, with respect to a
refundable single-dose container or single-use package drug of a
manufacturer assigned to a billing and payment code for a calendar
quarter beginning on or after
[[Page 46061]]
January 1, 2023, that the refund for which the manufacturer is liable
is the amount equal to the estimated amount (if any) by which:
The product of:
++ The total number of units of the billing and payment code for
such drug that were discarded during such quarter; and
++ The payment limit amount for the refundable single-dose
container or single-use package drug;
Exceeds an amount equal to the applicable percentage of
the estimated total allowed charges for such a drug (less the amount
paid for packaged drugs) during the quarter.
Section 1847A(h)(3) of the Act specifies that the applicable
percentage is 10 percent, but authorizes us to increase this percentage
as appropriate, through notice and comment rulemaking, in the case of a
refundable single-dose container or single-use package drug that has
unique circumstances involving similar loss of product as that
described in section 1847A(h)(8)(B)(ii) of the Act (discussed above in
section III.A.3. of this proposed rule).
We propose to calculate the refund required under section
1847A(h)(1) of the Act using the number of discarded units for dates of
services in the same calendar quarter to which the payment limit amount
applies. We propose to estimate the total allowed charges during the
quarter by multiplying the drug's payment limit amount for the quarter
by the total number of units of the billing and payment code of such
drug that were subject to JW modifier reporting (as described above in
sections III.A.1. and 2. of this proposed rule) including those for
which the JZ modifier would be required if no units were discarded. As
specified in section 1847A(h)(1)(C) of the Act, the total number of
units of the billing and payment code of a refundable single-dose
container furnished during a calendar quarter for purposes of
subparagraph (A)(i), and the determination of the estimated total
allowed charges for the drug in the quarter for purposes of paragraph
(3)(A)(ii), exclude such units that are packaged into the payment
amount for an item or service and are not separately payable.
To illustrate how the refund would be calculated, if 2,000 units of
a billing and payment code for a given drug were unused and discarded
during dates of service in the first calendar quarter of 2023, that
number would be multiplied by the drug's payment limit amount for the
first calendar quarter of 2023. If the payment limit amount was $100,
that would be multiplied by 2,000 (the number of discarded units) to
equal $200,000. If Medicare paid for 15,000 units of the billing and
payment code subject to the JW modifier with dates of service in the
first quarter of 2023, that would be multiplied by the same payment
limit amount ($100) to determine the total allowed charges during the
quarter ($1,500,000). Then, the applicable percentage (in this example,
10 percent) of those total allowed charges ($150,000) would be
subtracted out to determine the refund amount. For the sake of this
example, that would be $200,000 (the amount described in section
1847A(h)(3)(A)(i) of the Act) minus $150,000 (the amount described in
section 1847A(h)(3)(A)(ii) of the Act) to equal a refund amount of
$50,000 for the first calendar quarter of 2023.
Section 1847A(h)(3)(A) of the Act states that the refund amount is
equal to an estimated amount and that the determination of amount that
exceeds the applicable percentage of the estimated total allowed
charges for a refundable single-dose container or single-use package
drug during a given quarter. Exact amounts are likely not attainable
for these numbers because of, for example, lagged claims data, appeals,
or reversals in the case of an audit. To obtain the most accurate
estimates possible, we propose above in section III.A.2 to provide
information and determine any refund amount for discarded refundable
single-dose container or single-use package drugs annually, and to
include additional lagged claims data not included in the previous
year's report. Based on claims maturity data, we expect this approach
would capture over 99 percent of claims for a given date of service
quarter in an effort to make the most accurate estimates possible for
the purposes of calculating refund amounts. If the assessment of lagged
claims data increases the refund amount for a quarter, the manufacturer
would be liable for that additional refund amount, which would be
reflected in the report. If the assessment of lagged claims data
decreases the refund amount for a quarter, we propose that any
overpayment be corrected. In the event that an assessment of lagged
claims data for a calendar quarter causes the product of total
discarded units and the payment limit amount to fall below the
applicable percentage, which would result in no refund due from that
manufacturer for the given quarter, we propose that any overpayment be
corrected. We solicit comments on the operational process of
overpayment correction.
We propose to reflect these provisions at Sec. 414.940.
a. Increased Applicable Percentage for Drugs With Unique Circumstances
Section 1847A(h)(3)(B)(ii) of the Act provides that, in the case of
a refundable single-dose container or single-use package drug that has
unique circumstances involving similar loss of product as that
described in section 1847A(h)(8)(B)(ii) of the Act, the Secretary may
increase the applicable percentage otherwise applicable as determined
appropriate by the Secretary.
At this time, we do not propose an increase of the applicable
percentage for any drugs with unique circumstances. We expect that for
most drugs supplied in single-dose containers, the amount of drug
indicated on the vial or container reflects the amount of drug that
could potentially be administered to a patient. This is consistent with
FDA regulations at 21 CFR 201.51(g), which provide that for drugs in
ampules or vials intended for injection, the declaration of net
quantity of contents on the label is considered to express the minimum
quantity of contents and that variation above the stated measure must
comply with the excess volumes set forth in the United States
Pharmacopeia (USP). FDA guidance for industry \97\ explains that USP
General Chapter 1151 Pharmaceutical Dosage Forms provides excess volume
recommendations for mobile and viscous liquids in a range of fill
volumes, noting that the excess volumes recommended are usually
sufficient to permit withdrawal and administration of the labeled
volumes. In this guidance, FDA recommends that single-dose vials should
not contain a significant volume beyond what would be considered a
usual or maximum dose for the expected use of the drug product.
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\97\ https://www.fda.gov/media/88138/download.
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We recognize there may be very rare cases in which, as part of a
drug's FDA-approved preparation and administration in labeling, the
amount of drug identified on the package or labeling far exceeds the
amount administered to a patient, thus leading to a substantial
percentage of drug that is discarded. For example, in the case of a
drug that is reconstituted with a hydrogel and administered via
ureteral catheter or nephrostomy tube into the kidneys, there is
substantial amount of reconstituted hydrogel that adheres to
[[Page 46062]]
the vial wall during preparation.\98\ In this instance, the drug
adhering to the vial wall (and not able to be extracted from the vial)
must be discarded, which leads to a higher percentage of discarded
units billed with the JW modifier. If the labeled amount of the package
is 80 mg and the maximum extracted amount from the vial guarantees
delivery of the maximum dose of 60 mg, then there would be at least 25
percent discarded units. In the case that a patient does not require
the maximum dose, the percent of discarded units would be even higher.
In this circumstance, an applicable percentage of 35 percent may be
appropriate because it would allow for the amount drug diluted in
hydrogel that adheres to the vial wall (25 percent) plus an additional
10 percent to align with the applicable percentage for drugs without a
unique circumstance.
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\98\ https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d3d5053-5427-4a68-a40b-edb60699521e.
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We are considering whether we should adopt a higher applicable
percentage for a drug in this circumstance. We welcome comments on
specifying a higher applicable percentage for drugs that are diluted in
hydrogel and administered via the pyelocaliceal route, and we welcome
comments on whether an applicable percentage of 35 percent would be
appropriate in this circumstance. We welcome comments on whether there
are other drugs with unique circumstances as described under section
1847A(h)(3)(B)(ii) of the Act that may warrant an increase in the
applicable percentage.
7. Dispute Resolution
As a part of implementing this provision, we recognize the need for
establishing a dispute resolution process because of the nature of
determining the estimated total allowed charges for a given calendar
quarter and the methods by which the estimated refund amount is
determined. Although a dispute resolution process is not expressly
required by section 1847A(h) of the Act, we believe that proactively
establishing such a process will aid in the successful implementation
of this provision. We propose that each manufacturer have an
opportunity to dispute the report by submitting an error report as
described in this section.
We propose that to assert that there have been one or more errors
in a report, a manufacturer must submit a dispute with each asserted
error. We propose that the dispute must include the following
information: (1) Manufacturer name and address; (2) The name, telephone
number, and email address of one or more employees or representatives
of the manufacturer with whom the Secretary may discuss the claimed
errors; (3) For a mathematical calculation error, the specific
calculation element(s) that the manufacturer disputes and its proposed
corrected calculation; and (4) For any other asserted error, an
explanation of the nature of the error, how the error affects the
refund calculation, an explanation of how the manufacturer established
that an error occurred, the proposed correction to the error, and an
explanation of why CMS should use the proposed corrected data.
We propose that in order to dispute a report, manufacturers must
assert any basis for contesting its refund calculation during the 30-
day period following the issuance of the report. We would evaluate
error reports and would decide whether the information (such as number
of discarded billing units or refund amount calculation) requires
correction based on the information provided. We propose that we would
provide manufacturers who have submitted a dispute a response to each
dispute and inform manufacturers of the final refund amount no later
than 30 days after receipt of the dispute. We propose that if we find
that a different refund amount is owed than what was stated on the
report, we would issue a new report with updated discarded amounts and/
or refund. We propose that if we disagree with the dispute, we would
notify the manufacturer that refund amount on the report is still owed
and should be paid as described above in section 5 (no later than
December 31 of the year in which the report was sent). We welcome
comment on whether CMS should develop an appeal mechanism, which we
will consider for future rulemaking.
We propose to codify the dispute resolution process at Sec.
414.940.
8. Enforcement
a. Audits
Section 1847A(h)(6)(A)(i) of the Act requires that we perform
periodic audits on each manufacturer of a refundable single-dose
container or single-use package drug that is required to provide a
refund under section 1847A(h) of the Act with respect to such drug and
such refunds. We propose to specify at 414.940(e) that we periodically
audit manufacturers of refundable single-dose container or single-use
package drugs consistent with this requirement. We welcome comments
about what such audits should entail, which we will consider for future
rulemaking.
Section 1847A(h)(6)(A)(ii) of the Act requires us to conduct
periodic audits of claims submitted under Medicare Part B with respect
to refundable single-dose container or single-use package drugs in
accordance with the authority under section 1833(e) of the Act. Under
the JW modifier policy, claims for drugs furnished on or after January
1, 2017 containing billing for discarded drugs that do not use the JW
modifier may be subject to review.\99\ We propose that our review
contractors would periodically review Part B medication claims to
ensure the JW modifier, JZ modifier (if adopted), and discarded drug
amounts are billed appropriately consistent with our normal claims
audit policies and protocols.
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\99\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf.
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b. Civil Money Penalty
Provisions in section 1847A(h)(6)(B) of the Act give the Secretary
authority to impose a civil money penalty on a manufacturer of a
refundable single-dose container or single-use package drug who fails
to comply with the requirement under section 1847A(h)(2) of the Act for
such drug for a calendar quarter.
As set forth in section 1847A(h)(6)(B) of the Act, the civil money
penalty would be an amount equal to the sum of--
The amount that the manufacturer would have paid under
such paragraph with respect to such drug for such quarter; and
25 percent of such amount.
We propose to codify the civil money penalty at Sec. 414.940.
B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
As provided in 42 CFR part 405, subpart X, RHC and FQHC visits
generally are face-to-face encounters between a patient and one or more
RHC or FQHC practitioners during which one or more RHC or FQHC
qualifying services are furnished. RHC and FQHC practitioners are
physicians, NPs, PAs, CNMs, clinical psychologists (CPs), and clinical
social workers, and under certain conditions, a registered nurse or
licensed practical nurse furnishing care to a homebound RHC or FQHC
patient in an area with a shortage of home
[[Page 46063]]
health agencies. Transitional Care Management (TCM) services can also
be paid by Medicare as an RHC or FQHC visit. In addition, Diabetes
Self-Management Training (DSMT) or Medical Nutrition Therapy (MNT)
sessions furnished by a certified DSMT or MNT program may also be
considered FQHC visits for Medicare payment purposes. Only medically
necessary medical, mental health, or qualified preventive health
services that require the skill level of an RHC or FQHC practitioner
are RHC or FQHC billable visits. Services furnished by auxiliary
personnel (for example, 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.
RHCs generally are paid an all-inclusive rate (AIR) for all
medically necessary medical and mental health services and qualified
preventive health services furnished on the same day (with some
exceptions). The AIR is subject to a payment limit, meaning that an RHC
will not receive any payment beyond the specified limit amount. As of
April 1, 2021, all RHCs are subject to new payment limits on the AIR,
and this limit will be determined for each RHC in accordance with
section 1833(f) of the Act.
FQHCs were paid under the same AIR methodology until October 1,
2014. Beginning that date, in accordance with section 1834(o) of the
Act (as added by section 10501(i)(3) of the Affordable Care Act), they
began to transition to the FQHC PPS system, in which they are paid
based on the lesser of the FQHC PPS rate or their actual charges. The
FQHC PPS rate is adjusted for geographic differences in the cost of
services by the FQHC PPS geographic adjustment factor (GAF). The rate
is increased by 34 percent when an FQHC furnishes care to a patient
that is new to the FQHC, or to a beneficiary receiving an initial
preventive physical examination (IPPE) or has an annual wellness visit
(AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates 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.
b. Care Management Services in RHCs and FQHCs
We have been engaged in a multi-year examination of coordinated and
collaborative care services in professional settings, and as a result
established codes and separate payment in the PFS to separately
recognize and pay for these important services. The care coordination
included in services, such as office visits, do not always adequately
describe the non-face-to-face care management work involved in primary
care. Payment for office visits may not reflect all the services and
resources required to furnish comprehensive, coordinated care
management for certain categories of beneficiaries, such as those who
are returning to a community setting following discharge from a
hospital or skilled nursing facility (SNF) stay.
A separate payment was established in the CY 2016 PFS final rule
with comment period (80 FR 71080 through 71088) for RHCs and FQHCs that
furnish Chronic Care Management (CCM) services. We believe the non-
face-to-face time required to coordinate care is not captured in the
RHC AIR or the FQHC PPS payment, particularly for the rural and/or low-
income populations served by RHCs and FQHCs. Allowing separate payment
for CCM services in RHCs and FQHCs is intended to reflect the
additional resources necessary for the unique components of CCM
services.
In the CY 2018 PFS final rule with comment period (82 FR 53169 and
53180), we finalized revisions to the payment methodology for CCM
services furnished by RHCs and FQHCs and established requirements for
general Behavioral Health Integration (BHI) and psychiatric
Collaborative Care Management (CoCM) services furnished in RHCs and
FQHCs, beginning on January 1, 2018.
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.
In the CY 2019 PFS final rule (83 FR 59683), we explained for CY
2018 the payment amount for HCPCS code G0511 was 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. That is, for
CY 2018 the 3 codes that comprised G0511 were 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).
We also explained that another CCM code was introduced for
practitioners billing under the PFS, 99491, 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
(83 FR 56983). Therefore, for RHCs and FQHCs, we added CPT code 99491
as a general care management service and included it in the calculation
of HCPCS code G0511. Starting on January 1, 2019, RHCs and FQHCs were
paid for HCPCS code G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and 99491
(83 FR 59687).
In the CY 2020 PFS final rule with comment (84 FR 62692), we
established a separate payment for Principle Care Management (PCM)
services under the PFS. PCM services include comprehensive care
services for a single high-risk disease or complex condition, typically
expected to last at least 3 months and may have led to a recent
hospitalization, and/or placed the patient at significant risk of
death. Beginning January 1, 2020, practitioners billing under the PFS
can bill for PCM services using HCPCS codes G2064 or G2065. HCPCS code
G2064 is for at least 30 minutes of PCM services furnished by
physicians or nonphysicians during a calendar month. HCPCS code G2065
is for at least 30 minutes of PCM services furnished by clinical staff
under the direct supervision of a physician or non-physician during a
calendar month.
In the CY 2021 PFS final rule (85 FR 84697 through 84699), we
explained that since the requirements for the new PCM codes were
similar to the requirements for the services described by HCPCS code
G0511, we added HCPCS code G2064 and G2065 to G0511 as a general care
management service for RHCs and FQHCs starting January 1, 2021. The
payment rate for HCPCS G0511 for CY 2021 was the average of the
national non-facility PFS payment rate for the RHC and FQHC care
management and general behavioral health codes (CPT codes 99490, 99487,
99484, and 99491), and PCM codes (HCPCS G2064 and G2065). Finally, we
note that in the CY 2022 PFS final rule (86 FR 65118), HCPCS codes
G2064 and G2065 were replaced by CPT codes 99424 and 99435. Therefore,
for CY 2022 the current payment rate for HCPCS G0511 is the average of
the national non-facility PFS payment rate for the RHC and FQHC care
management and general behavioral health codes (CPT codes 99490, 99487,
[[Page 46064]]
99484, and 99491), and PCM codes (CPT codes 99424 and 99425).
Additional information on care management requirements is available
on the CMS Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html
and on the CMS RHC and FQHC Web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
2. New Care Management Codes for Chronic Pain Management (CPM) and
General Behavioral Health Integration (GBHI)
Consistent with the discussion earlier in section II.E.4 of this
proposed rule, there are two new HCPCS codes proposed to describe CPM
and the proposed CPM codes would be created to separately pay for a
specified set of pain management and treatment services, specifically
including the administration of validates rating scales, and a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes.
(1) HCPCS codes GYYY1: Chronic pain management and treatment,
monthly bundle including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and maintenance of a person-
centered care plan that includes strengths, goals, clinical needs, and
desired outcomes; overall treatment management; facilitation and
coordination of any necessary behavioral health treatment; medication
management; pain and health literacy counseling; any necessary chronic
pain related crisis care; and ongoing communication and care
coordination between relevant practitioners furnishing care, e.g.,
physical therapy and occupational therapy, and community-based care, as
appropriate. Required face-to-face visit at least 30 minutes provided
by a physician or other qualified health professional; first 30 minutes
personally provided by physician or other qualified health care
professional, per calendar month. (When using GYYY1, 30 minutes must be
met or exceeded.) and (2) HCPCS code GYYY2: Each additional 15 minutes
of chronic pain management and treatment by a physician or other
qualified health care professional, per calendar month). For GYYY1, CPM
services, we are requiring an face-to-face visit of at least 30 minutes
provided by a physician or other qualified health professional, per
calendar month to a beneficiary who has a diagnosis of pain that has
lasted more than 3 months, which could be the result of an underlying
medical disease or condition. HCPCS code GYYY2 will apply to up to
three units of an additional 15 minutes of CPM and treatment by a
physician or other qualified health care professional, per calendar
month (listed separately in addition to GYYY1). The new codes for CPM
would be valued using crosswalks to the CY 2023 ratesetting inputs for
the PCM services, CPT codes 99424 and 99425.
The new coding and payment for general BHI services, as described
in section II.E.4 of this proposed rule, would be a new HCPCS code
(GBHI1): (Care management services for behavioral health conditions, at
least 20 minutes of clinical psychologist or clinical social worker
time, per calendar month, with the following required elements: initial
assessment or follow-up monitoring, including the use of applicable
validated rating scales; behavioral health care planning in relation to
behavioral/psychiatric health problems, including revision for patients
who are not progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination with an/or
referral to physicians and practitioners who are authorized by Medicare
law to prescribe medications and furnish E/M services counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team) describing general BHI services performed by
clinical psychologists (CPs) and clinical social workers (CSWs). The
payment rate for the new General BHI code would be based on the payment
rate for the current general BHI code, 99484. CPs and CSWs are
statutorily authorized to furnish services in RHCs and FQHCs (Sec.
405.2411(a)(6)).
The requirements for the proposed CPM service (that is, HCPCS code
GYYY1) are similar to the requirements for the general care management
services furnished by RHCs and FQHCs and as such, we believe the non-
face-to-face time required to coordinate care is not captured in the
RHC AIR or the FQHC PPS payment, particularly for the rural and/or low-
income populations served by RHCs and FQHCs. The pain management
coordination included in services, such as office visits, do not always
adequately describe the non-face-to-face pain management work involved
in primary care. Payment for office visits may not reflect all the
services and resources required to furnish comprehensive, coordinated
pain care management described in the HCPCS code, such as the
assessment and monitoring; administration of a validated pain rating
scale or tool; the development, implementation, revision, and
maintenance of a person-centered care plan that includes strengths,
goals, clinical needs, and desired outcomes; overall treatment
management; facilitation and coordination of any necessary behavioral
health treatment; medication management; pain and health literacy
counseling; any necessary chronic pain related crisis care.
Allowing separate payment for CPM services in RHCs and FQHCs is
intended to reflect the additional time and resources necessary for the
unique components of care coordination services. We are not proposing
to utilize the add-on HCPCS code GYYY2 for RHC/FQHC payments because
RHCs and FQHCs do not pay their practitioners based on additional
minutes spent by practitioners, as is the case for practitioners under
the PFS. In an effort to be consistent with the new services that are
being proposed for practitioners billing under the PFS, we are
proposing to include CPM services in the general care management HCPCS
code G0511 when these services are provided by RHCs and FQHCs. Since
HCPCS code GYYY1 would be valued using a crosswalk to the PCM CPT code
99424, which is currently one of the CPT codes that comprise HCPCS code
G0511, we propose no change to the average used to calculate the G0511
payment rate.
In addition, since CPs and CSWs are considered practitioners that
can provide services in RHCs/FQHCs, in this proposed rule we clarify
that when CPs and CSWs provide the services described in HCPCS code
GBHI1 in an RHC or FQHC, they can bill HCPCS code G0511.
If finalized as proposed, RHCs and FQHCs that furnish the new CPM
and GBHI services performed by CPs and CSWs would be able to bill these
services using HCPCS code G0511, either alone or with other payable
services on an RHC or FQHC claim for dates of service on or after
January 1, 2023. The payment rate for HCPCS code G0511 would continue
to be the average of the national non-facility PFS payment rates for
the RHC and FQHC care management and general behavioral health codes
(CPT codes 99484, 99487, 99490, and 99491) and PCM codes (CPT codes
99424 and 99425) and would be updated annually based on the PFS amounts
for these codes.
In future rulemaking, we may consider other approaches for
[[Page 46065]]
calculating the rate of HCPCS code G0511 as the number of services is
growing each year. For example, we could value HCPCS code G0511 using a
weighted average of the services that comprise HCPCS code G0511 or
using the national average of the top three services comprising HCPCS
code G0511. We welcome comments on potential methodologies.
3. Conforming Technical Changes to 42 CFR 405.2463
Last year in the CY 2022 PFS final rule with comment (86 FR 65211),
we finalized a policy to revise the regulatory requirement that an RHC
or FQHC mental health visit must be a face-to-face (that is, in person)
encounter between an RHC or FQHC patient and an RHC or FQHC
practitioner. We revised the regulations under Sec. 405.2463 to state
that an RHC or FQHC mental health visit can also include encounters
furnished through interactive, real-time, audio and video
telecommunications technology or audio-only interactions in cases where
beneficiaries are not capable of, or do not consent to, the use of
devices that permit a two-way, audio/video interaction for the purposes
of diagnosis, evaluation or treatment of a mental health disorder. We
noted that these changes aligned with similar mental health services
furnished under the PFS. This change allows RHCs and FQHCs to report
and be paid for mental health visits furnished via real-time,
telecommunication technology in the same way they currently do when
these services are furnished in-person.
In addition, we finalized a revision to the regulation under Sec.
405.2463 to state that there must be an in-person mental health service
furnished within 6 months prior to the furnishing of the
telecommunications service and that an in-person mental health service
(without the use of telecommunications technology) must be provided at
least every 12 months while the beneficiary is receiving services
furnished via telecommunications technology for diagnosis, evaluation,
or treatment of mental health disorders, unless, for a particular 12-
month period, the physician or practitioner and patient agree that the
risks and burdens outweigh the benefits associated with furnishing the
in-person item or service, and the practitioner documents the reasons
for this decision in the patient's medical record (86 FR 65210 and
65211).
We also finalized a revision to the regulation under Sec.
405.2469, FQHC supplemental payments, to state that a supplemental
payment required under this section is made to the FQHC when a covered
face-to-face (that is, in-person) encounter or an encounter where
services are furnished using interactive, real-time, telecommunications
technology or audio-only interactions in cases where beneficiaries do
not wish to use or do not have access to devices that permit a two-way,
audio/video interaction for the purposes of diagnosis, evaluation or
treatment of a mental health disorder occurs between a MA enrollee and
a practitioner as set forth in Sec. 405.2463. At Sec. 405.2469, we
also finalized a revision to paragraph (d) to describe the same in-
person visit requirement referenced in Sec. 405.2463.
The Consolidated Appropriations Act, 2022 (Pub. L. 117-103) (CAA,
2022) was signed into law on March 15, 2022, and included extension of
a number of Medicare telehealth flexibilities established during the
PHE for a limited 151-day period beginning on the first day after the
end of the public health emergency (PHE) for COVID-19. Specifically,
section 303 of the CAA, 2022 amended section 1834(m)(8) of the Act to
extend payment for telehealth services furnished by FQHCs and RHCs for
the 151-day period beginning on the first day after the end of the
COVID-19 PHE. Payment would continue to be made under the methodology
established for telehealth services furnished by FQHCs and RHCs during
the PHE, which is based on payment rates that are similar to the
national average payment rates for comparable telehealth services under
the PFS.
We do not believe it necessary to conform the regulation to this
temporary provision. However, another provision applicable to RHCs and
FQHCs requires conforming regulatory text changes. Section 304 of the
CAA, 2022 delayed the in-person requirements under Medicare for mental
health services furnished through telehealth under the PFS and for
mental health visits furnished by RHCs and FQHCs via telecommunications
technology which requires conforming regulatory text changes. For RHCs
and FQHCs, in-person visits will not be required until the 152nd day
after the end of the PHE for COVID-19. We note that while the
extensions of mental health telehealth visits under section 304 of the
CAA, 2022 were placed into paragraphs of section 1834 of the Act
applicable only to hospice patients served by RHCs and FQHCs, the
overall intent of the amendments made by section 304 of the CAA, 2022
appear to be to provide an exception to the limitations otherwise in
place on payment for mental health visits that are not in-person
visits. Therefore, we are proposing to apply the 151-day extension of
non-in-person visits to all RHC and FQHC mental health visits.
Therefore, we are proposing to make conforming regulatory text
changes to the applicable RHC and FQHC regulations in 42 CFR part 405,
subpart X, specifically, at Sec. 405.2463, ``What constitutes a
visit,'' we propose to amend paragraph (b)(3) and at Sec. 405.2469
``FQHC supplemental payments'' we proposed to amend paragraph (d) to
include the delay of the in-person requirements for mental health
visits furnished by RHCs and FQHCs through telecommunication technology
under Medicare until the 152nd day after the PHE for COVID-19.
In addition, several other provisions of the CAA, 2022 would apply
to telehealth services (those that are not mental health visits)
furnished by RHCs and FQHCs.
Section 301 of the CAA, 2022 amended section 1834(m)(4)(C) of the
Act to add a new clause (iii) expand the originating site requirements
to include any site in the U.S. at which the beneficiary is located,
including an individual's home, for a 151-day period beginning on the
first day after the end of the PHE for COVID-19. It also prohibits an
originating site facility fee from being paid unless the site is a
setting included on the originating site list in section
1834(m)(4)(C)(ii) of the Act, excluding the home of an individual.
Section 305 of division P, title III, subtitle A of the CAA, 2022
amended section 1834(m) to extend coverage and payment of telehealth
services that are furnished via audio-only telecommunications system
for the 151-day period beginning on the first day after the end of the
PHE for COVID-19.
Section 309 of division P, title III, subtitle A of the CAA, 2022
authorized the Secretary to implement the Medicare telehealth
provisions via program instruction or otherwise. Therefore, given that
the end date of the PHE is not yet known and may occur prior to the
provisions of this rule being finalized, we note that we intend to
issue program instruction or other subregulatory guidance to implement
the provisions of this section of this rule to ensure a smooth
transition after the declared end of the PHE for COVID-19.
4. Specified Provider-Based RHC Payment-Limit Per-Visit
a. Background
Beginning April 1, 2021, provider-based RHCs that meet
qualifications in section 1833(f)(3)(B) of the Act are entitled to the
special payment rules
[[Page 46066]]
described in section 1833(f)(3)(A) of the Act. In order to have their
payment limit established based on their applicable All-Inclusive Rate
(AIR) and remain this way instead of being based on the national
statutory payment limit as applicable in section 1833(f)(2) of the Act,
RHCs must meet the following specified criteria:
As of December 31, 2020, the provider-based RHC was in a
hospital with less than 50 beds and after December 31, 2020 in a
hospital that continues to have less than 50 beds (not taking into
account any increase in the number of beds pursuant to a waiver during
the PHE for COVID-19); and one of the following circumstances:
++ As of December 31, 2020, was enrolled in Medicare (including
temporary enrollment during the PHE for COVID-19); or
++ Submitted an application for enrollment in Medicare (or a
request for temporary enrollment during the PHE for COVID-19) that was
received not later than December 31, 2020.
In accordance with section 1833(f)(3)(A)(i)(I) of the Act,
beginning April 1, 2021, for provider-based RHCs that had a per visit
payment amount (or AIR) established for services furnished in 2020, the
payment limit per visit shall be set at an amount equal to the greater
of: (1) the per visit payment amount applicable to such RHC for
services furnished in 2020, increased by the percentage increase in the
MEI applicable to primary care services furnished as of the first day
of 2021; or (2) the national statutory payment limit for RHCs per
visit. We note, the MEI was last revised in the CY 2014 PFS final rule
with comment period (78 FR 74264) and the proposal to rebase and revise
the MEI for CY 2023 can be found in section II.N. of this proposed
rule.
In a subsequent year (that is, after 2021), the provider-based
RHC's payment limit per visit shall be set at an amount equal to the
greater of: (1) the payment limit per visit established for the
previous year, increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first day of
such subsequent year; or (2) the national statutory payment limit for
RHCs.
In accordance with section 1833(f)(3)(A)(i)(II) of the Act,
beginning April 1, 2021, for provider-based RHCs that meet the
specified criteria under section 1833(f)(3)(B) of the Act, but did not
have a per visit payment amount (or AIR) established for services
furnished in 2020, the payment limit per visit shall be at an amount
equal to the greater of: (1) the per visit payment amount applicable to
the provider-based RHC for services furnished in 2021; or (2) the
national statutory payment limit for RHCs.
In a subsequent year (that is, after 2022), the provider-based RHCs
payment limit per visit will be the greater of: (1) the payment limit
per visit established for the previous year, increased by the
percentage increase in MEI applicable to primary care services
furnished as of the first day of such subsequent year; or (2) the
national statutory payment limit for RHCs.
Once a provider-based RHC meets the qualifications of section
1833(f)(3)(B) of the Act, it will lose its designation if the hospital
does not continue to have less than 50 beds, beyond the exemptions
provided for the COVID-19 PHE. If this occurs the provider-based RHC
would be subject to the statutory payment limit per visit applicable
for such year and will not be able to regain the specified provider-
based payment limit.
In the CY 2022 PFS final rule (86 FR 65204), we discussed the
provisions in section 1833(f) of the Act \100\ and finalized conforming
regulations under Sec. 405.2462. On March 16, 2021, we issued Change
Request 12185, Transmittal 10679, to instruct the Medicare
Administrative Contractors (MACs) to establish the provider-based RHC
payment limits per visit in accordance with section 1833(f)(3)(A),
beginning April 1, 2021. Change Request 12185, Transmittal 10679, was
rescinded and replaced by Transmittal 10780 issued on May 4, 2021.\101\
Change Request 12489, Transmittal 11130, issued on November 19, 2021,
implemented the RHC payment limits for CY 2022.\102\
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\100\ As amended by Division CC, section 130 of the Consolidated
Appropriations Act of 2021 (P.L. 116-260), December 27, 2020).
Section 2 of H.R. 1868 (Pub. L. 117-7), enacted April 14, 2021,
provided a technical correction to section 1833(f) of the Act. The
amendments made by this technical correction took effect as if
included in the enactment of the Consolidated Appropriations Act of
2021 (Pub. L. 116-260).
\101\ https://www.cms.gov/files/document/r10780OTN.pdf.
\102\ https://www.cms.gov/files/document/r11130cp.pdf.
