[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Proposed Rules]
[Pages 52262-53197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14624]
[[Page 52261]]
Vol. 88
Monday,
No. 150
August 7, 2023
Part II
Book 2 of 2 Books
Pages 52261-53348
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 2024 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Medicare
Advantage; Medicare and Medicaid Provider and Supplier Enrollment
Policies; and Basic Health Program; Proposed Rule
Federal Register / Vol. 88 , No. 150 / Monday, August 7, 2023 /
Proposed Rules
[[Page 52262]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 418, 422, 423, 424, 425, 455,
489, 491, 495, 498, and 600
[CMS-1784-P]
RIN 0938-AV07
Medicare and Medicaid Programs; CY 2024 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Advantage; Medicare and Medicaid Provider and Supplier
Enrollment Policies; and Basic Health Program
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; payment for dental services inextricably linked to specific
covered medical services; 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 and supplier enrollment
policies, 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 for Patients and Communities Act (SUPPORT Act);
updates to the Ambulance Fee Schedule regulations and the Medicare
Ground Ambulance Data Collection System; codification of the Inflation
Reduction Act and Consolidated Appropriations Act, 2023 provisions;
expansion of the diabetes screening and diabetes definitions; pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners; appropriate use
criteria for advanced diagnostic imaging; early release of Medicare
Advantage risk adjustment data; a social determinants of health risk
assessment in the annual wellness visit and Basic Health Program.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 11,
2023.
ADDRESSES: In commenting, please refer to file code CMS-1784-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-1784-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-1784-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, and Morgan Kitzmiller, (410) 786-
1623, 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.
[email protected], for issues related to
caregiver training services, community health integration services,
social determinants of health risk assessment, and principal illness
navigation services.
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 direct supervision
using two-way audio/video communication technology, telehealth, and
other services involving communications technology.
Tamika Brock, (312) 886-7904, for issues related to teaching
physician services.
Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-
9160, Erick Carrera, (410) 786-8949, or
[email protected], for issues related to
advancing access to behavioral health.
[email protected], for issues related to PFS
payment for evaluation and management services.
Morgan Kitzmiller, (410) 786-1623, for issues related to geographic
practice cost indices (GPCIs).
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 supervision of
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth services.
Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949,
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to dental
services inextricably linked to specific covered medical services.
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to Drugs and
Biological Products Paid Under Medicare Part B.
[email protected], for issues related to
complex drug administration.
Laura Ashbaugh, (410) 786-1113, Ariana Pitcher,
[email protected], Rasheeda Arthur, (410) 786-3434, or
[email protected] for issues related to Clinical Laboratory
Fee Schedule.
Lisa Parker, (410) 786-4949, or [email protected], for issues
related to FQHC payments.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHC and FQHC Conditions for Certification or Coverage.
Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for
issues related to RHCs and FQHCs definitions of staff.
Sarah Fulton, (410) 786-2749, for issues related to pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners.
Lindsey Baldwin, (410) 786-1694, Ariana Pitcher,
[email protected], or [email protected], for issues
related to Medicare coverage of opioid use
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disorder treatment services furnished by opioid treatment programs.
Sabrina Ahmed, (410) 786-7499, or [email protected],
for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment and benchmarking methodology.
Lucy Bertocci, (667) 290-8833, or [email protected],
for inquiries related to Shared Savings Program advance investment
payments, and eligibility requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to preventive vaccine administration services.
Mollie Howerton (410) 786-5395, for issues related to Medicare
Diabetes Prevention Program.
Sarah Fulton (410) 786-2749, for issues related to appropriate use
criteria for advanced diagnostic imaging.
Frank Whelan, (410) 786-1302, for issues related to Medicare and
Medicaid provider and supplier enrollment regulation updates.
Daniel Feller (410) 786-6913 for issues related to expanding
diabetes screening and definitions.
Daniel Feller (410) 786-6913 for issues related to a social
determinants of health risk assessment in the annual wellness visit.
Mei Zhang, (410) 786-7837, and Kimberly Go, (410) 786-4560, 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 Ambulance Fee Schedule (AFS) and the Medicare
Ground Ambulance Data Collection System.
Mary Rossi-Coajou (410) 786-6051, for issues related to hospice
Conditions of Participation.
Cameron Ingram (410) 409-8023 for issues related to Histopathology,
Cytology, and Clinical Cytogenetics Regulations under CLIA of 1988.
Meg Barry (410) 786-1536, for issues related to the Basic Health
Program (BHP) provisions.
Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648,
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 commenter will take actions to harm an 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
2024 PFS proposed rule, refer to item CMS-1784-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
copyright 2020 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
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 Consolidated Appropriations Act,
2023 (Pub. L. 117-328, September 29, 2022), Inflation Reduction Act of
2022 (IRA) (Pub. L. 117-169, August 16, 2022), Consolidated
Appropriations Act, 2022 (Pub. L. 117-103, March 15, 2022),
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 for Patients and
Communities Act (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. of this proposed rule.
This rulemaking proposes to update the Rural Health Clinic (RHC)
and Federally Qualified Health Clinic (FQHC) Conditions for
Certification and Conditions for Coverage (CfCs), respectively, to
implement the provisions of the Consolidated Appropriations Act (CAA),
2023 (Pub. L. 117-328, December 29, 2022), now allowing payment under
Medicare Part B for services furnished by a Marriage and Family
Therapist (MFT) or Mental Health Counselor (MHC).
This rulemaking would also update the Hospice Conditions of
Participation (CoPs) to implement division FF, section 4121 of the CAA
2023 regarding the addition of marriage and family therapists (MFTs) or
mental health counselors (MHCs) as part of the hospice
interdisciplinary team and would make changes to the hospice personnel
requirements. This rulemaking would also seek to further advance
Medicare's overall value-based care strategy of growth, alignment, and
equity through the Medicare Shared Savings Program (MSSP) and the
Quality Payment Program (QPP). The structure of the programs enables us
to develop a set of tools for measuring and encouraging improvements in
care, which may support a shift to clinician payment over time into
Advanced Alternative Payment Models (APMs) and accountable care
arrangements which reduce care fragmentation and unnecessary costs for
patients and the health system.
This rulemaking would also update the Ambulance Fee Schedule
regulations to implement division FF, section 4103 of the CAA 2023
regarding the ground ambulance extenders provisions and would also
provide further changes and clarifications to the
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Medicare Ground Ambulance Data Collection System.
This rulemaking would also update Medicare and Medicaid provider
and supplier enrollment regulations.
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 each year we establish, 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.
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 2024 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, Medicare and Medicaid provider and supplier
enrollment policies, and other policies regarding programs administered
by CMS.
Specifically, this proposed rule addresses:
Background (section II.A.)
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 Social Security Act (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.)
Payment for Skin Substitutes (section II.H.)
Supervision of Outpatient Therapy Services, KX Modifier
Thresholds, Diabetes Self-Management Training (DSMT) Services by
Registered Dietitians and Nutrition Professional, and DSMT Telehealth
Services (section II.I.)
Advancing Access to Behavioral Health (section II.J.)
Proposals on Medicare Parts A and B Payment for Dental
Services Inextricably Linked to Specific Covered Medical Services
(section II.K.)
Drugs and Biological Products Paid Under Medicare Part B
(section III.A.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) Conditions for Certification or Coverage (CfCs)
(section III.C.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions (section III.D.)
Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation Expansion of Supervising Practitioners (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.)
Medicare Diabetes Prevention Program Expanded Model (section
III.I.)
Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.J.)
Medicare and Medicaid Provider and Supplier Enrollment
(section III.K.)
Expand Diabetes Screening and Diabetes Definitions (section
III.L.)
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.M.)
Proposed Changes to the Regulations Associated with the
Ambulance Fee Schedule and the Medicare Ground Ambulance Data
Collection System (GADCS) (section III.N.)
Hospice: Changes to the Hospice Conditions of Participation
(section III.O.)
RFI: Histopathology, Cytology, and Clinical Cytogenetics
Regulations under the Clinical Laboratory Improvement Amendments (CLIA)
of 1988 (section III.P.)
Changes to the Basic Health Program Regulations (section
III.Q.)
Updates to the Definitions of Certified Electronic Health
Record Technology (section III.R.)
A Social Determinants of Health Risk Assessment in the Annual
Wellness Visit (section III.S.)
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.
II. Provisions of the Proposed Rule for the PFS
A. Background
In accordance with section 1848 of the Act, CMS has paid for
physicians' services under the Medicare physician fee schedule (PFS)
since January 1, 1992. The PFS relies on national relative values that
are established for work, practice expense (PE), and malpractice (MP),
which are adjusted for geographic cost variations. These values are
multiplied by a conversion factor (CF) to convert the relative value
units (RVUs) into payment rates. The concepts and methodology
underlying the PFS were enacted as part of the Omnibus Budget
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19,
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
(Pub. L. 101-508, November 5, 1990). The final rule published in the
November 25, 1991 Federal Register (56 FR 59502) set forth the first
fee schedule used for Medicare payment for physicians' services.
We note that throughout this proposed rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a
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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 Relative Value Scale Update Committee (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 in the CY 2007 PFS proposed rule (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
Socioeconomic Monitoring System (SMS). The AMA administered a new
survey in CY 2007 and CY 2008, the Physician Practice Information
Survey (PPIS). The PPIS is a multispecialty, nationally representative,
PE survey of both physicians and NPPs paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by cross-walking 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 cross-walked PE/
HR, we instead used the PPIS based PE/HR. We use cross-walks for
specialties that did not participate in the PPIS. These cross-walks
have been generally established through notice and comment rulemaking
and are available in the file titled ``CY 2024 PFS proposed rule PE/
HR'' on the CMS website under downloads for the CY 2024 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
[[Page 52266]]
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
direct 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 2024 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.
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 52983) 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
[[Page 52267]]
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 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.
[[Page 52268]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.000
Cross-walk certain low volume physician specialties:
Cross-walk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Cross-walk 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 52269]]
accordingly. Table 2 details the manner in which the modifiers are
applied.
[GRAPHIC] [TIFF OMITTED] TP07AU23.001
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)- 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 proposed 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 52270]]
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] TP07AU23.002
We are not proposing any changes to the equipment interest rates
for CY 2024.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
In the past, we have stated that we believe that the MEI is the
best measure available of the relative weights of the three components
in payments under the PFS--work, practice expense (PE), and malpractice
(MP). Accordingly, we believe that to assure that the PFS payments
reflect the relative resources in each of these PFS 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 Medicare
Economic Index (MEI). In the past, we have proposed (and subsequently,
finalized) to accomplish this by holding the work RVUs constant and
adjusting the PE RVUs, MP RVUs, and CF to produce the appropriate
balance in RVUs among the three PFS components and payment rates for
individual services, that is, that the total RVUs on the PFS are
proportioned to approximately 51 percent work RVUs, 45 percent PE RVUs,
and 4 percent MP RVUs. As the MEI cost shares are updated, we would
typically propose 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, and to recalibrate the relativity adjustment that
we apply in step 18 as described ``3. Adjusting RVUs To Match PE Share
of the Medicare Economic Index (MEI)'' of the CY 2023 PFS final rule
(87 FR 69414 and 69415) and CY 2014 PFS final rule (78 FR 74236 and
74237). The most recent recalibration was done for the CY 2014 RVUs.
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 final 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 CY 2023 PFS final rule (87 FR 69688 through 69711), we
finalized to rebase and revise the Medicare Economic Index (MEI) to
reflect more current market conditions faced by physicians in
furnishing physicians' services. We also finalized a delay of the
adjustments to the PE pools in steps 3 and 10 and the recalibration of
the relativity adjustment in step 18 until the public had an
opportunity to comment on the rebased and revised MEI (87 FR 69414
through 69416). Because we finalized significant methodological and
data source changes to the MEI in the CY 2023 PFS final rule and
significant time has elapsed since the last rebasing and revision of
the MEI in CY 2014, we believed that delaying the implementation of the
finalized CY
[[Page 52271]]
2023 rebased and revised MEI was consistent with our efforts to balance
payment stability and predictability with incorporating new data
through more routine updates. We refer readers to the discussion of our
comment solicitation in the CY 2023 PFS final rule (87 FR 69429 through
69432), where we reviewed our ongoing efforts to update data inputs for
PE to aid stability, transparency, efficiency, and data adequacy. We
also solicited comment in the CY 2023 PFS proposed rule on when and how
to best incorporate the CY 2023 rebased and revised MEI into PFS
ratesetting, and whether it would be appropriate to consider a
transition to full implementation for potential future rulemaking. We
presented the impacts of implementing the rebased and revised MEI in
PFS ratesetting through a 4-year transition and through full immediate
implementation, that is, with no transition period in the CY 2023 PFS
proposed rule. We also solicited comment on other implementation
strategies for potential future rulemaking in the CY 2023 PFS proposed
rule. In the CY 2023 PFS final rule, we discussed that many commenters
supported our proposed delayed implementation and many commenters
expressed concerns with the redistributive impacts of the
implementation of the rebased and revised MEI in PFS ratesetting. Many
commenters also noted that the AMA has said it intends to collect
practice cost data from physician practices in the near future which
could be used to derive cost share weights for the MEI and RVU shares.
In light of the AMA's intended data collection efforts in the near
future and because the methodological and data source changes to the
MEI finalized in the CY 2023 PFS final rule would have significant
impacts on PFS payments, we continue to believe that delaying the
implementation of the finalized 2017-based MEI cost weights for the
RVUs is consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. Therefore, we are not proposing to incorporate the 2017-based
MEI in PFS ratesetting for CY 2024.
As discussed above, in the CY 2023 PFS rulemaking, we finalized to
rebase and revise the MEI to reflect more current market conditions
faced by physicians in furnishing physicians' services. The final 2017-
based MEI relies on a methodology that uses publicly available data
sources for input costs that represent all types of physician practice
ownership, not limited to only self-employed physicians. The 2006-based
MEI relied on the 2006 AMA PPIS survey data; as of this CY 2024
rulemaking, this survey had not been updated. Given the changes in the
physician and supplier industry and the time since the last update to
the base year, we finalized a methodology that would allow us to update
the MEI on a consistent basis in the future. The 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). We supplement the 2017 SAS
expense data by using several data sources to further disaggregate
compensation costs and all other residual costs (87 FR 69688 through
69708).
We continue to review more recently available data from the Census
Bureau Services Annual Survey, the main data source for the major
components of the 2017-based MEI weights. Data is currently available
through 2021. Given that the impact of the PHE may influence the 2020
and 2021 data, we continue to evaluate whether the recent trends are
reflective of sustained shifts in cost structures or were temporary as
a result of the COVID-19 PHE. The 2022 data from the Services Annual
Survey will be available later this year. We will monitor that data and
any other data that may become available related to physician services'
input expenses and will propose any changes to the MEI, if appropriate,
in future rulemaking.
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 2024 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2024 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
[[Page 52272]]
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 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 cross-walked to
the new listing of clinical labor activity codes. These lists are
available on the CMS website under downloads for the CY 2024 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 2024, we are proposing to update the price of 16 supplies
and two equipment items in response to the public submission of
invoices following the publication of the CY 2023 PFS final rule. The
16 supply and equipment items with proposed updated prices are listed
in the valuation of specific codes section of the preamble under Table
14, CY 2024 Invoices Received for Existing Direct PE Inputs.
[[Page 52273]]
We are not proposing to update the price of another eleven supplies
which were the subject of public submission of invoices. Our rationale
for not updating these prices is detailed below:
Extended external ECG patch, medical magnetic tape
recorder (SD339): We received additional invoices for the SD339 supply
from an interested party. Upon review of the invoices, we determined
that they contained the identical price point that we previously
incorporated into last year's rule when we finalized a price of $260.35
for the supply item (87 FR 69514 through 69516). Since these invoices
did not contain any new information, we are maintaining the previously
finalized price of $260.35 for the SD339 supply.
Permanent marking pen (SL477), Liquid coverslip (Ventana
650-010) (SL479), EZ Prep (10X) (Ventana 950-102) (SL481), Cell
Conditioning 1 (Ventana 950-124) (SL482), and Hematoxylin II (Ventana
790-2208) (SL483): We received invoices from interested parties for use
in updating the price of these laboratory supplies. In each case,
however, we were able to find the same supply item available for sale
online at the current price or cheaper. Therefore, we do not believe
that the submitted invoices represent typical market pricing for these
supplies and we are not proposing to update their prices.
Mask, surgical (SB033), scalpel with blade, surgical (#10-
20) (SF033), eye shield, non-fog (SG049), gauze, non-sterile 4in x 4in
(SG051), and towel, paper (Bounty) (per sheet) (SK082): We received
invoices from interested parties for use in updating the price of these
common supply items. In each case, we received a single invoice and
once again we were able to find the same supply items available for
sale online at the current price or cheaper. Generally speaking, we
avoid updating the price for common supply items like the SB033
surgical mask (included in approximately 380 HCPCS codes) based on the
submission of a single invoice, as an invoice unrepresentative of
current market pricing will have far-reaching effects across the PFS.
We did not find that the typical price for a surgical mask had
increased by more than 60% since the supply and equipment pricing
update concluded in CY 2022, and as such we are maintaining the current
price for these supply items.
(1) Invoice Submission
We remind readers that 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.
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
cross-walked 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
[[Page 52274]]
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
cross-walked 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. (86 FR 65025) 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.003
(1) CY 2023 Clinical Labor Pricing Updates
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
proposed this $0.64 rate for the L037B clinical labor type for CY 2023;
we also proposed 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 also proposed 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).
Based on comments received on the CY 2023 proposed rule, we
finalized a change in the descriptive text of the L041A clinical labor
type from ``Angio Technician'' to ``Vascular Interventional
Technologist''. We also finalized an update in the pricing of three
clinical labor types: from $0.60 to $0.84 for the Vascular
Interventional Technologist (L041A), from $0.63 to $0.79 for the
Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT
Technologist (L046A) based on submitted wage data from the 2022
Radiologic Technologist Wage and Salary Survey (87 FR 69422 through
69425).
[[Page 52275]]
(2) CY 2024 Clinical Labor Pricing Update Proposals
We did not receive new wage data or other additional information
for use in clinical labor pricing from interested parties prior to the
publication of the CY 2024 PFS proposed rule. Therefore, our proposed
clinical labor pricing for CY 2024 is based on the clinical labor
pricing that we finalized in the CY 2023 PFS final rule, incremented an
additional step for Year 3 of the update:
BILLING CODE 4120-01-C
[[Page 52276]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.004
[[Page 52277]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.005
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 the 4-year transition period. We updated the pricing
of a number of clinical labor types in the CY 2022 and CY 2023 PFS
final rules in response to information provided by commenters. 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).
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Following the publication of the CY 2023 PFS proposed rule, an
interested party notified CMS that CPT code 86153 (Cell enumeration
using immunologic selection and identification in fluid specimen (e.g.,
circulating tumor cells in blood); physician interpretation and report,
when required) appeared to be missing its work time in the Physician
Work Time public use file. We reviewed the request from the interested
party and determined that this was indeed an unintended technical
error; we stated in the CY 2013 PFS final rule that we were finalizing
0 minutes pre-service time, 20 minutes intraservice time, and 0 minutes
post-service time to CPT code 86153 (77 FR 69059), however work time
was inadvertently completely missing for this code. Therefore, we are
proposing to add the correct 20 minutes of intraservice work time to
CPT code 86153 for CY 2024.
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
a. Background
The AMA PPIS was first introduced in 2007 as a means to collect
comprehensive and reliable data on the direct and indirect PEs incurred
by physicians (72 FR 66222). In considering the use of PPIS data, the
goal was to improve the accuracy and consistency of PE RVUs used in the
PFS. The data collection process included a stratified random sample of
physicians across various specialties, and the survey was administered
between August 2007 and March 2008. Data points from that period of
time that are integrated into PFS calculations today. In the CY 2009
PFS proposed rule (73 FR 38507 through 3850), we discussed the indirect
PE methodology that used data from the AMA's survey that predated the
PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate
the AMA PPIS data into the PFS ratesetting process, which would first
affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-
year transition period, during which we would phase in the AMA PPIS
data, replacing the existing PE data sources (74 FR 33554). We also
explained that our proposals intended to update survey data only (74 FR
33530 through 33531). In our CY 2010 final rule, we finalized our
proposal, with minor adjustments based on public comments (74 FR 61749
through 61750). We responded to the comments we received about the
transition to using the PPIS to inform indirect PE allocations (74 FR
61750). In the responses, we acknowledged concerns about potential gaps
in the data, which could impact the allocation of indirect PE for
certain physician specialties and suppliers, which are issues that
remain important today. The CY 2010 PFS final rule explains that
section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
L. 106-113, November 29, 1999) directed the Secretary to establish a
process under which we accept and use, to the maximum extent
practicable and consistent with sound data practices, data collected or
developed by entities and organizations to supplement the data we
normally collect in determining the PE component. BBRA required us to
establish criteria for accepting supplemental survey data. Since the
supplemental surveys were specific to individual specialties and not
part of a comprehensive multispecialty survey, we had required that
certain precision levels be met in order to ensure that the
supplemental data was sufficiently valid, and acceptable for use in the
development of the PE RVUs. At the time, our rationale included the
assumption that because the PPIS is a contemporaneous, consistently
collected, and comprehensive multispecialty survey, we do not believe
similar precision requirements are necessary, and we did not propose to
establish them for the use of the PPIS data (74 FR 61742). We noted
potential gaps in the data, which could impact the allocation of
indirect PE for certain physician and suppliers. The CY 2010 final rule
adopted the proposal, with minor adjustments based on public comments,
and explained that these minor adjustments were in part due to non-
response bias that results when the characteristics of survey
respondents differ in meaningful ways, such as in the mix of practices
sizes, from the general population (74 FR 61749 through 61750).
Throughout the 4-year transition period, from CY 2010 to CY 2013,
we gradually incorporated the AMA PPIS data into the PFS rates,
replacing the previous data sources. The process involved addressing
concerns and making adjustments as necessary, such as refining the PFS
ratesetting methodology in consideration of interested party feedback.
For background on the refinements that we considered after the
transition began, we refer readers to discussions in the CY 2011-2014
final rules (75 FR 73178 through 73179; 76 FR 73033 through 73034; 77
FR 98892; 78 FR 74272 through 74276).
In the CY 2011 PFS proposed rule, we requested comments on the
methodology for calculating indirect PE RVUs, explicitly seeking input
on using survey data, allocation methods, and potential improvements
(75 FR 40050). In our CY 2011 PFS final rule, we addressed comments
regarding the methodology for indirect PE calculations, focusing on
using survey data, allocation methods, and potential improvements (75
FR 73178 through 73179). We recognized some limitations of the current
PFS ratesetting methodology but maintained that the approach was the
most appropriate at the time. In the CY 2012 PFS final rule, we
responded to comments related to indirect PE methodology, including
concerns about allocating indirect PE to specific services and using
the AMA
[[Page 52278]]
PPIS data for certain specialties (76 FR 73033 through 73034). We
indicated that CMS would continue to review and refine the methodology
and work with interested parties to address their concerns. In the CY
PFS 2014 final rule, we responded to comments about fully implementing
the AMA PPIS data. By 2014, the AMA PPIS data had been fully integrated
into the PFS, serving as the primary source for determining indirect PE
inputs (78 FR 74235). We continued to review data and the PE
methodology annually, considering interested party feedback and
evaluating the need for updates or refinements to ensure the accuracy
and relevance of PE RVUs (79 FR 67548). In the years following the full
implementation of the AMA PPIS data, we further engaged with interested
parties, thought leaders and subject matter experts to improve our PE
inputs' accuracy and reliability. For further background, we refer
readers to our discussions in final rules for CY 2016-2022 (80 FR
70892; 81 FR 80175; 82 FR 52980 through 52981; 83 FR 59455 through
59456; 84 FR 62572; 85 FR 84476 through 84478; 86 FR 62572).
In our CY 2023 PFS final rule, we issued an RFI to solicit public
comment on strategies to update PE data collection and methodology (87
FR 69429 to 69432). We solicited comments on current and evolving
trends in health care business arrangements, the use of technology, or
similar topics that might affect or factor into PE calculations. We
remind readers that we have worked with interested parties and CMS
contractors for 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.
As described in last year's rule, we have continued interest in
developing a roadmap for updates to our PE methodology that account for
changes in the health care landscape. Of various considerations
necessary to form a roadmap for updates, we reiterate that allocations
of indirect PE continue to present a wide range of challenges and
opportunities. As discussed in multiple cycles of previous rulemaking,
our PE methodology relies on AMA PPIS data, which may represent the
best aggregated available source of information at this time. However,
we acknowledge the limitations and challenges interested parties have
raised about using the current data for indirect PE allocations, which
we have also examined in related ongoing research. We noted in last
year's rule that there are several competing concerns that CMS must
take into account when considering updated data sources, which also
should support and enable ongoing refinements to our PE methodology.
Many commenters last year asked that CMS wait for the AMA to
complete a refresh of AMA survey data. We responded to these comments
by explaining the tension that waiting creates in light of concerns
raised by other interested parties. Waiting for refreshed survey data
would result in CMS using data nearly 20 years old to form indirect PE
inputs to set rates for services on the PFS. We remind readers that
many of the critical issues discussed in the background and history
above are mainly unchanged and possibly would not be addressed by an
updated survey alone but may also require revisions to the PFS
ratesetting methodology.
b. Request for Information
We continue to encourage interested parties to provide feedback and
suggestions to CMS that give an evidentiary basis to shape optimal PE
data collection and methodological adjustments over time. Submissions
should discuss the feasibility and burden of implementing any suggested
adjustments and highlight opportunities to optimize the cadence,
frequency, and phase-in of resulting adjustments. We continue to
consider ways that we may engage in dialogue with interested parties to
better understand how to address possible long-term policies and
methods for PFS ratesetting. We believe some of those concerns may be
alleviated by having ways to refresh data and make transparent how the
information affects valuations for services payable under the PFS more
accurately and precisely.
Considering our ratesetting methodology and prior experiences
implementing new data, we are issuing a follow-up solicitation for
general information. We seek comments from interested parties on
strategies to incorporate information that could address known
challenges we experienced in implementing the initial AMA PPIS data.
Our current methodology relies on the AMA PPIS data, legislatively
mandated supplemental data sources (for, example, we use supplemental
survey data collected in 2003, as required by section 1848(c)(2)(H)(i)
of the Act to set rates for oncology and hematology specialties), and
in some cases crosswalks to allocate indirect PE as necessary for
certain specialties and provider types.
We also seek to understand whether, upon completion of the updated
PPIS data collection effort by the AMA, contingencies or alternatives
may be necessary and available to address lack of data availability or
response rates for a given specialty, set of specialties, or specific
service suppliers who are paid under the PFS.
In light of the considerations discussed above, we request feedback
on the following:
(1) If CMS should consider aggregating data for certain physician
specialties to generate indirect allocators so that PE/HR calculations
based on PPIS data would be less likely to over-allocate (or under-
allocate) indirect PE to a given set of services, specialties, or
practice types. Further, what thresholds or methodological approaches
could be employed to establish such aggregations?
(2) Whether aggregations of services, for purposes of assigning PE
inputs, represent a fair, stable and accurate means to account for
indirect PEs across various specialties or practice types?
(3) If and how CMS should balance factors that influence indirect
PE inputs when these factors are likely driven by a difference in
geographic location or setting of care, specific to individual
practitioners (or practitioner types) versus other specialty/practice-
specific characteristics (for example, practice size, patient
population served)?
(4) What possible unintended consequences may result if CMS were to
act upon the respondents' recommendations for any of highlighted
considerations above?
(5) Whether specific types of outliers or non-response bias may
require different analytical approaches and methodological adjustments
to integrate refreshed data?
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
[[Page 52279]]
potentially misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this proposed rule, under
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 considered information provided by
other interested parties such as from the general medical-related
community and the public. We conducted 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.
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
[[Page 52280]]
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'').\1\
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.
---------------------------------------------------------------------------
\1\ The research team and panels of experts at the Harvard
School of Public Health developed the original work RVUs for most
CPT codes, in a cooperative agreement with the Department of Health
and Human Services (HHS). Experts from both inside and outside the
Federal Government obtained input from numerous physician specialty
groups. This input was incorporated into the initial PFS, which was
implemented on January 1, 1992.
---------------------------------------------------------------------------
3. CY 2024 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 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 receive public nominations for potentially
misvalued codes by February 10th and we display these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. We sometimes receive
submissions for specific, PE-related inputs for codes, and discuss
these PE-related submissions, as necessary under the Determination of
PE RVUs section of the rule. We summarize below this year's submissions
under the potentially misvalued code initiative. For CY 2024, we
received 10 nominations concerning various codes. The nominations are
as follows:
(1) CPT Code 59200
In the CY 2022 PFS proposed rule, an interested party nominated CPT
code 59200 (Insertion cervical dilator (e.g., laminaria,
prostaglandin)) (000 zero day global code) as potentially misvalued,
because the direct PE inputs for this code do not include the supply
item, Dilapan-S. Previous parties had initially sought to establish a
Level II HCPCS code for Dilapan-S, but CMS did not find sufficient
evidence to support that request. The same interested party then
submitted Dilapan-S to be considered as a practice expense (PE) supply
input to a Level I CPT code 59200 (86 FR 65045). This year, a different
interested party has nominated CPT code 59200 again, and provided the
same reasoning as to why this code is potentially misvalued.
[[Page 52281]]
Specifically, the current nominee recommends adding 4 rods of
Dilapan-S at $80.00 per unit, for a total of $320.00 to this one PE
supply inputs, as a replacement for the current PE supply item--
laminaria tent (a small rod of dehydrated seaweed that rehydrates,
absorbing the water from the surrounding tissue). The laminaria tent is
currently listed at $4.0683 per unit, with a total of 3 units, for a
total of $12.20. The current nominee stated that Dilapan-S is more
consistent and reliable, and suggested that it had higher patient
satisfaction than the laminaria tent, and that it was less likely to
cause leukocytosis. CPT code 59200 is a relatively low volume code,
with respect to Medicare claims and, as the nominator has stated, this
service is more typically billed for the Medicaid population, as
evidenced by 1.3 million Medicaid claims for this service. Medicaid
programs are able to set their own payment policies, which can be
different from Medicare payment policies. The current Medicare payment
for CPT code 59200 in CY 2023 is about $108.10 in the nonfacility/
office setting, which is much less than the typical cost of the
Dilapan-S supplies requested by the interested party. The requested 4
rods of Dilapan-S would increase the supply costs of CPT code 59200 by
a factor of five and represent an enormous increase in the direct costs
for the service.
We do not agree that CPT code 59200 is potentially misvalued, and
we do not agree with interested parties that the use of the Dilapan-S
supply would be typical for this service. By including the increased
direct costs of the service ($320.00, the typical cost of four units of
this supply item, Dilapan-S) in the valuation for this code, the cost
of this service will expand both Medicare spending and cost sharing for
any beneficiary who receives this service. The cost of Dilapan-S is
over 19 times higher than the cost of the current supply item
(laminaria tent) for CPT code 59200. We do agree with the nominator
that CPT code 59200 is much more frequently reported in the Medicaid
population, and therefore, we suggest that interested parties submit a
request for new and separate Medicaid payments to Medicaid.
We are not proposing to consider this code as potentially misvalued
for CY 2024, though we welcome comments on this nomination for further
consideration. We are soliciting comments on CPT code 59200 and whether
the absence of supply item Dilapan-S makes the nonfacility/office
Medicare payment for this service potentially misvalued.
(2) CPT Code 27279
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) (090 day global code) has been nominated as
misvalued due to the absence of separate direct PE inputs for this 090
day global code in the nonfacility office setting. Currently, the PFS
only prices CPT code 27279 in the facility setting, at about $826.85
for the physician's professional services, but the nominators are
seeking separate direct PE inputs for this service to better account
for valuation when performed in the nonfacility/office setting. These
PE amounts for CPT code 27279 are expected to be approximately
$21,897.63 in total, which is the Medicare outpatient payment amount
for CY 2023.
The nominator claims that CPT code 27279 can be safely and
effectively furnished in the nonfacility setting, and that this
procedure has a low risk profile, similar to kyphoplasty (CPT codes
22513, 22514, and 22515), which is currently furnished in the
nonfacility setting. The nominator describes Kyphoplasty as ``a
percutaneous minimally invasive procedure depositing poly methyl
methacrylate via canula into vertebral bodies near neural structures.''
The nominator states that permitting payment for direct PE inputs for
CPT code 27279 in the nonfacility/office setting would increase access
to this service for Medicare patients. One sample invoice for
$17,985.00 with three units of the itemized supply item IFuse-3D
Implant 7.0 mm x 55 mm, US ($5,995.00 per unit) was submitted with this
nomination to illustrate the high direct PE costs for CPT code 27279,
should CMS value this code in the nonfacility/office setting.
We are concerned about whether this 090 day surgical service can be
safely and effectively furnished in the non-facility/office setting
(for example, in an office-based surgical suite). We welcome comments
on the nomination of CPT code 27279 for consideration as potentially
misvalued.
(3) CPT Codes 99221, 99222, and 99223
An interested party nominated the Hospital Inpatient and
Observation Care visit CPT codes 99221 (Initial hospital 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 are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit.),
99222 (Initial hospital care, per day, for the evaluation and
management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of moderate complexity. Counseling and/or coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity. Typically, 50
minutes are spent at the bedside and on the patient's hospital floor or
unit.), and 99223 (Initial hospital care, per day, for the evaluation
and management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of high severity. Typically, 70 minutes are
spent at the bedside and on the patient's hospital floor or unit.) as
potentially misvalued. CMS reviewed these codes in the CY 2023 final
rule (87 FR 69588) and established new physician work times and new
work RVU payments for these codes. The nominator disagrees with these
values and asserts that these ``facility-based codes are always
inherently (or proportionately) more intense than E/M services provided
in other settings [in particular],'' with patients presenting with
potentially infectious diseases, such as meningitis; pneumonia;
tuberculosis; HIV/AIDS; Ebola virus; Zika virus; and, most recently,
SARS-CoV-2 and mpox, and that the inpatient setting has a predominance
of more seriously ill patients, who are sometimes immunocompromised
and/or have multiple drug interaction issues and/or with comorbidities,
making them extraordinarily more complex than those patients typically
found in the
[[Page 52282]]
office setting (with many of these infections being health care-
associated infections and antibiotic-resistant bacterial infections).
It should be noted that these new requests did not offer appreciably
new information relative to last year's nomination/consideration.
The nominator seeks a new work RVU value of 1.92 for CPT code
99221, a new work RVU of 2.79 for CPT code 99222, and a new work value
of 4.25 for CPT code 99223. Currently, CPT code 99221 has a work RVU of
1.63, a reduction of 15.1 percent from its 1.92 work RVU from CY 2022.
CPT code 99222 had a work RVU of 2.61 in CY 2022 and is now at 2.60.
CPT code 99223 had a work RVU of 3.86 in CY 2022. It now has a value of
3.50, which is a reduction of 9.3 percent. The nominator has requested
that the work RVU for CPT code 99221 be restored back to 1.92, that the
work RVU of CPT code 99222 be increased to 2.79, and that the work RVU
of CPT code 99223 be increased to 4.25 (please see Table 6 for a
comparison of work RVU values for CY 2022, CY 2023, and of those
requested by the nominator).
[GRAPHIC] [TIFF OMITTED] TP07AU23.006
After consideration of this nomination and their requests for
higher work RVUs for CPT codes 99221, 99222, and 99223, we are
proposing to maintain the values that we finalized for these codes in
the CY 2023 PFS final rule (87 FR 69588). Even so, we welcome comments
on the nomination of these codes as potentially misvalued.
(4) CPT Codes 36514, 36516, 36522
An interested party nominated CPT codes 36514 (Therapeutic
apheresis; for plasma pheresis), 36516 (Therapeutic apheresis; with
extracorporeal immunoadsorption, selective adsorption or selective
filtration and plasma reinfusion), and 36522 (Photopheresis,
extracorporeal) (all 000 zero day global codes) as potentially
misvalued. The interested party stated that the direct PE of clinical
labor L042A, ``RN/LPN'' (for labor rate of $0.525 per minute) was
incorrect and should be changed to a more specific entry of ``a
therapeutic apheresis nurse specialist (RN)'' (for a labor rate of
about $1.06 to $1.14 per minute), which would approximately double all
three of these codes' clinical labor PE entries. In addition, the
nominator disagrees with the current direct PE of supply item SC085,
``Tubing set, plasma exchange'' at $186.12 per item, and believes that
this should be worth $248.77 per item with CPT code 36514, using a
quantity of one item. The nominator believes that supply item SC084,
``Tubing set, blood warmer,'' that we currently have listed at $8.01
per item, should be worth $14.71 per item with CPT code 36514, also
using a quantity of one item. Sample invoices (not actual invoices)
were submitted for illustration and support. We welcome comments on the
nomination of these codes as potentially misvalued, or not.
(5) CPT Codes 44205 and 44204
An interested party nominated CPT code 44205 (Laparoscopy,
surgical; colectomy, partial, with removal of terminal ileum with
ileocolostomy), as potentially misvalued, requesting that payment for
this code be made equivalent to the payment for CPT code 44204
(Laparoscopy, surgical; colectomy, partial, with anastomosis), which is
a higher amount. Both codes are 090 day global codes, currently valued
only in the facility setting. CPT code 44204 has a total RVU of 45.62
for CY 2023 and CPT code 44205 has a total RVU of 39.62 for CY 2023,
with a difference of 6.00 RVUs. CPT code 44204 is associated with 5 to
6 percent more physician work time: 455.0 minutes in total, as compared
to 428.5 minutes in total for CPT code 44205. The work RVU for CPT code
44204 is also 15 percent higher than the work RVU for CPT code 44205.
The direct PE entries for both codes are the same with regard to
supplies, equipment, and clinical labor, except that in the clinical
labor and equipment entries, the number of usage minutes is higher for
CPT code 44204.
Though these two codes appear to be similar, they are still
different in their purpose, physician work times, and direct PEs, with
CPT code 44204 involving more time and resources (and having a higher
payment, accordingly). For these reasons, we are not inclined to agree
that CPT code 44205 is potentially misvalued when compared to CPT code
44204, or to modify this payment differential by paying a higher amount
for CPT code 44205. We are soliciting feedback regarding the nomination
of CPT code 44205 as potentially misvalued.
(6) CPT Codes 93655 and 93657
An interested party nominated CPT codes 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)) and 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)), as potentially misvalued. These two add-
on codes were part of our code review in the cardiac ablation code
family in the CY 2022 (86 FR 65108) and CY 2023 (87 FR 69516) final
rules.
The nominator reiterates that the primary procedures involve ``high
intensity clinical decision making, complexity in the intraoperative
skills required for treatment, morbidity/mortality risks to the
patient, and work intensity'' and that the work RVUs for both of these
add-on codes should reflect the AMA RUC recommended 7.00 work RVUs. We
disagreed with this value in CY 2022, and we continue to believe that a
work RVU of 5.50 is appropriate for the 60 minutes of physician service
time for both codes. We see no reason to reconsider our valuation of
CPT codes 93655 and
[[Page 52283]]
93657 for CY 2022 or CY 2023, and we do not consider these codes to be
potentially misvalued now. We are not proposing to nominate these codes
as potentially misvalued for CY 2024.
(7) CPT Code 94762 and 95800
An interested party nominated CPT code 94762 (Noninvasive ear or
pulse oximetry for oxygen saturation; by continuous overnight
monitoring (separate procedure)) as potentially misvalued due to the PE
items listed for this code, which were last reviewed in 2009. There is
no physician work/professional component associated with this code. The
nominator states that the technology behind this code has changed
considerably over the last 14 years, and that the listed equipment
items for CPT code 94762, EQ212 ``pulse oxymetry recording software
(prolonged monitoring)'' and EQ353 ``Pulse oximeter 920 M Plus'' are
now typically found in a one-time use supply item: SD263 ``WatchPAT
pneumo-opt slp probes'' (extended external overnight pulse oximeter
device probe and battery with bluetooth, medical magnetic tape
recorder) (WatchPAT One Device) costing $99.00 each, derived from two
sample invoices (not actual invoices) that were included with the
nomination. According to our PE supply list, item SD263 costs $73.32,
which is $25.68 less than the amounts found in the sample invoices
submitted by the nominators. The nominator retains equipment item EQ212
``pulse oxymetry recording software (prolonged monitoring)'', and
replaces equipment item EQ353 with ED021, a ``computer, desktop, w-
monitor.'' Payment for CPT code 94762 is currently $25.75 in the
nonfacility office setting. There were 122,207 allowed service claims
for CPT code 94762 in CY 2021. The facility payment amount for CPT code
94762 under the Medicare Hospital Outpatient Prospective Payment System
(OPPS) is currently $145.43.
The same interested party who nominated CPT code 94762 also
nominated CPT code 95800 (Sleep study, unattended, simultaneous
recording; heart rate, oxygen saturation, respiratory analysis (e.g.,
by airflow or peripheral arterial tone), and sleep time) as potentially
misvalued, requesting that CMS update PE items for this code, which
were last reviewed in 2017. CPT code 95800 currently includes the entry
of a one-time use supply item, SD263 ``WatchPAT pneumo-opt slp probes''
(extended external overnight pulse oximeter device probe and battery
with bluetooth, medical magnetic tape recorder) (WatchPAT One Device),
which costs $73.32 per item, in contrast to the pricing in the sample
invoice--$99.00 each (case of 12 x $99.00 = $1,188.00). This is a
$25.68 difference in this supply item's cost.
The nominator excludes the current equipment for this code (EQ335
``WatchPAT 200 Unit with strap, cables, charger, booklet and patient
video'' and EQ336 ``Oximetry and Airflow Device'') and instead includes
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We
note that we have not previously included ED021 as a specialized
equipment item dedicated to this function (and EQ212 ``pulse oxymetry
recording software (prolonged monitoring)'' is also not included in the
PE for CPT code 95800, as it is with CPT code 94762). The nominator
included the PE listings for CPT code 93245 (Heart rhythm recording,
analysis, interpretation and report of continuous external EKG over
more than 1 week up to 1 weeks) as an example of how PE supply items
for CPT code 95800 should be structured, but this code includes a
supply item, SD339 ``extended external ECG patch, medical magnetic tape
recorder'' and equipment item ED021 ``computer, desktop, w-monitor,''
which is presumed to be used to record the data from the ECG patch and
to be used to analyze this data. CMS currently pays a total of $150.80
for CPT code 95800 in the non-facility office setting, and there were
53,793 allowed services for this code in CY 2021.
There is not clear evidence whether the WatchPAT One Device needs,
or does not need, the specific monitoring and recording system
(equipment item EQ212 ``pulse oxymetry recording software (prolonged
monitoring)'') for CPT code 95800 as opposed to any other system/
process. The interested party has requested the practice expense
changes discussed above as support for their argument that these CPT
codes are potentially misvalued (See Table 7.)
BILLING CODE 4120-01-P
[[Page 52284]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.007
We welcome comments as to whether or not these codes are
potentially misvalued.
(8) CPT Codes 0596T and 0597T
An interested party has nominated CPT codes 0596T (Initial
insertion of temporary valve-pump in female urethra) and 0597T
(Replacement of temporary valve-pump in female urethra) as potentially
misvalued due to MAC pricing, which is determined on a case-by-case
basis. These temporary CPT category III codes are all procedure status
``C'' (contractor priced), and the interested party is seeking status
``A'' (for active payment status) to account for physician work,
nonfacility PE, and professional liability costs. The nominator states
that the MAC-determined payment amounts have been inappropriately low,
and do not account for the time and the work that the physician expends
for these services, or for all of the PE costs associated with the
Vesiflo inFlow System. For CPT code 0596T, the nominator expects a
physician to spend 60 minutes of work on installing this Vesiflo inFlow
System. The nonfacility office PE items include a power table, a mayo
stand, an examination light, clinical labor time of a RN/LPN/MTA
totaling to 73 minutes, and a list of supplies summing to $1,902.76,
primarily from the inFlow Measuring Device of $140.00, the inflow
Device of $495.00, and the inflow Activator Kit of $1,250.00, making up
about 99 percent of the total cost of supplies.
For CPT code 0597T, the nominator expects a physician to spend 25
minutes of work replacing this Vesiflo inFlow System. The nonfacility
office PE items include a power table, a mayo stand, an examination
light, clinical labor time of a RN/LPN/MTA totaling to 38 minutes, and
a list of supplies summing to $505.30, primarily from the inflow device
of $495.00, making up about 98 percent of the total cost of supplies. A
sample invoice is included in this nomination (as opposed to an actual
invoice).
We welcome comments as to whether or not these two temporary
category II CPT codes, CPT codes 0596T and 0597T, are potentially
misvalued, and whether these codes should remain contractor priced or
not.
[[Page 52285]]
(9) CPT Code 93000
An interested party has nominated CPT code 93000
(Electrocardiogram, routine ECG with at least 12 leads; with
interpretation and report) as potentially misvalued, arguing that we
should increase Medicare payment for CPT code 93000 to $35.64, when
used in conjunction with other supplies and services, to adequately
compensate practitioners for their PE item costs for: (1) $6.10 for EKG
leads; (2) $21.19 for a nurse visit of typically 5 minutes time (as
illustrated by CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services.)); and (3) $7.64 for the interpretation and report for the
EKG service (as illustrated by CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only).
The interested party is asking for the grouping of these services to be
valued at $35.64 (the actual sum of these inputs is $34.93). No
invoices or other evidence were provided for consideration.
For CY 2023, the national payment amounts under the PFS for CPT
codes 93000, 93010, and 99211 in the nonfacility office setting are as
follows:
CPT code 93000; total RVUs 0.43 x CF $33.8872 = $14.57.
CPT code 93010; total RVUs 0.24 x CF $33.8872 = $8.13.
CPT code 99211; total RVUs 0.69 x CF $33.8872 = $23.38.
Sum total $46.08.
After consideration, we are not proposing to nominate CPT code
93000 as potentially misvalued for CY 2024. The sum of a mix of
services is not a persuasive indication that one code--in this case,
CPT code 93000--is potentially misvalued.
(10) 19 Therapy codes
An interested party has nominated 19 therapy codes as potentially
misvalued. These 19 therapy codes were last reviewed by CMS in the CY
2018 PFS final rule (82 FR 53073 through 53074). The interested party
stated that the direct PE clinical labor minutes as recommended by the
AMA Relative Value Scale Update Committee (RUC) and Healthcare
Professional Advisory Committee (HCPAC) Review Board might have had
inappropriate multiple procedure payment reductions (MPPR) applied to
their PE clinical labor time entries. The nominators are now seeking
correction for those clinical labor time entries, which, if adjusted in
accordance with the recommendations of the nominators, would likely
result in slightly higher or nominally changed payments for the 19
therapy codes.
We have reviewed the clinical labor time entries for these 19
therapy codes, and we are now reconsidering the values established in
the CY 2018 final rule. We do not believe that MPPR should be applied
to these 19 nominated therapy codes' clinical labor time entries
(listed in Table 8), and as a result, we would like the AMA RUC HCPAC
recommendations from January 2017 to be re-reviewed. We recommend
nomination of these 19 codes as potentially misvalued for CY 2024, and
we welcome comments on this nomination.
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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 signs or
symptoms.
Reduced recovery time.
Category 3: 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 public health emergency (PHE) for the COVID-19 pandemic.
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 criteria described above. In this proposed rule, we are
considering additional requests to add services to the Medicare
Telehealth Services List on a Category 3 basis using the previously
described Category 3 criteria. 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 2024, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2023. 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 mail 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 2024
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 criteria not only
[[Page 52287]]
streamline our review process for publicly requested services that fall
into this category, but also expedite our ability to identify codes for
the Medicare Telehealth Services List that resemble those services
already on the Medicare Telehealth Services List.
We also note that section 4113 of Division FF, Title IV, Subtitle A
of the Consolidated Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-
328, December 29, 2022) extends the telehealth policies enacted in the
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022) through December 31, 2024, if the PHE ends prior to
that date, as discussed in section II.D.c. of this proposed rule.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2024. 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. The requested
services are listed in Table 9.
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BILLING CODE 4120-01-C
We remind interested parties that the criterion for adding services
to the Medicare telehealth list under Category 1 is that the requested
services are similar to professional consultations, office visits, and
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 9 1 met the Category 1 criterion.
(1) Cardiovascular Procedures
We received a request to permanently add CPT code 93793
(Anticoagulant management for a patient taking warfarin, must include
review and interpretation of a new home, office, or lab international
normalized ratio (INR) test result, patient instructions, dosage
adjustment (as needed), and scheduling
[[Page 52290]]
of additional test(s), when performed)) to the Medicare Telehealth
Services List. We do not consider this service to be a Medicare
telehealth service, because the service is not an inherently face-to-
face service--a patient need not be present in order for the service to
be furnished in its entirety. For example, in many instances, clinical
staff will not change a patient's warfarin dosage as a result of the
lab INR test result, and they may or may not confirm the need for a
follow-up test via phone; either way there is no need for a face-to-
face encounter with a practitioner. As we have explained in previous
rulemaking (83 FR 59483), certain kinds of services that are furnished
remotely using communications technology are not considered Medicare
telehealth services and are not subject to the restrictions articulated
in section 1834(m) of the Act. This is true for services that were
routinely paid separately prior to the enactment of section 1834(m) of
the Act and do not usually include patient interaction such as the
remote interpretation of diagnostic tests. We do not consider CPT code
93793 to be a telehealth service under section 1834(m) of the Act or
our regulation at Sec. 410.78. Therefore, we are not proposing to add
this service to the Medicare Telehealth Services List on a Category 1
basis.
(2) Cardiovascular and Pulmonary Rehab
We received multiple requests to permanently add the following CPT
codes to the Medicare Telehealth Services List:
93797 (Physician or other qualified health care
professional services for outpatient cardiac rehabilitation; without
continuous ECG monitoring (per session)); and
94624 (Physician or other qualified health care
professional services for outpatient pulmonary rehabilitation; without
continuous oximetry monitoring (per session)).
In the CY 2022 PFS final rule (86 FR 65048), we explained that some
services were added temporarily to the Medicare Telehealth Services
List on an emergency basis to allow practitioners and beneficiaries to
have access to medically necessary care while avoiding both risk for
infection and further burdening healthcare settings during the PHE for
COVID-19. In the same rule, we considered available evidence and noted
that as evidence evolves on this subject matter, we welcome further
discussions with interested parties on the topic. In subsequent cycles
of annual rulemaking, we have continued conversations with interested
parties that furnish, support, and use Cardiovascular and Pulmonary
Rehabilitation services. In our CY 2022 PFS final rule (86 FR 65055),
we acknowledged that commenters provided a number of studies on the
safety and efficacy of these services when furnished via telehealth,
and we added the codes to the list on a temporary, Category 3 basis.
We note that some evidence submissions and ongoing discussions with
interested parties have focused on the clinical benefits of patients
receiving these services in the home. We note that, while demonstrating
the clinical benefits of services is important to our decision whether
to add a service to the Medicare Telehealth Services List, there are
other considerations when deciding whether to add codes to the list on
a permanent basis. For example, while the CAA, 2023, does extend
certain COVID-19 PHE flexibilities, including allowing the
beneficiary's home to serve as an originating site, such flexibilities
are only extended through the end of CY 2024. Under current law,
beginning on January 1, 2025, the beneficiary's home can be an
originating site only for Medicare telehealth services furnished for:
(1) the diagnosis, evaluation, or treatment of a mental health
disorder; or (2) a beneficiary with a diagnosed substance use disorder
(SUD) for purposes of treatment of the SUD or a co-occurring mental
health disorder; or (3) monthly ESRD-related clinical assessments
furnished to a beneficiary who is receiving home dialysis, beginning
January 1, 2025. Therefore, in the absence of further action by
Congress, CPT codes 93797 and 94626 will not be able to be furnished
via telehealth to a beneficiary in the home beginning January 1, 2025.
As such, we are not proposing to include these services permanently on
the Medicare Telehealth Services List on a Category 1 basis. We are
instead proposing to continue to include these services on the Medicare
Telehealth Services List through CY 2024. We would then remove CPT
codes 93797 and 94626 from the Medicare Telehealth Services List for CY
2025.
(3) Deep Brain Stimulation
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
95970 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (e.g., contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain, cranial nerve, spinal cord, peripheral nerve,
or sacral nerve, neurostimulator pulse generator/transmitter, without
programming);
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)).
In our CY 2023 proposed rule (85 FR 45891), we explained that these
services do not meet the Category 1 criterion for permanent addition to
the Medicare Telehealth Services List. Additionally, we discussed
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 to allow additional time for additional
information to be gathered and presented. 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 under
[[Page 52291]]
the Category 2 criterion. We are proposing to keep these services on
the Medicare Telehealth Services List for CY 2024. We would consider
additional evidence in future rulemaking to determine whether to add
the services to the Medicare Telehealth Services List on a permanent
basis.
(4) Therapy
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116; Physical Therapy Evaluations: CPT codes 97161-97164;
Therapy Personal Care services: CPT code 97530; and Therapy Tests and
Measurements services: CPT codes 97750, 97763 and Biofeedback: 90901,
to the Medicare Telehealth Services List on a Category 1 or 2 basis. We
have considered these codes over several years, in multiple cycles of
annual rulemaking. In the CY 2017 final rule (81 FR 80198), we first
assessed a request to add CPT codes 97110, 97112, and 97116 (the
therapy codes) to the Medicare Telehealth Services List. We did not add
the codes to the Medicare Telehealth Services List at the time, because
there was no emergency waiver providing an exception to the
requirements under section 1834(m)(4)(E) of the Act, and physical
therapists, occupational therapists, and speech-language pathologists
were not eligible telehealth practitioners. In the CY 2018 final rule
(82 FR 53008 and 53009), we reiterated our initial assessment that the
codes were not appropriate to add to the Medicare Telehealth Services
List, because the majority of the therapy codes listed above are
furnished over 90 percent of the time by therapy professionals who are
not included on the list of distant site practitioners who can furnish
telehealth services at section 1834(m)(4)(E) of the Act. We stated that
we believed that adding therapy services to the Medicare Telehealth
Services List could result in confusion about who is authorized to
furnish and bill for these services when furnished via telehealth (82
FR 53009).
Section 3703 of Division A, Title III, Subtitle D of the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L.
116-136, enacted March 27, 2020) amended section 1135(b)(8) of the Act
to give the Secretary emergency authorities to waive or modify Medicare
telehealth payment requirements under section 1834(m) of the Act during
the PHE for COVID-19. Using this authority, CMS issued a set of
emergency waivers that included waiving the restrictions in section
1834(m)(4)(E) of the Act on the types of practitioners who may furnish
telehealth services. This allowed for therapy professionals to furnish
telehealth services for the duration of the PHE. In the CY 2022 final
rule (86 FR 65051), we reviewed another round of submissions requesting
that CMS add therapy codes to the Medicare Telehealth Services List,
and we again determined that these codes did not meet the Category 1
criterion for addition to the list. In the CY 2023 PFS final rule (87
FR 69451), through our review of evidence that was submitted 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.
In reviewing this year's request, the evidence submission includes
evidence similar to what was submitted last year, with a few new
additions suggesting that some elements of the individual services may
have clinical benefit when furnished via telehealth, but not resolving
uncertainty about whether other elements of the services can be fully
furnished remotely via telehealth. The evidence submitted also suggests
that receiving therapy services via telehealth in the home may offer
some practical benefits, such as use of actual stairs in therapy
exercise instead of artificial stairs, or meal preparation instructions
focused on available kitchen tools and equipment. However, the evidence
submitted for review leaves open questions as to whether such
differences in the setting of care translate to a clinical benefit that
is more than minor or incidental, in typical circumstances for the
typical population of beneficiaries who may receive therapy services
via telehealth.
We note that for any submission, including submissions received for
these therapy services, we consider all elements of a service as
described by a particular HCPCS code and apply our review criteria to
the specific code. While some submitted information may focus on an
individual service within one specific clinical scenario, and furnished
within one specific individual model of care delivery, that information
may not be generalizable to the varied settings and scenarios under
which the service would be typically furnished via telehealth. We
reiterate that available evidence should give a reasonable degree of
certainty that all elements of the service could fully and effectively
be furnished by a remotely-located clinician using two-way, audio/video
telecommunications technology.
Based on the evidence we reviewed, we continue to question whether
the findings from therapy studies that focused on a specific clinical
issue for a narrow population (for example, joint replacement of a
specific joint) translate to clinical benefit for some or many of the
various other clinical issues that would typically be addressed when
therapists furnish therapy services via telehealth to beneficiaries.
Despite the evidence, we are still uncertain as to whether all of the
elements of a therapy service could typically be furnished through use
of only real-time, two-way audio/video communications technology.
Because we continue to have these questions, we are not proposing to
add these services to the Medicare Telehealth Services List on a
Category 1 or 2 basis, for the same reasons described in our CY 2018
through CY 2023 rulemaking cycles. Also, we continue to believe that
adding these therapy services to the Medicare Telehealth Services List
permanently would potentially generate confusion. As discussed in last
year's final rule, we note that we do not have authority to expand the
list of eligible Medicare telehealth practitioners to include
therapists (PTs, OTs, or SLPs) after CY 2024 (87 FR 69449 through
69451). We note that the CAA, 2023, did not permanently change the list
of practitioners who can furnish and bill for telehealth services;
rather, the CAA, 2023, extended the current telehealth flexibilities
through the end of CY 2024. That said, we are proposing to keep these
therapy services on the Medicare Telehealth Services List until the end
of CY 2024. We will consider any further action with regard to these
codes in future rulemaking.
(5) Hospital Care, Emergency Department and Hospital
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
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
[[Page 52292]]
encounter for code selection, 55 minutes must be met or exceeded.)
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 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.)
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.)
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.)
99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less on the date of the encounter)
99239 (Hospital inpatient or observation discharge day
management; more than 30 minutes on the date of the encounter)
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)
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)
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)
In the March 31, 2020 interim final rule with comment period (IFC-
1) (85 FR 19234), we added the above services to the Medicare
Telehealth Services List on a Category 2 basis for the duration of the
PHE for COVID-19, for telehealth services with dates of service
beginning March 1, 2020 through the end of the PHE (including any
renewals of the PHE). When we previously considered adding these
services to the Medicare Telehealth Services List, either through a
public request or through our own internal review, we considered
whether these services met the Category 1 or Category 2 criteria. In
many cases, we reviewed requests to add these services to the Medicare
Telehealth Services List on a Category 1 basis, but did not receive or
identify information that allowed us to determine whether these
services should be added on a Category 2 basis (CY 2017 PFS final rule,
at 81 FR 80194 to 80197). We reiterate that, while we do not believe
the context of the PHE for COVID-19 changes the assessment of whether
these services meet the Category 1 criterion, we reassessed all of
these services to determine whether they meet the criteria for
inclusion on the Medicare Telehealth Services List on a Category 2
basis, in the context of the widespread presence of COVID-19 in the
community. Given the exposure risks for beneficiaries, the health care
work force, and the community at large, in-person interaction between
professionals and patients posed an immediate potential risk that would
not have been present when we previously reviewed these services in
2017. This risk created a unique circumstance where health care
professionals needed to weigh the risks associated with disease
exposure. For further background, in the CY 2021 final rule (FR 84506
through 84509), we explained the reasoning and considerations necessary
for assigning a Category 3 status to certain codes that were added to
the Medicare Telehealth Services List on a temporary basis during the
PHE for COVID-19. We believe that some risk of COVID-19 remains, but
also remain uncertain that available evidence gives clear support for
continuing to include these services on a permanent basis under the
Category 2 criterion.
As discussed in the CY 2023 PFS final rule (86 FR 69450), we
believe these hospital and emergency department services may continue
to be furnished safely via two-way, audio-video communication
technology. We are not proposing to add these services to the list on a
permanent basis at this time, but we are proposing that they would
remain available on the Medicare Telehealth Services List through CY
2024.
(6) Health and Well-Being Coaching
We received a request to permanently add the following three Health
and Well-being Coaching services to the Medicare Telehealth Services
List:
CPT code 0591T (Health and well-being coaching face-to-
face; individual, initial assessment);
CPT code 0592T (Health and well-being coaching face-to-
face; individual, follow-up session, at least 30 minutes); and
CPT code 0593T (Health and well-being coaching face-to-
face; group (2 or more individuals), at least 30 minutes).
We are not proposing to add these health and well-being coaching
services to the Medicare Telehealth Services List on a permanent basis,
but we are proposing to add them to the list on a temporary basis for
CY 2024. The evidence included in the submitter's request notes that
these codes are similar to others already available on the Medicare
Telehealth Services List. Further, it appears that all elements of
these services may be furnished when using two-way interactive
communications technology to replace the face-to-face elements of the
service. The submission, which contained two published metanalyses of
literature on the clinical topic and an additional pre-publication
meta-analysis that focuses on outcomes and benefits of the delivery of
virtual health and well-being coaching, leaves some open questions as
to whether Medicare beneficiaries would receive meaningful clinical
benefit from receiving virtual-only health and well-being coaching.