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b. Clarification to the RHC Payment Limit for Specified Provider-Based
RHCs
As we state above, section 1833(f)(3)(A) of the Act instructed CMS
to set payment limits per visit for specified provider-based RHCs under
certain payment rules. For specified provider-based RHCs that had a per
visit payment amount (that is, an AIR) established for services
furnished in 2020, beginning April 1, 2021, section 1833(f)(3)(A)(i)(I)
of the Act requires the payment limit per visit to be set at an amount
equal to the greater of: (1) the per visit payment amount applicable to
such RHC for services furnished in 2020, increased by the percentage
increase in the MEI applicable to primary care services furnished as of
the first day of 2021 or; (2) the statutory payment limit per visit as
described in section 1833(f)(2)(A) of the Act. For subsequent years, in
accordance with section 1833(f)(3)(A)(ii) of the Act, the payment limit
per visit shall be set at an amount equal to the greater of: (1) the
payment limit per visit established for the previous year, increased by
the percentage increase in the MEI or; (2) the statutory payment limit
described in section 1833(f)(2) of the Act as applicable.
For specified provider-based RHCs that did not have an AIR
established for services furnished in 2020, beginning April 1, 2021,
section 1833(f)(3)(A)(i)(II) of the Act requires the payment limit per
visit shall be set at an amount equal to the greater of: (1) the per
visit payment amount applicable to such RHC for services furnished in
2021 or; (2) the statutory payment limit per visit as described in
section 1833(f)(2)(A) of the Act. For subsequent years, in accordance
with section 1833(f)(3)(A)(ii) of the Act, the payment limit per visit
shall be set at an amount equal to the greater of: (1) the amount
established in the previous year increased by the percentage increase
in the MEI or; (2) the statutory payment limit described in section
1833(f)(2) of the Act as applicable.
In the CY 2022 PFS final rule (86 FR 65201), we interpreted the
``per visit payment amount'' to align with the interim rate process the
MACs use in determining an RHC's AIR.\103\ That is, as explained in
Sec. 405.2464(a) the AIR is determined by the MAC using the most
recently available cost report. Therefore, using the RHCs discussed in
section 1833(f)(3)(A)(i)(I) of the Act as an example, we interpreted
the term ``services furnished in 2020'' to mean the period at which the
services were furnished in 2020 and that costs for those services were
reported. We acknowledged that there may be more than one cost report
that reports costs for services furnished in calendar year 2020 and
explained that since section 1833(f)(3)(A)(i)(I)(aa) of the Act
requires the ``per visit payment amount'' to be increased by the CY
2021 MEI, if a provider has a cost reporting period that differs from a
calendar year time-period
[[Page 46067]]
(that is, January 1, 2020 through December 31, 2020) then the MACs
should use data based on the relevant cost report period ending in
2020.
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\103\ Note: A discussion of the interim rate process is provided
in section III.A.2 of the CY 2022 PFS final rule (86 FR 65198 and
65199).
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In the CY 2022 PFS final rule (86 FR 65200), we received comments
from interested parties expressing concern about how the payment limit
per visit is established for specified provider-based RHCs. To be
appropriately reflective of an individual clinic's true costs, one
commenter stated that grandfathered, clinic specific, upper payment
limits should be based on the final cost settled amount for cost
reporting periods that end in 2020, or 2021 (for grandfathered RHCs
that did not have cost reporting period that end in 2020), not an
interim rate. If an interim final rate is necessary for the time period
before final cost settled rates are adjudicated, the commenter
suggested that CMS set interim clinic-specific upper limits only until
such time that a final rate is established. In our response to these
comments, we agreed, and stated that what the commenter described was
aligned with the statute and how we implemented the payment limit per
visit for specified provider-based RHCs through Change Request 12185,
Transmittal 10780, issued on May 4, 2021. That is, in accordance with
section 1833(f)(3)(A) of the Act, specified provider-based RHCs that
had a per visit payment amount (or AIR) established for services
furnished in 2020, had their payment limit per visit based on their AIR
determined from their final settled cost report ending in 2020
increased by the percentage increase in the MEI applicable to primary
care services furnished as of the first day of 2021 (CY 2021 MEI of 1.4
percent). However, if the product of those two numbers (AIR established
for services furnished in 2020 * 1.014) were less than the national
statutory payment limit of $100, their payment limit per visit was
established at $100. With regard to a specified provider based RHC that
did not have an AIR established for services furnished in 2020 and
received an interim rate until the MAC accepted and finalized the RHC's
initial cost report, we again agreed with the commenter. We believed
that what the commenter described also aligned with the statute and how
we implemented the payment limit per visit for these specified
provider-based RHCs through Change Request 12185, Transmittal 10780,
issued on May 4, 2021. That is, in accordance with section
1833(f)(3)(A) of the Act, specified provider-based RHCs that did not
have an AIR established for services furnished in 2020, would have
their payment limit per visit established based on their AIR determined
by MACs using the RHC's final settled cost report ending in 2021. The
interim rate estimate would be reconciled at cost report settlement for
the cost reporting period ending in 2021 which is used to establish the
RHC's payment limit per visit for services furnished in 2021.
Since publication of the CY 2022 PFS final rule, interested parties
requested clarification regarding the timing of cost reports,
specifically if the payment limit could be set using a short cost
report (less than 12 consecutive months). In the CY 2022 PFS final rule
(86 FR 65198 through 65202), we did not specifically address requiring
the cost report to span a full 12-consecutive month period or whether
MACs, following their interim rate setting process, could establish the
payment limit using a specified RHC's short period cost report (less
than 12-consecutive months). Since many questions were raised
subsequent to the publication of the CY 2022 PFS final rule regarding
the use of short-period cost reports (less than 12 consecutive months)
versus 12-consecutive month cost reports to establish the payment limit
for specified provider-based RHCs, in this proposed rule, we are
providing a discussion of this issue and providing clarification.
For purposes of establishing the payment limit effective April 1,
2021 for specified provider-based RHCs defined in section
1833(f)(3)(A)(i)(I) of the Act, that is, had an AIR established for
services furnished in 2020, we are proposing that MACs use the cost
report ending in 2020 that reports costs for 12 consecutive months. If
the RHC does not have a 12 consecutive month cost report ending in
2020, the MACs should use the next most-recent final settled cost
report that reports cost for 12 consecutive months. This proposal would
impact specified provider-based RHC's that had an established AIR for
services furnished in 2020 but submitted a short cost report (less than
12 consecutive months) ending in 2020 since that period would have been
used by MACs for determining the RHC's payment limit per Change Request
12185, Transmittal 10679.
The payment limit per visit is based on each specified provider-
based RHC's AIR determined from their final settled cost report ending
in 2020 when such cost reporting period is for 12-consecutive months.
If a 12-consecutive month cost report ending in 2020 is not available,
the MAC should use the next available 12-consecutive month cost report
that reports costs for RHC services furnished in 2020, (for example, a
cost reporting period October 1, 2020 through September 30, 2021 would
be acceptable).
We considered the idea of combining cost report data that spans
from the end of one year into the next year to equal a 12-consecutive
month cost report (for example, a cost report that consists of three
months ending December 31, 2020 plus a cost report that ends July 31,
2021) and prorating the rates from the time services were furnished in
both years. We decided against combining cost report data to equal a
12-consecutive month cost report because prorating may result in an
inaccurate AIR. We seek comment on whether we should combine cost
report data that spans from one year into the next year to equal a 12-
consecutive month cost report.
Consequently, for purposes of establishing the payment limit
effective April 1, 2021 for specified provider-based RHCs defined in
section 1833(f)(3)(A)(i)(II) of the Act (that is, those that did not
have an AIR established for services furnished in 2020), we are
proposing that MACs use the cost report ending in 2021 that reports
costs for 12 consecutive months. If the RHC does not have a 12-
consecutive month cost report ending in 2021, the MACs should use the
next most-recent final settled cost report that reports cost for 12
consecutive months.
In addition, for those specified provider-based RHCs who did not
have an AIR established for services furnished in 2020 the 2021 MEI
percentage increase update would not be applied. As discussed in the CY
2022 PFS final rule (86 FR 65200), for those specified provider-based
RHCs, the payment limit per visit would be at an amount equal to the
greater of: (1) The per visit payment amount applicable to the
provider-based RHC for services furnished in 2021; or (2) the national
statutory payment limit for RHCs, and since the MEI is already built in
the rate for services furnished in 2021 adding an MEI update would be
duplicative. Therefore, those specified provider-based RHCs that did
not have an AIR established for services furnished in 2020 would
receive the CY 2023 percentage increase in the MEI, which will be based
on the proposed 2017-based MEI update. We note that in section II. M.
of this proposed rule, we are proposing to rebase and revise the MEI
from a 2006-base year to a 2017-base year.
We believe 12 consecutive months of cost report data will more
accurately reflect the costs of providing RHC services and will
establish a more accurate base from which the payment limits will be
updated going forward.
[[Page 46068]]
We seek comment on this proposed interpretation.
C. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and
Phase-In of Payment Reductions, and Proposals for Specimen Collection
Fees and Travel Allowance for Clinical Diagnostic Laboratory Tests
1. Background on the Clinical Laboratory Fee Schedule
Prior to January 1, 2018, Medicare paid for clinical diagnostic
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule
(CLFS), with certain exceptions, under section 1833(a), (b), and (h) of
the Act. Under the previous payment system, 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 payment 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 productivity adjustment and other statutory adjustments, but were
not otherwise updated or changed. Coinsurance and deductibles generally
do not apply to CDLTs paid under the CLFS.
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. In the June 23,
2016 Federal Register (81 FR 41036), we published a final rule entitled
Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS
final rule), that implemented section 1834A of the Act at 42 CFR part
414, subpart G.
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.'' The first data collection period occurred
from January 1, 2016 through June 30, 2016. The first data reporting
period occurred from January 1, 2017 through March 31, 2017. On March
30, 2017, we announced a 60-day period of enforcement discretion for
the application of the Secretary's potential assessment of civil
monetary penalties (CMPs) for failure to report applicable information
with respect to the initial data reporting period.\104\
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\104\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we
solicited public comments from applicable laboratories and reporting
entities to better understand the applicable laboratories' experiences
with data reporting, data collection, and other compliance requirements
for the first data collection and reporting periods. We discussed these
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and
stated that we would consider the comments for potential future
rulemaking or guidance.
As part of the CY 2019 Medicare PFS rulemaking, we finalized two
changes to the definition of ``applicable laboratory'' at Sec. 414.502
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850, 35855
through 35862). First, we excluded Medicare Advantage (MA) plan
payments under Part C from the denominator of the Medicare revenues
threshold calculation, in an effort to broaden the types of
laboratories qualifying as an applicable laboratory. Specifically,
excluding MA plan payments could allow additional laboratories of all
types serving a significant population of beneficiaries enrolled in
Medicare Part C to meet the majority of Medicare revenues threshold and
potentially qualify as an applicable laboratory (if they also meet the
low expenditure threshold) and report data to CMS during the data
reporting period. Because MA plan payments are now excluded from the
total Medicare revenues calculation, the denominator amount (total
Medicare revenues) would decrease. If the denominator amount decreases,
the likelihood increases that a laboratory would qualify as an
applicable laboratory. This is because the laboratory's PFS and CLFS
revenues are being compared to a lower total Medicare payment amount
than what they would have been compared to if MA plan payments remained
in the denominator. Second, consistent with our goal of obtaining a
broader representation of laboratories that could potentially qualify
as an applicable laboratory and report data, we also amended the
definition of applicable laboratory to include hospital outreach
laboratories that bill Medicare Part B using the CMS-1450 14x Type of
Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
In general, under section 1834A of the Act, 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 CMS 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 for a phase-in of payment reductions, limiting the
amounts the CLFS rates for each CDLT (that is not a new advanced
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as
compared to the payment rates for the preceding year. Under the
provisions enacted by section 216(a) of PAMA, 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. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA,
for CDLTs that are not ADLTs, the data collection period, data
reporting period, and payment rate update occur every 3 years. As such,
the second data collection period for CDLTs that are not ADLTs occurred
from January 1, 2019 through June 30, 2019, and the next data reporting
period was scheduled to take place from January 1, 2020 through March
31, 2020, with the next update to the Medicare payment rates for these
tests based on that reported applicable information scheduled to take
effect as of January 1, 2021.
Section 216(a) of PAMA established a new subcategory of CDLTs known
as ADLTs, with separate reporting and payment requirements under
section 1834A of the Act. The definition of an ADLT is set forth in
section 1834A(d)(5) of the Act and implemented at Sec. 414.502.
Generally, under section 1834A(d) of the Act, the Medicare payment
rate for a new ADLT is equal to its actual list charge during an
initial period of 3 calendar quarters. After the new ADLT initial
period, ADLTs are paid using the same methodology based on the weighted
median of private payor rates as other CDLTs. However, under section
1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs
occur annually instead of every 3 years.
[[Page 46069]]
Additional information on the private payor rate-based CLFS is
detailed in the CLFS final rule (81 FR 41036 through 41101) and is
available on the CMS website.\105\
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\105\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
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3. Previous Statutory Revisions to the Data Reporting Period and Phase-
In of Payment Reductions
Section 105(a) of the Further Consolidated Appropriations Act, 2020
(FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718
of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES
Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to
the CLFS requirements for the next data reporting period for CDLTs that
are not ADLTs under section 1834A of the Act. Additionally, the CARES
Act made revisions to the phase-in of payment reductions under section
1834A of the Act. Specifically, section 105(a)(1) of the FCAA amended
the data reporting requirements in section 1834A(a) of the Act to delay
the next data reporting period for CDLTs that are not ADLTs by 1 year,
so that data reporting would be required during the period of January
1, 2021 through March 31, 2021; the 3-year data reporting cycle for
CDLTs that are not ADLTs would resume after that data reporting period.
Section 105(a)(1) of the FCAA also specified that the data collection
period that applied to the data reporting period of January 1, 2021
through March 30, 2021 would be the period of January 1, 2019 through
June 30, 2019, which was the same data collection period that would
have applied absent the amendments. In addition, section 105(a)(2) of
the FCAA amended section 1834A(b)(3) of the Act regarding the phase-in
of payment reductions to provide that payments may not be reduced by
more than 10 percent as compared to the amount established for the
preceding year through CY 2020, and for CYs 2021 through 2023, payment
may not be reduced by more than 15 percent as compared to the amount
established for the preceding year. These statutory changes were
consistent with our regulations implementing the private payor rate-
based CLFS at Sec. 414.507(d) (81 FR 41036).
Subsequently, section 3718 of the CARES Act further amended the
data reporting requirements for CDLTs that are not ADLTs and the phase-
in of payment reductions under the CLFS. Specifically, section 3718(a)
of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the
next data reporting period for CDLTs that are not ADLTs by one
additional year, to require data reporting during the period of January
1, 2022 through March 31, 2022. As amended by the CARES Act, section
1834A(a)(1)(B) of the Act provided that in the case of reporting with
respect to CDLTs that are not ADLTs, the Secretary shall revise the
reporting period under subparagraph (A) such that: (i) no reporting is
required during the period beginning January 1, 2020, and ending
December 31, 2021; (ii) reporting is required during the period
beginning January 1, 2022, and ending March 31, 2022; and (iii)
reporting is required every 3 years after the period described in
clause (ii).
The CARES Act did not modify the data collection period that
applied to the next data reporting period for these tests. Thus, under
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of
the FCAA, the next data reporting period for CDLTs that are not ADLTs
(January 1, 2022 through March 31, 2022) would have been based on the
data collection period of January 1, 2019 through June 30, 2019.
Section 3718(b) of the CARES Act further amended the provisions in
section 1834A(b)(3) of the Act regarding the phase-in of payment
reductions under the CLFS. First, it extended the statutory phase-in of
payment reductions resulting from private payor rate implementation by
an additional year, that is, through CY 2024. It further amended
section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable
percent for CY 2021 is 0 percent, meaning that the payment amount
determined for a CDLT for CY 2021 shall not result in any reduction in
payment as compared to the payment amount for that test for CY 2020.
Section 3718(b) of the CARES Act further amended section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent will apply for CYs 2022 through 2024, instead of CYs 2021
through 2023.
In the CY 2021 PFS rulemaking (85 FR 50210 through 50211 and 85 FR
84693 through 84694), in accordance with section 105(a) of the FCAA and
section 3718 of the CARES Act, we proposed and finalized conforming
changes to the data reporting and payment requirements at 42 CFR part
414, subpart G. Specifically, we finalized revisions to Sec. 414.502
to update the definitions of both the data collection period and data
reporting period, specifying that for the data reporting period of
January 1, 2022 through March 31, 2022, the data collection period is
January 1, 2019 through June 30, 2019. We also revised Sec.
414.504(a)(1) to indicate that initially, data reporting begins January
1, 2017 and is required every 3 years beginning January 2022. In
addition, we finalized conforming changes to our requirements for the
phase-in of payment reductions to reflect the CARES Act amendments.
Specifically, we finalized revisions to Sec. 414.507(d) to indicate
that for CY 2021, payment may not be reduced by more than 0.0 percent
as compared to the amount established for CY 2020, and for CYs 2022
through 2024, payment may not be reduced by more than 15 percent as
compared to the amount established for the preceding year.
4. Additional Statutory Revisions to the Data Reporting Period and
Phase-In of Payment Reductions
Section 4 of the Protecting Medicare and American Farmers from
Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, enacted on December 10,
2021) made additional revisions to the CLFS requirements for the next
data reporting period for CDLTs that are not ADLTs and to the phase-in
of payment reductions under section 1834A of the Act. Specifically,
section 4(b) of PMAFSCA amended the data reporting requirements in
section 1834A(a) of the Act to delay the next data reporting period for
CDLTs that are not ADLTs by 1 year, so that data reporting would be
required during the period of January 1, 2023 through March 31, 2023;
the 3-year data reporting cycle for CDLTs that are not ADLTs would
resume after that data reporting period. As amended by section 4 of
PMAFSCA, section 1834A(a)(1)(B) of the Act now provides that in the
case of reporting with respect to CDLTs that are not ADLTs, the
Secretary shall revise the reporting period under subparagraph (A) such
that--(i) no reporting is required during the period beginning January
1, 2020, and ending December 31, 2022; (ii) reporting is required
during the period beginning January 1, 2023, and ending March 31, 2023;
and (iii) reporting is required every 3 years after the period
described in clause (ii).
Section 4 of PMAFSCA does not modify the data collection period
that applies to the next data reporting period for these tests. Thus,
under section 1834A(a)(4)(B) of the Act, as amended by section
105(a)(1) of the FCAA, the next data reporting period for CDLTs that
are not ADLTs (January 1, 2023 through March 31, 2023) will continue to
be based on the data collection period of January 1, 2019 through June
30, 2019, as defined in Sec. 414.502.
[[Page 46070]]
Section 4 of PMAFSCA further amends the provisions in section
1834A(b)(3) of the Act regarding the phase-in of payment reductions
under the CLFS. First, it extends the statutory phase-in of payment
reductions resulting from private payor rate implementation by an
additional year, that is, through CY 2025. It further amends section
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent
for each of CY 2021 and 2022 is 0 percent, meaning that the payment
amount determined for a CDLT for CY 2021 and 2022 shall not result in
any reduction in payment as compared to the payment amount for that
test for CY 2020. Section 4(a) of PMAFSCA further amends section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent will apply for CYs 2023 through 2025, instead of CYs 2022
through 2024.
5. Proposed Conforming Regulatory Changes
In accordance with section 4(b) of PMAFSCA, we are proposing to
make certain conforming changes to the data reporting and payment
requirements at 42 CFR part 414, subpart G. Specifically, we are
proposing to revise Sec. 414.502 to update the definitions of both the
``data collection period'' and ``data reporting period,'' specifying
that for the data reporting period of January 1, 2023 through March 31,
2023, the data collection period is January 1, 2019 through June 30,
2019. We are also proposing to revise Sec. 414.504(a)(1) to indicate
that initially, data reporting begins January 1, 2017 and is required
every 3 years beginning January 2023. In addition, we are proposing to
make conforming changes to our requirements for the phase-in of payment
reductions to reflect the amendments in section 4(b) of PMAFSCA.
Specifically, we are proposing to revise Sec. 414.507(d) to indicate
that for CY 2022, payment may not be reduced by more than 0.0 percent
as compared to the amount established for CY 2021, and for CYs 2023
through 2025, payment may not be reduced by more than 15 percent as
compared to the amount established for the preceding year.
We note that the CYs 2022 and 2023 CLFS payment rates for CDLTs
that are not ADLTs are based on applicable information collected in the
data collection period of January 1, 2016 through June 30, 2016. Under
current law, the CLFS payment rates for CY 2024 through CY 2026 will be
based on applicable information collected during the data collection
period of January 1, 2019 through June 30, 2019 and reported to CMS
during the data reporting period of January 1, 2023 through March 31,
2023.
6. Laboratory Specimen Collection Fee and Travel Allowance Proposals
In general, section 1833(h)(3) of the Act requires the Secretary to
provide for and establish a nominal fee for specimen collection for
laboratory testing and a fee to cover transportation and personnel
expenses for trained personnel to collect specimens from homebound
patients and inpatients (not in a hospital), in addition to the amounts
provided under the Medicare CLFS. In this section of the proposed rule,
we are proposing to codify our longstanding specimen collection fee
policies at Sec. 414.523(a)(1) and our travel allowance policies at
Sec. 414.523(a)(2), as well as proposing certain changes to modify or
clarify those policies.
a. Background on Laboratory Specimen Collection Fee Policy
Medicare Part B, which includes a variety of outpatient services,
generally covers medically necessary CDLTs when a doctor or non-
physician practitioner orders them. Medically necessary CDLTs are
generally not subject to coinsurance or deductible. Section
1833(h)(3)(A) of the Act provides that, in addition to the amounts
provided under fee schedules (for tests furnished before January 1,
2017) or under section 1834A of the Act (for tests furnished on or
after January 1, 2017), the Secretary shall provide for and establish a
nominal fee to cover the appropriate costs in collecting the sample on
which a CDLTs was performed and for which payment is made under
Medicare Part B, except that not more than one such fee may be provided
with respect to samples collected in the same encounter. As detailed
later in this section of the proposed rule, we provided manual
instructions regarding payment of the nominal specimen collection fee
in the Medicare Claims Processing Manual Pub. 100-04, chapter 16,
section 60.1,\106\ but we have not reflected these general policies in
our regulations.\107\ The HCPCS codes for the nominal specimen
collection fees currently listed on the CLFS (HCPCS codes 36415, P9612,
and P9615 \108\) have a payment rate of $3. Neither the annual
deductible nor the 20 percent coinsurance for Medicare apply to the
specimen collection fees or travel allowance for laboratory tests.
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\106\ The Medicare Claims Processing Manual is available on the
CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS018912.
\107\ In 1993, we proposed to implement the payment
methodologies for the specimen collection fee and travel allowance
in the regulations, see 53 FR 43837 through 43838, but did not
finalize those proposals.
\108\ HCPCS codes and long descriptors: 36415 (Insertion of
needle into vein for collection of blood sample); P9612
(Catheterization for collection of specimen, single patient, all
places of); P9615 (Catheterization for collection of specimen(s)
(multiple patients)).
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Section 216(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted April 1, 2014) added section
1834A(b)(5) to the Act, which increases by $2 the nominal fee that
would otherwise apply under section 1833(h)(3)(A) of the Act for a
specimen collected from an individual in a skilled nursing facility
(SNF) or by a laboratory on behalf of a HHA. Therefore, effective April
1, 2014, the nominal fee that would otherwise apply for a specimen
collected from an individual in a SNF or by a laboratory on behalf of a
HHA is $5, and the relevant HCPCS code is G0471.\109\ We implemented
this provision in our regulations at Sec. 414.507(f). However, as we
discuss below, we are proposing to codify our specimen collection fee
policies in Sec. 414.523(a)(1), including moving that provision from
Sec. 414.507(f) to Sec. 414.523(a)(1)(iv).
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\109\ HCPCS code and descriptor: G0471 (Collection of venous
blood by venipuncture or urine sample by catheterization from an
individual in a skilled nursing facility (SNF) or by a labortory on
behalf of a home health agency (HHA)).
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In the ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' interim
final rule with comment period (IFC), which appeared in the Federal
Register on April 6, 2020 (85 FR 19230), we established that Medicare
would pay a nominal specimen collection fee and associated travel
allowance to independent laboratories for the collection of specimens
for COVID-19 CDLTs for homebound and non-hospital inpatients (85 FR
19256 through 19258). Under this policy, the nominal specimen
collection fee for COVID-19 testing for homebound and non-hospital
inpatients generally is $23.46 and for individuals in a SNF and
individuals whose samples are collected by laboratory on behalf of an
HHA is $25.46. We indicated in that IFC that this specimen collection
fee policy was established for the duration of the PHE for COVID-19 (85
FR 19256) and noted in that IFC and subsequent rules (86 FR 39309; 86
FR 65327) that this policy will end once the PHE for the COVID-19
pandemic has ended.
In the CY 2022 PFS proposed rule (86 FR 39310), we requested broad
[[Page 46071]]
comments on our policies for specimen collection fees for consideration
for possible updates to those policies in the future through notice and
comment rulemaking. We requested comments regarding the nominal
specimen collection fees for trained personnel to collect specimens
from homebound patients and inpatients (not in a hospital), how
specimen collection practices may have changed as a result of, or from
insight gained during, the PHE for COVID-19, and what additional
resources might be needed for specimen collection for COVID-19 CDLTs
and other tests after the PHE ends, as well as comments related to the
calculation of costs for transportation and personnel expenses for
trained personnel to collect specimens from such patients. In the CY
2022 PFS final rule (86 FR 65327 through 65328), we described the
comments received and provided responses to those comments. We
expressed appreciation for the comments regarding the nominal specimen
collection fees for the collection of specimens for COVID-19 CDLTs and
acknowledged that the types of resources utilized and supplies needed
for specimen collection have been influenced by the PHE for COVID-19.
We stated that although we would not extend the increased payment
amount beyond the PHE, we would take the feedback received from the
comment solicitation into consideration for possible future rulemaking
and guidance.
b. Longstanding Laboratory Specimen Collection Fee Policies and
Practices
We have longstanding policies and practices regarding the statutory
requirements under section 1833(h)(3)(A) of the Act for the laboratory
specimen collection fee, which are currently described in the Medicare
Claims Processing Manual Pub. 100-04, chapter 16, Sec. 60.1. However,
we do not have corresponding regulations text related to the manual
guidance and some of the manual guidance is no longer applicable. The
manual guidance specifies when a specimen fee is allowed and not
allowed. In particular, the manual provides guidance on the following
topics: (1) specimen drawing by a physician; (2) specimen drawing by an
independent laboratory; (3) specimen drawing for a dialysis patient;
and (4) the coding requirements for specimen collection. We note that
laboratory services, including specimen collection and travel for
specimen collection, paid under the CLFS must be reasonable and
necessary as required under section 1862(a)(1)(A) of the Act.
Specifically, the guidance provides that a specimen collection fee
is allowed in circumstances such as drawing a blood sample through
venipuncture (that is, inserting into a vein a needle with syringe or
vacutainer to draw the specimen) or collecting a urine sample by
catheterization. A specimen collection fee is not allowed for a throat
culture or a routine capillary puncture for clotting or bleeding time.
Additionally, the specimen fee will not be paid to anyone who has not
extracted the specimen. The manual guidance addresses the number of
specimen collection fees allowed for each specimen type per patient
encounter. The manual also addresses how to treat a series of
specimens; when a series of specimens is required to perform a single
test (for example, a glucose tolerance test), the series is treated as
a single encounter.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.1)
describes specimen collection fees for physicians. Specifically, the
manual states that Medicare allows a specimen collection fee for
physicians only when: (1) it is the accepted and prevailing practice
among physicians in the locality to make separate charges for drawing
or collecting a specimen; and (2) it is the customary practice of the
physician performing such services to bill separate charges for drawing
or collecting the specimen.
In reviewing the specimen collection criteria for physicians to be
paid for this service, we had concerns regarding outdated terminology
and the eligibility criteria for these suppliers to bill Medicare for a
specimen collection fee. For example, we found that these criteria were
established prior to January 1, 1992, which is when Medicare began to
pay for physicians' services under section 1848 of the Act (56 FR
59502). Since that time, the provision of laboratory services and
physicians' services have evolved. Therefore, we evaluated those
criteria as they would apply today. In consideration of current
standards of practice, we analyzed utilization of the specimen
collection Current Procedural Terminology (CPT[supreg]) codes to
determine if the physician office setting is billing for this fee. We
found that, in 2019, office-based physician and nonphysician
practitioners had 67.4 million claims billed with specimen collection,
comprising 31.1 percent of all specimen collection claims.
We also looked to the PFS to see if there are similar services that
physicians and nonphysician practitioners can bill and be paid for
under section 1848 of the Act. We found that there are codes available
that address collection of blood, for example, CPT[supreg] codes 36410
(Venipuncture, age 3 years or older, necessitating the skill of a
physician or other qualified health care professional (separate
procedure), for diagnostic or therapeutic purposes (not to be used for
routine venipuncture)). These findings confirm specimen collection
occurs in the physician's office setting and there are coding options
to bill for that service via the PFS when applicable. Therefore, we
believe the criteria currently included in the manual for physician
eligibility for the CLFS specimen collection fee no longer apply. We
would not reflect those policies in regulation and would remove this
section of the manual accordingly.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.2)
describes policies for specimen drawing by independent laboratories.
Specifically, the manual states the following:
Medicare allows separate charges made by laboratories for drawing
or collecting specimens whether or not the specimens are referred to
hospitals or independent laboratories. The laboratory does not bill for
routine handling charges where a specimen is referred by one laboratory
to another. Medicare allows payment for a specimen collection fee when
it is medically necessary for a laboratory technician to draw a
specimen from either a nursing home patient or homebound patient.
Payment for the specimen collection fee is made based on the CLFS. The
technician must personally draw the specimen, for example, venipuncture
or urine sample by catheterization. Medicare does not allow a specimen
collection fee to the visiting technician if a patient in a facility
is: (1) not confined to the facility; or (2) the facility has personnel
on duty qualified to perform the specimen collection. Medical necessity
for such services exists, for example, where a laboratory technician
draws a blood specimen from a homebound or an institutionalized
patient. A patient need not be bedridden to be homebound. However,
where the specimen is a type that would require only the services of a
messenger and would not require the skills of a laboratory technician,
for example, urine or sputum, a specimen pickup service would not be
considered medically necessary. The manual then refers to the Medicare
Benefit Policy Manual, Chapters 7 and 15 of Pub. 100-02, for a
discussion of ``homebound'' and a more complete definition of a
medically necessary laboratory service
[[Page 46072]]
to a homebound or an institutional patient.
Under sections 1814(a) and 1835(a) of the Act, an individual shall
be considered to be ``homebound'' or ``confined to his home'' if the
individual has a condition, due to an illness or injury, that restricts
the ability of the individual to leave his or her home except with the
assistance of another individual or the aid of a supportive device
(such as crutches, a cane, a wheelchair, or a walker), or if the
individual has a condition such that leaving his or her home is
medically contraindicated. While an individual does not have to be
bedridden to be considered ``confined to his home,'' the condition of
the individual should be such that there exists an inability to leave
home such that leaving home requires a considerable and taxing effort
by the individual. Moreover, Sec. 424.22(a)(1)(ii) describes homebound
for the purposes of the provision of Medicare home health services as
home health services are or were required because the individual is or
was confined to the home, as defined in sections 1835(a) and 1814(a) of
the Act, except when receiving outpatient services. Additionally,
chapter 15 of the Medicare Benefit Policy Manual \110\ Section 60.4.1--
``Definition of Homebound Patient Under the Medicare Home Health (HH)
Benefit'' describes the definition of homebound in that the patient is
confined to his/her home, which has two criteria: (1) the patient must
either, because of illness or injury, need the aid of supportive
devices such as crutches, canes, wheelchairs, and walkers; the use of
special transportation; or the assistance of another person in order to
leave their place of residence; or (2) otherwise have a condition such
that leaving his or her home is medically contraindicated. The patient
must also meet two additional requirements defined in criterion two
such that there must exist an inability to leave home; and leaving home
must require a considerable and taxing effort.
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\110\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.2)
also explains the information that must be included on an independent
laboratory claim for specimen drawing. Specifically, the manual states
that in addition to the usual information required on claim forms
(including the name of the prescribing physician), all independent
laboratory claims for such specimen drawing ordered by a physician
should be appropriately annotated, for example, ``patient confined to
home,'' ``patient homebound,'' or ``patient in nursing home, no
qualified person on duty to draw specimen.'' The manual states that A/B
MACs (B) must assure the validity of the annotation through scientific
claims samples, as well as through regular bill review techniques.
(This could be done by use of the information in A/B MAC (B) files, and
where necessary, contact with the ordering physician.) If a physician
requests an independent laboratory to obtain specimens in situations
which do not meet, or without regard to whether they meet, medical
necessity criteria in Medicare Benefit Policy Manual, Chapter 15, the
manual provides that an educational contact with the ordering physician
is warranted and, where necessary, corroborating documentation should
be obtained on claims until the A/B MAC (B) is assured that the
physician prescribes such services only when the criteria are met. The
manual states that the specimen collection fee is paid based on the
location of the independent laboratory where the test is performed and
is billed in conjunction with a covered laboratory test.
The Medicare Claims Processing Manual (chapter 16, Sec. 60.1.3)
describes specimen drawing for dialysis patients. It states that, with
the implementation of the End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS), effective for claims with dates of service on or
after January 1, 2011, all ESRD-related laboratory services are
included in the ESRD PPS base rate.\111\ Clinical laboratory tests for
dialysis patients can be performed individually or in predetermined
groups on automated profile equipment. The manual states that a
specimen collection fee determined by CMS will be allowed only in the
following circumstances:
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\111\ The manual refers to the Medicare Benefits Policy Manual,
Chapter 11, for a description of labortory services included in the
composite rate.
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Drawing a blood sample through venipuncture (that is,
inserting into a vein a needle with a syringe or vacutainer to draw the
specimen).
Collecting a urine sample by catheterization.
The manual provides that special rules apply when such services are
furnished to dialysis patients. That is, the specimen collection fee is
not separately payable for patients dialyzed in the ESRD facility or
for patients dialyzed at home. A specimen collection fee is also not
separately payable when an ESRD facility is collecting a specimen for
transplant eligibility or other transplant requirements. Payment for
specimen collection is included under the ESRD PPS, regardless of
whether the laboratory test itself is designated as payable under the
ESRD PPS as a renal dialysis service or is separately billable by the
ESRD facility with the AY modifier (see Medicare Claims Processing
Manual, chapter 16, Sec. 40.6). Fees for taking specimens in the
hospital setting, but outside of the dialysis unit, for use in
performing laboratory tests not included in the ESRD PPS base rate, may
be paid separately.
We believe that the implementation of the ESRD PPS made the
specimen collection provision for ESRD beneficiaries in the ESRD
facility setting obsolete. That is, prior to the ESRD PPS, ESRD
facilities could be paid for laboratory services furnished to ESRD
beneficiaries that were considered to be separately payable. Under the
prior composite rate system, ESRD facilities with the appropriate
Clinical Laboratory Improvement Amendments (CLIA) certification could
bill Medicare Part B directly and be paid based on the CLFS for certain
laboratory tests, and when appropriate, for a specimen collection
fee.\112\ In implementing the ESRD PPS, we also implemented
consolidated billing requirements in the CY 2011 ESRD PPS final rule
(75 FR 49168 through 49173). In that ESRD PPS final rule, we stated
that we established these consolidated billing requirements because the
ESRD PPS provides an all-inclusive payment for renal dialysis services
and home dialysis items and services and the ESRD facility is
responsible for all of the renal dialysis services that its patients
receive. We further explained that items and services that were paid
separately under the basic case-mix adjusted composite rate (such as
laboratory tests), would no longer be billed for by other entities
(such as laboratories), and therefore, payment for these services would
be made only to the ESRD facility so that duplicate payment is not made
by Medicare (75 FR 49168).
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\112\ Pub. 100-02, Chapter 11, Section 20.0.E.2 and 3. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf.
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Additionally, section 1881(b)(14)(B)(i) and (iv) of the Act
provides that items and services included in the prior composite rate
and other diagnostic laboratory tests not reflected in the composite
rate that are furnished to individuals for the treatment of ESRD are
renal dialysis services that must be included as part of the ESRD PPS
bundled payment. In the CY 2011 ESRD PPS final rule, we explained that
[[Page 46073]]
patients with ESRD often have comorbid conditions which would require
many of the same laboratory tests as those required to monitor a
patient's ESRD (75 FR 49168). In that ESRD PPS final rule, we
acknowledged that it may be difficult to differentiate between a renal
dialysis service laboratory test and tests ordered for non-renal
dialysis service conditions. Therefore, to ensure proper payment in all
settings, as part of the consolidated billing approach, we provided
ESRD facilities and independent laboratories the ability to identify
non-renal dialysis service laboratory tests, by using the AY modifier,
which allows for separate payment under Medicare Part B (75 FR 49168
through 49169). While this longstanding policy permits ESRD facilities
to be paid separately for the non-renal dialysis service laboratory
tests, the specimen collection fee is no longer available since staff
time used to collect specimens is considered to be a composite rate
service (Sec. 413.171) and therefore payment for specimen collection
is made through the ESRD PPS bundled payment to the ESRD facility.
Therefore, we believe this section of the manual guidance describing
specimen drawing for dialysis patients is no longer applicable, and we
would not reflect this policy in regulation and would remove this
section of the manual accordingly. We note when an ESRD beneficiary
goes to an independent laboratory or a hospital setting, the same
payment rules would apply for specimen collection as they would for a
non-ESRD beneficiary for that setting.
Lastly, the Medicare Claims Processing Manual (chapter 16, Sec.
60.1.4) includes coding requirements for the specimen collection fees.
Specifically, the following HCPCS codes and terminology must be used:
36415--Collection of venous blood by venipuncture.
G0471--Collection of venous blood by venipuncture or urine
sample by catheterization from an individual in a skilled nursing
facility (SNF) or by a laboratory on behalf of a home health agency
(HHA).
P9612--Catheterization for collection of specimen, single
patient, all places of service.
P9615--Catheterization for collection of specimen(s)
(multiple patients).
c. Proposal To Codify the Laboratory Specimen Collection Fee Policy in
Regulation
As noted previously, most of our laboratory specimen collection fee
policies are not reflected in the CLFS regulations. In this section of
the proposed rule, we propose the laboratory specimen collection fee
policies we would include in regulations.
Section 1833(h)(3) of the Act specifies that payment amounts for
the specimen collection fee and travel allowance are ``in addition'' to
the payment amounts for CDLTs on the CLFS. As Sec. 414.507 pertains to
payment for CDLTs, we believe it is appropriate to create a separate
regulation to more clearly reflect that payment for the specimen
collection fee and travel allowance is in addition to payment for
CDLTs. We are proposing to create a new Sec. 414.523 titled Payment
for laboratory specimen collection fee and travel allowance. We would
specify in Sec. 414.523(a) that in addition to the payment amounts
provided for CDLTs, new CDLTs, and new ADLTs, CMS pays a specimen
collection fee and a travel allowance. In Sec. 414.523(a)(1), we would
reflect the longstanding specimen collection fee policies described in
the manual that continue to be applicable. As noted previously in this
proposed rule, we would not reflect in the regulation the specimen
collection fee policies that are no longer applicable--specifically,
the policies relating to physician eligibility for specimen collection
and specimen drawing for dialysis patients--and would remove those
policies from the manual.
First, we are proposing that Sec. 414.523(a)(1) would specify that
CMS will pay $3 for all specimens collected in one patient encounter.
As previously stated in this proposed rule, section 1833(h)(3)(A) of
the Act requires the Secretary to provide for and establish a ``nominal
fee to cover the appropriate costs in collecting the sample'' for
laboratory testing. We have paid $3 as the nominal specimen collection
fee amount for several years and at this time we are proposing to
maintain the $3 amount. First, the statute specifies that the amount is
``nominal'' and we believe $3 is an appropriate nominal amount to
recognize the costs associated with specimen collection. Further, we
believe that in enacting section 216(a) of PAMA, Congress recognized
CMS's authority to establish the specific nominal fee amount as $3 when
it added section 1834A(b)(5) of the Act to increase by $2 the nominal
fee that would otherwise apply under section 1833(h)(3)(A) of the Act
for a specimen collected from an individual in a SNF or by a laboratory
on behalf of an HHA. We are soliciting comments on our proposal to
maintain the $3 nominal specimen collection fee amount, including how
this amount could be updated.
Next, we are proposing to move and clarify the provision in our
regulations regarding the increased specimen collection fee under
section 1834A(b)(5) of the Act, as discussed in the previous paragraph.
We implemented this PAMA requirement in a Medicare Change Request (CR)
transmittal effective December 1, 2014 (Transmittal R3056CP;
CR 8837) and ultimately finalized this policy in Sec.
414.507(f). \113\ The CR provides that, in the case of a specimen
collected from an individual in a SNF or from an individual by a
laboratory on behalf of a HHA (billed using new HCPCS code, G0471
(Collection of venous blood by venipuncture or urine sample by
catheterization from an individual in a skilled nursing facility (SNF)
or by a laboratory on behalf of a home health agency (HHA))), the
nominal fee that would otherwise apply under section 1833(h)(3)(A) of
the Act shall be increased by $2, from $3 to $5, in accordance with
section 216(a) of the PAMA. The specimen collection fee is raised from
$3 to $5 only when the specimen is being collected by a laboratory
technician and when the specimen is from an individual in either a SNF
or HHA. We are proposing that this requirement, which is currently
reflected in Sec. 414.507(f), would be moved to Sec.
414.523(a)(1)(iv) and would be revised to state that beginning April 1,
2014, for a specimen collected from a Medicare beneficiary in a SNF or
on behalf of an HHA, the specimen collection fee otherwise paid under
paragraph (a)(1) of Sec. 414.523 is increased by $2.
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\113\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3056CP.pdf.
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Next, we are proposing to include in regulation that one specimen
collection fee would be allowed for each single patient encounter. This
means that, if different types or multiple specimens are drawn from one
patient, only one specimen collection fee would be allowed. We believe
this policy is consistent with section 1833(h)(3)(A) of the Act, which
provides that not more than one such fee may be provided under this
paragraph with respect to samples collected in the same encounter. We
propose to reflect this policy in Sec. 414.523(a)(1) by indicating
that CMS pays $3 for ``all specimens collected in one patient
encounter.''
In Sec. 414.523(a)(1)(i) through (iii), we propose to indicate the
specimen collection requirements that must be met for a specimen
collection fee to be payable are as follows and described in more
detail below. The specimen is:
[[Page 46074]]
used to perform a CDLT paid under the CLFS regulations in 42 CFR part
414, subpart G; collected by a trained technician from a Medicare
beneficiary who is homebound as described in 42 CFR 424.22(a)(1)(ii) or
is a non-hospital inpatient, but only when no qualified personnel are
available at the facility to collect the specimen; of the following
type--blood specimen collected through venipuncture or a urine sample
collected by catheterization.
In Sec. 414.523(a)(1)(ii) we are proposing to clarify the
requirement that the specimen must be collected by a ``trained
technician.'' Section 1833(h)(3) of the Act refers to staff providing
specimen collection services as ``trained personnel'' whereas the
Medicare Claims Processing Manual, chapter 16, Sec. 60.2 refers to
``the technician.'' The United States Bureau of Labor Statistics (BLS)
defines clinical laboratory technologists and technicians as workers
who collect samples and also perform tests to analyze body fluids,
tissue, and other substances.\114\ The term ``laboratory technician''
may not apply to those staff that would generally be providing specimen
collection services, as the staff collecting specimens may not also
analyze the specimens. Therefore, for the purposes of our Medicare
payment policies for specimen collection and travel allowance, we
propose to use the phrase ``trained technician'' to refer to the staff
providing specimen collection services. We believe this clarification
would more closely align the regulatory text pertaining to specimen
collection and travel allowance with the statute.
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\114\ https://www.bls.gov/ooh/healthcare/clinical-laboratory-technologists-and-technicians.htm.
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As previously discussed in this proposed rule, Medicare allows
payment of a specimen collection fee when it is medically necessary for
a trained technician to draw a specimen from either a nursing home
patient or homebound patient. Medicare does not allow a specimen
collection fee for the technician if a patient in a facility is: (1)
Not confined to the facility; or (2) the facility has qualified
personnel available to perform the specimen collection. We are
proposing to reflect in regulation that the specimen must be collected
either from a Medicare beneficiary who is homebound as described in 42
CFR 424.22(a)(1)(ii), or from a non-hospital inpatient, but only when
no qualified personnel are available at the facility to collect the
specimen. We believe this proposed requirement regarding homebound
beneficiaries would be consistent with Medicare policy which describes
home health services requirements. We are proposing to clarify that
payment for specimen collection would only be made to the laboratory
when no qualified personnel are available at the inpatient facility to
collect the specimen. We believe this proposed clarification would
reflect the justification for ``medical necessity'' for purposes of
section 1862(a)(1) of the Act. We would reflect this requirement in
Sec. 414.523(a)(1)(ii)(B) but would not explicitly state the term
``medically necessary''.
We are proposing to clarify that a specimen collected by a trained
technician would have to be either blood collected through venipuncture
or a urine collected by catheterization. We would reflect this
requirement in Sec. 414.523(a)(1)(iii), which would state that the
specimen collection fees are permitted for only these two types of
specimens: (1) Blood collected through venipuncture or (2) a urine
sample by catheterization. We acknowledge that the manual guidance
(described above) uses the terms ``such as'' and ``example'' to
describe the types of specimens for which specimen collection fees are
paid, which suggests that specimen collections of other than blood and
urine are eligible for specimen collection fees. We note, however, that
there are only two HCPCS codes for the two types of specimen
collections, which means we do not pay, and have not been paying,
specimen collection fees for any other types of specimens. Therefore,
under our current policy and this proposal, a specimen collection fee
would not be payable for any other specimen types, for example, a
throat culture or a routine capillary puncture for clotting or bleeding
time.
We welcome public comment on the proposed codification and
modification of these laboratory specimen collection fee policies. If
finalized, we would make conforming changes to the Medicare Claims
Processing Manual, Chapter 16, section 60 to reflect changes or
clarifications and remove sections that are no longer applicable.
Lastly, we are soliciting comment on specimen collection by
physician office laboratories (POLs). As discussed previously in this
proposed rule, we are proposing to delete the section in the manual
regarding physician specimen collection as codes exist to describe
these services when performed by physicians under the PFS. However, we
understand that specimens may be collected in the physician's office by
POL personnel. As stated in 42 CFR 410.32(d)(1)(iii), Medicare Part B
pays for covered diagnostic laboratory tests that are furnished by the
office of the patient's attending or consulting physician if that
physician is a doctor of medicine, osteopathy, podiatric medicine,
dental surgery, or dental medicine. When the physician's office is
furnishing CDLTs for its own patients and collecting specimens for
those tests, we do not believe this would include specimen collection
for homebound or non-hospital inpatients or involve travel for specimen
collection, since a POL is not an independent laboratory. However, we
seek comments on any possible considerations for the removal of the
manual section related to POL specimen collection.
d. Background on the Laboratory Specimen Collection Travel Allowance
Policy
Section 1833(h)(3)(B) of the Act requires the Secretary to provide
for and establish a fee to cover the transportation and personnel
expenses for trained personnel to travel to the location of an
individual to collect the sample on which a CDLT was performed, except
that such a fee may be provided only to an individual who is homebound
or an inpatient in an inpatient facility (other than a hospital). Like
the laboratory specimen collection fee policy discussed in the previous
section of this proposed rule, our longstanding policies and
instructions regarding the statutory requirements for the CLFS specimen
collection travel allowance are described in the Medicare Claims
Processing Manual guidance and CRs, currently with no corresponding
regulations text. In an August 18, 1993 proposed rule titled ``Medicare
and Medicaid: Programs; Payment for Clinical Diagnostic Laboratory
Tests,'' we proposed to reflect both the CLFS specimen collection and
travel allowance payment policies in regulation (58 FR 43838); however,
the proposals therein were not finalized.
As discussed in that proposed rule, due to the variability in time,
distance, and wage circumstances in different localities, we
implemented the travel allowance under section 1833(h)(3)(B) of the Act
by allowing Medicare Administrative Contractors (MACs) discretion in
calculating travel allowances. We provided general guidance through our
manuals, specifically in the Medicare Claims Processing Manual, chapter
16, Sec. 60.2.\115\
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\115\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c16.pdf.
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The Medicare Claims Processing Manual guidance at chapter 16, Sec.
60.2 describes two methods for calculating and billing travel allowance
for
[[Page 46075]]
specimen collection. HCPCS code P9603 is used when the average round
trip to a beneficiary's home or nursing home is farther than 20 miles,
paid on a mileage per trip basis. HCPCS code P9604 is used when the
average round trip is less than or equal to 20 miles, paid on a flat
rate per trip basis. The manual further states that the travel
allowance is intended to cover the estimated travel costs for a
laboratory technician to travel to collect the specimen and to reflect
the technician's salary and travel costs. The travel allowance can be
made only where a specimen collection fee is also payable; that is, no
travel allowance is made where the technician merely performs a
messenger service to pick up a specimen drawn by a physician or nursing
home personnel. The manual also states that the travel allowance may
not be paid to a physician unless the trip to the beneficiary's home,
or to the nursing home where the beneficiary resides, was solely for
the purpose of drawing a specimen. Otherwise travel costs are
considered to be associated with the other purposes of the trip.
Furthermore, the manual states that the travel allowance is not
distributed by CMS. Instead, the MACs (that is, within the claims
processing system) calculate the travel allowance for each claim using
the rules for the HCPCS codes used for travel allowances, which are
P9603--Per Mile Travel Allowance and P9604--Flat Rate.
As described in the manual, the conditions for usage of HCPCS code
P9603 are that the minimum ``per mile travel allowance'' is $1.04
(based on CY 2022 instructions). The per mile travel allowance is to be
used in situations where the average trip to beneficiaries' homes is
farther than 20 miles, and is to be prorated in situations where
specimens are drawn or picked up from non-Medicare patients in the same
trip.
The manual further states that the per mile allowance is computed
using the Federal mileage rate (as determined by the Internal Revenue
Service (IRS)), plus an additional 45 cents a mile to cover the
technician's time and travel costs. For 2022, the Federal mileage rate
is 58.5 cents; \116\ that amount plus 45 cents equals $1.035, rounded
up to $1.04. Contractors have the option of establishing a higher per
mile rate in excess of the minimum ($1.04 a mile in CY 2022) if local
conditions warrant it. The manual also states that the minimum mileage
rate will be reviewed and updated in conjunction with the CLFS as
needed and that at no time will the laboratory be allowed to bill for
more miles than are reasonable or for miles not actually traveled by
the laboratory technician.\117\
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\116\ https://www.irs.gov/newsroom/irs-issues-standard-mileage-rates-for-2022.
\117\ The Medicare Claims Processing Manual is available on the
CMS website at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c16.pdf. The manual provides
examples of the per-mile travel allowance in section 60.2--Travel
Allowance.
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For the flat-rate HCPCS code, P9604, the manual provides the
following conditions of usage: CMS will pay a minimum of $10.40 for the
flat rate code (HCPCS code P9604, based on CY 2022 instructions), which
is the one-way flat rate travel allowance. The flat rate travel
allowance is to be used in areas where average trips are less than 20
miles. The flat rate travel allowance is to be prorated for more than
one blood draw at the same address, and for stops at the homes of
Medicare beneficiaries and non-Medicare patients. The laboratory
performs the proration calculation when the claim is submitted based on
the number of beneficiaries seen on that trip, and the specimen
collection fee will be paid for each beneficiary encounter.
The manual states that this rate is based on the assumption that a
trip is an average of 15 minutes and up to 10 miles one way and uses
the Federal mileage rate (as determined by the IRS) and a laboratory
technician's time of $17.66 an hour, including overhead. The manual
states that contractors have the option of establishing a flat rate in
excess of the minimum of $10.00, if local conditions warrant it, and
that the minimum national flat rate will be reviewed and updated in
conjunction with the CLFS, as necessitated by adjustments in the
Federal travel allowance and salaries. The manual provides examples of
the flat rate calculation and describes further MAC flexibilities
regarding payment for the CLFS specimen collection travel allowance.
The manual also indicates that MACs may use their discretion for the
payment of travel allowance in circumstances where the CDLTs are needed
on an emergency basis outside the general business hours of the
laboratory making the collection. The manual also states that updates
to the travel allowance amounts will be issued by CMS via Recurring
Update Notification (RUN) on an annual basis.
In summary, the Medicare Claims Processing Manual, chapter 16,
Sec. 60.2, indicates that HCPCS code P9603 is used when the average
round trip to a beneficiary's home or nursing home is farther than 20
miles, paid on a mileage per trip basis. HCPCS code P9604 is used when
the average round trip is less than or equal to 20 miles, paid on a
flat rate per trip basis. In instances where one trip is made in order
to execute specimen draws or pickups from multiple patients, the travel
payment component is prorated based on the number of Medicare
beneficiaries and non-Medicare patients (not the number of specimens
collected) on that trip. All instances of specimen collection and
pickups are included in the proration, and the prorated specimen
collection travel allowance is billed on behalf of each Medicare
patient.
Furthermore, we have provided additional payment instructions
through RUN CLFS--Medicare Travel Allowance Fees for Collection of
Specimens CRs; the latest being CR 12593,\118\ which was issued on
January 14, 2022. Consistent with the manual, CR 12593 states that the
travel allowance HCPCS codes allow for payment either on a per-mileage
basis (P9603) or on a flat-rate per-trip basis (P9604). The CR states
that under either method, when one trip is made for multiple specimen
collections (for example, at a nursing home), the travel payment
component is prorated based on the number of specimens collected on
that trip, for both Medicare and non-Medicare patients, either at the
time the claim is submitted by the laboratory or when the flat rate is
set by the contractor.
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\118\ https://www.cms.gov/files/document/r11184cp.pdf.
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CR 12593 states that the Per Mile Travel Allowance (P9603) is to be
used in situations where the average trip to the patients' homes is
longer than 20 miles round trip and is to be prorated in situations
where specimens are drawn from non-Medicare patients in the same trip.
For CY 2022, the allowance per mile was computed using the Federal
mileage rate of $0.585 per mile plus an additional $0.45 per mile to
cover the technician's time and travel costs. The IRS determines the
standard mileage rate for businesses based on periodic studies of the
fixed and variable costs of operating an automobile, and CMS utilizes
this amount for P9604. The CR also states that the Per Flat-Rate Trip
Basis Travel Allowance (P9604) is a set fee amount, which is $10.40 for
CY 2022.
In summary, CR 12593 states that the travel payment component is
prorated based on the number of specimens collected on the trip (and
not the number of Medicare and non-Medicare patients), for both
Medicare and non-Medicare patients, which differs from the manual
instruction which states that the travel allowance should be prorated
based on the number of Medicare
[[Page 46076]]
beneficiaries and non-Medicare patients (not the number of specimens
collected) on that trip.
e. Policy Concerns and Recommendations on the CLFS Specimen Collection
Travel Allowance
Laboratories, members of the laboratory industry, and other
interested parties have expressed concerns regarding our current CLFS
travel allowance payment policy, suggesting that the travel proration
methodology is unclear and guidance in the Medicare Claims Processing
Manual, payment CRs, and guidance provided by the MACs are conflicting.
Additionally, members of the public claim that the travel allowance
requirements are administratively complex.
In the CY 2022 PFS proposed rule (86 FR 39310), we requested broad
comments on our policies for specimen collection fees and the travel
allowance for consideration for possible updates to policies in the
future through notice and comment rulemaking. As discussed in the CY
2022 PFS final rule (86 FR 65328), commenters supported clarification
to the existing travel allowance policy and also made suggestions
regarding possible refinements.
Several commenters described their concerns regarding the current
travel allowance policy, stating that the current system requires the
individual tracking of miles and paperwork documenting those miles, as
well as the calculation of billable charges. Commenters stated that
this system creates inconsistencies across facilities providing
specimen collection services and creates confusion and burden for
health care providers and MACs. One commenter also noted that because
of the complex logistics involved in obtaining specimens from homebound
patients and non-hospital inpatients and transporting the specimens for
prompt processing, a disincentive is created for serving this
potentially underserved patient population, leading to potential access
issues for Medicare beneficiaries.
Several commenters requested that CMS simplify the travel allowance
by creating a single per-encounter flat-rate payment for travel, which
would simplify personnel and transportation expenses by eliminating the
individual tracking of miles and paper documenting of those miles as
well as the calculation of billable charges. The commenters stated that
a flat-rate approach would also provide greater consistency across
facilities served and reduce the burden on health care providers and
MACs, and therefore, further support continued patient access to these
laboratory services. A few commenters suggested the creation of a rural
add-on payment to provide payment to those laboratories serving
Medicare beneficiaries residing in remote areas. Several commenters
also stated that the current travel allowance is prone to billing
inconsistencies, so simplifying the calculation of the travel allowance
would increase the overall understanding of the policy among impacted
parties, decrease the instances of health care providers inadvertently
overbilling for mileage, reduce program integrity concerns, and improve
clarity for all parties involved.
Several commenters also recommended that business requirements
outlined in the annual Medicare travel allowance CR be updated to
require the contractor to search their files to adjust claims already
paid at the prior year travel allowance rather than require action by
laboratories. The commenter requested that contractors be instructed to
review claims and reprocess at the updated rates rather than require
laboratories to initiate the revisions.
Additionally, the OIG issued an August 25, 2021 report, CMS Needs
To Issue Regulations Related to Phlebotomy Travel Allowances (A-06-20-
04000),\119\ in which the OIG discussed ongoing concerns regarding the
Medicare CLFS travel allowance policy and summarized findings from
previous audits of MACs in which claims for phlebotomy travel
allowances were paid using incorrect prorated mileage and claims for
phlebotomy travel allowances were paid using incorrect payment rates.
The OIG also described instances in which health care provider
documentation was insufficient to warrant payment of the phlebotomy
travel allowances.
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\119\ https://oig.hhs.gov/oas/reports/region6/62004000.asp.
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The 2021 OIG report presented recommendations to CMS regarding the
CLFS travel allowance policy, including working with the MACs to
educate health care providers about the documentation requirements for
specimen collection travel allowances, instructing the MACs to identify
and adjust any paid claims that incorrectly used the previous year's
rate, and issuing regulations related to phlebotomy travel to clarify
various aspects of the travel allowance payment policy.
In the CY 2022 PFS proposed rule (86 FR 39310 through 39311) and CY
2022 PFS final rule (86 FR 65328), we discussed the travel allowance
policy and stated that we made permanent the option for laboratories to
maintain electronic documentation of miles traveled for the purposes of
covering the transportation and personnel expenses for trained
personnel to travel to the location of an individual to collect a
specimen sample. This option for laboratories to maintain electronic
documentation applies to specimen collection for any CDLT. We noted
that laboratories will need to be able to produce electronic
documentation in a form and manner that can be shared with MACs, and
should continue to consult with their local MACs regarding the format
and process for submission of this information if necessary. We believe
that this flexibility to maintain electronic documentation of miles
traveled provides clarity to laboratories about documentation
requirements for the Medicare CLFS travel allowance for specimen
collection payment policy.
Additionally, we have instructed the MACs to identify and adjust
any paid claims that incorrectly used the previous year's rate, thereby
addressing the OIG's and commenters' suggestions regarding reprocessing
using the updated rates through the revision of business requirements
in the January 14, 2022 RUN CLFS--Medicare Travel Allowance Fees for
Collection of Specimens CR 12593.\120\ The OIG and commenters alike
recommended that we update the business requirements outlined in the
annual Medicare travel allowance CR to require the MACs to search their
files to adjust claims already paid at the prior year's travel
allowance amount rather than require action by laboratories.
Specifically, in the CR, we included the Business Requirement 12593.5,
which states that ``Contractors shall adjust previously paid travel
allowance claims with dates of service on or after January 1, 2022, in
order to apply the updated payment rate and initiate those adjustments
within 60 days, if claims are paid at the prior year's rates before the
new rate is entered into the MACs' systems.'' We believe this
modification to the business requirements will eliminate the need for
action by laboratories for adjustments to claims and instead provide
instruction to contractors to review claims and reprocess at the
updated rates as appropriate.
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\120\ https://www.cms.gov/files/document/r11184cp.pdf.
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f. Proposed Codification and Modifications of the CLFS Specimen
Collection Travel Allowance Policy
In light of the concerns from the public, and in an effort to
respond to the OIG's recommendation that CMS issue regulations
regarding certain aspects of
[[Page 46077]]
the travel allowance for specimen collection payment policy, we are
proposing to codify in our regulations, and make certain modifications
and clarifications to, the Medicare CLFS travel allowance policies, as
described below. We believe these proposals would achieve CMS' aims of
simplifying and clarifying our travel allowance policies. We propose to
add Sec. 414.523(a)(2), ``Payment for travel allowance,'' to reflect
the requirements for the travel allowance for specimen collection.
Specifically, in accordance with section 1833(h)(3)(B) of the Act, we
are proposing to include in our regulations the following: (1) General
requirement, (2) travel allowance basis, (3) travel allowance amount,
and (4) travel allowance amount calculation.
Section 1833(h)(3)(B) of the Act states that the Secretary shall
provide for and establish a fee to cover the transportation and
personnel expenses for trained personnel to travel to the location of
an individual to collect the sample. We believe this language indicates
that only instances of specimen collection requiring trained
technicians \121\ for the purposes of collecting the sample are to be
included in the travel allowance calculation. Therefore, travel for
simple pickup of specimens or for specimen collection that does not
require the services of trained technicians should not be considered in
the calculation of the travel allowance. This means, the travel
allowance may be paid only if a specimen collection fee is also
payable; for example, no travel allowance would be paid if a trained
technician merely performs a messenger service to pick up a specimen
drawn by other technicians.
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\121\ As noted previously in this section of the proposed rule,
we are proposing to use the term ``trained technician'' for purposes
of our specimen collection fee and travel allowance policies.
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The Medicare Claims Processing Manual, chapter 16, Sec. 60.2
states, ``The additional allowance can be made only where a specimen
collection fee is also payable, i.e., no travel allowance is made where
the technician merely performs a messenger service to pick up a
specimen drawn by a physician or nursing home personnel.'' We propose
to codify this general requirement at Sec. 414.523(a)(2)(i). This
provision would state that CMS pays a travel allowance where the
specimen is one for which a specimen collection fee is paid and would
make clear that all of the requirements for the specimen collection fee
to be paid (which are specified in Sec. 414.523(a)(1)) would need to
be met for the travel allowance to be payable.
Additionally, section 1833(h)(3)(B) of the Act states that the
travel allowance may be provided only with respect to an individual who
is homebound or an inpatient in an inpatient facility (other than a
hospital). We interpret this statutory language to mean that the fee
only applies when a trained technician draws a specimen from a patient
who either is in an inpatient facility that is not a hospital or is a
homebound patient. (A discussion regarding the definition of a
homebound patient is provided in section III.B.6.b. of this proposed
rule.) The Medicare Claims Processing Manual, chapter 16, Sec. 60.2
states that ``Medicare, under Part B, covers a specimen collection fee
and travel allowance for a laboratory technician to draw a specimen
from either a nursing home patient or homebound patient''. We believe
it is appropriate to codify that the travel allowance is permitted only
where the individual from whom the specimen is collected is homebound
or is an inpatient in an inpatient facility (other than a hospital).
This requirement would be reflected at Sec. 414.523(a)(2), which as we
note above would require all of the specimen collection fee
requirements at Sec. 414.523(a)(1) to be met, and which would include
the proposed requirement at Sec. 414.523(a)(1)(ii) that the specimen
is collected from a Medicare beneficiary who is homebound as described
in 42 CFR 424.22(a)(1)(ii) or a non-hospital inpatient.