While the evidence is clearly evolving, it does suggest that these
services could possibly meet Category 2 criteria for inclusion on the
Medicare Telehealth Services List as more evidence builds. We also note
that the published meta-analyses in the submission make clear that
further study is necessary for a broader range of medical
professionals, because conceptual articles and research and existing
practice articles focus on nurses, but are sparse or silent about other
general categories of medical professionals. As a reminder, we would
expect that any evidence in support of adding these codes on a
permanent basis should also establish clinical benefit when delivered
directly by or under the supervision of the types of professionals who
are Medicare telehealth practitioners. The metanalyses demonstrate that
health
[[Page 52293]]
coaching only requires a few hours of training, and few articles
submitted to CMS discuss the intensity of health coach training at all.
The pre-publication metanalysis submitted for review draws less than
definitive conclusions about ``potential benefits'' of health and well-
being coaching and hedges that authors, ``did not find evidence of
long-term benefit, possibly due to the paucity of studies examining
longer-term outcomes. We caution that the certainty in the evidence for
the majority of outcomes was either very low or low, primarily due to
high risk of bias, heterogeneity, and impression.'' The submission and
its content are sufficient to serve as a basis for adding the codes to
the Medicare Telehealth Services List on a temporary basis, and we
appreciate the thoughtful and transparent way the submission lays out
gaps in available evidence. More time is needed to potentially close
these gaps. We are not aware of any evidence to suggest that it would
be inappropriate to assign a temporary status. Therefore, we are
proposing to add the services to the Medicare Telehealth Services List
on a temporary basis.
(7) CMS Proposal To Add New Codes to the List
In addition to the health and wellbeing coaching services submitted
as requests, we are proposing to add HCPCS code GXXX5 (Administration
of a standardized, evidence-based Social Determinants of Health Risk
Assessment tool, 5-15 minutes) to the Medicare Telehealth Services
List. Our proposal to add HCPCS code GXXX5 to the list is contingent
upon finalizing the service code description that we propose in section
II.E of this proposed rule. We refer readers to the proposal in section
II.E for further background. We are proposing that HCPCS code GXXX5, if
finalized as proposed, receive a permanent status on the Medicare
Telehealth Services List. One element of the service describes a face-
to-face encounter between the clinician and beneficiary. Practitioners
use clinical judgement to determine whether to complete the SDOH
screening with or without direct patient interaction. Because the
service description, as defined in section II.E. of this proposed rule,
expects that a patient encounter may be necessary for accurate and
complete screening, we believe that this element of the service
describes an inherently face-to-face clinical activity. Further, the
use of two-way interactive audio-video technology, as a substitute to
in-person interaction, means an analogous level of care, in that using
either modality would not affect the accuracy or validity of the
results gathered via a standardized screening tool. As discussed in
section II.E. of this proposed rule, we are proposing that this service
must be furnished by the practitioner on the same date they furnish an
E/M visit, as the SDOH assessment would be reasonable and necessary
when used to inform the patient's diagnosis, and treatment plan
established during the visit. Therefore, we believe it describes a
service that is sufficiently similar to services currently on the
Telehealth list, specifically E/M services, and that this service be
added on a permanent basis.
c. Proposed Clarifications and Revisions to the Process for Considering
Changes to the Medicare Telehealth Services List
1. Overview
In CY 2020, CMS issued an array of waivers and new flexibilities
for Medicare telehealth services to respond to the serious public
health threats posed by the spread of COVID-19 (85 FR 19230). Our goal
was to give individuals and entities that provide services to Medicare
beneficiaries needed flexibilities to respond effectively to the
serious public health threats posed by the spread of COVID-19.
Recognizing the urgency of this situation and understanding that some
pre-existing Medicare payment rules (including the statutory
restrictions on telehealth originating sites and telehealth
practitioners) needed to be modified in order to allow patients and
practitioners to have access to necessary care while mitigating the
risks from COVID-19, we used waiver and regulatory authorities to
change certain Medicare payment rules during the PHE for COVID-19 so
that physicians and other practitioners, home health and hospice
providers, inpatient rehabilitation facilities, rural health clinics
(RHCs), and federally qualified health centers (FQHCs) would be allowed
broad flexibilities to furnish services using remote communications
technology to avoid exposure risks to health care providers, patients,
and the community.
In 2003, as required by section 1834(m)(4)(F)(ii), we established a
process for adding or deleting services from the Medicare Telehealth
Services List, which included consideration under two categories of
criteria (Categories 1 and 2) (67 FR 79988). We finalized revisions to
the Category 2 review criterion in the CY 2012 PFS final rule (76 FR
73102). Prior to CY 2020, CMS had not added any service to the Medicare
Telehealth Services List on a temporary basis. In CY 2020, in response
to the PHE for COVID-19, we revised the criteria for adding or removing
services on the Medicare Telehealth Services List using a combination
of emergency waiver authority and interim final rule making, so that
some services would be available for the duration of the PHE on a
``temporary Category 2 basis.'' (85 FR 19234). In the CY 2021 PFS final
rule (85 FR 84507), we created a third, temporary category for services
included on the Medicare Telehealth Services List on a temporary basis.
This new Category 3 includes many, but not all of the services that we
added temporarily to the Medicare Telehealth Services List during the
COVID-19 PHE. Specifically, we reviewed the services we added
temporarily in response to the COVID-19 PHE and identified those for
which there is likely to be clinical benefit when furnished via
telehealth, but there is not yet sufficient evidence available to add
the services as permanent additions to the list. Services added to the
Medicare Telehealth Services List on a temporary, Category 3 basis will
ultimately need to meet the Category 1 or 2 criteria in order to be
added to the Medicare Telehealth Services List on a permanent basis.
Between CY 2020 and CY 2023, we added many services to the Medicare
Telehealth List on a temporary basis during the PHE, and through
rulemaking, we also added many of these services on a Category 3 basis.
Subsequent requests and evidence submitted to CMS supported possible
status changes for some of the services that are currently included on
the Medicare Telehealth Services List on a Category 3 basis. However,
submissions sometimes confused our use of waiver authority and
regulatory flexibilities tied to the COVID-19 PHE which allow us to
temporarily add services to the Medicare Telehealth Services List
through the end of the PHE, with the generally applicable categories
and criteria we use to consider changes to the Medicare Telehealth
Services List outside the circumstances of the COVID-19 PHE. Now that
the PHE for COVID-19 has ended, we intend to clarify and modify our
process for making changes to the Medicare Telehealth Services List. We
believe these clarifications will help address potential confusion
among interested parties that submit requests for additions to the
Medicare Telehealth List stemming from the distinction between services
that were added to the telehealth list on the basis of COVID-19 PHE-
related authorities versus services that were added temporarily on a
[[Page 52294]]
Category 3 basis, which does not rely on any PHE-related authority.
Specifically, we created the Category 3 basis for considering changes
in the Medicare Telehealth Services List as part of the process we are
required to establish under section 1834(m)(4)(F)(2) for considering
changes to the list in part because, with the significant expansion of
remotely-furnished services in response to the COVID-19 PHE, we
recognized the emergence of new data suggesting that there may be
clinical benefit when certain services are delivered via telehealth,
but more time is needed to develop additional evidence to support
potential addition of the services on a permanent, Category 1 or
Category 2 basis. Under Category 3, services are added to the list on a
temporary basis to allow them to continue to be furnished via
telehealth while additional evidence is developed.
In brief, throughout the COVID-19 PHE, we have reviewed all
requests to add services to the Medicare Telehealth Services List and
assessed whether the services in question should be added to the list,
temporarily or permanently, under any of the criteria for Category 1,
2, or 3. Further, we did not reject any submissions from interested
parties simply because they requested consideration under a specific
category, and the submitted data did not support adding the service to
the Medicare Telehealth Services List on that basis. Instead, we
considered whether the service(s) should be added to the Medicare
Telehealth Services List on any basis.
To avoid potential continuing confusion among those who submit
requests to add services to the Medicare Telehealth Services List, and
as we consider the expiration of the Medicare telehealth flexibilities
extended by the CAA, 2023 through the end of CY 2024, we believe it
would be beneficial to simplify our current taxonomy and multicategory
approach to considering submitted requests. Further, we believe that
simplification toward a binary classification approach could address
the confusion we have noticed from interested parties submitting
requests during the PHE. Our proposal would restore the simple binary
that existed with Category 1 and 2, without displacing or disregarding
the flexibility of Category 3. We propose to simply classify and
consider additions to the Medicare Telehealth Services List as either
permanent, or provisional.
At bottom, to consider a request to add a service to the Medicare
Telehealth Services List, we need evidence that supports how the
telehealth service is either clinically equivalent to a telehealth
service already permanently on the list, or evidence that presents
studies where findings suggest a clinical benefit sufficient for the
service to remain on the list to allow time for confirmative study. We
reemphasize the need for clinical evidence because that evidence serves
as the principal basis for our consideration of a request; and it is
sometimes missing from submissions we receive.
For example, we have received some submissions requesting the
addition of services to the Medicare Telehealth Services List that are
essentially framed as position papers advocating for changes in
statutory requirements of section 1834(m) of the Act. While we do give
such requests due consideration, the omission of clinical evidence to
support the addition of a service to the Medicare Telehealth Services
List using our established criteria generally leads us to conclude that
the service should not be proposed for addition to the list. A fair and
consistent review process for any and all submissions relies on a
standard application of uniform, repeatable procedures for any
individual submission, just as sound evidence should describe
repeatable methods and replicable findings. Submissions that rely on
narrative arguments for changes in the substantive requirements do not
fit within such a fair and consistent review process. Therefore, we
believe the following restatement of requirements and our review
process is appropriate. We also propose some procedural refinements to
the review process, specifically incorporating additional
considerations into our evaluation of services, that we believe would
serve to maintain scope and focus in a post-PHE context. We discuss
these proposed changes in detail in the following section.
Section 1834(m)(4)(F)(ii) of the Act requires that the Secretary
establish a process that provides, on an annual basis, for the addition
or deletion of services (and HCPCS codes), to the definition of
telehealth services for which payment can be made when furnished via
telehealth under the conditions specified in section 1834(m). As
specified at Sec. 410.78(f), with the exception of a temporary policy
that was limited to the PHE for COVID-19, we make changes to the list
of Medicare telehealth services through the annual physician fee
schedule rulemaking process. The proposed revisions to our current
permanent policies, specifically our proposed assignment of a
``permanent'' or ``provisional'' status to a service and changes in
status as described below, reflect the stepwise method by which we
propose to consider future requests to add services to, remove services
from, or change the status of, services on the Medicare Telehealth
Services List, beginning for the CY 2025 Medicare Telehealth Services
List, which will include submissions received no later than February
10, 2024.
2. Proposed Steps of Analysis for Services Under Consideration for
Addition, or Removal, or a Change in Status, as Updates to the Medicare
Telehealth Services List
Step 1. Determine whether the service is separately payable under
the PFS.
When considering whether to add, remove, or change the status of a
service on the Medicare Telehealth Services List, we are proposing to
first determine whether the service, as described by the individual
HCPCS code, is separately payable under the PFS. Under section
1834(m)(1) of the Act, Medicare telehealth services are limited to
those for which payment can be made to the physician or practitioner
when furnished using an interactive telecommunications system
notwithstanding that the practitioner furnishing the services is not in
the same location as the beneficiary; and under section 1834(m)(2)(A)
of the Act, Medicare pays the same amount for a telehealth service as
if the service is furnished in person. As such, Medicare telehealth
services are limited to those services for which separate Medicare
payment can be made under the PFS. Thus, through Step 1, we would
answer the threshold question of whether a service is separately
payable under the PFS. During the PHE, many submissions for addition to
the Medicare Telehealth Services List advocated for CMS to change the
definition of ``Medicare telehealth service'' for their specific
service; some of those submissions were for services that were not
separately payable under the PFS.\2\ (87 FR 69449). We anticipate that
Step 1, if finalized, will encourage submissions that focus on a
separately payable PFS service, and that the evidence included with
those submissions will show how use of interactive, two-way, audio/
video telecommunications technology allows a practitioner to complete
an entire, specific service, described by a HCPCS
[[Page 52295]]
code, that is equivalent to an in-person service.
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\2\ Services on the Medicare Telehealth List are used in the
definition of Medicare telehealth. Some submissions may have
conflated the distinction. Step 1 clarifies. Refer to the CMS
website instructions for a Request for Addition at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
---------------------------------------------------------------------------
We recognize that certain codes that had non-payable or bundled
(not separately payable) status under the PFS before the PHE for COVID-
19 were temporarily included on the Medicare Telehealth Services List
to facilitate access to health care services during the PHE. However,
the PHE for COVID-19 has now expired.
We believe that proposed Step 1, if finalized, would lessen the
administrative burden of our telehealth services review process for
both CMS and the public. We note that before gathering evidence and
preparing to submit a request to add a service to the Medicare
Telehealth Services List, the submitter should first check the payment
status for a given service and ensure that the service (as identified
by a HCPCS code), is a covered and separately payable service under the
PFS (as identified by payment status indicators A, C, T, or R on our
public use files). For a full list of all PFS payment status indicators
and descriptions, see the Medicare Claims Processing Manual (IOM Pub.
100-04, chapter 23, section 30.2.2) and the Addendum for the MPFSDB
File Record Layout. Researchers and others preparing submissions should
also refer to the data dictionaries available at https://resdac.org/cms-data/files/carrier-ffs/data-documentation, to review whether the
methodology and conclusions contained in supporting evidence, or a
submission itself, applies an appropriate methodology to study both
individual services and individuals that are representative of the
Medicare population.
We further propose that, if we find that a service identified in a
submission is not separately payable under the PFS, we would not
conduct any further review of that service. We would identify the code
submitted for consideration and explain that we are not proposing it
for addition. CMS sends confirmation from
[email protected] when we receive a submission
requesting addition of a service to, removal of a service from, or a
change in status for a service included on, the Medicare Telehealth
Services List. We are proposing to inform each submitter in the
confirmation whether the submission was complete, lacking required
information, or outside the scope of issues we consider under the
process for considering changes in the Medicare Telehealth Services
List. We note that we also expect submissions to include copies of any
source material used to support assertions, which has been the
longstanding direction included in our website instructions. For
further background, refer to details available on our website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
Step 2. Determine whether the service is subject to the provisions
of section 1834(m) of the Act.
If we determine at Step 1 that a service is separately payable
under the PFS, we propose to apply Step 2 under which we would
determine whether the service at issue is subject to the provisions of
section 1834(m) of the Act. A service is subject to the provisions of
section 1834(m) of the Act when at least some elements of the service,
when delivered via telehealth, are a substitute for an in-person, face-
to-face encounter, and all of those face-to-face elements of the
service are furnished using an interactive telecommunications system as
defined in Sec. 410.78(a)(3). The aim of this step is to determine
whether the service is, in whole or in part, inherently a face-to-face
service. As we discussed in the CY 2018 PFS final rule (83 FR 59483),
it has long been the case that certain services that are furnished
remotely using communications technology are not considered Medicare
telehealth services and are not subject to the requirements of section
1834(m) of the Act. We are proposing Step 2 to emphasize the
circumstances under which the criteria under section 1834(m) of the Act
apply, and also highlight circumstances in which the criteria under
section 1834(m) of the Act do not apply. As previously noted, section
1834(m) of the Act provides for payment to a physician or practitioner
for a service furnished via an interactive telecommunications system
notwithstanding that the furnishing practitioner and patient are not in
the same location at the same amount that would have been paid if the
service was furnished without the telecommunications system. We read
this to mean that the scope of section 1834(m) of the Act is limited to
services that would ordinarily be furnished with the furnishing
practitioner and patient in the same location.
Our application of Step 2 remains consistent with longstanding
policy. We reiterate that there is a range of services delivered using
certain telecommunications technology that do not fall within the scope
of Medicare telehealth services, though they are separately payable
under the PFS. Such services generally include services that do not
require the presence of, or involve interaction with, the patient (for
example, remote interpretation of diagnostic imaging tests, and certain
care management services). Other examples include virtual check-ins, e-
visits, and remote patient monitoring services which involve the use of
telecommunications technology to facilitate interactions between the
patient and practitioner, but do not serve as a substitute for an in-
person encounter, for example, to assess whether an in-person or
telehealth visit is needed or to transmit health information to the
practitioner.
In determining whether a service is subject to the provisions of
section 1834(m) of the Act, we will consider whether one or more of the
elements of the service, as described by the particular HCPCS code at
issue, ordinarily involve direct, face-to-face interaction between the
patient and practitioner such that the use of an interactive
telecommunications system to deliver the service would be a substitute
for an in-person visit. For interested parties preparing a request to
add a service to the Medicare Telehealth Services List, we believe this
Step 2 clarifies that a service must be inherently a face-to-face
service. We believe reframing this Step 2 has the practical advantage
of refining and improving consistency. We do not believe it would be
appropriate to add a service to the Medicare Telehealth Services List
if it is not subject to section 1834(m) of the Act. We would explain
our finding in notice and comment rulemaking.
Step 3. Review the elements of the service as described by the
HCPCS code and determine whether each of them is capable of being
furnished using an interactive telecommunications system as defined in
Sec. 410.78(a)(3).
We believe that the proposed Step 3 is fundamental to our
commitment to health equity, as this step could have a beneficial
impact on access to care for vulnerable populations. Step 3 is
corollary to Step 2, and used to determine whether one or more elements
of a service are capable of being delivered via an interactive
telecommunication system as defined in Sec. 410.78(a)(3). In Step 3,
we consider whether one or more face-to-face component(s) of the
service, if furnished via audio-video communications technology, would
be equivalent to the service being furnished in-person, and we seek
information from submitters to demonstrate evidence of substantial
clinical improvement in different beneficiary populations that may
benefit from the requested service when furnished via telehealth,
including, for example, in rural populations. The services are not
equivalent when the
[[Page 52296]]
clinical actions, or patient interaction, would not be of similar
content as an in-person visit, or could not be completed. We note that
completing each element of the defined service is a different question
than whether a beneficiary receives any benefit at all from the
telehealth-only form of a candidate service. The practical basis for
Step 3 mirrors the practical basis for proposed Step 1 and 2, which is
a consistent application of review criteria. Many submissions that CMS
received during the PHE lacked evidence indicating that some or all
elements of a service could be completed using an interactive
telecommunications system without still requiring an in-person
interaction with a patient to furnish the complete service. We note
that studies of patient satisfaction alone, and submissions with an
excessive focus on patient satisfaction alone, present risks of bias in
many ways, possibly complicating or obfuscating the question of whether
it is possible, or potentially safe, to deliver an inherently face-to-
face service via telehealth. Step 3 is integral to avoiding the
possible unintended consequences of creating new gaps in care when
telehealth is used as a substitute for in-person care.
Step 4. Consider whether the service elements of the requested
service map to the service elements of a service on the list that has a
permanent status described in previous final rulemaking.
The purpose of the proposed Step 4 of our analysis is to simplify
and reduce the administrative burden of submission and review. For Step
4, we are proposing to consider whether the service elements of a code
that we are considering for addition to, or removal from, the Medicare
Telehealth Services List map to the service elements of a service that
is already on the list and has a permanent status, because any code
that satisfies this criterion would require no further analysis: if a
code describes a service that maps to the service elements of a code
that is included on the Medicare Telehealth Services List on a
permanent basis, we would add the code to the Medicare Telehealth
Services List on a permanent basis.
We note that section 1834(m)(4)(F)(i) of the Act defines telehealth
services as professional consultations, office visits, and office
psychiatry services (as identified as of July 1, 2000, by HCPCS codes
99241-99275, 99201-99215, 90804-90809, and 90862 (and as subsequently
modified by the Secretary)), and any additional service specified by
the Secretary. Over the years, CMS has assigned Category 1 (permanent)
status to services that were either included in the list of codes
specified in section 1834(m)(4)(F)(i) of the Act or added as successor
codes to those enumerated by statute. Successor codes are updates to or
replacements for the codes listed in section 1834(m)(4)(F)(i) of the
Act. Therefore, this proposed step would ensure that CMS includes
successor codes on the Medicare Telehealth Services List. We note that
even if a code that we are considering for addition to the Medicare
Telehealth Services List is not a successor code, we would consider
whether the service described in the submission is similar to
professional consultations, office visits, and office psychiatry
services that are already on the Medicare Telehealth Services List on a
permanent basis. While we have not previously found that the elements
of service we are considering for addition to the list map to the
elements of a service that was previously added to the list on a
permanent basis using the Category 2 criteria, we believe that it would
be appropriate to apply this step 4 analysis to compare the candidate
service with any permanent code that is on the list on a permanent
basis. As such, in step 4, we propose to maintain any previous
analytical determinations from Steps 1 through 3 and directly map the
successor code to a code on the list that has a permanent status
described in previous final rulemaking. For example, if a code
currently categorized as a finalized Category 2 permanent code was
replaced or revised by a successor code in a future year, CMS would
ensure that these revisions did not change the Step 1-3 results and add
the successor code under Step 4. For example, in a future year, if a
code that would otherwise exist under the current categories as a
finalized Category 2 permanent code, and was subsequently replaced or
revised by a successor code, CMS would ensure any revisions did not
alter results under Steps 1-3, and add the successor code using this
Step 4. We further propose that if we find that the service we are
considering satisfies Step 4, we would end our review and propose to
add the service to the Medicare Telehealth Services List on a permanent
basis in the next PFS proposed rule. When Step 4 is met, further
evidence review is not necessary. If Step 4 is not met, then we propose
to continue to Step 5.
Step 5. Consider whether there is evidence of clinical benefit
analogous to the clinical benefit of the in-person service when the
patient, who is located at a telehealth originating site, receives a
service furnished by a physician or practitioner located at a distant
site using an interactive telecommunications system.
Similar to Steps 3, 4, and 5 above, the purpose of the proposed
step 5 is to simplify and reduce the administrative burden. Under
proposed Step 5, we would review the evidence provided with a
submission to determine the clinical benefit of a service. We would
then compare the clinical benefit of that service, when provided via
telehealth, to the clinical benefit of the service if it were to be
furnished in person. Proposed Step 5 would continue the existing
standard that we have applied when considering whether to add a code to
the Medicare Telehealth Services List on a Category 2 basis. We further
propose that: if there is enough evidence to suggest that further study
may demonstrate that the service, when provided via telehealth, is of
clinical benefit, CMS would assign the code a ``provisional'' status on
the Medicare Telehealth Services List. Where the clinical benefit of a
service, when provided via telehealth, is clearly analogous to the
clinical benefit of the service when provided in person, CMS would
assign the code ``permanent'' status on the Medicare Telehealth
Services List, even if the code's service elements do not map to the
service elements of a service that already has permanent status.
We remind readers that our evidentiary standard of demonstrated
clinical benefit does not include minor or incidental benefits (81 FR
80194), and if finalized, our proposal would not alter or displace this
longstanding requirement. We will review the evidence submitted by
interested parties, and other evidence that CMS has on hand. The
evidence should indicate that the service can be safely delivered using
two-way interactive audio-video communications technology. Clinical
practice guidelines, peer-reviewed literature, and similar materials,
should illustrate specifically how the methods and findings within the
material establish a foundation of support that each element of the
defined, individual service described by the existing face-to-face
service code has been studied in the typical setting of care, typical
population of beneficiaries, and typical clinical scenarios that
practitioners would encounter when furnishing the service using only
interactive, two-way audio-video communications technology to complete
the visit or encounter with Medicare beneficiaries. This analysis is
fundamental to either of the current Category 1 or Category 2
descriptions.
General evidence may also answer the question of whether a certain
[[Page 52297]]
beneficiary population requiring care for a specific illness or injury
may benefit from receiving a service via telehealth versus receiving no
service at all, but must establish that the service is a substitute for
an equivalent in-person service. Evidence should demonstrate how all
elements described by the individual service code can be met when two-
way, interactive audio-video communications technology is used as a
complete substitute for any face-to-face interaction required between
the patient and practitioner that are described in the individual code
descriptor. We further remind readers that submissions reflecting
practitioner services furnished to Medicare beneficiaries are helpful
in our considerations.
Proposed Assignment of ``permanent'' or ``provisional'' Status to a
Service and Changes in Status.
We are proposing to assign ``permanent'' or ``provisional'' status
to any services for which the service elements map to the service
elements of a service on the list that has a permanent status described
in previous final rulemaking (see proposed step 4) or for which there
is evidence of clinical benefit analogous to the clinical benefit of
the in-person service when the service is furnished via telehealth by
an eligible Medicare telehealth physician or practitioner (see proposed
steps 5). These two designations (that is, ``permanent'' or
``provisional'') are intended to replace the Category 1-3 taxonomy that
CMS currently uses. This proposed change is intended to reduce
confusion regarding the status of codes on the Medicare Telehealth
Services List and to simplify the outcome of our analysis. After a code
receives the ``provisional'' status, as evidence generation builds, we
may assign ``permanent'' status in a future year or we may remove the
service from the list in the interest of patient safety based on
findings from ongoing monitoring of telehealth services within CMS and
informed by publicly available information. We would revisit
provisional status through our regular annual submissions and
rulemaking processes where a submission provides new evidence, or our
claims monitoring shows anomalous activity, or as indicated by patient
safety considerations. CMS would handle changes in status by revisiting
the same steps 1 through 5 above.
Summary and Request for Feedback on Proposals To Update the Process of
Review for Adding, Removing, or Changing the Status of Services on the
Medicare Telehealth List
We note that the timeline for our proposed process to analyze
submissions would remain the same. CY 2025 submissions would be due by
February 10, 2024. Additionally, we would continue to address each
submitted request for addition, deletion, or modification of services
on the Medicare Telehealth Services List through annual notice and
comment rulemaking.
As the end of the PHE for COVID-19 was uncertain at the time of
last year's rule, many of the submissions for both CY 2023 and CY 2024
involved requests to change the status of services on the Medicare
Telehealth Services List from temporary to permanent. In other words,
many requestors asked CMS to consider changing the status of one or
more services from Category 3 to Category 1 or 2. Based on the number
of requests we received asking that CMS assign a different status to a
given service, we believe a clarification is necessary to remind
readers of the steps that we take when analyzing a given service for
addition to, removal from, or a change in status on the Medicare
Telehealth Services List. This proposal intends to refine our process
and reduce confusion going forward.
To reiterate some of our discussion above, our proposals are
consistent with the existing principles that CMS has applied to
requests to add, remove, or change the status of a code during the
COVID-19 PHE. When reviewing submissions during the PHE, in the absence
of evidence supporting clinical benefit, but public comment expressing
support for possible clinical benefit, CMS would generally accept a
temporary addition to the Medicare Telehealth Services list, allowing
more time for evidence generation. We anticipate that our approach
would generally remain consistent with this particular point of
flexibility if this proposal is finalized; a code could potentially
receive provisional status on the Medicare Telehealth Services List in
such a situation, with the caveat that our proposed Steps 1, 2, and 3,
are thresholds for inclusion on the Medicare Telehealth Services List.
If CMS finds that a service is not separately payable under the PFS
(see proposed step 1) or it is not subject to section 1834(m) of the
Act (see proposed Step 2), that service would not be added to the
Medicare Telehealth Services List on any basis (and notice of the
rejection would be provided to the submitter, as noted above). We do
not intend to reject a submission based solely on the fact that the
requestor did not request the appropriate basis for consideration; we
would still analyze the submission based on the proposed steps, and
then we would propose to add, remove, or change the status of the
service, or we would explain why we were not doing so.
We are soliciting comments on our proposed analysis procedures for
additions to, removals from, or changes in status for services on the
Medicare Telehealth Services List.
d. Consolidation of the Categories for Services Currently on the
Medicare Telehealth Services List
We are also proposing to consolidate Categories 1, 2, and 3, as
proposed above, for all services that are currently on the Medicare
Telehealth Services List. For CY 2024, we are proposing to redesignate
any services that are currently on the Medicare Telehealth Services
List on a Category 1 or 2 basis and would be on the list for CY 2024 to
the proposed new ``permanent,'' category while any services currently
added on a ``temporary Category 2'' or Category 3 basis would be
assigned to the ``provisional'' category. We believe that
redesignations in this calendar year would help ease confusion in
future years, including in the event that there is subsequent
legislation regarding Medicare telehealth services.
Further, for a code that receives provisional status, as evidence
generation builds, we may grant the code a permanent status in a future
year or remove the service from the list in the interest of patient
safety based on findings from ongoing monitoring of telehealth services
within CMS and informed by publicly available information. We propose
not to set any specific timing for reevaluation of services added to
the Medicare Telehealth Services List on a provisional basis because
evidence generation may not align with a specific timeframe. Our
proposal not to establish any specific timing for considering changes
from provisional to permanent status would avoid a potential situation
in which we must remove provisional services from the Medicare
Telehealth Services List because the set period tolls, only to later
find evidence demonstrating that the removed service should receive
permanent status. Under our proposal, we would assign a provisional
status for codes that satisfy the proposed threshold steps (1, 2, and
3), and then the evidence available leaves a ``close call'' between
permanent
[[Page 52298]]
and provisional status. We do not assign provisional status when it is
improbable that the code would ever achieve permanent status.
e. Implementation of Provisions of the CAA, 2023
(1) Overview and Background
The CAA, 2022 included several provisions that extend certain
Medicare telehealth flexibilities adopted during the COVID-19 PHE for
151 days after the end of the PHE. Specifically, sections 301 through
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 were on the Medicare Telehealth
Services List as of the date of enactment (March 15, 2021). The CAA,
2022, temporarily removed restrictions on telehealth originating sites
for those services to allow telehealth services to patients located in
any site in the United States at the time of the telehealth service,
including an individual's home; expanded the definition of telehealth
practitioners to include qualified occupational therapists, qualified
physical therapists, qualified speech-language pathologists, and
qualified audiologists; continued payment for telehealth services
furnished by FQHCs and RHCs using the methodology established for those
telehealth services during the PHE; delayed the requirement for an in-
person visit with the physician or practitioner within 6 months prior
to initiating mental health telehealth services to a beneficiary in
their home, and again at subsequent intervals as the Secretary
determines appropriate, as well as similar requirements for RHCs and
FQHCs; and continued to provide for payment of telehealth services
included on the Medicare Telehealth Services List as of the March 15,
2020, that are furnished via an audio-only telecommunications system. A
full discussion of these policies available in the CY 2023 PFS final
rule at 87 FR 69462.
In addition, section 309 of the CAA, 2022 authorized the Secretary
to implement the amendments described above, made by sections 301
through 305, through program instruction or otherwise. In the CY 2023
PFS final rule (87 FR 69446), we finalized specific telehealth policies
to conform to and align with amendments made by the CAA, 2022. In our
CY 2023 PFS final rule (87 FR 69462-69464), we described how CMS would
issue program instructions to implement specific requirements of the
CAA, 2022. We also implemented the provisions enacted in the CAA, 2022
for a 151-day extension period of certain telehealth flexibilities
(discussed previously in this proposed rule). On December 29, 2022, the
President signed the CAA, 2023 into law. Section 4113 of the CAA, 2023
further extends the previously-extended PHE-related telehealth
policies; it requires CMS to extend the telehealth flexibilities that
were previously extended (initially for 151 days after the end of the
PHE) under the CAA, 2022, through December 31, 2024.
We seek to address various telehealth policies that we finalized in
the CY 2023 final rule, in light of the CAA, 2023. For example, the
151-day extension period for certain flexibilities discussed in our CY
2023 final rule (and previously in this proposed rule) no longer
applies, since section 4113 of the CAA, 2023 extends these
flexibilities until December 31, 2024 (the extended flexibilities
include: temporary expansion of the scope of telehealth originating
sites for services furnished via telehealth 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; expansion of the
definition of eligible telehealth practitioners to include qualified
occupational therapists, qualified physical therapists, qualified
speech-language pathologists, and qualified audiologists; continued
payment for telehealth services furnished by FQHCs and RHCs using the
methodology established for those telehealth services during the PHE;
delaying the requirement for an in-person visit with the physician or
practitioner within 6 months prior to initiating mental health
telehealth services, and again at subsequent intervals as the Secretary
determines appropriate, as well as similar requirements for RHCs and
FQHCs; and continued coverage and payment of telehealth services
included on the Medicare Telehealth Services List as of March 15, 2020)
until December 31, 2024. Both the CAA, 2022 and CAA, 2023 have the same
operative effect on the scope of Medicare telehealth services; both the
CAA, 2022 and CAA, 2023 give the Secretary the authority to implement
the relevant telehealth provisions outside of notice and comment
rulemaking through program instruction or otherwise. We intend to
implement the provisions discussed above, as enacted by the CAA, 2023.
Similar to the goals of our telehealth policies addressed in last
year's final rule, for CY 2024, we again seek to retain payment
stability, reduce confusion and burden, and conform to all statutory
requirements without unnecessary restrictions on beneficiaries' access
to telehealth care. Our discussion here does not alter payment amounts
or billing rules that are in effect as of January 1, 2023, and those
policies will remain in effect through December 31, 2024. Instead, it
is our intent in this proposed rule to clarify that certain telehealth
flexibilities that were previously extended until 151 days after the
end of the PHE, by the CAA, 2022, have been extended until December 31,
2024, in accordance with the amendments made by provisions of the CAA,
2023.
(2) In-Person Requirements for Mental Health Telehealth
Section 4113(d)(1) of section FF, Title IV, Subtitle B of the CAA,
2023 amends 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
January 1, 2025. In addition, 4113(d)(2) of Section FF, Title IV,
Subtitle B of the CAA, 2023 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 propose to revise the regulatory text at Sec.
[thinsp]410.78(b)(3)(xiv) and (b)(4)(iv)(D) to recognize the delay of
the in-person requirements for mental health visits furnished by RHCs
and FQHCs through telecommunication technology under Medicare until
January 1, 2025, rather than until the 152nd day after the end of the
PHE, to conform with the CAA, 2023. See section III.B. of this proposed
rule for our proposal to implement similar changes for RHC and FQHC
mental health visits.
(3) Originating Site Requirements
Section 4113(a)(2) of the CAA, 2023 amends section
1834(m)(4)(C)(iii) of the Act to temporarily expand the telehealth
originating sites for any service on the Medicare Telehealth Services
List 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, beginning on the first day after the end of the PHE
for COVID-19 through December 31, 2024. We would not issue any program
[[Page 52299]]
instructions or proposals to limit or modify telehealth originating
sites for CY 2023 or CY 2024. The list of telehealth originating sites
remains as listed in our regulation at Sec. 410.78(b)(3).
(4) Telehealth Practitioners
Section 4113(b) of the CAA, 2023 amends section 1834(m)(4)(E) of
the Act to require that qualified occupational therapists, qualified
physical therapists, qualified speech-language pathologists, and
qualified audiologists continue to be included as telehealth
practitioners beginning on the first day after the end of the PHE for
COVID-19 through December 31, 2024. Therefore, the list of telehealth
practitioners remains as described in our CY 2023 final rule. We will
also recognize marriage and family therapists (MFT) and mental health
counselors (MHC) as telehealth practitioners, effective January 1,
2024, in accordance with amendments made by section 4121 of the CAA,
2023. That section of the CAA, 2023 amends section 1861(s)(2) of the
Act by adding a new subparagraph (II) that establishes a new benefit
category under Part B for marriage and family therapist services (as
defined in section 1861(lll)(1)) of the Act and mental health counselor
services (as defined in section 1861(lll)(3) of the Act). Further,
section 4121(a)(5) of the CAA, 2023 amended section 1842(b)(18)(C) of
the Act to add MFTs and MHCs to the list of practitioners to whom
Medicare payment may be made for their services on a reasonable charge
or fee schedule basis only on an assignment-related basis. Because the
definition of practitioners in section 1834(m)(4)(E) of the Act for
purposes of Medicare telehealth services includes the practitioners
described in section 1842(b)(18)(C) of the Act, this provision also has
the effect of adding MFTs and MHCs as practitioners who can furnish
telehealth services.
We are proposing to amend Sec. 410.78(b)(2) to add new paragraphs
(xi) and (xii) to specify that a marriage and family therapist as
described in proposed Sec. 410.53 and a mental health counselor as
described in proposed Sec. 410.54 are included as distant site
practitioners for purposes of furnishing telehealth services.
(5) Audio-Only Services
Section 4113(e) of Division FF, Title IV, Subtitle C of the CAA,
2023 amends section 1834(m)(9) of the Act to require that the Secretary
shall continue to provide for coverage and payment of telehealth
services via an audio-only communications system during the period
beginning on the first day after the end of such emergency period and
ending on December 31, 2024. This provision applies only to telehealth
services specified on the Medicare Telehealth Services List under
section 1834(m)(4)(F)(i) of the Act that are permitted to be furnished
via audio-only technology as of the date of enactment of the CAA, 2023
(that is, December 29, 2022).
e. Place of Service for Medicare Telehealth Services
When a physician or practitioner submits a claim for their
professional 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, which applies when the service is furnished in hospital
or skilled nursing facility (SNF) setting, and the non-facility rate,
which applies when the service is furnished in an office or other
setting. The PFS non-facility rate is the single geographically
adjusted fee schedule amount paid to a physician or other practitioner
for services furnished in their office or other non-facility outpatient
setting. The PFS facility rate is the single, geographically adjusted
amount paid to a physician or other practitioner when a service is
furnished in a hospital or SNF setting where Medicare is making a
separate payment for the services to the facility in addition to the
payment to the billing physician or practitioner for their professional
services. This separate payment to the facility (hospital or SNF),
often referred to as a ``facility fee,'' is made under other payment
systems and reflects the facility's costs associated with the service
(clinical staff, supplies, equipment, overhead) and is paid in addition
to what is paid to the professional under the PFS.
Prior to CY 2017, Medicare telehealth services were reported using
the GT modifier. In the CY 2017 PFS final rule, we finalized creation
of a new Place of Service (POS) code to identify services furnished as
Medicare telehealth services, POS ``02'' (81 FR 80199-80201). In the CY
2022 PFS final rule, we created a new POS code ``10'' to identify
Medicare telehealth services for which the patient's home is the
originating site (87 FR 70110 and 70111).
In response to the PHE for COVID-19, we adopted temporary policies
for POS codes and PFS payment rates applicable to Medicare telehealth
services. As discussed in the March 31, 2020 IFC, (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 COVID-19, 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 billed for Medicare telehealth services to report the
POS code that they would have 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 COVID-19, 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 is 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. This allowed
telehealth services to be paid at the PFS non-facility rate.
We further noted that we were 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 COVID-19. In the CY 2023 PFS
final rule (87 FR 69467), we finalized that we would continue to
maintain payment at the rate for a service had the service been
furnished in person, and that this would allow payments to continue to
be made at the non-facility based rate for Medicare telehealth services
through the latter of the end of CY 2023 or the end of the calendar
year in which the PHE ends.
In the CY 2023 PFS final rule (87 FR 69467), we finalized that,
following the end of the end of the calendar year in which the PHE,
practitioners will no longer bill claims with Modifier `95' along with
the POS code that would have applied had the service been furnished in
person, and telehealth claims will instead be billed with the POS
indicators:
POS ``02''--is redefined 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
[[Page 52300]]
when receiving health services or health related services through
telecommunication technology.); and
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 recognize that, throughout the PHE for COVID-19, behavioral
health services that otherwise would have been furnished in-person have
been furnished via telehealth in the patient's home. With few
exceptions, prior to the PHE for COVID-19, originating sites were
limited to sites such as physician's offices and hospitals. Now that
behavioral health telehealth services may be furnished in a patient's
home, which would then serve as an originating site, we believe these
behavioral health services are most accurately valued the way they
would have been valued without the use of telecommunications
technology, namely in an office setting. There was an increase in
utilization of these mental health services during the PHE that has
persisted throughout and after expiration of the PHE for COVID-19. It
appears that practice patterns for many mental health practitioners
have evolved, and they are now seeing patients in office settings, as
well as via telehealth. As a result, these practitioners continue to
maintain their office presence even as a significant proportion of
their practice's utilization may be comprised of telehealth visits. As
such, we believe their practice expenses (PEs) are more accurately
reflected by the non-facility rate.
Therefore, we are proposing that, beginning in CY 2024, claims
billed with POS 10 (Telehealth Provided in Patient's Home) be paid at
the non-facility PFS rate. When considering certain practice situations
(such as in behavioral health settings, where practitioners have been
seeing greater numbers of patients via telehealth), practitioners will
typically need to maintain both an in-person practice setting and a
robust telehealth setting. We expect that these practitioners will be
functionally maintaining all of their PEs, while furnishing services
via telehealth. When valuing services, we believe that there are few
differences in PE when behavioral health services are furnished to a
patient at home via telehealth as opposed to services furnished in-
person (that is, behavioral health settings require few supplies
relative to other healthcare services). Claims billed with POS 02
(Telehealth Provided Other than in Patient's Home) will continue to be
paid at the PFS facility rate beginning on January 1, 2024, as we
believe those services will be furnished in originating sites that were
typical prior to the PHE for COVID-19, and we continue to believe that,
as discussed in the CY 2017 PFS final rule (81 FR 80199 through 80201),
the facility rate more accurately reflects the PE of these telehealth
services; this applies to non-home originating sites such as
physician's offices and hospitals. In this way, we believe we would be
protecting access to mental health and other telehealth services by
aligning with telehealth-related flexibilities that were extended via
the CAA, 2023, as we will be more accurately recognizing the resource
costs of behavioral health providers, given shifting practice models.
f. Frequency Limitations on Medicare Telehealth Subsequent Care
Services in Inpatient and Nursing Facility Settings, and Critical Care
Consultations
When adding some services to the Medicare Telehealth Services List
in the past, we have included certain restrictions on how frequently a
service may be furnished via Medicare telehealth. These limitations
include a limit of once every 3 days for subsequent inpatient visits,
added in in the CY 2011 PFS final rule (75 FR 73317 through 73318), and
once every 14 days for subsequent nursing facility (NF) visits, added
in the CY 2016 final rule (80 FR 71062) furnished via Medicare
telehealth and a limit of once per day for critical care consultation
services; in establishing these limits, we cited concerns regarding the
potential acuity of these patients. End-stage renal disease (ESRD)-
related clinical assessments may be furnished via telehealth, subject
to the frequency limitations in section 1881(b)(3)(B) of the Act, which
provides that patients must receive a face-to-face visit, without the
use of telehealth, at least monthly in the case of the initial 3 months
of home dialysis and at least once every 3 consecutive months after the
initial 3 months.
In the March 31, 2020 COVID-19 IFC (85 FR 19241), we stated that as
it was our assessment that there was a patient population who would
otherwise not have had access to clinically appropriate in-person
treatment, and we did not believe these frequency limitations were
appropriate or necessary under the circumstances of the PHE. Therefore,
we removed the frequency restrictions for certain subsequent inpatient
visits, subsequent NF visits, and for critical care consultations
furnished via Medicare telehealth for the duration the PHE for COVID-
19. The frequency limitations resumed effect beginning on May 12, 2023,
(upon expiration of the PHE), in accordance with the March 31, 2020
IFC. However, we stated that, pursuant to waiver authority added under
section 1135(b)(8) of the Act by the Coronavirus Preparedness and
Response Supplemental Appropriations Act, 2020,\3\ we were exercising
enforcement discretion and will not consider these frequency
limitations through December 31, 2023; and that we anticipated
considering our policy further through our rulemaking process. As
discussed below, we are proposing to once again remove these telehealth
frequency limitations beginning CY 2024. We are proposing to remove the
telehealth frequency limitations for the following codes:
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1. Subsequent Inpatient Visit 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.)
2. Subsequent Nursing Facility Visit CPT Codes:
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
[[Page 52301]]
medical decision making. When using total time on the date of the
encounter for code selection, 10 minutes must be met or exceeded.);
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.);
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
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.)
3. Critical Care Consultation Services: HCPCS Codes:
G0508 (Telehealth consultation, critical care, initial,
physicians typically spend 60 minutes communicating with the patient
and providers via telehealth.); and
G0509 (Telehealth consultation, critical care, subsequent,
physicians typically spend 50 minutes communicating with the patient
and providers via telehealth.)
We are proposing to remove the frequency limitations for these
codes for the duration of CY 2024, which will align with other
telehealth-related flexibilities extended by the CAA, 2023. CMS is
broadly assessing our telehealth regulations, in light of the way
practice patterns may have changed in the roughly 3 years of the PHE
for COVID-19 and, while we engage in this assessment, we believe it is
reasonable to pause certain pre-pandemic restrictions, such as these
frequency limitations, to allow us to gather more information. We are
seeking information from interested parties on how practitioners have
been ensuring that Medicare beneficiaries receive subsequent inpatient
and nursing facility visits, as well as critical care consultation
services since the expiration of the PHE.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Direct Supervision via Use of Two-Way Audio/Video Communications
Technology
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 most services furnished by auxiliary personnel
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), direct
supervision by a physician, PA, NP, or CNS is required (see also Sec.
410.27(a)(1)(iv)(B)(1) for hospital outpatient services). 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 two-way, 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 Medicare telehealth services by
clinical staff of physicians and other practitioners' incident to their
own professional services. This is especially relevant for services
such as physical therapy, occupational therapy, and speech language
pathology services, since those practitioners were previously only able
to bill Medicare for telehealth services under Medicare telehealth
waivers that were effective during the PHE for COVID-19 (based on the
emergency waiver authority established in section 1135(b)(8) of the
Act), until the CAA, 2023 extended the time period during which these
practitioners could bill for Medicare telehealth services through
December 31, 2024. We noted that sections 1834(m)(4)(D) and (E) of the
Act specify the types of clinicians who may furnish and bill for
Medicare telehealth services. After December 31, 2024, the types of
clinicians who may furnish and bill for Medicare telehealth services
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 note
that this will include mental health counselors (MHCs) and marriage and
family therapists (MFTs) beginning January 1, 2024.
We noted in the CY 2021 PFS final rule (85 FR 84539) that, to the
extent our policy allows direct supervision through virtual presence
using audio/video real-time communications technology, the requirement
could be met by the supervising physician (or other practitioner) being
immediately available to engage via audio/video technology (excluding
audio-only), and would not require real-time presence or observation of
the service via interactive audio and video technology throughout the
performance of the procedure; this was the case during the PHE, and
will continue to be the case following the PHE. Under current policy as
described in the CY 2021 final rule (85 FR 84539 and 84540, after
December 31, 2023, 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 allowing immediate
availability for direct supervision through virtual presence, which
facilitates the provision of telehealth services by clinical staff of
physicians and other practitioners incident to their professional
services, will no longer apply after CY 2023.
We are concerned about an abrupt transition to our pre-PHE policy
that defines direct supervision under Sec. 410.32(b)(3)(ii) to require
the physical presence of the supervising practitioner beginning after
December 31, 2023, given that practitioners have established new
patterns of practice during the PHE for COVID-19. In the absence of
evidence that patient safety is
[[Page 52302]]
compromised by virtual direct supervision, we believe that an immediate
reversion to the pre-PHE definition of direct supervision would
prohibit virtual direct supervision, which may present a barrier to
access to many services, such as those furnished incident-to a
physician's service. We believe physicians and practitioners will need
time to reorganize their practice patterns established during the PHE
to reimplement the pre-PHE approach to direct supervision without the
use of audio/video technology. Recognizing these concerns, we are
proposing continue to define direct supervision to permit the presence
and ``immediate availability'' of the supervising practitioner through
real-time audio and visual interactive telecommunications through
December 31, 2024. We believe that extending this definition of direct
supervision through December 31, 2024, would align the timeframe of
this policy with many of the previously discussed PHE-related
telehealth policies that were extended under provisions of the CAA,
2023. We are proposing to revise the regulatory text at Sec.
410.32(b)(3)(ii) to state that, through December 31, 2024, the presence
of the physician (or other practitioner) includes virtual presence
through audio/video real-time communications technology (excluding
audio-only).
We believe this additional time will allow us further opportunity
to collect information through the coming year as we consider an
appropriate more permanent approach to direct supervision policy
following the PHE for COVID-19. We are soliciting comment on whether we
should consider extending the definition of direct supervision to
permit virtual presence beyond December 31, 2024. Specifically, we are
interested in input from interested parties on potential patient safety
or quality concerns when direct supervision occurs virtually; for
instance, if virtual direct supervision of certain types of services is
more or less likely to present patient safety concerns, or if this
flexibility would be more appropriate for certain types of services, or
when certain types of auxiliary personnel are performing the supervised
service. We are also interested in potential program integrity concerns
such as overutilization or fraud and abuse that interested parties may
have in regard to this policy.
One potential approach to direct supervision which we could
consider for future rulemaking, could be to extend or permanently
establish this virtual presence flexibility for services that are
valued under the PFS based on the presumption that they are nearly
always performed in entirety by auxiliary personnel. Such services
would include any service wholly furnished incident to a physician or
practitioner's professional service, as well as the Level I office or
other outpatient evaluation and management visit for established
patients and the Level I Emergency Department visit. Allowing virtual
presence for direct supervision of these services may balance patient
safety concerns with the interest of supporting access and preserving
workforce capacity for medical professionals while considering
potential quality and program integrity concerns. We are soliciting
comment on this potential approach for CY 2025, as well as any other
approaches by which direct supervision could occur virtually that would
both protect patient access and safety, as well as quality of care and
program integrity concerns following CY 2024.
(1) Supervision of Residents in Teaching Settings
In the CY 2021 PFS final rule (85 FR 84577 through 84584), we
established a policy that, after the end of the PHE for COVID-19,
teaching physicians may meet the requirements to be present for the key
or critical portions of services when furnished involving residents
through audio/video real-time communications technology (virtual
presence), but only for services furnished in residency training sites
that are located outside of an Office of Management and Budget (OMB)-
defined metropolitan statistical area (MSA). We made this location
distinction consistent with our longstanding interest to increase
beneficiary access to Medicare-covered services in rural areas and
noted the ability to expand training opportunities for residents in
rural settings. For all other locations, we expressed concerns that
continuing to permit teaching physicians to bill for services furnished
involving residents when they are virtually present, outside the
conditions of the PHE for COVID-19, may not allow the teaching
physician to have personal oversight and involvement over the
management of the portion of the case for which the payment is sought,
in accordance with section 1842(b)(7)(A)(i)(I) of the Act. In addition,
we stated concerns about patient populations that may require a
teaching physician's experience and skill to recognize specialized
needs or testing, and whether it is possible for the teaching physician
to meet these clinical needs while having a virtual presence for the
key portion of the service. For a more detailed description of our
specific concerns, we refer readers to the CY 2021 PFS final rule (85
FR 84577 through 84584). At the end of the PHE for COVID-19, and as
finalized in the CY 2021 PFS final rule, we intended for the teaching
physician to have a physical presence during the key portion of the
service personally provided by residents in order to be paid for the
service under the PFS, in locations that were within a MSA. This policy
applies to all services, regardless of whether the patient was co-
located with the resident or only present virtually (for example, the
service was furnished as a 3-way telehealth visit, with the teaching
physician, resident, and patient in different locations). However,
interested parties have expressed concerns regarding the requirement
that the teaching physician have a physical presence with the resident
when a service is furnished virtually within a MSA (that is, as a
Medicare telehealth service). Some interested parties have stated that
during the PHE for COVID-19, when residents provided telehealth
services and the teaching physician was virtually present, the same
safe and high-quality oversight was provided as when the teaching
physician and resident were physically co-located. In addition, these
interested parties have stated that during telehealth visits, the
teaching physician was virtually present during the key and critical
portions of the telehealth service, available immediately in real-time,
and had access to the electronic health record. As stated in section
II.D.2.a. of this proposed rule, we are concerned that an abrupt
transition to our pre-PHE policy may present a barrier to access to
many services, and we understand that practitioners have gained
clinical experience during the PHE for COVID-19, and could identify
circumstances for which the teaching physician can routinely render
sufficient personal and identifiable services to the patient, with a
virtual presence during the key portion of the telehealth service.
Given these considerations and in alignment with the telehealth
policies that were extended under the provisions of the CAA, 2023, we
are proposing to allow the teaching physician to have a virtual
presence in all teaching settings, only in clinical instances when the
service is furnished virtually (for example, a 3-way telehealth visit,
with all parties in separate locations). This would permit teaching
physicians to have a virtual presence during the key portion of the
Medicare telehealth service for which payment is sought, through audio/
video real-time communications technology,
[[Page 52303]]
for all residency training locations through December 31, 2024. The
virtual presence policy would continue to require real-time observation
(not mere availability) by the teaching physician, and excludes audio-
only technology. The documentation in the medical record must continue
to demonstrate whether the teaching physician was physically present or
present through audio/video real-time communications technology at the
time of the telehealth service, this includes documenting the specific
portion of the service for which the teaching physician was present
through audio/video real-time communications technology. This policy
does not preclude teaching physicians from providing a greater degree
of involvement in services furnished with residents, and teaching
physicians should still use discretion to determine whether it is
appropriate to have a virtual presence rather than in person, depending
on the services being furnished and the experience of the particular
residents involved.
We announced that we are exercising enforcement discretion to allow
teaching physicians in all residency training sites, to be present
through audio/video real-time communications technology, for purposes
of billing under the PFS for services they furnish involving residents.
We are exercising this enforcement discretion through December 31,
2023, as we consider our virtual presence policies for services
involving teaching physicians and residents further through our
rulemaking process for CY 2024. For more background we refer readers to
https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
We seek comment and information to help us consider how telehealth
services can be furnished in all residency training locations beyond
December 31, 2024, to include what other clinical treatment situations
are appropriate to permit the virtual presence of the teaching
physician. Specifically, we anticipate considering various types of
teaching physician services, when it is appropriate for the teaching
physician and resident to be co-located, and how virtual presence could
support patient safety for all patients, particularly at-risk patients.
We also invite commenters to provide data or other information on how
the teaching physician's virtual presence could continue to support
patient safety, while meeting the clinical needs for all patients, and
ensure burden reduction without creating risks to patient care or
increasing opportunities for fraud.
b. Clarifications for Remote Monitoring Services
(1) Background and Overview
In recent years, we have established payment for two code families
that describe certain remote monitoring services: remote physiologic
monitoring (RPM) and remote therapy monitoring (RTM).
Remote Physiologic Monitoring
99453 (Remote monitoring of physiologic parameter(s) (eg,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; set-up and patient education on use of equipment);
99454 (Remote monitoring of physiologic parameter(s) (eg,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; device(s) supply with daily recording(s) or programmed
alert(s) transmission, each 30 days);
99457 (Remote physiologic monitoring treatment management
services, clinical staff/physician/other qualified health care
professional time in a calendar month requiring interactive
communication with the patient/caregiver during the month; first 20
minutes); and
99458 (Remote physiologic monitoring treatment management
services, clinical staff/physician/other qualified health care
professional time in a calendar month requiring interactive
communication with the patient/caregiver during the month; each
additional 20 minutes (List separately in addition to code for primary
procedure)).
Remote Therapeutic Monitoring
98975 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); initial set-up and patient education on
use of equipment);
98976 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
respiratory system, each 30 days);
98977 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days);
98978 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days);
98980 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; first 20 minutes);
and
98981 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; each additional 20
minutes (List separately in addition to code for primary procedure))
In our CY 2018 PFS final rule, we summarized feedback solicited
from a comment period aimed at informing new payment policies that
would allow for separate payment for remote monitoring services (82 FR
53014). In our CY 2019 PFS final rule (83 FR 59574 to 59576), we
established valuations and payment policy for the RPM code family. In
our CY 2020 PFS final rule (84 FR 62697-8), we explained that the RPM
code family describes chronic care RPM services that involve the
collection, analysis, and interpretation of digitally collected
physiologic data, followed by the development of a treatment plan and
the managing of a patient under the treatment plan. (84 FR 62697). In
our CY 2020 PFS final rule, we also discussed that remote monitoring
codes would be designated as care management services, which means our
rules for general supervision would apply (84 FR 62698). In our CY 2023
PFS final rule, in response to comments, we clarified that RTM or RPM
services could be billed concurrently with Chronic Care Management
(CCM), Transitional Care Management TCM, Principal Care Management
(PCM), Chronic Pain Management (CPM), or Behavioral Health Integration
(BHI) (86 FR 69528-69539).
We have received many questions from interested parties about
billing scenarios and requests for clarifications on the appropriate
use of these codes in general. We believe it is important to share with
all interested parties a restatement/clarification of certain policies.
We refer readers to the CY 2021 PFS final rule (85 FR 84542 to 84546)
for further discussion and explanation of the basis for interim
policies that expired on the last day of the PHE for COVID-19.
[[Page 52304]]
(2) New vs. Established Patient Requirements
In the CY 2021 PFS final rule (85 FR 84542-6), we established that,
when the PHE for COVID-19 ends, we again will require that RPM services
be furnished only to an established patient. Patients who received
initial remote monitoring services during PHE are considered
established patients for purposes of the new patient requirements that
are effective after the last day of the PHE for COVID-19.
(3) Data Collection Requirements
We have received various comments and inquiries about our temporary
exception to minimum data collection for remote monitoring. As
discussed in our CY 2021 final rule, we are not extending beyond the
end of the PHE the interim policy to permit billing for remote
monitoring codes, which require data collection for at least 16 days in
a 30-day period, when less than 16 of days data are collected within a
given 30-day period. (85 FR 84542 through 84546). As of the end of the
PHE, the 16-day monitoring requirement was reinstated. Monitoring must
occur over at least 16 days of a 30-day period. We are proposing to
clarify that the data collection minimums apply to existing RPM and RTM
code families for CY 2024.
The following remote monitoring codes currently depend on
collection of no fewer than 16 days of data in a 30-day period, as
defined and specified in the code descriptions:
98976 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
respiratory system, each 30 days);
98977 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days);
98978 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days);
98980 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; first 20 minutes);
and
98981 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; each additional 20
minutes (List separately in addition to code for primary procedure))
We remind readers that our discussion in the CY 2021 PFS final rule
addresses the interim policy on data collection minimums, and provides
notice and the rationale for the data collection policy that is in
effect now that the PHE for COVID-19 has ended. Remotely monitored
monthly services should be reported only once during a 30-day period--
and only when reasonable and necessary. As a clarification for either
RPM or RTM, only one practitioner can bill CPT codes 99453 and 99454,
or CPT codes 98976, 98977, 98980, and 98981, during a 30-day period,
and only when at least 16 days of data have been collected on at least
one medical device as defined in section 201(h) of the FFDCA.
We reiterate our analysis described in the CY 2021 PFS final rule,
in which we explained that CPT code descriptor language suggests that,
even when multiple medical devices are provided to a patient, the
services associated with all the medical devices can be billed only
once per patient per 30-day period and only when at least 16 days of
data have been collected (85 FR 84545). We refer readers to our CY 2021
PFS final rule (85 FR 84545) for additional background.
(4) Use of RPM, RTM, in Conjunction With Other Services
Practitioners may bill RPM or RTM, but not both RPM and RTM,
concurrently with the following care management services: CCM/TCM/BHI,
PCM, and CPM. These various codes, which describe other care management
services, may be billed with RPM or RTM, for the same patient, if the
time or effort is not counted twice. As specified in the CY 2023 PFS
final rule, if all requirements to report each service are met, without
time or effort being counted more than once, RPM or RTM (not both RPM
and RTM) may be billed in conjunction with any one of CCM, TCM, BHI,
PCM, or CPM codes. According to the 2023 CPT Codebook (pg. 849), CPT
code 98980 (RTM treatment management) cannot be reported in conjunction
with CPT codes 99457/99458 (RPM treatment management). Our intention is
to allow the maximum flexibility for a given practitioner to select the
appropriate mix of care management services, without creating
significant issues of possible fraud, waste, and abuse associated with
overbilling of these services. We continue to gain experience with each
family of remote monitoring codes, and request feedback from commenters
that would provide additional context that could inform us as we
continue to develop and clarify our payment policies for these
services.
We propose to clarify that RPM and RTM may not be billed together,
so that no time is counted twice by billing for concurrent RPM and RTM
services. In instances where the same patient receives RPM and RTM
services, there may be multiple devices used for monitoring, and in
these cases, we will to apply our existing rules, which we finalized
when establishing the RPM code family, meaning that the services
associated with all the medical devices can be billed by only one
practitioner, only once per patient, per 30-day period, and only when
at least 16 days of data have been collected; and that the services
must be reasonable and necessary (85 FR 84544 through 84545).
(5) Other Clarifications for Appropriate Billing
We have received inquiries from interested parties during public
forums regarding use of remote monitoring during global periods for
surgery. We are proposing to clarify that, in circumstances where an
individual beneficiary may receive a procedure or surgery, and related
services, which are covered under a payment for a global period, RPM
services or RTM services (but not both RPM and RTM services
concurrently) may be furnished separately to the beneficiary, and the
practitioner would receive payment for the RTM or RPM services,
separate from the global service payment, so long as other requirements
for the global service and any other service during the global period
are met. For an individual beneficiary who is currently receiving
services during a global period, a practitioner may furnish RPM or RTM
services (but not both RPM or RTM services) to the individual
beneficiary, and the practitioner will receive separate payment, so
long as the remote monitoring services are unrelated to the diagnosis
for which the global procedure is performed, and as long as the purpose
of the remote monitoring addresses an episode of care that is separate
and distinct from the episode of care for the global procedure--meaning
that the remote monitoring services address an underlying condition
that is not linked to the global procedure or service.
[[Page 52305]]
We are soliciting comment on the above proposals and clarifications
and request general feedback from the public that may be useful in
further development of our payment policies for remote monitoring
services that are separately payable under the current PFS.
c. Telephone Evaluation and Management Services
In the March 31st COVID-19 IFC (85 FR 19264 through 19265), we
finalized separate payment for CPT codes 99441 through 99443 and 98966
through 98968, which describe E/M and assessment and management
services furnished via telephone. CPT codes 99441 through 99443 are
telehealth services and will remain actively priced through 2024. CPT
codes 98966-98968, however, describe telephone assessment and
management services provided by a qualified non-physician healthcare
professional, and they are not telehealth services. We are proposing to
continue to assign an active payment status to CPT codes 98966 through
98968 for CY 2024 to align with telehealth-related flexibilities that
were extended via the CAA, 2023, specifically section 4113(e), which
permits the provision of telehealth services through audio-only
telecommunications through the end of 2024.
3. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002 at $20.00, 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 2024 is 4.5 percent and is based on the
expected historical percentage increase of the 2017-based MEI. For the
final rule, we propose to update the MEI increase for CY 2024 based on
historical data through second quarter of 2023.
Therefore, for CY 2024, the proposed payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is $29.92. Table 10
shows the Medicare telehealth originating site facility fee and the
corresponding MEI percentage increase for each applicable time period.
[GRAPHIC] [TIFF OMITTED] TP07AU23.011
[[Page 52306]]
4. Payment for Outpatient Therapy Services, Diabetes Self-Management
Training, and Medical Nutrition Therapy When Furnished by Institutional
Staff to Beneficiaries in Their Homes Through Communication Technology
a. Background on Outpatient Therapy Services, Diabetes Self-Management
Training and Medical Nutrition Therapy
Section 1861(p) of the Act establishes the benefit category for
outpatient PT, SLP and OT services, (expressly for PT services and,
through section 1861(ll)(2) of the Act, for outpatient SLP services
and, through section 1861(g) of the Act, for outpatient OT services).
Section 1861(p) of the Act defines outpatient therapy services in the
three disciplines as those furnished by a provider of services, a
clinic, rehabilitation agency, or a public health agency, or by others
under an arrangement with, and under the supervision of, such provider,
clinic, rehabilitation agency, or public health agency to an individual
as an outpatient; and those furnished by a therapist not under
arrangements with a provider of services, clinic, rehabilitation
agency, or a public health agency. As such, section 1861(p) of the Act
defines outpatient therapy services very broadly to include those
furnished by providers and other institutional settings, as well as
those furnished in office settings. Section 1834(k)(3) of the Act
requires payment for outpatient therapy services to be made based on
the PFS (via section 1848 of the Act), for all institutional providers
listed at sections 1833(a)(8) and (9) of the Act. These providers
include clinics, rehabilitation agencies, public health agencies,
comprehensive outpatient rehabilitation agencies (CORFs), SNFs, home
health agencies (HHAs) (to individuals who are not homebound),
hospitals to outpatients or hospital inpatients who are entitled to
benefits under part A but have exhausted benefits for inpatient
hospital services during a spell of illness or is not so entitled to
benefits under part A), and all other CORF services.
Section 1861(qq) of the Act defines Diabetes Self-Management
Training (DSMT) services and authorizes CMS to regulate Medicare DSMT
outpatient services. A ``certified provider'' of DSMT is further
defined in section 1861(qq)(2)(A) of the Act as a physician or other
individual or entity designated by the Secretary who meets certain
quality requirements described in section 1861(qq)(2)(B) of the Act. In
CY 2000, we finalized a standalone rule titled ``Medicare Program;
Expanded Coverage for Outpatient Diabetes Self-Management Training and
Diabetes Outcome Measurements.'' In that rule, we finalized that
payment for outpatient DSMT would be made under the PFS (65 FR 83132).
We further established that, in the case of payments made to other
approved entities, such as hospital outpatient departments, ESRD
facilities, and durable medical equipment suppliers, the payment would
be equal to the amounts established under the PFS and made under the
appropriate payment systems (65 FR 83142).
Section 1861(s)(2)(V) of the Act authorizes Medicare Part B
coverage of medical nutrition therapy services (MNT) for certain
beneficiaries who have diabetes or a renal disease. In the CY 2000 PFS
final rule, we established that payment for MNT services furnished in
the institutional setting, including hospital outpatient departments
(HOPDs), would be made under the PFS, not under the hospital Outpatient
Prospective Payment System (OPPS) (66 FR 55279).
During the PHE for COVID-19, outpatient therapy services, DSMT, and
MNT could be furnished via a telecommunications system to beneficiaries
in their homes, and bills for these services were submitted and paid
either separately or as part of a bundled payment, when either
personally provided by the billing practitioner or provided by
institutional staff and billed for by institutions, such as HOPDs,
SNFs, and HHAs. For professionals, CMS used waiver authority to expand
the range of practitioners that can serve as distant site practitioners
for Medicare telehealth services as described in section 1834(m)(4)(E)
of the Act and Sec. 410.78 (b)(2), as well as to waive the originating
site requirements for Medicare telehealth services described in section
1834(m)(4)(C) of the Act. This allowed for outpatient therapy services
to be furnished and billed by therapists in private practice, as well
as for outpatient therapy services, DSMT, and MNT to be furnished via
Medicare telehealth to beneficiaries in urban, as well as rural, areas,
including to beneficiaries located in their homes.
When therapists (PTs, OTs and SLPs) were added as distant site
telehealth practitioners using waiver authority during the PHE for
COVID-19, CMS generally took the position for services furnished in
HOPDs that waiver authority was needed to allow hospitals to bill for
services furnished by hospital staff through communication technology
to beneficiaries in their homes. CMS implemented the Hospitals Without
Walls (HWW) policy that relied on waiver authority, which allowed
hospitals to reclassify patients' homes as part of the hospital. HWW
allowed hospitals to bill two different kinds of fees for services
furnished remotely to patients in their homes: (1) hospital facility
payment in association with professional services billed under the PFS;
and (2) single payment for a limited number of practitioner services,
when statute or other applicable rules only allow the hospital to bill
for services personally provided by their staff. These services are
either billed by hospitals or by professionals, there would not be
separate facility and professional billing. This latter category
includes outpatient therapy services, DSMT, and MNT. However, while
maintaining that waiver authority was needed to allow hospital billing
for these services, CMS also issued guidance instructing HOPDs to bill
using modifiers consistent with those used for Medicare telehealth
services. For further background, we refer readers to https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. In the same
referenced document, CMS also issued specific guidance for other
institutional providers of therapy services to use modifier 95
(indicating a Medicare telehealth service), along with the specific
bill types for outpatient therapy services furnished by their staff.
The CAA, 2023 extended many of the flexibilities that were
available for Medicare telehealth services during the PHE for COVID-19
under emergency waiver authorities, including adding physical and
occupational therapists and speech-language pathologists as distant
site practitioners through the end of CY 2024. In developing post-PHE
guidance, CMS initially took the position that institutions billing for
services furnished remotely by their employed practitioners (where the
practitioners do not bill for their own services), would end with the
PHE for COVID-19 along with the HWW waivers. However, after reviewing
input from interested parties, as well as relevant guidance, including
applicable billing instructions, we are considering whether certain
institutions, as the furnishing providers, can bill for certain
remotely furnished services personally performed by employed
practitioners.
b. Proposal To Extend Billing Flexibilities for Certain Remotely
Furnished Services Through the End of CY 2024 and Comment Solicitation
While we consider how we might address this ambiguity in future
rulemaking, in the interests of maintaining access to outpatient
therapy, DSMT, and MNT services furnished remotely by institutional
staff
[[Page 52307]]
to beneficiaries in their homes consistent with the accessibility of
these services when furnished by professionals via Medicare telehealth,
we are proposing to continue to allow institutional providers to bill
for these services when furnished remotely in the same manner they have
during the PHE for COVID-19 through the end of CY 2024. We are seeking
comment on current practice for these services when billed, including
how and to what degree they continue to be provided remotely to
beneficiaries in their homes. We are seeking comment as to whether
these services may fall within the scope of Medicare telehealth at
section 1834(m) of the Act or if there are other relevant authorities
CMS might consider in future rulemaking.
For DSMT specifically, the clinical staff personally delivering the
service may be a type of practitioner authorized to furnish Medicare
telehealth services under section 1834(m) of the Act; but we also
understand that DSMT may be provided by other types of staff.
Accordingly, we noted in sub-regulatory guidance that we are exercising
enforcement discretion in reviewing the telehealth eligibility status
of the practitioner personally providing any part of a remotely
furnished DSMT service, so long as the persons were otherwise qualified
to provide the service. For more background we refer readers to https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
As we review our telehealth policies following the end of the PHE
for COVID-19, and consider care delivery and beneficiary access
concerns raised by practitioners and beneficiary advocates, we are
broadly considering billing and payment for telehealth services in
institutional settings, including when these services are furnished by
practitioners who have reassigned their rights to bill under and
receive payment from the Medicare program (billing rights) to an
institution. We acknowledge that one such setting where this billing
arrangement exists includes Critical Access Hospitals (CAHs), where a
practitioner has reassigned their billing rights to the CAH, and CMS
makes payment for the practitioner's services under an optional payment
method, referred to as CAH method II (Pub. 100-04, Chapter 4, Section
250.2). We note that in situations when a practitioner is furnishing a
telehealth service and has reassigned their billing rights to a CAH
under Method II, CMS makes payment for the telehealth service at the
same rate generally paid for other in-person services (100 percent of
the PFS payment amount) rather than the payment amount established
under the optional method as discussed in Pub. 100-04, Chapter 4,
Section 250.2. We are interested in and are soliciting comment on how
telehealth services furnished under CAH method II arrangements are
furnished, and whether they would be most accurately characterized in
the context of section 1834(m) of the Act or services of the CAH under
Method II.
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 accepted public comment about those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we paid for services based upon the
interim final values established in the final rule. In the final rule
with comment period for the subsequent year, we considered and
responded to public comments received on the interim final values, and
typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (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, 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
[[Page 52308]]
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. When they exist we also include a summary of
interested party reactions to our approach. We note that many
commenters and interested parties have expressed concerns over the
years with our ongoing adjustment of work RVUs based on changes in the
best information we had regarding the time resources involved in
furnishing individual services. We have been particularly concerned
with the RUC's and various specialty societies' objections to our
approach given the significance of their recommendations to our process
for valuing services and since much of the information we used to make
the adjustments is derived from their survey process. We note that we
are obligated under the statute to consider both time and intensity in
establishing work RVUs for PFS services. As explained in the CY 2016
PFS final rule with comment period (80 FR 70933), we recognize that
adjusting work RVUs for changes in time is not always a straightforward
process, so we have applied various methodologies to identify several
potential work values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have started by looking at the change
in the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
[[Page 52309]]
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 and deemed our
actions in adjusting the recommended work RVUs as inappropriate; other
interested parties have also expressed general concerns with CMS
refinements to RUC-recommended values in general. In the CY 2017 PFS
final rule (81 FR 80272 through 80277), we responded in detail to
several comments that we received regarding this issue. In the CY 2017
PFS proposed rule (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. 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.
In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified that terms ``reference services'', ``key reference
services'', and ``crosswalks'' as described by the commenters are part
of the RUC's process for code valuation. These are not terms that we
created, and we do not agree that we necessarily must employ them in
the identical fashion for the purposes of discussing our valuation of
individual services that come up for review. However, in the interest
of minimizing confusion and providing clear language to facilitate
feedback from interested parties, we stated that we would seek to limit
the use of the term, ``crosswalk,'' to those cases where we are making
a comparison to a CPT code with the identical work RVU. (83 FR 59515)
We note that we also occasionally make use of a ``bracket'' for code
valuation. A ``bracket'' refers to when a work RVU falls between the
values of two CPT codes, one at a higher work RVU and one at a lower
work RVU.
We look forward to continuing to engage with interested parties and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and we will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 13 contains a list of codes and
descriptors for which are proposing work RVUs for CY 2024; this
includes all codes for which we received RUC recommendations by
February 10, 2023. The proposed work RVUs, work time and other payment
information for all CY 2024 payable codes are available on the CMS
website under downloads for the CY 2024 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
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 13 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 Practice Expense Relative Value Units (PE RVUs), we address certain
refinements that will be common across codes. Refinements to particular
codes are addressed in the portions of that section that are dedicated
to particular codes. We note that for each refinement, we indicate the
impact on direct costs for that service. We note that, on average, in
any case where the impact on the direct cost for a particular
refinement is $0.35 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.
[[Page 52310]]
In this proposed rule, we also note that many of the refinements listed
in Table 12 of the proposed rule resulted in changes under the $0.35
threshold and were unlikely to result in a change to the RVUs.
We note that the direct PE inputs for CY 2024 are displayed in the
CY 2024 direct PE input files, available on the CMS website under the
downloads for the CY 2024 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 CY 2024 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time 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 Practice Expense Relative Value Units (PE RVUs), for
more information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. 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 2024 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
[[Page 52311]]
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 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
2024 are available on the CMS website under downloads for the CY 2024
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 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 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 2024, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined
previously in this proposed rule for purposes of this cap. Beginning
for CY 2024, we are proposing to include the following services on the
list of codes to which the OPPS cap applies: CPT codes 76883
(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), 7X000
(Ultrasound, intraoperative thoracic aorta (e.g., epiaortic),
diagnostic), 7X001 (Intraoperative epicardial cardiac (eg,
echocardiography) ultrasound for congenital heart disease, diagnostic;
including placement and manipulation of transducer), 7X002
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound
for congenital heart disease, diagnostic; placement, manipulation of
transducer, and image acquisition only), 7X003 (Intraoperative
epicardial cardiac (e.g.,)echocardiography) ultrasound for congenital
heart disease, diagnostic; interpretation and report only), 9X000
(Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; anomalous
or persistent superior vena cava when it exists as a second
contralateral superior vena cava, with native drainage to heart (List
separately in addition to code for primary procedure)), 9X002
(Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; azygos/
hemi-azygos venous system (List separately in addition to code for
primary procedure)), 9X003 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; coronary sinus (List separately in addition to code for
primary procedure)), 9X004 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; venovenous collaterals originating at or above the
heart (e.g., from innominate vein) (List separately in addition to code
for primary procedure)), and 9X005 (Venography for congenital heart
defect(s), including catheter placement, and radiological supervision
and interpretation; venovenous collaterals originating below the heart
(e.g., from the inferior vena cava) (List separately in addition
[[Page 52312]]
to code for primary procedure)). We believe that these codes meet the
definition of imaging services under section 1848(b)(4)(B of the Act,
and thus, should be subject to the OPPS cap. We note that we previously
proposed to add CPT code 76883 to the list of codes to which the OPPS
cap applies in the CY 2023 PFS proposed rule, but we did not finalize
its addition, noting that it was not within the statutory scope of
services to which the OPPS cap applies, as it could not be split into
professional and technical components at that time (87 FR 69475). Since
that time, we have reinstated CPT code 76883's PC/TC split based on
feedback from billing practitioners, therefore we are proposing to add
it to the OPPS cap list for CY 2024.
4. Valuation of Specific Codes for CY 2024
(1) Dorsal Sacroiliac Joint Arthrodesis (CPT Code 2X000)
In September 2022, CPT deleted category III CPT code 0775T
(Arthrodesis, sacroiliac joint, percutaneous, with image guidance,
includes placement of intra-articular implant(s) (eg, bone
allograft[s], synthetic device[s]) and created a new Category I CPT
code 2X000 (Arthrodesis, sacroiliac joint, percutaneous, with image
guidance, including placement of intra-articular implant(s) (eg, bone
allograft[s], synthetic device[s]), without placement of transfixation
device), which was surveyed for the January 2023 RUC meeting. CPT codes
27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally
invasive (indirect visualization), with image guidance, includes
obtaining bone graft when performed, and placement of transfixing
device) and 27280 (Arthrodesis, sacroiliac joint, open, includes
obtaining bone graft, including instrumentation, when performed) were
added as family codes to the level of interest (LOI) form for the RUC
to review. However, the specialty societies indicated that they do not
consider CPT codes 27279 and 27280 as part of the same code family and
requested that they not be re-reviewed by the RUC for the January 2023
meeting. The RUC agreed with the specialty societies and did not review
these codes at the January 2023 meeting. The RUC stated in their
recommendations for 2X000 that the clinical nature of CPT codes 27279
and 27280 is extensively disparate from 2X000 for both the surgical
approach and the specialties that perform the procedures. Additionally,
they stated that no substantive changes were made to CPT codes 27279
and 27280 at the September 2022 CPT panel meeting and 27279 has been
reviewed by the RUC as recently as 2018.
We are proposing the RUC-recommended work RVU of 7.86 for CPT code
2X000. We are also proposing the RUC-recommended direct PE inputs
without refinement.
(2) Vertebral Body Tethering (CPT Codes 2X002, 2X003, and 2X004)
At the September 2022 CPT Panel meeting, two new Category I CPT
codes, 2X002 (Anterior thoracic vertebral body tethering, including
thoracoscopy, when performed; up to 7 vertebral segments) and 2X003
(Anterior thoracic vertebral body tethering, including thoracoscopy,
when performed; 8 or more vertebral segments) were established for
thoracic tethering. In addition, another new Category I CPT code, 2X004
(Revision (eg, augmentation, division of tether), replacement, or
removal of thoracic vertebral body tethering, including thoracoscopy,
when performed) was established for tether revision, replacement or
removal. This code family was then surveyed for the January 2023 RUC
meeting.
We are proposing the RUC-recommended work RVUs of 32.00 for CPT
code 2X002, 35.50 for CPT code 2X003, and 36.00 for CPT code 2X004. We
are also proposing the RUC-recommended direct PE inputs without
refinement.
(3) Total Disc Arthroplasty (CPT Codes 22857 and 22860)
In September 2021, the CPT Editorial Panel created CPT Category I
code 22860 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
22860 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 22860 were erroneous and that the
codes should be resurveyed for the April 2022 RUC meeting. Therefore,
we proposed and finalized to maintain the RUC-recommended work RVU of
27.13 for CPT code 22857 and contractor pricing for CPT code 22860 for
CY 2023.
For CY 2024, we are proposing the April 2022 RUC-recommended work
RVU of 27.13 for CPT code 22857, which represents no change from the
current work RVU. For CPT code 22860, we disagree with the April 2022
RUC-recommended survey median work RVU of 7.50 and are proposing the
survey (with experience) 25th percentile work RVU of 6.88. We note
that, of the 46 ZZZ-codes with an intraservice time of 60 minutes, only
four have a work RVU higher than the RUC-recommended 7.50.
We note that our proposed work RVU of 6.88 will maintain relativity
with CPT codes 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))
(work RVU = 6.50, 45 minutes intra-service and 50 minutes total time),
which is an anterior approach spine procedure that requires less time,
and CPT code 22208 (Osteotomy of spine, posterior or posterolateral
approach, 3 columns, 1 vertebral segment (eg, pedicle/vertebral body
subtraction); each additional vertebral segment (List separately in
addition to code for primary procedure)) (work RVU = 9.66, 120 minutes
intra-service and 135 minutes total time). As the RUC mentioned in
their recommendations, these codes appropriately bracket CPT code 22860
and demonstrate relativity among similar surgical spine add-on codes.
The RUC noted that their recommended work RVU of 7.50 reflects the
increased intensity of spine procedures performed from an anterior
approach, but we note that CPT code 22226 (Osteotomy of spine,
including discectomy, anterior approach, single vertebral segment; each
additional vertebral segment (List separately in addition to code for
primary procedure)), which represents an anterior approach, and CPT
code 22216 (Osteotomy of spine, posterior or posterolateral approach, 1
vertebral segment; each additional vertebral segment (List separately
in addition to primary procedure)), which represents a posterior or
posterolateral approach, are both valued at 6.03 work RVUs and have
identical IWPUTs of 0.1005. CPT codes 22216 and 22226 are ZZZ codes and
have identical times as CPT code
[[Page 52313]]
22860, therefore, we believe the proposed survey (with experience) 25th
percentile work RVU of 6.88 for CPT 22860 is more appropriate than the
RUC recommended work RVU.
We are proposing the RUC-recommended direct PE inputs for both
codes without refinement.
(4) Phrenic Nerve Stimulation System (CPT Codes 3X008, 3X009, 3X010,
3X011, 3X012, 3X013, 3X014, 3X015, 9X045, 9X046, 9X047, and 9X048)
In September 2022, the CPT Editorial Panel created eight new
Category I CPT codes to describe insertion, repositioning, removal, and
removal and replacement of a phrenic nerve stimulator system, as well
as adding four additional new Category I codes to describe activation,
interrogation, and programming of a phrenic nerve stimulator system.
These new codes will replace thirteen Category III codes, 0424T-0436T.
The twelve new Category I codes were surveyed and then reviewed for the
January 2023 RUC meeting.
We are proposing the RUC-recommended work RVU for all 12 codes in
the Phrenic Nerve Stimulation System family. We are proposing a work
RVU of 9.50 for CPT code 3X008 (Insertion of phrenic nerve stimulator
system (pulse generator and stimulating lead[s]) including vessel
catheterization, all imaging guidance, and pulse generator initial
analysis with diagnostic mode activation when performed), a work RVU of
5.43 for CPT code 3X009 (Insertion of phrenic nerve stimulator
transvenous sensing lead), a work RVU of 9.55 for CPT code 3X010
(Removal of phrenic nerve stimulator including vessel catheterization,
all imaging guidance, and interrogation and programming, when
performed; system, including pulse generator and lead(s)), a work RVU
of 5.42 for CPT code 3X011 (Removal of phrenic nerve stimulator
including vessel catheterization, all imaging guidance, and
interrogation and programming, when performed; transvenous stimulation
or sensing lead(s) only), a work RVU of 3.04 for CPT code 3X012
(Removal of phrenic nerve stimulator including vessel catheterization,
all imaging guidance, and interrogation and programming, when
performed; pulse generator only), a work RVU of 6.00 for CPT code 3X013
(Repositioning of phrenic nerve stimulator transvenous lead(s)), a work
RVU of 6.05 for CPT code 3X014 (Removal and replacement of phrenic
nerve stimulator including vessel catheterization, all imaging
guidance, and interrogation and programming when performed; pulse
generator), a work RVU of 8.51 for CPT code 3X015 (Removal and
replacement of phrenic nerve stimulator including vessel
catheterization, all imaging guidance, and interrogation and
programming when performed; transvenous stimulation or sensing lead), a
work RVU of 0.85 for CPT code 9X045 (Therapy activation of implanted
phrenic nerve stimulator system including all interrogation and
programming), a work RVU of 0.80 for CPT code 9X046 (Interrogation and
programming (minimum one parameter) of implanted phrenic nerve
stimulator system), a work RVU of 1.82 for CPT code 9X047
(Interrogation and programming of implanted phrenic nerve stimulator
system during a polysomnography), and a work RVU of 0.43 for CPT code
9X048 (Interrogation, without programming of implanted phrenic nerve
stimulator system).
We are proposing to refine the CA039 Post-operative visits (total
time) for CPT code 3X014 from 36 minutes to 53 minutes to reflect the
fact that this code has a Level 4 office visit and not a Level 3 office
visit included in its global period; we believe that this was an
unintended technical error in the RUC recommendation. We are also
proposing to refine the equipment time for the exam table (EF023)
equipment from 36 minutes to 53 minutes for CPT code 3X014 to conform
to this proposed change in clinical labor time. For all other codes, we
are proposing the direct PE inputs as recommended by the RUC without
refinement.
(5) Posterior Nasal Nerve Ablation (CPT Codes 30117, 30118, 3X016, and
3X017)
In September 2022, the CPT Editorial Panel created two new
endoscopy codes for ablation of the posterior nasal nerve: CPT code
3X016 (Nasal/sinus endoscopy, surgical; with destruction by
radiofrequency ablation, posterior nasal nerve), and CPT code 3X017
(Nasal/sinus endoscopy, surgical; with destruction by cryoablation,
posterior nasal nerve). In preparation for the January 2023 RUC
meeting, both new posterior nasal nerve codes, 3X016 and 3X017, as well
as family CPT codes 30117 and 30118, were surveyed. For CY 2024, the
RUC recommended a work RVU of 3.91 for CPT code 30117, a work RVU of
9.55 for CPT code 30118, and a work RVU of 2.70 for both CPT codes
3X016 and 3X017.
We are proposing the RUC-recommended work RVU of 3.91 for CPT code
30117. We are proposing to remove the clinical labor for the CA037
(Conduct patient communications) activity code for CPT code 30117. This
clinical labor is associated with patient communications which already
take place during the CA036 (Discharge day management) activity code
for 10-day and 90-day global procedures. We are proposing to remove
this clinical labor as it would be duplicative with the communications
already taking place under the CA036 activity code. We are proposing to
delete supply item SB027 (gown, staff, impervious) because supply items
SA042 (pack, cleaning and disinfecting, endoscope) and SA043 (pack,
cleaning, surgical instruments) each include this same item. Supply
items SA042 and SA043 are both included in the direct PE inputs for CPT
Code 30117.
We disagree with the RUC-recommended work RVU of 9.55 for CPT code
30118 and are proposing a work RVU of 7.75, based on a direct crosswalk
from CPT code 28298 (Correction, hallux valgus (bunionectomy), with
sesamoidectomy, when performed; with proximal phalanx osteotomy, any
method) which has the same 60 minutes of intra-service time and similar
total time as CPT code 30118. We believe the work RVU should be lower
than the RUC recommendation of 9.55 to reflect the decrease in intra-
service time from 105 minutes to 60 minutes, and the decrease in total
time from 288 minutes to 211 minutes. In the case of CPT code 30118,
the intra-service work time is decreasing by 43 percent and the total
work time is decreasing by 27 percent but the RUC-recommended work RVU
is only decreasing by 4 percent. Although we do 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 the surveyed work time should be reflected in commensurate
decreases to work RVUs.
We also note that at the RUC-recommended work RVU of 9.55, the
intensity of CPT code 30118 would be increasing by more than 50
percent. We disagree that there would be such a significant increase in
the intensity for the procedure, as it is transitioning from inpatient
to outpatient status which suggests that the intensity has remained the
same or decreased over time. We also disagree that this would be the
case since the intensity for CPT code 30117 is decreasing at the RUC-
recommended work RVU of 3.91. Therefore, we are also proposing a work
RVU of 7.75 because it maintains the current intensity of CPT code
30118 instead of resulting in an increase in intensity. The proposed
work RVU of 7.75 is supported by the reference CPT codes
[[Page 52314]]
we compared to CPT code 30118 with the same 60 minutes of intra-service
time and similar total time as CPT code 30118; reference CPT code 11970
(Replacement of tissue expander with permanent implant) has a work RVU
of 7.49, and reference CPT code 19325 (Breast augmentation with
implant) has a work RVU of 8.12. We believe the proposed RVU of 7.75 is
a more appropriate value overall than 9.55 when compared to the range
of codes with the same intra-service time and similar total time.
We are proposing to remove the clinical labor for the CA037
(Conduct patient communications) activity code for CPT code 30118. This
clinical labor is associated with patient communications which already
take place during the CA036 (Discharge day management) activity code
for 10-day and 90-day global procedures. We are proposing to remove
this clinical labor from CPT code 30118 as it would be duplicative with
the communications already taking place under the CA036 activity code.
We are proposing the RUC-recommended work RVU of 2.70 for CPT codes
3X016 and 3X017. Both CPT codes 3X016 and 3X017 are endoscopic
procedures; therefore, we are proposing CPT code 31231 (Nasal
endoscopy, diagnostic, unilateral or bilateral (separate procedure)) as
the endoscopic base code for both of these codes because the
description of these procedures includes what is described for CPT code
31231, with the additional component of the posterior nasal nerve
ablation. Both of these procedures are performed with an endoscope. CPT
codes 3X016 and 3X017 are not add-on codes, and both have a 0-day
global period. The endoscopic base code that we are assigning to CPT
codes 3X016 and 3X017 is used in a specific type of multiple procedure
payment reduction that applies to some endoscopy codes.
We are proposing to refine the RUC-recommended direct PE inputs for
both CPT codes 3X016 and 3X017. For CPT code 3X016, we are refining the
equipment time for the ES031 equipment (scope video system (monitor,
processor, digital capture, cart, printer, LED light)) from 39 minutes
to 32 minutes. The RUC used the CA025 (clean scope) time of 10 minutes
instead of the CA024 (clean room/equipment by clinical staff) time of 3
minutes in the Scope Systems formula, when the time for CA024 is the
standard; we believe that this was an unintended technical error in the
RUC recommendation. We are similarly refining the equipment time for
ES031 from 39 minutes to 34 minutes for CPT code 3X017.
For CPT code 3X017, we are refining the equipment time for the
ES040 equipment (PROXY endoscope, rigid, sinoscopy (0 degrees)) from 39
minutes to 41 minutes because the RUC used 18 minutes of intra-service
time for CA018 (Assist physician or other qualified healthcare
professional--directly related to physician work time (100%)) instead
of 20 minutes in the standard Scope formula. Also, for both CPT codes
3X016 and 3X017, we propose to delete supply item SB027 (gown, staff,
impervious) because SA042 (pack, cleaning and disinfecting, endoscope)
and SA043 (pack, cleaning, surgical instruments) each include this same
item. Supply items SA042 and SA043 are both included in the PE inputs
for CPT codes 3X016 and 3X017.
(6) Cystourethroscopy With Urethral Therapeutic Drug Delivery (CPT Code
5X000)
In September 2022, the CPT Editorial Panel replaced Category III
code 0499T (Cystourethroscopy, with mechanical dilation and urethral
therapeutic drug delivery for urethral stricture or stenosis, including
fluoroscopy, when performed) with the new Category I CPT code 5X000
(Cystourethroscopy, with mechanical urethral dilation and urethral
therapeutic drug delivery by drug coated balloon catheter for urethral
stricture or stenosis, male, including fluoroscopy, when performed) to
describe cystourethroscopy with mechanical urethral dilation and
urethral therapeutic drug delivery. For CY 2024, the RUC recommended a
work RVU of 3.10 for CPT code 5X000.
We are proposing the RUC-recommended work RVU of 3.10 for CPT code
5X000. We are also proposing the RUC-recommended direct PE inputs for
CPT code 5X000 without refinement.
Since this is an endoscopic procedure, we propose CPT code 52000
(Cystourethroscopy (separate procedure)) as the endoscopic base code
for CPT code 5X000 because the description of this procedure includes
what is described for CPT code 52000 with the additional component of
the urethral therapeutic drug delivery. This procedure is performed
with a cystoscope. CPT code 5X000 is not an add-on code, it has a 0-day
global period. The endoscopic base code that we are assigning to CPT
code 5X000 is a specific type of multiple procedure payment reduction
that applies to some endoscopy codes.
(7) Transcervical RF Ablation of Uterine Fibroids (CPT Code 5X005)
In September 2022, the CPT Editorial Panel deleted Category III
code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound
guidance, radiofrequency) and created a new Category I CPT code 5X005
(Transcervical ablation of uterine fibroid(s), including intraoperative
ultrasound guidance and monitoring, radiofrequency) to report and
describe transcervical radiofrequency ablation of uterine fibroid(s)
which prompted CPT code 5X005 to be surveyed for the January 2023 RUC
meeting. At the January 2023 RUC meeting, the specialty societies
indicated, and the RUC agreed, that the survey results for CPT code
5X005 showed that the survey 25th percentile work RVU of 7.21
appropriately recognizes the work involved in this service.
We are proposing the RUC-recommended work RVU of 7.21 for CPT code
5X005. The RUC recommends that CPT code 5X005 be placed on the New
Technology list to be re-reviewed by the RUC in 3 years to ensure
correct valuation and utilization assumptions. We will revisit the
valuations of CPT code 5X005 in future rulemaking as needed, based on
our annual review process discussed in the background section of this
proposed rule.
CPT code 5X005 includes a medium instrument pack (EQ138) as one of
the practice expense inputs for this code. Since the medium instrument
pack is classified as equipment, it should include time for cleaning
the surgical instrument package. We noted a mistake in one of the
equipment time formulas for the medium instrument pack (EQ138) which
used the CA024 clean room/equipment by clinical staff time instead of
the CA026 clean surgical instrument package time in the equipment
formula. Therefore, we are proposing to refine the medium instrument
pack equipment time from 65 minutes to 77 minutes to conform to our
established policy for surgical instrument packs, otherwise we are
proposing the RUC-recommended direct PE inputs without refinement.
(8) Suprachoroidal Injection (CPT Code 6X000)
In September 2022, the CPT Editorial Panel introduced category I
CPT code 6X000 as a new code. CPT code 6X000 describes suprachoroidal
injection, which is the injection of medication into the space between
the choroid and the sclera of the eye with procedure-specific needles
and an injection kit. CPT code 6X000 replaces temporary
[[Page 52315]]
category III CPT code 0465T (Suprachoroidal injection of a
pharmacologic agent (does not include supply of medication)), which was
contractor priced. While there are other existing general CPT codes for
injections to the eye, the AMA RUC is adding CPT code 6X000
(Suprachoroidal space injection of pharmacologic agent (separate
procedure) (Report medication separately)) to describe a more specific
service to better distinguish this procedure from the rest of the codes
for eye injections in this family. CPT code 6X000 is a 000-day global
code and currently, there is only one FDA-approved medication to treat
macular edema associated with uveitis which is reported separately with
HCPCS J-code J3299 triamcinolone acetonide (Xipere[supreg]).
We are proposing the RUC-recommended work RVU of 1.53 for CPT code
6X000. We are also proposing the RUC-recommended direct PE inputs for
the code without refinement.
(9) Skull Mounted Cranial Neurostimulator (CPT Codes 619X1, 619X2, and
619X3)
In February 2022, the CPT Editorial Panel created codes 619X1,
619X2, and 619X3 to describe Skull-Mounted Cranial Neurostimulator, and
these codes were surveyed for the October 2022 RUC meeting.
We are proposing the RUC-recommended work RVU of 25.75 for CPT code
619X1 (Insertion of skull-mounted cranial neurostimulator pulse
generator or receiver, including craniectomy or craniotomy, when
performed, with direct or inductive coupling, with connection to depth
and/or cortical strip electrode array(s)), the RUC-recommended work RVU
of 11.25 for CPT code 619X2 (Revision or replacement of skull-mounted
cranial neurostimulator pulse generator or receiver with connection to
depth and/or cortical strip electrode array(s)), and the RUC-
recommended work RVU of 15.00 for CPT code 619X3 (Removal of skull-
mounted cranial neurostimulator pulse generator or receiver with
cranioplasty, when performed).
We are proposing the RUC-recommended direct PE inputs for CPT codes
619X1, 619X2, and 619X3 without refinement.
(10) Spinal Neurostimulator Services (CPT Codes 63685, 63688, 64XX2,
64XX3, and 64XX4)
For CPT codes 63685 (Insertion or replacement of spinal
neurostimulator pulse generator or receiver requiring pocket creation
and connection between electrode array and pulse generator or receiver)
and 63688 (Revision or removal of implanted spinal neurostimulator
pulse generator or receiver, with detachable connection to electrode
array) we are proposing the RUC-recommended work RVUs of 5.19 and 4.35,
respectively. We are proposing the RUC-recommended direct PE inputs for
CPT codes 63685 and 63688 without refinement.
We agree with the RUC recommended contractor pricing for CPT codes
64XX2 (Insertion or replacement of percutaneous electrode array,
peripheral nerve, with integrated neurostimulator including imaging
guidance, when performed; initial electrode array), 64XX3 (Insertion or
replacement of percutaneous electrode array, peripheral nerve, with
integrated neurostimulator including imaging guidance, when performed;
each additional electrode array), and 64XX4 (Revision or removal of
neurostimulator electrode array, peripheral nerve, with integrated
neurostimulator); and we are proposing contractor pricing for these
three codes.
(11) Neurostimulator Services-Bladder Dysfunction (CPT Codes 64590 and
64595)
For CPT codes 64590 (Insertion or replacement of peripheral,
sacral, or gastric neurostimulator pulse generator or receiver,
requiring pocket creation and connection between electrode array and
pulse generator or receiver) and 64595 (Revision or removal of
peripheral, sacral, or gastric neurostimulator pulse generator or
receiver, with detachable connection to electrode array) we are
proposing the RUC-recommended work RVUs of 5.10 and 3.79, respectively.
We are requesting clarification on the direct PE inputs for CPT
code 64590 in the non-facility setting. Specifically, we believe the
RUC inadvertently proposed 56 minutes of equipment time for the EQ114
equipment (electrosurgical generator), instead of 48 minutes using the
default formula for calculating equipment time. We believe that 48
minutes of equipment time for EQ114 is appropriate and matches the
clinical labor time; therefore, we are proposing 48 minutes for the
EQ114 equipment for CPT code 64590. We also believe that the EQ209
equipment (programmer, neurostimulator (w-printer)) was intended to
match the same 84 minutes of equipment time listed for the EF031 power
table as both were indicated to be used during the follow-up office
visit. Therefore, we are proposing 84 minutes of equipment time for
EQ209 for CPT code 64590.
We are proposing the remaining RUC-recommended direct PE inputs for
CPT code 64590 without refinement. We are also proposing the RUC-
recommended direct PE inputs for CPT code 64595 without refinement.
(12) Ocular Surface Amniotic Membrane Placement/Reconstruction (CPT
Codes 65778, 65779, and 65780)
CPT code 65778 (Placement of amniotic membrane on the ocular
surface; without sutures) was identified by the Relativity Assessment
Workgroup (RAW) via the high-volume growth screen for codes with
Medicare utilization over 10,000 screen. During the September 2022 RAW
meeting, the specialty societies stated that CPT codes 65778, 65779
(Placement of amniotic membrane on the ocular surface; single layer,
sutured), and 65780 (Ocular surface reconstruction; amniotic membrane
transplantation, multiple layers) would be surveyed for the January
2023 RUC meeting.
For CY 2024, we are proposing the RUC-recommended work RVUs for all
three CPT codes. We are proposing a work RVU of 0.84 for CPT code 65778
(Placement of amniotic membrane on the ocular surface; without
sutures), a work RVU of 1.75 for CPT code 65779 (Placement of amniotic
membrane on the ocular surface; single layer, sutured), and a work RVU
of 7.03 for CPT code 65780 (Ocular surface reconstruction; amniotic
membrane transplantation, multiple layers). We are also proposing the
RUC-recommended direct PE inputs for CPT codes 65778, 65779, and 65780
without refinement.
(13) Fractional Flow Reserve With CT (CPT Code 7X005)
For CY 2018, the CPT Editorial Panel established four new Category
III CPT codes for fractional flow reserve derived from computed
tomography (FFRCT): CPT codes 0501T-0504T. Medicare began payment for
CPT code 0503T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease;
analysis of fluid dynamics and simulated maximal coronary hyperemia,
and generation of estimated FFR model) in the hospital outpatient
department setting under the Outpatient Prospective Payment System
(OPPS) in CY 2018 (82 FR 59284). For the PFS, we typically assign
contractor pricing for Category III codes since they are temporary
codes assigned to emerging technology and services. However, we
[[Page 52316]]
made an exception for FFRCT services and we have since been trying to
understand the costs of the PE resource inputs for CPT code 0503T in
the physician office setting. In the CY 2021 PFS final rule (85 FR
84630), we stated that we found FFRCT to be similar to other
technologies that use algorithms, artificial intelligence, or other
innovative forms of analysis to determine a course of treatment, where
the analysis portion of the service cannot adequately be reflected
under the PE methodology; and that our recent reviews for the overall
cost of CPT code 0503T had shown the costs in the physician office
setting to be similar to costs reflected in payment under the OPPS (85
FR 84630). As such, we proposed to use the geometric mean costs under
the OPPS as a proxy for CPT code 0503T and ultimately finalized
national pricing for CPT code 0503T based on a valuation crosswalk to
the technical component (TC) of CPT code 93457 in the CY 2022 PFS final
rule (86 FR 65037-65042).
For CY 2024, the CPT Editorial Panel approved the replacement of
Category III codes 0501T-0504T with a single new Category I code
(7X005) to report non-invasive estimate of coronary fractional flow
reserve derived from augmentative software analysis of the dataset from
a coronary computed tomography angiography. CPT code 7X005 (Noninvasive
estimate of coronary fractional flow reserve derived from augmentative
software analysis of the data set from a coronary computed tomography
angiography, with interpretation and report by a physician or other
qualified health care professional) was reviewed at the January 2023
RUC meeting and valuation recommendations were submitted to CMS. These
recommendations include a software analysis fee for FFRCT listed as a
supply input which accounts for the overwhelming majority of the code's
valuation.
We have long had concerns that the software algorithm in the
analysis fee for CPT code 7X005 is not well accounted for in our PE
methodology; however, we recognize that practitioners are incurring
resource costs for purchasing the FFRCT software and its ongoing use.
This was the rationale for our previous policy to use a crosswalk that
reflected the overall relative resource costs for this service while we
continued to consider potentially refining and updating our PE
methodology. The RUC recommendations include the previously mentioned
software analysis fee for FFRCT as a supply input. However, analysis
fees are not well accounted for in our current PE methodology. Although
we recognize that these fees are a type of cost for practitioners, we
have not traditionally recognized these analysis fees as forms of
direct PE in our methodology. We previously stated our belief that
crosswalking the RVUs for CPT code 0503T to a code with similar
resource costs (the TC for CPT code 93457) allowed CMS to recognize
that practitioners are incurring resource costs for the purchase and
ongoing use of the software employed in CPT code 0503T, which would not
typically be considered direct PE under our current methodology (86 FR
65038 and 65039).
We are therefore proposing to maintain the previous valuation
crosswalk to the technical component of CPT code 93457 for the new
FFRCT code 7X005. This new Category I code is intended as a direct
replacement for Category III code 0503T, and maintaining the current
crosswalk will allow the geometric mean costs under the OPPS to
continue to serve as a proxy for valuation. We are specifically
crosswalking the technical component of CPT code 7X005 to the technical
component of CPT code 93457; we are proposing the RUC-recommended work
RVU of 0.75 for the professional component of CPT code 7X005, and the
global component will be comprised of their sums as usual. We also note
that there was an error in the RUC's recommended equipment time for the
Professional PACS Workstation (ED053), which was listed at 14.5 minutes
instead of the correct 13.5 minutes based on the sum of the
intraservice work time (11 minutes) plus half of the preservice work
time (5 divided by 2 = 2.5 minutes).
(14) Ultrasound Guidance for Vascular Access (CPT Code 76937)
In order to specify the insertion of a peripherally inserted
central venous catheter (PICC), the CPT Editorial Panel decided to
create two new codes: CPT 36572 and CPT 36573, and revised CPT codes
36568, 36569 and 36584 in September of 2017. This revision of these
codes created a scenario where these bundled services could be
performed by a clinician that performs the procedure without imaging
guidance or a radiologist that performs the procedure with imaging
guidance. When this code family was surveyed again in January 2018, CPT
code 76937 (Ultrasound guidance for vascular access requiring
ultrasound evaluation of potential access sites, documentation of
selected vessel patency, concurrent realtime ultrasound visualization
of vascular needle entry, with permanent recording and reporting (List
separately in addition to code for primary procedure) was identified as
part of this code family. Since it was expected that utilization of
PICC procedures would decrease once CPT code 76937 was bundled with
these services, the specialty societies that perform this service
proposed to review CPT code 76937 after 2 years, once more data about
these services became available. CPT code 76937 was reviewed at the
October 2022 RUC meeting for CY 2024.
We are proposing the RUC-recommended work RVU of 0.30 for CPT
76937. We are also proposing the RUC-recommended direct PE inputs for
CPT 76937.
(15) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
Since their creation in 2011, CPT codes 76881 (Ultrasound, complete
joint (i.e., 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 PE inputs. The RAW recommended referral to the Practice Expense
Subcommittee for review of the direct PE 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 PE 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 the 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 76883 (Ultrasound, nerve(s) and accompanying structures
throughout their entire anatomic course in one extremity,
comprehensive, including real-time cine imaging with image
[[Page 52317]]
documentation, per extremity) 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 76883 and surveyed for the January 2022 RUC meeting. We reviewed
these recommendations for CY 2023 and discussed our concerns with the
commenters' assertions regarding typical PE inputs for CPT code 76882
in the CY 2023 PFS final rule (87 FR 69506 through 69510).
Specifically, given the changes in dominant specialty for these CPT
codes from 2010 to 2017, and again from 2017 to 2022, we recommended
that the RUC and interested parties reconsider the PE inputs for each
code based on the dominant specialty for each CPT code, based on the
most recent year's Medicare claims data, and consideration of survey
responses submitted to CMS in response to the CY 2023 PFS proposed
rule.
The PE inputs for CPT codes 76881, 76882, and 76883 were
subsequently re-reviewed at the January 2023 RUC meeting and the RUC
submitted refinements to the PE inputs for CPT code 76882 only. We are
proposing the RUC-recommended PE refinements for CPT code 76882 with
the exception of the RUC-recommended 13.5 minutes for ED053
(Professional PACS workstation) and 23 minutes for EQ250 (ultrasound
unit, portable). We note that the old intraservice time of 11 minutes
was used in error when calculating the standard equipment time for
ED053. Therefore, we disagree with the RUC-recommended equipment time
of 13.5 minutes and are proposing 17.5 minutes for ED053, which is
calculated by using the standard equipment formula for ED053
established in the CY 2017 PFS final rule (81 FR 80182) with the
updated intraservice time from the CY 2023 PFS final rule ((0.5 * 5) +
15 = 17.5).
We disagree with the RUC-recommended 23 minutes of equipment time
for EQ250, which includes one minute of clinical labor time for CA014
(Confirm order, protocol exam) in the highly technical equipment
formula, as discussed beginning in the CY 2013 PFS final rule (77 FR
69028), in error. Therefore, the correct equipment time for EQ250 using
the highly technical equipment formula would be 22 minutes. However,
because the Summary of Recommendations included in the RUC
recommendations did not provide a rationale for the use of the highly
technical equipment formula for EQ250, we are proposing to maintain the
15 minutes of equipment time for EQ250 for CPT code 78882, which
corresponds to the interservice time for this code and maintains
consistency with how equipment time is allotted for EQ250 across the
three codes in this family. We refer readers to the classification of
highly technical equipment in the CY 2014 PFS final rule (79 FR 67639).
The RUC did not make recommendations on and we are not proposing
any changes to the work RVU for CPT codes 76881, 76882, and 76883.
(16) Intraoperative Ultrasound Services (CPT Codes 76998, 7X000, 7X001,
7X002, and 7X003)
In October 2018, the Relativity Assessment Workgroup (RAW) created
a screen for CMS/Other codes with Medicare utilization of 20,000 or
more, and CPT code 76998 (Ultrasonic guidance, intraoperative) was
subsequently identified as part of that screen. When CPT code 76998 was
identified in the CMS/Other screen, it was noted that many specialties
were represented in the Medicare claims data. Specialties representing
cardiothoracic surgery, general surgery, breast surgery, urology,
interventional cardiology, interventional radiology and vascular
surgery jointly submitted an action plan that the RAW reviewed in
October 2019. Based on the variability of intraoperative ultrasound for
each specialty with differences in the typical patient and physician
work, it was decided that each society would submit applications for
new code(s) as needed to carve out the work currently reported with
76998 until the code was no longer needed, or until it was clear what
the final dominant use of 76998 was so that a survey could be
conducted.
In October 2019, the RUC referred this issue to the CPT Editorial
Panel to clarify correct coding and accurately differentiate physician
work, as multiple specialties currently report CPT code 76998. The CPT
Editorial Panel addressed CPT code 76998 in 2020 and 2021 by adding
instructional parentheticals that restrict the use of imaging guidance
with vein ablation procedures and adding new codes that bundled imaging
guidance for urological procedures. In May 2022, the CPT Editorial
Panel created four new codes to report intraoperative cardiac
ultrasound services, thus carving out most of the prior reporting of
code 76998 by cardiothoracic surgeons and cardiologists.
After utilization was removed from code 76998 for vein ablation
procedures, most urological procedures, cardiac procedures and intra-
abdominal procedures through instructions and/or new or revised codes,
it was determined that the dominant use of the code would be related to
breast surgery, allowing for code 76998 to be surveyed. CPT codes 7X000
(Ultrasound, intraoperative thoracic aorta (e.g., epiaortic),
diagnostic), 7X001 (Intraoperative epicardial cardiac (e.g.,
echocardiography) ultrasound for congenital heart disease, diagnostic;
including placement and manipulation of transducer, image acquisition,
interpretation and report), 7X002 (Intraoperative epicardial cardiac
(e.g., echocardiography) ultrasound for congenital heart disease,
diagnostic; placement, manipulation of transducer, and image
acquisition only), 7X003 (Intraoperative epicardial cardiac (e.g.,
echocardiography) ultrasound for congenital heart disease, diagnostic;
interpretation and report only), and 76998 were surveyed by the
specialty societies for the September 2022 RUC meeting.
We disagree with the RUC-recommended work RVU of 1.20 for CPT code
76998 and are proposing the total time ratio work RVU of 0.91. The RUC
recommended a 7-minute total time decrease for CPT code 76998. We agree
with the RUC that the intensity of CPT code 76998 (real-time during an
operation) is greater than the identically-timed CPT code 76641
(Ultrasound, breast, unilateral, real time with image documentation,
including axilla when performed; complete), which represents a single
ultrasound session typically performed by a technician, whereas CPT
code 76998 includes multiple, separate ultrasound maneuvers during a
surgical procedure that require a more intense, immediate
interpretation in order to direct resection of the breast tissue and
ensure a thorough and complete surgical excision of the abnormal breast
tissue. The proposed work RVU of 0.91 for CPT code 76998 adequately
values the surgeon's 5 minutes of pre-service time, 12 minutes of
intraservice time, and 5 minutes of immediate post-service time more
than the same 5, 12, and 5 minutes of the technician's time for CPT
code 76641, which has a work RVU of 0.73.
Additionally, the IWPUT of CPT code 76641 is appropriately less
than the IWPUT of CPT code 76698, with IWPUTs of 0.0422 and 0.0572,
respectively. We remind interested parties that 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, decreases in time should
[[Page 52318]]
be reflected in decreases to work RVUs. We disagree with the RUC-
recommended maintenance of the current work RVU for CPT code 76998 for
a few reasons: the RUC recommendations did not advocate for a change in
intensity, and presumably some higher-intensity cardiac procedures will
no longer be reported using CPT code 76998, as they can now be reported
using CPT codes 7X000 through 7X003. Instead, we are proposing an
appropriately lower work RVU and associated IWPUT to account for the 7-
minute decrease in total time and removal of higher-intensity cardiac
procedures previously reported by CPT code 76998. We note that the
proposed work RVU of 0.91 for CPT code 76998 is supported by the upper
brackets of CPT codes 72125 (Computed tomography, cervical spine;
without contrast material), 72128 (Computed tomography, thoracic spine;
without contrast material), and 72131 (Computed tomography, lumbar
spine; without contrast material), and a lower bracket of CPT code
76641. CPT codes 72125, 72128, and 72131 represent spinal computed
tomography (CT) of the cervical, thoracic, and lumbar spine,
respectively.
We are proposing the RUC-recommended work RVU of 0.60 and work
times of 5 minutes of pre-evaluation time, 10 minutes of intraservice
time, and 3 minutes of immediate postservice time for total time of 18
minutes for CPT code 7X000. We are also proposing the RUC-recommended
work times for CPT codes 7X001 and 7X002 of 10 minutes of pre-
evaluation time and 20 minutes of intraservice time for both codes, and
5 and 10 minutes of immediate postservice time, for total times of 40
and 35 minutes, respectively. We are proposing the RUC-recommended work
times for CPT code 7X003 with the exception of the intraservice time.
We are proposing the survey median intraservice time of 15 minutes
rather than the RUC-recommended 75th percentile based on the assertion
in the RUC's Summary of Recommendations that the cardiologist is
typically in the operating room intraoperatively with the
cardiothoracic surgeon prior to and after the cardiac repair. Based on
this assertion, we do not believe the cardiologist spends the same
amount of time in the operating room as the cardiothoracic surgeon in
CPT codes 7X001 and 7X002. Therefore, we are proposing 5 minutes of
pre-evaluation time, 15 minutes of intraservice time, and 10 minutes of
immediate postservice time for total time of 30 minutes for CPT code
7X003.
Due to the CPT code descriptor for CPT code 7X001, we believe that
the appropriate work for this service is reflected in the combined work
of CPT codes 7X002 and 7X003. We note that in the CY 2015 PFS final
rule (79 FR 67669), we reviewed a similarly constructed family of codes
representing interventional transesophageal echocardiography (TEE) for
congenital cardiac anomalies in the same way by proposing and
finalizing a work RVU for CPT code 93315 (Transesophageal
echocardiography for congenital cardiac anomalies; including probe
placement, image acquisition, interpretation and report) equal to the
combined work RVUs of CPT codes 93316 (Transesophageal echocardiography
for congenital cardiac anomalies; placement of transesophageal probe
only) and 93317 (Transesophageal echocardiography for congenital
cardiac anomalies; image acquisition, interpretation and report only).
We note that the Summary of Recommendations for 7X001 through 7X003
state that these intraoperative ultrasound services are expected to be
very rare, as intraoperative TEE is considered the gold standard and
can be performed for most patients instead, which could be reported
using CPT codes 93315 through 93317. Because CPT codes 7X001 through
7X003 are an alternative to CPT codes 93315 through 93317 for
congenital cardiac anomalies when intraoperative TEE is
contraindicated, we believe we should maintain consistency and propose
a work RVU for CPT code 7X001 that equals the combined work RVUs of CPT
codes 7X002 and 7X003.
Therefore, we disagree with the RUC-recommended work RVUs of 1.90,
1.20, and 1.55 for CPT codes 7X001, 7X002, and 7X003, respectively. We
are proposing a work RVU of 1.62 for CPT code 7X001 based on a
crosswalk to CPT codes 73219 (Magnetic resonance (e.g., proton)
imaging, upper extremity, other than joint; with contrast material(s))
and 78452 (Myocardial perfusion imaging, tomographic (SPECT) (including
attenuation correction, qualitative or quantitative wall motion,
ejection fraction by first pass or gated technique, additional
quantification, when performed); multiple studies, at rest and/or
stress (exercise or pharmacologic) and/or redistribution and/or rest
reinjection). We note that this crosswalk is strongly supported by
total time ratios between CPT code 7X001 and reference CPT codes 93312
(Echocardiography, transesophageal, real-time with image documentation
(2D) (with or without M-mode recording); including probe placement,
image acquisition, interpretation and report) and 93315, which equal
1.66 and 1.67 respectively. We also note that this is supported by a
total time ratio to the current time and work RVU for the code that
cardiothoracic surgeons currently use to report this service prior to
the creation of CPT code 7X001, CPT code 76998 ((40/29) * 1.20 = 1.66).
Lastly, this is also supported by a total time ratio to the same CPT
code 76998 after factoring in the updated total time of 22 minutes and
our proposed work RVU for CPT code 76998 of 0.91 ((40/22) * 0.91 =
1.65). We note that a work RVU of 1.62 for CPT code 7X001 yields an
IWPUT of 0.059, which is slightly higher than the IWPUTs of the
intraoperative TEE CPT codes 93315 and 93312 that represent the
complete procedure, which are 0.0532 and 0.0580, respectively.
Similar to how CPT code 7X001 is broken down into service parts by
CPT code 7X002 and 7X003 to allow for multiple providers to perform
different parts of the whole service done by one provider (represented
by 7X001), CPT codes 93312 through 93314 and 93315 through 93317 are
broken down as well. According to the RUC Database, CPT code 93316
represents placement of transesophageal probe only, typically performed
by a cardiac anesthesiologist. CPT code 93313 (Echocardiography,
transesophageal, real-time with image documentation (2D) (with or
without M-mode recording); placement of transesophageal probe only)
also represents placement of transesophageal probe only, when performed
by a cardiac anesthesiologist. Similarly, CPT code 7X002 represents
placement and manipulation of transducer and image acquisition only,
which is typically performed by a cardiothoracic surgeon according to
the Summary of Recommendations.
According to the RUC Database, CPT code 93317 represents image
acquisition and interpretation and report only, typically done by the
cardiologist after probe placement typically performed by the cardiac
anesthesiologist, represented by CPT code 93316. CPT code 93314
(Echocardiography, transesophageal, real-time with image documentation
(2D) (with or without M-mode recording); image acquisition,
interpretation and report only) also represents image acquisition and
interpretation and report only, typically done by the cardiologist
after probe placement typically performed by the anesthesiologist,
represented by CPT code 93313. Similarly, CPT code 7X003 represents
interpretation and report
[[Page 52319]]
only, which is typically performed by a cardiologist according to the
Summary of Recommendations.
Because this family is broken down into service parts in the same
way CPT codes 93312 through 93314 and 93315 through 93317 are, we
disagree with the RUC's recommendation to assign work RVUs for CPT
codes 7X002 and 7X003 that sum to more than the aggregate work RVU for
CPT code 7X001. Therefore, we are proposing a work RVU of 1.08 for CPT
code 7X002 and a work RVU of 0.54 for CPT code 7X003, which sum to the
proposed aggregate work RVU of 1.62 for CPT code 7X001. The proposed
work RVUs for CPT code 7X002 and 7X003 were calculated by taking the
aggregate work RVU of the whole service, represented by CPT code 7X001,
and dividing by three based on the number of discernable service parts:
probe placement and manipulation, image acquisition, and interpretation
and report. Because CPT code 7X002 represents two of the three service
parts performed by a cardiothoracic surgeon, we allotted \2/3\ rds of
the aggregated work RVU for CPT code 7X001, equaling 1.08 (1.62 * \2/3\
= 1.08). Because CPT code 7X003 represents one of the three service
parts performed by a cardiologist, we allotted \1/3\ rd of the
aggregated work RVU for CPT code 7X001, equaling 0.54 (1.62 * \1/3\ =
0.54). Because the Summary of Recommendations was unclear regarding the
intensity of each part of the service as broken out, we invite comments
on additional ways to break down the aggregate work RVU of CPT code
7X001 to adequately account for the cardiothoracic surgeon and
cardiologist's time and intensity to perform CPT codes 7X002 and 7X003,
but we believe that the work RVUs should sum to no more than the
aggregate work RVU for CPT code 7X001 based on similarly broken down
code families that represent the more widely used intraoperative TEE
procedures. The RUC did not recommend and we are not proposing any
direct PE inputs for the five codes in the Intraoperative Ultrasound
family.
(17) Percutaneous Coronary Interventions (CPT Code 9X070)
In September 2022, the CPT Editorial Panel created one new Category
I CPT code for percutaneous coronary lithotripsy. Sixteen other
percutaneous coronary intervention (PCI) codes were considered part of
the code family but were ultimately not reviewed by the RUC. New add-on
CPT code 9X070 was reviewed by the RUC on an interim basis for CY 2024
while the entire percutaneous coronary intervention code family was
referred to the CPT Editorial Panel for restructuring for the CY 2025
cycle.
We are proposing the RUC-recommended work RVU of 2.97 for CPT code
9X070 (Percutaneous transluminal coronary lithotripsy). The RUC did not
recommend and we are not proposing any direct PE inputs for this
facility-based add-on service.
(18) Auditory Osseointegrated Device Services (CPT Codes 926X1 and
926X2)
In February 2022, the CPT Editorial Panel created CPT code 926X1
(Diagnostic analysis, programming, and verification of an auditory
osseointegrated sound processor, any type; first 60 minutes) and 926X2
(Diagnostic analysis, programming, and verification of an auditory
osseointegrated sound processor, any type; each additional 15 minutes
(list separately in addition to code for primary procedure) for CY
2024. CPT code 926X2 serves as the add-on code for base CPT code 926X1.
We are proposing the RUC-recommended work RVU of 1.25 for CPT code
926X1 and 0.33 for CPT 926X2. We are also proposing the RUC-recommended
direct PE inputs for both codes. Additionally, because audiologists
provide these services, we are proposing to add CPT codes 926X1 and
926X2 to the list of audiology services that can be billed with the AB
modifier, that is personally provided by audiologists without a
physician/NPP referral for non-acute hearing conditions--the list for
CY 2023 is available at https://www.cms.gov/audiology-services.