In addition to proposing to codify the general requirement for
travel allowance, we are also proposing to clarify and make
modifications to the methodology for and the calculation of the CLFS
travel allowance amounts. In accordance with section 1833(h)(3)(B) of
the Act, we are proposing to reflect the travel allowance payment
methodology in the regulations and include the following components:
(1) travel allowance basis, (2) travel allowance amount, and (3) travel
allowance amount calculation.
In Sec. 414.523(a)(2)(ii), we are proposing to codify and clarify
that CMS pays a travel allowance on the following bases: (1) flat-rate
travel allowance basis and (2) per-mile travel allowance basis. We
interpret the statutory language in section 1833(h)(3)(B) of the Act
that requires us to pay a fee for trained personnel to travel to the
location of an individual to collect the sample to mean that the travel
allowance fee is only applicable to travel that is for the purpose of
collecting the specimen from a Medicare beneficiary. To that end, we
believe only one travel allowance payment may be made for specimen
collection for a Medicare beneficiary based on the beneficiary's
location, and only when a Medicare beneficiary requires the collection
of a specimen necessary for performance of CDLTs. We believe that non-
Medicare patients should not be included in any portion of the
calculation of the travel allowance. This interpretation would be a
modification to existing guidance in the Medicare Claims Processing
Manual, chapter 16, Sec. 60.2, which states that the travel allowance
``is to be pro-rated in situations where specimens are drawn or picked
up from non-Medicare patients in the same trip.'' This modification
would reflect that we believe only Medicare patients should be
considered in the calculation and payment of the travel allowance,
which would more closely align with the statutory language regarding
``the location of an individual,'' that is, the location of a Medicare
beneficiary receiving specimen collection services. We also believe
this modification would address concerns from laboratories, the OIG,
and other interested parties who requested clarification regarding the
inclusion of Medicare and non-Medicare beneficiaries in the travel
allocation calculation.
We are proposing that, whether a laboratory bills the flat-rate
travel allowance basis or the per-mile travel allowance basis would
depend upon the total miles traveled and number of locations. Section
1833(h)(3)(B) of the Act states, in establishing a fee to cover the
transportation and personnel expenses for trained personnel to travel
to the location of an individual to collect a sample, the Secretary
shall provide a method for computing the fee based on the number of
miles traveled and the personnel costs associated with the collection
of each individual sample. Therefore, we believe a key component of the
travel allowance payment for specimen collection is the number of miles
traveled for the specimen collection.
In considering potential methodologies for calculating a travel
allowance for specimen collection, we conducted an analysis of the
usage of the existing Per Mile Travel Allowance HCPCS code (P9603) to
understand the usage of P9603 and analyze the billing of miles related
to travel allowance for specimen collection. In CY 2019, among
professional and institutional Medicare claims, there were
approximately 3.2 million total claim lines billed for HCPCS code P9603
(per-mile travel allowance). Among the P9603 claim lines, the average
mileage billed per claim line was 18.8 with a standard
[[Page 46078]]
deviation of 33.4. However, the median distance traveled per line was 7
miles. Of all P9603 claim lines, 76.3 percent were billed with less
than 20 miles, and 37.9 percent of all P9603 claim lines were billed
with less than five miles. The average payment per line for P9603 in CY
2019 was $18.13; however, the median payment per line was $6.09.
Additionally, our analysis also shows that 23.7 percent of miles
traveled were greater than 20 miles, with 150,442 claim lines of the
approximately 3.2 million total claim lines, or 4.7 percent, logging
more than 85 miles per trip. We believe that these long-distance trips
likely reflect specimen collection from beneficiaries in rural areas
(which are generally underserved zones). Given that the majority of
P9603 claim lines (76.3 percent) are billed with less than 20 miles, we
believe that 20 miles would be an appropriate threshold for use in the
travel allowance bases for specimen collection. In addition, to address
concerns about administrative complexity, we are proposing that the
flat-rate travel allowance basis only would be available for trips
involving one location.
Specifically, we are proposing in Sec. 414.523(a)(2)(ii)(A) that
the flat-rate travel allowance basis would apply when the trained
technician travels 20 eligible miles or less to and from one location
for specimen collection from one or more Medicare beneficiaries. We
discuss our proposal for calculating eligible miles below. As discussed
previously in this section of the proposed rule, we believe that
section 1833(h)(3) of the Act supports payment for specimen collection
and travel allowance for only Medicare beneficiaries and should not
include non-Medicare beneficiaries. Under this proposal, laboratories
would bill Medicare using existing HCPCS code P9604 to receive payment
for the flat-rate travel allowance amount, prorated by the number of
beneficiaries for whom a specimen collection fee is paid, which we
discuss more fully in the travel allowance amount calculation proposal
below. We believe that providing payment for the flat-rate travel
allowance basis we are proposing would serve to simplify the
administrative requirements for laboratories in terms of billing and
record-keeping activities. Additionally, our proposed clarification
regarding requirements for proration would address issues raised by
interested parties, including the OIG, who expressed concerns regarding
inconsistencies in current guidance. We are seeking comment on
considerations related to the flat-rate travel allowance basis,
including considerations for proposed distance, alternatives for a
possible flat-rate travel allowance basis, as well as the utility of
this basis or the potential exclusion of this basis for the purposes of
the travel allowance for specimen collection.
In addition to the flat-rate travel allowance basis, we are
proposing in Sec. 414.523(a)(2)(ii)(B) the per-mile travel allowance
basis, which would apply when the trained technician travels more than
20 eligible miles to and from one location for specimen collection from
one or more beneficiaries or when the trained technician travels to
more than one location for specimen collection from more than one
Medicare beneficiary. To be clear, this proposed basis would apply in
two circumstances--where round trip travel to one location is greater
than 20 eligible miles and where travel is to more than one location,
regardless of the number of miles traveled. We are proposing to modify
our per-mile travel allowance policy in this way for greater clarity,
administrative simplification, and consistency with statute. Under this
proposed travel allowance basis, the laboratory would receive payment
for the total number of miles traveled for specimen collection, which
would be allocated to each Medicare beneficiary for whom a specimen
collection fee is paid. We believe this proposal would serve to address
the OIG's recommendations that CMS clarify various aspects of the
travel allowance payment policy, including requirements for proration,
which we discuss more fully in the travel allowance amount calculation
proposal below. We seek comment on all aspects of the proposed per-mile
travel allowance basis.
Additionally, we are proposing to specify travel allowance amount
requirements pertaining to eligible miles and the travel allowance
mileage rate. In Sec. 414.523(a)(2)(iii)(A), we propose that eligible
miles would begin at the laboratory and end at the laboratory where the
trained technician returns the specimen(s) for testing. We believe the
laboratory is the most likely place where the trained technician would
become aware of the laboratory order and acquire the necessary supplies
to perform the specimen collection. Although we do not believe the
trained technician would commence travel related to specimen collection
from a location other than the laboratory, we seek comment as to
whether there are alternative starting locations we should consider.
This proposed provision, requiring that the mileage calculation begins
at a laboratory, would codify existing policy in the Medicare Claims
Processing Manual, chapter 16, Sec. 60.2, which provides several
examples of travel allowance scenarios that reference the start of a
travel allowance route as beginning at a laboratory, and would be
consistent with section 1833(h)(3)(B) of the Act.
We are further proposing in Sec. 414.523(a)(2)(iii)(A) that
eligible miles would not include miles traveled for any purpose
unrelated to specimen collection, such as collecting specimens from
non-Medicare beneficiaries or for personal reasons. We believe the
statutory language in section 1833(h)(3)(B) of the Act supports our
proposal to exclude from the calculation of eligible miles any miles
traveled to a location where no specimens are collected, to the
location of a non-Medicare beneficiary for specimen collection, to a
Medicare beneficiary where no specimen collection occurs, or for
personal purposes. This proposed provision would codify the Medicare
Claims Processing Manual, chapter 16, Sec. 60.2, which states that
``the travel allowance is intended to cover the estimated travel costs
of collecting a specimen.''
In Sec. 414.523(a)(2)(iii)(B), we are proposing to set forth the
travel allowance mileage rate, which would be used in the travel
allowance amount calculations discussed below. Section 1833(h)(3)(B) of
the Act requires the travel allowance to cover both the
``transportation'' and ``personnel expenses'' for trained personnel to
travel to the location of an individual to collect a sample. Our
proposed travel allowance mileage rate therefore would reflect both of
these components.
As described previously in this section of the proposed rule, we
currently issue annual travel allowance amounts through CR
publications, such as CR 12593.\122\ Currently, CMS adds the Internal
Revenue Service (IRS) standard mileage rate to an additional $0.45 per
mile, which is intended to pay for the trained personnel's time, as
described in CR 12593, where the additional $0.45 per mile addresses
time and travel costs required by the technician for approximately 15
minutes of labor. The manual states that this rate is based on the
assumption that a trip is an average of 15 minutes and up to 10 miles
one way and uses the Federal mileage rate (as determined by the IRS)
and a technician's time of $17.66 an hour, including overhead. For CY
2022, the IRS standard mileage rate is $0.585. That amount plus $0.45
for the trained personnel's labor yields a
[[Page 46079]]
travel allowance mileage rate of $1.035, which is rounded up to $1.04
for CY 2022. We are proposing to codify the travel allowance mileage
rate in regulation as well as modify and clarify certain aspects of it.
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\122\ https://www.cms.gov/files/document/r11184cp.pdf.
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The IRS updates and issues standard mileage rates on a periodic
basis, generally annually.\123\ These rates are used to calculate the
deductible costs of operating an automobile for business, charitable,
medical, or moving for the purpose of calculating Federal taxes. We are
proposing that the ``transportation'' component of the travel allowance
mileage rate would equal the IRS standard mileage rate, which would be
consistent with our current policy. We believe using the IRS standard
mileage rate would continue to be an appropriate way to cover
transportation as the IRS rate accounts for the costs associated with
transportation per mile traveled. We seek comment on our proposal to
use the IRS standard mileage rate to cover the transportation component
of the travel allowance mileage rate.
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\123\ https://www.irs.gov/newsroom/irs-issues-standard-mileage-rates-for-2022.
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In addition, we are proposing to include an amount to cover the
``personnel expenses'' component of the travel allowance mileage rate
where the trained technician's personnel expenses would be based on a
wages-per-mile amount. First, we are proposing that personnel expenses
are wages in this context, where wages would represent the cost of the
trained technician's time for traveling to collect the sample. We are
proposing to base the specific wage amount on data from the BLS, which
publishes salary statistics for occupations in the United States. The
BLS defines a phlebotomist as a professional who draws blood for tests,
transfusions, research, or blood donations.\124\ The BLS separately
defines clinical laboratory technologists and technicians as workers
who collect samples and perform tests to analyze body fluids, tissue,
and other substances.\125\ For purposes of the travel allowance, we
believe the BLS definition of phlebotomist more closely aligns with the
trained technicians that we believe are providing the types of specimen
collection services described earlier in this section, as a
phlebotomist typically draws blood or other specimens, while a
laboratory technologist may both collect the specimen as well as
analyze the specimen. We do not believe that trained technicians
collecting the specimen for the purposes of our specimen collection
policies are also analyzing the specimens. Therefore, we propose to use
wage data in the BLS-defined category of phlebotomist to establish the
personnel expense component of the travel allowance mileage rate.
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\124\ https://www.bls.gov/ooh/healthcare/phlebotomists.htm.
\125\ https://www.bls.gov/ooh/healthcare/clinical-laboratory-technologists-and-technicians.htm.
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For CY 2021, (the latest available information), the BLS states
that the median pay (or the wage at which half of the workers in the
occupation earned more than that amount and half earned less) for
phlebotomists is $17.97 per hour.\126\ To account for the personnel
expenses associated with travel for specimen collection, we propose to
use the latest available published figure for the median hourly wage
amount for phlebotomists, which is published by the BLS, for the
purposes of annually updating the travel allowance amount for specimen
collection. We propose to codify this aspect of the travel allowance
mileage rate at Sec. 414.523(a)(2)(iii)(B) by describing that the
travel allowance mileage rate includes an amount to cover expenses for
a trained technician equal to the most recent median hourly rate for
phlebotomists, as published by the BLS. This approach would be a
clarification of and modification to current guidance, as CR 12593
describes that the $0.45 per mile added to the IRS rate is meant to
address the trained personnel's time and travel costs by the technician
based on approximately 15 minutes of labor.
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\126\ https://www.bls.gov/ooh/healthcare/phlebotomists.htm.
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Next, we would calculate a per-mile amount to derive the
approximate number of miles traveled by the trained technician each
hour. To do this, we are proposing to use an average driving speed. The
average miles-per-hour driving speed would be multiplied by the trained
technician's estimated wages, as described above, and the result would
be an amount that represents wages per mile, which would be the
personnel expenses associated with travel for specimen collection. We
are proposing to use an average driving speed of 40 miles per hour, as
we believe most of the travel related to specimen collection would be
performed in local and residential areas, as our data show that the
median number of miles traveled for specimen collection is
approximately 7 miles.
Therefore, to establish the personnel expenses component of the
travel allowance mileage rate, which would be a per-mile amount, we
propose that we would divide the most recent median hourly wage for
phlebotomists, as published by the BLS, by 40 to represent an average
miles-per-hour. We propose to codify this aspect of the travel
allowance mileage rate at Sec. 414.523(a)(2)(iii)(B). For CY 2023, the
amount would be equal to the most recent BLS median hourly wage for a
phlebotomist of $17.97 per hour (which is currently the BLS CY 2021
rate) divided by 40, which is $0.45 per mile. This amount is consistent
with the amount that we add to the IRS rate under our current travel
allowance policy.
In summary, we propose to establish in 414.523(a)(2)(iii)(B) that
the travel allowance mileage rate is equal to the IRS standard mileage
rate plus an amount to cover expenses for a trained technician equal to
the most recent median hourly wage for phlebotomists, as published by
the BLS, divided by 40 to represent an average miles-per-hour driving
speed. The travel allowance mileage rate would be updated annually
using the most recent IRS and BLS information, which we would issue in
subregulatory guidance annually through CRs.
We seek comment on all aspects of this proposed travel allowance
mileage rate, including the use of the IRS standard mileage rate to
cover transportation, the proposed use of estimated wages and average
driving speed to cover personnel expenses, and other specific
considerations or alternatives for establishing this rate.
Finally, we are proposing to include in Sec. 414.523(a)(2)(iii)(C)
the travel allowance amount calculations for the flat-rate travel
allowance basis and the per-mile travel allowance basis discussed
previously in this section of the proposed rule. We believe that these
proposed calculations would be a modification to existing guidance, as
we would clarify and revise the travel allowance amount calculations in
several respects.
In our analysis of mileage traveled for the purposes of specimen
collection, described above, the results indicate that the median
mileage per trip for specimen collection per Medicare beneficiary is
approximately 7 miles; therefore, we believe that a reasonable
approximation of the typical mileage required for specimen collection
per beneficiary is about 10 miles. As such, for the flat-rate travel
allowance basis, we are proposing in Sec. 414.523(a)(2)(iii)(C)(1)
that the travel allowance amount is the travel allowance mileage rate
described above multiplied by ten (10) (for CY 2023 example purposes,
this amount would be $10.40) and divided by the number of beneficiaries
for whom a specimen
[[Page 46080]]
collection fee is paid. Dividing by the number of beneficiaries for
whom a specimen collection fee is paid would ensure that the flat-rate
travel allowance amount is apportioned to each beneficiary receiving
specimen collection services and that payment is calculated in a
operationally feasible manner, as a laboratory must submit a claim for
each beneficiary to receive payment for travel allowance; this would
allow for a fixed payment amount to be straightforwardly apportioned to
the number of beneficiaries for whom a specimen collection fee is paid
in a single location. We believe this proposed flat-rate travel
allowance calculation would simplify payment for travel to one location
for specimen collection services requiring travel of 20 miles or less,
which would ease administrative burden.
Additionally, this proposed methodology would be consistent with
the existing flat-rate travel allowance payment policy described in CR
12593 and would clarify the proration methodology.
For an example of the proposed flat-rate travel allowance
calculation, consider a situation in which a trained technician travels
seven (7) miles from the laboratory to a nursing home to collect blood
specimens collected through venipuncture from five patients, four of
whom are Medicare beneficiaries. The trained technician collects three
specimens from Medicare beneficiaries, collects one specimen from the
non-Medicare patient, and simply picks up a previously collected
specimen from one Medicare beneficiary. The trained technician then
drives seven (7) miles back to the laboratory to deliver the specimens
without making any other stops. The trained technician has provided
specimen collection services to three Medicare beneficiaries. One
Medicare beneficiary did not require specimen collection services, and
therefore, a specimen collection fee would not be payable. In this
example, the laboratory would use the flat-rate travel allowance basis
because the trained technician traveled a total of 14 miles. To
calculate the travel allowance mileage rate, the laboratory would
divide flat-rate travel allowance amount of $10.40 by the number of
beneficiaries for whom a specimen collection fee is paid (three
beneficiaries), which equals $3.47. To bill for the travel allowance,
the laboratory would submit one claim for each beneficiary for whom a
specimen collection fee is paid by billing HCPCS code P9604.
We propose that updates travel allowance mileage rates would be
issued through subregulatory guidance, specifically the existing CMS
change request process, on an annual basis. We seek comment on all
aspects of the proposed calculation of the flat-rate travel allowance
amount, including considerations for the proposed mileage factor of ten
(10) and the proposed proration by the number of beneficiaries for whom
a specimen collection fee is paid.
We are also proposing to clarify, modify, and codify in regulation
the calculation for the per-mile travel allowance amount. Under
proposed Sec. 414.523(a)(2)(iii)(C)(2), the per-mile travel allowance
amount would equal the number of eligible miles multiplied by the
travel allowance mileage rate discussed above, divided by the number of
beneficiaries for whom a specimen collection fee is paid.
As discussed previously in this section of the proposed rule, we
believe that section 1833(h)(3) of the Act supports payment for
specimen collection and travel allowance only for Medicare
beneficiaries, and we are proposing that the per-mile travel allowance
amount calculation would only consider the number of Medicare
beneficiaries from whom specimens are collected in the proration of the
per-mile travel allowance. As the current policy in manual guidance and
the CR factor are inconsistent in referring to the number of specimens
or number of patients, our proposal would be a policy change to clarify
that only the number of Medicare beneficiaries for whom a specimen
collection fee is paid should be included in the calculation.
To calculate the per-mile travel allowance amount, the laboratory
would first calculate the total number of eligible miles, as set forth
in proposed Sec. 414.523(a)(2)(iii)(A), the trained technician
traveled--this would be the total number of miles traveled by the
trained technician to locations where one or more Medicare
beneficiaries received specimen collection services and back to the
laboratory where the technician returns the specimen(s) for testing.
The eligible miles would be multiplied by the travel allowance mileage
rate as set forth in proposed Sec. 414.523(a)(2)(iii)(B), then divided
by the number of beneficiaries for whom a specimen collection fee is
paid, which would yield a prorated travel allowance amount. Under this
proposed approach, the laboratory would receive payment for the total
number of eligible miles traveled for specimen collection, apportioned
equally to each Medicare beneficiary for whom a specimen collection fee
is paid. The laboratory would then submit a claim billing HCPCS code
P9603 for payment of the per-mile travel allowance amount for each
beneficiary for whom a specimen collection fee is paid. We believe this
proposed calculation for the per-mile travel allowance basis would
resolve concerns raised by the public about inconsistent guidance.
For an example of the per-mile travel allowance amount calculation,
consider a trained technician traveling 45 miles from a laboratory in a
city to a rural SNF, collecting blood specimens through venipuncture
from 6 Medicare beneficiaries, and then driving 45 miles to return to
the laboratory. In this example, the laboratory would use the per-mile
travel allowance basis because the trained technician traveled more
than 20 eligible miles to one location for specimen collection. To
calculate the per-mile travel allowance amount, the laboratory would
sum the eligible miles traveled to the location of Medicare
beneficiaries receiving specimen collection services, which, in this
case is 45 miles from the laboratory to the SNF and 45 miles from the
SNF returning to the laboratory, for a total of 90 eligible miles. The
eligible miles would then be multiplied by the travel allowance mileage
rate of $1.04, yielding a total of $93.60. This total amount would then
be prorated by dividing by the number of Medicare beneficiaries for
whom a specimen collection fee is paid (6), yielding a per-beneficiary
amount of $15.60 ($93.60/6 = $15.60). To bill for the travel allowance,
the laboratory would submit one claim for each beneficiary in the
amount of $15.60 HCPCS code P9603.
In another example, a trained technician travels 40 miles from a
laboratory to the location of a Medicare beneficiary to collect a
specimen, then travels 10 miles to the location of a non-Medicare
patient to collect a blood specimen through venipuncture, then travels
20 miles to the location of two Medicare beneficiaries to collect urine
specimens by catheterization, and then travels 20 miles to return to
the laboratory. In this example, the laboratory would use the per-mile
travel allowance basis because the trained technician traveled to more
than one location for specimen collection. To calculate the per-mile
travel allowance amount, the laboratory would sum the eligible miles,
which would include the miles traveled from the laboratory to the
locations of Medicare beneficiaries to collect specimens plus the miles
back to the laboratory for specimen drop-off. Eligible miles would not
would not include the 10 miles traveled to the
[[Page 46081]]
location of the non-Medicare patient to collect a specimen, but would
include the 40 miles traveled from the laboratory to the location of
the first Medicare beneficiary, the 20 miles to the location of the two
Medicare beneficiaries, and the return trip to the laboratory of 20
miles, for a total of 80 eligible miles. The eligible miles would then
be multiplied by the travel allowance mileage rate of $1.04, yielding a
total of $83.20. This total would then be prorated by dividing by three
(3) Medicare beneficiaries for whom a specimen collection fee is paid,
yielding an amount of $27.73. The laboratory would then submit a claim
using HCPCS code P9603 for travel allowance for each of the Medicare
beneficiaries in the amount of $27.73. Again, the laboratory receives
payment for the eligible miles traveled by the trained technician,
apportioned equally to each Medicare beneficiary for whom a specimen
collection fee is paid.
In conclusion, the proposed travel allowance payment policies would
represent both modifications to and clarifications of the specimen
collection travel allowance payment methodologies currently described
in guidance. We believe these proposed changes and clarifications, if
finalized, would improve and simplify the administration of the travel
allowance payment policy. Laboratories would use HCPCS code P9604 to
bill for the flat-rate travel allowance basis for shorter trips to one
location, and HCPCS code P9603 to bill for the per-mile travel
allowance basis for longer trips to one location and trips to multiple
locations, which we believe would ensure payment for specimen
collection services based upon eligible miles required for such travel
and address concerns of interested parties about the provision of
specimen collection services for individuals residing in remote
locations.
We seek comment on all aspects of this travel allowance proposal,
including the proposed general requirement, the proposed provisions
regarding the flat-rate and the per-mile travel allowance bases and the
utility of having both approaches, the proposed provisions regarding
eligible miles and the travel allowance mileage rate, as well as
considerations for the methodologies to calculate the travel allowance
amounts. We also seek comments on possible alternative considerations
for the CLFS travel allowance, including suggestions based on private-
payor and/or other approaches for tracking mileage and paying for
travel allowance, including per-beneficiary per-encounter bases, or
other approaches for providing payment for travel for specimen
collection. We note that our proposed regulations would not require
MACs to calculate travel allowance payments, nor would they reflect the
MAC flexibilities with respect to travel allowance payment that are
currently in guidance, such as their discretion to pay the travel
allowance in circumstances where CDLTs are needed on an emergency
basis; we seek comment on this issue as well.
We would make conforming changes to the Claims Processing Manual,
Chapter 16, section 60 to reflect these proposed travel allowance
policies, if finalized, including any changes or clarifications. As
noted previously, we would remove sections of the manual containing
policies that are no longer applicable.
D. Expansion of Coverage for Colorectal Cancer Screening and Reducing
Barriers
Medicare coverage for colorectal cancer (CRC) screening tests under
Part B are described in statutes (sections 1861(s)(2)(R), 1861(pp),
1862(a)(1)(H) and 1834(d) of the Act), regulation (42 CFR 410.37), and
National Coverage Determination (NCD) (Section 210.3 of the Medicare
National Coverage Determinations Manual). The statute and regulations
expressly authorize the Secretary to add other tests and procedures
(and modifications to tests and procedures) for colorectal cancer
screening with such frequency and payment limits as the Secretary finds
appropriate based on consultation with appropriate organizations.
(Section 1861(pp)(1)(D) of the Act; Sec. 410.37(a)(1)(v)). For a
number of CRC screening tests, the statute at section 1834(d) of the
Act established frequency and payment limits restricting coverage to
individuals at least 50 years of age. We are proposing to expand
Medicare coverage of certain CRC screening tests by reducing the
minimum age payment limitation to 45 years in our regulations at Sec.
410.37 and in NCD 210.3. Our proposal would align our coverage with a
recently revised recommendation by the United States Preventive
Services Task Force (USPSTF) for certain CRC tests as permitted by
section 1834(n) of the Act. Moreover, after consulting with appropriate
organizations, we are also proposing to modify the payment limitation
for other CRC screening tests identified in Sec. 410.37 and in NCD
210.3 to permit coverage for individuals to begin at age 45.
In addition, we propose to expand the regulatory definition of CRC
screening tests to include a follow-on screening colonoscopy after a
Medicare covered non-invasive stool-based CRC screening test returns a
positive result. Historically, CMS has viewed a colonoscopy after a
positive non-invasive stool-based CRC screening test to be a diagnostic
colonoscopy. In recent years, the clinical recommendations and guidance
of medical professional societies and screening experts have evolved
for stool-based colorectal cancer screening due to a number of factors
including the relative number of false positive results, low follow-up
colonoscopy rates and patient access barriers. For example, the
positive predictive value of a FIT (fecal immunochemical test) (the
likelihood that an individual with a positive FIT test result actually
has colorectal cancer) reportedly varies widely from 8 to 21 percent
depending on the test and testing center.\127\ Importantly, recent
published evidence has again highlighted that individuals that did not
get a follow-up colonoscopy were about twice as likely to die of
colorectal cancer compared to individuals that did have one.\128\ Since
the overall goal of programmatic cancer screening using any CRC
screening test is to prevent cancer, allow for early detection and
treatment and reduce cancer mortality, the follow-up colonoscopy is
integral to non-invasive stool-based CRC screening since improvements
in health outcomes would not be possible without the follow-up. Medical
professional organizations and clinical experts have reached consensus
based on the evidence on this recommendation. In May 2021 USPSTF
revised their evidence-based recommendation to include the statement
``Positive results on stool-based screening tests require follow-up
colonoscopy for the screening benefits to be achieved.'' \129\
Accordingly, we propose to modify CRC screening tests within our
authority in consultation with appropriate organizations. The outcome
of our more appropriate and complete approach to CRC screening will be
that beneficiary cost sharing for the initial screening stool-based
test and the follow-on screening colonoscopy test would not apply and
that they are both tests paid at 100 percent (no applicable copayment
percentage) as specified screening services under the Act. The issue of
[[Page 46082]]
when the follow-on screening colonoscopy involves the removal of tissue
or other matter or other procedure furnished in connection with, as a
result of, and in the same clinical encounter as the screening test
would not change from current policy and is described later in our
proposal. We believe this new understanding will encourage the wider
utilization of non-invasive CRC screening tests and reduce barriers to
screening, prevention and early detection of CRC.
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\127\ Nielson CM, Petrik AF, Jacob L, et al. Positive predictive
values of fecal immunochemical tests used in the STOP CRC pragmatic
trial. Cancer Med. 2018;7(9):4781-4790. doi:10.1002/cam4.1727.
\128\ Zorzi M, Battagello J, Selby K, et al. Non-compliance with
colonoscopy after a positive faecal immunochemical test doubles the
risk of dying from colorectal cancer. Gut. 2022;71(3):561-567.
doi:10.1136/gutjnl-2020-322192.
\129\ https://ww.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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Our proposals will update Medicare coverage and payment policies to
align with our new understanding of CRC screening. We believe these
proposals will expand access to quality care and improve health
outcomes through prevention, early detection, more effective treatment
and reduced mortality. Moreover, they would directly advance health
equity by promoting access and removing barriers for much needed cancer
prevention and early detection within rural communities and communities
of color that are especially impacted by the incidence of CRC.
Our proposals also directly support President Biden's Cancer
Moonshot Goal to cut age-adjusted death rate from cancer by at least 50
percent and addresses his recent Proclamation of March as National
Colorectal Cancer Awareness Month. The proclamation stated that ``early
stages of colorectal cancer often emerge without symptoms, and it is
important to begin regular screenings starting at the age of 45.'' It
goes on to read ``Thanks to the Affordable Care Act, most health
insurance plans must cover certain preventive services with no out-of-
pocket costs. This coverage now includes colorectal cancer screenings
for adults over the age of 45, making it easier to get colorectal
cancer screenings and helping improve access to earlier treatment.''
\130\
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\130\ https://www.whitehouse.gov/briefing-room/presidential-actions/2022/02/28/a-proclamation-on-national-colorectal-cancer-awareness-month-2022/.
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1. Background
In CY 2019, the last year for which incidence data are available,
CRC accounted for the 4th highest rate of new cancer cases and 4th
highest rate of cancer deaths in the United States.\131\ The National
Cancer Institute estimates that in 2021, 149,500 individuals will be
newly diagnosed with CRC and 52,980 individuals will die from CRC in
the United States.\132\ The Center for Disease Control and Prevention
(CDC) advises, ``Colorectal cancer almost always develops from
precancerous polyps (abnormal growths) in the colon or rectum.
Screening tests can find precancerous polyps, so that they can be
removed before they turn into cancer. Screening tests can also find
colorectal cancer early, when treatment works best. . . Regular
screening, beginning at age 45, is the key to preventing colorectal
cancer and finding it early.'' \133\
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\131\ https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/.
\132\ https://seer.cancer.gov/statfacts/html/colorect.html.
\133\ https://www.cdc.gov/cancer/colorectal/basic_info/screening/.
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Rural communities and communities of color are especially impacted
by the incidence of CRC. A CDC study found the death rate of CRC (per
100,000) to be 17.1 in rural nonmetropolitan counties verses 14.0 in
metropolitan counties with populations greater than 1 million.\134\
African Americans experience both new cases and deaths from colorectal
cancer at rates significantly above those of all races.\135\ An article
in the American Journal of Pathology states African Americans also are
often diagnosed at a younger age (median ages, 66 and 70 years for
African American men and women compared with 72 and 77 years for white
men and women, respectively). Moreover, African Americans are two times
more likely to be diagnosed with CRC before the age of 50 years, which
justified the recommendation to begin endoscopic screening at the age
of 45 years instead of 50 years.\136\
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\134\ Henley SJ, Anderson RN, Thomas CC, Massetti GM, Peaker B,
Richardson LC. Invasive Cancer Incidence, 2004-2013, and Deaths,
2006-2015, in Nonmetropolitan and Metropolitan Counties--United
States. MMWR Surveill Summ 2017;66(No. SS-14):1-13. DOI: http://dx.doi.org/10.15585/mmwr.ss6614a1.
\135\ https://seer.cancer.gov/statfacts/html/colorect.html.
\136\ Augustus GJ, Ellis NA. Colorectal Cancer Disparity in
African Americans: Risk Factors and Carcinogenic Mechanisms. Am J
Pathol. 2018;188(2):291-303. doi:10.1016/j.ajpath.2017.07.023.
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In May 2021, the USPSTF issued a revised Final Recommendation
Statement on CRC Screening. This replaced the prior USPSTF 2016 Final
Recommendation Statement and included a number of updated policy
recommendations based on new evidence and understandings of CRC and CRC
Screening. In terms of health disparities in CRC and CRC screening, the
May 2021 revised USPSTF statement reads, ``The causes for these health
disparities are complex; recent evidence points to inequities in the
access to and utilization and quality of colorectal cancer screening
and treatment as the primary driver for this health disparity rather
than genetic differences . . . Black adults across all age groups,
including those younger than 50 years, continue to have higher
incidence of and mortality from colorectal cancer than White adults.''
\137\
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\137\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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In addition to reducing the minimum age for Medicare payment for
CRC screening test payment, we are proposing to address a longstanding
barrier and disincentive to CRC screening using a non-invasive stool-
based test as a first step of a complete screening. Examples of
Medicare covered non-invasive stool-based CRC screening tests include a
guaiac-based fecal-occult blood test (gFOBT) described in regulation at
Sec. 410.37(a)(2)(i) and in National Coverage Determination 210.3
Colorectal Cancer Screening Tests, as well as immunoassay-based fecal-
occult blood test (iFOBT) and the Cologuard\TM\--Multitarget Stool DNA
(sDNA) test described in NCD 210.3. For the best health outcomes (CRC
prevention and early detection), it is important that patients receive
a complete CRC screening.
In recent years, government bodies and professional societies have
reconsidered their understanding of a complete CRC screening and now
consider CRC screening incomplete for individuals with a positive
result on a stool-based test until a follow-on screening colonoscopy is
also completed. The National Colorectal Cancer Roundtable recommends
that the patient should only be counted as having completed the CRC
screening process after a colonoscopy is performed.\138\ Under current
Medicare policies, if a Medicare patient initially receives a positive
result from a non-invasive and less burdensome screening stool-based
CRC test, the test would be viewed as showing signs or symptoms of
colorectal cancer. If a beneficiary received a subsequent colonoscopy,
we viewed the test as a diagnostic procedure and normal cost sharing
rules for diagnostic test would apply. Our current policy, however, may
discourage patients from seeking a follow-on colonoscopy because of the
Medicare cost-sharing. A 2018 guideline update from the American Cancer
Society on CRC screening for average-risk adults reads ``Trials
offering a choice between a stool test and a
[[Page 46083]]
structural examination compared with either test alone have generally
demonstrated greater uptake when a choice is offered. The best evidence
in the United States derives from a randomized trial in a safety-net
population comparing annual gFOBT versus colonoscopy versus choice
between the 2 in which it was demonstrated that choice was more
effective than offering colonoscopy alone. In the first year of the
study, which included patient navigation (year 1 only), the screening
completion rate was 38% for patients offered colonoscopy, 66 percent
for those offered gFOBT, and 68 percent for those offered a choice.
While uptake overall was similar in the gFOBT group versus the choice
group, it is clear that a ``colonoscopy-only'' referral resulted in
substantially lower adherence.'' \139\
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\138\ http://nccrt.org/wp-content/upload/0305.60-Colorectal-Cancer-Manual_FULFILL.pdf.
\139\ https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21457.
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One of the goals of CRC screening is to enable the healthcare
system to identify patients who need treatment early enough to prevent
or treat the condition most effectively. In order to encourage patients
to obtain a follow-on colonoscopy, a number of appropriate
organizations have suggested that we adopt a new approach that looks at
colorectal cancer screening as a continuum in the scenario where an
initial stool-based test returns a positive result and includes a
follow-on screening colonoscopy, when determined appropriate by the
patient and the healthcare provider. There currently exists a
misalignment of applicable patient cost sharing for a follow-on
screening colonoscopy after a positive non-invasive stool-based test as
Medicare coverage policies have not yet been updated to align to this
new understanding of a complete CRC screening described earlier. If the
patient had chosen the more expensive, invasive and burdensome
screening colonoscopy as the first step in their CRC screening, there
would be no applicable beneficiary cost sharing for the screening
colonoscopy. However, under current policy, if the patient initially
receives a positive result from a non-invasive, less burdensome and
less expensive stool-based test as the first step in their CRC
screening, beneficiary cost sharing would not be applicable for the
initial stool-based test, but would be applicable for the subsequent
colonoscopy (because it would be considered a diagnostic testing
service given the presence of signs and symptoms of disease based on
the result of the initial stool-based test).
2. Statutory Authority
Section 1861(s)(2)(R) of the Act includes CRC screening tests in
the definition of medical and other health services that fall within
the scope of Medicare Part B benefits described in section 1832(a)(1)
of the Act. Section 1861(pp) of the Act defines ``colorectal cancer
screening tests'' and specifically names the following tests:
Screening fecal-occult blood test;
Screening flexible sigmoidoscopy; and
Screening colonoscopy.
Section 1861(pp)(1)(D) of the Act also authorizes the Secretary to
include in the definition of CRC screening tests other tests or
procedures and modifications to the tests and procedures described
under this subsection, with such frequency and payment limits as the
Secretary determines appropriate, in consultation with appropriate
organizations. Section 1834(d) of the Act describes limitations for
payment of CRC screening tests, including that no payment may be made
for CRC screening tests of screening fecal-occult blood test at section
1834(d)(1)(B)(i) of the Act and screening flexible sigmoidoscopy at
section 1834(d)(2)(E)(i) of the Act for patients under the age of 50.
Section 1834(d) of the Act does not describe a minimum age limit for
screening colonoscopy.
Section 1834(n) of the Act, added by section 4105 of the Affordable
Care Act, grants the Secretary the authority to modify coverage of
certain preventive services identified in section 1861(ddd)(3) of the
Act, which in turn cross-references section 1861(ww)(2) of the Act
(including CRC screening tests at section 1861(ww)(2)(E) of the Act).
The Secretary may modify coverage to the extent that such modification
is consistent with the recommendations of the USPSTF, per section
1834(n)(1)(A) of the Act.
3. Regulatory Authority
Our implementing regulations for CRC screening are codified at
Sec. 410.37. Similar to section 1834(d) of the Act, Sec. 410.37
describes limitations on coverage and provide that payment may not be
made for screening fecal-occult blood tests at Sec. 410.37(c) or
screening flexible sigmoidoscopies at Sec. 410.37(e) for individuals
under the age of 50. Also similar to section 1834(d) of the Act, Sec.
410.37(g) does not describe a minimum age requirement for screening
colonoscopies. Section 410.37 also establishes coverage for screening
barium enemas at paragraph (h) and limits coverage to and individual 50
years of age or greater for an individual who is not at high risk of
CRC at paragraph (h). Section 410.37(h) does not describe a minimum age
limit for coverage of screening barium enemas for individuals who are
at high risk of CRC.
4. National Coverage Determination
NCD 210.3 CRC Screening Tests was last revised effective January
19, 2021, when coverage was expanded to include Blood-based Biomarker
Tests. NCD 210.3 was previously revised effective October 9, 2014, when
coverage was expanded to include The CologuardT--Multi-target Stool DNA
(sDNA) Test. Prior to that, NCD 210.3 was revised effective January 1,
2004, when coverage was expanded to include immunoassay-based fecal
occult blood test (iFOBT), which can be used as alternative to existing
guaiac-based fecal occult blood test (gFOBT). Under NCD 210.3, the
Blood-based Biomarker Tests, sDNA test, iFOBT and gFOBT tests all
include a limitation of coverage that the patient be at least 50 years
of age.
In the NCD 210.3 Final Decision Memo dated January 19, 2021, we
noted that multiple commenters provided an alert that a draft USPSTF
revised CRC recommendation was circulating and which included a
recommendation that CRC screening begin at age 45 instead of 50. The
commenters on the draft NCD Decision Memo, in the course of the NCD
process, also encouraged CMS to align screening age limitations for all
CRC screening tests. At that time, the draft USPSTF recommendation had
not been finalized. Therefore, we responded that we are finalizing NCD
210.3 coverage of CRC screening tests with an age range of 50 to 85
years of age. That said, if the draft USPSTF recommendation is
finalized and/or other society guidelines are revised, we may
reconsider, in consultation with appropriate professional
organizations, the appropriate CRC screening tests limitations and
address appropriately in an efficient manner.
5. Proposed Revisions
In May 2021, the USPSTF issued a revised recommendation (with a
Grade B) that adults who do not have signs or symptoms of CRC and who
are at average risk for CRC begin screening at age 45 instead of the
previous recommendation of age 50.\140\ Accordingly, we propose to
exercise our authority under section 1834(n) of the Act to modify
coverage of certain CRC screening tests to begin when the individual is
age 45 or older. The tests
[[Page 46084]]
included in the May 2021 USPSTF revised recommendation, including
stool-based tests of gFOBT, iFOBT and sDNA, and direct visualization
test of flexible sigmoidoscopy. Screening colonoscopy does not have a
minimum age requirement under Medicare coverage. We invite public
comment on this proposal.
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\140\ https://www.uspreventiveservicetaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
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We also propose to exercise our authority under section
1861(pp)(1)(D) of the Act to expand coverage of certain CRC screening
tests to begin for individuals at age 45 for barium enema test
(coverage described in Sec. 410.37(h)) and blood-based biomarker tests
(coverage described in NCD 210.3). While these tests were not
recommended in the earlier mentioned May 2021 revised USPSTF
recommendation, they are Medicare covered CRC screening tests and would
be an important alternative to the stool based and direct visualization
tests, especially for individuals with medical complexity and those in
rural and underserved communities. We believe that aligning the minimum
age requirements for certain Medicare covered CRC screening tests
described in our proposal to consistently begin for individuals at age
45 would avoid confusion and reduce barriers for beneficiaries and
healthcare professionals. Our proposal reflects our belief that
consistent coverage and payment policies will be important in promoting
CRC screening, which will result in expanded prevention, early
detection and improved health outcomes.
Conforming changes for our proposals to reduce the minimum age for
certain CRC screening tests would be made at Sec. 410.37 and NCD 210.3
authorities described earlier. We are not proposing to modify existing
conditions of coverage or payment for maximum age limitations and
frequency limitations. We also retain the same existing frequency
limitations except in the instance of a follow-on screening colonoscopy
after a positive result from a non-invasive stool-based CRC screening
test described earlier and later in our proposal). We propose to amend
Sec. 410.37 paragraph (c)(1), by removing the phrase ``under age 50''
and adding in its place the phrase ``under age 45'', amend paragraph
(c)(2), by removing the phrase ``individual 50 years of age'' and
adding in its place the phrase ``individual 45 years of age'', amend
paragraph (e)(1), by removing the phrase ``under age 50'' and adding in
its place the phrase ``under age 45'', amend paragraph (e)(2) by
removing the phrase ``individual 50 years of age'' and adding in its
place the phrase ``individual 45 years of age'', and amend paragraph
(i)(1), by removing the phrase ``individual age 50'' and adding in its
place the phrase ``individual age 45''. We also propose to issue formal
instructions that would revise the minimum age for the CRC screening
tests described in NCD 210.3 from 50 to 45 years.
We consulted with and reviewed recommendations from the following
appropriate organizations in our proposal to uniformly reduce the
minimum age for certain CRC screening tests from 50 to 45. ACS
recommends that people of average risk of CRC start regular screening
at age 45 and recommends stool-based tests and visual exam-based
tests.\141\ The American Society of Colon and Rectal Surgeons (ASCRS)
recommends CRC screenings for individuals 45 years of age and older and
identifies barium enema as one of multiple screening options.\142\ The
U.S. Multi-Society Task Force on Colorectal Cancer, which represents
the American College of Gastroenterology, the American
Gastroenterological Association, and the American Society for
Gastrointestinal Endoscopy, also recently revised their recommendation
that CRC screening for individuals of average risk of CRC begin at age
45 instead of 50.\143\ The Centers for Disease Control and Prevention
(CDC) website advises regular screening, beginning at age 45, is the
key to preventing colorectal cancer and finding it early. The CDC
website goes on to describe the earlier mentioned May 2021 revised
USPSTF recommendations.\144\
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\141\ https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/acs-recommendations.html.
\142\ https://fascrs.org/patients/diseases-and-conditions/frequently-asked-questions-about-colorectal-cancer.
\143\ Gastroenterology. 2022 Jan; 162(1):285-299. doi: 10.1053/
j-gastr5o.2021.10.007. Epub 2021 Nov 15.
\144\ https://www.cdc.gov/cancer/colorectal/basic_info/screening/.
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We considered the importance of aligning the minimum age
requirement for CRC screening across Medicare covered CRC screening
tests, as well as private health plans and Medicaid impacted by the May
2021 revised USPSTF recommendation. We believe consistent policy across
payers in terms of minimum age limits for CRC screening tests is
critical to the public's understanding of evolving CRC screening
recommendations. As added by section 2713 of the ACA, 42 U.S.C 300gg-13
requires a that group health plan and a health insurance issuer
offering group or individual health insurance coverage shall, at a
minimum, provide coverage for and shall not impose any cost sharing
requirements for evidence-based items or services that have in effect a
rating of ``A'' or ``B'' by the USPSTF. In addition, we considered that
section 1905(a)(13) of the Act, added by section 4106 of the ACA, which
expands Medicaid coverage to include screening services that are
assigned a grade of A or B by the USPSTF. We believe that expanding
coverage for barium enema and blood-based biomarker CRC screening tests
to a minimum age of 45, in alignment with the direct visualization and
stool-based tests recommended in the May 2021 revised USPSTF
recommendation, will allow additional, low burden options and
alternatives that may be preferred by some health professionals and
patients. While the recommendations from different professional
societies and other appropriate organizations include varying detail in
terms of specific tests, we understand the growing consensus in the
health care community is that the pathology of CRC now requires that
broad preventative screening should begin for individuals at age 45
instead of 50. We believe that reducing the minimum age for the
Medicare covered CRC screening tests barium enema test (coverage
described in Sec. 410.37(h)) and blood-based biomarker tests (coverage
described in NCD 210.3) from 50 to 45 years of age, in addition to and
in alignment with the direct visualization and stool-based tests
described in the 2021 USPSTF recommendation, is appropriate and
consistent with our purpose of early detection of colorectal cancer
described in Sec. 410.37(a)(1). We received public comment broadly
supportive of reducing the minimum age for certain CRC screening tests
in both the CY 2022 PFS final rule (86 FR 65179) and in the public
comments in response to our Proposed Decisions Memo for NCD 210.3
Screening for Colorectal Cancer--Blood-Based Biomarker Tests (Final
Decision Memo dated January 19, 2021). We look forward to further
consultation with the public and appropriate organizations through the
public comment period for this proposed rule. We invite public comment
on this proposal.
We also propose to exercise our authority under section
1861(pp)(1)(D) of the Act to expand coverage of CRC screening tests to
include a follow-on screening colonoscopy after a Medicare covered non-
invasive stool-based CRC screening test returns a positive result. In
this scenario, we now understand the follow-on screening colonoscopy to
be part of a continuum of a complete CRC
[[Page 46085]]
screening and not a separate diagnostic, therapeutic or other
procedure. Relatedly, we propose that the frequency limitations
described for screening colonoscopy in Sec. 410.37(g) would not apply
in the instance of a follow-on screening colonoscopy test after a
positive result from a Medicare covered stool-based test. We propose to
add new paragraph (k) toSec. 410.37 to state that, effective January
1, 2023, colorectal cancer screening tests include a follow-on
screening colonoscopy after a Medicare covered non-invasive stool-based
colorectal cancer screening test returns a positive result. We aim to
avoid disruption to the existing conditions of coverage and payment for
CRC screening for this unique scenario and include text noting the
frequency limitations described for screening colonoscopy in paragraph
(g) of this section shall not apply in the instance of a follow-on
screening colonoscopy test described in this paragraph.
We acknowledge that under current Medicare policy, a colonoscopy
after a stool-based CRC screening test returns a positive result would
be subject to beneficiary cost sharing because it would be considered a
diagnostic, therapeutic or other non-screening procedure. Section
410.32(a) describes a diagnostic test as an instance when the physician
who furnishes a consultation or treats a beneficiary for a specific
medical problem and who uses the results in the management of the
beneficiary's specific medical problem. Under current policy, a
positive result from the CRC screening stool-based test would be a sign
of illness or disease and the subsequent colonoscopy would be for
treatment and management of that specific medical problem. We now
believe our current policy of CRC screening to not include a follow-on
screening colonoscopy after a stool-based test returns a positive
result is incomplete and not in full support of our definition of CRC
screening test at Sec. 410.37(a)(1) for the purpose of ``early
detection of colorectal cancer''.
Our proposal to expand the definition of CRC screening to include
a follow-on screening colonoscopy after a stool-based test returns a
positive result will include implications for beneficiary cost sharing.
Under our proposal, beneficiary cost sharing (coinsurance and
deductible) would not be applicable for the stool-based test nor the
follow-on colonoscopy screening tests, as described at section
1833(1)(W)(ii) of the Act, as added by section 4104(b) of the
Affordable Care Act. When the follow-on screening colonoscopy requires
additional procedures furnished in the same clinical encounter, the
phased-in Medicare payment percentages for colorectal cancer screening
services described in regulation at Sec. 410.152(l) and finalized in
the CY 2022 PFS final rule (86 FR 65177 through 65179) will apply. That
is, when the follow-on screening colonoscopy includes the removal of
tissue or other related services during the same clinical encounter the
beneficiary coinsurance will be reduced over time from 15 percent for
services furnished during CY 2023 through CY 2026 to 10 percent for
services furnished during CY 2027 through 2029 to zero percent
beginning in CY 2030 and thereafter.
Our goal is that the patient and their healthcare professional
make the most appropriate choice in CRC screening, which includes
considerations of the risks, burdens and barriers presented with an
invasive screening colonoscopy in a clinical setting as their first
step. CRC screening presents a unique scenario where there are
significant differences between screening stool-based tests and
screening colonoscopy tests in terms of invasiveness and burdens to the
patient and healthcare system. We recognize there are several
advantages to choosing a non-invasive stool-based CRC screening test as
a first step compared to a screening colonoscopy, including relative
ease of administering the test and potentially reducing the experience
of unnecessary burdensome preparation and invasive procedures. It has
been reported that a large proportion (46 percent) of screening
colonoscopies found no polyps\145\ so optimizing use of a non-invasive
stool-based screening test as a first step (when determined appropriate
by the patient and their healthcare professional) would benefit the
patient and also the Medicare program. In many instances, a colonoscopy
is not the most appropriate first step in colorectal cancer screening
and would represent an unnecessary burden and over-servicing for both
the patient and healthcare system. The May 2021 revised USPSTF
recommendation reads, ``stool-based screening requires persons to
collect samples directly from their feces, which may be unpleasant for
some, but the test is quick and noninvasive and can be done at home
(the sample is mailed to the laboratory for testing), and no bowel
preparation is needed to perform the screening test.'' \146\ The May
2021 revised USPSTF recommendation goes on to described that direct
visualization CRC screening tests such as screening colonoscopy and
screening flexible sigmoidoscopy must be performed in a clinical
setting rather than home and require bowel preparation prior to the
test. In addition, sedation or anesthesia is usually used during
screening colonoscopy and the patient requires additional recovery time
and assistance with transportation home.
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\145\ Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H,
Chejfec G. Use of colonoscopy to screen asymptomatic adults for
colorectal cancer. Veteran sAffairs Cooperative Study Group 380. N
Engl J Med. 2000 Jul 20;343(3):162-8. doi:10.1056/
NEJM200007203430301. Erratum in: N Engl J Med 2000 Oct
19;343(16):1204. PMID: 10900274.
\146\ https://www.uspreventiveservicetask.org//uspstf/recommendation/colorectal-cancer-screening.
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We have heard from interested parties that CMS should consider a
complete CRC screening to include a follow-on screening colonoscopy
when a non-invasive stool-based test returns a positive result. We
consulted with and reviewed recommendations from a number of
professional societies in developing this proposal, including
supportive letters and communications with representatives from
American Gastroenterological Association, American Cancer Society
Cancer Action Network, and Fight Colorectal Cancer. Our proposal
regarding a new understanding of a complete CRC screening aligns with a
policy recommendation from the National Colorectal Cancer Roundtable,
which was ``established by the American Cancer Society (ACS) and the
Centers for Disease Control and Prevention (CDC) in 1997, is a national
coalition of public organizations, private organizations, voluntary
organizations, and invited individuals.'' \147\ Our proposal also
aligns to a 2018 CRC screening guideline update from the American
Cancer Society, which reads ``Implementation of the screening options
included in this guideline is premised on the requirement that the
appropriate follow-up to a positive (noncolonoscopic) test is a timely
colonoscopy. The follow-up colonoscopy should not be considered a
``diagnostic'' colonoscopy but, rather, an integral part of the
screening process, which is not complete until the colonoscopy is
performed. The information provided to patients to facilitate a choice
among tests must include the importance of follow-up of a positive
(noncolonoscopic) test with colonoscopy. Repeating a positive stool-
based test to determine whether to proceed to colonoscopy is not an
appropriate screening strategy.'' \148\
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\147\ https://nccrt.org/about/.
\148\ https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21457.
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We also considered the May 2021 revised USPSTF recommendation,
[[Page 46086]]
which includes the statement ``When stool-based tests reveal abnormal
results, follow-up with colonoscopy is needed for further evaluation .
. . Positive results on stool-based screening tests require follow-up
colonoscopy for the screening benefits to be achieved.''\149\ We also
note that the U.S. Departments of Labor, Health and Human Services
(HHS), and the Treasury issued a Frequently Asked Questions guidance on
January 10, 2022 that reads, ``A [non-grandfathered group health] plan
or [health insurance issuers offering non-grandfathered group or
individual health insurance coverage] must cover and may not impose
cost sharing with respect to a colonoscopy conducted after a positive
non-invasive stool-based screening test or direct visualization
screening test for colorectal cancer for individuals described in the
USPSTF recommendation. As stated in the May 18, 2021 USPSTF
recommendation, the follow-up colonoscopy is an integral part of the
preventive screening without which the screening would not be
complete.\150\ The follow-up colonoscopy after a positive non-invasive
stool-based screening test or direct visualization screening test is
therefore required to be covered without cost sharing in accordance
with the requirements of PHS Act section 2713 and its implementing
regulations.'' \151\
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\149\ https://www.uspreventiveservicetaskforce.org/uspstf/recommendation/colorectal-cancer-screening.
\150\ The quoted text from the January 10, 2022 Frequently Asked
Questions guidance includes a footnote to this portion of the text
that reads, ``In addition, in its `Supporting Evidence' section, the
USPSTF Full Recommendation Statement states: `Several comments
requested that colonoscopy to follow up an abnormal noncolonoscoy
screening test result be considered part of screening. The USPSTF
recognizes that the benefits of screening can only be fully achieved
when follow-up of abnormal screening test results is performed. The
USPSTF added language to the Practice Considerations section to
clarify this.' ''
\151\ https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf.
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We believe that our proposal to update our regulations to align to
our new understanding of a complete CRC screening will address the
beneficiary cost sharing barrier that currently exists for a subsequent
colonoscopy after an initial stool-based test returns a positive
result, would allow more options for healthcare professionals and
patients, would help optimize non-invasive CRC screening test use, and
improve health outcomes for Medicare beneficiaries. We received public
comment supportive of the policy described in our proposal in both the
CY 2022 PFS final rule (86 FR 65179) and in public comments to our
Proposed Decision Memo for the NCD 210.3 Screening for Colorectal
Cancer--Blood-Based Biomarker Tests (Final Decision Memo dated January
19, 2021).\152\ We look forward to further consultation with the public
and appropriate organizations through the public comment period for
this proposed rule. We invite public comment on this proposal.
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\152\ https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=299.
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The scope of our proposals is limited to CRC screening tests and
do not address the coverage or payment status of other screening
services or tests recommended by the USPSTF or covered by Medicare.
6. Summary
In summary, we propose to exercise our authority in section 1834(n)
and 1861(pp)(1)(D) of the Act to expand CRC screening coverage by
reducing the minimum age for CRC screening tests from 50 to 45 years of
age for certain Medicare covered CRC screening tests that currently
include a minimum age of 50 as a limitation of payment or coverage. A
screening colonoscopy would continue to not have a minimum age
limitation under our proposal. We also propose to exercise our
authority in section 1861(pp)(1)(D) of the Act to expand coverage of
CRC screening to include a follow-on screening colonoscopy after a non-
invasive stool-based test returns a positive result. We believe our
proposals will expand access to quality care and improve health
outcomes for patients through prevention, early detection, more
effective treatment and reduced mortality.
E. Removal of Selected National Coverage Determinations
CMS periodically identifies and proposes to remove National
Coverage Determinations (NCDs) that no longer contain clinically
pertinent and current information, in other words those items and
services that no longer reflect current medical practice, or that
involve items and services that are used infrequently by beneficiaries.
Clinical science and technology evolve, and items and services that
were once considered state-of-the-art or cutting edge and experimental
may later be established as reasonable and necessary for Medicare
beneficiaries or replaced by more beneficial technologies or clinical
paradigms.
Since the CY 2021 PFS final rule (85 FR 84472), we have used notice
and comment rulemaking to obtain public comment on removing outdated
NCDs, replacing the prior subregulatory administrative process used on
two occasions in 2013 and 2015. Using rulemaking under section
1871(a)(2) of the Act allows for efficiencies in timing and process to
consider removal of NCDs, as compared to the public comment process
established in section 1862(l) of the Act, to be used in making and
reconsidering individual NCDs through the National Coverage Analysis
process.
Eliminating an NCD that provides national coverage for items and
services means that the item or service will no longer be
automatically, nationally covered by Medicare (42 CFR 405.1060).
Instead, the initial coverage determinations for those items and
services will be made by local Medicare Administrative Contractors
(MACs). On the other hand, removing an NCD that bars coverage for an
item or service under title XVIII of the Act (that is, national
noncoverage NCD), allows MACs to cover the item or service if the MAC
determines that such action is appropriate under the statute. Removing
a national non-coverage NCD may permit more immediate access to
technologies that may now be beneficial for some uses. As the
scientific community continues to conduct research, which produces new
evidence, the evidence base we previously reviewed may have evolved to
support other policy conclusions.
In the CY 2021 PFS final rule, we did not establish an exclusive
list of criteria that we would use for identifying and evaluating NCDs
for removal. Instead, based on recommendations in public comments, and
to be more flexible and nimble, we added considerations to the six
factors established in 2013 to guide our decision making process. In
addition to the six factors listed below, we also consider the general
age of an NCD, changes in medical practice/standard of care, the pace
of medical technology development since the last determination, and
availability and quality of clinical evidence and information to
support removal of an NCD. We would consider proposing the removal of
an NCD if any of the following factors are present:
We believe that allowing local contractor discretion to
make a coverage decision better serves the needs of the Medicare
program and its beneficiaries.
The technology is generally acknowledged to be obsolete
and is no longer marketed.
In the case of a noncoverage NCD based on the experimental
status of an item or service, the item or service in the NCD is no
longer considered experimental.
[[Page 46087]]
The NCD has been superseded by subsequent Medicare policy.
The national policy does not meet the definition of an
``NCD'' as defined in sections 1862(l) or 1869(f) of the Act.
The benefit category determination is no longer consistent
with a category in the statute.
When we evaluate particular NCDs for removal, we review and
consider information gathered from interested parties, particularly
literature or evidence that supports a change in coverage, the Medicare
claims data for those items and services, and other factors such as
whether there may be documentation requirements within the NCD that are
outdated or create a barrier to coverage. The rulemaking process
provides an opportunity to consider public input before the NCD would
be removed. We could decide to retain those NCDs after considering
public comments.
In addition to conducting an internal review to identify
appropriate NCDs for removal, we receive removal requests from a
variety of external interested parties, such as medical specialty
societies, device manufacturers, beneficiaries, physicians and
providers, and other interested individuals with many of those requests
submitted as public comments to the PFS proposed rules. Additionally,
sometimes topics are brought to our attention by the MAC medical
directors.
The following outlines the NCD proposed for removal and provides a
summary of the rationale for removal. The current NCD below is
available in the Medicare National Coverage Determinations Manual
located at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
1. NCD 160.22 Ambulatory EEG Monitoring (06/12/1984)
Circumstances/Factor: We believe that allowing local
contractor discretion to make a coverage decision better serves the
needs of the Medicare program and its beneficiaries.
Rationale: Ambulatory, or prolonged
electroencephalographic (EEG) monitoring is a diagnostic test that
continuously records the brain's electrical activity during a patient's
routine daily activities and sleep. Ambulatory EEG monitoring may be
used to diagnose seizure disorders and metabolic, infectious, or
inflammatory disorders that affect the brain's activity, particularly
when a resting/routine EEG is not conclusive. The NCD currently defines
ambulatory EEG monitoring as 24-hour EEG monitoring and provides
coverage for patients in whom a seizure diathesis is suspected but not
defined by history, physical or resting EEG. The NCD also provides that
ambulatory EEG can be utilized in the differential diagnosis of syncope
and transient ischemic attacks if not elucidated by conventional
studies. Additionally, the NCD states that ambulatory EEG ``should
always be preceded by a resting EEG''. External interested parties
recommended removal of this NCD. The NCD contains outdated language
that is inconsistent with, and contrary to current standards of care.
For example, the NCD contains references to cassette tapes. This
outmoded technology has been supplanted with more modern techniques
that are more accurate and convenient for monitoring. The document uses
the word ``ambulatory,'' implying certain sites of service whereas this
diagnostic test is not site specific. The NCD makes mention of a 24-
hour duration of monitoring. However, the more recent coding structures
permit monitoring in increments including 36-60 hours, 60-84 hours, and
>84 hours. Additionally, interested parties stated that the language
``should always be preceded by a resting EEG'' could potentially create
waste and a burden. Interested parties indicated that in some clinical
scenarios, a ``resting/routine'' EEG is unlikely to adequately detect
seizure or other brain activity that would be useful for diagnostic
purposes, but would be detected by prolonged EEG testing. Removing the
outdated NCD will allow MACs to update guidance for this established
diagnostic test.
In summary, we solicit comment on the proposal to remove NCD 160.22
Ambulatory EEG Monitoring. We use the public comments to help inform
our decision to take one of three actions on the NCD proposed for
removal:
Remove the NCD, as proposed, allowing for coverage to be
determined by the MACs.
Retain the current policy as an NCD.
Reconsider the NCD by opening a National Coverage
Analysis. Comments suggesting that the NCD should be revised, rather
than eliminated, should include new evidence that was not previously
available at the time of the original NCD or at the time the NCD was
last reconsidered, in order to support a change in national coverage.
F. Modifications Related to Medicare Coverage for Opioid Use Disorder
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
1. Background
Section 2005 of the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities (SUPPORT)
Act established a new Medicare Part B benefit category for OUD
treatment services furnished by OTPs during an episode of care
beginning on or after January 1, 2020. In the CY 2020 PFS final rule
(84 FR 62630 through 62677 and 84 FR 62919 through 62926), we
implemented Medicare coverage and provider enrollment requirements and
established a methodology for determining the bundled payments for
episodes of care for the treatment of OUD furnished by OTPs. We
established new codes for and finalized bundled payments for weekly
episodes of care that include methadone, oral buprenorphine,
implantable buprenorphine, injectable buprenorphine or naltrexone, and
non-drug episodes of care, as well as add-on codes for intake and
periodic assessments, take-home dosages for methadone and oral
buprenorphine, and additional counseling. In the CY 2021 PFS final rule
(85 FR 84683 through 84692), we adopted new add-on codes for take home
supplies of nasal naloxone and injectable naloxone. In the CY 2022 PFS
final rule (86 FR 65340 and 65341), we established a new add-on code
and payment for a higher dose of nasal naloxone. We also revised the
regulations at Sec. 410.67(b)(3) and (4) to allow OTPs to furnish
individual and group therapy and substance use counseling using audio-
only telephone calls rather than two-way interactive audio/video
communication technology after the conclusion of the PHE for COVID-19
in cases where audio/video communication is not available to the
beneficiary, provided all other applicable requirements are met (86 FR
65342). We are continuing to monitor Medicare enrollment by OTPs and
utilization of OUD treatment services furnished by OTPs to ensure that
Medicare beneficiaries have appropriate access to care, as well as
monitoring for fraud, waste, and abuse. For CY 2023, we are proposing
several modifications to the regulations and policies governing
Medicare coverage and payment for OUD treatment services furnished by
OTPs.