(19) Venography Services (CPT Codes 9X000, 9X002, 9X003, 9X004, and
9X005)
In February 2022, the CPT Editorial Panel created six new CPT add-
on codes to describe Venography services that are performed during
cardiac catheterization for congenital heart defects in the superior
vena cava (SVC), the inferior vena cava (IVC), and in other congenital
veins, that will be reported in conjunction with the main cardiac
catheterization procedure codes (CPT codes 93593-93598). CPT codes
9X000 (Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; anomalous
or persistent superior vena cava when it exists as a second
contralateral superior vena cava, with native drainage to heart (List
separately in addition to code for primary procedure)) and CPT codes
9X001 (Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; inferior
vena cava (List separately in addition to code for primary procedure))
were to replace the two more general CPT codes 75827 (Venography,
caval, superior, with serialography, radiological supervision and
interpretation) and 75825 (Venography, caval, inferior, with
serialography, radiological supervision and interpretation). CPT code
9X001 has since been rescinded, and all the remaining new add-on codes
have been clarified to state in their descriptors that they are
specifically for congenital heart defects.
For CPT code 9X000 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; anomalous or persistent superior vena cava when it
exists as a second contralateral superior vena cava, with native
drainage to heart (List separately in addition to code for primary
procedure)), the AMA RUC proposes a work RVU of 1.20 for 10 minutes of
intra-service time and total time. We are proposing the AMA RUC
recommended work RVU of 1.20 with 10 minutes of intra-service time and
total time for CPT code 9X000.
For CPT code 9X002 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; azygos/hemi-azygos venous system (List separately in
addition to code for primary procedure)), the AMA RUC proposes a work
RVU of 1.13 for 10 minutes of intra-service time and total time. We
note that this code has the same number of minutes as CPT code 9X000,
but with a lower recommended work RVU. We are proposing the AMA RUC
recommended work RVU of 1.13 with 10 minutes of intra-service time and
total time for CPT code 9X002.
For CPT code 9X003 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; coronary sinus (List separately in addition to code for
primary procedure)) the AMA RUC proposes a work RVU of 1.43 for 12
minutes of intra-service time and total time. We note that this code
has two additional minutes than CPT code 9X000 which is 20 percent more
in physician time than the 10 minutes from CPT code 9X000. We are
proposing the AMA RUC recommended work RVU of 1.43 with 12 minutes of
intra-service time and total time for CPT code 9X003.
For CPT code 9X004 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; venovenous collaterals originating at or
[[Page 52320]]
above the heart (e.g., from innominate vein) (List separately in
addition to code for primary procedure)), the AMA RUC proposes a work
RVU of 2.11 for 16 minutes of intra-service time and total time. We
note that this code has six additional minutes more than CPT code 9X000
(10 minutes), which is 60 percent more physician time. Although we do
not imply that increases 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, significant increases in time within the same code family
should typically be reflected in increases to work RVUs. In the case of
CPT code 9X004, we believe that it would be more accurate to propose a
work RVU of 1.92 to account for this increase in the surveyed work time
as compared with CPT code 9X000. Therefore, we are proposing a work RVU
of 1.92 along with 16 minutes of intra-service time and total time for
CPT code 9X004.
For CPT code 9X005 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; venovenous collaterals originating below the heart
(e.g., from the inferior vena cava) (List separately in addition to
code for primary procedure)), the AMA RUC proposes a work RVU of 2.13
for 17 minutes of intra-service time and total time. We note that this
code has seven additional minutes more than CPT code 9X000 (10
minutes), which is 70 percent more physician time than CPT code 9X000.
Although we do not imply that increases 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, significant increases in time within the same code
family should typically be reflected in increases to work RVUs. In the
case of CPT code 9X005, we believe that it would be more accurate to
propose a work RVU of 2.04 to account for this increase in the surveyed
work time as compared with CPT code 9X000. Therefore, we are proposing
a work RVU of 2.04 along with 17 minutes of intra-service time and
total time for CPT code 9X005.
The RUC did not recommend and we are not proposing any direct PE
inputs for the five codes in the Venography Services family.
(20) General Behavioral Health Integration Care Management (CPT Code
99484, and HCPCS Code G0323)
We are proposing to refine the work RVU of both CPT code 99484 and
HCPCS code G0323, as proposed (see section II.J.1.c of this proposed
rule), by increasing the work RVU to 0.93 from the current 0.61 and
increasing the work time to 21 minutes to match the results of the
surveyed work time. For CPT code 99484 we are proposing the direct PE
inputs as recommended by the RUC without refinement. We are also
proposing the same PE inputs for HCPCS code G0323.
CMS created four behavioral health integration (BHI) HCPCS G-codes
for CY 2017. In 2018 the codes were replaced by new CPT codes. At that
time RUC specialty societies undertook a survey but the RUC did not use
the survey results to establish work RVUs, and instead adopted the
valuations we had finalized in 2017. For CY 2017 we finalized a work
RVU of 0.61 based on a direct crosswalk from CPT code 99490 (chronic
care management services) (81 FR 80351). We recognized that the
services described by CPT code 99490 are distinct from those furnished
under BHI, but we stated that until we have more information about how
the services described by G0507 (replaced in 2018 by CPT 99484) are
typically furnished, we believed valuation based on an estimate of the
typical resources would be most appropriate (81 FR 80351). For CY 2022
we increased the value of CPT code 99490 from 0.61 to 1.00 (86 FR
65118).
In the CY 2023 PFS final rule (87 FR 69549) we finalized a new
HCPCS code, G0323 (care management services for behavioral health
conditions, at least 20 minutes of clinical psychologist or clinical
social worker time, per calendar month. (These services include 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 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.)) (See section II.J.1.c. of this proposed
rule, for proposed code descriptor refinement.) We valued HCPCS code
G0323 based on a direct crosswalk to the work values and direct PE
inputs for CPT code 99484, because we believed the services described
by G0323 mirrored those described by CPT code 99484. We noted that we
may consider changes in how this code is valued for future rulemaking.
We continue to be concerned about undervaluing care management
services under the PFS given the variability of costs involved with
these evolving models of care. The RUC has recommended revaluing CPT
code 99484, following a survey of 63 respondents. The median survey
work RVU was 1.30, and the median time was 21 minutes (all intra-
service). The specialty societies recommend a value of 0.93 based on a
crosswalk to code 99202. We believe the specialty societies are in a
good position to understand the evolving practice models. The RUC has
recommended the 25th percentile survey work RVU of 0.85. Consistent
with our goals of ensuring continued and consistent access to these
crucial care management services we are proposing to increase the work
RVU of CPT code 99484 to 0.93. This value reflects the work RVU of CPT
code 99202, which has a similar work time.
We continue to believe that the services described by HCPCS code
G0323 as proposed (section II.J.1.c. of this proposed rule) closely
mirror those described by CPT code 99484. As we are proposing to update
the work RVU and one of the PE inputs for CPT code 99484, we continue
to believe that a direct crosswalk to the work values and direct PE
inputs for CPT code 99484, is an appropriate valuation of the level,
time, and intensity of the services under G0323 as proposed (section
II.J.1.c. of this proposed rule). As such we propose to value HCPCS
code G0323, as proposed (section II.J.1.c. of this proposed rule),
based on a direct crosswalk to the work values and direct PE inputs for
CPT code 99484, as proposed, previously in this section.
We continue to believe that there is a systemic undervaluation of
work estimates for behavioral health services. We are proposing values
for CY 2024 that we believe will more accurately value the work
involved in delivering behavioral health services.
(21) Advance Care Planning (CPT Codes 99497 and 99498)
In January 2022, the Relativity Assessment Workgroup reviewed CPT
codes 99497 and 99498. The Workgroup determined these advance care
planning services should be examined given the recent changes in
evaluation and management services. The RUC recommended that CPT codes
99497 and 99498 be surveyed for physician work and practice expense for
the April 2022 RUC meeting. The RUC recommended no changes in physician
[[Page 52321]]
time, work RVUs, or direct PE inputs for these services for CY 2024.
We are proposing the RUC-recommended work RVU of 1.50 for CPT code
99497 and 1.40 for CPT code 99498, which are the current values for
these codes. We are proposing the RUC-recommended direct PE inputs for
these codes without refinement.
(22) Pelvic Exam (CPT Code 9X036)
In September 2022, the CPT Editorial Panel created a new CPT code
for reporting a pelvic exam--CPT code 9X036. The specialty societies
noted that reimbursement for the work would be captured with the
problem-oriented E/M code billed for the visit. The CPT Editorial Panel
agreed, thus the new code is a practice expense only code that captures
the direct practice expenses associated with performing a pelvic exam
in the non-facility setting. CPT code 9X036 (Pelvic Exam) captures the
4 minutes of clinical staff time associated with chaperoning a pelvic
exam.
We are proposing the RUC-recommended direct-PE inputs for CPT code
9X036 without refinement. As a PE-only service, the RUC did not
recommend and we are not proposing a work RVU for this code.
(23) Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (CPT Codes 9X034
and 9X035)
In September 2022, the CPT Editorial Panel created two time-based
add-on Category I CPT codes 9X034 (Intraoperative hyperthermic
intraperitoneal chemotherapy (HIPEC) procedure, including separate
incision(s) and closure, when performed; first 60 minutes) and 9X035
(Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
procedure, including separate incision(s) and closure, when performed;
each additional 30 minutes). CPT codes 9X034 and 9X035 were surveyed
for the January 2023 RUC meeting. While reviewing the survey data, it
was noted by specialty societies that the instructions were not
sufficient as the survey data reflected time estimates that exceeded
the time specified in the new time-based code descriptors. The RUC has
stated that the survey results for both CPT codes 9X034 and 9X035 are
inaccurate and that the codes should be resurveyed for 2025. Therefore,
the RUC recommended contractor pricing for CPT codes 9X034 and 9X035
and that they be referred to the CPT Editorial Panel for revision.
We are proposing to contractor price CPT codes 9X034 and 9X035 for
CY 2024.
(24) Hyperbaric Oxygen Under Pressure (HCPCS Code G0277)
In 2015, CMS created HCPCS code G0277 (Hyperbaric oxygen under
pressure, full body chamber, per 30 minute interval) to describe direct
practice expense inputs associated with CPT code 99183 (Physician or
other qualified health care professional attendance and supervision of
hyperbaric oxygen therapy, per session) (consistent with the Medicare
Hospital Outpatient Prospective Payment System coding mechanism). At
the September 2022 Relativity Assessment Workgroup meeting, HCPCS code
G0277 was identified as a high-volume growth code with Medicare
utilization of 10,000 or more that have increased by at least 100
percent from 2015 through 2022, and was reviewed at the January 2023
RUC meeting. Hyperbaric oxygen therapy is typically administered to one
patient in one hyperbaric chamber for two hours. Two hours is typical,
and all inputs are prorated for four units being performed (each 30
minutes, totaling 2 hours). All medical supply and time inputs have
been divided into quarters.
There has been a change in the dominant specialty providing this
service, which is now primarily performed by family medicine. There has
also been a change in clinical staff type, and it is now typical for a
single staff person to perform all activities (RN/Respiratory
Therapist) as opposed to two staff (an RN/LPN/MA and an RN/respiratory
therapist). This is primarily due to a 2016 change by the National
Board of Diving and Hyperbaric Medical Technology to no longer allow
certified nursing assistants and certified medical assistants to be
eligible to take the certified hyperbaric technologist examination. The
PE Subcommittee agreed with the specialty societies to update the
clinical staff type to reflect solely L047C RN/Respiratory Therapist.
We agree with the specialties that the intra-service time is now more
appropriately labeled as clinical activity CA021 (Perform procedure/
service--NOT directly related to physician work time) as opposed to
CA018 due to the change in clinical staff type.
We are proposing to refine the clinical labor time for the CA013
activity (Prepare room, equipment, and supplies) from 1.5 minutes to
0.5 minutes, as well as the clinical labor time for the CA016 activity
(Prepare, set-up and start IV, initial positioning and monitoring of
patient) from 1 minute to 0.5 minutes to align with the 2-minute
standard for these clinical activities. We arrived at these refinements
by dividing the standard 2-minutes of clinical labor times for CA013
and CA016 by four to account for all inputs being prorated for four
units being performed for one typical two-hour session. CA013 and CA016
would each be 0.5 minutes per 30-minute interval, which amounts to the
standard 2 minutes for these clinical activities when four units are
billed for the typical two-hour session. The RUC recommends 30 minutes
for clinical labor activity CA021 (Perform procedure/service--Not
directly related to physician work time (intra-service time) based on a
flawed assumption that the current 15 minutes for CA021 accounts for
two patients receiving treatment at the same time. We note that it has
been standard for one patient to receive treatment at a time and the
current 15 minutes for CA021 is based on a time ratio to the CY 2015
RUC-recommended direct PE inputs for CPT code 99183; therefore, we
disagree with this RUC recommendation and are proposing to refine the
recommended intra-service CA021 clinical labor time to maintain the
current 15 minutes. This is to reflect the 2015 PFS final rule where
``we used the RUC recommended direct PE inputs for 99183 and adjusted
them to align with the 30 minute treatment interval'' (79 FR 67677).
Each PE input is prorated for four units of G0277 being provided in one
typical two-hour session. Since CPT code 99183 (Physician or other
qualified health care professional attendance and supervision of
hyperbaric oxygen therapy, per session) is a 120-minute code with 60-
minute intra-service time, all PE inputs in HCPCS code G0277 are
prorated for four units being performed.
To conform to these changes in clinical labor time, we are also
proposing to refine the equipment time for the EQ362 (HBOT air break
breathing apparatus demand system (hoses, masks, penetrator, and demand
valve)) and EQ131 (hyperbaric chamber) equipment items from the
recommended 39.75 minutes to 23.25 minutes. This is a result of the 15-
minute intra-service time, as opposed to the RUC recommendation of 30
minutes of intra-service time.
(25) Remote Interrogation Device Evaluation--Cardiovascular (HCPCS Code
G2066, and CPT Codes 93297, and 93298)
CPT code 93299 (Interrogation device evaluation(s), (remote) up to
30 days; implantable cardiovascular physiologic monitor system or
subcutaneous cardiac rhythm monitor system, remote data
acquisitions(s), receipt of transmissions and technician review,
technical support and distribution of results) was
[[Page 52322]]
meant to serve as a catch-all for both base CPT codes 93297 and 93298,
which are work-only codes. However, the CPT Editorial Panel determined
that CPT code 93299 was no longer necessary if CPT codes 93297 and
93298 were assigned direct PE inputs and therefore recommended CMS to
delete CPT code 93299 at the beginning of CY 2020 under the assumption
that CPT codes 93297 and 93298 would be assigned direct PE inputs.
Since CMS did not agree with the recommended values, CMS decided to not
allocate direct PE inputs for CPT codes 93297 or 93298 and instead
created contractor priced HCPCS code G2066 for CY 2020 to ensure these
services could still be furnished that were previously described under
93299 (84 FR 62777-62778). Since the publication of the CY 2020 PFS
Final Rule, HCPCS code G2066 has remained contractor priced and CPT
codes 93297 and 93298 remain as work-only codes. CMS continues to work
with MACs and interested parties to address a lot of the payment
concerns surrounding G2066 such as discrepancies in payment between
jurisdictions. However, interested parties have indicated that a long-
term solution is needed from CMS in order to help establish payment
stability for these services.
Therefore, for CY 2024, we are proposing to delete HCPCS code G2066
and propose the RUC-recommended direct PE inputs for CPT codes 93297
and 93298. Since CPT code 93298 is most commonly billed with G2066, the
RUC recommended the same inputs for CPT code 93298 and HCPCS code G2066
in the event that no change would be made for HCPCS code G2066. Since
CMS does agree with the RUC recommended values, we are proposing to
delete HCPCS code G2066 altogether and establish direct PE-inputs for
CPT codes 93297 and 93298 based on the RUC recommendations.
The RUC did not make recommendations on and we are not proposing
any changes to the work RVUs for CPT codes 93297 and 93298.
(26) Payment for Caregiver Training Services
a. Background
In CY 2022, we received AMA RUC recommendations for a new code
family of two codes (CPT code 96202 (Multiple-family group behavior
management/modification training for parent(s)/guardian(s)/caregiver(s)
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 parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and CPT code 96203
(Multiple-family group behavior management/modification training for
parent(s)/guardian(s)/caregiver(s) 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 parent(s)/guardian(s)/caregiver(s); each
additional 15 minutes (List separately in addition to code for primary
service)) that describe group caregiver training services for patient
behavior management/modification (without the patient in attendance).
In CY 2023 we received AMA RUC recommendations for a family of three
new caregiver training codes (CPT codes 9X015 (Caregiver training in
strategies and techniques to facilitate the patient's functional
performance in the home or community (e.g., activities of daily living
[ADLs], instrumental ADLs [IADLs], transfers, mobility, communication,
swallowing, feeding, problem solving, safety practices) (without the
patient present), face-to-face; initial 30 minutes), and add-on code,
CPT code 9X016 (each additional 15 minutes (List separately in addition
to code for primary service) (Use 9X016 in conjunction with 9X015)),
and 9X017 (Group caregiver training in strategies and techniques to
facilitate the patient's functional performance in the home or
community (e.g., activities of daily living [ADLs], instrumental ADLs
[IADLs], transfers, mobility, communication, swallowing, feeding,
problem solving, safety practices) (without the patient present), face-
to-face with multiple sets of caregivers).
Historically, we have taken the position that codes describing
services furnished to other individuals without the patient's presence
are not covered services. As we noted in the CY 2023 PFS final rule (87
FR 69521), we have explained in previous rulemaking 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 patient's illness or
injury or that improve the functioning of an individual Medicare
patient'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 furnished to parties other than the
patient. 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 patient, we indicated that we did not review the
RUC-recommended valuation of these codes or propose to establish RVUs
for these codes for purposes of PFS payment. While we did not establish
payment for the new caregiver behavior management training codes in the
CY 2023 PFS final rule, we indicated that we believed there could be
circumstances where separate payment for such services may be
appropriate. We stated that we would continue to consider the status of
these and similar services in rulemaking for CY 2024 (87 FR 69522
through 69523). We specifically requested public comment on how a
patient may benefit in medical circumstances when a caregiver is
trained to effectively modify the patient's behavior, how current
Medicare policies regarding these caregiver training services (CTS) can
impact a patient's health, and how the services described by these
codes might currently be bundled into existing Medicare-covered
services. (87 FR 69521). Public comments were generally in favor of CMS
making payment for these codes, stating that there is extensive
empirical support for training parents/guardians/caregivers in behavior
management/modification as a component of the standard of care for the
treatment of certain health-related behavior issues and that this
training promotes improved outcomes. Commenters also noted that there
are several CPT codes paid under the PFS that describe services that do
not include direct contact with the patient but are still considered
integral to the patient's care, including, for example, separately
billable care management services, interprofessional consultations, and
caregiver-focused health risk assessment instrument (e.g., depression
inventory) for the benefit of the patient. In response to public
comments, we acknowledged the important role caregivers could have in a
patient's overall care.
As indicated in the CY 2023 PFS final rule, we have continued to
consider whether the caregiver behavior management training and similar
caregiver training services could be considered to fall within the
scope of services that are reasonable and necessary under section
1862(a)(1)(A) of the Act, in alignment with the principles of the
recent Executive Order on Increasing Access to High-Quality Care and
Supporting Caregivers (https://
[[Page 52323]]
www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/
executive-order-on-increasing-access-to-high-quality-care-and-
supporting-caregivers/) and as part of a HHS level review of our
payment policies to identify opportunities to better account for
patient-centered care (https://acl.gov/programs/support-caregivers/raise-family-caregiving-advisory-council), changes in medical practice
that have led to more care coordination and team-based care, and to
promote equitable access to reasonable and necessary medical services.
We also believe it is important for practitioners furnishing patient
centered care to use various effective communication techniques when
providing patient centered care, in alignment with requirements under
section 1557 of the Affordable Care Act. We believe that, in certain
circumstances, caregivers can play a key role in developing and
carrying out the treatment plan or, as applicable to physical,
occupational, or speech-language therapy, the therapy plan of care
(collectively referred to in this discussion as the ``treatment plan'')
established for the patient by the treating practitioner (which for
purposes of this discussion could include a physician; nonphysician
practitioner such as a nurse practitioner, physician assistant,
clinical nurse specialist, clinical psychologist; or a physical
therapist, occupational therapist, or speech-language pathologist). In
this context, we believe Caregiver Training Services (CTS) could be
reasonable and necessary to treat the patient's illness or injury as
required under section 1862(a)(1)(A) of the Act. We have had the
opportunity to consider the best approach to establishing separate
payment for the services described by the caregiver training codes,
especially as it relates to a practitioner who is treating a patient
and expending resources to train a caregiver who is assisting or acting
as a proxy for the patient. However, we continue to explore these
issues and would appreciate public comments on all aspects of the CTS
proposals.
In this proposed rule for CY 2024, we include a proposed definition
of ``caregiver'' for purposes of CTS, discuss the circumstances under
which patients may benefit from care involving caregivers, and propose
that CTS may meet the conditions for Medicare payment when treating
practitioners identify a need to involve and train caregivers to assist
the patient in carrying out a treatment plan. We also propose values
for each of the CTS codes.
(1) Definition of a Caregiver
In our ongoing education and outreach work on the use of caregivers
in assisting patients, we have broadly defined a caregiver as a family
member, friend, or neighbor who provides unpaid assistance to a person
with a chronic illness or disabling condition (https://www.cms.gov/
outreach-and-education/outreach/partnerships/
caregiver#:~:text=Caregivers%20are%20broadly%20defined%20as,chronic%20il
lness%20or%20disabling%20condition). Further, in the context of our
proposals for CTS services, we believe a caregiver is an individual who
is assisting or acting as a proxy for a patient with an illness or
condition of short or long-term duration (not necessarily chronic or
disabling); involved on an episodic, daily, or occasional basis in
managing a patient's complex health care and assistive technology
activities at home; and helping to navigate the patient's transitions
between care settings. For purposes of CTS, we also are including a
guardian in this definition when warranted. For CTS, when we say
``caregiver'' we are also referring to guardians who for purposes of
CTS, are the caregiver for minor children or other individuals who are
not legally independent. In these circumstances, a caregiver is a
layperson assisting the patient in carrying out a treatment plan that
is established for the patient by the treating physician or
practitioner and assists the patient with aspects of their care,
including interventions or other activities directly related to a
treatment plan established for the patient to address a diagnosed
illness or injury. In this context, caregivers would be trained by the
treating practitioner in strategies and specific activities that
improve symptoms, functioning, and adherence to treatment related to
the patient's primary clinical diagnoses. Caregiver understanding and
competence in assisting and implementing these interventions and
activities from the treating practitioner is critical for patients with
functional limitations resulting from various conditions.
(2) Patients Who Benefit From Care Involving Caregivers
We believe that a patient-centered treatment plan should
appropriately account for clinical circumstances where the treating
practitioner believes the involvement of a caregiver is necessary to
ensure a successful outcome for the patient and where, as appropriate,
the patient agrees to caregiver involvement. There may be clinical
circumstances when it might be appropriate for the physician or
practitioner to directly involve the caregiver in developing and
carrying out a treatment plan. Such clinical circumstances could
include various physical and behavioral health conditions and
circumstances under which CTS may be reasonable and necessary to train
a caregiver who assists in carrying out a treatment plan. Conditions
include but are not limited to, stroke, traumatic brain injury (TBI),
various forms of dementia, autism spectrum disorders, individuals with
other intellectual or cognitive disabilities, physical mobility
limitations, or necessary use of assisted devices or mobility aids. The
previously mentioned clinical scenarios are examples of circumstances
under which CTS may be reasonable and necessary to train a caregiver
who assists in carrying out a treatment plan. For example, patients
with dementia, autism spectrum disorder, or individuals with other
intellectual or cognitive disabilities, may require assistance with
challenging behaviors in order to carry out a treatment plan, patients
with mobility issues may need help with safe transfers in the home to
avoid post-operative complications, patients with persistent delirium
may require guidance with medication management, patients with certain
degenerative conditions or those recovering from stroke may need
assistance with feeding or swallowing. Separate from medical
circumstances noted previously in this section above, we also seek to
avoid potentially duplicative payment. We would not expect the
caregiver population receiving these services on behalf of the patient
to also receive CTS on behalf of the patient under another Medicare
benefit category or Federal program. Also, we note that when Medicare
and Medicaid cover the same services for patients eligible for both
programs, Medicare generally is the primary payer in accordance with
section 1902(a)(25) of the Act. Based on the specificity of the coding
for our proposal, we do not expect that CTS will neatly overlap with
any other coverage for patients who are dually eligible for Medicare
and Medicaid. However, we are seeking public comment regarding whether
States typically cover services similar to CTS under their Medicaid
programs, and whether such coverage would be duplicative of the CTS
service codes. We are seeking comment on this issue and whether payment
is currently available for CTS through other Federal or other programs.
[[Page 52324]]
(3) Reasonable and Necessary CTS
We believe CTS could be reasonable and necessary when furnished
based on an established individualized, patient-centered treatment plan
or therapy plan of care accounting for the patient's specific medical
needs, including, but not limited to, the examples specified previously
in this proposed rule.
As provided in the code descriptors, treating practitioners may
train caregivers in a group setting with other caregivers who are
involved in care for patients with similar needs for assistance to
carry out a treatment plan. Training for all of the caregivers for the
patient could occur simultaneously, and the applicable CTS codes (CPT
code 96202, 96203, and 9X017) would be billed once per beneficiary. We
are seeking comment on this issue. We also seek comment on whether
payment is currently available for CTS through other Federal or other
programs. We are considering whether CTS would be reasonable and
necessary when furnished to caregivers in more than one single session,
or to (presumably the same) caregivers by the same practitioner for the
same patient more than once per year and are seeking comment on this.
We want to note that the treating physician or NPP may provide training
to more than one caregiver for a single patient.
(4) Proposals
For CY 2024, we propose to establish an active payment status for
CPT codes 96202 and 96203 (caregiver behavior management/modification
training services) and CPT codes 9X015, 9X016, and 9X017 (caregiver
training services under a therapy plan of care established by a PT, OT,
SLP). These codes allow treating practitioners to report the training
furnished to a caregiver, in tandem with the diagnostic and treatment
services furnished directly to the patient, in strategies and specific
activities to assist the patient to carry out the treatment plan. As
discussed previously in this section, we believe that CTS may be
reasonable and necessary when they are integral to a patient's overall
treatment and furnished after the treatment plan (or therapy plan of
care) is established. The CTS themselves need to be congruent with the
treatment plan and designed to effectuate the desired patient outcomes.
We believe this is especially the case in medical treatment scenarios
where assistance by the caregiver receiving the CTS is necessary to
ensure a successful treatment outcome for the patient--for example,
when the patient cannot follow through with the treatment plan for
themselves (see examples previously mentioned in this section under
``Patients Who Benefit from Care Involving Caregivers'').
We are seeking public comment on this definition of `caregiver' for
purposes of CTS and are interested if there are any additional elements
of a caregiver that we should consider incorporating in this proposed
CTS caregiver definition. We think that our proposed definition would
allow for holistic care of the patient with those who know and
understand the patient, their condition, and their environment.
We propose that payment may be made for CTS services when the
treating practitioner identifies a need to involve and train one or
more caregivers to assist the patient in carrying out a patient-
centered treatment plan. We further propose that because CTS services
are furnished outside the patient's presence, the treating practitioner
must obtain the patient's (or representative's) consent for the
caregiver to receive the CTS. We further propose that the identified
need for CTS and the patient's (or representative's) consent for one or
more specific caregivers to receive CTS must be documented in the
patient's medical record.
We are proposing to require the full 60 minutes of time to be
performed in order to report CPT code 96202. The add on code, CPT code
96203, may be reported once 75 minutes of total time is performed. We
are interested in and seeking comment on how the clinician and
caregiver interactions would typically occur, including when the
practitioner is dealing with multiple caregivers and how often these
services would be billed considering the established treatment plan
involving caregivers for the typical patient.
We are soliciting public comment on each of our proposals for CTS.
b. Coding
(1) Behavior Management/Modification Training for Guardians/Caregivers
of Patients With a Mental or Physical Health Diagnosis (CPT Codes 96202
and 96203)
CPT code 96202 (Multiple-family group behavior management/
modification training for parent(s)/guardian(s)/caregiver(s) 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 parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and its add-on code, CPT
code 96203 (Multiple-family group behavior management/modification
training for parent(s)/guardian(s)/caregiver(s) 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 parent(s)/guardian(s)/caregiver(s); each
additional 15 minutes (List separately in addition to code for primary
service)), were two 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 behavior management/
modification 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 effectuating the
practitioner's treatment plan through addressing challenging behaviors
and other behaviors that may pose a risk to the person, and/or others.
According to the Summary of Recommendations (which was submitted by the
AMA RUC with the valuation of this code), during the face-to-face
service time, caregivers are taught how to structure the patient's
environment to support and reinforce 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
the patient's challenging behavior.
Behavior management/modification training for guardians/caregivers
of patients with a mental or physical health diagnosis should be
directly relevant to the person-centered treatment plan for the patient
in order for the services to be considered reasonable and necessary
under the Medicare program. Each behavior should be clearly identified
and documented in the treatment plan, and the caregiver should be
trained in positive behavior management strategies.
(a) Valuation
The RUC recommended the survey median work value for both CPT codes
96202 and 96203. Three specialty societies sent surveys to a random
sample of a subset of their members. Based on survey results and after
discussion, the RUC recommended a work RVU of 0.43 for a specific
patient who is represented in the group session being billed for CPT
code 96202. 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
[[Page 52325]]
minutes post-time for a total time of 90 minutes. For CPT code 96203,
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. We are proposing
the RUC-recommended work RVU of 0.43 for CPT code 96202 and the RUC-
recommended work RVU of 0.12 for CPT code 96203. We are also proposing
the RUC-recommended direct PE inputs for these codes.
Finally, we note that the RUC recommendation included information
suggesting that the RUC intends to review the valuation of these
services again soon.
(2) Caregiver Training in Strategies and Techniques To Facilitate the
Patient's Functional Performance (CPT Codes 9X015, 9X016, and 9X017)
CPT codes 9X015 (Caregiver training in strategies and techniques to
facilitate the patient's functional performance in the home or
community (e.g., activities of daily living [ADLs], instrumental ADLs
[IADLs], transfers, mobility, communication, swallowing, feeding,
problem solving, safety practices) (without the patient present), face-
to-face; initial 30 minutes), and add-on code, CPT code 9X016 (each
additional 15 minutes (List separately in addition to code for primary
service) (Use 9X016 in conjunction with 9X015)), and 9X017 (Group
caregiver training in strategies and techniques to facilitate the
patient's functional performance in the home or community (e.g.,
activities of daily living [ADLs], instrumental ADLs [IADLs],
transfers, mobility, communication, swallowing, feeding, problem
solving, safety practices) (without the patient present), face-to-face
with multiple sets of caregivers) are new codes created by the CPT
Editorial Panel during its October 2022 meeting. The three 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 individual
or group training to caregivers of patients. Although the patient does
not attend the trainings, the goals and outcomes of the sessions focus
on interventions aimed at improving the patient's ability to
successfully perform activities of daily living (ADL's). Activities of
daily living generally include ambulating, feeding, dressing, personal
hygiene, continence, and toileting.
During the face-to-face service time, caregivers are taught by the
treating practitioner how to facilitate the patient's activities of
daily living, transfers, mobility, communication, and problem-solving
to reduce the negative impacts of the patient's diagnosis on the
patient's daily life and assist the patient in carrying out a treatment
plan. These specific services are reasonable and necessary when
treating practitioners identify a need to involve and train caregivers
to assist the patient in carrying out a treatment plan. As part of an
individualized plan of care, the caregiver is trained in skills to
assist the patient in completing daily life activities. These trainings
to the caregiver include the development of skills such as safe
activity completion, problem solving, environmental adaptation,
training in use of equipment or assistive devices, or interventions
focusing on motor, process, and communication skills.
(a) Valuation
The RUC recommended work values for CPT codes 9X015, 9X016, and
9X017 based on the survey median values and the key reference CPT codes
97535 and 97130. The surveyed codes fall appropriately between these
key reference services compared to the work RVU, total time, and
related intensity of each service. 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
1.00 for CPT code 9X015, a work RVU of 0.54 for 9X016, and a work RVU
of 0.23 per specific patient represented in the group service being
billed for CPT code 9X017.
We are proposing the RUC-recommended work RVU 1.00 for CPT code
9X015, the RUC-recommended work RVU of 0.54 for 9X016, and the RUC-
recommended work RVU of 0.23 per identified patient service for CPT
code 9X017. The RUC noted that the recommendation for 9X017 is based on
a median group size of five caregivers. We are also proposing the RUC-
recommended direct PE inputs for these codes.
Finally, we note that the RUC recommendation included information
suggesting that the RUC intends to review the valuation of these
services again soon. We are proposing to designate 9X015, 9X016, and
9X017 as ``sometimes therapy''. This means that the services of these
codes are always furnished under a therapy plan of care when provided
by PTs, OTs, and SLPs; but, in cases where they are appropriately
furnished by physicians and NPPs outside a therapy plan of care, that
is where the services are not integral to a therapy plan of care, they
can be furnished under a treatment plan by physicians and NPPs.
We are proposing to accept RUC recommendations as stated previously
in this section for these codes.
(27) Services Addressing Health-Related Social Needs (Community Health
Integration Services, Social Determinants of Health Risk Assessment,
and Principal Illness Navigation Services)
a. Background
In recent years, we have sought to recognize significant changes in
health care practice and been engaged in an ongoing, incremental effort
to identify gaps in appropriate coding and payment for care management/
coordination and primary care services under the PFS. See, for example,
our CY 2013, 2015, and 2017 PFS final rules, where we finalized new
coding to provide separate payment for transitional care management
services, chronic care management services, and behavioral health care
management services to improve payment accuracy to better recognize
resources involved in care management and coordination for certain
patient populations (77 FR 68978, 79 FR 67715 and 82 FR 53163,
respectively). To improve payment accuracy, we are exploring ways to
better identify and value practitioners' work when they incur
additional time and resources helping patients with serious illnesses
navigate the healthcare system or removing health-related social
barriers that are interfering with the practitioner's ability to
execute a medically necessary plan of care. Practitioners and their
staff of auxiliary personnel sometimes obtain information about and
help address, social determinants of health (SDOH) that significantly
impact the practitioner's ability to diagnose or treat a patient.
Additionally, practitioners and their staff of auxiliary personnel
sometimes help newly diagnosed cancer patients and other patients with
similarly serious, high-risk illnesses navigate their care, such as
helping them understand and implement the plan of care, and locate and
reach the right practitioners and providers to access recommended
treatments and diagnostic services, taking into account the personal
circumstances of each patient. Payment for these activities, to the
extent they are reasonable and necessary for the diagnosis and
treatment of the patient's illness or injury, is currently included in
payment for other services such as evaluation and management (E/M)
visits and some care management services. Medical practice has evolved
to increasingly recognize the importance of these activities, and we
believe practitioners are performing them more often. However, this
work is not explicitly identified in current coding, and as such, we
believe it is
[[Page 52326]]
underutilized and undervalued. Accordingly, we are proposing to create
new coding to expressly identify and value these services for PFS
payment, and distinguish them from current care management services. We
expect that our proposed new codes would also support the CMS pillars
\4\ for equity, inclusion, and access to care for the Medicare
population and improve patient outcomes, including for underserved and
low-income populations where there is a disparity in access to quality
care. They would also support the White House's National Strategy on
Hunger, Nutrition and Health, and the White House's Cancer Moonshot
Initiative.\5\
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\4\ CMS Strategic Plan [verbar] CMS.
\5\ White-House-National-Strategy-on-Hunger-Nutrition-and-
Health-FINAL.pdf (whitehouse.gov); Fact Sheet: President Biden
Reignites Cancer Moonshot to End Cancer as We Know It [verbar] The
White House https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/.
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As part of this effort, in the CY 2023 PFS final rule (87 FR 69551
through 69551), we issued a Request for Information (RFI) related to
Medicare Part B Payment for services involving Community Health Workers
(CHWs). For CY 2024, we are considering how we could better recognize,
through coding and payment policies, when members of an
interdisciplinary team, including CHWs, are involved in treatment of
Medicare beneficiaries. Currently, there is no separately enumerated
statutory Medicare benefit category that provides direct payment to
CHWs for their services. Additionally, current HCPCS coding does not
specifically identify services provided by CHWs, even though CHWs may
facilitate access to healthcare through community-based services that
are necessary to alleviate barriers to care that are interfering with a
practitioner's ability to diagnosis or treat an illness or injury. In
rulemaking for the CY 2023 PFS, to gain a broader perspective on CHWs
and how we could refine our coding and payment policies to better
recognize their role in furnishing Medicare-covered services, we
solicited comment through an RFI on how services involving CHWs are
furnished in association with the specific Medicare benefits
established by the statute.
Commenters were supportive overall of potential, separate coding
and payment for services involving CHWs. The public comments indicated
that a number of physicians, practitioners, group practices, and other
entities currently utilize the services of CHWs to bridge gaps in the
continuum of their medical and behavioral healthcare furnished to
Medicare patients. In public comments on our RFI, interested parties
provided testimonials and evidence about the effectiveness of CHWs and
the services that they provide to patients in the community by
monitoring, interpreting, clarifying, and supporting the plans of care
that physicians and practitioners establish for delivering care to
patients.
In addition, in 2021, the AMA CPT Editorial Panel recognized in the
CPT E/M Guidelines that SDOH needs can increase complexity of a
practitioner's medical decision making (MDM) for an E/M visit and
increase risk to the patient, when diagnosis or treatment is
significantly limited by SDOH.\6\ Specifically, the CPT Editorial Panel
included as an example of moderate level MDM for E/M visit coding and
level selection, a situation where diagnosis or treatment is
significantly limited by SDOH. This situation is listed as an example
of moderate risk of morbidity from additional diagnostic testing or
treatment. The CPT E/M Guidelines defined SDOH as, ``Economic and
social conditions that influence the health of people and communities.
Examples may include food or housing insecurity.'' \7\ We adopted these
revised CPT guidelines for MDM in E/M visits through notice and comment
rulemaking, effective January 1, 2021 (84 FR 62844 through 62860, 87 FR
69587 through 69614).
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\6\ 2021 CPT Codebook, p. 16.
\7\ 2021 CPT Codebook, p. 14.
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Physicians and NPPs are generally trained to obtain a patient's
social and family history, in support of patient-centered care, to aid
in diagnosis, and to better understand and help address problem(s)
addressed in a medical visit and associated risk factors.\8\ For
example, a practitioner who discovers that a patient's living situation
does not permit reliable access to electricity may need to prescribe an
inhaler rather than a power-operated nebulizer to treat asthma. Some
practices and facilities employ social workers or other ancillary staff
to help address SDOH needs that are impacting the ability to provide
medically necessary care, such as appropriate treatment or diagnostic
services after an office visit or following discharge from a facility.
---------------------------------------------------------------------------
\8\ See for example Patient-Centered Communication: Basic Skills
[verbar] AAFP; https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html; https://doi.org/10.7326/M17-2441; https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/; https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf; https://edhub.ama-assn.org/steps-forward/module/2702762. The Origins of the
History and Physical Examination--Clinical Methods--NCBI Bookshelf
(nih.gov) https://www.ncbi.nlm.nih.gov/books/NBK458/.
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Practitioners are increasingly expending resources to obtain
information from the patient about health-related social needs and
risks, and formulate diagnosis and treatment plans that take these
needs into account. We believe that social workers, CHWs and other
auxiliary personnel are currently performing some of these activities,
and that the resources involved in these activities are not
consistently appropriately reflected in current coding and payment
policies. As such, we believe it would be appropriate to create codes
to separately identify and more accurately value this work.
Accordingly, we are proposing new coding to describe and separately
value three types of services that may be provided by auxiliary
personnel incident to the billing physician or practitioner's
professional services, and under the billing practitioner's
supervision, when reasonable and necessary to diagnose and treat the
patient: community health integration services, SDOH risk assessment,
and principal illness navigation. This section of our proposed rule
lays out the proposed codes and their proposed valuation, and describes
the circumstances under which we believe these services may be
reasonable and necessary for the diagnosis or treatment of illness or
injury such that Medicare payment may be made for them.
b. Community Heath Integration (CHI) Services
In light of the feedback we have received from our RFI regarding
CHWs, and increased recognition within the medical community of the
role that social needs can play in patients' health (specifically,
interfering with ability to diagnose and treat patients), we are
proposing to establish separate coding and payment for community health
integration (CHI) services. We are proposing to create two new G codes
describing CHI services performed by certified or trained auxiliary
personnel, which may include a CHW, incident to the professional
services and under the general supervision of the billing practitioner.
We are proposing that CHI services could be furnished monthly, as
medically necessary, following an initiating E/M visit (CHI initiating
visit) in which the practitioner identifies the presence of SDOH
need(s) that significantly limit the practitioner's ability to diagnose
or treat the problem(s) addressed in the visit.
[[Page 52327]]
We propose that the CHI initiating visit would be an E/M visit
(other than a low-level E/M visit that can be performed by clinical
staff) performed by the billing practitioner who will also be
furnishing the CHI services during the subsequent calendar month(s).
The CHI initiating visit would be separately billed (if all
requirements to do so are met), and would be a pre-requisite to billing
for CHI services. We believe that certain types of E/M visits, such as
inpatient/observation visits, ED visits, and SNF visits would not
typically serve as CHI initiating visits because the practitioners
furnishing the E/M services in those settings would not typically be
the ones to provide continuing care to the patient, including
furnishing necessary CHI services in the subsequent month(s).
The CHI initiating visit would serve as a pre-requisite to billing
for CHI services, during which the billing practitioner would assess
and identify SDOH needs that significantly limit the practitioner's
ability to diagnose or treat the patient's medical condition and
establish an appropriate treatment plan. The subsequent CHI services
would be performed by a CHW or other auxiliary personnel incident to
the professional services of the practitioner who bills the CHI
initiating visit. The same practitioner would furnish and bill for both
the CHI initiating visit and the CHI services, and CHI services must be
furnished in accordance with the ``incident to'' regulation at Sec.
410.26. We would not require an initiating E/M visit every month that
CHI services are billed, but only prior to commencing CHI services, to
establish the treatment plan, specify how addressing the unmet SDOH
need(s) would help accomplish that plan, and establish the CHI services
as incident to the billing practitioner's service. This framework is
similar to our current requirements for billing care management
services, such as chronic care management services. It also comports
with our longstanding policy in the Medicare Benefit Policy Manual
which provides, ``where a physician supervises auxiliary personnel to
assist him/her in rendering services to patients and includes the
charges for their services in his/her own bills, the services of such
personnel are considered incident to the physician's service if there
is a physician's service rendered to which the services of such
personnel are an incidental part. This does not mean, however, that to
be considered incident to, each occasion of service by auxiliary
personnel (or the furnishing of a supply) need also always be the
occasion of the actual rendition of a personal professional service by
the physician. Such a service or supply could be considered to be
incident to when furnished during a course of treatment where the
physician performs an initial service and subsequent services of a
frequency which reflect his/her active participation in and management
of the course of treatment'' (Chapter 15, Section 60.1.B of the
Medicare Benefit Policy Manual (Pub. 100-02), available on our website
at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf (cms.gov)).
We are also seeking comment on whether we should consider any
professional services other than an E/M visit performed by the billing
practitioner as the prerequisite initiating visit for CHI services,
including, for example, an annual wellness visit (AWV) that may or may
not include the optional SDOH risk assessment also proposed in this
rule. Under section 1861(hhh)(3)(C) of the Act, the AWV can be
furnished by a physician or practitioner, or by other types of health
professionals whose scope of practice does not include the diagnosis
and treatment involved in E/M services, for example a health educator.
When the AWV is furnished by other types of health professionals, it is
not necessarily furnished incident to the professional services of a
physician or other practitioner. Therefore, if we were to allow an AWV
furnished by a health care practitioner other than a physician or
practitioner to serve as the initiating visit for CHI services, the CHI
services would not necessarily be furnished consistent with our
proposed application of the ``incident to'' regulations as a condition
of payment. Further, we believe that practitioners would normally bill
an E/M visit in addition to the AWV when medical problems are addressed
in the course of an AWV encounter, in accordance with our manual policy
providing that a medically necessary E/M visit may be billed when
furnished on the same occasion as an AWV in those circumstances
(Chapter 12, Section 30.6.1.1.H of the Medicare Claims Processing
Manual (Pub. 100-04).
For purposes of assigning a supervision level for these ``incident
to'' services, we are proposing to designate CHI services as care
management services that may be furnished under the general supervision
of the billing practitioner in accordance with Sec. 410.26(b)(5).
General supervision means the service is furnished under the
physician's (or other practitioner's) overall direction and control,
but the physician's (or other practitioner's) presence is not required
during the performance of the service (Sec. 410.26(a)(3)).
In this proposal, the phrase or term ``problem addressed'' refers
to the definition in the CPT E/M Guidelines that we have adopted for E/
M visits. Specifically, ``[a] problem is a disease, condition, illness,
injury, symptom, finding, complaint, or other matter addressed at the
encounter, with or without a diagnosis being established at the time of
the encounter. Problem addressed [means the following]: A problem is
addressed or managed when it is evaluated or treated at the encounter
by the physician or other qualified healthcare professional reporting
the service. This includes consideration of further testing or
treatment that may not be elected by virtue of risk/benefit analysis or
patient/parent/guardian/surrogate choice. Notation in patient's medical
record that another professional is managing the problem without
additional assessment or care coordination documented does not qualify
as being addressed or managed by the physician or other qualified
healthcare professional reporting the service. Referral without
evaluation (by history, examination, or diagnostic study[ies]) or
consideration of treatment does not qualify as being addressed or
managed by the physician or other qualified healthcare professional
reporting the service. For hospital inpatient and observation care
services, the problem addressed is the problem status on the date of
the encounter, which may be significantly different than on admission.
It is the problem being managed or co-managed by the reporting
physician or other qualified healthcare professional and may not be the
cause of admission or continued stay'' (2023 CPT Codebook, p. 6-8).
For purposes of CHI services (and PIN services discussed later in
this section), we propose that SDOH means economic and social
condition(s) that influence the health of people and communities, as
indicated in these same CPT E/M Guidelines (2023 CPT codebook, page
11). We are proposing to adopt CPT's examples of SDOH, with additional
examples. Specifically, we are proposing that SDOH(s) may include but
are not limited to food insecurity, transportation insecurity, housing
insecurity, and unreliable access to public utilities, when they
significantly limit the practitioner's ability to diagnose or treat the
problem(s) addressed in the CHI initiating visit. Since Medicare
payment generally is limited to items and services that are reasonable
and necessary for the
[[Page 52328]]
diagnosis or treatment of illness or injury, the focus of CHI services
would need to be on addressing the particular SDOH need(s) that are
interfering with, or presenting a barrier to, diagnosis or treatment of
the patient's problem(s) addressed in the CHI initiating visit.
We propose the following specific codes and descriptors:
GXXX1 Community health integration services performed by certified
or trained auxiliary personnel, including a community health worker,
under the direction of a physician or other practitioner; 60 minutes
per calendar month, in the following activities to address social
determinants of health (SDOH) need(s) that are significantly limiting
ability to diagnose or treat problem(s) addressed in an initiating E/M
visit:
Person-centered assessment, performed to better understand
the individualized context of the intersection between the SDOH need(s)
and the problem(s) addressed in the initiating E/M visit.
++ Conducting a person-centered assessment to understand patient's
life story, strengths, needs, goals, preferences and desired outcomes,
including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal-setting and establishing an
action plan.
++ Providing tailored support to the patient as needed to
accomplish the practitioner's treatment plan.
Practitioner, Home-, and Community-Based Care
Coordination.
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if
applicable).
++ Communication with practitioners, home- and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) to address the
SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, and preferences, in the context of the SDOH
need(s), and educating the patient on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services addressing the SDOH need(s), in ways that are
more likely to promote personalized and effective diagnosis or
treatment.
Health care access/health system navigation
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care and helping
secure appointments with them.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the problem(s) addressed in the initiating
visit, the SDOH need(s), and adjust daily routines to better meet
diagnosis and treatment goals.
Leveraging lived experience when applicable to provide
support, mentorship, or inspiration to meet treatment goals.
GXXX2--Community health integration services, each additional 30
minutes per calendar month (List separately in addition to GXXX1).
By way of example, tailored support could be provided through CHI
services to a patient experiencing homelessness with signs of potential
cognitive impairment and a history of frequent ED admissions for
uncontrolled diabetes. The patient's primary care practitioner (PCP)
learns during a clinic visit after discharge from the ED, that the
patient has been able to reliably fill their prescriptions for diabetes
medication, but frequently loses the medication (or access to it) while
transitioning between homeless shelters and a local friend's home. In
the medical record, the PCP documents SDOH need(s) of housing
insecurity and transportation insecurity contributing to medication
noncompliance, resulting in inadequate insulin control and a recent ED
visit for hypoglycemia. The PCP's treatment plan is daily diabetes
medication, with the goal of maintaining hemoglobin A1c within
appropriate levels. To accomplish the treatment plan, the PCP orders
CHI services to develop an individualized plan for daily medication
adherence/access while applying for local housing assistance, and also
orders a follow up visit for cognitive impairment assessment and care
planning to further evaluate the potential contribution of cognitive
impairment. The PCP's auxiliary personnel provide tailored support,
comprised of facilitating communication between the patient, local
shelters, and the friend, to help the patient identify a single
location to reliably store their medication while applying for local
housing assistance. The auxiliary personnel also help the patient
identify a reliable means of transportation daily to that location for
their medication, and show the patient how to create a daily automated
phone reminder to take the diabetes medication. The auxiliary personnel
document these activities (including amount of time spent) in the
medical record at the PCP's office, along with periodic updates
regarding the status of the patient's housing assistance application.
To help inform whether our proposed descriptor times are
appropriate and reflect typical service times, and whether a frequency
limit is relevant for the add-on code, we are seeking comment on the
typical amount of time practitioners spend per month furnishing CHI
services to address SDOH needs that pose barriers to diagnosis and
treatment of problem(s) addressed in an E/M visit. We are also seeking
comment to better understand the typical duration of CHI services, in
terms of the number of months for which practitioners furnish the
services.
We are proposing that all auxiliary personnel who provide CHI
services must be certified or trained to perform all included service
elements, and authorized to perform them under applicable State laws
and regulations. Under Sec. 410.26(a)(1) of our regulations, auxiliary
personnel must meet any applicable requirements to provide the services
performed incident to the billing practitioner's professional services,
including licensure, that are imposed by the State in which the
services are being furnished. In States where there are no applicable
licensure or other laws or regulations relating to individuals
performing CHI services, we are proposing to require auxiliary
personnel providing CHI services to be trained to provide them.
Training must include the competencies of patient and family
communication, interpersonal and relationship-building, patient and
family capacity-building, service coordination and system navigation,
[[Page 52329]]
patient advocacy, facilitation, individual and community assessment,
professionalism and ethical conduct, and the development of an
appropriate knowledge base, including of local community-based
resources. We are proposing these competencies because they reflect
professional consensus regarding appropriate core competencies for
CHWs, applied to this context.\9\ We are seeking public comment on
whether it would be appropriate to specify the number of hours of
required training, as well as the training content and who should
provide the training.
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\9\ https://chwtraining.org/c3-project-chw-skills/.
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We are proposing to require that time spent furnishing CHI services
for purposes of billing HCPCS codes GXXX1-2 must be documented in the
patient's medical record in its relationship to the SDOH need(s) they
are intended to address and the clinical problem(s) they are intended
to help resolve. The activities performed by the auxiliary personnel
would be described in the medical record, just as all clinical care is
documented in the medical record. We are proposing to require the SDOH
need(s) to be recorded in the patient's medical record, and for data
standardization, practitioners would be encouraged to record the
associated ICD-10 Z-code (Z55-Z65) in the medical record and on the
claim.
Since CHI services are community-based and involve connecting the
patient with local resources in their community, and are highly
personalized, e.g., hearing and understanding a patient's life story
and culture, we believe that most of the elements of CHI services would
involve direct contact between the auxiliary personnel and the patient,
and that a substantial portion would be in-person but a portion might
be performed via two-way audio. We are seeking to confirm our
understanding of where and how these services would be typically
provided (e.g., in-person, audio-video, two-way audio).
We are seeking public comment, in particular, regarding whether we
should require patient consent for CHI services. For care management
services that could generally be performed without any direct patient
contact, we require advance patient consent to receive the services as
a prerequisite to furnishing and billing the services, to avoid
patients receiving bills for cost sharing that they might not be
expecting to receive. For example, a patient might receive chronic care
management services comprised of practitioners coordinating care with
each other and reviewing or exchanging medical records between visits
in ways that do not require involving the patient directly. As we have
frequently discussed in prior rulemaking for care management services
(for example, at 81 FR 80240), we do not have statutory authority to
waive cost sharing for care management or other services. Rather, cost
sharing remains applicable except as specified by statute such as for
certain preventive services. In recent years, we have required advance
documented patient consent to receive most care management services as
a condition of the practitioner billing those services, to avoid a
situation where the patient is surprised to receive a bill for the
associated cost sharing. These consent requirements include informing
the patient about applicable cost sharing, the right to discontinue
services, and, where applicable, the limitation that payment is made
for the service to only one practitioner per month. We have heard from
interested parties over time that requiring advance patient consent is
an administrative burden and may pose a barrier to receipt of needed
services. We are not proposing to require consent for CHI services,
since we believe these services typically would involve direct patient
contact, and largely be provided in-person. However, if we hear from
public commenters that CHI services would frequently not involve direct
contact with the patient, or could extend for periods of time for which
the patient might not be expecting to incur cost sharing obligations
(such as multiple months), we would consider requiring patient consent
to receive CHI services in our final rule.
We are proposing that a billing practitioner may arrange to have
CHI services provided by auxiliary personnel who are external to, and
under contract with, the practitioner or their practice, such as
through a community-based organization (CBO) that employs CHWs, if all
of the ``incident to'' and other requirements and conditions for
payment of CHI services are met. While we are proposing to allow CHI
services to be performed by auxiliary personnel under a contract with a
third party, we wish to be clear, as we have in our regulations for
current care management services, that there must be sufficient
clinical integration between the third party and the billing
practitioner in order for the services to be fully provided, and the
connection between the patient, auxiliary personnel, and the billing
practitioner must be maintained. As we discussed in a similar context
for care management services the CY 2017 PFS final rule, if there is
little oversight by the billing practitioner or a lack of clinical
integration between a third party providing the services and the
billing practitioner, we do not believe CHI services, as we propose to
define them, could be fully performed; and therefore, in such cases,
CHI services should not be billed (see 81 FR 80249). We would expect
the auxiliary personnel performing the CHI services to communicate
regularly with the billing practitioner to ensure that CHI services are
appropriately documented in the medical record, and to continue to
involve the billing practitioner in evaluating the continuing need for
CHI services to address the SDOH need(s) that limit the practitioner's
ability to diagnose and treat the problem(s) addressed in the
initiating visit.
As noted in the CY 2023 PFS final rule (87 FR 69790) and explained
in the CY 2023 PFS proposed rule (87 FR 46102), when 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. They may include community-action agencies, housing
agencies, area agencies on aging, centers for independent living, aging
and disability resource centers or other non-profits that apply for
grants or contract with healthcare entities to perform social services.
As described earlier, 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), the Centers for
Disease Control and Prevention (CDC), the Substance Abuse and Mental
Health Services Administration (SAMHSA), or State-funded grants to
provide social services. Generally, we believe such organizations know
the populations and communities they serve, and may have the
infrastructure or systems in place to assist practitioners to provide
CHI services. We understand that many CBOs provide social services and
do other work that is beyond the scope of CHI services, but we believe
they are well-positioned to develop relationships with practitioners
for providing reasonable and necessary CHI services.
Because we are concerned about potential fragmentation that could
occur in addressing specific SDOH, we are proposing that only one
practitioner per beneficiary per calendar month could bill for CHI
services. This would allow
[[Page 52330]]
the patient to have a single point of contact for all their CHI
services during a given month.
We are proposing that the practitioner could separately bill for
other care management services during the same month as CHI services,
if time and effort are not counted more than once, requirements to bill
the other care management service are met, and the services are
medically reasonable and necessary.
We propose that CHI services could not be billed while the patient
is under a home health plan of care under Medicare Part B, since we
believe there would be significant overlap between services furnished
under a home health plan of care and CHI services, particularly in the
home health services referred to as ``medical social services,'' and in
comprehensive care coordination. For example, medical social services
can be furnished to the patient's family member or caregiver on a
short-term basis when the home health agency (HHAs) can demonstrate
that a brief intervention by a medical social worker is necessary to
remove a clear and direct impediment to the effective treatment of the
patient's medical condition or to the patient's rate of recovery.
Additionally, the home health agency (HHA) conditions of participation
require that HHAs coordinate all aspects of the beneficiary's care
while under a home health plan of care, such as integrating services,
whether provided directly or under arrangement, to assure the
identification of patient needs and factors that could affect patient
safety and treatment effectiveness and the coordination of care
provided by all disciplines; and involvement of the patient,
representative (if any), and caregiver(s), as appropriate, in the
coordination of care activities.
Also, we note that when Medicare and Medicaid cover the same
services for patients eligible for both programs, Medicare generally is
the primary payer in accordance with section 1902(a)(25) of the Act.
Based on the specificity of the coding for our proposal, we do not
expect that CHI services will neatly overlap with any other coverage
for patients who are dually eligible for Medicare and Medicaid.
However, we are seeking public comment regarding whether States
typically cover services similar to CHI under their Medicaid programs,
and whether such coverage would be duplicative of the CHI service
codes. We also seek comment on whether there are other service elements
not included in the proposed CHI service codes that should be included,
or are important in addressing unmet SDOH need(s) that affect the
diagnosis or treatment of medical problems, where CMS should consider
coding and payment in the future.
c. Proposed CHI Services Valuation
For HCPCS code GXXX1, we are proposing a work RVU of 1.00 based on
a crosswalk to CPT code 99490 (Chronic care management services with
the following required elements: multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions that place the patient at significant
risk of death, acute exacerbation/decompensation, or functional
decline, comprehensive care plan established, implemented, revised, or
monitored; first 20 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month) as we believe these values most accurately reflect the resource
costs incurred when the billing practitioner furnishes CHI services.
CPT code 99490 has an intraservice time of 25 minutes and the work is
of similar intensity to our proposed HCPCS code GXXX1. We are,
therefore, proposing a work time of 25 minutes for HCPCS code GXXX1,
based on this same crosswalk to CPT code 99490. We are also proposing
to use this crosswalk to establish the direct PE inputs for HCPCS code
GXXX1.
For HCPCS code GXXX2, we are proposing a crosswalk to the work RVU
and direct PE inputs associated with CPT code 99439 (Chronic care
management services with the following required elements: multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient, chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored; each additional 20
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)) as we believe these values
reflect the resource costs incurred when the billing practitioner
furnishes CHI services. Therefore, we are proposing a work RVU of 0.70
and a work time of 20 minutes for HCPCS code GXXX2.
d. Social Determinants of Health (SDOH)--Proposal To Establish a Stand-
Alone G Code
i. Background
As previously discussed, there is increasing recognition within the
health care system of the need to take SDOH into account when providing
health care services, given that it is estimated \10\ that around 50
percent of an individual's health is directly related to SDOH. Healthy
People 2030 define the broad groups of SDOH as: economic stability,
education access and quality, healthcare access and quality,
neighborhood and built environment, and social and community context,
which include factors like housing, food and nutrition access, and
transportation needs. Many Federal agencies are also developing
policies to better address the impact SDOH have on patients, in support
of HHS's Strategic Approach to Addressing Social Determinants of Health
to Advance Health Equity,\11\ as well as the CMS Framework for Health
Equity.\12\
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\10\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
\11\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
\12\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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ii. Proposed SDOH Risk Assessment Code
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.
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. Practitioners across specialties have opined and
recognized the importance of SDOH on the health care provided to their
patients, including by recommending the assessment of SDOH through
position or discussion papers,13 14 15 organizational
strategic plans,\16\ and provider training modules.\17\ Previously in
this section of our proposed rule, we discuss how the practice of
medicine currently includes assessment of health-related social needs
or SDOH in taking patient histories, assessing patient risk, and
informing medical decision making, diagnosis, care and treatment. The
taking of a social history is generally
[[Page 52331]]
performed by physicians and practitioners in support of patient-
centered care to better understand and help address relevant problems
that are impacting medically necessary care. We believe the resources
involved in these activities are not appropriately reflected in current
coding and payment policies. As such, we are proposing to establish a
code to separately identify and value a SDOH risk assessment that is
furnished in conjunction with an E/M visit.
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\13\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
\14\ https://doi.org/10.7326/M17-2441.
\15\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
\16\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
\17\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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We are proposing a new stand-alone G code, GXXX5, Administration of
a standardized, evidence-based Social Determinants of Health Risk
Assessment, 5-15 minutes, not more often than every 6 months. SDOH risk
assessment refers to a review of the individual's SDOH or identified
social risk factors that influence the diagnosis and treatment of
medical conditions. We are proposing GXXX5 to identify and value the
work involved in the administering a SDOH risk assessment as part of a
comprehensive social history when medically reasonable and necessary in
relation to an E/M visit. SDOH risk assessment through a standardized,
evidence-based tool can more effectively and consistently identify
unmet SDOH needs, and enable comparisons across populations. For
example, through administration of the SDOH risk assessment for a
patient presenting for diabetes management, a practitioner might
discover that a patient's living situation does not permit reliable
access to electricity, impacting the patient's ability to keep insulin
refrigerated. The practitioner may then prescribe a type of insulin
that remains stable at room temperature, or consider oral medication
instead. In this example, the practitioner could furnish an SDOH risk
assessment in conjunction with the E/M visit to gain a more thorough
understanding of the patient's full social history and to determine
whether other SDOH needs are also impacting medically necessary care.
We further propose that the SDOH risk assessment must be furnished
by the practitioner on the same date they furnish an E/M visit, as the
SDOH assessment would be reasonable and necessary when used to inform
the patient's diagnosis, and treatment plan established during the
visit. Required elements would include:
Administration of a standardized, evidence-based \18\ SDOH
risk assessment tool that has been tested and validated through
research, and includes the domains of food insecurity, housing
insecurity, transportation needs, and utility difficulties.
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\18\ https://health.gov/healthypeople/tools-action/browse-evidence-based-resources/types-evidence-based-resources.
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++ Billing practitioners may choose to assess for additional
domains beyond those listed above if there are other prevalent or
culturally salient social determinants in the community being treated
by the practitioner.
Possible evidence-based tools include the CMS Accountable Health
Communities \19\ tool, the Protocol for Responding to & Assessing
Patients' Assets, Risks & Experiences (PRAPARE) \20\ tool, and
instruments identified for Medicare Advantage Special Needs Population
Health Risk Assessment.\21\
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\19\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
\20\ https://www.nachc.org/research-and-data/prapare/.
\21\ CMS-10825.
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Given the multifaceted nature of unmet SDOH needs, appropriate
follow-up is critical for mitigating the effects of the identified,
unmet SDOH needs on a person's health. An SDOH risk assessment without
appropriate follow-up for identified needs would serve little purpose.
As such, CMS is seeking comment on whether we should require as a
condition of payment for SDOH risk assessment that the billing
practitioner also have the capacity to furnish CHI, PIN, or other care
management services, or have partnerships with community-based
organizations (CBO) to address identified SDOH needs.
The SDOH needs identified through the risk assessment must be
documented in the medical record, and may be documented using a set of
ICD-10-CM codes known as ``Z codes'' \22\ (Z55-Z65) which are used to
document SDOH data to facilitate high-quality communication between
providers. We are proposing GXXX5 have a duration of 5-15 minutes for
the administration of an SDOH risk assessment tool, billed no more
often than once every 6 months. We propose to limit the SDOH assessment
service to once every six months, as we believe there are generally not
significant, measurable changes to health outcomes impacted by a
patient's SDOH in intervals shorter than 6 months.
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\22\ https://www.cms.gov/files/document/z-codes-data-highlight.pdf.
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iii. Proposed Valuation for SDOH Risk Assessment GXXX5
We propose a direct crosswalk to HCPCS code G0444 (Screening for
depression in adults, 5-15 minutes), with a work RVU of 0.18, as we
believe this service reflects the resource costs associated when the
billing practitioner performs HCPCS code GXXX5. HCPCS code G0444 has an
intraservice time of 15 minutes, and the physician work is of similar
intensity to our proposed HCPCS code GXXX5. Therefore, we are proposing
a work time of 15 minutes for HCPCS code GXXX5 based on this same
crosswalk to G0444. We are also proposing to use this crosswalk to
establish the direct PE inputs for HCPCS code GXXX5.
We believe these services would largely involve direct patient
contact between the billing practitioner or billing practitioner's
auxiliary personnel and the patient through in-person interactions,
which could be conducted via telecommunications as appropriate.
Therefore, we are proposing to add this code to the Medicare Telehealth
Services List to accommodate a scenario in which the practitioner (or
their auxiliary personnel incident to the practitioner's services)
completes the risk assessment in an interview format, if appropriate.
We believe it is important that when furnishing this service, all
communication with the patient be appropriate for the patient's
educational, developmental, and health literacy level, and be
culturally and linguistically appropriate. We are seeking comment on
where and how these services would be typically provided, along with
other aspects of the proposed SDOH assessment service.
e. Principal Illness Navigation (PIN) Services
i. Background
Experts on navigation of treatment for cancer and other high-risk,
serious illnesses have demonstrated the benefits of navigation services
for patients experiencing these conditions.\23\ Experts have noted the
importance of these services for all affected patients, but especially
those with socioeconomic disadvantages or barriers to care. Navigation
generally means the process or activity of ascertaining one's position
and planning and following a route; the act of directing from one place
to another; the skill or process of plotting a route and directing; the
act, activity, or process of finding the way to get to a place you are
traveling. In the context of healthcare, it refers to providing
individualized help to the patient (and caregiver, if applicable) to
identify appropriate practitioners and providers for care needs and
support, and access necessary care timely, especially when the
landscape is complex and delaying care can be deadly. It is often
referred
[[Page 52332]]
to in the context of patients diagnosed with cancer or another severe,
debilitating illness, and includes identifying or referring to
appropriate supportive services. It is perhaps most critical when a
patient is first undergoing treatment for such conditions, due to the
extensive need to access and coordinate care from a number of different
specialties or service-providers for different aspects of the diagnosis
or treatment, and in some cases, related social services (for example,
surgery, radiation, chemotherapy for cancer; psychiatry, psychology,
vocational rehabilitation for severe mental illness; psychiatry,
psychology, vocational rehabilitation, rehabilitation and recovery
programs for substance use disorder; infectious disease, neurology and
immunology for human immunodeficiency virus (HIV)-associated
neurocognitive disorders). For some conditions, patients are best able
to engage with the healthcare system and access care if they have
assistance from a single, dedicated individual who has ``lived
experience'' (meaning they have personally experienced the same illness
or condition the patient is facing). While we currently make separate
payment under the PFS for a number of care management and other
services that may include aspects of navigation services, those care
management services are focused heavily on clinical aspects of care
rather than social aspects, and are generally performed by auxiliary
personnel who may not have lived experience or training in the specific
illness being addressed. We are seeking to better understand whether
there are gaps in coding for patient navigation services for treatment
of serious illness, that are not already included in current care
management services such as advance care planning services (CPT codes
99497-99498), chronic care management services (CPT codes 99490, 99439,
99491, 99437, 99487 and 99489), general behavioral health integration
care management services (CPT code 99484), home health and hospice
supervision (HCPCS codes G0181-G0182), monthly ESRD-related services
(CPT codes 90951-90970), principal care management services (CPT codes
99424-99427), psychiatric collaborative care management services (CPT
codes 99492-99494), and transitional care management services (CPT
codes 99495-99496). See additional information on our PFS Care
Management Services web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
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\23\ See for example, https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide.
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For CY 2024, we are proposing to better recognize through coding
and payment policies when certified or trained auxiliary personnel
under the direction of a billing practitioner, which may include a
patient navigator or certified peer specialist, are involved in the
patient's health care navigation as part of the treatment plan for a
serious, high-risk disease expected to last at least 3 months, that
places the patient at significant risk of hospitalization or nursing
home placement, acute exacerbation/decompensation, functional decline,
or death. Examples of serious, high-risk diseases for which patient
navigation services could be reasonable and necessary could include
cancer, chronic obstructive pulmonary disease, congestive heart
failure, dementia, HIV/AIDS, severe mental illness, and substance use
disorder. We are proposing new coding for Principal Illness Navigation
(PIN) services. In considering the appropriate patient population, we
considered the patient population eligible for principal care
management service codes (CPT codes 99424 through 99427), as well as
clinical definitions of ``serious illness.'' For example, one peer-
review study defined ``serious illness'' as a health condition that
carries a high risk of mortality and either negatively impacts a
person's daily function or quality of life, or excessively strains
their caregivers.\24\ Another study describes a serious illness as a
health condition that carries a high risk of mortality and commonly
affects a patient for several years.\25\ Some measure serious illness
by the amount of urgent health care use (911 calls, emergency
department visits, repeated hospitalizations) and polypharmacy.\26\ The
navigation services such patients need are similar to CHI services (as
discussed previously in this section), but SDOH need(s) may be fewer or
not present; and there are specific service elements that are more
relevant for the subset of patients with serious illness. Accordingly,
we are proposing for PIN services a parallel set of services to the
proposed CHI services, but focused on patients with a serious, high-
risk illness who may not necessarily have SDOH needs; and adding
service elements to describe identifying or referring the patient to
appropriate supportive services, providing information/resources to
consider participation in clinical research/clinical trials, and
inclusion of lived experience or training in the specific condition
being addressed.
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\24\ https://pubmed.ncbi.nlm.nih.gov/29125784/.
\25\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
\26\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
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ii. Proposed Principal Illness Navigation (PIN) Service Definition
PIN services could be furnished following an initiating E/M visit
addressing a serious high-risk condition/illness/disease, with the
following characteristics:
One serious, high-risk condition expected to last at least
3 months and that places the patient at significant risk of
hospitalization, nursing home placement, acute exacerbation/
decompensation, functional decline, or death;
The condition requires development, monitoring, or
revision of a disease-specific care plan, and may require frequent
adjustment in the medication or treatment regimen, or substantial
assistance from a caregiver.
Examples of a serious, high-risk condition/illness/disease include,
but are not limited to, cancer, chronic obstructive pulmonary disease,
congestive heart failure, dementia, HIV/AIDS, severe mental illness,
and substance use disorder.
We propose that the PIN initiating visit would be an E/M visit
(other than a low-level E/M visit that can be performed by clinical
staff) performed by the billing practitioner who will also be
furnishing the PIN services during the subsequent calendar month(s).
The PIN initiating visit would be separately billed (if all
requirements to do so are met), and would be a pre-requisite to billing
for PIN services. We believe that certain types of E/M visits, such as
inpatient/observation visits, ED visits, and SNF visits would not
typically serve as PIN initiating visits because the practitioners
furnishing the E/M services in those settings would not typically be
the ones to provide continuing care to the patient, including
furnishing necessary PIN services in the subsequent month(s).
The PIN initiating visit would serve as a pre-requisite to billing
for PIN services, during which the billing practitioner would identify
the medical necessity of PIN services and establish an appropriate
treatment plan. The subsequent PIN services would be performed by
auxiliary personnel incident to the professional services of the
practitioner who bills the PIN initiating visit. The same practitioner
would furnish and bill for both the PIN initiating visit and the PIN
services, and PIN services must be furnished in accordance with the
``incident to'' regulation at Sec. 410.26. We would not require an
initiating E/M visit every month that PIN services are billed, but
[[Page 52333]]
only prior to commencing PIN services, to establish the treatment plan,
specify how PIN services would help accomplish that plan, and establish
the PIN services as incident to the billing practitioner's service.
This framework is similar to our current requirements for billing care
management services, such as chronic care management services. It also
comports with our longstanding policy in the Medicare Benefit Policy
Manual which provides, ``where a physician supervises auxiliary
personnel to assist him/her in rendering services to patients and
includes the charges for their services in his/her own bills, the
services of such personnel are considered incident to the physician's
service if there is a physician's service rendered to which the
services of such personnel are an incidental part. This does not mean,
however, that to be considered incident to, each occasion of service by
auxiliary personnel (or the furnishing of a supply) need also always be
the occasion of the actual rendition of a personal professional service
by the physician. Such a service or supply could be considered to be
incident to when furnished during a course of treatment where the
physician performs an initial service and subsequent services of a
frequency which reflect his/her active participation in and management
of the course of treatment'' (Chapter 15, Section 60.1.B of the
Medicare Benefit Policy Manual (Pub. 100-02), available on our website
at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf.
We are also seeking comment on whether we should consider any
professional services other than an E/M visit performed by the billing
practitioner as the prerequisite initiating visit for PIN services,
including, for example, an annual wellness visit (AWV) that may or may
not include the optional SDOH risk assessment also proposed in this
rule. Under section 1861(hhh)(3)(C) of the Act, the AWV can be
furnished by a physician or practitioner, or by other types of health
professionals whose scope of practice does not include the diagnosis
and treatment involved in E/M services, for example a health educator.
When the AWV is furnished by other types of health professionals,
it is not necessarily furnished incident to the professional services
of a physician or other practitioner. Therefore, if we were to allow an
AWV furnished by a health care practitioner other than a physician or
practitioner to serve as the initiating visit for PIN services, the PIN
services would not necessarily be furnished consistent with our
proposed application of the ``incident to'' regulations as a condition
of payment. Further, we believe that practitioners would normally bill
an E/M visit in addition to the AWV when medical problems are addressed
in the course of an AWV encounter, in accordance with our manual policy
providing that a medically necessary E/M visit may be billed when
furnished on the same occasion as an AWV in those circumstances
(Chapter 12, Section 30.6.1.1.H of the Medicare Claims Processing
Manual (Pub, 100-04).
For purposes of assigning a supervision level for payment, we are
proposing to designate PIN services as care management services that
may be furnished under general supervision under Sec. 410.26(b)(5).
General supervision means the service is furnished under the
physician's (or other practitioner's) overall direction and control,
but the physician's (or other practitioner's) presence is not required
during the performance of the service (Sec. 410.26(a)(3)).
We propose the following codes for PIN services. As described
previously, and in our proposed PIN code descriptors, the term ``SDOH
need(s)'' means an SDOH need(s) that is identified by the billing
practitioner as significantly limiting the practitioner's ability to
diagnose or treat the serious, high-risk condition/illness/disease
addressed in the initiating E/M visit. ``Addressed'' means the
definition in the CPT E/M Guidelines that we have adopted for E/M
visits. Specifically, ``[a] problem is a disease, condition, illness,
injury, symptom, finding, complaint, or other matter addressed at the
encounter, with or without a diagnosis being established at the time of
the encounter. Problem addressed [means the following]: A problem is
addressed or managed when it is evaluated or treated at the encounter
by the physician or other qualified healthcare professional reporting
the service. This includes consideration of further testing or
treatment that may not be elected by virtue of risk/benefit analysis or
patient/parent/guardian/surrogate choice. Notation in patient's medical
record that another professional is managing the problem without
additional assessment or care coordination documented does not qualify
as being addressed or managed by the physician or other qualified
healthcare professional reporting the service. Referral without
evaluation (by history, examination, or diagnostic study[ies]) or
consideration of treatment does not qualify as being addressed or
managed by the physician or other qualified healthcare professional
reporting the service. For hospital inpatient and observation care
services, the problem addressed is the problem status on the date of
the encounter, which may be significantly different than on admission.
It is the problem being managed or co-managed by the reporting
physician or other qualified healthcare professional and may not be the
cause of admission or continued stay'' (2023 CPT Codebook, pages. 6
through 8).
For purposes of PIN services, we propose that SDOH means economic
and social condition(s) that influence the health of people and
communities, as indicated in these same CPT E/M Guidelines (2023 CPT
codebook, page 11). We are proposing to adopt CPT's examples of SDOH,
with additional examples. Specifically, we are proposing that SDOH(s)
may include but are not limited to food insecurity, transportation
insecurity, housing insecurity, and unreliable access to public
utilities, when they significantly limit the practitioner's ability to
diagnose or treat the serious, high-risk illness/condition/disease.
Since Medicare payment is limited to items and services that are
reasonable and necessary for the diagnosis or treatment of illness or
injury, with respect to addressing SDOH need(s), the focus of PIN
services would need to be on addressing particular SDOH need(s) that
are interfering with, or presenting a barrier to, diagnosis or
treatment of the serious, high-risk condition.
GXXX3 Principal Illness Navigation services by certified or trained
auxiliary personnel under the direction of a physician or other
practitioner, including a patient navigator or certified peer
specialist; 60 minutes per calendar month, in the following activities:
Person-centered assessment, performed to better understand
the individual context of the serious, high-risk condition.
++ Conducting a person-centered assessment to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal setting and establishing an
action plan.
++ Providing tailored support as needed to accomplish the
practitioner's treatment plan.
Identifying or referring patient (and caregiver or family,
if applicable) to appropriate supportive services.
Practitioner, Home, and Community-Based Care Coordination
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; home- and
[[Page 52334]]
community-based service providers; and caregiver (if applicable).
++ Communication with practitioners, home-, and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) as needed to
address SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, preferences, and SDOH need(s), and educating
the patient (and caregiver if applicable) on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services (as needed), in ways that are more likely to
promote personalized and effective treatment of their condition.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care, and helping
secure appointments with them.
++ Providing the patient with information/resources to consider
participation in clinical trials or clinical research as applicable.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the condition, SDOH need(s), and adjust
daily routines to better meet diagnosis and treatment goals.
Leverage knowledge of the serious, high-risk condition
and/or lived experience when applicable to provide support, mentorship,
or inspiration to meet treatment goals.
GXXX4--Principal Illness Navigation services, additional 30 minutes
per calendar month (List separately in addition to GXXX3).
To help inform whether our proposed descriptor times are
appropriate and reflect typical service times, and whether a frequency
limit is relevant for the add-on code, we are seeking comment on the
typical amount of time practitioners spend per month furnishing PIN
services. We are also seeking comment to better understand the typical
duration of PIN services, in terms of the number of months for which
practitioners furnish PIN services following an initiating visit.
We are proposing that all auxiliary personnel who provide PIN
services must be certified or trained to provide all included PIN
service elements, and be authorized to perform them under applicable
State law and regulations. Under Sec. 410.26(a)(1) of our regulations,
auxiliary personnel must meet any applicable requirements to provide
incident to services, including licensure, imposed by the State in
which the services are being furnished. Many States have applicable
rules and certifications, and there are existing certification programs
for navigators working in certain settings of care or with specified
conditions, such as cancer navigators, diabetes navigators,
cardiovascular navigators, mental health navigators, geriatric care
navigators, pediatric navigators, social worker navigators, primary
care navigators, general patient advocate navigators, and nurse
navigators in ambulatory settings.\27\ Approximately 48 States have
professional certification programs for peer support specialists
providing services to patients with substance use or mental health
conditions, which is required for billing peer support specialists'
services to Medicaid. For substance use and mental health conditions,
SAMHSA recently published National Model Standards for Peer Support
Certification.\28\
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\27\ https://resumecat.com/blog/patient-navigator-certifications.
\28\ https://peerrecoverynow.org/product/comparative-analysis-of-state-requirements-for-peer-support-specialist-training-and-certification-in-the-us/ and https://store.samhsa.gov/sites/default/files/pep23-10-01-001.pdf.
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In States that do not have applicable licensure, certification, or
other laws or regulations, we are proposing to require auxiliary
personnel providing PIN services to be trained to provide them.
Training must include the competencies of patient and family
communication, interpersonal and relationship-building, patient and
family capacity building, service coordination and systems navigation,
patient advocacy, facilitation, individual and community assessment,
professionalism and ethical conduct, and the development of an
appropriate knowledge base, including specific certification or
training on the serious, high-risk condition/illness/disease addressed
in the initiating visit. We are proposing these competencies because we
believe they reflect professional consensus regarding appropriate core
competencies, adjusted to this context.\29\ We are seeking public
comment on the number of hours of training to require, as well as the
training content and who should provide the training.
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\29\ https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide; https://chwtraining.org/c3-project-chw-skills/; and https://peerrecoverynow.org/wp-content/uploads/Comparative-Analysis_Jan.31.2022-003.pdf; https://www.samhsa.gov/sites/default/files/national-model-standards-for-peer-support-certification.pdf?utm_source=SAMHSA&utm_campaign=4b88ba3e51-EMAIL_CAMPAIGN_2023_06_05_02_41&utm_medium=email&utm_term=0_-4b88ba3e51-%5BLIST_EMAIL_ID%5D.
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We are proposing that time spent furnishing PIN services for
purposes of billing HCPCS codes GXXX3-4 must be documented in the
medical record in its relationship to the serious, high-risk illness.
The activities performed by the auxiliary personnel, and how they are
related to the treatment plan for the serious, high-risk condition,
would be described in the medical record, just as all clinical care is
documented in the medical record. We would require identified SDOH
need(s), if present, to be recorded in the medical record, and for data
standardization, practitioners would be encouraged to record the
associated ICD-10 Z-code (Z55-Z65) in the medical record and on the
claim.
Similar to CHI services (discussed previously in this proposed
rule), we believe that many of the elements of PIN services would
involve direct contact between the auxiliary personnel and the patient,
but may not necessarily be in-person and a portion might be performed
via two-way audio. We are seeking to confirm our understanding of where
and how PIN services would be typically provided (for example, with or
without direct patient contact, in-person, using audio-video, using
two-way audio; and whether navigators are typically local to the
patient).
We are seeking public comment in particular regarding whether we
should require patient consent for PIN services. For care management
services that could generally be performed without any direct patient
contact, we require advance patient consent to receive the services as
a prerequisite to furnishing and billing the services, to avoid
patients receiving bills for cost sharing
[[Page 52335]]
that they might not be expecting to receive. For example, a patient
might receive chronic care management services comprised of
practitioners coordinating care with each other and reviewing or
exchanging medical records between visits, in ways that do not require
involving the patient directly. As we have frequently discussed in
prior rulemaking for care management services (for example, at 81 FR
80240), we do not have statutory authority to waive cost sharing for
care management or other services. Rather, cost sharing remains
applicable, except as specified by statute such as for certain
preventive services. In recent years, we have required advance
documented patient consent to receive most care management services as
a condition of the practitioner billing those services, to avoid a
situation where the patient is surprised to receive a bill for the
associated cost sharing. These consent requirements include informing
the patient about applicable cost sharing, the right to discontinue
services, and, where applicable, the limitation that payment is made
for the service to only one practitioner per month. We have heard from
interested parties over time that requiring advance patient consent is
an administrative burden and may unnecessarily prevent patient receipt
of needed services. We are not proposing to require consent for PIN
services, since we believe these services typically would involve
direct patient contact, and largely be provided in-person. However, if
we hear from public commenters that PIN services would frequently not
involve direct contact with the patient, or could extend for periods of
time for which the patient might not be expecting to incur cost sharing
obligations (such as several months), we would consider requiring
patient consent to receive PIN services in our final rule.
We are proposing that a billing practitioner may arrange to have
PIN services provided by auxiliary personnel who are external to, and
under contract with, the practitioner or their practice, such as
through a community-based organization (CBO) that employs CHWs, if all
of the ``incident to'' and other requirements and conditions for
payment of PIN services are met. While we are proposing to allow PIN
services to be performed by auxiliary personnel under a contract with a
third party, we wish to be clear, as we have in our regulations for
current care management services, that there must be sufficient
clinical integration between the third party and the billing
practitioner in order for the services to be fully provided, and the
connection between the patient, auxiliary personnel, and the billing
practitioner must be maintained. As we discussed in a similar context
for care management services the CY 2017 PFS final rule, if there is
little oversight by the billing practitioner or a lack of clinical
integration between a third party providing the services and the
billing practitioner, we do not believe PIN services, as we propose to
define them, could be fully performed; and therefore, in such cases,
PIN services should not be billed (81 FR 80249). We would expect the
auxiliary personnel performing the PIN services to communicate
regularly with the billing practitioner to ensure that PIN services are
appropriately documented in the medical record, and to continue to
involve the billing practitioner in evaluating the continuing need for
PIN services to address the serious, high-risk condition.
In the CY 2023 final rule (87 FR 69790) and as explained in the CY
2023 PFS proposed rule (87 FR 46102), 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. They may include community-action agencies, housing
agencies, area agencies on aging, centers for independent living, aging
and disability resource centers or other non-profits that apply for
grants or contract with healthcare entities to perform social services.
As described earlier, 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), the Centers for
Disease Control and Prevention (CDC), the Substance Abuse and Mental
Health Services Administration (SAMHSA), or State-funded grants to
provide social services. Generally, we believe such organizations know
the populations and communities they serve, and may have the
infrastructure or systems in place to assist practitioners to provide
PIN services. We understand that many CBOs provide social services and
do other work that is beyond the scope of PIN services, but we believe
they are well-positioned to develop relationships with practitioners
for providing reasonable and necessary PIN services.
We are proposing that only one practitioner per beneficiary per
calendar month could bill for PIN services for a given serious, high-
risk condition, because we are concerned about potential care
fragmentation if the patient has more than one navigator for their
condition during a given month. Our proposal would allow the patient to
have a single point of contact for navigation of their condition.
We are proposing that the practitioner could bill separately for
other care management services during the same month as PIN, if time
and effort are not counted more than once, requirements to bill the
other care management services are met, and the services are medically
reasonable and necessary.
Similar to CHI service (as discussed previously in this proposed
rule), there are aspects of PIN services, or PIN services for certain
conditions, that may be covered under a Medicaid program. When Medicare
and Medicaid cover the same services for patients eligible for both
programs, Medicare generally is the primary payer in accordance with
section 1902(a)(25) of the Act. We are seeking public comment regarding
whether States typically cover services similar to PIN under their
Medicaid programs, and whether such coverage would be duplicative of
the PIN service codes. We also seek comment on if there are other
service elements not included in the PIN service codes that are part of
associated care that should be included in the PIN service codes, or
are important in navigation for high-risk conditions, where CMS should
consider coding and payment in the future. For example, are there
circumstances when clinical navigators, under the supervision of
another professional, typically spend time face-to-face with patients
that the PIN services codes, as currently described, may not fully
account for?
iii. Proposed PIN Services Valuation
For HCPCS code GXXX3, we are proposing a work RVU of 1.00 based on
a crosswalk to CPT code 99490 (Chronic care management services with
the following required elements: multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions that place the patient at significant
risk of death, acute exacerbation/decompensation, or functional
decline, comprehensive care plan established, implemented, revised, or
monitored; first 20 minutes of clinical staff time directed by a
physician or other qualified health care professional, per calendar
month) as we believe these values most accurately reflect the resource
costs associated when the billing practitioner performs PIN services.
CPT code 99490 has an
[[Page 52336]]
intraservice time of 25 minutes and the physician work is of similar
intensity to our proposed HCPCS code GXXX3. Therefore, we are proposing
a work time of 25 minutes for HCPCS code GXXX3 based on this same
crosswalk to CPT code 99490. We are proposing to use this crosswalk as
well to establish the direct PE inputs for HCPCS code GXXX3.
For HCPCS code GXXX4, we are proposing a crosswalk to the work RVU
and direct PE inputs associated with CPT code 99439 (Chronic care
management services with the following required elements: multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient, chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored; each additional 20
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)) as we believe these values
reflect the resource costs associated with the clinician's direction of
clinical staff who are performing the PIN services. Therefore, we are
proposing a work RVU of 0.70 and a work time of 20 minutes for HCPCS
code GXXX4.
(28) Maternity Services (CPT codes 59400, 59410, 59425, 59426,
59430, 59510, 59515, 59610, 59614, 59618, 59622)
In the CY 2021 PFS final rule with comment period (85 FR 84554-
84555), we finalized our proposal to revalue the bundled maternity
codes used to bill for delivery, antepartum, and postpartum maternity
care services to account for increases in the values of office/
outpatient E/M services. These codes are all designated with a unique
global period indicator ``MMM.'' There are 11 MMM codes that include E/
M visits as part of their valuation.
For CY 2024, we are proposing to update the work RVUs and work
times of these MMM codes to reflect any relevant E/M updates associated
with their global periods that were finalized in CY 2023. Table 11
contains a list of these codes and the proposed work RVUs for CY 2024.
MMM codes are unique within the PFS in that they are the only global
codes that provide a single payment for almost 12 months of services,
which include a relatively large number of E/M visits performed along
with delivery services and imaging; and were valued using a building-
block methodology as opposed to the magnitude estimation method.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
F. Evaluation and Management (E/M) Visits
1. Background
Over the past several years, we have 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 improve payment
accuracy and help reduce practitioner burnout.
E/M visits comprise approximately 40 percent of all allowed charges
under the PFS. The office/outpatient (O/O) E/M visits comprise
approximately half of these allowed charges (approximately 20 percent
of total PFS allowed charges), and Other E/M visits (such as inpatient/
observation visits, nursing facility visits and home/residence visits)
comprise the other half (approximately 20 percent of total PFS allowed
charges). As we have discussed in prior rules, within the E/M services
represented in these percentages, there is wide variation in the volume
and level of E/M visits billed by different specialties (84 FR 62844).
According to Medicare claims data, E/M visits are furnished by nearly
all specialties, but represent a greater share of total allowed
services for physicians and other practitioners who do not routinely
furnish procedural interventions or diagnostic tests. Accordingly, our
policies for revaluation of E/M visits 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 continue our work to
address two outstanding issues in E/M visit payment: implementing
separate payment for the O/O E/M visit complexity add-on code for
separate payment, and our definition of split (or shared) visits which
we delayed last year.
For CY 2018, we solicited public comment regarding how we could
comprehensively reform the E/M documentation guidelines to reduce
administrative and clinical burden, improve payment accuracy, and
better align E/M coding and documentation with the current practice of
medicine (82 FR 34078-34079, 82 FR 53163). We believed that the
documentation requirements for history and physical exam were
particularly outdated clinically and that medical decision making (MDM)
and time were the more significant factors in distinguishing visit
levels (82 FR 53164). Public commenters recommended a transparent,
iterative, and perhaps transitional approach, and some commenters
suggested that CMS and the AMA should also undertake revision and
revaluation of the E/M visit code set itself, in addition to updating
the documentation guidelines (82 FR 53165). Having reviewed the public
comments, we noted they illustrated how difficult it is to utilize or
rely upon such a relatively small set of codes to describe and pay for
the work of a wide range of physicians and practitioners in many vastly
different clinical contexts; that E/M documentation guidelines were not
simply a matter of administrative burden, but were also clinically
outdated and intimately related to the definition and description of E/
M work as well as valuation; and that there were different opinions on
potential redefinition and revaluation of the E/M code set depending on
practitioner specialty, and the type of work dominating the specialty
(for example, primary care, so-called ``cognitive'' specialty work, or
global
[[Page 52351]]
procedures that have E/M visits bundled in rather than separately
performed and documented) (82 FR 53165). We stated that we would
continue working on these issues with interested parties in future
years.
Because we agreed with commenters that we should take an
incremental approach to these issues, the following year we proposed
changes largely limited to the O/O E/M visit code family (83 FR 59628).
In our CY 2019 PFS final rule, we finalized documentation changes, some
of which took effect in CY 2019 (83 FR 59628-59535), while others
(notably choice of MDM or time for supporting documentation) would be
effective in CY 2021 in conjunction with finalized coding and payment
changes for O/O E/M visits (83 FR 59636-59645). The coding and payment
changes included a single payment rate for levels 2 through 4 O/O E/M
visits (retaining separate payment for level 5 visits to account for
the most complex patients and visits); two HCPCS add-on codes to
provide separate, additional payments for the resource costs involved
in furnishing certain types of O/O E/M visit care, specifically visit
complexity inherently associated with primary care and non-procedural
specialty care; and a third HCPCS code for O/O E/M visits taking
extended amounts of time (83 FR 59638).
In January-February 2019, we held listening sessions, and we
learned that the AMA was convening an E/M Workgroup to develop an
alternative solution to some of these issues (84 FR 40673). The AMA
proceeded to revise and resurvey the O/O E/M visit code family (see 84
FR 62844 through 62847). Effective January 1, 2021, the CPT Editorial
Panel redefined the codes for O/O E/M visits such that the furnishing
practitioner may select the level of visit to bill based either on the
amount of practitioner time spent performing the visit or the level of
medical decision-making (MDM) involved. The CPT Editorial Panel
redefined MDM in the CPT E/M Guidelines, which are an accompanying set
of CPT interpretive guidelines delineating different levels of MDM and
various other reporting parameters. Additionally, history of present
illness (History) and a physical exam were no longer used to select the
O/O E/M visit level. These service elements were updated to remove
reliance on clinically outdated parameters to contribute to selection
of visit level, such as number of body systems reviewed, and to require
instead that a medically appropriate history and exam are performed.
Also, effective January 1, 2021, the CPT Editorial Panel revised the O/
O E/M visit descriptor times. Previously, the CPT code descriptors
included typical service times, but they were revised to specify new
time ranges that must be furnished in order to select a given visit
level using time. The AMA RUC resurveyed the O/O E/M visit CPT codes,
and provided us with revaluation recommendations that we then addressed
in our CY 2020 PFS proposed rule, a year in advance of when the revised
codes would take effect in CY 2021 (84 FR 40675 through 40678).
In our CY 2020 PFS final rule, we generally adopted the revised O/O
E/M code set and the related changes in the CPT E/M Guidelines,
including the revised approach to visit level selection and
documentation, 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 finalized Medicare-
specific coding for prolonged O/O service codes, because we were
concerned that the CPT codes were administratively complex, and their
use would have impacted our ability to tell how much total time was
spent with the patient and could have resulted in inappropriately
inflated payment (84 FR 62849 through 62850, and 85 FR 84572 through
84575).
In our CY 2020 PFS final rule, 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 visit
codes beginning in CY 2021. However, since we believed these increased
valuations still did not account for the resources involved in
furnishing certain kinds of care included in the O/O E/M visit code
set, in the CY 2021 PFS final rule, we retained our add-on codes for
visit complexity inherently associated with primary care and non-
procedural specialty care, though we refined and consolidated them into
a single code, a HCPCS add-on code G2211 (O/O E/M visit complexity)
that can be reported in conjunction with O/O E/M visits to better
account for additional resources associated with primary care, or
similarly ongoing medical care related to a patient's single, serious
condition, or complex condition (84 FR 62854 through 62856, 85 FR
84571). (Hereafter in this rule, we refer to this code as the O/O E/M
visit complexity add-on).
After we issued the CY 2021 PFS final rule, section 113 of Division
CC of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260,
December 27, 2020) (CAA, 2021) imposed a moratorium on Medicare payment
for this service by prohibiting CMS from making payment under the PFS
for services described by HCPCS code G2211 (or any successor or
substantially similar code) before January 1, 2024. Accordingly, the O/
O E/M visit complexity add-on code can be reported, but it is currently
assigned a bundled payment status indicator. See our fact sheet
available at Physician Fee Schedule (PFS) Payment for Office/Outpatient
Evaluation and Management (E/M) Visits--Fact Sheet \30\ (cms.gov).
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\30\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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In the CY 2022 PFS final rule, we established revised payment rules
for split (or shared) visits (86 FR 65150 through 65159). The following
year the CPT Editorial Panel defined a split (or shared) visit for the
first time in the CPT E/M Guidelines for 2023. However, we did not
adopt the CPT definition as it did not conform with our established
final policy or address which practitioner should report a shared
visit.
For CY 2023, the CPT Editorial Panel also 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. 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 redefined the Other E/M visits so that
they parallel the O/O E/M visits, where visit level is 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. As for the O/O E/M
visits, a medically appropriate history and/or physical exam is a
required element of the services, but no longer impacts the Other E/M
visit level. The CPT Editorial Panel also revised the service times
within the descriptors, the associated CPT prolonged service codes, and
the CPT E/M Guidelines for the Other E/M CPT codes. 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. 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
resurveyed the Other E/M visits and associated prolonged service codes,
[[Page 52352]]
and provided revaluation recommendations to CMS.
We addressed all of these changes to the Other E/M visit families
in the CY 2023 PFS final rule (87 FR 69586 through 69616). In that
final rule, we adopted the revised CPT codes and descriptors for Other
E/M visits, except for prolonged services for which we finalized
Medicare-specific coding. We also adopted the CPT E/M Guidelines for
levels of MDM as revised for 2023. Regarding valuation, we adopted most
of the RUC-recommended values for Other E/M visits, which increased
their relative valuation in aggregate. However, we stated our belief
that certain types of O/O E/M visits remain undervalued, given the
moratorium on separate payment for the O/O E/M visit complexity add-on
(87 FR 69588).We expressed concern about assumptions made in the RUC
recommendations for Other E/M visits 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 (87 FR 69587 through 69588). We stated
that this direct comparison between Other E/M visits and the O/O E/M
visit codes may not be appropriate or accurate, and laid out reasons
why practitioners in office settings may expend more resources than
practitioners in institutional and other settings. We note that the
survey times for O/O E/M visits increased significantly when resurveyed
(85 FR 50123), while times for Other E/M visits generally decreased
significantly or remained the same when resurveyed, despite the level
of MDM remaining constant (87 FR 69598, 69605). To the extent we
adopted the RUC-recommended values for Other E/M visits beginning in CY
2023, we expressed that we did not agree that the RUC-recommended
relative values for E/M visits fully accounted 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 the O/O E/M visit complexity add-on (87 FR
69588).
During the CAA, 2021 moratorium on separate payment for the O/O E/M
visit complexity add-on, interested parties have continued to engage
CMS about the appropriate valuation of O/O E/M visits relative to other
PFS services, including through public comments on the proposed
revaluation of Other E/M visits (87 FR 70218), as well as in meetings
and letters submitted to CMS outside of the rulemaking process.
Anticipating the end of the CAA, 2021 moratorium, interested parties
including the AMA, several medical associations, and others recently
approached CMS outside of the rulemaking process with recommendations
regarding implementation and potential refinements to the service
beginning in 2024 to ensure the appropriate relative valuation of O/O
E/M visits. Interested parties have also continued to approach CMS and
the CPT Editorial Panel with questions and recommendations about
payment rules for split (or shared) visits.
2. Office/Outpatient (O/O) E/M Visit Complexity Add-On Implementation
a. Background
As discussed above, in the CY 2021 PFS final rule, CMS refined the
O/O E/M visit complexity add-on code, GPC1X (which was replaced by
HCPCS code G2211), to describe intensity and complexity inherent to O/O
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, or complex condition. (85 FR 84569-84571).
While we adopted the AMA RUC recommendations for the revised O/O E/M
CPT visit codes, those values did not fully account for the resource
costs associated with primary care and other longitudinal care of
complex patients. Under our final policy, which was delayed by the CAA,
2021 before it was implemented, the O/O E/M visit complexity add-on
code could be reported with all O/O E/M visit levels. We disagreed with
comments suggesting that billing of the O/O E/M visit complexity add-on
code should be restricted to higher level office/outpatient E/M visits;
and responded that, given the wide variety of visit types billable with
the office/outpatient E/M visit code set, we did not believe that the
value associated with the typical visit accounts for the additional
resources associated with primary care or ongoing care related to a
patient's single, serious, or complex chronic condition, regardless of
the visit level. The full descriptor for the O/O E/M visit complexity
add-on code, as refined in the CY 2021 PFS final rule, is HCPCS code
G2211 (Visit complexity inherent to evaluation and management
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. (Add-on code, list
separately in addition to office/outpatient evaluation and management
visit, new or established)) (85 FR 84571) We also estimated that the O/
O E/M visit complexity add-on service would be reported by specialties
that rely on office/outpatient E/M visits to report the majority of
their services and would be billed in addition to those E/M visits.
While we did not explicitly prohibit billing the O/O E/M visit
complexity add-on in conjunction with visits that are reported with
various modifiers, and did not exclude those from our utilization
estimates, we stated we did not expect the add-on service to be
reported for visits billed with a payment modifier, for example, to
identify a separately billable E/M visit in conjunction with a minor
procedure (85 FR 84571 through 84572).We stated that visits reported
with payment modifiers are likely to involve resources that are
distinct from the stand-alone O/O E/M visits for primary care and other
longitudinal care of complex patients, and that we may consider this
issue in potential future rulemaking. We further stated that we do not
expect the O/O E/M visit complexity add-on code to be reported when the
O/O E/M visit is reported with payment modifiers such as modifier-25
which describes separately billed visits on the same day as another
visit or procedure (see our fact sheet, identifying additional
modifiers, available at Physician Fee Schedule (PFS) Payment for
Office/Outpatient Evaluation and Management (E/M) Visits--Fact Sheet
(cms.gov)).
Interested parties have continued to express uncertainty about when
it would be appropriate to report the O/O E/M visit complexity add-on
service. Some interested parties have expressed larger concerns about
potential reductions to the PFS CF or redistributive impacts among
specialties if we were to implement the O/O E/M visit complexity add-on
code. In the CY 2021 PFS final rule, we clarified and refined the
service definition to alleviate some of these concerns and revised our
utilization estimates (85 FR 84572). Conversely, some interested
parties, specifically practitioners that rely on office/outpatient E/M
visits to report the majority of their services, who could use the add-
on code to better reflect the resources they use to furnish complex
longitudinal services expressed continued support for our policy. We
reiterated our belief that the O/O E/M visit complexity add-on reflects
the time, intensity, and PE resources involved when practitioners
furnish the kinds of O/O E/M office visit services that enable them to
build longitudinal relationships with all patients (that is, not only
those patients who have a
[[Page 52353]]
chronic condition or single high-risk disease) and to address the
majority of patients' health care needs with consistency and continuity
over longer periods of time. In response to comments, we also made
further refinements to the HCPCS code descriptor to clarify that the
code applies to a serious condition rather than any single condition.
We also acknowledged concerns that, given the request by some medical
societies for additional time to educate their members about
appropriate use of the O/O E/M visit complexity add-on code, ongoing
implementation of the revisions to the O/O E/M visit code set,
electronic health records integration, and the persistence of the
COVID-19 pandemic, practitioners that rely on O/O E/M visits to report
the majority of their services are not likely to report the complexity
add-on code with every office visit. However, we disagreed with
commenters who thought the O/O E/M visit complexity add-on code would
be billed with only 10 to 25 percent of O/O E/M services. Because we
had not implemented any additional policies that restricted the billing
of this code, we estimated that the add-on code would be billed with 90
percent of O/O E/M visits billed by certain physician specialties
(roughly 58 percent of all office/outpatient E/M visits).
b. Proposal for O/O E/M Visit Complexity Add-On HCPCS Code G2211
Interested parties have continued to engage with us and provide
recommendations for implementation of the O/O E/M visit complexity add-
on. Some commenters recommended that CMS delay the implementation of
HCPCS add-on code G2211, citing concerns about the expected budget
neutrality adjustment necessitated by implementation of the O/O E/M
visit complexity add-on and redistributive impact on PFS payment (85 FR
84572). Many commenters who rely upon O/O E/M visits to report the
majority of their services continued to be supportive of HCPCS add-on
code G2211 (85 FR 84570) and have recommended that we speedily
implement it. Some of these commenters also recommended ways to clarify
the intended use of the O/O E/M visit complexity add-on code, which
could reduce redistributive impacts. Finally, as noted above, 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 (87 FR
69588).To the extent we adopted the RUC-recommended values for Other E/
M visits beginning in CY 2023, we expressed that we did not agree that
the RUC-recommended relative values for E/M visits fully reflected
appropriate relative values, since separate payment is not yet made for
HCPCS code G2211.
The CAA, 2021 moratorium on Medicare payment under the PFS for
HCPCS code G2211 will end on December 31, 2023. We are proposing to
change the status of HCPCS code G2211 to make it separately payable by
assigning the ``active'' status indicator, effective January 1, 2024.
After considering feedback we have received from interested parties,
both through the CY 2021 PFS rulemaking process and during the
moratorium, we are also proposing several policy refinements (with
respect to HCPCS code G2211). We stated in the CY 2021 PFS final rule
that we would not expect HCPCS add-on code G2211 to be reported when
the O/O E/M service is reported with a payment modifier, such as the
modifier-25, which denotes a separately billable E/M service by the
same practitioner furnished on the same day of a procedure or other
service (85 FR 84572). We continue to believe that separately
identifiable O/O E/M visits occurring on the same day as minor
procedures (such as zero-day global procedures) have resources that are
sufficiently distinct from the costs associated with furnishing stand-
alone O/O E/M visits to warrant different payment (85 FR 84572). As
such we are proposing that the O/O E/M visit complexity add-on code,
HCPCS code G2211, would not be payable when the O/O E/M visit is
reported with payment modifier-25.
Interested parties have also requested that we reconsider our
previous utilization assumptions. In the CY 2021 PFS final rule, we had
assumed that specialties that rely on O/O E/M visit codes to report the
majority of their services would be most likely to report the O/O E/M
visit complexity add-on code, and that they would report the add-on
code with every O/O E/M visit they report. We acknowledged commenters'
concerns that, given the request by some medical societies to educate
their members about appropriate use, and ongoing implementation of the
revisions to the office/outpatient E/M visit code set, and electronic
health records integration, practitioners that rely on office/
outpatient E/M visits to report the majority of their services would
not be likely to report HCPCS code G2211 with every O/O E/M visit they
report (85 FR 84572).
Interested parties have presented reasons we find persuasive that
such practitioners would not be likely to report HCPCS code G2211 with
every O/O E/M visit they report. They reasoned that many practitioners
delivering care in settings specifically designed to address acute
health care needs, without coordination or follow-up, will regularly
have encounters with patients that are not part of continuous care.
Furthermore, in contrast to situations, where the patient's
overall, ongoing care is being managed, monitored, and/or observed by a
specialist for a particular disease condition, we continue to believe
that there are many visits with new or established patients where the
O/O E/M visit complexity add-on code would not be appropriately
reported, such as when the care furnished during the O/O E/M visit is
provided by a professional whose relationship with the patient is of a
discrete, routine, or time-limited nature; such as, but not limited to,
a mole removal or referral to a physician for removal of a mole; for
treatment of a simple virus; for counseling related to seasonal
allergies, initial onset gastroesophageal reflux disease; treatment for
a fracture; and where comorbidities are either not present or not
addressed, and/or when the billing practitioner has not taken
responsibility for ongoing medical care for that particular patient
with consistency and continuity over time, or does not plan to take
responsibility for subsequent, ongoing medical care for that particular
patient with consistency and continuity over time (85 FR 84570 and
84571).
These considerations taken together with our proposal that the O/O
E/M visit complexity add-on code, HCPCS code G2211, would not be
payable when the O/O E/M visit is reported with payment modifier-25
have informed our revised utilization assumptions. Taking into
consideration the comments received by interested parties, and the
reasons discussed above, we now estimate that HCPCS code G2211 will be
billed with 38 percent of all O/O E/M visits initially. We calculated
these revised utilization assumptions by considering the uptake of new
codes in prior years, and the O/O E/M billing patterns of all
specialties. Specifically, we took into account the likelihood that
primary care specialties will have a higher utilization of the add-on
code than other specialties, surgical specialties will have the lowest
utilization since they are less likely to establish longitudinal care
relationships with patients, and other specialists are more likely to
have longitudinal care
[[Page 52354]]
relationships than surgical specialties but less likely than primary
care specialists. We also revised our estimates by excluding (1) claims
from practitioners participating in CMS capitated models, and (2)
claims for established patient visits performed by certain specialties
that are unlikely to have a longitudinal care relationship with a
beneficiary. We also accounted for the proportion of visits billed that
were furnished as consults or for the purpose of obtaining a second
clinical opinion and excluded these types of visits from our estimates.
We estimate that when fully adopted, HCPCS code G2211 will be billed
with 54 percent of all O/O E/M visits. This fully adopted estimate is
informed by considering uptake of new codes after several years. We
seek comment on these utilization assumptions and the application of
this proposed policy for CY 2024.
c. Request for Comment About Evaluating E/M Services More Regularly and
Comprehensively
Over the last several years, we have received suggestions/
recommendations outside of the rulemaking process that CMS consider
using a different approach for valuing services that relies on research
and data other than the AMA RUC's specialty-specific valuation
recommendations. These commenters have highlighted that the evolving
practice of medicine looks significantly different than it did when the
resource-based relative value scale (RBRVS) was established three
decades ago. Disease prevention and health promotion have grown in
practice and patient expectations are higher for the management of
hypertension, diabetes, and hypercholesterolemia. Additionally, more
pharmaceuticals and new biologics have expanded therapeutic options for
non-procedural care. Commenters have suggested convening expert panels
that might review pertinent research and recommend resource
recalibrations for purposes of updating relative values under the PFS.
The commenters suggested that such independent assessments could
support CMS and the broader health delivery and health finance
community in addressing growing distortions in resource allocations
under the PFS for certain types of services, including evaluation and
management visits and other non-procedural/non-surgical services.
For many years, CMS has worked to address coding and payment
deficiencies, explicitly focusing on instances where resources are not
well accounted for in the inputs for certain services, including where
significant differences in relative resources involved in furnishing
care are not reflected in the coding distinctions, or where too-
specific coding makes valuation at appropriate intervals impractical.
As we continue ongoing work to establish resource-based relative units
for PFS services, we also seek public comment about the potential range
of approaches CMS could take to improve the accuracy of valuing
services. We are especially interested in how we might improve the
accuracy of valuation for services, and we are seeking information
about how we might evaluate E/M services with greater specificity, more
regularly and comprehensively.
As we consider how CMS can potentially move forward with reforms to
the way we establish values for E/M and other services, we are
particularly interested in receiving comments from the public on the
following questions:
a. Do the existing E/M HCPCS codes accurately define the full range
of E/M services with appropriate gradations for intensity of services?
b. Are the methods used by the RUC and CMS appropriate to
accurately value E/M and other HCPCS codes?
c. Are the current Non-E/M HCPCS codes accurately defined?
d. Are the methods used by the RUC and CMS appropriate to
accurately value the non-E/M codes?
e. What are the consequences if services described by HCPCS codes
are not accurately defined?
f. What are the consequences if services described by HCPCS codes
are not accurately valued?
g. Should CMS consider valuation changes to other codes similar to
the approach in section II.J.5. of this rule?
We are particularly interested in ways that CMS could potentially
improve processes and methodologies, and we request that commenters
provide specific recommendations on ways that we can improve data
collection and to make better evidence-based and more accurate payments
for E/M and other services. We are particularly interested in
recommendations on ways that we can make more timely improvements to
our methodologies to reflect changes in the Medicare population,
treatment guidelines and new technologies that represent standards of
care. We are also interested in recommendations that would ensure that
data collection from, and documentation requirements for, physician
practices are as least burdensome as possible while also maintaining
strong program integrity requirements. Finally, we are also interested
in whether commenters believe that the current AMA RUC is the entity
that is best positioned to provide recommendations to CMS on resource
inputs for work and PE valuations, as well as how to establish values
for E/M and other physicians' services; or if another independent
entity would better serve CMS and interested parties in providing these
recommendations.
3. Split (or Shared) Visits
The split (or shared) ``substantive portion'' policy for services
furnished in facility settings was reflected in subregulatory guidance
until it was withdrawn in May 2021, in response to a petition under
the, since rescinded, Good Guidance regulation (see 87 FR 44002
(February 25, 2022). In the CY 2022 PFS final rule (86 FR 65150 through
65159), we finalized a policy for evaluation and management (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 non-physician practitioner (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 CY 2022 proposals; however, there were
divided comments with regard to our proposed definition of
``substantive portion.'' Some commenters preferred the use of medical
decision making (MDM) or one of the three key visit components as
opposed to time for purposes of defining 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. Otherwise, the NPP would bill for the service. 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, certain NPPs are paid
for the services they furnish and bill for at a reduced PFS rate (85
percent of the PFS).
For CY 2023, after considering the public comments we received, we
finalized that we would delay implementation of our definition of the
[[Page 52355]]
substantive portion as more than half of the total practitioner time
until January 1, 2024. 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 of ``substantive
portion'' as one of the following: either one of the three key E/M
elements (that is, history, exam, or MDM) or more than half of total
time. We also stated that we would delay the full implementation of the
definition of ``substantive portion'' as more than half of total time
until CY 2023 (86 FR 65152 and 65153).
Additionally, in the CY 2022 PFS final rule (86 FR 65158 through
65159), we finalized our proposal to create a payment modifier
(modifier FS), to describe split (or shared) visits (see 86 FR 65158
through 65159 for this discussion). Over time, implementing and using
this modifier will better enable us to quantify split (or shared)
visits and better understand the billing patterns of practitioners that
typically furnish them. Such information is helpful to CMS for program
integrity purposes and may also inform us on whether we need to clarify
or further revise the policy for these services in future rulemaking.
To date, we have roughly one year's worth of claims data from the time
the modifier was instituted as part of our ongoing engagement with
interested parties. We have continued to hear concerns about our intent
to implement our policy to use more than half of the total time to
define the ``substantive portion'' of a split or shared visit, and have
received requests to continue to recognize MDM as the ``substantive
portion.'' Many of these concerns specifically reference disruptions to
current team-based practice patterns, and the potential for significant
adjustments to the practice's internal processes or information systems
to allow for tracking visits based on time, rather than MDM. With these
concerns in mind, in the CY 2023 PFS final rule (87 FR 69614 through
69616), we finalized a policy to delay implementation of our definition
of substantive portion as more than half of the total practitioner time
until January 1, 2024.
After much consideration, we are proposing to delay the
implementation of our definition of the ``substantive portion'' as more
than half of the total time through at least December 31, 2024 for the
same reasons outlined in the CY 2023 PFS final rule (87 FR 69614
through 69616). We are proposing to maintain the current definition of
substantive portion for CY 2024 that allows for use of either one of
the three key components (history, exam, or MDM) or more than half of
the total time spent to determine who bills the visit. This proposed
additional delay allows interested parties to have another opportunity
to comment on this policy, and gives CMS time to consider more recent
feedback and evaluate whether there is a need for additional rulemaking
on this aspect of our policy. We are interested in how facilities are
currently implementing our split (or shared) services policy in their
workflows and how facilities are currently accounting for services of
billing practitioners that are performed split (or shared). We are also
interested in how to better account for the services of the billing
practitioner in team-based care clinical scenarios. We understand that
the AMA CPT Editorial Panel is considering revisions to aspects of
split or shared visits that may impact our policies, but those changes
may not be finalized before this proposed rule is published. We will
review the AMA CPT Editorial Panel's changes to split or shared visits
when and if available before the final rule and in the context of our
policy proposal. We will consider any changes that are made and their
relationship to our previously finalized policies, and whether a
further implementation delay beyond CY 2024 or revision of the
definition of substantive portion is warranted. We would address any
changes through future rulemaking.
We are proposing to amend 42 CFR 415.140 to revise the definition
of ``substantive portion'' in the interim while we continue to analyze
and collect information from interested parties and commenters as to
whether we should permanently modify our current definition. We note
the current definition of ``substantive portion'' applies for visits
other than critical care visits furnished in CY 2022 through CY 2024.
We are amending Sec. 415.140 by removing ``the year 2022 and 2023''
and adding in its place ``years 2022 through 2024'' after the phrase
``For visits other than critical care visits furnished in calendar.''
Therefore, the proposed paragraph would specify, for visits other than
critical care visits furnished in calendar years 2022 through 2024,
substantive portion means either 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.
G. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires CMS 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)). Section 1848(e)(1)(E) of the Act provides
for a 1.0 floor for the work GPCIs for the purposes of payment for
services furnished on or after January 1, 2004, and before January 1,
2024. Congress recently extended the 1.0 work GPCI floor only through
December 31, 2023, in division CC, section 101 of the Consolidated
Appropriations Act, 2021 (Pub. L. 116-260, enacted December 27, 2020).
Therefore, the CY 2024 work GPCIs and summarized GAFs do not reflect
the 1.0 work floor. See Addenda D and E to this proposed rule for the
CY 2024 GPCIs and summarized GAFs. These Addenda are available on the
CMS website under the supporting documents section of the CY 2024 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Review of the California Fee Schedule Areas Used for Payment for CY
2024
Section 220(h) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, April 1, 2014) 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
previous locality structure to 27 under the MSA-based locality
structure;
[[Page 52356]]
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, Napa, and
Solano counties. 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 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, in the CY 2017 PFS final rule (81 FR
80266), 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).
a. Refinement to Number of Unique Fee Schedule Areas in California for
CY 2024
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 the CY 2023 PFS
proposed rule (87 FR 46008), we proposed 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
proposed 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 three, thus retiring locality
numbers 06 and 07, as they are no longer needed. Additionally, we noted
that 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 noted 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 needed to retain a unique locality
number for San Francisco-Oakland-Berkeley (Marin Cnty), locality 52.
Based on support from commenters in the CY 2023 PFS final rule (87 FR
69621), we finalized to identify the Los Angeles-Long Beach-Anaheim
MSA, containing Orange County and Los Angeles County, by one unique
locality number, 18, and the San
[[Page 52357]]
Francisco-Oakland-Berkeley MSA containing San Francisco, San Mateo,
Alameda, and Contra Costa counties by one unique locality number, 05,
as proposed. We noted that, while we believed these changes were
appropriate to consolidate fee schedules areas that are no longer
operationally necessary, we were unable to operationalize these changes
for CY 2023 due to timing constraints relating to the actions and
coordination with the various systems maintainers required to
effectuate changes to claims processing (87 FR 69621). Therefore, for
CY 2023, there were no changes to the existing locality numbers 05, 06,
08, 18, or 26. We noted in the CY 2023 PFS final rule that we would
operationalize these finalized changes for CY 2024. We reiterate here
that we are operationalizing these locality number changes for CY 2024
via instruction to the MACs, and therefore, locality numbers 06, 07,
and 26 will no longer be used for the PFS starting January 1, 2024. We
note that these changes, when operationalized, do not have any payment
implications under the PFS because these counties are not transition
areas and will receive the same GPCI values, for PFS payment purposes,
going forward.
H. Payment for Skin Substitutes
1. Background
In the CY 2023 PFS proposed rule, CMS outlined several objectives
related to refining skin substitute policies under Medicare, including:
(1) ensuring a consistent payment approach for skin substitute products
across the physician office and hospital outpatient department setting;
(2) ensuring that appropriate HCPCS codes describe skin substitute
products; (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, to
incorporate more consistent payment methodologies; and (4) maintaining
clarity for interested parties on CMS skin substitutes policies and
procedures. When considering potential changes to policies involving
skin substitutes, we noted that we believe it would be appropriate to
take a phased approach over multiple rulemaking cycles to examine how
we could appropriately incorporate skin substitutes as supplies under
the PFS ratesetting methodology. 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. 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).
Similar to how we assess costs for other incident to supplies, our
approach to identifying appropriate PE direct costs for skin substitute
products may include: reviewing various sources for price information,
including performing market research, reviewing invoices submitted by
interested parties, or reviewing cost information on Medicare claims.
Further, we would assess how the incident to supplies are billed or
represented while also considering the service with which it is
typically furnished. For example, if the supply is billed separately,
with the base service, or usually bundled and incident to the base
service. Also, we would consider whether there are different supply
costs or other meaningful stratifications (for example, a unit of
measure or product type) that should be accounted for as we develop
direct PE costs, considering how the base service is furnished.
We are soliciting comments on how best to use these approaches
under our PFS ratesetting methodology as potential methods to establish
appropriate payment for skin substitute products under the PFS.
2. Sources of Price Information
We have refined specific PE data inputs in recent years, using
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. Historically, under the PFS, various sources
of information have helped inform payment for specific services used to
establish direct PE inputs. Direct PE inputs may derive from assessing
the current value of products on the market, which may be achieved by
utilizing Average Sales Price (ASP) data or Wholesale Acquisition Cost
data (WAC). Since some manufacturers self-report ASP/WAC data at the
end of every quarter, this may help to inform CMS of the current market
value of these products.
We also review submitted invoices, which reflect the specific cost
of products that practitioners are paying manufacturers for these
products. We note in the CY 2011 PFS final rule (75 FR 73205) we update
supply and equipment prices through an invoice submission process. In
this process, we consider the invoice information and incorporate it
into our direct costs database if the submitted pricing data indicates
the typical market price of the supply or equipment item.
While performing market research and the invoice submission process
are different methods to derive pricing for specific products,
reviewing cost information on Medicare claims may also help us identify
the variability in product costs. For example, assessing detailed cost
information on claims with skin substitute products could inform how
these products are priced and allow us to consider how the skin
substitutes are typically furnished and where these services are
performed. This information would enable us to refine our payment
policies for these products across different care settings.