2. Methadone Pricing
In the CY 2020 PFS final rule (84 FR 62667), we finalized a policy
in
[[Page 46088]]
Sec. 410.67(d)(2)(i) under which the payment for the drug component of
episodes of care would be updated annually using the most recent data
available from the applicable pricing mechanism at the time of
ratesetting for the applicable calendar year. Under the policy
finalized at Sec. 410.67(d)(2)(i)(B), for oral medications, if average
sales price (ASP) data are available, the payment amount is 100 percent
of ASP, which will be determined based on ASP data that have been
calculated consistent with the provisions in 42 CFR part 414, subpart J
and voluntarily-submitted by drug manufacturers. If ASP data are not
available, the payment amount for methadone will be based on the
TRICARE rate. Using this established method, we determined that the
payment amount for methadone furnished by OTPs during an episode of
care in CY 2021 was $37.38,\153\ which was 100 percent of ASP, as
determined based on voluntarily-submitted ASP data for methadone.
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\153\ https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf.
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In early September 2021, while gathering available manufacturer-
reported ASP data for the annual update to the OTP drug pricing for CY
2022, we found that the volume-weighted ASP for oral methadone had
decreased by just over 50 percent compared to the CY 2021 rate, from
$37.38 to $17.64.\154\ This reduction was due to inclusion of newly
reported ASP data for methadone tablets, whereas previously the
manufacturer-reported ASP data reflected only sales of the methadone
oral concentrate. The ASP is volume-weighted; however, ASP reporting is
not required for oral methadone and only a small subset of methadone
manufacturers voluntarily submit ASP data. In September 2021, of the
nearly 50 available NDCs for oral methadone preparations with available
pricing in the Red Book[supreg] compendia, voluntarily-submitted ASP
data was available for only three of these NDCs. Pricing for oral
methadone is distinct from most other drug pricing based on ASP because
oral methadone is not separately payable as a drug or biological under
Medicare Part B, and manufacturers are not subject to ASP reporting
requirements under section 1927(b)(3)(A)(iii) of the Act for those
NDCs. Additionally, we do not have utilization data on the different
forms of methadone that can be dispensed or administered at OTPs. That
is, we do not have data showing whether OTPs utilize oral methadone
concentrate or tablets more often, or if the two formulations are
utilized equally. When we researched OTP practice patterns as we were
preparing to implement the new benefit for OUD treatment services
furnished by OTPs, we received anecdotal reports that several OTPs used
the oral concentrate exclusively.
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\154\ The TRICARE rate for the drug portion of its weekly
bundled payment for methadone treatment is $24.04 for 2022, which
would also have been a decrease from the CY 2021 payment rate under
Medicare and could not be used to set the Medicare payment rate for
methadone in CY 2022 under Sec. 410.67(d)(2)(i)(B) because ASP data
was available for methadone.
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For these reasons, while performing our annual ratesetting exercise
for CY 2022, we had concerns as to whether the ASP data available to us
at that time, which reflected voluntarily reported data from only a
very small subset of methadone manufacturers, was representative of
utilization of the two forms of oral methadone by the Medicare
beneficiaries receiving OUD treatment services in OTPs. Additionally,
given reports regarding the effects of the public health emergency
(PHE) for COVID-19 on individuals with substance use disorders (SUDs),
including OUD, and the questions we had related to whether the ASP data
we had for methadone was reflective of OTP utilization due to the
distinct nature of methadone pricing, as described above, we believed
it was in the public's best interest not to implement a significant
decrease in the payment rate for methadone furnished by OTPs as part of
OUD treatment services without first having an opportunity to review
the issue, seek input from the OTP community regarding utilization of
methadone oral concentrate compared to utilization of methadone
tablets, and consider how this information should factor into the
determination of the payment rate for methadone furnished by OTPs. We
noted that section 1834(w)(2) of the Act allows for flexibility to
consider the scope of services furnished, the characteristics of the
individuals receiving services, and such other factors as the Secretary
determines appropriate, in determining the rates paid to OTPs under
Medicare.
Therefore, we issued the ``Medicare Program; Opioid Treatment
Programs: CY 2022 Methadone Payment Exception'' interim final rule with
comment period (IFC) (hereafter referred to as ``Methadone IFC''),
which appeared in the November 19, 2021 Federal Register (86 FR 66031
through 66036). In the Methadone IFC, we established a limited
exception to the methodology for determining the payment amount for the
drug component of an episode of care in order to freeze the payment
amount for methadone furnished during an episode of care in CY 2022 at
the $37.38 payment amount that was determined for CY 2021. We also
revised the regulation at Sec. 410.67(d)(2)(i)(B), which governs the
determination of the payment amount for oral medications, to reflect
this exception for CY 2022 and to make a conforming change to the
reference to 42 CFR part 414, subpart J.
Under this exception, the payment amount for the drug component of
the methadone bundle described by HCPCS code G2067 (Medication assisted
treatment, methadone; weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing, if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program)) and the methadone add-on
code described by HCPCS code G2078 (Take-home supply of methadone; up
to 7 additional day supply (provision of the services by a Medicare-
enrolled Opioid Treatment Program); List separately in addition to code
for primary procedure) was maintained at the CY 2021 rate of $37.38 for
the duration of CY 2022. We also applied the annual update to the non-
drug component of HCPCS G2067 for CY 2022 as required under Sec.
410.67(d)(4)(iii). We stated that we believed maintaining the payment
amount for methadone at the CY 2021 rate during CY 2022 would allow
time for CMS to study the issue further and, if appropriate, to develop
an alternative payment methodology for methadone that could be proposed
through notice-and-comment rulemaking for CY 2023 (86 FR 66033). We
solicited comments on this exception to the payment methodology for the
drug component of an episode of care in order to maintain the payment
rate for methadone at the CY 2021 payment amount during CY 2022. In
addition, we sought comments on OTP utilization patterns for methadone,
particularly the frequency with which methadone oral concentrate is
used compared to methadone tablets in the OTP setting, including any
applicable data on this topic. We also stated that we would consider
the comments received in determining how best to determine the payment
rate for methadone in CY 2023, including whether we should propose
changes to the structure of OTP coding and payment in order to account
for differences in pricing and utilization of the different
formulations of methadone.
We received several comments in response to the Methadone IFC from
medical associations, national associations representing OTPs, and
[[Page 46089]]
individual commenters that expressed strong support for stabilizing the
payment rate for methadone. One commenter stated cutting reimbursements
to providers who specialize in treatment for OUD in the middle of an
OUD epidemic that has been exacerbated by the COVID-19 pandemic could
have harmful consequences for beneficiaries and cited that the HHS
Office of Inspector General (OIG) expressed concern that Medicare
beneficiaries face challenges accessing OUD treatment. The commenter
also stated that if Medicare reimbursements for methadone fall well
below OTPs' costs of acquiring and administering the medication, OTPs
may have no choice but to prescribe a much more expensive medication
(buprenorphine or naloxone) as part of medication-assisted treatment
(MAT)/Medications for Opioid Use Disorder (MOUD), which would result in
higher costs for the Medicare program and taxpayers, while not
necessarily improving care. For example, methadone is often more ideal
for severe dependence or if there is a high risk of divergence, while
buprenorphine may be more advantageous for mild to moderate dependence
and when extensive supervision by a practitioner is not needed.\155\
Another commenter stated that it is possible that freezing the payment
rate for methadone at the current level could still result in some
negative outcomes, as supply chain and logistics issues have generally
resulted in increased prices across the country such that a payment
rate increase may be necessary, but thought that freezing the rate at
the current level was a prudent solution for 2022. A commenter
representing a large number of OTPs across the country stated that OTPs
rarely dispense methadone tablets and instead administer the oral
concentrate formulation. This commenter stated that methadone oral
concentrate is more expensive to acquire and administer than the tablet
form, but that it has been shown to lead to better clinical outcomes
for their patients, which is why it is their doctors' formulation of
choice. This commenter went on to state that the existing methodology
to calculate the payment rate for the drug component of the methadone
weekly bundle does not accurately capture the extra costs associated
with administration of the oral concentrate, explaining that oral
concentrate formulations require careful measurement in addition to
maintaining electric pumps and updating computer software. The
commenter also noted that it is expensive to employ the necessary
nursing staff, and stated that a number of States require full-time
pharmacists for the dispensing and administration of medication.
Another commenter noted that the National Association of State Alcohol
and Drug Abuse Directors (NASADAD), in conjunction with the State
Opioid Treatment Authorities (SOTAs), conducted a survey that was
distributed to the 1,800 OTPs throughout the United States. As of
December 31, 2021, NASADAD and the SOTAs had collected data from 1,550
OTPs. These data include the number of patients being treated at OTPs
as of January 1, 2021, including the number of patients using one of
the three FDA-approved medications to treat opioid use disorder
(methadone, buprenorphine, and extended-release naltrexone) and the
specific forms of the medication being used.
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\155\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3271614/.
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We appreciate the feedback received in response to the Methadone
IFC. We agree with commenters that decreasing the payment amount for
methadone in the middle of an OUD epidemic that has been exacerbated by
the COVID-19 pandemic could have harmful consequences for beneficiaries
as we discussed in the Methadone IFC (86 FR 66032). We are also looking
forward to seeing the results of the survey initiated by NASADAD and
the SOTA, so that we can better understand the utilization of methadone
tablets and oral concentrate in OTPs.
In light of the comments received, we have considered how best to
maintain access to treatment with methadone in the OTP setting for
Medicare beneficiaries. We considered splitting the methadone bundled
payment code into two codes--one for oral concentrate and one for the
tablet. This would allow us to track Medicare utilization of each
formulation. However, because of the inconsistency in available ASP
data for orally administered methadone due to the fact that
manufacturer reporting of sales data for these dosage forms of
methadone is voluntary, (that is, orally administered methadone is not
a drug that falls under the ASP reporting requirements under sections
1927(b)(3)(A)(iii) or 1847A(f)(2)(A) of the Act), we do not believe
that voluntary reporting of ASP data for either form of orally
administered methadone (oral concentrate or tablet) currently provides
a reliable source for pricing the methadone codes. For example, for the
first quarter of 2022, there was no ASP data reported for orally
administered methadone. Under the policy at Sec.
410.67(d)(2)(i)(B)(1), when ASP data are not available for methadone,
we would base the payment amount for methadone on the TRICARE rate. We
found that the applicable TRICARE payment amount for methadone for CY
2022 would be $24.04. Using the TRICARE payment amount for methadone
for CY 2023 would result in a decrease of $13.34 compared to the rate
that applied in CY 2021 and CY 2022. We believe that this decrease
would be problematic for all of the reasons that we expressed in the
Methadone IFC (86 FR 66034 through 66035). For these reasons, we
believe that it is appropriate to propose an alternate methodology for
pricing the drug component of the methadone bundle and the methadone
add-on code in order to maintain payment stability, and therefore,
maintain appropriate access to OUD treatment services furnished at OTPs
for Medicare beneficiaries.
In the CY 2020 PFS final rule (84 FR 62667), we discussed the
methods we had considered for providing an update each year to the drug
component of the OTP bundled payment rates. We stated that we
considered annually updating the pricing of the drug component of the
OUD treatment services payment rate via an established update factor
such as the Producer Price Index (PPI) for chemicals and allied
products, analgesics (WPU06380202). We explained that the PPI for
chemicals and allied products, analgesics is a subset of the PPI
produced by the Bureau of Labor Statistics (BLS). We solicited comments
on this approach but did not receive any comments. Ultimately, we
decided against proposing to update the pricing of the drug component
of the OUD treatment services payment rate via an established update
factor, such as the PPI, in favor of an update using the most recently
available ASP data at the time of ratesetting for the applicable
calendar year. We explained that we believed an ASP-based approach
would update the pricing of the drug component of the OUD treatment
services payment rate in a manner that would be more consistent with
other Medicare payments under Part B.
Because we do not believe that ASP data can provide an appropriate
reflection of the changes in methadone costs for OTPs until such a time
that more complete and reliable ASP data are available for methadone,
we are reconsidering the use of the PPI to update the payment rate for
methadone. According to the U.S. BLS,\156\ the PPI program measures the
average change over time in the selling prices received
[[Page 46090]]
by domestic producers for their output. The application of an annual
adjustment factor would be consistent with Medicare payment policy in
other areas, such as the outpatient prospective payment system, which
updates the conversion factor used to set payment rates under that
payment system by applying the outpatient department fee schedule
increase factor, which is equal to the percentage change in the
hospital inpatient market basket (86 FR 63498 through 63500). The
percentage change in the market basket reflects the average change in
the price of goods and services hospitals purchase to provide inpatient
care.
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\156\ https://www.bls.gov/ppi/.
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The PPI for Pharmaceuticals for Human Use (Prescription)
(WPUSI07003) reflects price changes associated with the average mix of
all pharmaceuticals in the overall economy and is both publicly
available and regularly published. We believe that this PPI would be an
appropriate factor to adjust the payment rate for methadone to reflect
the changes in methadone costs for OTPs over time. Methadone is an
established drug in the drug supply chain, and we believe that an
overall price trend that incorporates price changes for prescription
pharmaceuticals would provide an appropriate update to reflect any
increase in the costs incurred by OTPs in furnishing methadone during
episodes of care.
Accordingly, for CY 2023 and subsequent years, we are proposing to
revise our methodology for pricing the drug component of the methadone
weekly bundle and the add-on code for take-home supplies of methadone.
Under this proposal, we would base the payment amount for the drug
component of HCPCS codes G2067 and G2078 for CY 2023 and subsequent
years on the payment amount for methadone in CY 2021 and update this
amount annually to account for inflation using the PPI for
Pharmaceuticals for Human Use (Prescription). We propose to update the
methadone payment amount for CY 2023 based on the projected increase in
the PPI for Pharmaceuticals for Human Use (Prescription) to reflect the
forecasted price growth for prescription drugs for the 2-year period
from CY 2021 to 2022 and from CY 2022 to 2023. Because we froze the
payment amount for methadone at the 2021 amount for CY 2022, we propose
to account for the inflation for both CY 2022 and CY 2023 in setting
the payment rate for CY 2023. Based on the 2022 Q1 forecast from IHS
Global Inc. (IGI) the proposed CY 2023 methadone payment amount would
be $39.29, which is the CY 2022 payment amount of $37.38 increased by a
projected 5.1 percent growth in the PPI for Pharmaceuticals for Human
Use (Prescription) from CY 2021 to CY 2023 ($37.38 * 1.051 = $39.29).
IGI is a nationally recognized economic and financial forecasting firm
that contracts with CMS to forecast various price proxies used in the
CMS market baskets. Additionally, we are proposing that if more recent
data become subsequently available (for example, a more recent estimate
of the PPI), we would use such data in the final rule to determine the
final CY 2023 methadone payment amount. For subsequent years, we are
proposing to continue to update this rate annually using the PPI for
Pharmaceuticals for Human Use (Prescription). We note that under this
proposal, we would continue to monitor methadone pricing in order to
determine whether we may need to propose additional changes to this
methodology through future rulemaking to account for any significant
changes in the acquisition costs for methadone. We may also revisit
this policy in the event that new or more reliable data on methadone
pricing become available. We also solicit public comment on other
potential data sources that could be used to estimate an OTP's cost for
acquiring methadone.
Accordingly, we are proposing to revise the regulation at Sec.
410.67(d)(2)(i)(B)(2) to state that for CY 2023 and subsequent years,
the payment amount for methadone will be based on the payment amount
for methadone in CY 2021 as determined under Sec.
410.67(d)(2)(i)(B)(1) and updated by the PPI for Pharmaceuticals for
Human Use (Prescription). Under this proposal, the TRICARE rate would
no longer be an alternative pricing methodology for methadone. As part
of this proposal, we would also correct an inadvertent error in the
text of the current regulation at Sec. 410.67(d)(2)(i)(B)(2), which
includes an inaccurate cross-reference to paragraph (d)(2)(i)(B)(1).
3. Proposed Changes to the Rate for Individual Therapy in the Bundled
Rate
In the CY 2020 PFS final rule (84 FR 62658), we finalized a payment
rate for the non-drug component of the bundled payment for episodes of
care that was calculated using a building block methodology in which we
took the sum of rates for similar services paid under the PFS. The
payment rate for individual therapy included in the non-drug component
of the bundled payment for an episode of care is currently based on a
crosswalk to CPT code 90832, which describes 30 minutes of
psychotherapy.
In its December 2021 report,\157\ titled ``Many Medicare
Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use
Disorder,'' OIG indicated that approximately one million Medicare
beneficiaries were diagnosed with OUD in 2020, but less than 16 percent
of those beneficiaries received medication to treat OUD (in any
setting), raising concerns that beneficiaries face challenges accessing
treatment. In this report, OIG also stated that in 2020, less than 4
percent of Medicare beneficiaries with OUD received treatment from
OTPs. We note that 2020 was the first year of the Medicare OTP benefit
and that OTPs had to submit applications for enrollment with Medicare
and have those applications approved prior to billing services to
Medicare. As a result, we expect these numbers to improve in future
years. However, CMS has been working to identify and track drivers of
disparities in the treatment of OUD.
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\157\ https://oig.hhs.gov/oei/reports/OEI-02-20-00390.pdf.
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Additionally, we have received feedback from interested parties,
including associations and groups that represent OTPs, indicating that
the current rate for individual therapy provided as part of the weekly
bundle may not accurately reflect the resource costs involved with
furnishing this service in the OTP setting and that for the first
several months of treatment, patients typically receive weekly 50-
minute individual therapy sessions. Now that we have 2 years of
utilization data, we have reviewed how we implemented the OTP benefit
to determine whether refinements to the bundled rate may be warranted
to reflect more accurately the level of services furnished by OTPs.
We believe that the severity of needs of the patient population
diagnosed with OUD and receiving services in the OTP setting is
generally greater than that of patients receiving 30-minute
psychotherapy services paid under the PFS. For example, co-occurring
substance use and mental health disorders are common among adults with
OUD.\158\ Individuals with co-occurring SUD and mental health disorders
likely have complex treatment needs and may have different patterns of
treatment than individuals diagnosed with a single condition.\159\
During the first few months of treatment at an OTP, patients generally
receive care at the OTP on a daily basis. Based on the generally
greater severity of needs of the patient population receiving services
at
[[Page 46091]]
OTPs compared to patients receiving psychotherapy services billed under
CPT code 90382 and paid under the PFS, and therefore, the greater
intensity of the work, we believe it is appropriate to re-visit the
rate for individual therapy that is included in the non-drug component
of the weekly episodes of care.
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\158\ https://www.sciencedirect.com/science/article/pii/S0376871618305209.
\159\ https://www.sciencedirect.com/science/article/pii/S0740547218304781.
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Accordingly, we are proposing to modify the payment rate for the
non-drug component of the bundled payment for an episode of care to
base the rate for individual therapy on a crosswalk to CPT code 90834
(Psychotherapy, 45 minutes with patient), instead of a crosswalk to CPT
code 90832 (Psychotherapy, 30 minutes with patient), as is our current
policy. We believe CPT code 90834 most closely corresponds to a 50-
minute therapy session, which interested parties have indicated is the
typical amount of therapy received by patients in the first few months
of treatment at an OTP. In the CY 2020 PFS final rule (84 FR 62658), we
stated that we based the rate for individual therapy in the bundled
payment on the 2019 non-facility payment rate for CPT code 90832, which
was $68.47. Therefore, in order to change the rate for individual
therapy, we are proposing to substitute the 2019 rate for CPT code
90832 included in the non-drug component of each of the bundled
payments for an episode of care with the 2019 PFS non-facility payment
rate for CPT code 90834, which was $91.18, to determine an adjusted
payment rate for CY 2020 for the non-drug component of each applicable
HCPCS code. As described in Sec. 410.67(d)(4)(iii), we would then
apply the Medicare Economic Index (MEI) updates for 2021, 2022, and
2023 to these adjusted payment rates to determine the CY 2023 payment
amounts for the non-drug component of the bundled payments for an
episode of care. In section II.M. of this proposed rule, we are
proposing to rebase and revise the MEI from a 2006-base year to a 2017-
base year. The MEI for CY 2023 is currently projected to be 3.8 percent
based on the proposed 2017-based MEI, and is based on the most current
forecast of the percentage increase of the proposed 2017-based MEI for
the second quarter of 2022 (4.2 percent), and the most recent estimate
of the historical productivity adjustment for calendar year 2021 (0.4
percent). The MEI for CY 2023 will be revised for the final rule based
on the historical data through the second quarter 2022 and the most
recently available total factor productivity data.
We note that in the CY 2020 PFS final rule (84 FR 62644), we also
finalized an adjustment to the bundled payment rates through the use of
an add-on code to account for instances in which effective treatment
requires additional counseling or group or individual therapy to be
furnished for a particular patient that substantially exceeds the
amount specified in the patient's individualized treatment plan. This
adjustment is described by HCPCS code G2080 (Each additional 30 minutes
of counseling or group or individual therapy in a week of medication
assisted treatment, (provision of the services by a Medicare enrolled
Opioid Treatment Program); List separately in addition to code for
primary procedure.). We are not proposing any changes to HCPCS code
G2080. We believe that our proposal to update the crosswalk we use to
calculate the individual therapy portion of the non-drug component of
the bundled payment to reflect 45 minutes of psychotherapy does not
duplicate the add-on code for additional counseling. Rather, we believe
that our proposal to update the crosswalk for individual therapy will
ensure that the payment for the non-drug component of the bundled
payment is more representative of the typical case in the OTP setting
and better reflects the resource costs involved in furnishing this
service in the OTP setting compared to the current crosswalk.
Accordingly, we are proposing to revise the regulation text at
Sec. 410.67(d)(2) to adjust the payment for the non-drug component of
the bundled payment for an episode of care to reflect 45 minutes of
psychotherapy beginning in CY 2023. We welcome comments on this
proposal.
4. Mobile Components Operated by OTPs
Effective July 28, 2021, the Drug Enforcement Administration (DEA)
issued a final rule (86 FR 33861) that authorized OTPs to add a
``mobile component'' to their existing registration, which eliminated a
requirement for mobile medication units of OTPs to have a separate
registration. Additionally, we note that SAMHSA has issued guidance to
OTP Directors, State Opioid Treatment Authorities (SOTAs), and State
Directors that revised and superseded related portions of SAMHSA's 2015
Federal Guidelines for OTPs by clarifying the range of services that
can be provided by mobile units.\160\
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\160\ https://www.samhsa.gov/sites/default/files/2021-letter-mobile-component.pdf.
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In light of the new SAMHSA guidance, we wish to clarify that
services furnished via OTP mobile units will be considered for purposes
of determining payments to OTPs under the Medicare OTP bundled payment
codes and/or add-on codes to the extent that the services are medically
reasonable and necessary and are furnished in accordance with SAMHSA
and DEA guidance. We believe that allowing OTPs to bill Medicare for
services furnished via mobile units is an opportunity to expand access
to medications for treatment of OUD for Medicare beneficiaries by
extending the reach of OTPs, particularly in remote or underserved
areas. Because OTPs receive a bundled payment, we believe it would be
appropriate to apply locality adjustments for services furnished via
mobile units as if the service were furnished at the OTP registered
with DEA and certified by SAMHSA. We anticipate that for beneficiaries
receiving OUD treatment services from a mobile unit, some services
included in the bundle for a given week may still be provided at the
OTP, while some may be furnished via the mobile unit, which would make
it difficult to determine which geographic locality adjustment to apply
to the weekly bundle if the OTP and the location served by the mobile
unit are subject to different geographic locality adjustments.
Additionally, when services are furnished from a mobile unit, the OTP
still incurs the cost of rent, staffing, supplies, etc. at the location
of the OTP; therefore, we believe it is appropriate to apply the
geographic locality adjustment as if the service were furnished at the
OTP. Accordingly, we are proposing to amend the regulation at Sec.
410.67(d)(4)(ii) to clarify that for purposes of the geographic
adjustment OUD treatment services furnished via an OTP mobile unit will
be treated as if the services were furnished at the physical location
of the OTP registered with DEA and certified by SAMHSA. As stated in
the CY 2020 PFS final rule, because HCPCS codes G2067-G2075 cover
episodes of care of 7 contiguous days, OTPs should not bill any of
these codes for the same beneficiary more than once per 7 contiguous
day period, with limited exceptions (84 FR 62649), and we are not
proposing any changes to this policy, regardless of the location(s) at
which the services are provided. As noted previously, we will continue
monitoring the benefit for OUD treatment services furnished by OTPs,
including services furnished by mobile units, for fraud, waste, and
abuse, and will use existing administrative authorities to take
necessary action, as appropriate.
[[Page 46092]]
5. Flexibilities for OTPs to Use Telecommunications for Initiation of
Treatment With Buprenorphine
We have finalized several flexibilities for OTPs regarding the use
of telecommunications, both during the PHE for COVID-19 and outside of
the PHE. In the CY 2020 PFS final rule, we finalized a policy allowing
OTPs to furnish substance use counseling and individual and group
therapy via two-way interactive audio-video communication technology.
In the IFC entitled ``Medicare and Medicaid Programs: Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency,'' which appeared in the April 6, 2020 Federal Register (85
FR 19258), we revised Sec. 410.67(b)(3) and (4) on an interim final
basis to allow the therapy and counseling portions of the weekly
bundles, as well as the add-on code for additional counseling or
therapy, to be furnished using audio-only telephone calls rather than
via two-way interactive audio-video communication technology during the
PHE for the COVID-19 if beneficiaries do not have access to two-way
audio/video communications technology, provided all other applicable
requirements are met. In the CY 2022 PFS final rule (86 FR 65341
through 65343), we finalized that after the conclusion of the PHE for
COVID-19, OTPs are permitted to furnish substance use counseling and
individual and group therapy via audio-only telephone calls when the
beneficiary cannot access or does not consent to the use of audio and
video.
In the IFC entitled ``Medicare and Medicaid Programs, Basic Health
Program, and Exchanges; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency and Delay of Certain
Reporting Requirements for the Skilled Nursing Facility Quality
Reporting Program,'' which appeared in the May 8, 2020 Federal Register
(85 FR 27558), we revised Sec. 410.67(b)(7) on an interim final basis
to allow periodic assessments to be furnished during the PHE for COVID-
19 via two-way interactive audio-video communication technology and, in
cases where beneficiaries do not have access to two-way audio-video
communication technology, to permit the periodic assessments to be
furnished using audio-only telephone calls rather than via two-way
interactive audio-video communication technology, provided all other
applicable requirements are met. In the CY 2021 PFS final rule (85 FR
84690), we finalized our proposal to revise Sec. 410.67(b)(7) to
provide that periodic assessments (HCPCS code G2077) must be furnished
during a face-to-face encounter, which includes services furnished via
two-way interactive audio-video communication technology, as clinically
appropriate, provided all other applicable requirements are met, on a
permanent basis. However, the flexibility for OTPs to furnish periodic
assessments via audio-only communication is limited to the duration of
the PHE for COVID-19. There are currently no flexibilities under
Medicare for OTPs to furnish the intake add-on code via communication
technology.
SAMHSA regulations under 42 CFR 8.12(f)(2) require a complete
physical evaluation before a patient begins treatment at an OTP.
However, during the PHE, DEA and SAMHSA have allowed OTPs to initiate
treatment with buprenorphine via audio-video and audio-only
communication without first conducting an in-person evaluation.\161\
According to guidance issued by SAMHSA \162\ regarding the treatment of
OUD during the PHE, SAMHSA made the decision to exercise its authority
to exempt OTPs from the requirement to perform an in-person physical
evaluation (under 42 CFR 8.12(f)(2)) for any patient who will be
treated by the OTP with buprenorphine if a program physician, primary
care physician, or an authorized healthcare professional under the
supervision of a program physician, determines that an adequate
evaluation of the patient can be accomplished via telehealth. This
exemption applies exclusively to OTP patients treated with
buprenorphine and does not apply to new patients treated with
methadone. This exemption will continue only for the duration of the
declared PHE for COVID-19 unless regulations are issued making this
flexibility permanent.
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\161\ https://www.deadiversion.usdoj.gov/coronavirus.html.
\162\ https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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For services paid under the PFS, Medicare telehealth services fall
under the authority of section 1834(m) of the Act, which generally
limits payment for telehealth services to those furnished to patients
located in specified types of medical care settings in mostly rural
locations. The codes describing new patient office/outpatient visits
(CPT codes 99202 through 99205) are on the Medicare Telehealth list. As
discussed in the CY 2019 PFS final rule (83 FR 59496), section 2001(a)
of the SUPPORT Act (Pub. L. 115-271, October 24, 2018) amended section
1834(m) of the Act, adding a new paragraph (7) that removed the
geographic limitations for telehealth services furnished on or after
July 1, 2019, to individuals with a diagnosed SUD for the purpose of
treating the SUD or a co-occurring mental health disorder. Section
1834(m)(7) of the Act also allows telehealth services for treatment of
a diagnosed SUD or co-occurring mental health disorder to be furnished
to individuals at any telehealth originating site (other than a renal
dialysis facility), including in a patient's home. In addition, as
discussed in the CY 2022 PFS final rule (86 FR 65055), section 123 of
the Consolidated Appropriations Act, 2021 (CAA 2021) (Pub. L. 116-260,
December 27, 2020) modified the circumstances under which Medicare
makes payment under the PFS for mental health services furnished via
telehealth following the PHE. Specifically, it removed the geographic
originating site restrictions and added the home of the individual as a
permissible originating site for telehealth services when furnished for
the purposes of diagnosis, evaluation, or treatment of a mental health
disorder. In addition to the flexibilities authorized by section
2001(a) of the SUPPORT Act and section 123 of the CAA 2021, in the CY
2022 PFS final rule (86 FR 65055), for services for the diagnosis,
evaluation or treatment of mental health conditions, including SUDs,
CMS revised the regulatory definition of an ``interactive
telecommunications system'' to permit the use of audio-only
communications technology for mental health telehealth services under
certain conditions when provided to beneficiaries located in their
home.
Given these flexibilities for the treatment, diagnosis, or
evaluation of mental health disorders, including SUDs, under the PFS,
we are proposing to allow the OTP intake add-on code to be furnished
via two-way audio-video communications technology when billed for the
initiation of treatment with buprenorphine, to the extent that the use
of audio-video telecommunications technology to initiate treatment with
buprenorphine is authorized by DEA and SAMHSA at the time the service
is furnished. We are also proposing to permit the use of audio-only
communication technology to initiate treatment with buprenorphine in
cases where audio-video technology is not available to the beneficiary.
As we explained in the CY 2022 PFS final rule (86 FR 65342), we
interpret the requirement that audio/video technology is ``not
available to the beneficiary'' to include circumstances in which the
beneficiary is not capable of
[[Page 46093]]
or has not consented to the use of devices that permit a two-way,
audio/video interaction because in each of these instances audio/video
communication technology is not able to be used in furnishing services
to the beneficiary. We note under this proposal, the initiation of
treatment with buprenorphine using telecommunications technology would
be considered an intake activity for purposes of Sec. 410.67(b)(6)
only to the extent that the use of such telecommunications technology
is permitted under the applicable DEA and SAMHSA regulations and
guidance at the time the services are furnished.
Accordingly, we are proposing to revise the regulation at Sec.
410.67(b)(6) to state that services to initiate treatment with
buprenorphine may be furnished via two-way interactive audio-video
communication technology, as clinically appropriate, and in compliance
with all applicable requirements. In cases where two-way audio-video
communications technology is not available to the beneficiary, services
to initiate treatment with buprenorphine can be furnished using audio-
only telephone calls if all other applicable requirements are met.
Finally, we are seeking comment on whether we should allow periodic
assessments to continue to be furnished using audio-only communication
technology following the end of the PHE for COVID-19 for patients who
are receiving treatment via buprenorphine, and if this flexibility
should also continue to apply to patients receiving methadone or
naltrexone.