We seek comment on the various cost-gathering approaches discussed
above that could inform how we establish direct PE inputs for skin
substitute products and appropriately develop payment rates for
physician services that involve furnishing skin substitute products.
3. Approaches to Billing
We acknowledge that there are various approaches that we could use
to identify and establish direct cost inputs for the skin substitute
products. We are also considering how to account for these products'
variability and resource costs, especially as new products increasingly
become available.
Similar to how different sources of information can influence cost
information for supplies, specifically considering variables such as
different units of measurement, product type, product composition, or
in what clinical circumstances the product is used, for example, would
help us appropriately reflect costs in payment for the services that
include the specific supply. We believe this to be pertinent to how we
propose to pay for skin substitute products. For instance, grouping the
direct costs for particular skin substitute products based on the
typically associated application procedure could help us systematically
incorporate the resource costs involved for different product billing
scenarios. This approach can be seen in the Outpatient Prospective
Payment System (OPPS), where a high-cost/low-cost system is used for
skin substitute products billed with a specific procedure code based on
their cost grouping.
Alternatively, when services and products are not performed
frequently enough to be grouped, retaining separate procedure coding
can help inform specificity and granularity for coding
[[Page 52358]]
and payment of these services. Specifically, we could create separate
procedure coding for specific product types, which could be billed with
the appropriate skin substitute application services. We would account
for cost variability for the different products (that is, establishing
individual or group direct cost profiles and allocating direct costs
inputs based on these groupings) under any combination of approaches
discussed above. We could also review the unit of measurement for
billed products, as available in our internal data or received in
submissions, and create direct cost groupings for the products based on
the reviewed/billed units of measurement. We could also establish
direct cost inputs by employing our standard `crosswalk' method using
information from interested parties. Specifically, we would derive PE
inputs by reviewing similarly resourced services to establish RVUs for
a service that includes the cost of the skin substitute products and
other information to account for the physician's work in furnishing the
skin substitute product. We would employ this method to establish
payment for individual services that include specific skin substitute
products or services that describe cost groupings of similarly priced
skin substitute products. As we have discussed in prior rulemaking, we
believe that the nature of the PFS relative value system is such that
all services are appropriately subject to comparisons to one another.
There is a long history of using crosswalk codes for this kind of
valuation under the PFS, which is generally established through notice
and comment rulemaking.
We seek comment on how these methods discussed above may help
reflect the resource costs involved with skin substitute products as
furnished with different skin application procedures.
I. Supervision of Outpatient Therapy Services, KX Modifier Thresholds,
Diabetes Self-Management Training (DSMT) Services by Registered
Dietitians and Nutrition Professionals, and DSMT Telehealth Services
1. Supervision of Outpatient Therapy Services in Private Practices
(a) Remote therapeutic monitoring for physical therapists and
occupational therapists in private practice.
In the CY 2023 PFS final rule, we finalized new policies that would
allow Medicare payment for remote therapeutic monitoring (RTM)
services, including allowing any RTM service to be furnished under our
general supervision requirements (87 FR 69649). RTM refers to the use
of devices to monitor a patient's health or response to treatment using
non-physiological data (please see more detailed list of RTM services
at section II.D. of this proposed rule). The current regulations,
however, at Sec. Sec. 410.59(a)(3)(ii) and 410.60(a)(3)(ii) specify
that all occupational and physical therapy services are performed by,
or under the direct supervision of, the occupational or physical
therapist, respectively, in private practice. These regulations make it
difficult for physical therapists in private practice (PTPPs) and
occupational therapists in private practice (OTPPs) to bill for the RTM
services performed by the physical therapist assistants (PTAs) and
occupational therapy assistants (OTAs) they are supervising, since the
PTPP or OTPP must remain immediately available when providing direct
supervision of PTAs and OTAs (even though we noted in the CY 2022 PFS
final rule that PTPPs and OTPPs were intended to be among the primary
billers of RTM services (86 FR 65116)). We designated the RTM codes as
``sometimes therapy'' codes (originally in the CY 2022 PFS final rule
(86 FR 65116)), meaning that these services may be furnished outside a
therapy plan of care when they are performed by physicians and certain
NPPs where their State practice includes the provision of physical
therapy, occupational therapy, and/or speech-language pathology
services. Because we did not propose revisions to Sec. Sec. 410.59 and
410.60 last year for OTPPs and PTPPs, we are proposing to establish an
RTM-specific general supervision policy at Sec. Sec. 410.59(a)(3)(ii)
and (c)(2) and 410.60(a)(3)(ii) and (c)(2) to allow OTPPs and PTPPs to
provide general supervision only for RTM services furnished by their
OTAs and PTAs, respectively.
We also note that Medicare requires each therapist in private
practice to meet the requirements specified in our current regulations
at Sec. Sec. 410.59(c) and 410.60(c) to qualify under Medicare as a
supplier of outpatient occupational therapy or physical therapy
services. Given that occupational therapists (OTs) and physical
therapists (PTs) who are not enrolled and working as employees of OTPPs
or PTPPs do not meet these requirements, we believe they should
continue to function under direct supervision of the OTPP or PTPP. This
is consistent with the Medicare Benefit Policy Manual, Pub. 100-02,
Chapter 15, section 230.4.B which states that in a private practice,
OTPPs and PTPPs must provide direct supervision of all services,
including those furnished by OTs and PTs who are not yet enrolled in
Medicare (even if they meet the other requirements for occupational
therapists and physical therapists at 42 CFR part 484). As such, we are
proposing to retain the OTPP and PTPP direct supervision requirement
for unenrolled PTs or OTs by clarifying that the proposed RTM general
supervision regulation at Sec. Sec. 410.59(c)(2) and 410.60(c)(2)
applies only to the OTA and PTA and does not include the unenrolled OT
or PT. We are seeking comment on this specific proposal as we want to
know more about how this policy is now functioning with OTs and PTs who
are not enrolled and our proposal to maintain this longstanding policy
for direct supervision.
We believe this proposal will increase access to these remotely
provided services performed by PTAs and OTAs under the general
supervision furnished by PTPPs and OTPPs. This aligns the regulatory
text at Sec. Sec. 410.59 and 410.60 with the RTM general supervision
policy that we finalized in our CY 2023 rulemaking.
(b) General Supervision for PTs and OTs in Private Practice Comment
Solicitation: Sections 1861(p) and 1861(g) (by cross-reference to
section 1861(p)) of the Act describe outpatient physical therapy and
occupational therapy services furnished to individuals by physical and
occupational therapists meeting licensing and other standards
prescribed by the Secretary, including conditions relating to the
health and safety of individuals who are furnished services on an
outpatient basis. The second sentence of section 1861(p) of the Act
describes outpatient therapy services that are provided to an
individual by a physical therapist or occupational therapist (in their
office or in such individual's home) who meets licensing and other
standards prescribed by the Secretary in regulations, and
differentiates the therapists that furnish these outpatient therapy
services from those working for an institutional provider of therapy
services. In regulations, we have specifically addressed these
therapists, previously referred to as PTPPs and OTPPs, since 1999 (63
FR 58868 through 58870). Because we wanted to create consistent
requirements for therapists and therapy assistants, we clarified in the
CY 2005 PFS final rule with comment period (69 FR 66345) that the
personnel qualifications applicable to home health agencies (HHAs) in
42 CFR part 484 are applicable to all outpatient physical therapy,
occupational therapy, and speech-language pathology services. Also, in
the CY 2005 PFS final rule, we
[[Page 52359]]
cross-referenced the qualifications for OTs and their OTAs and PTs and
their PTAs for all occupational therapy and physical therapy services,
respectively, including those who work in private practices, to 42 CFR
part 484 by adding a basic rule at Sec. Sec. 410.59(a) and 410.60(a),
respectively. Under Medicare Part B, outpatient therapy services are
generally covered when reasonable and necessary and when provided by
PTs and OTs meeting the qualifications set forth at 42 CFR part 484.
Services provided by qualified therapy assistants, including PTAs and
OTAs, may also be covered by Medicare when furnished under the
specified level of therapist supervision that is required for the
setting in which the services are provided (institutions, and private
practice therapist offices and patient homes).
In accordance with various regulations, the minimum level of
supervision for services performed by PTAs and OTAs by PTs and OTs
working in institutional settings is a general level of supervision
(see Table A in the Report to Congress titled Standards for Supervision
of PTAs and the Effects of Eliminating the Personal PTA Supervision
Requirement on the Financial Caps for Medicare Therapy Services found
at https://www.cms.gov/Medicare/Billing/TherapyServices/Downloads/61004ptartc.pdf). For example, 42 CFR 485.713 specifies that when an
OTA or PTA provides services at a location that is off the premises of
a clinic, rehabilitation agency, or public health agency, those
services are supervised by a qualified occupational or physical
therapist who makes an onsite supervisory visit at least once every 30
days. We note that the Medicare Benefit Policy Manual, Pub. 100-02,
chapter 8, section 30.2.1 defines skilled nursing and/or skilled
rehabilitation services as those services, furnished pursuant to
physician orders, that, among other requirements, ``must be provided
directly by or under the general supervision of these skilled nursing
or skilled rehabilitation personnel to assure the safety of the patient
and to achieve the medically desired result.'' The same manual
provision notes that in the SNF setting, skilled nursing or skilled
rehabilitation personnel include PTs, OTs, and SLPs. However, since
2005 in the private practice setting, we have required direct
supervision for physical and occupational therapy services furnished by
PTAs and OTAs, requiring an OTPP or PTPP to be immediately available to
furnish assistance and direction throughout the performance of the
procedure(s). We finalized this direct supervision policy in the CY
2005 PFS final rule (69 FR 66354 through 66356)--changing it from
personal supervision, which required the OTPP or PTPP to be in the same
room as the therapy assistant when they were providing the therapy
services. Under the current regulations Sec. Sec. 410.59(c)(2) and
410.60(c)(2), all services not performed personally by the OTPP or
PTPP, respectively, must be performed under the direct supervision of
the therapist by employees of the practice. Subsequently, in the CY
2008 PFS final rule (72 FR 66328 through 66332), we updated the
qualification standards at 42 CFR part 484 for OTs, OTAs, PTs, PTAs,
along with those for speech-language pathologists (SLPs).
Over the last several years, interested parties have requested that
we revise our direct supervision policy for PTPPs and OTPPs to align
with the general supervision policy for physical and occupational
therapists working in Medicare institutional providers that provide
therapy services (for example, outpatient hospitals, rehabilitation
agencies, SNFs and CORFs), to allow for the general supervision of
their therapy assistants. Additionally, the interested parties have
informed us that all-but-one State allows for general supervision of
OTAs and at least 44 States allow for the general supervision of PTAs,
via their respective State laws and policies.
We are considering whether to revise the current direct supervision
policy for PTPPs and OTPPs of their PTAs and OTAs, to general
supervision for all physical therapy and occupational therapy services
furnished in these private practices at this time, and are soliciting
comments from the public that we may consider for possible future
rulemaking. We are particularly interested in receiving comments
regarding the possibility of changing the PTA and OTA supervision
policy from direct supervision to general supervision in the private
practice setting, and whether a general supervision policy could have
implications for situations or conditions raised below:
Because we want to ensure quality of care for therapy
patients, could the general supervision policy raise safety concerns
for therapy patients if the PT or OT is not immediately available to
assist if needed? Do State laws and policies allow a PTA or OTA to
practice without a therapist in a therapy office or in a patient's
home?
Could any safety concerns be addressed by limiting the
types of services permitted under a general supervision policy?
Would a general supervision policy be enhanced with a
periodic visit by the PT or OT to provide services to the patient? If
so, what number of visits or time period should we consider?
Would a general supervision policy potentially cause a
change in utilization? Would such a change in the supervision policy
cause a difference in hiring actions by the PT or OT with respect to
therapy assistants?
Interested parties have been requesting that CMS reconsider its
supervision policies with respect to occupational therapy or physical
therapy services, and in light of experiences during the PHE for COVID-
19, we may consider proposing a general supervision policy for all
services furnished by OTAs and PTAs employed by a PTPP or OTPP in the
future after reviewing the comments and supporting data in response to
this comment solicitation. We are, therefore, soliciting public
comment, along with supporting data, about the questions and concerns
we highlighted above, for our consideration for possible future
rulemaking. We are further interested in public comment regarding
changing Sec. Sec. 410.59(a)(3)(ii), 410.59(c)(2), 410.60(a)(3)(ii),
and 410.60(c)(2) to allow for general supervision of OTAs and PTAs by
the OTPP and PTPP, respectively, when furnishing therapy services.
Additionally, we are seeking public comment for our consideration for
possible future rulemaking regarding any appropriate exceptions to
allowing general supervision in the furnishing of therapy services.
2. KX Modifier Thresholds
Formerly referred to as the therapy cap amounts, the KX modifier
thresholds were established through section 50202 of the Bipartisan
Budget Act (BBA) of 2018 (Pub. L. 115-123, February 9, 2018). These
per-beneficiary amounts under section 1833(g) of the Act (as amended by
section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33,
August 5, 1997) are updated each year based on the percentage increase
in the Medicare Economic Index (MEI). In the CY 2023 PFS final rule (87
FR 69688 through 69710), we rebased and revised the MEI to a 2017 base
year. Specifically, these amounts are calculated by updating the
previous year's amount by the percentage increase in the MEI for the
upcoming calendar year and rounding to the nearest $10.00. Thus, for CY
2024, we propose to increase the CY 2023 KX modifier threshold amount
by the most recent forecast of the 2017-based MEI. For CY 2024, the
proposed growth rate of the 2017-based MEI is estimated to be
[[Page 52360]]
4.5 percent, based on the IHS Global, Inc. (IGI) first quarter 2023
forecast with historical data through the fourth quarter of 2022.\31\
Multiplying the CY 2023 KX modifier threshold amount of $2,230 by the
proposed CY 2024 percentage increase in the MEI of 4.5 percent ($2,230
x 1.045), and rounding to the nearest $10.00, results in a proposed CY
2024 KX modifier threshold amount of $2,330 for physical therapy and
speech-language pathology services combined and $2,330 for occupational
therapy services. We are also proposing that if more recent data are
subsequently available (for example, a more recent estimate of the CY
2024 2017-based MEI percentage increase) later this year, we would use
such data, if appropriate, to determine the CY 2024 MEI percentage
increase and would apply that new estimate to formulate our values in
the CY 2024 PFS final rule.
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\31\ IGI is a nationally recognized economic and financial
forecasting firm with which we contract to forecast the components
of the MEI and other CMS market baskets.
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Section 1833(g)(7)(B) of the Act describes the targeted medical
review (MR) process for services of physical therapy, speech-language
pathology, and occupational therapy services. The threshold for
targeted MR is $3,000 until CY 2028, when it will be updated by the
percentage increase in the MEI. Consequently, for CY 2024, the MR
threshold is $3,000 for physical therapy and speech-language pathology
services combined and $3,000 for occupational therapy services. Section
1833(g)(5)(E) of the Act states that CMS shall identify and conduct
targeted medical review using factors that may include the following:
(1) The therapy provider has had a high claims denial percentage
for therapy services under this part or is less compliant with
applicable requirements under this title.
(2) The therapy provider has a pattern of billing for therapy
services under this part that is aberrant compared to peers or
otherwise has questionable billing practices for such services, such as
billing medically unlikely units of services in a day.
(3) The therapy provider is newly enrolled under this title or has
not previously furnished therapy services under this part.
(4) The services are furnished to treat a type of medical
condition.
(5) The therapy provider is part of a group that includes another
therapy provider identified using the factors described previously in
this section.
We track each beneficiary's incurred expenses for therapy services
annually and count them towards the KX modifier and MR thresholds by
applying the PFS rate for each service less any applicable MPPR amount
for services of CMS-designated ``always therapy'' services (see the CY
2011 PFS final rule at 75 FR 73236). We also track therapy services
furnished by critical access hospitals (CAHs), applying the same PFS-
rate accrual process, even though they are not paid for their therapy
services under the PFS and may be paid on a cost basis (effective
January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through
74410).
When the beneficiary's incurred expenses for the year for
outpatient therapy services exceeds one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. Through the use of
the KX modifier, the therapist and therapy provider attest that the
services above the KX modifier thresholds are reasonable and necessary
and that documentation of the medical necessity for the services is in
the beneficiary's medical record. Claims for outpatient therapy
services exceeding the KX modifier thresholds without the KX modifier
included are denied. (See the CY 2023 PFS final rule at 87 FR 69650
through 69651.)
3. Diabetes Self-Management Training (DSMT) Services Furnished by
Registered Dietitians (RDs) and Nutrition Professionals
During the CY 2022 PFS rulemaking, we adopted a regulation at Sec.
410.72(d) that requires the services that RDs and nutrition
professionals furnish to beneficiaries to be directly performed by
them. This is based on the MNT regulations at subpart G, Sec. Sec.
410.130-410.134. When developing this policy, we were only referring to
MNT services. These MNT services are distinct from the DSMT services
that RDs or nutrition professionals may furnish when they are or
represent an accredited DSMT entity.
We note that the RD or nutrition professional, when named in or a
sponsor of an accredited DSMT entity, may act as the DSMT certified
provider, which is defined at section 1861(qq) of the Act as a
physician, or other individual or entity to which Medicare makes
payment for other services. RDs and nutrition professionals may qualify
as DSMT certified providers within the meaning of the statute since
they provide and bill for MNT services. This is reinforced in our sub-
regulatory manual provisions (Pub. 100-02, Chapter 15, section 300.2),
which specifies that DSMT certified providers may bill and be paid for
the entire DSMT program and further clarifies that the RD or nutrition
professional is eligible to bill on behalf of an entire DSMT program
(or entity) on or after January 1, 2002, after obtaining a Medicare
provider number. In addition, section 1861(qq) of the Act requires that
DSMT certified providers meet quality standards established by the
Secretary, except that the physician or other individual or entity
shall be deemed to have met such standards if the physician or other
individual or entity meets applicable standards originally established
by the National Diabetes Advisory Board and subsequently revised by
organizations who participated in the establishment of standards by
such Board. DSMT entities are required to meet the National Standards
for Diabetes Self-management Education Programs (NSDSMEP) set of
quality standards at Sec. 410.144(b). DSMT entities are also required
to be recognized or accredited by CMS Accreditation Organizations
(AOs). There are currently two national DSMT AOs--the American Diabetes
Association (ADA) or the Association of Diabetes Care & Education
Specialists (ADCES) (Medicare Program Integrity Manual, Pub. 100-08,
chapter 10, section 10.2.4.B). The ADA and ADCES also review and
approve the credentials of DSMT program instructors.
Interested parties have alerted us that the wording of Sec.
410.72(d) has caused confusion for DSMT entities/suppliers and Part B
Medicare Administrative Contractors (MACs) about whether RD or
nutrition professionals must personally provide DSMT services. To
alleviate any confusion, we believe a clarification is needed to
distinguish between when a RD or nutritional professional is personally
providing MNT services, in accordance with the MNT regulations, and
when they are acting as or on behalf of an accredited DSMT entity and
billing for DSMT services that may be provided by a group of other
professionals working under an accredited DSMT entity, for example
registered nurses (RNs), pharmacists, or RDs other than the sponsoring
RD. Under the NSDSMEP quality standards, the RD, RN, or pharmacist is
permitted to provide the educational DSMT services on a solo basis,
that is without a multi-disciplinary team; however, only the RD or
nutrition professional, when enrolled as a Medicare supplier, in these
accredited DSMT entities is authorized by statute at section
1861(qq)(2)(A) to bill Medicare on behalf of the entire DSMT entity as
the DSMT certified provider.
[[Page 52361]]
Consequently, we propose to amend the regulation at Sec. 410.72(d)
to clarify that a RD or nutrition professional must personally perform
MNT services. Additionally, we propose to clarify that a RD or
nutrition professional may bill for, or on behalf of, the entire DSMT
entity as the DSMT certified provider regardless of which professional
furnishes the actual education services. We propose to clarify Sec.
410.72(d) to provide that, except for DSMT services furnished as, or on
behalf of, an accredited DSMT entity, registered dietitians and
nutrition professionals can be paid for their professional MNT services
only when the services have been directly performed by them.
4. DSMT Telehealth Issues
(a) Distant Site Practitioners
Since 2006, RDs and nutrition professionals have been recognized as
distant site practitioners for purposes of Medicare telehealth services
under section 1834(m)(4)(E) of the Act. Section 1834(m)(4)(E) of the
Act specifies that the practitioners listed at section 1842(b)(18)(C)
of the Act, which include RDs and nutrition professionals as of 2006,
can serve as distant site practitioners for Medicare telehealth
services. Our regulations and sub-regulatory policies for Medicare
telehealth services do not address scenarios involving the furnishing
of DSMT services via telehealth when the actual services are personally
furnished by individuals who provide them, for example, RNs,
pharmacists, or other multidisciplinary team members, who are not
recognized as telehealth distant site practitioners under the statutory
definition. In keeping with the NSDSMEP quality standards, an RD is
often part of a DSMT entity, and when they are, they can be considered
a ``certified provider'' when they are enrolled in Medicare and intend
to bill for the DSMT services, in accordance with the statutory
provision at section 1861(qq)(2)(A) of the Act, which defines certified
providers as physicians, or other individuals or entities designated by
the Secretary, that, in addition to providing DSMT services, provides
other items or services for which Medicare payment may be made. As we
noted previously in this section of the proposed rule, there may be
other RDs among the group or team of professionals, along with RNs and/
or pharmacists, that are performing DSMT services in addition to the
sponsoring or billing RD or nutrition professional functioning as the
certified provider. Additionally, our Medicare Benefit Policy Manual,
Pub. 100-02, Chapter 15, section 300.2 clarifies that these certified
providers, including RDs or nutrition professionals, may bill for
services of the DSMT entity. Since we allow RDs and other DSMT
certified providers to bill on behalf of the DSMT entity when other
professionals personally furnish the service in face-to-face
encounters, we believe that this should also be our policy when DSMT is
furnished as a Medicare telehealth service. To increase access to DSMT
telehealth services, we are proposing to codify billing rules for DSMT
services furnished as Medicare telehealth services at Sec.
410.78(b)(2)(x) to allow distant site practitioners who can
appropriately report DSMT services furnished in person by the DSMT
entity, such as RDs and nutrition professionals, physicians, nurse
practitioners (NPs), physician assistants (PAs), and clinical nurse
specialists (CNSs), to also report DSMT services furnished via
telehealth by the DSMT entity, including when the services are
performed by others as part of the DSMT entity. This proposed revision
to our regulation will preserve access to DSMT services via telehealth
for Medicare beneficiaries in cases where the DSMT service is provided
in accordance with the NSDSMEP quality standards. We note that DSMT
services are on the Medicare Telehealth Services List, and are subject
to the requirements and conditions of payment under section 1834(m) of
the Act and Sec. 410.78 of our regulations, including originating site
and geographic location requirements, when they are in effect. See
section II.D. for a discussion of Medicare telehealth policies.
(b) Telehealth Injection Training for Insulin-Dependent Beneficiaries
Currently, our manual instruction for Payment for Diabetes Self-
Management Training (DSMT) in the Medicare Claims Processing Manual,
Pub. 100-04, chapter 12, section 190.3.6, requires 1 hour of the 10-
hour DSMT benefit's initial training and 1 hour of the 2-hour follow-up
annual training to be furnished in-person to allow for effective
injection training when injection training is applicable for insulin-
dependent beneficiaries. This policy was clarified for 2019 to specify
that in-person training only applies to a beneficiary for whom the
injection training was applicable via CMS Transmittal 4173, available
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4173CP.pdf.
We believe that, with the expansion of the use of telehealth during
the PHE for COVID-19, there have been significant changes in clinical
standards, guidelines, and best practices regarding services furnished
using interactive telecommunications technology, including for
injection training for insulin-dependent patients. We do not want our
policies to prevent injection training via telehealth when clinically
appropriate. Consequently, we are proposing to revise our policy at
410.78(e) to allow the 1 hour of in-person training (for initial and/or
follow-up training), when required for insulin-dependent beneficiaries,
to be provided via telehealth. If finalized, we anticipate revising the
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, section
190.3.6 to reflect that flexibility.
J. Advancing Access to Behavioral Health Services
1. Implementation of Section 4121(a) of the Consolidated Appropriations
Act, 2023
a. Statutory Amendments
Section 4121(a) of Division FF, Title IV, Subtitle C of the
Consolidated Appropriations Act of 2023 (CAA, 2023) (Pub. L. 117-328,
December 29, 2022), Coverage of Marriage and Family Therapist Services
and Mental Health Counselor Services under Part B of the Medicare
Program, provides for Medicare coverage of and payment for the services
of health care professionals who meet the qualifications for marriage
and family therapists (MFTs) and mental health counselors (MHCs) when
billed by these professionals.
Specifically, section 4121(a)(1) of the CAA, 2023 amended section
1861(s)(2) of the Act by adding a new benefit category under Medicare
Part B in new subparagraph (II) to include marriage and family
therapist services (as defined in an added section 1861(lll)(1) of the
Act) and mental health counselor services (as defined in an added
section 1861(lll)(3) of the Act).
Section 4121(a)(2) of the CAA, 2023 added a new subsection (lll) to
section 1861 of the Act, which defines marriage and family therapist
services, marriage and family therapist (MFT), mental health counselor
services, and mental health counselor (MHC). Section 1861(lll)(1) of
the Act defines ``marriage and family therapist services'' as services
furnished by an MFT for the diagnosis and treatment of mental illnesses
(other than services furnished to an inpatient of a hospital), which
the MFT 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 furnished, as would otherwise be covered if furnished by a
physician or
[[Page 52362]]
as an incident to a physician's professional service. Section
1861(lll)(2) of the Act defines the term MFT to mean an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a MFT pursuant to State law of the
State in which such individual furnishes marriage and family therapist
services;
Is licensed or certified as a MFT by the State in which
such individual furnishes such services;
After obtaining such degree has performed at least 2 years
of clinical supervised experience in marriage and family therapy; and
Meets such other requirements as specified by the
Secretary.
Section 1861(lll)(3) of the Act defines ``mental health counselor
services'' as services furnished by a mental health counselor (MHC) for
the diagnosis and treatment of mental illnesses (other than services
furnished to an inpatient of a hospital), which the MHC is legally
authorized to perform under State law (or the State regulatory
mechanism provided by the State law) of the State in which such
services are furnished, as would otherwise be covered if furnished by a
physician or as incident to a physician's professional service. Section
1861(lll)(4) of the Act defining MHC as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a mental health counselor, clinical
professional counselor, or professional counselor under State law of
the State in which such individual furnishes MHC services;
Is licensed or certified as a mental health counselor,
clinical professional counselor, or professional counselor by the State
in which the services are furnished;
After obtaining such degree has performed at least 2 years
of clinical supervised experience in mental health counseling; and
Meets such other requirements as specified by the
Secretary.
Section 4121(a)(3) of the CAA, 2023 amended section 1833(a)(1) of
the Act to add a new subparagraph (FF), which provides that, with
respect to MFT services and MHC services under section 1861(s)(2)(II)
of the Act, the amounts paid shall be 80 percent of the lesser of the
actual charge for the services or 75 percent of the amount determined
for payment of a psychologist under subparagraph (L).
Section 1888(e)(2)(A)(ii) of the Act, as amended by section
4121(a)(4) of the CAA, 2023, excludes MFT and MHC services from
consolidated billing requirements under the skilled nursing facility
(SNF) prospective payment system. For further discussion about this
exclusion of MFT and MHC services from SNF consolidated billing, see
discussion in the FY 2024 SNF Prospective Payment System (PPS) proposed
rule (88 FR 21316).\32\ Section 4121(a)(5) of the CAA, 2023 amended
section 1842(b)(18)(C) of the Act to add MFTs and MHCs to the list of
practitioners whose services can only be paid by Medicare on an
assignment-related basis. MFTs, MHCs, and other practitioners described
in section 1842(b)(18)(C) of the Act may not bill (or collect any
amount from) the beneficiary or another person for any services for
which Medicare makes payment, except for deductible and coinsurance
amounts applicable under Part B. More information on assignment of
claims can be found at in the Medicare Claims Processing Manual, Pub.
100-04, Chapter 1, Section 30.3.1.
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\32\ https://www.govinfo.gov/content/pkg/FR-2023-04-10/pdf/2023-07137.pdf.
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We also note that section 1861(aa)(1)(B) of the Act was amended by
section 4121(b)(1) of the CAA, 2023 to add services furnished by MFTs
and MHCs to the definition of rural health clinic services. See section
III.B of this proposed rule for discussion related to MFT and MHC
services furnished in RHCs and FQHCs.
Additionally, section 1861(dd)(2)(B)(i)(III) of the Act was amended
by 4121(b)(2) of the CAA, 2023 to require a hospice program to have an
interdisciplinary team that includes at least one social worker, MFT or
MHC. For further discussion about this amended requirement for hospice
program interdisciplinary teams, see section III.O of this proposed
rule.
b. Proposed Changes to Regulations
Consistent with the changes to the statute described above, we are
proposing to create two new regulation sections at Sec. 410.53 and
Sec. 410.54 to codify the coverage provisions for MFTs and MHCs,
respectively.
Specifically, we are proposing to define a marriage and family
therapist at Sec. 410.53 as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a marriage and family therapist
pursuant to State law of the State in which such individual furnishes
the services defined as marriage and family therapist services;
After obtaining such degree, has performed at least 2
years or 3,000 hours of post master's degree clinical supervised
experience in marriage and family therapy in an appropriate setting
such as a hospital, SNF, private practice, or clinic; and
Is licensed or certified as a marriage and family
therapist by the State in which the services are performed.
We note that we are aware that there may be some States that
require a number of hours of clinical supervised experience for MFT
licensure that may be inconsistent with the statutory requirement in
section 1861(s)(2) of the Act that requires at least 2 years of
clinical supervised experience. We believe it could be possible for an
MFT to have completed the required number of clinical supervised hours
required for licensure in their State, but to have accomplished this in
less than two years. Therefore, we are proposing a requirement for MFTs
to have performed at least 2 years or 3,000 hours of post master's
degree clinical supervised experience, if consistent with State
licensure requirements. We believe that 3,000 hours is roughly
equivalent to the statutory requirement to have performed 2 years of
clinical supervised experience and note that the regulatory
requirements for clinical social workers (CSWs) at Sec.
410.73(a)(3)(ii) allow 2 years or 3,000 hours of supervised experience.
Additionally, the statutory benefit category for both MFTs and CSWs is
defined as services for the diagnosis and treatment of mental
illnesses. As such, we believe it would be appropriate to provide
similar flexibility in the required amount of clinical supervised
experience for MFTs and CSWs. We are also interested in public comments
regarding States that have a supervised clinical hour requirement for
MFT licensure that is less than 2 years.
We are proposing to define ``Marriage and family therapist
services'' at Sec. 410.53(b)(1) as services furnished by a marriage
and family therapist for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital), which the marriage and family therapist 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 furnished. We are also proposing at Sec. 410.53(b)(1) that the
services must be of a type that would be covered if they were furnished
by a physician or as an incident to a physician's professional service
and must meet the requirements of this section.
Lastly, we are proposing at Sec. 410.53(b)(2) that the following
services do not fall under the Medicare Part B benefit category for MFT
services:
[[Page 52363]]
Services furnished by a marriage and family therapist to
an inpatient of a Medicare-participating hospital.
Similarly, we are proposing to define a mental health counselor at
Sec. 410.54 as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a mental health counselor, clinical
professional counselor, or professional counselor under the State law
of the State in which such individual furnishes the services defined as
mental health counselor services;
After obtaining such a degree, has performed at least 2
years or 3,000 hours of post master's degree clinical supervised
experience in mental health counseling in an appropriate setting such
as a hospital, SNF, private practice, or clinic; and
Is licensed or certified as a mental health counselor,
clinical professional counselor, or professional counselor by the State
in which the services are performed. As previously explained for MFTs,
and for the same reasons, we are proposing a requirement for MHCs to
have performed at least 2 years or 3,000 hours of post master's degree
clinical supervised experience, if consistent with State licensure
requirements. We believe that 3,000 hours is roughly equivalent to the
statutory requirement to have performed 2 years of clinical supervised
experience and note that the regulatory requirements for clinical
social workers at Sec. 410.73(a)(3)(ii) allows 2 years or 3,000 hours.
The MHC statutory benefit category authorizes MHCs to furnish services
for the diagnosis and treatment of mental illnesses as it does for
CSWs. We are also interested in public comments regarding States that
have a supervised clinical hour requirement for MHC licensure that is
less than 2 years.
We are proposing to define ``mental health counselor services'' at
Sec. 410.54(b)(1) as services furnished by a mental health counselor
(as defined in paragraph (a) of this section) for the diagnosis and
treatment of mental illnesses (other than services furnished to an
inpatient of a hospital), which the mental health counselor 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 furnished. We are also proposing at Sec. 410.54(b)(1) that the
services must be of a type that would be covered if they were furnished
by a physician or as an incident to a physician's professional service.
We are proposing at Sec. 410.54(b)(2) that the following services
do not fall under the Medicare Part B benefit category for MHC
services:
Services furnished by a mental health counselor to an
inpatient of a Medicare-participating hospital.
We are proposing to amend Sec. 410.10 to add marriage and family
therapist services and mental health counselor services to the list of
included medical and other health services. We are also proposing to
amend Sec. 410.150 to add marriage and family therapists and mental
health counselors, to the list of individuals or entities to whom
payment is made.
Currently, Sec. 410.32(a)(2) lists the health care practitioners
that may order diagnostic tests. Since this list currently includes
CSWs and clinical psychologists (CPs), who are also authorized by
statute to furnish services for the diagnosis and treatment of mental
illnesses, we are proposing to amend Sec. 410.32(a)(2) to add MFTs and
MHCs to the list of practitioners who may order diagnostic tests, as
for the other non-physician practitioners, to the extent that the MFT
or MHC is legally authorized to perform the service under State law (or
the State regulatory mechanism provided by State law) of the State in
which such services are furnished.
We are also proposing to codify in a new Sec. 414.53 the payment
amounts authorized under section 1833(a)(1)(FF) for MFT and MHC
services. Additionally, we are proposing to codify at Sec. 414.53 the
payment amount for clinical social worker (CSW) services as authorized
under section 1833(a)(1)(F) of the Act. As we reviewed our regulations
to implement section 4121 of the CAA, 2023, we found that the payment
amounts for CSWs are not yet codified under regulations. Specifically,
we are proposing to add that the payment amount for CSW, MFT, and MHC
services is 80 percent of the lesser of the actual charge for the
services or 75 percent of the amount determined for clinical
psychologist services under the PFS.
We are also proposing to add MFTs and MHCs to the list of
practitioners who are eligible to furnish Medicare telehealth services
at the distant site. See section II.D. of this proposed rule for a
discussion of this proposal.
Additionally, we are proposing to allow Addiction Counselors who
meet all of the applicable requirements (possess a master's or doctor's
degree which qualifies for licensure or certification as a mental
health counselor; after obtaining such degree have performed at least 2
years (or, as proposed, 3,000 hours) of clinical supervised experience
in mental health counseling; and licensed or certified as a MHC,
clinical professional counselor, or professional counselor by the State
in which the services are furnished) to enroll in Medicare as MHCs.
That is, under this proposal, Addiction Counselors would be considered
Mental Health Counselors and would be eligible to enroll and bill
Medicare for MHC services if they meet these requirements. We
understand there is variation in the terminology used for licensure
across States for MHCs and MFTs and are seeking information pertaining
to other types of professionals who may meet the applicable
requirements for enrollment as mental health counselors. We note that
in past rulemaking, we have discussed the term `mental health' to be
inclusive of diagnosis and treatment of substance use disorders. For
example, in the CY 2022 PFS final rule (86 FR 65061), we stated that
SUD services are considered mental health services for the purposes of
the expanded definition of ``interactive telecommunications system.''
We propose to apply that same interpretation for purposes of the mental
health services included in the definition of MFT, MHC, and to clarify
that the same interpretation applies for CSW, and CP services.
c. Coding Updates To Allow MFT and MHC Billing
In light of the new statutory benefits for MFTs and MHCs authorized
by section 4121(a) of the CAA, 2023, we have considered whether updates
to certain HCPCS codes are required in order to allow MFTs and MHCs to
bill for the services described by those HCPCS codes. In the CY 2023
PFS final rule, we finalized new coding and payment for General
Behavioral Health Integration services performed by CPs or CSWs to
account for monthly care integration where the mental health services
furnished by a CP or CSW serve as the focal point of care integration.
In light of the new coverage under Medicare for MFT and MHC services
for the diagnosis and treatment of mental illness, we are proposing to
revise the code descriptor for HCPCS code G0323 in order to allow MFTs
and MHCs, as well as CPs and CSWs, to be able to bill for this monthly
care integration service. We note that MFTs and MHCs, like CSWs, are
authorized by statute for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital), which the MFT or MHC 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 furnished, as would otherwise be
covered if furnished by a physician or
[[Page 52364]]
as an incident to a physician's professional service. The proposed code
descriptor for HCPCS code G0323 is: Care management services for
behavioral health conditions, at least 20 minutes of clinical
psychologist, clinical social worker, mental health counselor, or
marriage and family therapist time, per calendar month. (These services
include 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 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.)
Lastly, we note that consistent with the proposed changes to
valuation of CPT code 99484 in the Valuation of Specific Codes section
(section II.E. of this proposed rule), which describes General BHI and
is the crosswalk code used for valuation of HCPCS code G0323, we are
also proposing conforming updates to the valuation for work and PE
inputs for HCPCS code G0323. See section II.E. of this proposed rule
for further discussion of changes to the valuation for HCPCS code
G0323.
We welcome comments regarding any other HCPCS codes that may
require updating to allow MFTs and MHCs to bill for the services
described in the HCPCS code descriptor.
d. Medicare Enrollment of MFTs and MHCs
MFTs and MHCs who meet the applicable requirements (possess a
master's or doctor's degree which qualifies for licensure or
certification as a mental health counselor; after obtaining such degree
have performed at least 2 years (or, as proposed, 3,000 hours) of
clinical supervised experience in mental health counseling; and is
licensed or certified as a MHC, clinical professional counselor, or
professional counselor by the State in which the services are
furnished) described in detail above in this section, as finalized,
will need to enroll in Medicare as MFTs and MHCs in order to submit
claims for marriage and family therapist services and mental health
counselor services, respectively, furnished to Medicare beneficiaries.
Under Sec. 424.510, a provider or supplier must complete, sign, and
submit to its assigned MAC the appropriate Form CMS-855 (OMB Control
No. 0938-0685) application in order to enroll in the Medicare program
and obtain Medicare billing privileges. The Form CMS-855, which can be
submitted via paper or electronically through the internet-based
Provider Enrollment, Chain, and Ownership System (PECOS) process (SORN:
09-70-0532; 104 Provider Enrollment, Chain, and Ownership System),
captures information about the provider or supplier that is needed for
CMS or its MACs to determine whether the provider or supplier meets all
Medicare requirements. We propose that the MFT and MHC supplier types,
like most non-physician practitioner types, be subject to limited-risk
screening under Sec. 424.518, for we have no basis on which to assign
these suppliers as a class to a higher screening category.
MFTs and MHCs that meet the proposed requirements in Sec. Sec.
410.53 and 410.54 as finalized, would enroll in Medicare via the Form
CMS-855I application (Medicare Enrollment Application--Physicians and
Non-Physician Practitioners; OMB No. 0938-1355) and could begin
submitting their enrollment applications after the publication of the
CY 2024 PFS final rule. However, as the new benefit categories
authorized by section 4121(a) of the CAA, 2023, do not take effect
until January 1, 2024, MFT or MHC claims for MFT or MHC services
furnished to Medicare beneficiaries with dates of service prior to
January 1, 2024 will not be payable under Medicare Part B. MFTs and
MHCs can visit https://www.cms.gov/medicare/provider-enrollment-and-certification for basic information on the provider enrollment process.
2. Implementation of Section 4123 of the CAA, 2023
Section 4123(a)(1) of the CAA, 2023, Improving Mobile Crisis Care
in Medicare, amended section 1848 of the Act by adding a new paragraph
(b)(12) regarding payment for psychotherapy for crisis services
furnished in an applicable site of service. New subparagraph (A) of
section 1848(b)(12) of the Act requires the Secretary to establish new
HCPCS codes under the PFS for services described in subparagraph (B)
that are furnished on or after January 1, 2024. Subparagraph (B) of
section 1848(b)(12) of the Act describes these services as
psychotherapy for crisis services that are furnished in an applicable
site of service. Section 1848(b)(12)(C) of the Act specifies that the
payment amount for these psychotherapy for crisis services shall be
equal to 150 percent of the fee schedule amount for non-facility sites
of service for each year for the services identified (as of January 1,
2022) by HCPCS codes 90839 (Psychotherapy for crisis; first 60 minutes)
and 90840 (Psychotherapy for crisis; each additional 30 minutes (List
separately in addition to code for primary service)), and any
succeeding codes.
For purposes of this provision, subparagraph (D)(i) of new section
1848(b)(12) of the Act defines an applicable site of service as a site
of service other than a site where the facility rate under the PFS
applies and other than an office setting, while subparagraph (D)(ii)
requires that the code descriptors for these new psychotherapy for
crisis services be the same as the services identified (as of January
1, 2022) by HCPCS codes 90838 and 90840, and any succeeding codes,
except that the new codes shall be limited to services furnished in an
applicable site of service.
Therefore, consistent with the requirements described in new
paragraph (12) of section 1848(b) of the Act, we are proposing to
create two new G-codes describing psychotherapy for crisis services
furnished in any place of service at which the non-facility rate for
psychotherapy for crisis services applies, other than the office
setting: HCPCS codes GPFC1 and GPFC2.
To identify the places of service that are assigned the non-
facility rate, Sec. 414.22(b)(5)(i) states that there are usually two
levels of PE RVUs that correspond to each code paid under the PFS:
facility PE RVUs and non-facility PE RVUs. Under Sec.
414.22(b)(5)(i)(A), the facility PE RVUs apply to services furnished in
a hospital, skilled nursing facility, community mental health center,
hospice, ambulatory surgical center, or wholly owned or wholly operated
entity providing preadmission services under Sec. 412.2(c)(5), or for
services furnished via telehealth under Sec. 410.78 (though we note
that special rules relating to the PHE for COVID-19 currently apply,
and we include proposals regarding the place of service for telehealth
services in section II.D). Under Sec. 414.22(b)(5)(i)(B), the non-
facility rate is paid in all other settings, including a physician's
office, the patient's home, a nursing facility, or a comprehensive
outpatient rehabilitation facility. We provide the full list of places
of service that are assigned a non-facility rate on the CMS website at
https://www.cms.gov/Medicare/Coding/place-of-service-codes. We propose
that the two new G-codes describing psychotherapy for crisis services
can be
[[Page 52365]]
billed when the services are furnished in any non-facility place of
service other than the physician's office setting. We also note that in
the CY 2022 PFS final rule (86 FR 65059), in our discussion of Medicare
telehealth services where the patient's home is a permissible
originating site for services furnished for diagnosis, evaluation, or
treatment of a mental health disorder, we indicated that we define the
term ``home'' broadly to include temporary lodging, such as hotels and
homeless shelters (86 FR 65059). 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, that would qualify as the patient's home. For
purposes of implementing section 1848(b)(12) of the Act, we are
proposing to use the same broad definition of the patient's home for
purposes of these proposed G-codes describing psychotherapy for crisis
services.
The proposed new G-codes and their descriptors are:
GPFC1 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); first 60 minutes); and
GPFC2 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); each additional 30 minutes (List separately in addition to
code for primary service)).
As required by section 1848(b)(12)(C) of the Act, we are proposing
to establish a fee schedule amount for these two new G-codes that is
150 percent of the current PFS non-facility RVUs for CPT codes 90839
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy
for crisis; each additional 30 minutes (List separately in addition to
code for primary service)), respectively. Specifically, we are
proposing to calculate the work, PE, and MP RVUs for HCPCS codes GPFC1
and GPFC2 by multiplying the work, PE, and MP RVUs for CPT codes 90839
and 90840, respectively, by 1.5.
We note that section 4123(a)(2) of the CAA, 2023 amends section
1848(c)(2)(B)(iv) of the Act to include a waiver of budget neutrality
providing that subsection (b)(12) shall not be taken into account in
applying PFS budget neutrality requirements under section
1848(c)(2)(B)(ii)(II) of the Act for 2024. Accordingly, we are
proposing to exclude expected expenditures for HCPCS codes GPFC1 and
GPFC2 from the budget neutrality calculation for CY 2024 PFS
ratesetting.
Additionally, section 4123(d) of the CAA, 2023 requires that the
Secretary use existing communication mechanisms to provide education
and outreach to providers of services, physicians, and practitioners
with respect to the ability of auxiliary personnel, including peer
support specialists, to participate, consistent with applicable
requirements for auxiliary personnel, in the furnishing of
psychotherapy for crisis services billed under the PFS under section
1848 of the Act, behavioral health integration services, as well as
other services that can be furnished to a Medicare beneficiary
experiencing a mental or behavioral crisis. We understand that there
are varying definitions of the term ``peer support specialist.'' The
Substance Abuse and Mental Health Services Administration (SAMHSA)
defines a ``peer support specialist'' as a person who uses their lived
experience of recovery from mental illness and/or addiction, plus
skills learned in formal training, to deliver services to promote
recovery and resiliency. The essential principles of peer support
include shared personal experience and empathy, a focus on individual
strengths, and supporting individuals as they work toward recovery
pursuant to a person-centered plan of care. However, for Medicare
payment purposes, we note that the term auxiliary personnel is defined
at Sec. 410.26(a)(1) as any individual who is acting under the
supervision of a physician (or other practitioner), regardless of
whether the individual is an employee, leased employee, or independent
contractor of the physician (or other practitioner) or of the same
entity that employs or contracts with the physician (or other
practitioner), has not been excluded from the Medicare, Medicaid, and
all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in which the services are
being furnished. We do not include definitions of any specific types of
personnel who could be included under the definition of auxiliary
personnel in our regulations and are not proposing to do so through
this rule. CMS anticipates conducting this outreach and education
through existing communications mechanisms as required by the CAA,
2023.
3. Implementation of Section 4124 of the Consolidated Appropriations
Act, 2023 (CAA, 2023)
Section 4124 of the CAA, 2023, Ensuring Adequate Coverage of
Outpatient Mental Health Services under the Medicare Program,
establishes Medicare coverage and payment for intensive outpatient
services for individuals with mental health needs when furnished by
hospital outpatient departments, community mental health centers, RHCs,
and FQHCs, effective January 1, 2024. Please see the discussion of our
proposed implementation of section 4124 in the CY 2024 Outpatient
Prospective Payment System (OPPS) proposed rule, section VIII. Payment
for Partial Hospitalization and Intensive Outpatient Services.
4. Health Behavior Assessment and Intervention (HBAI) Services
The current Health and Behavior Assessment and Intervention codes
(CPT codes 96156, 96158, 96159, 96164, 96165, 96167, 96168, 96170, and
96171) were created by the CPT Editorial Panel during its September
2018 meeting. The CPT Editorial Panel deleted the six previous HBAI CPT
codes and replaced them with nine new CPT codes. As discussed in the CY
2023 PFS final rule (87 FR 69541), the HBAI range of CPT codes are
intended to be used for psychological assessment and treatment, when
the primary diagnosis is a medical condition. A health behavior
assessment under these HBAI services is conducted through health-
focused clinical interviews, behavioral observation and clinical
decision-making and includes evaluation of the person's responses to
disease, illness or injury, outlook, coping strategies, motivation, and
adherence to medical treatment. HBAI services are provided
individually, to a group (two or more patients), and/or to the family,
with or without the patient present, and include promotion of
functional improvement, minimization of psychological and/or
psychosocial barriers to recovery, and management of and improved
coping with medical conditions. The HBAI codes apply to services that
address psychological, behavioral, emotional, cognitive, and
interpersonal factors in the treatment/management of people diagnosed
with physical health issues. According to the CPT prefatory language in
the CPT 2023 Professional Edition, the patient's primary diagnosis is
physical in nature and the focus of the assessment and intervention is
on factors complicating medical conditions and treatments. The HBAI
codes capture services related to
[[Page 52366]]
physical health, such as adherence to medical treatment, symptom
management, health-promoting behaviors, health related risky behaviors,
and adjustment to physical illness.
In light of the new benefit categories authorized by section
4121(a)(2) of the CAA, 2023, which authorize MFTs and MHCs to furnish
services for the diagnosis and treatment of mental illness, this
prompted us to consider whether MFTs and MHCs could furnish and bill
for HBAI services. Additionally, we re-examined whether CSWs could
furnish and bill these HBAI codes given that their statutory benefit
category also authorizes them to furnish services for the diagnosis and
treatment of mental illnesses. We note that prior to the passage of the
CAA, 2023, which authorized benefit categories for MFTs and MHCs, there
was previously a National Coverage Determination (NCD) that stated, the
CPT codes 96156, 96158, 96159, 96164, 96165, 96167 and 96168 may be
used only by a Clinical Psychologist (CP), (Specialty Code 68).
However, we note that this NCD was retired on December 8, 2022.\33\
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\33\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57754&ver=12&=.
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Like CPs, who can currently bill Medicare for HBAI services, CSWs,
MFTs, and MHCs have the education and training to address psychosocial
barriers to meet the needs of patients with physical health conditions.
In accordance with State law and scope of practice, CSWs, MFTs, and
MHCs can assess, diagnose, and treat psychological and/or psychosocial
behaviors associated with physical health conditions. Interested
parties have informed us that like CSWs, MHCs and MFTs can play a key
role in a multidisciplinary team approach that leads to successful
outcomes in patient care, including offering integrated care within
hospitals and medical practices where patients are diagnosed with
physical health conditions. For example, mental health professionals
such as MHCs and MFTs facilitate ``behavioral management and
reinforcement, guided problem-solving, supporting patients in setting
realistic and attainable goals, and teaching relaxation strategies for
managing diabetes-related stressors.'' \34\ In this role, mental health
professionals such as CSWS, MHCs, and MFTs help patients manage mental
health symptoms associated with a physical health condition. Moreover,
according to the National Cancer Institute at the National Institutes
of Health, mental health professionals can also provide emotional and
social support to assist cancer patients in reducing ``levels of
depression, anxiety, and disease and treatment-related symptoms among
patients.'' \35\ Therefore, we are proposing to allow the HBAI services
described by CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and
96168, and any successor codes, to be billed by CSWs, MFTs, and MHCs,
in addition to CPs. We note that in order for payment to be made under
Medicare for HBAI services furnished to a beneficiary, the HBAI
services must be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member, in accordance with section 1862(a)(1)(A) of the
Act.
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\34\ Powell PW, Hilliard ME, Anderson BJ (2014). Motivational
interviewing to promote adherence behaviors in pediatric type 1
diabetes. Curr Diab Rep. 2014;14(10):531. 10.1007/sll892-014-0531-z.
\35\ National Cancer Institute at the National Institutes of
Health, (nd). ``Stress and Cancer'' https://www.cancer.gov/about-cancer/coping/feelings/stress-fact-sheet.
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5. Adjustments to Payment for Timed Behavioral Health Services
There is an ongoing behavioral health crisis in the United States,
which has been exacerbated by the COVID-19 pandemic, the overdose
crisis,\36\ and worsening behavioral healthcare workforce
shortages.\37\ Public comments received in response to the CY 2023 PFS
proposed rule described practices that furnish treatment for behavioral
health conditions experiencing difficulty recruiting and retaining
behavioral health clinicians and expressed concern that people are
experiencing unprecedented delays in receiving medically necessary
services across care settings. Commenters described workforce shortages
nationwide that, combined with increasing demand for behavioral health
care services, have limited Medicare beneficiary access to these vital
services. Prior to the pandemic, the Health Resources and Services
Administration (HRSA) projected shortages of seven selected types of
behavioral health providers by 2025.\38\ As of March 31, 2023, HRSA
designated more than 6,635 health professional shortage areas for
mental health, with more than one-third of Americans living in these
shortage designations.\39\ Additionally, according to SAMHSA's guide on
Addressing Burnout in the Behavioral Health Workforce Through
Organizational Strategies, staffing shortages, and high turnover rates
place enormous demands on the workforce, jeopardizing the provision of
care, especially to underserved individuals.\40\ The behavioral health
workforce experiences high levels of work-related stress, relatively
low salaries, and full caseloads; these combined factors place
individuals working in the behavioral health field at high risk for
experiencing burnout.\41\ Over 50 percent of behavioral health
providers report experiencing burnout symptoms. The rate of burnout
will likely increase, given the continued growth in the number of
people seeking behavioral health care, behavioral health staffing, and
retention challenges.\42\
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\36\ https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.
\37\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\38\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\39\ Health Resources and Services Administration, Health
Workforce Shortage Areas, https://data.hrsa.gov/topics/health-workforce/shortage-areas.
\40\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/bh-workforce-projections-fact-sheet.pdf.
\41\ Kelly, R.J., Hearld, L.R. Burnout and Leadership Style in
Behavioral Health Care: a Literature Review. J Behav Health Serv Res
47, 581-600 (2020). https://doi.org/10.1007/s11414-019-09679-z.
\42\ https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep22-06-02-005.pdf.
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In CY 2023 PFS rulemaking, we sought comment on how we can best
help 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. We described that 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 PE. In the CY 2018 PFS final rule (82 FR
52999), we discussed feedback we received from some interested parties
suggesting that, for codes with very low direct PE inputs, our
methodology for allocating indirect PE does not produce a differential
between facility and nonfacility PE RVUs 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 the treatment of behavioral
health conditions, including substance use disorders, are among the
services most
[[Page 52367]]
affected by our methodology. For example, we stated at the time that,
for the most commonly reported psychotherapy service (CPT code 90834),
the difference between the nonfacility and facility PE RVUs was only
0.02 RVUs, which seemed unlikely to represent the difference in
relative PE resource costs in terms of administrative labor, office
expense, and all other expenses incurred by the billing practitioner
for 45 minutes of psychotherapy services when furnished in the office
setting versus the facility setting. We agreed with these interested
parties that the site of service differential for these services
produced by our PE methodology seems unlikely to reflect the relative
resource costs for the practitioners furnishing these services in
nonfacility settings. For example, we believe the 0.02 RVUs, which
translated at the time to approximately $0.72, was unlikely to reflect
the relative administrative labor, office rent, and other overhead
involved in furnishing the 45-minute psychotherapy service in a
nonfacility setting. Consequently, we modified our PE methodology to
establish a minimum nonfacility PE RVU for certain outlier codes with
very low direct PE inputs as compared to work RVUs, most of which are
primarily furnished by behavioral health professionals. We finalized a
policy to implement only one quarter of the minimum value for
nonfacility indirect PE for the identified outlier codes over a 4-year
transition period, beginning with CY 2018. We stated that we recognized
that this change in the PE methodology could significantly impact the
allocation of indirect PE RVUs across all PFS services (82 FR 53000).
In light of increasing patient needs for behavioral health services
and continued workforce shortages, we have been examining a number of
dynamics in our processes for developing values for behavioral health
services under the PFS. We continue to consider approaches to ensuring
that the relative values we establish for these services accurately
reflect the resources involved in furnishing them, especially since any
potential systemic undervaluation could serve as an economic deterrent
to furnishing these kinds of services and be a contributing factor to
the workforce shortage.
Interested parties have long raised concerns regarding the
valuation of services that primarily involve person-to-person
interactions with beneficiaries, particularly those services that are
comprised of conversational interactions rather than physical
interactions, because these services require minimal equipment and
supplies compared to other services, and therefore, valuation is based
almost entirely on the practitioner's work. Because the physician/
practitioner work RVU is developed based on the time and intensity of
the service, the issues regarding the valuation of these types of
services are particularly pronounced for services that are billed in
time units (like psychotherapy codes) that directly reflect the
practitioner time inputs used in developing work RVUs, compared to
other services that are not billed in time units in which work RVUs are
based on estimates of typical time, usually based on survey data. For
example, a 2016 report by the Urban Institute entitled Collecting
Empirical Physician Time Data \43\ (the Urban Institute report)
reviewed empirical time estimates for 60 services paid under the PFS
with relative values developed based on time estimates derived from
survey data (as opposed to actual reported time). The Urban Institute
report suggested that there may be systemic overestimations of times
for these services within the PFS, which would lead to overvaluation of
these services and, by implication, undervaluation of other services.
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\43\ https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_0.pdf.
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The dynamic described by the Urban Institute report can lead to
systemic undervaluation for some kinds of time-based codes for several,
interrelated reasons. First, overestimates of time for some kinds of
codes compared to other kinds of codes results in ``implied intensity''
(that is the ratio of work RVU/per minute, sometimes referred to by the
AMA RUC as intra-service work per unit of time, or IWPUT) that is
artificially low. This is important since we understand that the
implied intensity is used as part of the AMA RUC review of survey data
to contextualize the credibility of data and the resulting recommended
work RVUs compared to codes with similar times. CMS' review of the RUC
recommendations similarly utilizes implied intensity as important
contextual information in order to assess the relative values assigned
to particular services.
The second reason this dynamic could result in potential
undervaluation of certain services is that time-based codes that
describe one-on-one time with the patient are highly unlikely to become
more efficient over multiple years. In contrast, surgical procedures
tend to become more efficient over the years as they become more
common, professionals gain more experience with them, improved
technology is deployed, and other general operational improvements are
implemented. Meanwhile, 45 minutes of psychotherapy remains static in
terms of efficiency since, by definition, it requires 45 minutes of
time, personally spent by the billing professional, one-on-one with the
patient. Moreover, even if there were efficiencies that reduced the
time required to furnish therapy services, the services would then be
reported with time-based codes with lower total values. Additionally,
in contrast to services such as procedures that utilize clinical staff,
no part of the one-on-one therapy service can be performed by clinical
staff working with the billing professional. This means that any
overestimations in the initial estimates of time used to established
work times and values, as discussed above, are likely compounded over
time as there are gains in efficiencies for some services in terms of
time, clinical staff delegation, and improved technology, but no such
gains for other services.
For many professionals who provide a heterogenous range of services
paid under the PFS, this phenomenon may not have a significant overall
impact on their Medicare PFS payments. However, this phenomenon would
have an outsized impact on Medicare PFS payments for professionals who
predominantly furnish services involving person-to-person interactions
with patients that are reported and valued in time-based units. It
would not be logical to assume that the marketplace ignores this
dynamic, since the opportunity for increased revenue generation through
efficiency for timed, one-on-one services is limited as compared to
services for which there are multiple avenues to gain efficiencies.
We also recognize that, while this underlying valuation dynamic may
create distortion of increasing magnitude over time, the quickly
changing needs of Medicare beneficiaries relative to behavioral health
also likely contribute to systemic distortion. This is especially the
case as beneficiaries rely on behavioral health professionals for
ongoing care of chronic and acute mental health needs. In other words,
at the same time that the intensity of the work involved in furnishing
services to Medicare beneficiaries increases, the work RVUs assigned to
these services may be initially undervalued relative to other services
that are valued based on potentially inflated time data, and therefore,
may not accurately reflect the current relative resource costs
associated with these services.
[[Page 52368]]
One approach to curb the impact of this dynamic would be to conduct
more frequent revaluations of these kinds of services, including timed
psychotherapy services. However, our current valuation process relies
primarily, as noted, on times reported through survey data of
professionals who furnish these services and assessment by the RUC of
those survey data. We believe that survey results from the
professionals that currently provide behavioral health services,
including physicians, psychologists, and social workers could reflect
the increased intensity of the work due to changes in the complexity of
care for beneficiaries, but would be unlikely to address any relative
undervaluation of work estimates. We are interested in working with the
broader community, including the AMA RUC, to address these specific
concerns over the long term.
However, given the emerging need for access to behavioral health
care and the continuing difficulties in behavioral health workforce
capacity, we believe it would be appropriate to take immediate steps to
improve the accuracy of the valuation of these services until we can
develop systemic solutions to longstanding process limitations.
Consequently, we propose to address the immediate need for improvement
in valuation for timed psychotherapy services in such a way that
considers the policy we initially finalized in the CY 2020 PFS final
rule (84 FR 62856) to address valuation distortions for primary and
longitudinal care through implementation of an add-on code for office/
outpatient E/M services that involve inherent complexity, and are
proposing to reestablish in this rule. Our proposed implementation of
that policy is discussed in section II.F. of this proposed rule. Like
E/M visits that are furnished for primary and longitudinal care, we
believe that the psychotherapy codes similarly describe treatment that
is ongoing or longitudinal, and therefore, we believe it is appropriate
to propose to address the need for improvement in valuation for timed
psychotherapy services based on the proposed valuation for the inherent
complexity add-on code for office/outpatient E/M services.
Under this proposal, we would apply an adjustment to the work RVUs
for the psychotherapy codes payable under the PFS. We propose to base
this adjustment on the difference in total work RVUs for office/
outpatient E/M visit codes (CPT codes 99202-99205 and 99211-99215)
billed with the proposed inherent complexity add-on code (HCPCS code
G2211) compared to the total work RVUs for visits that are not billed
with the inherent complexity add-on code. This would result in an
approximate upward adjustment of 19.1 percent for work RVUs for these
services, comparable to the relative difference in office/outpatient
visits that are also systemically undervalued absent such an
adjustment, which we are proposing to implement over a 4-year
transition. In making significant adjustments to RVUs in past
rulemaking, we have implemented such changes using a 4-year transition,
noting that a transition period allows for a more gradual adjustment
for affected practitioners. We are proposing to apply this adjustment
to the following time-based psychotherapy codes that describe one-on-
one time with the patient that are significantly unlikely to become
more efficient over multiple years: CPT code 90832 (Psychotherapy, 30
minutes with patient); CPT code 90834 (Psychotherapy, 45 minutes with
patient); CPT code 90837 (Psychotherapy, 60 minutes with patient);
90839 (Psychotherapy for crisis; first 60 minutes); CPT code 90840
(Psychotherapy for crisis; each additional 30 minutes (List separately
in addition to code for primary service); CPT code 90845
(Psychoanalysis); 90846 (Family psychotherapy (without the patient
present), 50 minutes); CPT code 90847 (Family psychotherapy (conjoint
psychotherapy) (with patient present), 50 minutes); CPT code 90849
(Multiple-family group psychotherapy); CPT code 90853 (Group
psychotherapy (other than of a multiple-family group) and newly
proposed HCPCS codes GPFC1 and GPFC2 ((Psychotherapy for crisis
furnished in an applicable site of service (any place of service at
which the non-facility rate for psychotherapy for crisis services
applies, other than the office setting). We are not proposing to
include CPT codes 90833, 90836, and 90838 in this list of codes for
which we would make the adjustment because these are add-on codes for
psychotherapy that is performed with an E/M visit and under our
proposal described at section II.E of this proposed rule, E/M codes
will be eligible to be billed with HCPCS code G2211, therefore, the
psychotherapy codes that are performed with an E/M visit will already
be eligible for an adjustment to account for the resources costs
involved in furnishing longitudinal care. We believe that implementing
an adjustment to the work RVUs for psychotherapy services concurrent
with implementation of HCPCS code G2211 will help address distortions
that may occur within our valuation process that may otherwise result
in understated estimates of the relative resources involved in
furnishing psychotherapy services. We recognize that many other
services share some similarities with these psychotherapy services. For
example, there are other services that are reported in time units.
Likewise, there are other codes that primarily describe conversational
interactions between medical professionals and beneficiaries. However,
we believe that these services are unique because neither technology
nor clinical staff can be utilized to increase efficiency, and because
these services represent the significant majority of services furnished
by certain types of professionals. If finalized, the implementation of
this proposal for CY 2024, concurrent with the proposal to implement
the inherent complexity add-on code, if finalized, will also mitigate
any negative impact in valuation for psychotherapy services based on
redistributive impacts if we were to finalize only the inherent
complexity add-on code for E/M visits without proposing and finalizing
any adjustments for psychotherapy. We welcome comments on this
proposal, including and especially how the PFS valuation processes for
these services and other services with similar characteristics can be
improved in the future in order to mitigate the kinds of distortions
described above.
Additionally, as noted above in this section, in the CY 2018 PFS
final rule (82 FR 52999), we identified a set of outlier codes for
which we believed it would be appropriate to establish a minimum
nonfacility indirect PE RVU that would be a better reflection of the
resources involved in furnishing these services. For each of the
outlier codes, we compared the ratio between indirect PE RVUs and work
RVUs that result from the application of the standard methodology to
the ratio for a marker code, which was CPT code 99213. The finalized
change in the methodology then increased the allocation of indirect PE
RVUs to the outlier codes to at least one quarter of the difference
between the two ratios. We stated we believed this approach reflected a
reasonable minimum allocation of indirect PE RVUs, but that we did not
have empirical data that would be useful in establishing a more precise
number. We finalized implementation of one quarter of the minimum value
for nonfacility indirect PE for the identified outlier codes. We stated
that we recognized that this change in the PE methodology could have a
significant impact on the allocation of indirect PE RVUs across all PFS
services and finalized that we
[[Page 52369]]
would implement this change over a 4-year transition, beginning in CY
2018 and ending in CY 2021. We welcome comments on whether we should
consider further adjustments to the nonfacility indirect PE for the
identified outlier codes. Specifically, we request comment on whether
this minimum value adjustment to the indirect PE for certain services
sufficiently accounted for the resources involved in furnishing these
services, or whether we should consider further adjustments, such as
applying 50 percent of the calculated minimum value for nonfacility
indirect PE values for these services, and whether we should consider
implementing further changes using a similar 4-year transition.
6. Updates to the Payment Rate for the PFS Substance Use Disorder (SUD)
Bundle (HCPCS Codes G2086-G2088)
In the CY 2023 PFS final rule (87 FR 69772 through 69774), we
finalized a modification to the payment rate for the non-drug component
of the bundled payment for episodes of care under the Opioid Treatment
Program (OTP) benefit to base the rate for individual therapy on a
crosswalk to CPT code 90834 (Psychotherapy, 45 minutes with patient),
which reflects a 45-minute psychotherapy session, instead of a
crosswalk to CPT code 90832 (Psychotherapy, 30 minutes with patient),
as was our current policy at the time. We received public comments
urging us to consider adopting this modification for other bundled
payments for SUD under the PFS, such as the bundled rate for office-
based SUD treatment, to reflect the complexity of treating these
patients and ensure that there is consistent and sufficient access to
counseling for SUD across settings of treatment. The commenters noted
that some patients who are prescribed buprenorphine in non-OTP settings
will have similarly complex care needs requiring more intensive
therapeutic care, and that by recognizing the appropriate complexity
and intensity of the services in setting the rates, CMS can incentivize
more office-based practices to offer these services and build out the
treatment teams that deliver this care.
In the CY 2020 PFS final rule (84 FR 62673 through 62677), we
finalized the establishment of bundled payments for the overall
treatment of OUD, including management, care coordination,
psychotherapy, and counseling activities. We stated that for the
purposes of valuation of HCPCS codes G2086 (Office-based treatment for
a substance use disorder, including development of the treatment plan,
care coordination, individual therapy and group therapy and counseling;
at least 70 minutes in the first calendar month) and G2087 (Office-
based treatment for a substance use disorder, including care
coordination, individual therapy and group therapy and counseling; at
least 60 minutes in a subsequent calendar month), we assumed two
individual psychotherapy sessions per month and four group
psychotherapy sessions per month, and noted that we understand that the
number of therapy and counseling sessions furnished per month will vary
among patients and also fluctuate over time based on the individual
patient's needs. We are persuaded by the public comments received in
response to the CY 2023 PFS proposed rule requesting that these codes
be priced consistent with the crosswalk codes used to value the bundled
payments made for OUD treatment services furnished at OTPs, as
beneficiaries receiving buprenorphine in settings outside of OTPs may
have similarly complex care needs as compared to beneficiaries
receiving OUD treatment services at OTPs. In order to update the
valuation for HCPCS codes G2086 and G2087, we are proposing to increase
the current payment rate to reflect two individual psychotherapy
sessions per month, based on a crosswalk to the work RVUs assigned to
CPT code 90834 (Psychotherapy, 45 minutes with patient), rather than
CPT code 90832 (Psychotherapy, 30 minutes with patient). The current
work RVU assigned to CPT code 90834 is 2.24, compared to the work RVU
assigned to CPT code 90832, which is 1.70, which results in a
difference of 0.54 work RVUs. Because the bundled payments described by
HCPCS codes G2086 and G2087 include two individual psychotherapy
sessions per month, we are proposing to add 1.08 RVUs to the work value
assigned to HCPCS codes G2086 and G2087, which results in a new work
RVU of 8.14 for HCPCS code G2086 and 7.97 for HCPCS code G2087. We note
that as described above, we are also proposing to update the work RVUs
assigned to CPT code 90834 in this proposed rule. If our proposal to
update the work RVUs for the standalone psychotherapy codes is
finalized, CPT code 90834 would be assigned a work RVU of 2.35. In that
case, our proposed update to HCPCS codes G2086 and G2087 would also
reflect the updated work RVUs for 90834, and would result in a work RVU
of 8.36 for HCPCS code G2086 and a work RVU of 8.19 for HCPCS code
G2087.
7. Comment Solicitation on Expanding Access to Behavioral Health
Services
In recent years, we have made efforts to undertake rulemaking and
establish policies to expand access to behavioral health services,
consistent with the CMS Behavioral Health Strategy, which aims to
strengthen quality and equity in behavioral health care; improve access
to substance use disorders prevention, treatment, and recovery
services; ensure effective pain treatment and management; improve
mental health care and services; and utilize data for effective actions
and impact.\44\ We continue to be interested in hearing feedback
regarding ways we can continue to expand access to behavioral health
services. For example, we welcome feedback regarding ways to increase
access to behavioral health integration (BHI) services, including the
psychiatric collaborative care model; whether we could consider new
coding to allow interprofessional consultation to be billed by
practitioners who are authorized by statute for the diagnosis and
treatment of mental illness; intensive outpatient (IOP) services
furnished in settings other than those addressed in the CY 2024 OPPS
proposed rule; and how to increase psychiatrist participation in
Medicare given their low rate of participation relative to other
physician specialties. Additionally, we are seeking comment on whether
there is a need for potential separate coding and payment for
interventions initiated or furnished in the emergency department or
other crisis setting for patients with suicidality or at risk of
suicide, such as safety planning interventions and/or telephonic post-
discharge follow-up contacts after an emergency department visit or
crisis encounter, or whether existing payment mechanisms are sufficient
to support furnishing such interventions when indicated.
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\44\ https://www.cms.gov/cms-behavioral-health-strategy.
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We welcome comments from the public on these topics as well as any
other ways we might consider expanding access to behavioral health
services for Medicare beneficiaries.
8. Request for Information on Digital Therapies, Such as, But Not
Limited to, Digital Cognitive Behavioral Therapy
The widespread adoption and use of software technologies,
including, but not limited to digital therapeutics, is creating new
ways to treat patients. In recent years, the Food and Drug
Administration (FDA) has reviewed and cleared several mobile medical
applications (``apps'') that have been
[[Page 52370]]
shown to demonstrate a reasonable assurance of safety and effectiveness
for addressing a variety of health conditions including sleep disorders
disturbances and substance use disorders. These breakthrough devices
include apps for depression and anxiety. Our understanding is that
these mobile medical apps generally require a prescription or referral
from a clinician and are used for specific medical purposes rather than
general wellness and education.
As technologies have evolved, we have sought public comment and
expanded Medicare payment under Part B for use of technologies in
remote monitoring of treatment and physical health. Beginning in 2018,
CMS began making separate payment for the services described by CPT
code 99091, which paid for collection and interpretation of physiologic
data digitally stored and/or transmitted to the practitioner. Beginning
in 2019, we began paying for additional new remote physiologic
monitoring (RPM) codes.
We have continued to improve and expand payment for remote
treatment and monitoring in subsequent years. In 2022, we began paying
for a new class of CPT codes (98975, 98980, and 98981) for Remote
Therapeutic Monitoring (RTM) in addition to RPM, which enabled
reimbursement of monitoring of non-physiologic data, to help ensure
Medicare beneficiaries have access to these services. RTM is currently
limited to monitoring respiratory system status, musculoskeletal
status, and therapy adherence, or therapy response (87 FR 69647).
However, we continue to add, clarify, and refine payment for RTM codes.
In the CY 2023 PFS final rule (87 FR 69645), we finalized a new RTM
code for supply of a device for cognitive behavioral therapy monitoring
(CPT Code 989X6 Remote therapeutic monitoring (e.g., therapy adherence,
therapy response); device(s) supply with scheduled (e.g., daily))
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavior therapy, each 30 days). In that rule, we noted
specialty societies indicated the technologies for this service are
still evolving, and 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. We accepted the RUC
recommendation to contractor price CPT code 989X6, a PE-only device
code. We stated we would work with Medicare Administrative Contractors
(MACs) to better understand the devices and device costs they encounter
as they review claims for payment for the new cognitive behavioral
monitoring code.
For both RPM and RTM codes, the device used must meet the FDA
definition of a device as described in section 201(h) of the Federal
Food, Drug and Cosmetic Act (FFDCA). As we continue to gather
information on how remote monitoring services are used in clinical
practice and experience with coding and payment policies for these
codes, we request information on the following areas to improve our
understanding of the opportunities and challenges related to our
coverage and payment policies, as well as claims processing, as we
consider the need for further practitioner education, program
instructions, and guidance, or potential future rulemaking regarding
these services.
How do practitioners determine which patients might be
best served by digital therapeutics? How do practitioners monitor the
effectiveness of prescribed interventions, such as, but not limited to,
for their patients on an ongoing basis once the intervention has begun?
We seek comment and real-life examples where digital
cognitive behavioral therapy or other digital enabled therapy services
are used by clinicians, and how the technology is imbedded in various
practice models. For example, how is the patient evaluated and/or how
is the treating clinician involved in the services received when the
patient participates in digital cognitive behavioral therapy?
What standards have interested parties developed or
consulted to ensure the physical safety and privacy of beneficiaries
utilizing digital cognitive behavioral therapy (CBT) and/or other
digital therapeutics for behavioral health?
What are effective models for distribution/delivery of
digital therapeutics, such as prescription digital mental health
therapy products to patients? What best practices exist to ensure that
patients have the necessary support and training to use applications
effectively?
What practitioners and auxiliary staff are involved in
furnishing RPM and RTM services, including training patients on its
use, and to what extent is additional training or supervision of
auxiliary staff necessary to provide an appropriate for and/or
recommended standard of care in the delivery of these services?
How are data that are collected by the technology
maintained for recordkeeping and care coordination?
What information exists about how an episode of care
should be defined, particularly in circumstances when a patient may
receive concurrent RTM or digital CBT services from two different
clinicians engaged in separate episodes of care?
We noted in previous rulemaking that even when multiple
medical devices are provided to a patient, the services associated with
all the medical devices can be billed by only one practitioner, only
once per patient, per 30-day period, and only when at least 16 days of
data have been collected. We seek information on the type and frequency
of circumstances that involve multiple medical devices and multiple
clinicians. How might allowing multiple, concurrent RTM services for an
individual beneficiary affect access to health care, patient out-of-
pocket costs, the quality of care, health equity, and program
integrity?
Do interested parties believe digital CBT could be billed
using the existing remote therapeutic monitoring codes described by CPT
codes 98975, 98980, and 98981? What impediments may exist to using
these codes for digital CBT?
In the past, commenters generally supported the concept of
a generic RTM device code, and offered a wide variety of possible use
cases, including where FDA approved devices and devices that have gone
through other premarket pathways exist for the purpose of monitoring
various conditions that do not meet the current scope of the existing
RTM codes.
++ What are the advantages and disadvantages of a generic RTM
device code, versus specific RTM codes?
++ Would generic device codes undermine or stall progress toward a
wider set of specific codes that would provide less ambiguity on
reimbursement?
++ How might generic RTM codes for supply of a device be valued
given the broad array of pricing models?
What scientific and clinical evidence of effectiveness
should CMS consider when determining whether digital therapeutics for
behavioral health are reasonable and necessary?
What aspects of digital therapeutics for behavioral health
should CMS consider when determining whether it fits into a Medicare
benefit category, and which category should be used?
If CMS determines the services fit within an existing
Medicare benefit category or if other coverage requirements are met,
what aspects of delivering digital cognitive based therapy services
should be considered when determining potential Medicare payment? Under
current practice models, are these products used as
[[Page 52371]]
incident-to supplies or are they used independent of a patient visit
with a practitioner? If used independently of a clinic visit, does a
practitioner issue an order for the services?
Are there barriers to digital CBT reaching underserved
populations, and would a supervision requirement impact access to
digital CBT for underserved populations?
What strategies, if any, within the digital therapeutics
for behavioral health support disadvantaged/hard to reach populations
in advancing equity in health care services?
What are some potential considerations for protecting the
privacy and confidentiality of the patient population in digital
therapeutics, including compliance with State behavioral health privacy
requirements?
K. Proposals on Medicare Parts A and B Payment for Dental Services
Inextricably Linked to Specific Covered Services
1. Medicare Payment for Dental Services
a. Overview
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.'') In the CY 2023 PFS final rule (87 FR 69663
through 69688), we identified certain clinical scenarios where payment
is permitted under both Medicare Parts A and 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.
The regulation at Sec. 411.15(i)(3)(i) includes examples of
services for which payment can be made under Medicare Parts A and B for
dental services, furnished in an inpatient or outpatient setting, that
are inextricably linked to, and substantially related to the clinical
success of, certain other covered services (hereafter in this section,
``inextricably linked to other covered services'').
Recognizing that there may be other instances where covered
services necessary to diagnose and treat the individual's underlying
medical condition and clinical status may require the performance of
certain dental services, we are proposing to expressly identify other
instances where dental services are inextricably linked to other
covered services such that they are not in connection with dental
services within the meaning of section 1862(a)(12) of the Act. At the
same time, we recognize that there are dental services that are not
inextricably linked to other covered services. 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.
In the CY 2023 PFS final rule (87 FR 69682, 69685, 69687), we also
established a process for the public to submit additional dental
services that may be inextricably linked to other covered services for
our consideration and review, and finalized a policy to permit payment
for certain dental services, such as dental examinations and necessary
treatment, prior to or contemporaneously with the treatment of head and
neck cancers, beginning in CY 2024.
We are proposing to codify in section Sec. 411.15(i)(3)(i)(A)
additional policies to permit payment for certain dental services that
are inextricably linked to, and substantially related and integral to,
the clinical success of, other covered services. We are also proposing
to make non-substantive technical changes to improve clarity of the
regulation text.
b. Other Medical Services for Which Dental Services May Be Inextricably
Linked
In the CY 2023 PFS final rule, we discussed whether we should
specify that payment can be made under Medicare Parts A and B for
certain dental services prior to the initiation of immunosuppressant
therapy, joint replacement procedures, or other surgical procedures. We
stated that we remain committed to exploring the inextricable link
between dental and covered services associated with immunosuppressant
therapy, joint replacement surgeries, and other surgical procedures,
and that we welcomed continued engagement with the public to review the
clinical evidence to determine whether certain dental services were
inextricably linked to covered services (87 FR 69668 and 69680 through
69686).
We partnered with researchers at the Agency for Healthcare Research
and Quality (AHRQ) to consider the relationship between dental services
and specific covered services, and review available clinical evidence
regarding the relationship between dental services and medical services
in the treatment of cancer using chemotherapeutic agents, which may
lead to more clinically severe infections and often involve
immunosuppression in patients.45 46 The AHRQ report \47\
regarding dental services and the link between medical services is
available at https://effectivehealthcare.ahrq.gov/products/receiving-chemotherapy-cancer/rapid-review. For example, it is generally
understood that many chemotherapeutic agents used in the treatment of
cancer target rapidly proliferating cells (which include those cells
found in healthy tissue, like the oral mucosa). This targeting of
rapidly reproducing cells in the oral mucosa can lead to the
development of oral mucositis, which can negatively affect individuals
with periodontitis and other dental conditions more severely,
especially when they are exposed to higher doses/duration of
chemotherapy.\48\ Another example of a dental-related issue resulting
from covered services that are immunosuppressive in nature is
medication-related osteonecrosis of the jaw (MRONJ). MRONJ may occur as
an adverse effect when patients with cancer receive specific covered
services, such as high-dose antiresorptive and/or antiangiogenic drug
therapy (for example, high doses of bisphosphonates or drugs like
denosumab used to treat osteoporosis) or bone-modifying therapy in
conjunction with their chemotherapy regimen. Patients with existing
dental disease are most at risk for developing MRONJ secondary to bone-
modifying therapy. MRONJ complicates the cancer treatment and can lead
to reduced survival rates up to 3 years post-
[[Page 52372]]
treatment.\49\ Dental services to identify and treat oral
complications/comorbidities prior to and, sometimes, throughout
chemotherapy treatment have been associated with improved outcomes for
the patient receiving medical services in the treatment of cancer.\50\
Further, AHRQ noted that there is abundant worldwide experience and
related standards of care in the management of patients whose medical
conditions require chemotherapy regimens that induce immunosuppression,
and that this experience has led to an understanding of how improved
dental care potentially can reduce the incidence of serious infections
and improve overall patient outcomes.
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\45\ Immunosuppression describes an impairment of the cells of a
patient's immune system and a reduction in their ability to fight
infections and other diseases.
\46\ National Cancer Institute. NCI Dictionary of Cancer Terms.
2019. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms.
\47\ Hickam DH, Gordon CJ, Armstrong CE, Coen MJ, Paynter R,
Helfand M. The Efficacy of Dental Services for Reducing Adverse
Events in Those Receiving Chemotherapy for Cancer. Rapid Response.
(Prepared by the Scientific Resource Center under Contract No.
75Q80122C00002.) AHRQ Publication No. 23-EHC021. Rockville, MD:
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/AHRQEPCRAPIDDENTALCANCER.
\48\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions -a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
\49\ Corraini, P., Heide-J[oslash]rgensen, U., Schi[oslash]dt,
M., N[oslash]rholt, S. E., Acquavella, J., S[oslash]rensen, H. T., &
Ehrenstein, V. (2017). Osteonecrosis of the jaw and survival of
patients with cancer: a nationwide cohort study in Denmark. Cancer
medicine, 6(10), 2271-2277. https://doi.org/10.1002/cam4.1173.
\50\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions -a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
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The AHRQ examined the effects of dental care prior to treatment on
the success of medical services for patients receiving chemotherapy
regimens (primary medical service) in the treatment of cancer (primary
medical illness). As part of this analysis, AHRQ identified 26 primary
research studies, 7 systematic reviews, and 5 practice guidelines that
outline benefits and harms of pre-treatment dental services and their
effects on cancer chemotherapy regimens. The studies were selected
using specific inclusion criteria: a sample of patients beginning
cancer treatment within two months; targeted dental services occurring
prior to cancer treatment; outcomes data, such as rates of serious
adverse events, quality of life, cancer relapse rates, mortality, or
adherence to cancer treatment; and a minimum sample size of 10
patients.
The 26 primary research studies identified by AHRQ included
prospective cohort studies, retrospective cohort studies, randomized
controlled trials, and registry-based studies. From this group of
studies, AHRQ found evidence to support that dental evaluation/
treatment prior to cancer treatment led to decreased incidence and/or
less severity of serious oral infections and complications (such as,
oral mucositis and osteonecrosis) with the covered services, as well as
requiring fewer emergency treatments.51 52 There was further
evidence found in systematic reviews that showed a possible increased
incidence of oral mucositis when dental treatment is not administered
at least 2-3 weeks prior to initiation of cancer treatment, further
complicating the totality of services a patient received to treat their
cancer.\53\ They note that treatment of a broad range of malignancies
often requires the use of chemotherapeutic agents that suppress the
body's production of white blood cells, thereby impairing the body's
ability to resist serious (often life-threatening) bacterial and fungal
infections, and that the route of entry of these offending bacteria can
be the mouth. AHRQ also analyzed several clinical practice guidelines
that supported a dental evaluation/treatment before initiating
chemotherapy so that any oral complications could be mitigated prior to
initiating care to treat the cancer. 54 55 56
---------------------------------------------------------------------------
\51\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
\52\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related
osteonecrosis of the jaw: An update on the memorial sloan kettering
cancer center experience and the role of premedication dental
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
\53\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H,
et al. Required time for pre-oncological dental management--A rapid
review of the literature. Oral Oncol. 2022 11;134:106116. doi:
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID:
36115328.
\54\ Elad S, Cheng KKF, Lalla RV, et al. MASCC/ISOO clinical
practice guidelines for the management of mucositis secondary to
cancer therapy. Cancer. 2020 Oct 1;126(19):4423-31. doi: https://dx.doi.org/10.1002/cncr.33100. PMID: 32786044.
\55\ Yarom N, Shapiro CL, Peterson DE, et al. Medication-Related
Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice
Guideline. J Clin Oncol. 2019 Sep 1;37(25):2270-90. doi: https://dx.doi.org/10.1200/JCO.19.01186. PMID: 31329513.
\56\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
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c. Submissions Received Through Public Submission Process
In the CY 2023 PFS final rule, we stated that we believed there may
be additional clinical scenarios we have not yet identified under which
Medicare payment could be made for certain dental services on the basis
that dental services are inextricably linked to other covered services
(87 FR 69686). In order to ensure we are appropriately considering
other potential clinical scenarios that may involve such dental
services, we finalized an annual public process, including notice and
comment rulemaking, whereby interested parties can submit
recommendations for other clinical scenarios for potential inclusion on
the list of dental services for which payment can be made under Sec.
411.15(i)(3)(i).
Through this process, we stated that we would review clinical
evidence to assess whether there is an inextricable link between
certain dental and covered services because the standard of care for
that medical service is such that one would not proceed with the
medical procedure or service without performing the dental service(s)
because the covered services would or could be significantly and
materially compromised absent the provision of the inextricably-linked
dental services, or where dental services are a clinical prerequisite
to proceeding with the primary medical procedure and/or treatment (87
FR 69685). We also stated that, 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 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 services. (87 FR 69666) As
such, we requested that documentation accompanying recommendations
should include medical evidence to support that certain dental services
are inextricably linked to certain other covered services.
Specifically, we requested that the medical evidence should:
(1) Provide support that 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 medical implant
and/or interfered with the medical implant to the skeletal structure;
(2) Be clinically meaningful and demonstrate that the dental
services result in a material difference in terms of the clinical
outcomes and success of the procedure such that the dental services are
inextricably linked to, and substantially related and integral to the
clinical success of, the covered services; and
(3) Be compelling to support that certain dental services would
result in clinically significant improvements in quality and safety
outcomes (for example, fewer revisions, fewer readmissions, more rapid
healing, quicker discharge, and quicker rehabilitation for the
patient). (87 FR 69686)
[[Page 52373]]
We stated that interested parties should submit medical evidence to
support, for the recommended clinical scenario, the inextricable link
between certain dental services and other covered services by providing
any of the following:
(1) Relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care;
(2) Evidence of clinical guidelines or generally accepted standards
of care for the suggested clinical scenario;
(3) Other ancillary services that may be integral to the covered
services; and/or
(4) Other supporting documentation to justify the inclusion of the
proposed medical clinical scenario requiring dental services (87 FR
69686, 69687).
We stated that we intended to use the PFS annual rulemaking process
to discuss public submissions when considering whether the recommended
dental services associated with certain clinical scenarios should be
considered outside the scope of the general preclusion on payment for
dental services under section 1862(a)(12) of the Act because they are
inextricably linked to other covered services. We continue to believe
that public feedback is important, especially when considering Medicare
payment for dental services that may benefit the clinical outcomes for
certain covered services. We believe that using our annual notice and
comment rulemaking process to discuss submitted recommendations will
allow the public to comment and submit further medical evidence to
assist us in evaluating whether certain dental services furnished in
certain clinical scenarios would meet the standard to permit Medicare
payment for the dental services. Under the public process established
in the CY 2023 PFS final rule, 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. The deadline for submissions for potential consideration
for CY 2024 rulemaking was February 10, 2023. We received eight
submissions from various organizations on or before February 10, 2023.
We received one submission after the deadline that presented
nominations for covered services that have already been addressed by
this payment policy.
Submissions included recommendations for payment under Medicare
Parts A and B of dental services prior to covered services associated
with the treatment of cancer (chemotherapy, chimeric antigen receptor
(CAR) T-cell therapy, bone-modifying agents or antiresorptive therapy),
total joint arthroplasty, all cardiovascular procedures, diabetes
treatment, treatment for sickle-cell anemia and hemophilia, and
systemic autoimmune diseases. Additionally, many submissions
recommended that CMS refine certain terminology surrounding previously
finalized policies, specifically around whether payment can be made for
dental services furnished during and after the performance of certain
covered services.
Several submissions recommended that Medicare make payment under
Parts A and B for dental services prior to covered services associated
with the treatment of patients with leukemia and lymphoma, as well as
other cancers. Most submitting organizations stated that, by examining
and addressing the oral health of the patient prior to the initiation
of chemotherapy in the treatment of cancer, with or without radiation,
oral complications could be appropriately addressed or prevented that
would improve the clinical success of the overall cancer treatment.
Submissions also recommended Medicare payment under Parts A and B for
dental services before, during, and after CAR T-cell therapy and other
lymphodepleting covered services (lymphodepleting therapy involves a
short course of chemotherapy that targets T-cells, preconditioning the
body prior to enhance treatments like CAR T-cell therapy). These
submissions stressed the need to detect early and monitor dental issues
and to avoid the increased risk of related infections and
complications.
Most submissions stated that medication-related osteonecrosis of
the jaw (MRONJ) is a serious complication of antiresorptive and/or
antiangiogenic drug therapy used to help manage the treatment of
cancer. Several recommended that Medicare make payment under Parts A
and B for dental services for patients where high-dose bisphosphonate
therapy for cancers is indicated, such as blood and solid tumor cancers
and metastatic cancers associated with risk of osteonecrosis of the
jaw. These submissions recommended payment of dental services prior to
and during antiresorptive therapy or prior to, during, and after the
use of bone-modifying drugs. One provided references that support the
provision of dental services to prevent, or as part of treatment for
MRONJ. Another submission stated that the risk of MRONJ is
significantly greater in patients receiving antiresorptive therapy in
connection with cancer treatment compared to patients receiving
antiresorptive therapy for osteoporosis. However, the submitter stated
that the combination of poly-pharmaceutical management of cancer
patients and related immunosuppression are risk factors for MRONJ
without exposure to antiresorptive agents, and that it would be
difficult to identify a single medication as the etiologic agent for
MRONJ in case reports or mini-case series. The submitter stated that
prevention of MRONJ would be the clinical gold standard.
One submission also recommend that Medicare make payment under
Parts A and B for dental services prior to all cardiovascular
procedures. In their view, the provision of dental services to reduce
risk of perioperative and postoperative infection and complications is
critical to ensure optimal surgical outcomes for all patients requiring
invasive and/or interventional cardiac procedures. They cited a
literature review in support of the need for screening and treatment
for oral/dental infections prior to cardiac surgery. This submission
did not recommend dental services prior to a specific cardiovascular
procedure; rather, it recommended dental services prior to all
cardiovascular procedures. The literature review they cited, (which we
discuss below at section II.K.3. of this proposed rule) noted that
there was a mixture of medical literature to support the performance of
dental services prior to all cardiac procedures in part because such
cardiovascular procedures are more urgent or emergent than elective.
One submission recommended that Medicare make payment under
Medicare Parts A and B for dental services prior to joint replacement
surgeries, specifically total knee and hip arthroplasty. The submitting
organization stated that the provision of dental services prior to or
contemporaneously with joint replacement surgeries may result in more
rapid healing and quicker rehabilitation, especially if a known dental
infection could be addressed and potentially prevent surgical and
rehabilitation complications for the patient. However, the submission
acknowledged that there is no consensus on whether performing dental
services prior to joint replacement surgeries improves the clinical
outcomes of the medical service, or whether it is typical in practice
to furnish dental services before joint replacement procedures.
Other submissions recommended Medicare make payment for dental
services for patients diagnosed with a
[[Page 52374]]
specific condition(s), such as patients with poorly controlled diabetes
mellitus, or individuals living with sickle cell disease (SCD) or
hemophilia.
Submissions also recommended Medicare payment for dental services
for persons affected by systemic autoimmune disease. They argued that
dental services are an essential component of medical treatment for
these individuals who are at much higher risk of advanced dental decay,
dental loss, and/or gum disease. They stated that reducing oral
infection of the mucosa, teeth, and gums; oral inflammation; and tooth
loss through consistent oral management reduces the systemic impact
that these dental conditions have on a patient's systemic autoimmune
disease. One submission stated that oral health disparities
disproportionately affect members of racial or ethnic minority groups,
which they offered is most pronounced in populations aged 65 and older.
Another presented their proposal to bridge the gap in health equity and
to improve the health outcomes for those ages 65 and older living with
autoimmune diseases.
We thank all those who submitted recommendations for clinical
scenarios for which they believe Medicare payment for dental services
would be consistent with the policies we codified and clarified in the
CY 2023 PFS final rule under which Medicare payment could be made for
dental services when inextricably linked to other covered services. We
continue to encourage interested parties to engage with us regularly
and to submit recommendations for our consideration of additional
clinical scenarios where dental services may be inextricably linked to
specific covered services. As stated earlier, interested parties should
provide evidence to support or refute that at least one of the three
criteria listed above for submissions is met. Furthermore, submissions
should focus on the inextricably linked relationship between dental and
medical services, not a specific medical condition, and whether it is
not clinically advisable to move forward with the medical service
without having first completed the dental service(s). We remind readers
that, to be considered for purposes of CY 2025 PFS rulemaking,
submissions through our public process for recommendations on payment
for dental services should be received by February 10, 2024, via email
at [email protected]. Interested parties should
include the words ``dental recommendations for CY 2025 review'' in the
subject line of their email submission to facilitate processing. We
stress to submitters that recommendations must include at least one of
the types of evidence listed earlier when submitting documentation to
support the inextricable link between specified dental services and
other covered services. We note that we may also consider
recommendations that are submitted as public comments during the
comment period following the publication of the PFS proposed rule.
2. Proposed Additions to Current Policies Permitting Payment for Dental
Services Inextricably Linked to Other Covered Services
Under our current policy, we have identified several clinical
scenarios where dental services are inextricably linked to a primary
medical service that is covered by Medicare, such that Medicare payment
for the dental services is not precluded by section 1862(a)(12) of the
Act. After further review of current medical practice, and through
internal and external consultations and consideration of the
submissions received through the public process established in the CY
2023 PFS final rule (87 FR 69669), we believe there are additional
circumstances that are clinically similar to the scenarios we codified
in our regulation at Sec. 411.15(i)(3)(i) as examples of clinical
scenarios under which Medicare payment may be made for certain dental
services because they are inextricably linked to other covered medical
service(s).
In the case of the proposed primary, covered services, we believe
that dental services are inextricably linked to, and substantially
related and integral to the clinical success of, the proposed covered
services because such dental services serve to mitigate the substantial
risk to the success of the medical services, due to the occurrence and
severity of complications caused by the primary medical services,
including infection. Additionally, 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 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 services or if the dental
services are considered to be a critical clinical precondition to
proceeding with the primary medical procedure and/or treatment. As
such, we believe the dental services 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, the following medical services, and the statutory dental
exclusion would not apply:
(1) Chemotherapy when used in the treatment of cancer;
(2) CAR T-Cell therapy, when used in the treatment of cancer; and
(3) Administration of high-dose bone-modifying agents
(antiresorptive therapy) when used in the treatment of cancer.
As such, we propose to amend our regulation at Sec.
411.15(i)(3)(i)(A) to permit payment under Medicare Parts A and Part B
for:
(1) Dental or oral examination performed as part of a comprehensive
workup in either the inpatient or outpatient setting prior to Medicare-
covered: chemotherapy when used in the treatment of cancer, chimeric
antigen receptor (CAR) T-cell therapy when used in the treatment of
cancer, and the administration of high-dose bone-modifying agents
(antiresorptive therapy) when used in the treatment of; and
(2) Medically necessary diagnostic and treatment services to
eliminate an oral or dental infection prior to, or contemporaneously
with: chemotherapy when used in the treatment of cancer, CAR T-cell
therapy when used in the treatment of cancer, and the administration of
high-dose bone-modifying agents (antiresorptive therapy) when used in
the treatment of cancer. 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 as currently described in our
regulation at Sec. 411.15(i)(3)(ii).
a. Dental Services Inextricably Linked to Chemotherapy Services When
Used in the Treatment of Cancer
In the CY 2023 PFS final rule (87 FR 69663 through 69688), and as
described in section II.K.1 of this proposed rule, we stated that we
would continue to study the relationship between dental care and
medical services that cause immunosuppression in patients, and the risk
of dental infection and complications that arise because of the
treatment-induced immunosuppression. As discussed in section II.K.1 of
this proposed rule, we received submissions through the public process
and comments on the CY 2023 PFS proposed rule requesting that Medicare
payment should be permitted under Parts A and B for dental services
when medical services that cause
[[Page 52375]]
immunosuppression are being provided to treat a variety of medical
conditions.
Commenters asserted that immunocompromised patients are at an
increased risk of serious infection that can lead to severe conditions
(87 FR 69683). We stated that we agreed with commenters that
individuals who are immunocompromised may be prone to serious
infection, and that we would continue to consider feedback and the
clinical literature provided by interested parties to determine whether
there are other clinical scenarios, such as the initiation of
immunosuppressive therapies, where Medicare payment should not be
excluded for dental services under section 1862(a)(12) of the Act,
because the services are inextricably linked to certain other covered
services.
In the CY 2023 PFS final rule (87 FR 69681) and as discussed in
section II.K.2 of this rule, we stated that we were finalizing a policy
for CY 2024 that Medicare Parts A and B payment may be made for dental
or oral examination performed as part of a comprehensive workup in
either the inpatient or outpatient setting, as well as medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection, prior to or contemporaneously with Medicare-covered
treatments for head and neck cancer. We stated that removing infections
in the oral cavity is necessary to prepare patients for treatment and
is inextricably linked to the clinical success of treatment for cancers
of the head and neck. Additionally, as described in the comments
received on the CY 2023 PFS proposed rule and summarized in the CY 2023
PFS final rule (87 FR 69683), commenters suggested that the patient
population with any cancer receiving chemotherapy treatments required
dental services that were linked to the clinical success of the
completion of the chemotherapy treatment. They indicated that
immunocompromised patients, such as individuals with blood cancers
(leukemia and lymphoma) or other types of cancers, are at increased
risk of serious infection that can lead to severe complications and
adverse outcomes. Commenters provided information showing that
chemotherapy drugs used for treatment of head and neck cancers can have
many side effects, including sores and lesions in the mouth and throat
tissues, difficulty swallowing, bleeding in the mouth, and tooth decay.
Additionally, commenters stated that, because chemotherapy reduces the
body's ability to fight opportunistic infections, patients who begin
chemotherapy with untreated infections (including infections in the
oral cavity) are at risk of developing a number of complications,
ranging from fungal or viral infections of the mouth and throat to
systemic infections or fatal sepsis. Commenters observed that
complications arising from untreated infections could cause treatment
interruptions which could compromise the success of the treatment and
the patient's outcomes. One commenter observed that the need for
removing oral infection prior to starting chemotherapy is analogous to
the rationale for providing oral care prior to renal transplant, and
thus (like a dental exam prior to renal transplant) should be
considered substantially related and inextricably linked to the
clinical success of the treatment. Commenters recommended that patients
receiving chemotherapy for head or neck cancer receive a dental exam
and stabilization, if applicable. Several commenters noted that
providing an oral exam prior to starting chemotherapy is the standard
of care in many cancer centers (87 FR 69681 through 69683).
Additionally, in the CY 2023 PFS final rule (87 FR 69682), we
stated that many commenters recommended that we permit payment under
Medicare Parts A and B for dental services prior to treatment for all
types of cancer patients instead of just those with head and neck
cancers; commenters suggested that the linkage between the medical
services (chemotherapy, with or without radiation) and dental services
was the same whether the medical services are used to specifically
treat head and neck cancers or other cancers. Commenters stated that
the increased risk of infections and sepsis among cancer patients could
constitute major health setbacks that are costly to treat and can
compromise the success of the cancer treatment. We reiterated that we
would continue to review and evaluate information that supports the
relationship between dental care and covered treatments for cancer
(including treatments related to conditions not localized in the head,
neck, or oral cavity), and have continued to study this issue.
We believe immunosuppression is commonly understood to be a
suppression or reduction of the body's immune response, which can be
caused by various factors that increase susceptibility to infections
and an increased risk of developing certain types of conditions.\57\
There is significant and abundant worldwide experience and research
regarding the care of patients whose medical conditions require
chemotherapy regimens that induce acute
immunosuppression.58 59 The treatment of a broad range of
malignancies often requires the use of chemotherapeutic agents that in
turn suppress the body's production of white blood cells, thereby
impairing the body's ability to resist serious (potentially life-
threatening) infections. The route of entry of the offending pathogens
can be the mouth.60 61 62 Therefore, individuals receiving
chemotherapy treatment for cancer who become immunosuppressed may be
more susceptible to infection and other adverse events with serious
consequences for the patient. We understand that medical services used
in the treatment of cancer, such as chemotherapy, induce
immunosuppression. As such, we believe that cancer patients being
treated with chemotherapy represent an acutely-impacted,
immunocompromised patient population due to the nature of the effects
of such chemotherapy treatment. If dental or oral infections are left
undetected or untreated in these patients, serious complications may
occur, negatively impacting the clinical success of the medical
services and outcomes for the patients. Moreover, the immunosuppression
induced by the chemotherapy medical services in the treatment of cancer
increases the likelihood and intensity of complications for the patient
that could potentially jeopardize or impact the ability to complete the
totality of the treatment across a normal course of
treatment.63 64 If an oral or dental
[[Page 52376]]
infection is not properly diagnosed and treated prior to and/or during
the chemotherapy in the treatment of cancer, which suppresses the
immune system, there may be an increased risk for local and systemic
infections from odontogenic sources; and furthermore, the successful
completion of that treatment could be compromised. Additionally, if
such an infection is not treated, then there is an increased likelihood
of morbidity and mortality resulting from the spreading of the local
infection to sepsis 65 66
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\57\ Abbas AK, Lichtman AH, Pillai S. Basic Immunology:
Functions and Disorders of the Immune System. 5th edition.
Philadelphia: Elsevier; 2016. Chapter 8, Immune Suppression.
\58\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should
oral foci of infection be removed before the onset of radiotherapy
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
\59\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi:
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
\60\ Mirowski GW, Bettencourt JD, Hood AF. Oral infections in
the immunocompromised host. Semin Cutan Med Surg. 1997
Dec;16(4):249-56. doi: https://dx.doi.org/10.1016/s1085-5629(97)80013-2. PMID: 9421215.
\61\ Greenberg MS, Cohen SG, McKitrick JC, et al. The oral flor
as a source of septicemia in patients with acute leukemia. Oral Surg
Oral Med Oral Pathol. 1982 Jan;53(1):32-6. PMID: 6948251.
\62\ King A, Irvine S, McFadyen A, et al. Do we overtreat
patients with presumed neutropenic sepsis? Postgrad Med J. 2022
Nov;98(1165):825-9. doi: https://dx.doi.org/10.1136/postgradmedj-2021-140675. PMID: 34611037.
\63\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should
oral foci of infection be removed before the onset of radiotherapy
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
\64\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi:
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
\65\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST.
The impact of mucositis on alpha-hemolytic streptococcal infection
in patients undergoing autologous bone marrow transplantation for
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed:
9610710].
\66\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral
mucositis and outcomes of allogeneic hematopoietic stem-cell
transplantation in patients with hematologic malignancies. Support
Care Cancer May;2007 15(5):491-496. [PubMed: 17139495].
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Individuals undergoing chemotherapy services used in the treatment
of cancer who become immunosuppressed by the treatment may also
experience oral mucositis, which often facilitates entry of oral
bacteria into the body, potentially increasing the risk of infection
for the patient and compromising the chemotherapy regimen. The risk of
mucositis and potential complications to the clinical success of
medical services for cancer treatment is similar to the risk for
patients receiving Hematopoietic Stem Cell Transplants (HSCT) and bone
marrow transplants,67 68 for which we finalized payment for
certain dental services prior to these medical services (87 FR 69677).
These potential complications, resulting from the combined
immunosuppression and mucositis caused by the chemotherapy services,
present a risk to the patient and the success of the medical
chemotherapy regimen, unless mitigated by the provision of dental
services. Additionally, as described above, evidence found in
systematic reviews showed a possible increased incidence of oral
mucositis when dental treatment is not administered at least 2-3 weeks
prior to initiation of cancer treatment, further complicating the
totality of services a patient received to treat their cancer.\69\
---------------------------------------------------------------------------
\67\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral
mucositis and outcomes of allogeneic hematopoietic stem-cell
transplantation in patients with hematologic malignancies. Support
Care Cancer May,2007 15(5):491-496. [PubMed: 17139495].
\68\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST.
The impact of mucositis on alpha-hemolytic streptococcal infection
in patients undergoing autologous bone marrow transplantation for
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed:
9610710].
\69\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H,
et al. Required time for pre-oncological dental management--A rapid
review of the literature. Oral Oncol. 2022 11;134:106116. doi:
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID:
36115328.
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Moreover, as described above in section II.K.1. of this proposed
rule, dental services to identify and treat oral complications/
comorbidities prior to and, sometimes, throughout chemotherapy
treatment have been associated with improved outcomes for the patient
receiving medical services in the treatment of cancer.\70\
Additionally, as discussed in section II.K.1. of this proposed rule,
research studies support that dental evaluation/treatment prior to
cancer treatment led to decreased incidence and/or less severity of
serious oral infections and complications (such as, oral mucositis and
osteonecrosis) with the medical services, as well as requiring fewer
emergency treatments.71 72
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\70\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions-a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
\71\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
\72\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related
osteonecrosis of the jaw: An update on the memorial sloan kettering
cancer center experience and the role of premedication dental
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
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Consequently, we believe that the evidence supports that the
standard of care is such that one would not proceed with the
chemotherapy when used in the treatment of cancer without performing
the dental services, because the covered services would or could be
significantly and materially compromised, such that clinical outcomes
of the chemotherapy treatment could be compromised absent the provision
of the inextricably-linked dental services.
As described in the CY 2023 PFS final rule (87 FR 69685), we noted
that evidence to support the linkage between the dental and covered
services could include information demonstrating that the standard of
care would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to clear the patient of an oral or
dental infection; or, in instances where a known oral or dental
infection is present, the standard is such that the medical
professional would not proceed with the medical service until the
patient received the necessary treatment to eradicate the infection.
Our review of relevant clinical practice guidelines demonstrated that
multiple professional societies recommend the performance of dental
services prior to the initiation of or during
chemotherapy.73 74 For instance, the United Kingdom
published a guideline for dental evaluation and treatment before and
after treatments for head and neck cancer (5th edition of the UK Multi-
Disciplinary Guidelines for Head and Neck Cancer), based on guidance
from the National Institute for Health and Care Excellence (NICE) and
expert recommendations: ``Preventive oral care must be delivered to
patients whose cancer treatment will affect the oral cavity, jaws,
salivary glands and oral accessibility.'' \75\ Additionally, as
described in the CY 2023 PFS final rule (87 FR 69680), several
commenters provided data regarding the treatment of head and neck
cancer that illustrated that conditions such as oral mucositis or
osteonecrosis of the jaw that occur during the treatment may compromise
the clinical success of the primary medical service (chemotherapy for
the treatment of head and neck cancer), potentially leading to multiple
hospitalizations, including systemic infections or fatal sepsis, if
dental infections remained untreated.
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\73\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
\74\ American Academy of Pediatric Dentistry. Dental management
of pediatric patients receiving immunosuppressive therapy and/or
head and neck radiation. The Reference Manual of Pediatric
Dentistry. Chicago, Ill.; 2022:507-16.
\75\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
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We believe chemotherapy used in the treatment of cancer causes
acute immunosuppression, causing significant oral complications and
adverse events, including the possibility of an oral or dental
infection, which in turn may lead to serious and imminent risks to the
success of the primary medical procedures and treatments. These
treatment-induced complications, including possible infection, prevent
the ability to proceed with the primary, covered medical service (that
is, lead to delays in treatment and/or cause inability of the patient
to complete the course of treatment, thereby potentially reducing
effectiveness of the therapy)
[[Page 52377]]
and the standard of care would be to not proceed with the covered
medical procedure until a dental or oral exam is performed to address
the oral complications and/or clear the patient of an oral or dental
infection. In the case of the Medicare covered chemotherapy when used
in the treatment of cancer, dental services serve to mitigate the
likelihood of occurrence and severity of complications caused by the
primary medical services, including infection, and consequently the
dental services facilitate the successful completion of the prescribed
course of treatment and therefore the dental services are integral and
inextricably linked to these medical services, and the statutory dental
exclusion would not apply.
We believe that proceeding without a dental or oral exam and
necessary diagnosis and treatment of any presenting infection of the
mouth prior to chemotherapy when used in the treatment of cancer could
lead to systemic infection or sepsis, as well as other complications
for the patient. We also believe that an oral or dental infection could
present substantial risk to the success of chemotherapy when used in
the treatment of cancer, 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 and medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection prior to, or contemporaneously with chemotherapy when
used in the treatment of cancer 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 these
other covered services.
We also seek comment on whether we should consider radiation
therapy in the treatment of cancer more broadly (not in conjunction
with chemotherapy, and not in relation to head and neck cancer
treatment) as medical services that may be inextricably linked to
dental services. We do not believe that radiation therapy alone
necessarily leads to the same level of treatment-induced
immunosuppression as for cancer patients receiving chemotherapy since
radiation specifically targets malignant cells and has more targeted
and localized effects on the body as compared to system-wide
immunosuppression effects of chemotherapy for cancer treatment.
However, we seek comment on whether dental services prior to radiation
therapy in the treatment of cancer, when furnished without
chemotherapy, such as second line therapy for metastasized cancer in
the head and neck, would be inextricably linked to the radiation
therapy services, and therefore payable under Medicare Parts A and B.
In summary, after consideration of clinical practice guidelines,
recommendations provided by the public, and our analyses of the studies
and research available regarding the connection between dental services
and the clinical success of chemotherapy services, we believe that
there is an inextricable link between certain dental and chemotherapy
services when used in the treatment of cancer because the standard of
care is such that one would not proceed with the medical procedure or
service without performing the dental service(s) because the covered
medical services would or could be significantly and materially
compromised absent the provision of the inextricably-linked dental
services and that dental services are a clinical prerequisite to
proceeding with the chemotherapy services when used in the treatment of
cancer. Chemotherapy services when used in the treatment of cancer
cause immunosuppression which may lead to significant oral
complications and adverse events, including the possibility of an oral
or dental infection, which in turn lead to serious and imminent risks
to the success of the primary medical procedures and treatments. The
complications, including possible infection, may prevent the ability to
both initiate and proceed with the primary, covered medical service
(that is, lead to delays in treatment and/or cause inability of the
patient to complete the course of treatment, thereby potentially
reducing effectiveness of the therapy) such that the standard of care
would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of
chemotherapy services when used in the treatment of cancer, dental
services serve to mitigate the likelihood of occurrence and severity of
complications caused by the primary medical services, including
infection, and consequently the dental services facilitate the
successful completion of the prescribed course of treatment. Therefore,
we believe the dental services are integral and inextricably linked to
the chemotherapy when used in the treatment of cancer, and the
statutory dental exclusion under section 1862(a)(12) of the Act would
not apply.
We are proposing to add this clinical scenario to the examples of
clinical scenarios under which payment can be made for certain dental
services in our regulation at Sec. 411.15(i)(3)(i)(A). Specifically,
we propose to amend the regulation to include dental or oral
examination performed as part of a comprehensive workup in either the
inpatient or outpatient setting prior to Medicare-covered chemotherapy
when used in the treatment of cancer; and, medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to, or contemporaneously with chemotherapy when used in
the treatment of cancer. We seek comments on all aspects of this
proposal. Additionally, we note that we are proposing to make payment
for dental services that are inextricably linked to chemotherapy used
in the treatment of cancer with or without the use of other therapy
types, including radiation therapy in the treatment of cancer. That is,
this proposal is not meant to be limited to cases where chemotherapy in
the treatment of cancer is provided without the use of other therapies.
We seek comment on this aspect of the proposal.
b. Dental Services Inextricably Linked to CAR T-Cell Therapy, When Used
in the Treatment of Cancer
In the CY 2023 PFS final rule (87 FR 69677), commenters stated that
individuals receiving CAR T-cell treatment for cancer may also require
dental services, suggesting that these dental services are inextricably
linked to covered CAR T-cell medical services, asserting that dental
and oral services improve clinical outcomes for these types of medical
services. We also received submissions through the public process
providing evidence to show that dental services are inextricably linked
to the clinical success of CAR T-cell medical services and other
lymphodepleting therapy when used in the treatment of cancer. The
submissions stated that, because CAR T-cell medical services cause a
patient to be immunosuppressed, an untreated oral or dental infection
could complicate or compromise the clinical outcome of the CAR T-cell
medical service. Two submissions cited research indicating that
patients undergoing CAR T-cell therapy and other lymphodepleting
therapy, which is a short course of chemotherapy for the purpose of
killing off a portion (or all) of the patient's own lymphocytes and/or
other white blood cells prior to an immunotherapy or a bone marrow
transplant, experience a higher infection risk in the first 100 days
post-
[[Page 52378]]
treatment.\76\ Submitters also stressed the need to detect early and
monitor for dental issues during CAR T-cell therapy in order to avoid
the increased risk of related infections and complications. These
submissions also highlighted that clinical practice guidelines
recommend dental services prior to initiating the CAR T-cell therapy
and other lymphodepleting therapy in order to eliminate any sources of
infection before and during treatment.77 78 79 80 81
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\76\ Wudhikarn K, Palomba ML, Pennisi M, Garcia-Recio M, Flynn
JR, Devlin SM, Afuye A, Silverberg ML, Maloy MA, Shah GL, Scordo M,
Dahi PB, Sauter CS, Batlevi CL, Santomasso BD, Mead E, Seo SK,
Perales MA. Infection during the first year in patients treated with
CD19 CAR T cells for diffuse large B cell lymphoma. Blood Cancer J.
2020 Aug 5;10(8):79. doi: 10.1038/s41408-020-00346-7. PMID:
32759935; PMCID: PMC7405315.
\77\ Elad S, Raber-Durlacher JE, Brennan MT, Saunders DP, Mank
AP, Zadik Y, Quinn B, Epstein JB, Blijlevens NM, Waltimo T, Passweg
JR, Correa ME, Dahll[ouml]f G, Garming-Legert KU, Logan RM, Potting
CM, Shapira MY, Soga Y, Stringer J, Stokman MA, Vokurka S, Wallhult
E, Yarom N, Jensen SB. Basic oral care for hematology-oncology
patients and hematopoietic stem cell transplantation recipients: a
position paper from the joint task force of the Multinational
Association of Supportive Care in Cancer/International Society of
Oral Oncology (MASCC/ISOO) and the European Society for Blood and
Marrow Transplantation (EBMT). Support Care Cancer. 2015
Jan;23(1):223-36. Epub 2014 Sep 5. PMID: 25189149; PMCID:
PMC4328129. doi: 10.1007/s00520-014-2378-x.
\78\ University of Michigan, CAR-T Cell Patient Dental Clearance
Instructions, no date. CellularTherapyDentalForm.pdf (umich.edu).
\79\ Guideline on dental management of pediatric patients
receiving chemotherapy, hematopoietic cell transplantation, and/or
radiation. Pediatr Dent, 2008; 30(7 Suppl):219-225.
\80\ McGuire DB, Correa ME, Johnson J, Wienandts P. The role of
basic oral care and good clinical practice principles in the
management of oral mucositis. Support Care Cancer, 2006; 14(6):541-
547. doi:10.1007/s00520-006-0051-8 8.
\81\ Vendrell Rankin K, Jones DL, Redding SW (Eds.), Oral Health
in Cancer Therapy: A Guide for Health Care Professionals [3rd
edition], Baylor Oral Health Foundation and the Cancer Prevention
and Research Institute of Texas, 2008. https://doi.org/10.1002/9781118416426.ch101.
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After consideration of clinical practice guidelines,
recommendations provided by the public, and our analyses of the studies
and research available regarding the connection between dental services
and the clinical success of CAR T-cell therapy, we are persuaded that
dental services to diagnose and treat infection prior to CAR T-cell
therapy are inextricably linked to the clinical success of CAR T-cell
therapy, and that these services also represent a clinically analogous
scenario to dental services for which Medicare payment under Parts A
and B is currently permitted when furnished in the inpatient or
outpatient setting, such as prior to organ transplant, cardiac valve
replacement, or valvuloplasty procedures. We believe there is an
inextricable link between dental and CAR T-cell therapy when used in
the treatment of cancer because the standard of care is such that one
would not proceed with the medical procedure or service without
performing the dental service because the covered medical services
would or could be significantly and materially compromised absent the
provision of the inextricably-linked dental services and that dental
services are a clinical prerequisite to proceeding with the CAR T-cell
therapy when used in the treatment of cancer.
We believe that proceeding without a dental or oral exam and
necessary diagnosis and treatment of any presenting infection of the
mouth prior to (CAR) T-cell therapy when used in the treatment of
cancer could lead to systemic infection or sepsis, as well as other
complications for the patient. We also believe that an oral or dental
infection could present substantial risk to the success of the (CAR) T-
cell therapy when used in the treatment of cancer, 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 and medically necessary diagnostic and treatment services to
eliminate an oral or dental infection prior to, or contemporaneously
with (CAR) T-cell therapy when used in the treatment of cancer 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 these other covered medical
services. As such, we are proposing to add this clinical scenario to
the examples of clinical scenarios under which payment can be made for
certain dental services in our regulation at Sec. 411.15(i)(3)(i)(A).
Specifically, we propose to amend the regulation to include a dental or
oral examination performed as part of a comprehensive workup in either
the inpatient or outpatient setting prior to Medicare-covered CAR T-
cell therapy when used in the treatment of cancer; and medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection prior to, or contemporaneously with, CAR T-cell
therapy when used in the treatment of. We seek comments on all aspects
of this proposal.
We also seek comment on whether we should add as an example of
dental services for which payment may be made under Medicare Parts A
and B other types of lymphodepleting medical services used for cancer
treatment, in addition to those used in conjunction with CAR T-cell
therapy for cancer treatment. Commenters specifically stated that CAR
T-Cell therapies constituted lymphodepleting therapies, and we believe
there may be other immunotherapies that may have a similar
lymphodepletion component, but we received no specific information
regarding such therapies. Evidence submitted by the public through the
finalized public submission process indicates that treatment-induced
immunosuppression may also occur with lymphodepleting medical services,
and that complications caused by the treatment-induced
immunosuppression, including possible infection, may prevent the
ability to proceed with the primary, covered medical service (that is,
lead to delays in treatment and/or cause inability of the patient to
complete the course of treatment, thereby potentially reducing the
effectiveness of the therapy) and the standard of care would be to not
proceed with the covered medical procedure until a dental or oral exam
is performed to address the oral complications and/or clear the patient
of an oral or dental infection. However, we request comment on what
specific medical services also involve lymphodepletion and should
therefore be considered in addition to CAR T-cell therapy. We also
request additional information regarding how those specific services
might be impacted by dental infections/conditions. We note that if we
receive compelling clinical evidence, we may finalize in the CY 2024
PFS final rule additional clinical scenarios, such as dental services
prior to other types of specific lymphodepleting medical services where
the treatment may induce immunosuppression for patients with cancer and
the standard of care would be to not proceed with the medical services
without having first complete the dental services, 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 these other types of
lymphodepleting medical services, and if so, we request a description
of that systematic evidence. Specifically, similar to the evidence we
requested in the CY 2023 PFS proposed rule, we are looking for medical
evidence that 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
[[Page 52379]]
skeletal structure. If commenters are able to provide us with
compelling evidence to support that a dental exam and necessary
treatment prior to specific other lymphodepleting medical services
where the treatment may induce immunosuppression for patients with
cancer, 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 specific lymphodepleting medical services for
patients with cancer.
c. Dental Services Inextricably Linked To Administration of High-Dose
Bone-Modifying Agents (Antiresorptive Therapy) When Used in the
Treatment of Cancer
As discussed above, submissions received through the public process
we established in the CY 2023 PFS final rule stated that medication-
related osteonecrosis of the jaw (MRONJ) is a serious complication of
the administration of bone-modifying agents (such as bisphosphonates
and denosumab, and other biosimilar agents) used when managing certain
cancers.\82\ MRONJ is a rare occurrence, multifactorial in nature, and
can have the same clinical presentation in patients who have not been
exposed to an antiresorptive medication.\83\ that Medicare make payment
under Parts A and B for dental services for patients where high-dose
bisphosphonate therapy for cancers is indicated and recommended payment
for dental services prior to and during antiresorptive therapy or prior
to, during, and after the use of bone-modifying drugs. Additionally, in
our internal review of clinical practice guidelines, we noted that one
professional society provided recommendations regarding dental services
prior to the initiation of, or during, the administration of high-dose
bone-modifying agents (antiresorptive therapy) when used in the
treatment of cancer. Specifically, the Multinational Association of
Supportive Care in Cancer/International Society of Oral Oncology
(MASCC/ISOO) and American Society of Clinical Oncology (ASCO) Clinical
Practice Guideline \84\ states that cancer patients should receive an
oral care assessment (including a comprehensive dental, periodontal,
and oral radiographic exam, when feasible) prior to initiating the
administration of high-dose bone-modifying agents (antiresorptive
therapy) when used in the treatment of cancer in order to reduce
complications and manage modifiable risk factors. We believe that this
practice guideline demonstrate that the standard of care would be to
address dental infections prior to proceeding with the covered medical
procedure, including oral care assessments and the completion of
medically necessary dental procedures prior to the start of the
administration of high-dose bone-modifying agents (antiresorptive
therapy) when used in the treatment of cancer, especially as these
dental concerns and/or procedures may relate to the cancer treatment
and avoidance of MRONJ.