G. Medicare Shared Savings Program
1. Executive Summary and Background
a. Purpose
As of January 1, 2022, over 11 million people with Medicare receive
care from one of the 528,966 health care providers in the 483
accountable care organizations (ACOs) participating in the Medicare
Shared Savings Program (Shared Savings Program), the largest value-
based purchasing program in the country.\163\ Eligible groups of
providers and suppliers, including physicians, hospitals, and other
healthcare providers, may participate in the Shared Savings Program by
forming or joining an ACO and in so doing agree to become accountable
for the total cost and quality of care provided under Traditional
Medicare to an assigned population of Medicare fee-for-service
beneficiaries. Under the Shared Savings Program, providers and
suppliers that participate in an ACO continue to receive traditional
Medicare FFS payments under Parts A and B, and the ACO may be eligible
to receive a shared savings payment if it meets specified quality and
savings requirements, and in some instances may be required to share in
losses if it increases health care spending. The proposed changes to
the Shared Savings Program described in this section of this proposed
rule, and the topics on which we seek comment, are intended to advance
Medicare's value-based care strategy of growth, alignment, and equity,
with many proposals overlapping these categories.
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\163\ Refer to CMS, Shared Savings Program Fast Facts--As of
January 1, 2022, available at https://www.cms.gov/sites/default/files/2022-01/2022_Shared_Savings_Program_Fast_Facts.pdf.
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The Shared Savings Program offers different participation options
(tracks) that allow ACOs to assume various levels of risk. The BASIC
track offers a glide path for eligible ACOs to transition from a one-
sided shared savings-only model to progressively higher increments of
financial risk and potential reward under two-sided shared savings and
shared losses models \164\ within a single 5-year agreement
period.\165\ ACOs that enter the ENHANCED track accept greater
financial risk for their assigned beneficiaries in exchange for
potentially higher financial rewards. For the performance year
beginning on January 1, 2022, 59 percent of Shared Savings Program ACOs
are under two-sided models. Historically, we have observed that ACOs in
performance-based risk tracks have better financial performance than
ACOs in shared savings only tracks and that low revenue ACOs (which may
tend to be small, physician only ACOs) have better financial
performance than high revenue ACOs (whose composition likely includes
institutional providers, particularly hospitals and health
systems).\166\ We have also observed that the highest earning ACOs had
a higher proportion of beneficiaries that were members of racial and
ethnic minority communities and included a greater proportion of ESRD,
disabled, and aged/dual eligible Medicare and Medicaid beneficiaries
than the lowest earning ACOs.
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\164\ As explained in earlier rulemaking, we have tended to use
the terms ``two-sided model'' and ``performance-based risk''
interchangeably, considering them to be synonymous when describing
payment models offered under the Shared Savings Program and Medicare
ACO initiatives more broadly (83 FR 67827).
\165\ As explained in earlier rulemaking (for example, 83 FR
67844), the BASIC track's glide path includes 5 levels: a one-sided
model available only for the first 2 consecutive performance years
of a 5-year agreement period, each year of which is identified as a
separate level (Levels A and B); and three levels of progressively
higher risk and potential reward in performance years 3 through 5 of
the agreement period (Levels C, D, and E).
\166\ See for example, 83 FR 67820.
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Through the changes we are proposing in this proposed rule, we also
seek to reverse certain recent trends 167 168 in the Shared
Savings Program: in recent years growth in the number of beneficiaries
assigned to ACOs has plateaued; higher spending populations are
increasingly underrepresented in the program since the change to
regionally-adjusted benchmarks; and access to ACOs appears inequitable
as shown by data indicating that Black (or African American), Hispanic,
Asian/Pacific Islander, and American Indian/Alaska Native beneficiaries
are less likely to be assigned to a Shared Savings Program ACO than
their Non-Hispanic White counterparts.
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\167\ Refer to the ``Shared Savings Program Fast Facts--As of
January 1, 2022'' available at https://www.cms.gov/sites/default/files/2022-01/2022_Shared_Savings_Program_Fast_Facts.pdf.
\168\ Refer to the ``Performance Year Financial and Quality
Results'' Public Use Files available at https://data.cms.gov/medicare-shared-savings-program/performance-year-financial-and-quality-results.
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Several of the proposals we are making in this proposed rule are
expected to advance equity within the Shared Savings Program. Based on
feedback from health care providers treating underserved populations
that they require upfront capital to make the necessary investments to
succeed in accountable care and may also need additional time under a
one-sided model before transitioning to performance-based risk, we are
proposing to provide advance shared savings payments to low revenue
ACOs that are inexperienced with performance-based risk Medicare ACO
initiatives, that are new to the Shared Savings Program (that is, not a
renewing ACO or a re-entering ACO), and that serve underserved
populations. These advance investment payments (AIPs) would increase
when more beneficiaries who are dually eligible for Medicare and
Medicaid or who live in areas with high deprivation (measured by the
area deprivation index (ADI)), or both, are assigned to the ACO.
Subject to certain limitations, these funds would be available to
address the social needs of people with Medicare, as well as health
care provider staffing and infrastructure. We are also proposing other
modifications to certain existing policies under the Shared Savings
Program to support organizations new to accountable care by providing
greater flexibility in the progression to performance-based risk,
allowing these organizations more time to redesign
[[Page 46094]]
their care processes to be successful under risk arrangements. We are
proposing a health equity adjustment that would upwardly adjust ACOs'
quality performance scores to continue encouraging high ACO quality
performance, transition ACOs to all-payer eCQMs/MIPS CQMs, and support
those ACOs serving a high proportion of underserved beneficiaries while
also encouraging all ACOs to treat underserved populations. Finally, we
are proposing certain changes to our benchmarking methodologies that
are designed to encourage participation by health care providers who
care for populations that include a high percentage of beneficiaries
with high clinical risk factors and beneficiaries dually eligible for
Medicare and Medicaid.
Many of these proposals are the result of our efforts to align
policies under the Shared Savings Program and under the Innovation
Center's ACO models. For example, the proposed AIPs are derived from
learnings from the ACO Investment Model (AIM), an Innovation Center
model that tested the effects of making advanced payments to certain
ACOs participating in the Shared Savings Program. This proposal to
incorporate AIPs into the Shared Savings Program payment methodology is
an example of how our larger ACO strategy of having the Innovation
Center test new payment and service delivery models on the Shared
Savings Program ``chassis'' can better harmonize policies across
Medicare ACO initiatives and enable us to scale any findings.
The Innovation Center recently announced the elimination of the ACO
Track of the Community Health and Rural Transformation (CHART) Model,
which would have provided advance shared savings payments to new rural
ACOs participating in SSP, similar to AIM. We believe the proposal to
incorporate AIPs into the Shared Savings Program will make the Shared
Savings Program attractive to organizations that were previously
considering participation in the ACO Track of the Community Health and
Rural Transformation (CHART) Model. The CHART Model ACO Track
specifically targeted ACOs whose providers and suppliers were located
in rural areas. We believe the proposed methodology to determine
payments based upon a beneficiary's risk factors-based score will allow
for greater reach to ACOs operating in under-resourced communities and
encourage providers and suppliers in rural areas to form ACOs.
As we seek to increase the percentage of people with Medicare in
accountable care arrangements, we are balancing incentives and
participation options to serve a dual purpose of sustaining
participation by existing ACOs and increasing program growth,
recognizing that ACOs vary in their composition of providers/suppliers,
the needs of the populations they serve, and have varying degrees of
efficiency relative to their region and experience with accountable
care initiatives. In this proposed rule, we are building on the
existing Shared Savings Program benchmarking methodology by proposing
modifications to strengthen financial incentives for long term
participation by reducing the impact of ACOs' performance on their
benchmarks, to address the impact of ACO market penetration on regional
expenditures used to adjust and update benchmarks, and to support the
business case for ACOs serving high risk and high dually eligible
populations to participate, which will help sustain participation and
grow the program. Additionally, we are proposing modifications to the
benchmarking methodology to mitigate bias in regional expenditure
calculations that benefits ACOs electing prospective assignment. The
changes we are proposing to the benchmarking methodology used in the
Shared Savings Program would align with our consideration of more long-
term benchmarking concepts that would move toward the use of
administratively set benchmarks in order to grow and sustain long term
program participation as discussed in the Request for Information. We
are also proposing to expand opportunities for certain low revenue ACOs
participating in the BASIC track to share in savings even if they do
not meet the minimum savings rate (MSR) to allow for investments in
care redesign and quality improvement activities among less capitalized
ACOs.
We are proposing changes to the quality reporting and the quality
performance requirements that are responsive to interested parties'
feedback, and designed to support the transition of ACOs to all payer
quality measure reporting. These proposals include reinstitution of a
sliding scale reflecting an ACO's quality performance for use in
determining shared savings for ACOs, regardless of how they report
quality data, and to revise the approach for determining shared losses
for ENHANCED track ACOs. We are proposing to implement a health equity
adjustment to an ACO's quality performance score to recognize high
quality performance by ACOs with high underserved populations. We are
also proposing to extend the incentive for reporting eCQMs/MIPS CQMs
through performance year 2024 to align with the sunsetting of the CMS
Web Interface reporting option. We are soliciting input from interested
parties to inform future rulemaking through requests for information
addressing social determinants of health in ACO populations, and the
addition of new Consumer Assessment of Healthcare Providers and Systems
(CAHPS) for the Merit-based Incentive Payment System (MIPS) survey
questions. We are also proposing to resolve a gap in our current policy
for benchmarking quality measures reported through the CMS Web
Interface.
We are proposing changes that are important for improved operations
of the Shared Savings Program, including policies to reduce ACO
administrative burden. Specifically, we are proposing to eliminate the
requirement for an ACO to submit marketing materials to CMS for review
and approval prior to disseminating materials to beneficiaries and ACO
participants, and modifications to streamline the SNF 3-day rule waiver
application review process. We are also proposing modifications to the
beneficiary notification requirements, including to reduce the
frequency with which beneficiary information notices are provided to
beneficiaries from annually to a minimum of once per agreement period,
with a proposed follow-up beneficiary communication serving to promote
beneficiary comprehension of the standardized written notice. Further,
we are proposing to revise the data sharing requirements to recognize
ACOs structured as organized health care arrangements (OHCAs) for data
sharing purposes.
b. Statutory and Regulatory Background on the Shared Savings Program
On March 23, 2010, the Patient Protection and Affordable Care Act
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30,
2010, which amended certain provisions of the Patient Protection and
Affordable Care Act (hereinafter collectively referred to as ``the
Affordable Care Act''). Section 3022 of the Affordable Care Act amended
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899
of the Act to establish the Medicare Shared Savings Program (Shared
Savings Program) to facilitate coordination and cooperation among
healthcare providers to improve the quality of care for Medicare FFS
beneficiaries and reduce the rate of
[[Page 46095]]
growth in expenditures under Medicare Parts A and B. (See 42 U.S.C.
1395jjj.)
Section 1899 of the Act has been amended through subsequent
legislation. The requirements for assignment of Medicare FFS
beneficiaries to ACOs participating under the program were amended by
the 21st Century Cures Act (the CURES Act) (Pub. L. 114-255, December
13, 2016). The Bipartisan Budget Act of 2018 (Pub. L. 115-123, February
9, 2018), further amended section 1899 of the Act to provide for the
following: expanded use of telehealth services by physicians or
practitioners participating in an applicable ACO to furnish services to
prospectively assigned beneficiaries; greater flexibility in the
assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in
tracks under retrospective beneficiary assignment a choice of
prospective assignment for the agreement period; permitting Medicare
FFS beneficiaries to voluntarily identify an ACO professional as their
primary care provider and requiring that such beneficiaries be notified
of the ability to make and change such identification, and mandating
that any such voluntary identification will supersede claims-based
assignment; and allowing ACOs under certain two-sided models to
establish CMS-approved beneficiary incentive programs.
The Shared Savings Program regulations are codified at 42 CFR part
425. 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''). A final
rule, ``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'',
appeared in the November 23, 2018 Federal Register (83 FR 59452)
(hereinafter referred to as the ``November 2018 final rule'' or the
``CY 2019 PFS final rule''). In the November 2018 final rule, we
finalized a voluntary 6-month extension for existing ACOs whose
participation agreements would otherwise expire on December 31, 2018;
allowed beneficiaries greater flexibility in designating their primary
care provider and in the use of that designation for purposes of
assigning the beneficiary to an ACO if the clinician they align with is
participating in an ACO; revised the definition of primary care
services used in beneficiary assignment; provided relief for ACOs and
their clinicians impacted by extreme and uncontrollable circumstances
in performance year 2018 and subsequent years; established a new
Certified Electronic Health Record Technology (CEHRT) use threshold
requirement; and reduced the Shared Savings Program quality measure set
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through
59715).
A final rule redesigning the Shared Savings Program appeared in the
December 31, 2018 Federal Register (Medicare Program: Medicare Shared
Savings Program; Accountable Care Organizations--Pathways to Success
and Uncontrollable Circumstances Policies for Performance Year 2017;
final rule) (83 FR 67816) (hereinafter referred to as the ``December
2018 final rule''). In the December 2018 final rule, we finalized a
number of policies for the Shared Savings Program, including a 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; and revisions to ensure rigorous benchmarking.
In the interim final rule with comment period (IFC) entitled
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency'', which was effective
on the March 31, 2020 date of display and appeared in the April 6, 2020
Federal Register (85 FR 19230) (hereinafter referred to as the ``March
31, 2020 COVID-19 IFC''), we removed the restriction which prevented
the application of the Shared Savings Program extreme and
uncontrollable circumstances policy for disasters that occur during the
quality reporting period if the reporting period is extended, to offer
relief under the Shared Savings Program to all ACOs that may be unable
to completely and accurately report quality data for 2019 due to the
PHE for COVID-19 (85 FR 19267 and 19268).
In the IFC entitled ``Medicare and Medicaid Programs; Basic Health
Program, and Exchanges; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency and Delay of Certain
Reporting Requirements for the Skilled Nursing Facility Quality
Reporting Program'' which was effective on May 8, 2020, and appeared in
the May 8, 2020 Federal Register (85 FR 27573 through 27587)
(hereinafter referred to as the ``May 8, 2020 COVID-19 IFC''), we
modified Shared Savings Program policies to: (1) allow ACOs whose
agreement periods expired on December 31, 2020, the option to extend
their existing agreement period by 1-year, and allow ACOs in the BASIC
track's glide path the option to elect to maintain their current level
of participation for performance year 2021; (2) adjust program
calculations to remove payment amounts for episodes of care for
treatment of COVID-19; and (3) expand the definition of primary care
services for purposes of determining beneficiary assignment to include
telehealth codes for virtual check-ins, e-visits, and telephonic
communication. We also clarified the applicability of the program's
extreme and uncontrollable circumstances policy to mitigate shared
losses for the period of the PHE for COVID-19 starting in January 2020.
We have also made use of the annual CY PFS rules to address quality
reporting for the Shared Savings Program and certain other issues.
Refer to the CY 2020 PFS final rule and the CY 2022 PFS final rule for
a summary of policies finalized in prior PFS rules (84 FR 40705 and 86
FR 65253). In the CY 2022 PFS final rule (86 FR 65253 through 65306),
we finalized changes to Shared Savings Program policies, including to
amend the reporting requirements under the APM Performance Pathway
(APP) for performance year 2022 and subsequent
[[Page 46096]]
performance years, to freeze the quality performance standard at the
30th percentile MIPS Quality performance category score for performance
year 2023, to update the definition of primary care services used in
beneficiary assignment at Sec. 425.400(c), to revise the repayment
mechanism arrangement policy, to streamline the application process,
and to amend the beneficiary notification process.
Policies applicable to Shared Savings Program ACOs for purposes of
reporting for other programs have also continued to evolve based on
changes in the statute. The Medicare Access and CHIP Reauthorization
Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015) established the
Quality Payment Program. In the CY 2017 Quality Payment Program final
rule with comment period (81 FR 77008), we established regulations for
the Merit-Based Incentive Payment System (MIPS) and Advanced APMs and
related policies applicable to eligible clinicians who participate in
APMs, including the Shared Savings Program. We have also made updates
to policies under the Quality Payment Program through the annual CY PFS
rules.
c. Summary of Shared Savings Program Proposals
In sections III.G.2. through III.G.6. of this proposed rule, we
propose modifications to the Shared Savings Program's policies. As a
general summary, we are proposing the following changes to Shared
Savings Program policies to:
Allow low revenue ACOs, inexperienced with performance-
based risk Medicare ACO initiatives, that are new to the Shared Savings
Program (that is, not a renewing or re-entering ACO) to receive AIPs
based on assigned beneficiary dual eligibility status and ADI national
percentile rank of the census block group in which the beneficiary
resides (section III.G.2.a. of this proposed rule). Advance investment
payments would include a one-time fixed payment of $250,000 and
quarterly payments for the first 2 years of an ACO's 5-year agreement
period. Quarterly payments would be based on a risk factors-based score
set to 100 if the beneficiary is dually eligible for Medicare and
Medicaid or set to the ADI national percentile rank (an integer between
1 and 100) of the census block group in which the beneficiary resides
if the beneficiary is not dually eligible, with higher payment amounts
for assigned beneficiaries with a higher risk factors-based score.
Allow ACOs applying to the program that are inexperienced
with performance-based risk to participate in one 5-year agreement
under a one-sided shared savings model, in order to provide these ACOs
more time to invest in infrastructure and redesigned care processes for
high quality and efficient health care service delivery before
transitioning to performance-based risk (section III.G.2.b.(2) of this
proposed rule).
Revise the limitation on the number of agreement periods
an ACO can participate in BASIC track Level E (section III.G.2.b.(3) of
this proposed rule).
Revise the policies for determining beneficiary assignment
(section III.G.3. of this proposed rule).
++ Update the definition of primary care services used in
beneficiary assignment at Sec. 425.400(c).
++ Identify how CMS certification numbers will be used in
beneficiary assignment.
Revise the quality reporting and the quality performance
requirements for performance year 2023 and subsequent performance years
(section III.G.4. of this proposed rule).
++ Establish an alternative quality performance standard for ACOs
that do not meet the quality performance standard to share in savings
at the maximum rate by reinstating a sliding scale approach for
determining shared savings for ACOs, regardless of how they report
quality data and revise the approach for determining shared losses for
ENHANCED track ACOs.
++ Establish a health equity adjustment that would upwardly adjust
an ACO's quality performance score, to reward ACOs that report all-
payer eCQMs/MIPS CQMs, that are high performing on quality, and serve a
high proportion of underserved beneficiaries. This proposed adjustment
would add up to 10 bonus points to the ACO's MIPS quality performance
category score. The resulting health equity adjusted quality
performance score would be used to determine whether the ACO meets the
quality performance standard set at the 30th percentile (for
performance year 2023) or 40th percentile (for performance year 2024
and subsequent years) across all MIPS quality performance category
scores; the final sharing rate for calculating shared savings payments
under the BASIC track and the ENHANCED track for an ACO that meets the
proposed alternative quality performance standard allowing for
application of a sliding scale based on quality performance; and the
shared loss rate for calculating shared losses under the ENHANCED track
under the proposed modified approach to scaling shared losses. It would
also be used when applying the extreme and uncontrollable circumstances
policy for ACOs that report quality data via the APP and meet data
completeness and case minimum requirements.
++ Extend the incentive for reporting eCQMs/MIPS CQMs through
performance year 2024 to align with the sunsetting of the CMS Web
Interface reporting option.
++ Change the nomenclature of the administrative claims measure
Risk Standardized, All-Cause Unplanned Admissions for Multiple Chronic
Conditions for MIPS to Clinician and Clinician Group Risk-standardized
Hospital Admission Rates for Patients with Multiple Chronic Conditions
to align with the MIPS program.
++ Clarify use of unweighted MIPS Quality performance category
scores to determine the quality performance standard under the Shared
Savings Program.
++ Clarify our policies on reopenings to address changes to MIPS
quality performance category scores.
++ Establish policies for benchmarking quality measures reported
through the CMS Web Interface for performance year 2022 through
performance year 2024.
Revise the benchmarking methodology to reduce the effect
of ACO performance on ACO historical benchmarks, increase opportunities
for ACOs caring for medically complex, high cost beneficiaries, and
strengthen incentives for ACOs to enter and remain in the Shared
Savings Program, and meet the programmatic goals of improving quality
of care and lowering growth in FFS expenditures:
++ Incorporate a prospectively projected administrative growth
factor, a variant of the United States Per Capita Cost (USPCC) referred
to in this proposed rule as the Accountable Care Prospective Trend
(ACPT), into a three-way blend with national and regional growth rates
to update an ACO's historical benchmark and address increasing market
saturation by ACOs in a regional service area (section III.G.5.c.(3) of
this proposed rule).
++ Adjust benchmarks to account for prior savings, helping to
mitigate lowering of an ACO's benchmark over time by returning to an
ACO's benchmark an amount that reflects its success in lowering growth
in expenditures from the previous agreement period (section
III.G.5.c.(4) of this proposed rule).
++ Reduce the impact of negative regional adjustments on ACO
benchmarks by reducing the cap on negative regional adjustments and
gradually decreasing the negative
[[Page 46097]]
regional adjustment amount as an ACO's weighted-average prospective HCC
risk score increases, or the proportion of dually eligible Medicare and
Medicaid beneficiaries increases, or both (section III.G.5.c.(5) of
this proposed rule).
Change how we calculate regional factors used in
benchmarking to increase internal consistency of benchmark calculations
for ACOs under prospective beneficiary assignment by using an
assignment window that is consistent with an ACO's selected assignment
methodology to identify the assignable population used to calculate
regional FFS expenditures (section III.G.5.d. of this proposed rule).
Revise how we apply the existing 3 percent cap on positive
prospective HCC risk score growth to better account for medically
complex, high cost populations while continuing to guard against coding
initiatives (section III.G.5.e. of this proposed rule).
Increase opportunities for low revenue ACOs participating
in the BASIC track to share in savings by expanding the criteria ACOs
can meet to qualify for shared savings payments as described in Sec.
425.605 (section III.G.5.f. of this proposed rule).
Discuss ongoing considerations regarding the impact of the
PHE for COVID-19 on ACO expenditures (section III.G.5.g. of this
proposed rule), although there are no associated proposed revisions to
the regulations at this time.
Exclude the proposed new supplemental payment under the
Medicare Hospital Inpatient Prospective Payment System (IPPS) for
Indian Health Service (IHS)/Tribal hospitals and hospitals located in
Puerto Rico from the determination of Medicare Parts A and B
expenditures for purposes of calculations under the Shared Savings
Program (section III.G.5.h. of this proposed rule).
Remove the requirement to submit marketing materials prior
to use (section III.G.6.b. of this proposed rule). ACOs would be
required to submit marketing materials only upon request from CMS, but
we would retain the requirement that an ACO must discontinue use of any
marketing materials or activities for which CMS has issued a notice of
disapproval.
Amend the beneficiary notification requirements to reduce
the frequency with which beneficiary information notices are provided
to beneficiaries from annually to a minimum of once per agreement
period, with a follow up beneficiary communication serving to promote
beneficiary comprehension of the standardized written notice and
occurring no later than 180 days following the date that the
standardized written notice was provided to the beneficiary (section
III.G.6.c. of this proposed rule).
Amend the beneficiary notification requirements to clarify
that ACOs and ACO participants are required to post signs in all
facilities and make standardized written notices available upon request
in all settings in which beneficiaries receive primary care services
(section III.G.6.c. of this proposed rule).
Remove the requirement for an ACO to submit certain
narratives when applying for the SNF 3-day rule waiver and replace with
a requirement that an ACO submit an attestation that it has established
the narratives and will make them available to CMS upon request
(section III.G.6.d. of this proposed rule).
Amend regulations to recognize ACOs structured as OHCAs
for data sharing purposes (section III.G.6.e. of this proposed rule).
We also describe several comment solicitations:
As discussed in section III.G.4. of this proposed rule and
elsewhere in this proposed rule, we are seeking comment on two
potential social determinants of health (SDOH) measures for future
measure development, and the addition of new Consumer Assessment of
Healthcare Providers and Systems (CAHPS) for the Merit-based Incentive
Payment System (MIPS) Survey Questions.
In section III.G.7. of this proposed rule, we seek comment
on an alternative approach to calculating ACO historical benchmarks
that would use administratively-set benchmarks that are decoupled from
ongoing observed FFS spending.
In combination, the Shared Savings Program proposals are
anticipated to grow participation particularly from ACOs serving
beneficiaries with greater needs and higher baseline spending. The
incentive for ACOs to reduce spending over multiple agreement periods
is also expected to be bolstered, for example by reducing the weighting
on the regional component of the benchmark update and by providing a
prior savings adjustment at rebasing. A further change will prevent an
assignment bias from inflating benchmark adjustments for ACOs electing
prospective assignment. In summary, we project a $15.5 billion decrease
in spending on benefits (that is, savings from efficiency) and $650
million in higher net shared savings payments to ACOs, or $14.8 billion
lower overall spending compared to the program baseline (which would
have been projected to be a $4.2 billion net cost absent these
changes).
Certain policies, including both existing policies and the proposed
new policies described in this proposed rule, rely upon the authority
granted in section 1899(i)(3) of the Act to use other payment models
that the Secretary determines will improve the quality and efficiency
of items and services furnished under the Medicare program, and that do
not result in program expenditures greater than those that would result
under the statutory payment model. The following proposals require the
use of our authority under section 1899(i) of the Act: allowing for
AIPs as described in section III.G.2. of this proposed rule: the
proposed modifications to the calculation of the shared loss rate under
the ENHANCED track to allow for a sliding scale based on an alternative
quality performance standard as described in section III.G.4. of this
proposed rule; use of the ACPT/national-regional three-way blended
benchmark update factor as described in section III.G.5.c.(3) of this
proposed rule; the expansion of the criteria for certain low revenue
ACOs participating in the BASIC track to qualify for shared savings in
the event the ACO does not meet the MSR as required under section
1899(d)(1)(B)(i) of the Act as described in section III.G.5.f. of this
proposed rule; and the exclusion of the proposed new supplemental
payment for IHS/Tribal hospitals and Puerto Rico hospitals from the
determination of Medicare Parts A and B expenditures used in certain
financial calculations under the Shared Savings Program as described in
section III.G.5.h. of this proposed rule. As described in the
Regulatory Impact Analysis in section VII. and elsewhere in this
proposed rule, these proposed changes to our payment methodology are
expected to improve the quality and efficiency of care and are not
expected to result in a situation in which the payment methodology
under the Shared Savings Program, including all policies adopted under
the authority of section 1899(i) of the Act, results in more spending
under the program than would have resulted under the statutory payment
methodology in section 1899(d) of the Act. We will continue to
reexamine this projection in the future to ensure that the requirement
under section 1899(i)(3)(B) of the Act that an alternative payment
model not result in additional program expenditures continues to be
satisfied. In the event that we later determine that the payment model
that includes policies established under section 1899(i)(3) of
[[Page 46098]]
the Act no longer meets this requirement, we would undertake additional
notice and comment rulemaking to make adjustments to the payment model
to assure continued compliance with the statutory requirements.
2. Shared Savings Program Participation Options
a. Increasing Participation in Accountable Care Models in Underserved
Communities by Providing an Option for Advance Investment Payments to
Certain ACOs
(1) Background
In the November 2011 final rule (76 FR 67969), we estimated an
average of $0.58 million for the start-up investment costs and $1.27
million in ongoing annual operating costs for an ACO participating in
the Shared Savings Program. This can be a substantial investment
particularly for a small organization or an organization caring for
underserved or more medically complex patients. The CMS Innovation
Center has tested two models designed to support new ACOs in joining
and succeeding in the Shared Savings Program. The Advance Payment (AP)
ACO Model operated from 2012 to 2015, and the AIM operated from 2015 to
2018. The models tested whether up-front payments would increase
participation in the Shared Savings Program by ACOs serving rural or
underserved regions. The models also tested whether such payments would
improve quality or reduce Medicare spending without negatively
affecting quality.\169\ Both models operated by pre-paying shared
savings to ACOs participating in the Shared Savings Program and later
recouping such amounts from earned shared savings.
---------------------------------------------------------------------------
\169\ Centers for Medicare & Medicaid Services, Advance Payment
Accountable Care Organization (ACO) Model (updated January 10,
2013), available at https://innovation.cms.gov/files/fact-sheet/advanced-payment-aco-model-fact-sheet.pdf; Centers for Medicare &
Medicaid Services, Accountable Care Organization Investment Model
(AIM) Request for Applications (October 14, 2014), available at
https://innovation.cms.gov/files/x/aim-rfa.pdf.
---------------------------------------------------------------------------
The AP ACO model tested whether the pre-payment of shared savings
would increase participation in the Shared Savings Program by smaller
providers and suppliers in rural and underserved areas, and whether
these payments would allow ACOs to improve care for beneficiaries,
generate Medicare savings more quickly, and increase the amount of
total Medicare savings.\170\ The eligibility standards for the AP ACO
model required that an ACO enter the Shared Savings Program in April
2012 or July 2012. The ACO also had to meet one of the following
standards: (1) not include any inpatient facilities and have less than
$50 million in total annual revenue; or (2) not include any inpatient
facilities other than critical access hospitals (CAHs) and/or Medicare
low-volume rural hospitals and have less than $80 million in total
annual revenue.\171\ Prepaid shared savings included an up-front
payment of $250,000 and a one-time payment of $36 per beneficiary,
followed by an $8 per beneficiary per month payment for 2 years. AP
ACOs received between $1.3-$2.7M in total prepaid shared savings.\172\
CMS recovered pre-paid shared savings from an ACO's earned shared
savings only if the ACO terminated before 3 years, in which case the
ACO was required to immediately repay its prepaid shared savings
payments in full.\173\
---------------------------------------------------------------------------
\170\ Centers for Medicare & Medicaid Services, Advance Payment
Accountable Care Organization (ACO) Model (updated January 10,
2013), available at https://innovation.cms.gov/files/fact-sheet/advanced-payment-aco-model-fact-sheet.pdf.
\171\ Centers for Medicare & Medicaid Services, Advance Payment
Accountable Care Organization (ACO) Model Application Process
(updated January 5, 2012), available at https://innovation.cms.gov/files/slides/advance-payment-model-aco-odf-application-process-slides.pdf.
\172\ L&M Policy Research, Evaluation of CMMI Accountable Care
Organization Initiatives: Advance Payment ACO Final Report 39-41
(November 25, 2016), available at https://innovation.cms.gov/files/reports/advpayaco-fnevalrpt.pdf.
\173\ Ibid at 14.
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AIM tested whether the pre-payment of shared savings helped to
recruit and accelerated favorable outcomes for new ACOs in the Shared
Savings Program from rural, low-penetration and underserved
geographies.\174\ There were two cohorts of AIM, referred to as Test 1
and Test 2. The eligibility standards to join Test 1 of AIM required
that an ACO be: (1) new to the Shared Savings Program; (2) not include
a hospital unless it was a critical access hospital or a small
Inpatient Prospective Payment System (IPPS) hospital; and (3) not owned
or operated by a health plan.\175\ The prepaid shared savings amounts
were distributed and recouped in the same amounts and manner as the AP
ACO model for the majority of model participants.\176\ ACOs joining
Test 2 of AIM were not new to the Shared Savings Program and were
required to directly repay any unrecouped prepaid shared savings at the
end of their second Shared Savings Program agreement period.
Conclusions from Test 2 of AIM were unable to be drawn due to low
participation.\177\ All further references to AIM refer to Test 1 of
the model, unless otherwise specified.
---------------------------------------------------------------------------
\174\ Centers for Medicare & Medicaid Services, Accountable Care
Organization Investment Model (AIM) Request for Applications
(October 14, 2014), available at https://innovation.cms.gov/files/x/aim-rfa.pdf.
\175\ Ibid.
\176\ Ibid.
\177\ Abt Associates, Evaluation of the Accountable Care
Organization Investment Model Final Report 20 (September 2020),
available at https://innovation.cms.gov/data-and-reports/2020/aim-final-annrpt.
---------------------------------------------------------------------------
The results of the Innovation Center's evaluation of the AP ACO
Model were inconclusive regarding the impact on quality or cost of
care. While most ACOs included in the test continued to participate in
the Shared Savings Program after the AP ACO Model ended, the Model did
not significantly improve the quality or cost of care when compared to
care provided outside the Shared Savings Program.\178\ The results of
the evaluation of AIM, however, found that the model was successful in
meeting both its goals. AIM successfully encouraged ACOs to form in
areas where ACOs may not have otherwise formed and where other Medicare
payment and delivery innovations were less likely to be present.\179\
The AIM Model also generated an estimated net aggregate reduction in
spending by Medicare of $381.5 million after accounting for Medicare's
payment of AIM funds and ACOs' earned shared savings.\180\ AIM did not
reduce the quality of care provided to beneficiaries.\181\
---------------------------------------------------------------------------
\178\ L&M Policy Research, Evaluation of CMMI Accountable Care
Organization Initiatives: Advance Payment ACO Final Report 39-41
(November 25, 2016), available at https://innovation.cms.gov/files/reports/advpayaco-fnevalrpt.pdf.
\179\ Abt Associates, Evaluation of the Accountable Care
Organization Investment Model Final Report 20 (September 2020),
available at https://innovation.cms.gov/data-and-reports/2020/aim-final-annrpt.
\180\ Ibid. at 39.
\181\ Ibid. at 57-60.
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We have received continued interest in the AIM and AP ACO models
and ongoing requests to implement policies with similar up-front and
ongoing payments for ACOs newly participating in the Shared Savings
Program. Interested parties believe these models were valuable for
transitioning small and rural practices into ACOs and believe there is
ongoing need for this type of support. We agree, and we also believe
that the Shared Savings Program should provide an entry point for all
willing organizations who wish to move towards providing value-driven
healthcare.
Section 1899(i) of the Act authorizes the Secretary to use other
payment models instead of the one-sided model described in section
1899(d) of the Act
[[Page 46099]]
so long as the Secretary determines that the other payment model will
improve the quality and efficiency of items and services furnished to
Medicare beneficiaries without additional program expenditures. We are
interested in using the learnings from AIM and incorporating critical
design features of AIM into the Shared Savings Program more broadly
with the goals of increasing participation in the program by easing up-
front costs for inexperienced, low revenue ACOs and supporting these
ACOs in providing accountable care for underserved beneficiaries. We
believe that advance payments of shared savings will improve health
equity outcomes for Medicare beneficiaries by increasing Shared Savings
Program participation in underserved regions and improving the success
of ACOs in achieving shared savings and meeting quality metrics.
Consequently, in accordance with the authority provided to the
Secretary by section 1899(i) of the Act, we are proposing to make
advance shared savings payments, referred to herein as advance
investment payments (AIPs), to certain ACOs participating in the Shared
Savings Program to improve the quality and efficiency of items and
services furnished to Medicare beneficiaries by enhancing the
accessibility of the Shared Savings Program. Such payments would be
made pursuant to the standards we propose to establish in new Sec.
425.630.
We envision that this new payment option would distribute AIPs to
ACOs for 2 years in order to reduce the financial barriers encountered
by small providers and suppliers as they join the Shared Savings
Program. These payments would be recouped from any shared savings the
ACO earned. Funding the ACOs for 2 years would align with the policy in
AIM. The AIPs are designed to reduce up-front costs that prevent
providers and suppliers from forming ACOs, caring for beneficiaries in
underserved communities, and achieving long term success in the Shared
Savings Program.
Section 1899(i)(3)(A) of the Act requires CMS to determine that
AIPs will improve the quality and efficiency of items furnished to
Medicare in order to make such payments. We believe that AIPs meet this
standard because such payments would be modeled on the AIM payments,
which were shown to improve the quality and efficiency of care. The AIM
evaluation report concluded that AIM successfully encouraged ACOs to
form in geographic areas where ACOs may not otherwise have formed, the
up-front funding provided by CMS assisted in the formation of the ACOs,
and there was a reduction in Medicare spending and utilization without
a reduction in the quality of care provided or patient and caregiver
experiences.\182\ The AIM evaluation found that, across all AIM Test 1
ACOs, the model reduced per beneficiary per month (PBPM) total Medicare
spending by an estimated $28.21 in PY1, $36.94 in PY2, and $38.73 in
PY3 compared to beneficiaries in the AIM ACOs' non-ACO FFS market
comparison group.\183\ The estimates translated to an aggregate
Medicare spending reduction of $131.0M in 2016, $187.7M in 2017, and
$207.7 in 2018.\184\
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\182\ Abt Associates, Evaluation of the Accountable Care
Organization Investment Model Final Report 2-3 (September 2020),
available at https://innovation.cms.gov/data-and-reports/2020/aim-final-annrpt.
\183\ Abt Associates, Evaluation of the Accountable Care
Organization Investment Model Final Report 2 (September 2020),
available at https://innovation.cms.gov/data-and-reports/2020/aim-final-annrpt.
\184\ Ibid. at 41.
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Section 1899(i)(3)(B) of the Act requires CMS to determine that
AIPs, when implemented in combination with existing modifications made
to the Shared Savings Program payment model specified in section
1899(d) of the Act, will not result in additional program expenditures.
The addition of AIP meets this standard. Please review section VI.E.7
of this proposed rule for a fuller discussion of the financial impact
of the Shared Savings Program payment model, including the findings
necessary to demonstrate compliance with section 1899(i)(3)(B) of the
Act.
We intend to periodically reassess whether a payment model
established under section 1899(i)(3) of the Act, including the payment
of advance investments, continues to improve the quality and efficiency
of items and services furnished to Medicare beneficiaries without
resulting in additional program expenditures. If we determine that the
payment model no longer satisfies the requirements of section
1899(i)(3) of the Act, for example if the payment model results in net
program costs, we would undertake additional notice and comment
rulemaking to make adjustments to our payment methodology to assure
continued compliance with the statutory requirements.
(2) Eligibility
In October of 2021, CMS outlined a renewed vision and strategy for
how the Innovation Center will drive health system transformation to
achieve equitable outcomes through high-quality, affordable, person-
centered care for all beneficiaries.\185\ We believe accountable care
reduces fragmentation in patient care and lowers costs by giving
providers and suppliers the incentives and tools to deliver high-
quality, coordinated, team-based care. In partnership with the
Innovation Center and in support of our shared goal of increasing the
number of beneficiaries in a care relationship with accountability for
quality and total cost of care, we are proposing broad eligibility
requirements for AIPs that will lower the barrier of entry to the
Shared Savings Program for low revenue ACOs who are inexperienced with
risk.
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\185\ https://innovation.cms.gov/strategic-direction.
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As discussed above, the AIPs are designed to assist ACOs that face
difficulty funding the start-up costs for forming ACOs, caring for
beneficiaries in underserved communities, and achieving long term
success in the Shared Savings Program. Building upon AIM's success with
new ACOs and ACOs inexperienced with performance-based risk Medicare
ACO initiatives, we propose to limit the eligibility for these AIPs to
these same groups. Our experience administering the Shared Savings
Program suggests that re-entering and renewing ACOs have APM experience
and would not need, or benefit as significantly from, the start-up
funds that AIPs provide because they have already invested in creating
an ACO. Additionally, we do not have data from our experience with AIM
to conclude that previously established ACOs need or benefit from up-
front shared savings. The final evaluation report for AIM could not
draw conclusions for AIM Test 2 ACOs, which involved only previously
established ACOs, because of the small number of AIM Test 2 ACOs and
the variation in results between them. Six AIM Test 2 ACOs started AIM
in April 2015 or January 2016. Two AIM Test 2 ACOs ceased participating
in the Shared Savings Program at the end of 2015, leaving four AIM Test
2 ACOs evaluated in each of three performance years.\186\
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\186\ Centers for Medicare & Medicaid Services, ACO Investment
Model (AIM) Final Evaluation Report (September 2020) available at
https://innovation.cms.gov/data-and-reports/2020/aim-finalannrpt-perspective.
---------------------------------------------------------------------------
We are proposing eligibility criteria modified from the AIM
eligibility criteria. The eligibility standards to join Test 1 of AIM
required that an ACO be: (1) new to the Shared Savings Program; (2) not
include a hospital unless it was a critical access hospital or a small
IPPS hospital; and (3) not owned or operated by a health plan.\187\ The
model also
[[Page 46100]]
prioritized ACOs in rural locations and those in locations with low ACO
penetration through the use of scoring criteria.\188\ We believe
certain eligibility modifications are necessary to scale advance
payments from a model to a regular component of the Shared Savings
Program and to align with the Innovation Center's stated vision for
health care transformation. As AIM was only available to a limited
number of ACOs, it relied on scoring criteria in addition to its
eligibility standards to select the highest scoring applicants. The
Shared Savings Program does not have a similar limitation; therefore,
we are proposing more inclusive eligibility criteria.
---------------------------------------------------------------------------
\187\ Centers for Medicare & Medicaid Services, Accountable Care
Organization Investment Model (AIM) Request for Applications
(October 14, 2014), available at https://innovation.cms.gov/files/x/aim-rfa.pdf.
\188\ Ibid.
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We are also broadening the eligibility criteria compared to AIM to
reflect our belief that it is important to provide an incentive for
providers and suppliers who serve high need beneficiaries in all areas
to form ACOs. Similar to AIM, the Shared Savings Program intends to
encourage the formation of new ACOs in rural areas; however, unlike AIM
we also want to recognize that there are underserved beneficiaries who
reside in urban areas who can also benefit from the high-quality
coordinated care an ACO can provide. Additionally, underserved
beneficiaries may receive care from providers and suppliers within a
geographic area with high alternative payment model (APM) penetration.
Generally, such providers and suppliers and the beneficiaries they
serve are not or have not been part of an ACO previously. Therefore, we
do not believe we should limit the opportunity for an ACO to receive
AIPs to ACOs in only rural communities or in areas with low ACO
penetration.
We propose to establish the eligibility criteria for AIPs in Sec.
425.630(b). Specifically, we propose that CMS must determine that an
ACO meets all of the following criteria for the ACO to be eligible to
begin receiving AIPs:
The ACO is not a renewing ACO or re-entering ACO (as such
terms are defined under Sec. 425.20).
The ACO has applied to participate in the Shared Savings
Program under any level of the BASIC track glide path and is eligible
to participate in the Shared Savings Program.
The ACO is inexperienced with performance-based risk
Medicare ACO initiatives.
The ACO is a low revenue ACO.
AIM required applicants to demonstrate an exceptional need for
prepaid shared savings. In the Shared Savings Program, the definition
of low revenue is a similar criterion for determining ACO funding
needs. Under Sec. 425.20, a low revenue ACO means an ACO whose total
Medicare Parts A and B fee-for-service revenue of its ACO participants
based on revenue for the most recent calendar year for which 12 months
of data are available, is less than 35 percent of the total Medicare
Parts A and B fee-for-service expenditures for the ACO's assigned
beneficiaries based on expenditures for the most recent calendar year
for which 12 months of data are available. Low revenue ACOs tend to be
small, physician-only ACOs that are less well capitalized
organizations. These ACOs may be encouraged to participate and remain
in the program based on the availability of additional incentives, such
as the opportunity to receive AIPs.
We are proposing conforming changes to Sec. 425.611(c)(4) to limit
eligibility to low revenue ACOs. In accordance with Sec.
425.611(c)(4), we adjust Shared Savings Program calculations to exclude
all Parts A and B fee-for-service payment amounts for a beneficiary's
episodes of care for treatment of COVID-19 from expenditure and revenue
calculations for purposes of identifying whether an ACO is a high
revenue ACO or low revenue ACO and determining an ACO's eligibility for
participation options. We are proposing to revise Sec. 425.611(c)(4)
to exclude all Parts A and B fee-for-service payment amounts for a
beneficiary's episodes of care for treatment of COVID-19 from
expenditure and revenue calculations for purposes of determining an
ACO's eligibility to receive AIPs.
We propose to limit eligibility to ACOs applying to participate
under any level of the BASIC track glide path because this
participation option is indicative of an ACO's inexperience with
performance-based risk. ACOs in the BASIC track are typically less
experienced with risk and are more likely to benefit from up-front
funding or ongoing financial assistance.
In summary, we are proposing to create a new paragraph in Sec.
425.100(d) to establish that an ACO may receive AIPs. We are also
proposing in Sec. 425.630(b) to specify the eligibility criteria for
an ACO to begin receiving receive AIPs, and we are proposing conforming
changes to Sec. 425.630(c)(4). We seek comments on these proposals.
(3) Application Procedure & Contents
We propose to address the process for an ACO to apply for AIPs in
Sec. 425.630(c). Specifically, we propose that, to obtain a
determination regarding whether an ACO may receive AIPs, the ACO must
submit, as part of its application to participate in the Shared Savings
Program, complete supplemental application information in the form and
manner and by a deadline specified by CMS. The application cycle for
AIPs would be conducted as part of and in conjunction with the Shared
Savings Program application process under Sec. 425.202 with
instructions and timeline published through the Shared Savings Program
website. We propose the initial application cycle to apply for AIPs
would be for a January 1, 2024, start date. As noted in section
III.G.2.a.(2) of this proposed rule, ACOs currently participating in
the Shared Savings Program or applying to renew their participation
agreement would not be eligible to apply. We intend to provide further
information regarding the process, including the application and
specific requirements such as the deadline for submitting applications,
through subregulatory guidance and will also provide a feedback process
to afford an opportunity for the applicant to clarify or revise its
application.
We propose in Sec. 425.630(d)(1) that an ACO must submit
sufficient information for CMS to determine whether the ACO is eligible
to receive such payments. CMS would provide preliminary information to
the applicant ACO about its eligibility to receive AIPs during the
Phase 1 application cycle requests for information, and a final
determination about its eligibility to receive AIPs at the time of
final application dispositions. For example, we would provide
preliminary information identifying whether an ACO is low revenue and
inexperienced with performance-based risk through the ACO's application
to participate in the Shared Savings Program.
We further propose at Sec. 425.630(d)(1) that an ACO would be
required to submit a spend plan as part of its application for AIPs. At
Sec. 425.630(d)(2), we propose content requirements for spend plans.
We propose that the plan must identify how the ACO will spend the AIPs
during the agreement period to build care coordination capabilities
(including coordination with community-based organizations, as
appropriate), address specific health disparities, and meet other
criteria under Sec. 425.630. In addition, we propose that the spend
plan must identify the categories of goods and services that will be
purchased, the dollar amounts to be spent on the various categories,
and such other information as may be specified by CMS. As more fully
explained in section III.G.2.a.(4) of this proposed rule, we are
[[Page 46101]]
proposing at Sec. 425.630(e)(4) to require ACOs to segregate AIPs from
all other revenues by establishing and maintaining a separate account
into which the ACO must immediately deposit all AIPs. Accordingly, we
are also proposing at Sec. 425.630(d)(2)(iii) that the spend plan must
include a statement that the ACO has established a separate designated
account for the deposit and expenditure of all AIPs in accordance with
Sec. 425.630(e)(4).
We do not intend for the proposed spend plan to create a benchmark
requirement against which we would hold the ACO accountable. Instead,
we intend it to aid CMS in tracking ACO progress toward implementing
their spend plan and any challenges or changes in strategy that occur
following their receipt of AIPs. We believe that ACOs have the
flexibility to better understand their needs over time and evolve their
spending accordingly.
While we do not intend an ACO's spend plan to limit it to specific
uses of AIPs within the broad categories of acceptable uses, we would
reserve the right to terminate an ACO's ability to receive the advance
incentive payments if it is not in compliance with requirements of the
Shared Savings Program (see our proposal described in section
III.G.2.a.(7).(b) of this proposed rule). In addition, by certifying
its application under Sec. 425.202(a)(2), the ACO certifies that the
information contained in the application, including the information
necessary to determine eligibility for AIPs, is accurate, complete, and
truthful.
We propose at Sec. 425.630(d)(3) that we would review the
information submitted in the ACO's application to determine whether an
ACO meets the eligibility criteria and other requirements for AIP and
would approve or deny the application for AIPs accordingly. We would
review the ACO's Shared Savings Program application simultaneously with
the supplemental information in its AIP application. We note that the
denial of an AIP application would be subject to reconsideration review
in accordance with the standards specified in subpart I of part 425.
In addition, we are proposing at Sec. 425.630(d)(3) that CMS may
review the spend plan at any time and require the ACO to make changes
to its spend plan comply with Sec. 425.630(e)(1) as a result of that
review. Examples of permitted uses are described in section
III.G.2.a.(4) of this proposed rule. Under our proposal, if the ACO
fails to provide a spend plan that complies with Sec. 425.630(e), CMS
could terminate the ACO's AIPs pursuant to Sec. 425.630(h)(1)(i) and
take other remedial action under Sec. 425.216 or Sec. 425.218.
As discussed in section III.G.2.a.(7).(a) of this proposed rule, we
are also proposing to update our public reporting requirements under
Sec. 425.308 by adding new paragraph (b)(8) to require an ACO to
publicly report its spend plan. We propose to require that the ACO post
on its dedicated public reporting web page: (1) the total amount of
AIPs received from CMS for each performance year; (2) the ACO's spend
plan; and (3) an itemization of how the AIPs were actually spent during
the year, including expenditure categories, the dollar amounts spent on
the various categories, any changes to the spend plan as submitted
under Sec. 425.630(d)(1), and such other information as may be
specified by CMS. The public reporting template that CMS provides to
ACOs annually would be updated to reflect the new information
categories that an ACO must report.
We propose to add Sec. 425.630(c) and (d) to establish standards
for the contents of an application to be determined eligible for AIPs
as well as the procedures for filing such an application. We solicit
comments on these proposals.
(4) Use and Management of Payments
Under section Sec. 425.308(b)(4), ACOs are required to publicly
report the total proportion of shared savings invested in
infrastructure, redesigned care processes, and other resources required
to support the goals of better health for populations, better care for
individuals, and lower growth in expenditures, including the proportion
of shared savings distributed among ACO participants. Although ACOs are
required to report this information, our regulations do not require an
ACO to spend its shared savings in any particular way. However, given
the purpose of AIPs, the fact that they are made before any shared
savings are actually earned by an ACO, and our proposed limitations on
the recovery of these funds in the absence of any earned shared
savings, we propose at Sec. 425.630(e) to specify how an ACO may use
AIPs.
Similar to our experience with AIM, AIPs are intended to provide
the means to build the ACO's population health management capabilities,
including the provision of accountable care for underserved
beneficiaries. AIPs are not intended to sit idle in an investment
account or to serve purposes unrelated to the goals of AIPs. We propose
at Sec. 425.630(e) that AIPs must be used to improve the quality and
efficiency of items and services furnished to beneficiaries by
investing in increased staffing, health care infrastructure, and the
provision of accountable care for underserved beneficiaries, which may
include addressing social determinants of health. We emphasize,
however, that AIP amounts are advance shared savings, and not payment
or reimbursement for items or services under the three specified
categories. We propose that expenditures of AIPs must comply with the
beneficiary incentive provision at Sec. 425.304 and all other
applicable laws and regulations. Our proposal is intended to provide
ACOs with flexibility to use payments within three specified categories
of allowable uses. We solicit comment on whether there are additional
categories of expenses that should be permitted in light of the
purposes of AIPs. We will monitor how ACOs are spending these funds and
will revisit these categories in future rulemaking if additional
flexibilities or boundaries are required.
We recognize that there are many ways to improve population health
management and support the provision of accountable care for
underserved beneficiaries. The most effective ways will vary by ACO. We
believe ACOs know best the needs of their populations and how to use
funds to meet program goals. We offer the following examples of
permitted uses within the three categories:
Increased staffing. Hiring nurse case managers or other
relevant support staff to implement screening for social determinants
of health (SDOH); hiring community health workers, certified peer
recovery specialists, other health care professionals with training in
delivering culturally and linguistically tailored services; hiring a
health equity officer; hiring behavioral health clinicians and case
managers to integrate behavioral health treatment into the primary care
setting; hiring oral health providers to integrate dental services into
the primary care setting; or encouraging partnerships with healthcare
systems and local, community-based organizations to increase
organizational capacity to identify and address SDOH and connect
individuals with culturally and linguistically tailored, accessible
health care services, supports, and information at an appropriate
literacy level.
SDOH strategies. Examples include developing or securing
transportation services; housing-related services to address housing
insecurity or homelessness, home or environmental modifications to
support a healthy lifestyle, legal aid services to help patients'
address social needs, employment-related services, food-
[[Page 46102]]
related services, utilities-related supports, services to support
personal safety, services to reduce social isolation, services to help
patients cope with or address financial strain or poverty, patient
caregiver supports, providing remote access technologies,
telemonitoring, and meals; ensuring individuals are able to access
culturally and linguistically tailored, accessible health care services
and supports that meet their needs, partnering with community-based
organizations such as Area Agencies on Aging or Centers for Independent
Living to address SDOH needs; or implementing systems to provide and
track patient referrals to available community-based social services
that assess and address social needs, as well as enable coordination
and measurement of health and social care across the community where
beneficiaries reside. CMS reserves the right to review any SDOH
strategies and require that the ACO make changes as a result of that
review.
Health Care Provider Infrastructure. Examples include
investment in certified electronic health record technology (CEHRT)
(including system enhancements and upgrades), connections to clinical
data registries and networks that support health information exchange
across disparate providers and systems involved in patient care,
integration of ACO participant systems including tools to share and
analyze operational and quality data, remote access technologies,
telemonitoring, screening tools, case management or practice management
systems to improve care coordination operations across the health and
social care continuum, physical accessibility improvements, and tools
to further integrate behavioral health or dental services into primary
care settings.
Where we refer to community-based organizations, we mean public or
private not-for-profit entities that provide specific services to the
community or targeted populations in the community to address the
health and social needs of those populations. Such organizations are
trusted entities that know the populations they serve and their
communities, want to be engaged, and may have the infrastructure or
systems in place to help coordinate supportive services that address
social determinants of health or serve as a trusted source to share
information.\189\ They may include community-action agencies, housing
agencies, area agencies on aging, or other non-profits that apply for
grants to perform social services. They may receive grants from other
agencies in the U.S. Department of Health and Human Services, including
Federal grants administered by the Administration for Children and
Families (ACF), Administration for Community Living (ACL), or the
Centers for Disease Control, or other State-funded grants to provide
social services. If an ACO wishes to address a social need, it is
important for health providers who may not have expertise in providing
social services to work with those community-based organizations that
do have such expertise.
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\189\ https://www.phe.gov/emergency/events/COVID19/atrisk/returning-to-work/Pages/default.aspx.
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We note that the Shared Savings Program does not prohibit ACOs from
partnering with community-based organizations. Currently, if a
community-based organization is enrolled in Medicare, they may already
be an ACO participant or ACO provider or supplier. We believe
community-based organizations play an important role in identifying and
addressing gaps in health equity. We hope to encourage more ACOs to
partner with community-based organizations whether they provide items
and services reimbursed by Medicare or not.
Regarding investments in networks that support health information
exchange, we encourage ACOs to review the request for information in
section II.A.3.B of this proposed rule regarding the recently released
Trusted Exchange Framework and Common Agreement or TEFCA,\190\ which
includes discussion about how connecting to entities exchanging
information under TEFCA can help to support health information exchange
for a variety of use cases that may be relevant to ACOs.
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\190\ For more information, see https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement-tefca.
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We propose in Sec. 425.630(e)(2) to prohibit the use of AIPs for
any expenses that would not constitute a permitted use of the funds.
Similar to the AIM model, we intend for advance investment payments to
encourage the formation of new ACOs that provide care to underserved
beneficiaries, not simply to fund another business venture of an
established company or to furnish items or services unrelated to the
ACO or the beneficiaries it serves.
Examples of prohibited uses of AIPs would include management
company or parent company profit, performance bonuses, other provider
salary augmentation, provision of medical services covered by Medicare,
or items or activities unrelated to ACO operations that improve the
quality and efficiency of items and services furnished to
beneficiaries. However, performance bonuses could be tied to successful
implementation of SDOH screenings or care management guidelines, or
ACOs could pay a higher salary as necessary to retain a clinician who
treats underserved beneficiaries. We solicit comment on these examples
of prohibited uses and whether there are additional categories of
expenses that should be prohibited in light of the purposes of AIPs. We
will monitor how ACOs are spending these funds and will revisit these
categories in future rulemaking if additional flexibilities or
boundaries are required.
Additionally, we propose that an ACO participating in Level E of
the BASIC track may not use any advance shared savings payments to pay
back any shared losses that it would have incurred as specified in a
written notice from CMS under Sec. 425.605(e)(2). To ensure
compliance, we propose updating the annual certification requirements
under Sec. 425.302(a)(3) to require that the ACO certify that the
payments were disbursed only for allowable uses. Level E of the BASIC
track is currently an Advanced APM, and we expect it to remain an
Advanced APM in future years. The level of risk in an Advanced APM is,
by definition at Sec. 414.1415(c), greater than a nominal amount;
therefore, we are proposing that an ACO eligible to receive advance
shared savings payments that is willing to take on such additional risk
must remain liable for any losses incurred regardless of advance
payments received.
We propose at Sec. 425.630(e)(4) to require ACOs to segregate AIPs
from all other revenues by establishing and maintaining a separate
account into which the ACO must immediately deposit all AIPs and from
which all disbursements of such funds are made only for allowable uses.
This would allow us to monitor whether the funds are used only for
allowable uses and to ensure that AIPs do not pay for any prohibited
uses under Sec. 425.630(e)(2). We note that CMS would deposit AIPs
into the same account used for the deposit of shared savings payments;
that account must be specified in an ACO's Electronic Funds Transfer
form submitted with its application. We propose that, upon receipt of
AIPs, the ACO must immediately deposit the funds into the separate
account designated for maintaining AIPs.
As noted in section III.G.2.a.(4) of this proposed rule, we propose
that the ACO's spend plan must also include a statement that the ACO
has established a separate account for purposes of
[[Page 46103]]
segregating AIPs. Additionally, we propose to update our annual
certification requirements under Sec. 425.302 by adding new paragraph
(a)(3)(iv) to require an ACO to certify at the end of each performance
year that it has moved all AIPs received during that performance year
into a designated AIP account, where the funds remained until spent as
required under Sec. 425.630(d).
(5) Advance Investment Payment Methodology
In AIM, prepaid shared savings included an up-front payment of
$250,000 and a one-time payment of $36 per beneficiary, followed by a
monthly payment of $8 per beneficiary per month for the first 2
performance years of an AIM ACO's agreement period. According to the
AIM evaluation, AIM ACO leadership conveyed through interviews and the
ACO Web survey that they wanted to join the Shared Savings Program to
gain experience in delivering value-based care and remain independent,
and that AIM funds were critical to building the infrastructure needed
to implement their ACOs.\191\ The evaluation also found that these new
AIM ACOs consistently demonstrated greater reductions in key Medicare
spending categories and related utilization compared to similar non-AIM
Shared Savings Program ACOs.\192\ Furthermore, there were greater
reductions in all components of Medicare spending examined, including
acute inpatient hospitalizations, outpatient visits, skilled nursing
facility care, and home health use. The evaluation did not find
reductions in Medicare spending and utilization to be offset by
reductions in the quality of care provided or patient and caregiver
experiences.
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\191\ Abt Associates, Evaluation of the Accountable Care
Organization Investment Model Final Report 20 (Sep. 2020), available
at https://innovation.cms.gov/data-and-reports/2020/aim-final/annrpt.
\192\ Ibid.
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We are proposing to provide an ACO that CMS determines meets the
eligibility criteria described in section III.G.2.a.(2) of this
proposed rule with AIPs during the first 2 performance years of the
ACO's participation agreement. We are proposing that AIPs are comprised
of two types of payments: a one-time payment of $250,000 and eight
quarterly payments based on the number of assigned beneficiaries,
capped at 10,000 beneficiaries.
The proposed $250,000 one-time payment is informed by the AIM
payment structure, which offered a $250,000 up-front fixed payment to
new AIM ACO participants starting in the Shared Savings Program in 2015
and 2016. Under the model, the upfront fixed payment reflected the
estimated upfront investment requirements to establish ACOs. Here, we
are proposing a $250,000 one-time AIP because we believe that such a
payment would similarly support an ACO in addressing the upfront
investment requirements for a new, low revenue and inexperienced ACO to
join the Shared Savings Program. We have experience with a fixed
$250,000 upfront payment from AIM, which served ACOs that are similar
in many ways to ACOs that would be served by the proposed AIPs.
Furthermore, we believe that initial ACO start-up costs do not vary
significantly by the size of an ACO or by the underlying level of risk
of an assigned beneficiary population. However, we are considering
alternative values of the one-time payment, such as allowing the one-
time payment to vary by ACO based on the number of assigned
beneficiaries, the risk factors of the ACO's assigned beneficiary
population, or both. We seek comment on the proposal to provide ACOs
with a one-time payment of $250,000, as well as these alternatives.
The quarterly payments are informed by our experience in AIM where
ACO participants had variable costs for clinical care management
activities, such as clinical staff, which were supported by the per
beneficiary per month payments offered to them in the model.
We are proposing to make payments on a quarterly basis to balance
providing ACOs with predictable cash flow to participate in the Shared
Savings Program and simplifying operations for CMS. We considered other
options for the frequency of the payments, such as monthly payments as
were tested in AIM, or annual payments. Making more frequent payments,
such as on a monthly basis, would result in additional operational
burden for CMS because we would need to calculate the payments more
frequently. Because the Shared Savings Program operates on a larger
scale than AIM did, the burden of administering monthly advance
payments is not feasible. Moreover, we believe that monthly payments
offer little additional benefit to ACOs relative to quarterly payments.
We are not proposing a single annual payment as we believe the benefit
to ACOs of consistent payments on a quarterly basis outweighs the
administrative costs of calculating quarterly payments. We seek comment
on the proposed schedule of the AIPs to ACOs.
We propose to determine the value of an ACO's upcoming quarterly
payment amount prior to the start of the quarter based on the latest
available assignment list for the performance year (see Table 40). We
believe it is important to use the latest available assignment list
because under current regulation the individual beneficiaries assigned
to the ACO may change between annual and quarterly assignment runs. For
ACOs under preliminary prospective assignment with retrospective
reconciliation as described at Sec. 425.400(a)(2) the assignment list
is updated quarterly based on the most recent 12 months of data. For
ACOs under prospective assignment as described at Sec. 425.400(a)(3),
the assignment list is updated quarterly to exclude beneficiaries that
meet any of the exclusion criteria during the performance year.
Therefore, we believe that using the latest available assignment list
to determine the upcoming quarterly payment will best reflect the
attributes of the ACO's assigned population.
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We are also considering an alternative proposal for the timing of
the quarterly payments calculation. Under this alternative, we would
determine the ACO's quarterly payment at the start of the performance
year based on the beneficiaries assigned to the ACO at the beginning of
a performance year. The quarterly payment amount determined at the
beginning of a performance year could remain fixed for the duration of
that performance year. The total payments ACOs would receive over the
course of a performance year would be known by the ACO at the start of
that performance year. However, this alternative also carries the risk
that CMS would underpay or overpay an ACO relative to an approach of
redetermining the quarterly payment amount prior to the start of each
quarter. We seek comment on this alternative proposal.
We are proposing that the quarterly payments made to ACOs would be
equal to the sum of per beneficiary payments for up to 10,000
beneficiaries. The per beneficiary payment amount would vary for each
beneficiary based on a risk factors-based score that we would calculate
for the beneficiary. The risk factors-based score would be informed by
the beneficiary's dual eligibility status and the ADI national
percentile ranking of the census block group of the beneficiary's
primary address, described in further detail later in this section. The
quarterly payments reflect expected variable ongoing operating costs
that are related to the number and risk factors of the ACO's assigned
beneficiaries.
We propose to add a new Sec. 425.630(f) to establish the frequency
and payment methodology for AIPs. Specifically, we propose a one-time
payment for ACOs at or near the beginning of PY 1 of the ACO's
agreement period. Quarterly payments would be made each quarter for the
first 2 performance years of the ACO's agreement period. We would
complete the following steps to calculate the ACO's quarterly payment
amount:
Step 1: Determine the ACO's assigned beneficiary
population. The assigned beneficiaries used in determining the
quarterly payment amount would be the beneficiaries most recently
assigned to the ACO under Sec. 425.400(a)(2) (for ACOs under
preliminary prospective assignment with retrospective reconciliation)
or Sec. 425.400(a)(3) (for ACOs under prospective assignment), based
on the certified ACO participant list for the relevant performance
year.