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\82\ American Association of Oral and Maxillofacial Surgeons.
(2022). Medication-related osteonecrosis of the Jawn-2022 update
(position paper). Available at: https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf.
\83\ American Association of Oral and Maxillofacial Surgeons.
(2022). Medication-related osteonecrosis of the Jawn-2022 update
(position paper). Available at: https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf.
\84\ Yarom N, Shapiro CL, Peterson DE, et al. Medication-Related
Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice
Guideline. J Clin Oncol. 2019 Sep 1;37(25):2270-90. doi: https://dx.doi.org/10.1200/JCO.19.01186. PMID: 31329513.
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In summary, after consideration of clinical practice guidelines,
recommendations provided by the public, and our analyses of the studies
and research available regarding the connection between dental services
and the clinical success of the administration of high-dose bone-
modifying agents (antiresorptive therapy) when used in the treatment of
cancer, we are proposing to add this clinical scenario to the examples
of clinical scenarios under which payment can be made for certain
dental services in our regulation at Sec. 411.15(i)(3)(i)(A). We
believe that there is an inextricable link between dental and
administration of high-dose bone-modifying agents (antiresorptive
therapy) when used in the treatment of cancer because the standard of
care is such that one would not proceed with the medical procedure or
service without performing the dental service because the covered
medical services would or could be significantly and materially
compromised absent the provision of the inextricably-linked dental
services and that dental services are a clinical prerequisite to
proceeding with the administration of high-dose bone-modifying agents
(antiresorptive therapy) when used in the treatment of cancer.
Specifically, we propose to amend the regulation to include dental or
oral examination performed as part of a comprehensive workup in either
the inpatient or outpatient setting prior to Medicare-covered the
administration of Medicare-covered high-dose bone-modifying agents
(antiresorptive therapy), when used in the treatment of cancer; and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with,
administration of high-dose bone-modifying agents (antiresorptive
therapy), when used in the treatment of cancer. We seek comments on all
aspects of this proposal.
We note that in the CY 2023 PFS final rule (87 FR 70225) and now
codified in our regulation at Sec. 411.15(i)(3)(i), we finalized that
for dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, a certain covered
medical service, payment may be made under Medicare Parts A and B for
services when furnished in either the inpatient or outpatient setting;
therefore, we proposed that these provisions would apply to the
proposed amendments to regulation at Sec. 411.15(i)(3)(i) to allow for
payment under Medicare Parts A and Part B in either the inpatient or
outpatient setting. We further 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 as described in our
regulation at Sec. 411.15(i)(3)(ii).
If the proposed policies are finalized, we anticipate making
conforming changes to the Medicare Benefit Policy Manual (IOM Pub. 100-
02) to reflect the final changes or clarifications. Additionally, if
finalized, we intend to issue educational and outreach materials to
inform billing and payment for any policies finalized in the final rule
We seek comments on these proposals.
d. Proposed Amendments to Regulations Regarding Dental Services
Inextricably Linked to Treatment for Head and Neck Cancer
In the CY 2023 PFS final rule, we finalized for CY 2024 that
payment under Medicare Parts A and B can be made for an oral or dental
examination as part of a comprehensive workup in either the inpatient
or outpatient setting, and medically necessary diagnostic and treatment
services to eliminate an oral or dental infection, prior to and
contemporaneously with treatments (radiation, chemotherapy, and
surgery) for head and neck cancer (87 FR 69671, 69677, and 69681-
69682). We note that we stated the policy in some instances
[[Page 52380]]
without explicitly including both ``prior to'' and ``contemporaneously
with.'' (87 FR 69669, 69681, 69682, and 69687.)
We also indicated that we wanted to continue to consider various
aspects of our finalized policy and that we anticipated additional
clarifying rulemaking on this final policy for CY 2024. In the CY 2023
PFS final rule we stated that we wanted to examine the clinical data
and consider whether greater specificity may be needed to describe the
medical services involved in this type of treatment. We stated that we
were cognizant of concerns that, absent clear guidelines and
definitions, beneficiaries, practitioners, and MACs may need additional
information prior to providing payment under Medicare Parts A and B,
and without it could lead to inconsistent application of the policy. In
particular, we stated that it is important to determine whether any
additional guidance is necessary to identify conditions considered
``head and neck cancer'' and qualifying covered medical services
considered within the treatments for these cancers beyond just
radiation (with or without chemotherapy).
Upon further study, as pointed out by one submitter, we understand
that the term ``head and neck cancer'' encompasses a multitude of
pathologies that often require multi-modality therapies including
radiation, chemotherapy and surgery. This submitter noted that
approximately 80 percent of head and neck cancer patients will receive
radiation therapy at least once during the course of their disease.
While the majority of head and neck cancers are squamous cell
carcinomas that originate from the mucosa of the oral cavity, pharynx
or larynx, they may also arise from the salivary glands, the nasal
cavities and the paranasal sinuses. They can be locally advanced,
regionally metastatic to the cervical nodes and can spread to distant
sites such as the lungs and liver. According to the submitter,
regardless of origin, the clinical diagnostic and therapeutic
approaches for head and neck cancers are fundamentally similar, and
treatment modalities often result in both acute and chronic oral
toxicities.
If unaddressed, existing oral or dental infection may compromise
the delivery of the appropriate modalities of care (radiation,
chemotherapy, surgery). The standard of care is to address and
eliminate oral and dental infections prior to the treatment of some (or
many) head and neck cancers. Additionally, as discussed in section
II.K.2.a of this proposed rule, the complications caused by treatment-
induced vulnerabilities, which may include infection and
osteoradionecrosis, can prevent the ability to proceed with the
primary, covered medical service (that is, can lead to delays in
treatment and/or cause inability of the patient to complete the course
of treatment, thereby potentially reducing effectiveness of the
therapy); and the standard of care would be to not proceed with the
covered medical procedure until a dental or oral exam is performed to
address the oral complications and/or clear the patient of an oral or
dental infection.
As discussed in the CY 2023 final rule, we believe that addressing
any oral or dental infection prior to the initiation of treatment
serves to minimize the potential development of the treatment-induced
complications. Moreover, we believe that these treatment-induced
complications can occur as a result of and during multiple rounds of
treatment.
Therefore, we are proposing to clarify that Medicare Parts A and B
payment may be made for dental or oral examination performed as part of
a comprehensive workup in either the inpatient or outpatient setting,
as well as for the medically necessary diagnostic and treatment
services to eliminate an oral or dental infection prior to the
initiation of, or during, treatments for head and neck cancer, whether
primary or metastatic, regardless of site of origin, and regardless of
initial modality of treatment.
In summary, we are proposing to amend our regulation at Sec.
411.15(i)(3)(i)(A) to allow for payment under Medicare Parts A and Part
B for:
(1) Dental or oral examination in either the inpatient or
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer; and
(2) Medically necessary diagnostic and treatment services to
eliminate an oral or dental infection in either the inpatient or
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer.
We note that in the CY 2023 PFS final rule (87 FR 70225) and now
codified in our regulation at Sec. 411.15(i)(3)(i), we finalized that
for dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, a certain covered
medical service, payment may be made under Medicare Parts A and B for
services when furnished in either the inpatient or outpatient setting;
therefore, we proposed that these provisions would apply to the
proposed amendments to regulation at Sec. 411.15(i)(3)(i) to allow for
payment under Medicare Parts A and Part B in either the inpatient or
outpatient setting. We further 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 as described in our
regulation at Sec. 411.15(i)(3)(ii). If finalized, we anticipate
making conforming changes to the Medicare Benefit Policy Manual (IOM
Pub. 100-02) to reflect the final changes or clarifications. We seek
comments on all aspects of these proposals.
3. Request for Information on Dental Services Integral to Covered
Cardiac Interventions
In the CY 2023 PFS final rule, we finalized a policy to permit
payment for dental or oral examination performed as part of a
comprehensive workup in either the inpatient or outpatient setting
prior to Medicare-covered cardiac valve replacement or valvuloplasty
procedures; and medically necessary diagnostic and treatment services
to eliminate an oral or dental infection prior to, or contemporaneously
with, the cardiac valve replacement or valvuloplasty procedure (87 FR
69675).
We recognized that, without a dental or oral exam and necessary
diagnosis and treatment of any presenting infection of the mouth prior
to a cardiac valve replacement or valvuloplasty procedure, an
undetected, non-eradicated oral or dental infection could lead to
bacteria seeding the valves and the 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 (87 FR 69667).\85\ Specifically, we noted that the replaced
valve is also at risk of being a seeding source for future
endocarditis. Endocarditis can carry a high risk of mortality for these
patients, and eliminating an infection prior to or contemporaneously
with the procedure would be important for preventing future
endocarditis related to the new valve (87 FR 69678).
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\85\ 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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We also concluded that an oral or dental infection could present a
substantial risk to the success of organ transplants, 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 stated
[[Page 52381]]
that 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 these other covered medical services (89 FR 69667).
We encouraged the public to use the public submission process
finalized in the CY 2023 PFS final rule to identify additional clinical
scenarios and related medical evidence to support an inextricable link
between specified dental services and other covered medical services.
Through the submission process, an interested party has encouraged
CMS to consider extending Medicare payment to include dental services
to eliminate infection prior to all cardiovascular procedures, as the
mitigation of risks of perioperative and postoperative infection and
complications is critical to ensure optimal surgical outcomes for all
patients requiring invasive and/or interventional cardiac procedures.
This submission noted that the current standard of care does not
conclusively require dental evaluation, diagnosis, or treatment
services prior to certain cardiac procedures, perhaps in part because
such cardiac procedures are often performed on a more urgent or
emergent basis where there is not an opportunity to consider the
possible presence of dental infection. Moreover, the submission noted
that much of the scientific literature is inconclusive as to whether
pre-operative dental treatments impact postoperative surgical outcomes
in cardiovascular surgery, including cardiac valve procedures.\86\ A
systematic literature review by Cotti et al. found that, based upon
expert opinion, there is general agreement on the need for screening
and treatment of oral/dental infections in patients who are to undergo
cardiac surgery (although no standardized clinical guidelines or
protocols exist to outline the screening process, in terms of either
dental treatment options and/or timing of such procedures in relation
to the planned cardiac intervention).\87\ The authors convened an
expert panel from six Italian scientific societies (including
cardiologists, cardiac surgeons, and dental specialists) to establish a
consensus on early screening and resolution of dental or periodontal
infections prior to cardiac surgery, that they intended would result in
a standardized protocol for evaluating oral infections and dental
treatments for cardiac patients to be used in the interventional
preparation phase by both dental and cardiac teams.\88\ The authors
noted, however, the lack of scientific evidence on the risk-to-benefit
ratio for perioperative dental treatment in patients undergoing
cardiovascular surgery.
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\86\ Lockhart, P.B., DeLong, H.R., Lipman, R.D., Estrich, C.G.,
Araujo, M.W.B. and Carrasco-Labra, A. (2019). Effect of dental
treatment before cardiac valve surgery: Systematic review and meta-
analysis. Journal of the American Dental Association,150(9). 739-
747. https://doi.org/10.1016/j.adaj.2019.04.024.
\87\ Cotti, E., Cairo, F., Bassareo, P.P., Fonzar, F., Venturi,
M., Landi, L., Parolari, A., Franco, V., Fabiani, C., Barili, F., Di
Lenarda, A., Gulizia, M., Borzi, M., Campus, G., Musumeci, F., and
Mercuro, G. (2019). Perioperative dental screening and treatment in
patients undergoing cardiothoracic surgery and interventional
cardiovascular procedures. A consensus report based on RAND/UCLA
methodology. International Endodontic Journal,53. 186-199. https://doi.org/10.1111/iej.13166.
\88\ Ibid.
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We believe, after further review of current medical practice,
through consultations with interested parties (including commenters on
last year's final rule and those commenting on current topics) and our
medical officers, and through evidence submitted through the public
submission process we established in the CY 2023 PFS final rule, that
there may be additional circumstances that are clinically similar to
examples we codified in our regulation at Sec. 411.15(i)(3)(i) where
Medicare payment for dental services could be made under other clinical
circumstances where the dental services are inextricably linked to a
covered cardiac medical service(s).
To gain further understanding of any potential relationship between
dental services and specific covered cardiac medical services, we again
partnered with researchers at the AHRQ to review available clinical
evidence regarding the relationship between dental services and covered
cardiac medical services, including implantation of ventricular assist
devices, artificial pacemakers, implantable defibrillators, synthetic
vascular grafts and patches, and coronary and vascular stents. This
AHRQ report \89\ is available at https://effectivehealthcare.ahrq.gov/products/implantable-cardiovascular-devices/rapid-review.
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\89\ Hickam DH, Gordon CJ, Armstrong CE, Paynter R. The Efficacy
of Dental Services for Reducing Adverse Events in Those Undergoing
Insertion of Implantable Cardiovascular Devices. Rapid Response.
(Prepared by the Scientific Resource Center under Contract No.
75Q80122C00002.) AHRQ Publication No. 23-EHC020. Rockville, MD:
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/AHRQEPCRAPIDDENTALCARDIO.
---------------------------------------------------------------------------
As stated in their report, the available evidence does not permit
conclusions regarding the effect of pre-treatment dental care for
preventing downstream infections related to any of these devices. They
noted that professional society guidelines endorse the provision of
patient education on routine oral hygiene practices but have not
recommended other pre-treatment dental care prior to insertion of these
devices. They also noted that professional society guidelines recommend
ongoing routine dental examinations for some patients treated with
cardiovascular devices.
Nonetheless we seek comment to identify additional cardiac
interventions (that is, specific medical services) where the risk of
infection posed to beneficiaries is similar to that associated with
cardiac valve replacement or valvuloplasty. We note that, in order to
consider whether certain dental services are inextricably linked to the
clinical success of other covered medical services, we need to identify
specific medical services for which there is clinical evidence that
certain dental services are so integral to the clinical success that
they are inextricably linked to other covered service(s). We encourage
interested parties to use the public submission process to submit
recommendations and relevant clinical evidence for establishing this
connection. Above, in section II.K.1.c. of this proposed rule, we have
described the various types of documentation to support recommendations
through this process. We are considering, and seek comment on, whether
the following cardiac interventions are examples of specific medical
services for which dental services are inextricably linked to clinical
success: implantation of electronic devices in the heart, such as
pacemakers, cardioverter defibrillators, and monitors. We are also
considering, and seek comment on, whether the following procedures
would be considered examples of specific medical services for which
dental services are inextricably linked to their clinical success: the
placement of intracardiac or intravascular foreign material, such as a
stent or for hemodialysis, or for a vascular access graft, whereas you
would not proceed with the medical service without having first
completed a dental evaluation and/or treatment as determined necessary.
We seek comment on whether preoperative and perioperative dental
services are inextricably linked to any other covered cardiac
interventions as supported by clinical evidence.
[[Page 52382]]
4. Request for Comment on Dental Services Integral to Specific Covered
Services To Treat Sickle Cell Disease (SCD) and Hemophilia
Interested parties using the public submission process we finalized
in the CY 2023 PFS final rule urged us to propose to provide that
payment can be made for dental services for individuals living with SCD
and hemophilia.
These submissions provided information and references supporting
prevention of dental infection among individuals with SCD to reduce
need for more extensive procedures that may result in bleeding
complications and require hospitalization. They also provided
information detailing increased dental caries and periodontal disease
in people with SCD,\90\ many of whom lose a number of teeth, which
greatly limits nutrition, general well-being, and overall quality of
life.
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\90\ Kakkar M, Holderle K, ShethM, Arany S, Schiff L, Planerova
A. Orofacial Manifestation and Dental Management of Sickle Cell
Disease: A Scoping Review. Anemia. 2021 Oct 22; 2021:5556708. Doi:
10.1155/2021/5556708. PMID: 34721900; PMCID: PMC8556080.
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We seek comment on whether certain dental services are inextricably
linked to other covered services used in the treatment of SCD, such as,
but not limited to, hydroxyurea therapy. We seek comment identifying
such covered services for SCD and whether an inextricable link is
supported by clinical evidence as described in section II.K.1.c. of
this proposed rule.
Interested parties also urged us to propose a policy to permit
payment for dental services for individuals living with hemophilia.
They noted that periodic dental care reduces the risks of dental
complications requiring haemostatic therapy (such as tooth extractions
that may require clotting factor treatment) or oral surgeries requiring
clotting factor replacement therapy.91 92 93
---------------------------------------------------------------------------
\91\ Raso S, Napolitano M, Sirocchi D, Siragusa S, Hermans C.
The important impact of dental care on haemostatic treatment burden
in patients with mild haemophilia. Haemophilia. 2022 Nov;28(6):996-
999. doi: 10.1111/hae.14626. Epub 2022 Jul 25. PMID: 35879819.
\92\ Srivastava A, Santagostino E, Dougall A, Kitchen S,
Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J,
Llin[aacute]s A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM,
Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the
Management of Hemophilia panelists and co-authors. WFH Guidelines
for the Management of Hemophilia, 3rd edition. Haemophilia. 2020
Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3.
Erratum in: Haemophilia. 2021 Jul;27(4):699. PMID: 32744769.
\93\ Peisker A, Raschke GF, Schultze-Mosgau S. Management of
dental extraction in patients with Haemophilia A and B: a report of
58 extractions. Med Oral Patol Oral Cir Bucal. 2014 Jan 1;19(1):e55-
60. doi: 10.4317/medoral.19191. PMID: 24121912; PMCID: PMC3909433.
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We note that many submitters stated that good dental and oral
health benefits a patient's overall health generally. Several
commenters on the CY 2023 PFS proposed rule also expressed that good
oral hygiene, along with routine dental services, contributes to better
outcomes for patients. We recognized in the CY 2023 PFS final rule in
response to those comments that there is a great deal of evidence
suggesting that dental health is generally an important component of
overall health; however, we are interested in comments on whether
certain dental services are considered so integral to the primary
covered services that the necessary dental interventions are
inextricably linked to, and substantially related and integral to
clinical success of, the primary covered services such that they are
not subject to the statutory preclusion on Medicare payment for dental
services under section 1862(a)(12) of the Act.
We seek comment on whether certain dental services are inextricably
linked to certain other covered services for hemophilia, supported by
clinical evidence as described in section II.K.1.c., above. We seek
comment identifying such covered services for the treatment of
hemophilia. We also seek comment specifically on whether dental
services such as prophylaxis are a standard of care in the management
of hemophilia.
5. Request for Comment Regarding Dental Services Possibly Inextricably
Linked to Other Medicare-Covered Services
Commenters, submitters, and other interested parties have urged us
to consider the importance of access to oral health care for people
with chronic auto-immune conditions, and other chronic disease
conditions, such as, but not limited to, diabetes. We understand and
appreciate the interest in such requests. Because the Medicare statute
generally prohibits payment for dental services payment may only be
made when the dental services are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered services. We urge interested parties to consider the
circumstances under which dental services are inextricably linked to
specific covered services (not diagnoses) used to treat patients with
auto-immune conditions or other chronic conditions, supported by
clinical evidence as described in section II.K.1.c. of this proposed
rule.
We have encouraged interested parties who believe certain dental
services are inextricably linked to certain covered services to use our
public submission process to provide information on these clinical
scenarios, supported by clinical evidence or other documentation, as
discussed in section II.K.1.c. of this proposed rule, such as that it
would be the standard of care to not proceed with the medical service
without having completed the dental service. Commenters are welcome to
submit additional information regarding clinical scenarios presented in
the CY 2023 PFS rulemaking discussions, which we are not proposing for
the CY 2024, such as dental services involved with the treatment of
chronic conditions such as, but not limited to, diabetes (87 FR 69686).
As summarized above in section II.K.1.c. of this proposed rule, through
the public submission process we finalized in the CY 2023 PFS final
rule, interested parties should submit medical evidence to support an
inextricable link between certain dental services and covered services
by providing any of the following:
(1) Relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care;
(2) Evidence of clinical guidelines or generally accepted standards
of care for the suggested clinical scenario;
(3) Other ancillary services that may be integral to the covered
services; and/or
(4) Other supporting documentation to justify the inclusion of the
proposed medical clinical scenario requiring dental services.
As discussed above in section II.K.1.c. of this proposed rule, in
order to consider whether certain dental services are inextricably
linked to the clinical success of other covered services, we need to
identify specific medical services for which there is medical evidence
that certain dental services are so integral to the clinical success
that they are inextricably linked to the covered service. The medical
evidence should support that in the case of surgery, 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 medical implant and/or interfered with the medical implant to the
skeletal structure. Medical evidence should be clinically meaningful
and demonstrate that the dental services result in a material
difference in terms of the clinical outcomes and success of the primary
medical procedure such that the dental services are inextricably linked
to, and substantially related and integral to, the
[[Page 52383]]
clinical success of the covered services. Medical evidence should
support that the dental services would result in clinically significant
improvements in quality and safety outcomes (for example, fewer
revisions, fewer readmissions, more rapid healing, quicker discharge,
and quicker rehabilitation for the patient), or, medical evidence
should demonstrate that the standard of care would be to not proceed
with the covered medical procedure until a dental or oral exam is
performed to address the oral complications and/or clear the patient of
an oral or dental infection.
6. Request for Information on Implementation of Payment for Dental
Services Inextricably Linked to Other Specific Covered Services
We continue to consider improvements to our payment policies for
dental services as finalized in the CY 2023 PFS final rule (87 FR 69663
through 69688). As such, we are interested in receiving comments from
interested parties on ways to best continue to implement these
policies. Additionally, given comments and questions we have received
from interested parties through rulemaking and the public submission
process, we want to provide further clarity on the policies we
finalized in the CY 2023 PFS final rule. Therefore, we are requesting
comments on several policies related to implementation of policies for
dental services for which Medicare payment can be made.
In the CY 2023 PFS final rule, we clarified and codified our policy
on payment for dental services and added in Sec. 411.15(i)(3)(i) of
our regulation examples of circumstances where payment can be made for
certain dental services, including a dental exam and services to
diagnose and eliminate an oral or dental infection prior to organ
transplant, cardiac valve replacement, or valvuloplasty procedures (87
FR 69664 through 69667).
We provided as examples of dental services that could be furnished
to eradicate infection services such as, but not limited to, diagnostic
services, evaluations and exams (for example, CDT codes payable with
D0120, D0140 or D0150), extractions (for example, CDT codes payable
with D7140, D7210), restorations (removal of the infection from tooth/
actual structure, such as filling procedures--for example, CDT codes
payable with D2000-2999), periodontal therapy (removal of the infection
that is surrounding the tooth, such as scaling and root planing--for
example, CDT codes payable with 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 codes payable with D3000-3999). However, we
continue to believe that 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. Therefore, we
reiterate that such additional services would not be inextricably
linked to the specific covered services. As such, no Medicare payment
would be made for the additional services that are not immediately
necessary to eliminate or eradicate the infection. We further clarify
that we did not in CY 2023 nor are we proposing in CY 2024 to adjust
any payment policy for services involving the preparation for, or
placement of dentures, and maintain that these services are not payable
under Medicare Parts A and B. We also reiterate our policy, as
finalized in the CY 2023 PFS final rule, that Medicare could make
payment for dental services occurring over multiple visits, as
clinically appropriate. We refer readers to 87 FR 69678 for a more full
description of this policy.
We continue to recognize that many Medicare beneficiaries have
separate or supplemental dental coverage, such as through a Medigap
plan, another private insurance plan offering commercial dental
coverage, or for those individuals dually eligible for Medicare and
Medicaid, through a state Medicaid program. As a result, we seek
comment on the coordination of multiple dental benefits that Medicare
beneficiaries may have, if and how other plans currently cover and pay
for dental services, and what type of guidance CMS should provide about
the dental payment policies we have established and their relationship
to other separate or supplemental dental coverages. We also seek
comment on approaches utilized by other plans to mitigate issues with
third party payment, including when Medicare is secondary payer and
when coordinating with state Medicaid programs. In addition, we note
there is an informal practice where dental professionals may submit a
dental claim to Medicare for the purposes of producing a denial so that
Medicaid or another third-party payer can make primary payment. Given
the complexity of dental professionals submitting claims for purposes
of denial, we seek comment on the impact of third-party payers,
including state Medicaid programs, requiring a Medicare denial for
adjudication of primary payment for dental services that are not
inextricably linked to another specific covered service. In these cases
where the dental services are not inextricably linked to another
specific covered service, dental professionals must include the
appropriate HCPCS modifier on the respective dental claim form, which
serves as a certification that the professionals believe that Medicare
should not pay the claim. We also seek comment regarding an informal
process on claims denials for the purposes of supporting payment by
other payers is currently achieved in practice when using the dental
claim form 837d. We note that the submission of a claim without one or
more of the HCPCS modifier(s) meant to produce a denial shows belief by
the enrolled billing practitioner that Medicare, not another payer,
should be the primary payer in accordance with all applicable payment
policies. As such, submission of a claim for dental services without
such a modifier would mean that the billing practitioner believes the
dental service is inextricably linked to another Medicare-covered
service, or that payment for the service is otherwise permitted under
our regulation at Sec. 411.15(i). We seek comment on the practices of
other payers related to submission of claims in order to generate a
denial and how these practices impact claim submission and claim
adjudication with third party payers, including state Medicaid
programs. Additionally, we are seeking comment on types of guidance,
such as best practices or criteria, that are needed for purposes of
coordinating payment for dental services under the policies specified
in the rule.
As described in the CY 2023 PFS final rule (87 FR 69663 through
69688), Medicare payment under Parts A and B may be made for dental
services that are inextricably linked to the covered primary service.
We believe the dental and covered services would most often be
furnished by different professionals, and that in order for the dental
services to be inextricably linked to the covered services such that
Medicare payment can be made, there must be coordination between these
professionals. This coordination should occur between the practitioners
furnishing the dental and covered services regardless of whether both
individuals are affiliated with or employed by the same entity. This
coordination can occur in various forms such as, but not limited to, a
referral or exchange of information between the practitioners
furnishing the dental and covered services. Additionally, any
[[Page 52384]]
evidence of coordination between the professionals furnishing the
primary medical service and dental services should be documented. If
there is no evidence to support exchange of information, or
integration, between the professionals furnishing the primary medical
service and the dental services, then there would not be an
inextricable link between the dental and other covered services within
the meaning of our regulation at Sec. 411.15(i)(3). As such, Medicare
payment for the dental services would be excluded under section
1862(a)(12) of the statute (though payment for the dental services
might be available through supplemental health or dental coverage).
Additionally, we are seeking information regarding the potential impact
of these payment policies in settings other than inpatient and
outpatient facilities, such as federally qualified health centers,
rural health clinics, etc. We understand that some Medicare
beneficiaries may access dental services in these settings and seek to
understand what, if any, impact may potentially occur within the
context of this payment policy.
As stated in the CY 2023 PFS final rule, we note that, to be
eligible to bill and receive direct payment for professional services
under Medicare Part B, a dentist must be enrolled in Medicare and meet
all other requirements for billing under the PFS. Alternatively, a
dentist not enrolled in Medicare could perform services incident to the
professional services of a Medicare enrolled physician or other
practitioner. In that case, the services would need to meet the
requirements for incident to services under Sec. 410.26, including the
appropriate level of supervision, and payment would be made to the
enrolled physician or practitioner who would bill for the services (87
FR 69673). In the CY 2023 PFS final rule (87 FR 69687), we finalized
that we would continue to contractor price the dental services for
which payment is made under Sec. 411.15(i)(3). We will maintain this
policy and continue to contractor price the dental services for which
payment is made under Sec. 411.15(i)(3) for CY 2024. Additionally, in
the CY 2023 PFS final rule, we agreed with the suggestions made by
commenters that there may be publicly available data sources that could
aid MACs in determining these payment rates in order to account for
geographic variation. Recognizing that dental offices may range in the
services that they provide, from simple office visits to complex
surgical procedures, dental services will continue to be contractor
priced. We are seeking comment on what specific information could help
inform appropriate payment for these dental services (87 FR 69679).
In the CY 2023 PFS final rule (87 FR 69682), we stated that we
would update our payment files, so that these dental services could be
billed appropriately under the applicable payment system for services
furnished in either the inpatient or outpatient setting. We have
revised the HCPCS and PFS payment and coding files to include payment
indicators for Current Dental Terminology (CDT) codes, such as
bilateralism, multiple procedures, and other indicators that are
included in the PFS Relative Value (RVU) files (posted at our website
at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files) for CDT codes. We seek
comment on whether payment indicators as outlined in the PFS RVU files
appropriately align with existing dental billing and coding
conventions, or whether edits are necessary. Medical and dental
providers should bill using CDT or Current Procedure Terminology (CPT)
codes where applicable, and for claims submissions during CY 2023,
should submit claims using the professional or institutional claim
forms, as appropriate. Although we propose to continue contractor
pricing services billed using CDT codes, we are soliciting comment on
whether the current payment indicators included for these CDT codes
follow existing dental billing conventions, for example, for payment
adjustment for multiple procedures, and whether there is a need for
additional guidance regarding the submission of claims for services for
which payment is permitted under the regulation at Sec. 411.15(i)(3).
In the CY 2023 PFS final rule (87 FR 69679), we acknowledged the need
to address and clarify certain operational issues, and we are
continuing to work to address these operational issues, including
efforts to adopt the dental claim form. These efforts include
continuing to work with our MACs and encouraging continued feedback
from interested parties to help identify concerns or questions
regarding the submission and processing of dental claims.
Finally, in order to promote the correct coding and processing of
Medicare claims, dentists who practice general or specialized dentistry
currently self-designate their specialty under two specialty codes,
specialty 19 (oral surgery--dentists only) or specialty 85
(maxillofacial surgery). We seek comment on whether additional
specialty codes should be considered for use in Medicare, and if so,
what are the other specific specialties that should be included. We
also seek comment on whether these specialty codes may impact the
coordination of benefits with a third-party payer. Finally, we
recognize that issues could occur related to coordination of benefits
for dual eligible beneficiaries, for example beneficiaries with
hemophilia, and we seek comment on how to best coordinate a potential
payment policy in this area with respect to state Medicaid plans or
private insurance. We also seek comment on other coordination of
benefits issues, or implementation topics that would be helpful for CMS
to address in relation to continuing to implement these PFS payment
policies.
III. Other Provisions of the Proposed Rule
A. Drugs and Biological Products Paid Under Medicare Part B
1. Provisions From the Inflation Reduction Act Relating to Drugs and
Biologicals Payable Under Medicare Part B (Sec. Sec. 410.152, 414.902,
414.904, 489.30)
Drugs and biologicals (for the purposes of the discussion in this
section III.A., ``drugs'') 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(n) 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 amounts for
most drugs separately payable under Medicare Part B are determined
using the methodology 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.
The Inflation Reduction Act (Pub. L. 117-169, August 16, 2022)
(hereinafter referred to as ``IRA'') contains several provisions that
affect payment limits or beneficiary out-of-pocket costs for certain
drugs payable under Part B. Among those provisions, two affect payment
limits for biosimilar biological products (hereinafter referred to as
``biosimilars''):
Section 11402 of the IRA amends the payment limit for new
biosimilars furnished on or after July 1, 2024 during the initial
period when ASP data is not available. We are proposing to codify this
provision in regulation.
Section 11403 of the IRA makes changes to the payment
limit for certain
[[Page 52385]]
biosimilars with an ASP that is not more than the ASP of the reference
biological for a period of 5 years. We implemented section 11403 of the
IRA under program instruction,94 95 as permitted under
section 1847A(c)(5)(C) of the Act. We are now proposing conforming
changes to regulatory text to reflect these provisions.
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\94\ https://www.cms.gov/files/document/r11496cp.pdf.
\95\ https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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In addition, two provisions (among others in the IRA) make
statutory changes that affect beneficiary out-of-pocket costs for
certain drugs payable under Medicare Part B:
Section 11101 of the IRA requires that beneficiary
coinsurance for a Part B rebatable drug is to be based on the
inflation-adjusted payment amount if the Medicare payment amount for a
calendar quarter exceeds the inflation-adjusted payment amount,
beginning on April 1, 2023. We issued initial guidance implementing
this provision, as permitted under section 1847A(c)(5)(C) of the Act,
on February 9, 2023.\96\ We are proposing conforming changes to
regulatory text.
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\96\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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Section 11407 of the IRA provides that for insulin
furnished through an item of DME on or after July 1, 2023, the
deductible is waived and coinsurance is limited to $35 for a month's
supply of insulin furnished through a covered item of DME. We have
implemented this provision under program instruction for 2023, as
permitted under section 11407(c) of the IRA.\97\ We are now proposing
to codify this provision in a manner that is consistent with the
program instruction for 2023.
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\97\ https://www.congress.gov/bill/117th-congress/house-bill/5376/text.
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a. Payment for Drugs Under Medicare Part B During an Initial Period
Section 1847A of the Act provides for certain circumstances in
which the payment limit of a drug is based on its wholesale acquisition
cost (WAC). For a single source drug or biological (as defined in
section 1847A(c)(6)(D) of the Act), the Medicare payment could have a
WAC-based payment determined under the methodology specified in section
1847A(b)(4) of the Act and described at Sec. 414.904(d)(1), which
requires that payment limits for such drugs are determined using the
lesser of ASP plus 6 percent or WAC plus 6 percent. Typically, the ASP-
based payment limit is the lesser of the two. Under section 1847A(c) of
the Act, payments for new drugs during an initial period for which ASP
data is not sufficiently available are based on WAC or the Medicare
Part B drug payment methodology in effect on November 1, 2003.
Historically, WAC-based payment under section 1847A(c)(4) of the Act
was up to 106 percent of WAC, but in the CY 2019 PFS final rule (83 FR
59661 through 59666), we adopted a policy of paying up to 103 percent
of WAC in this instance. Subsequently, section 6 of the Sustaining
Excellence in Medicaid Act of 2019 (Pub. L. 116-39, enacted August 6,
2019), amended section 1847A(c)(4) of the Act to specify, effective
January 1, 2019, a payment limit not to exceed 103 percent of the WAC
or based on the Part B drug payment methodology in effect on November
1, 2003 during an initial period when ASP data is not sufficiently
available. There were no regulatory changes at that time. Therefore, we
are proposing to amend Sec. 414.904(e)(4) to reflect this statutory
change.
More recently, section 11402 of the IRA amended section 1847A(c)(4)
of the Act by adding subparagraph (B), which limits the payment amount
for biosimilars during the initial period described in section
1847A(c)(4)(A) of the Act. The provision requires that for new
biosimilars furnished on or after July 1, 2024, during the initial
period when ASP data is not sufficiently available, the payment limit
for the biosimilar is the lesser of (1) an amount not to exceed 103
percent of the WAC of the biosimilar or the Medicare Part B drug
payment methodology in effect on November 1, 2003, or (2) 106 percent
of the lesser of the WAC or ASP of the reference biological, or in the
case of a selected drug during a price applicability period, 106
percent of the maximum fair price of the reference biological.
We propose to codify these changes to section 1847A(c)(4) of the
Act at Sec. 414.904. Specifically, we are proposing to revise
paragraph (e)(4) at Sec. 414.904 by adding paragraphs (e)(4)(i)(A) and
(B) to conform the regulatory text for WAC-based payment limits before
January 1, 2019 and for such payment limits on or after January 1, 2019
with the requirements established in section 6 of the Sustaining
Excellence in Medicaid Act of 2019. We are also proposing to add
paragraphs (A) and (B) to Sec. 414.904(e)(4)(ii) to codify the payment
limit for new biosimilars furnished on or after July 1, 2024 during the
initial period as required by section 1847A(c)(4)(B) of the Act.
b. Temporary Increase in Medicare Part B Payment for Certain Biosimilar
Biological Products
Consistent with section 1847A(b)(8) of the Act, Medicare Part B
payment limit for a biosimilar is its ASP plus 6 percent of the
reference biological product. In the CY 2016 PFS final rule (80 FR
71096 through 71101), we clarified that the payment limit for a
biosimilar biological product is based on the ASP of all National Drug
Codes (NDCs) assigned to the biosimilar biological products included
within the same billing and payment code and amended Sec.
[thinsp]414.904(j) to reflect this policy. In the CY 2018 PFS final
rule (82 FR 53182 through 53186), we finalized a policy to separately
assign individual biosimilar biological products to separate billing
and payment codes and pay for biosimilar biological products
accordingly. However, we did not change the regulation text at Sec.
414.904(j) at that time.
Section 11403 of the IRA amended section 1847A(b)(8) of the Act by
establishing a temporary payment limit increase for qualifying
biosimilar biological products furnished during the applicable 5-year
period. Section 1847A(b)(8)(B)(iii) of the Act defines ``qualifying
biosimilar biological product'' (hereinafter referred to as
``qualifying biosimilars'') as a biosimilar biological product (as
described in section 1847A(b)(1)(C) of the Act) with an ASP (as
described in section 1847A(b)(8)(A)(i) of the Act) less than the ASP of
the reference biological for a calendar quarter during the applicable
5-year period. Section 11403 of the IRA requires that a qualifying
biosimilar be paid at ASP plus 8 percent of the reference biological's
ASP rather than 6 percent during the applicable 5-year period. Section
1847A(b)(8)(B)(ii) of the Act defines the applicable 5-year period for
a qualifying biosimilar for which payment has been made using ASP (that
is, payment under section 1847A(b)(8) of the Act) as of September 30,
2022 as the 5-year period beginning on October 1, 2022. For a
qualifying biosimilar for which payment is first made using ASP during
the period beginning October 1, 2022 and ending December 31, 2027, the
statute defines the applicable 5-year period as the 5-year period
beginning on the first day of such calendar quarter of such
payment.\98\
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\98\ In accordance with these provisions, the ASP Drug Pricing
File reflects the temporary increased payment limit for qualifying
biosimilars beginning with the October 2022 file available at
https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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[[Page 52386]]
In this proposed rule, we propose to add definitions of
``applicable 5-year period'' and ``qualifying biosimilar biological
product'' at Sec. 414.902 to reflect the definitions in statute, and
we propose to make conforming changes to regulatory text to reflect the
requirements mandated under section 1847A(b)(8)(B) of the Act for the
temporary payment limit increase for qualifying biosimilar biological
products at Sec. 414.904 (j) by adding paragraphs (j)(1) and (2).
c. Inflation-Adjusted Beneficiary Coinsurance and Medicare Payment for
Medicare Part B Rebatable Drugs
Section 11101(a) of the IRA amended section 1847A of the Act by
adding a new subsection (i), which requires the payment of rebates into
the Supplementary Medical Insurance Trust Fund for Part B rebatable
drugs if the payment limit amount exceeds the inflation-adjusted
payment amount, which is calculated as set forth in section
1847A(i)(3)(C) of the Act. The provisions of section 11101 of the IRA
are currently being implemented through program instruction, as
permitted under section 1847A(c)(5)(C) of the Act. As such, we issued
final guidance for the computation of inflation-adjusted beneficiary
coinsurance under section 1874A(i)(5) of the Act and amounts paid under
section 1833(a)(1)(EE) of the Act on February 9, 2023.99 100
For additional information regarding implementation of section 11101 of
the IRA, please see the inflation rebates resources page at https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare.
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\99\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
\100\ In addition, beginning with the April 2023 ASP Drug
Pricing file, the file includes the coinsurance percentage for each
drug and specifies ``inflation-adjusted coinsurance'' in the
``Notes'' column if the coinsurance for a drug is less than 20
percent of the Medicare Part B payment amount. Drug pricing files
are available at https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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Section 1847A(i)(5) of the Act requires that for Part B rebatable
drugs, as defined in section 1847A(i)(2)(A) of the Act, furnished on or
after April 1, 2023, in quarters in which the amount specified in
section 1847A(i)(3)(A)(ii)(I) of the Act (or, in the case of selected
drugs described under section 1192(c) of the Act, the amount specified
in section 1847A(b)(1)(B) of the Act), exceeds the inflation-adjusted
payment amount determined in accordance with section 1847A(i)(3)(C) of
the Act, the coinsurance will be 20 percent of the inflation-adjusted
payment amount for such quarter (hereafter, the inflation-adjusted
coinsurance amount). This inflation-adjusted coinsurance amount is
applied as a percent, as determined by the Secretary, to the payment
amount that would otherwise apply for such calendar quarter in
accordance with section 1847A(b)(1)(B) or (C) of the Act, as
applicable, including in the case of a selected drug. In this proposed
rule, we propose to codify the coinsurance amount for Part B rebatable
drugs as required by section 1847A(i)(5) of the Act in Sec. 489.30,
specifically by adding a new paragraph (b)(6).
Section 11101(b) of the IRA amended section 1833(a)(1) of the Act
by adding a new subparagraph (EE), which requires that if the
inflation-adjusted payment amount of a Part B rebatable drug exceeds
the payment amount described in section 1847A(i)(3)(A)(ii)(I) (or, in
the case of a selected drug, the payment amount described in section
1847A(b)(1)(B), the Part B payment will, subject to the deductible and
sequestration, equal the difference between such payment amount and the
inflation-adjusted coinsurance amount. In this proposed rule, we
propose to codify the Medicare payment for Part B rebatable drugs in
Sec. [thinsp]410.152, specifically by adding new paragraph (m).
d. Limitations on Monthly Coinsurance and Adjustments to Supplier
Payment Under Medicare Part B for Insulin Furnished Through Durable
Medical Equipment
Drugs furnished through a covered item of DME are covered under
Medicare Part B as provided in sections 1861(n) and (s)(6) of the Act.
Insulin administered through covered DME, such as a durable insulin
pump, is covered under this benefit. As required by section
1842(o)(1)(C) and (D) of the Act, effective January 1, 2017, infusion
drugs furnished through DME, including insulin, are paid under section
1847A of the Act (see 82 FR 53180 through 53181), which is typically
ASP plus 6 percent. Prior to July 1, 2023, beneficiaries are
responsible for coinsurance of 20 percent of the payment amount of such
insulin, subject to the Part B deductible.
Section 11407 of the IRA made three changes to the manner in which
beneficiaries pay for insulin furnished through covered DME. First,
section 11407(a) of the IRA amended section 1833(b) of the Act to waive
the Part B deductible for insulin furnished through covered DME on or
after July 1, 2023. Second, section 11407(b)(2) of the IRA amended
section 1833(a) of the Act to establish a limit of $35 on the
beneficiary coinsurance amount for a month's supply of such insulin
furnished on or after July 1, 2023. This statutory change means that
the beneficiary coinsurance responsibility, which is limited to $35 for
a month's supply of insulin, could equal less than 20 percent if the
Part B payment amount of a month's supply of insulin is greater than
$175. Third, section 11407(b)(2) of the IRA also added a new sentence
to section 1833(a) of the Act to require the Secretary to increase to
the Medicare Part B payment to above 80 percent in the case the
coinsurance amount for insulin furnished through covered DME equals
less than 20 percent of the payment amount to pay for the full
difference between the payment amount and coinsurance. The adjustment
specified in paragraph (b)(2) ensures the supplier is not responsible
for the reduction in the beneficiary coinsurance amount.
The above provisions were implemented through program
instruction,\101\ as required by section 11407(c) of the IRA, for CY
2023. Section 80 in Chapter 17 and section 140 in Chapter 20 of the
Medicare Claims Processing Manual will be updated to reflect these
changes, effective July 1, 2023. To operationalize this provision, the
$35 coinsurance limit applies to the duration of the calendar month in
which the date of service occurs. As stated in the section 110.5,
Chapter 15 of the Medicare Benefit Policy Manual,\102\ the date of
service on the claim must be the date that the beneficiary or
authorized representative receives the insulin or, for mail order, the
date the insulin is shipped. A new $35 coinsurance limit for a month's
supply applies to each calendar month. It follows that, as stated in
the program instruction, when a 3-month supply (that is, the amount of
such insulin that is required for treatment for up to 3 calendar
months) is billed for insulin furnished through covered DME, that a
coinsurance limit of $105 would apply for that 3-calendar month period
($35 coinsurance limit for each month's supply of insulin). The program
instruction also states that the Medicare Administrative Contractors
(MACs) will ensure that coinsurance does not exceed $35 for a 1-month
supply or $105 for a 3-month supply for claims billing insulin
administered through covered DME.
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\101\ https://www.cms.gov/files/document/r11917cp.pdf.
\102\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/bp102c15.pdf.
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[[Page 52387]]
Here, we propose to codify these elements (that are currently in
program instruction) for CY 2024 and future years in regulation text,
because section 11407(c) of the IRA states that only implementation for
CY 2023 may be through program instruction or other forms of guidance.
Specifically, we propose to codify the new statutory monthly
coinsurance limits of $35 for a 1-month supply and $105 for a 3-month
supply at Sec. [thinsp]489.30 by adding paragraph (b)(7) and the
adjustment to the provider payment at Sec. 410.152 by adding paragraph
(n). In addition, we propose to codify at Sec. [thinsp]489.30 that the
$35 coinsurance limit for a month's supply of insulin furnished through
covered DME will apply to the duration of the calendar month in which
the date of service (or services) occurs. In other words, the $35
coinsurance limit will apply for a month's supply of insulin each
calendar month. Similarly, we propose to codify that the $105
coinsurance limit for 3 months' supply of insulin furnished through
covered DME will apply to the duration of the calendar month in which
the date of service (or services) occurs and the 2 following calendar
months
2. Request for Information (RFI): Drugs and Biologicals Which Are Not
Usually Self-Administered by the Patient, and Complex Drug
Administration Coding
Section 1861(s)(2)(A) of the Act allows Medicare to pay for
services and supplies, including drugs and biologicals (hereafter,
drugs) that are not usually self-administered by the patient, which are
furnished as ``incident to'' a physician's professional service.
Section 112 of the Benefits, Improvements & Protection Act of 2000
(BIPA) (Pub. L. 106-554, December 21, 2000) amended the above-
referenced sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Act, which
formerly referred to drugs ``which cannot be self-administered,'' to
read, ``which are not usually self-administered.'' Drugs that are
``usually self-administered'' are thus statutorily excluded from
coverage and payment under Part B under the ``incident to'' benefit.
We have provided definitions and other guidance for MACs regarding
determinations on drugs that are ``not usually self-administered by the
patient'' in Chapter 15, Section 50.2 of the Medicare Benefit Policy
Manual. Chapter 15 also describes the evidentiary criteria that MACs
should use in determining whether a drug is usually self-administered.
The guidance directs MACs to publish a description of the process they
use to make that determination, and to publish a list of the drugs that
are subject to the self-administered exclusion on their website. The
guidance also requires that this list include the data and rationale
that led to the determinations. This list is referred to as the ``self-
administered drug (SAD) list,'' and each MAC maintains their own
version of the list, which is applicable to that MAC's area of
jurisdiction. While the lists are often similar between MACs, they are
not identical. Drugs that are put on a SAD list are excluded from Part
B coverage, but in those situations, they are almost always covered by
Medicare Part D prescription drug coverage. For several years,
interested parties have requested that we update and clarify this SAD
list guidance. These parties believe that the current guidance may not
adequately address circumstances posed by newly approved drugs.
In a similar vein, we have received concerns from interested
parties that non-chemotherapeutic complex drug administration payment
has become increasingly inadequate due to existing coding and Medicare
billing guidelines that do not accurately reflect the resources used to
furnish these infusion services. Interested parties have asserted that
these infusion services are similar to complex and clinically intensive
Chemotherapy and Other Highly Complex Biological Agent Administration
(``Chemotherapy Administration'') services that are billed using CPT
code series 96401-96549, as opposed to Therapeutic, Prophylactic, and
Diagnostic Injections and Infusion services billed using CPT code
series 96360-96379. We note that we discuss our policies for these
services in Pub. 100-04 Medicare Claims Processing Manual, Chapter 12,
Section 30.5D.
We are soliciting comments on the above two policy areas, since
they both involve Part B drug payment policies that have been impacted
by new developments in the field. In an effort to promote coding and
payment consistency and patient access to infusion services, we are
seeking comment and information from interested parties regarding the
relevant resources involved, as well as inputs and payment guidelines
and/or considerations, that could be used in determining appropriate
coding and payment for complex non-chemotherapeutic drug
administration. We are seeking comment on whether or not we should
revise our policy guidelines as discussed to better reflect how these
specific infusion services are furnished and should be billed.
We are also soliciting comments regarding our policies on the
exclusion of coverage for certain drugs under Part B which are usually
self-administered by the patient. Specifically, we are soliciting
comments regarding our policies for the following items:
Definitions of the following terms, as referenced in this
section:
++ ``Administered.''
++ ``Self-Administered.''
++ ``Usually.''
++ ``By the patient.''
The process for determining which drugs are classified as
those ``not usually self-administered by the patient.''
The process for issuing decisions on which drugs are
classified as those ``not usually self-administered by the patient,''
and the process for issuing any changes to those classifications.
The relevant resources involved, as well as inputs and
payment guidelines and/or considerations, that could be used in
determining appropriate coding and payment for complex non-
chemotherapeutic drug administration.
Whether or not CMS should revise policy guidelines to
better reflect how complex non-chemotherapeutic drug administration
infusion services are furnished and billed.
3. Requiring Manufacturers of Certain Single-Dose Container or Single-
Use Package Drugs To Provide Refunds With Respect To Discarded Amounts
(Sec. Sec. [thinsp]414.902 and 414.940)
a. Background
Section 90004 of the Infrastructure Investment and Jobs Act (Pub.
L. 117-58, 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 (hereafter referred to as ``refundable 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.
In the CY 2023 PFS final rule (87 FR 69710 through 69734), we
adopted many policies to implement section 90004 of the Infrastructure
Act. We finalized the requirement that billing providers and suppliers
report the JW modifier for all separately payable drugs with discarded
drug amounts from single use vials or single use packages payable under
Part B, beginning January 1, 2023. We also finalized the requirement
that billing providers and suppliers report the JZ modifier for all
[[Page 52388]]
such drugs with no discarded amounts beginning no later than July 1,
2023, and we stated that we would begin claims edits for both the JW
and JZ modifiers beginning October 1, 2023 (87 FR 69718 through 69719).
Subsequent to the issuance of the CY 2023 PFS final rule, CMS published
the JW Modifier and JZ Modifier Policy Frequently Asked Questions (FAQ)
document \103\ addressing the correct use of these modifiers. We
adopted a definition of ``refundable single-dose container or single-
use package drug'' at 42 CFR 414.902, which also specifies exclusions
from this definition (87 FR 69724). These three exclusions are:
radiopharmaceutical or imaging agents, certain drugs requiring
filtration, and 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. Regarding reports to manufacturers, we specified that CMS would
send reports (including information described in section 1847A(h)(1) of
the Act) for each calendar quarter on an annual basis to all
manufacturers of refundable drugs (87 FR 69726). We finalized the
manner in which the refund amount will be calculated at Sec.
[thinsp]414.940 (87 FR 69731). Regarding drugs with unique
circumstances for which CMS can increase the applicable percentage
otherwise applicable for determining the refund, we adopted an
increased applicable percentage of 35 percent for drugs reconstituted
with a hydrogel and with variable dosing based on patient-specific
characteristics (87 FR 69731). Lastly, we adopted a dispute resolution
process through which manufacturers can challenge refund calculations,
and we established enforcement provisions (including manufacturer
audits, provider audits, and civil money penalties required by statute)
(87 FR 69732 through 69734).
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\103\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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As noted in the CY 2023 PFS final rule (87 FR 69711), sections
11101 and 11102 of the Inflation Reduction Act (IRA) (Pub. L. 117-169,
August 16, 2022) established new requirements under which manufacturers
must pay inflation rebates if they raise their prices for certain Part
B and Part D drugs faster than the rate of inflation. Drug
manufacturers are required to pay rebates to Medicare if prices for
certain Part B drugs increase faster than the rate of inflation for
quarters beginning with the first quarter of 2023; drug manufacturers
are required to pay rebates to Medicare if prices for certain Part D
drugs increase faster than the rate of inflation over 12-month periods,
starting with the 12-month period that began October 1, 2022.
We explained that we believe implementation of the Part B and Part
D inflation rebate programs established under the IRA should be
considered together with the operational implications of the discarded
drug refunds, because the refunds and rebates both require CMS to
accept from drug manufacturers payments that must be deposited into the
Federal Supplementary Medical Insurance (SMI) Trust Fund.
Therefore, to align the operation of these programs and minimize
burden, we declined to finalize some aspects of the invoicing and
collection of discarded drug refunds. Specifically, we declined to
finalize the timing of the initial reports and which quarters'
information will be included in each report. We also declined to
finalize specific dates by which manufacturer refund obligations are
due and those associated with the dispute resolution process, as those
are scheduled in tandem with the reporting dates. Lastly, we stated our
intent to address these aspects in future rulemaking.
In this proposed rule, we propose the date of the initial report to
manufacturers, the date for subsequent reports, method of calculating
refunds for discarded amounts in lagged claims data, method of
calculating refunds when there are multiple manufacturers for a
refundable drug, increased applicable percentages for certain drugs
with unique circumstances, and a future application process by which
manufacturers may apply for an increased applicable percentage for a
drug, which would precede proposals to increase applicable percentages
in rulemaking. We also propose modification to the JW and JZ modifier
policy for drugs payable under Part B from single-dose containers that
are furnished by a supplier who is not administering the drug.
b. Provision of Information to Manufacturers
In the CY 2023 PFS final rule (87 FR 69724 through 69726), we
discussed our proposals related to meeting the requirements under
section 1847A(h)(1) of the Act related to the timing and contents of
the report to manufacturers, including what types of information to
include, which quarters' data we would include in the initial report,
the amount of lagged claims data we would include, whether to send
reports quarterly or annually, and the definition of a manufacturer.
However, we explained that due to the enactment of the IRA and our
efforts to align the operations of the refunds with the inflation
rebate programs and minimize burden, we did not finalize certain
aspects of the discarded drug refund provision. Specifically, we did
not finalize the date that we would send the first report to
manufacturers or which quarters' information would be included in each
report.
Although we did not finalize the noted aspects related to timing,
we adopted regulations at Sec. 414.940(a)(3) providing that we will
send reports to manufacturers on an annual basis and indicated in the
preamble text that reports will contain discard information (described
in section 1847A(h)(1)(A) of the Act) for each calendar quarter (87 FR
69724 through 69726). We also finalized that we will send reports to
all manufacturers of refundable drugs. In addition, in response to
commenters suggesting that we provide manufacturers an opportunity to
engage with us on discard amount data in the first year of this
provision's implementation, we stated that we would issue, no later
than December 31, 2023, a preliminary report on estimated discarded
amounts based on available claims data from the first two quarters of
CY 2023.
To implement the discarded drug refund in a timely manner, we
propose to issue the initial refund report to manufacturers, to include
all calendar quarters for 2023, no later than December 31, 2024. (Note
that this report, which we refer to as the ``initial refund report'' in
this proposed rule, would be separate and distinct from the preliminary
report that we intend to issue by December 31, 2023, that will include
estimated discarded amounts based on available claims data for the
first two quarters of CY 2023.)
With respect to subsequent annual reports, that is, reports for
quarters in 2024 and thereafter, we intend to align delivery of the
refund reports with the delivery of Part B and Part D inflation rebate
reports to the extent practicable. As stated in the initial guidance
for Part B inflation rebates,\104\ inflation rebate reports will be
sent on a quarterly basis, each no later than 6 months after the end of
the calendar quarter as required in section 1847A(i)(1)(A) of the Act.
Consistent with section 1847A(i)(1)(C) of the Act, CMS may delay
reporting Part B inflation rebate information for
[[Page 52389]]
calendar quarters in CY 2023 and CY 2024 until September 30, 2025.\105\
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\104\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
\105\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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To align these reports, we propose that, other than for the initial
refund report, we will send annual refund reports for discarded drug
refunds for the 4 quarters of a calendar year at or around the time we
send Part B inflation rebate report for the first quarter of the
following year. Thus, for example, we would send the second refund
report for the calendar quarters in 2024 when we send the inflation
rebate report for Q1 2025, which is required to be sent no later than
September 30, 2025.
As noted in the CY 2023 PFS final rule (87 FR 69725), because
providers and suppliers have a 12-month period to submit Medicare Part
B claims, including claims for drugs payable under Part B, there can be
a lag between the date of service when a drug is administered and when
the claim is submitted and adjudicated. Therefore, there is 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 after the date of
service, 99.83 and 100 percent of the claims, respectively, were
considered to be final. Since, based on our evaluation of the 2010
claims data, a small percentage of lagged claims data from a calendar
quarter likely would not be available when the quarter is first
included on a report, we propose that annual reports (subsequent to the
initial report) include lagged claims data (that is, true-up
information) for quarters from 2 calendar years prior. In other words,
we propose that each report would include information for 8 calendar
quarters: 4 from the previous calendar year (hereafter, referred to as
new refund quarters) and 4 from 2 calendar years prior (hereafter,
referred to as updated refund quarters). We propose all reports (except
the initial refund report) would include the following information for
updated refund quarters to address lagged claims data:
The updated total number of units of the billing and
payment code of such drug, if any, that were discarded during such
updated refund 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 updated refund amount that the manufacturer is liable
for with respect to such updated quarter that was not previously
accounted for in the prior year's report.
For example, as proposed above, the second annual report (sent no
later than September 30, 2025) would include: (1) the total number of
units of the billing and payment code of such drug, if any, that were
discarded during new refund quarters (all calendar quarters in 2024),
(2) the refund amount that the manufacturer is liable for pursuant to
section 1847A(h)(3) of the Act for all calendar quarters in 2024, (3)
the updated total number of units of the billing and payment code of
such drug, if any, that were discarded during the updated refund
quarters (all calendar quarters in 2023), and (4) the refund amount
that the manufacturer is liable for or the amount CMS owes the
manufacturer pursuant to section 1847A(h)(3) of the Act for all
calendar quarters in 2023 that was not accounted for in the previous
year's report.
We are proposing to define ``new refund quarter'' and ``updated
refund quarter'' at Sec. 414.902 and to revise Sec. 414.940(a)(3) to
reflect the inclusion of lagged data in reports subsequent to the
initial refund report. We solicit comment on these proposals. See
section III.A.3.d. of this rule for the proposed calculation of refund
amounts for updated refund quarters.
c. Manufacturer Provision of Refund
In the CY 2023 PFS final rule (87 FR 69726 through 69727) we
adopted Sec. 414.940(b), which requires manufacturers to pay refunds
in 12-month intervals in a form and manner specified by CMS. In the CY
2023 PFS final rule (87 FR 69727), we also discussed our proposal for
the timing of both the initial report and manufacturers' corresponding
refund obligations. That is, we proposed to issue reports to
manufacturers by October 1 and require refund obligations to be paid by
December 31, except in circumstances where a dispute is pending.
Regulations at Sec. 414.940(b)(2) specify that in the case that a
disputed report results in a refund amount due, that amount must be
paid no later than 30 days after resolution of the dispute.
However, we declined to finalize the deadlines by which
manufacturer refund obligations are due and those associated with the
dispute resolution process, as those timelines correspond with the
dates of the annual refund reports and, as explained above, we declined
to finalize the timeline for the report in the CY 2023 PFS final rule
in order to align the operation of the discarded drug refunds with the
inflation rebate programs. In the CY 2023 PFS final rule (87 FR 69727),
we stated our intent to revisit the process and timeline for
manufacturers' provisions of refunds in future rulemaking.
As described in section III.A.3.b. of this proposed rule, we are
proposing to issue the initial refund report to manufacturers no later
than December 31, 2024. Accordingly, we propose to require that the
refund amounts specified in the initial refund report be paid no later
than February 28, 2025, except in circumstances where a report is under
dispute. We believe a payment deadline that is two calendar months
after the issuance of the report provides adequate time for
manufacturers to review the reports and submit a dispute if needed
prior to the refund payment deadline.
As noted above, we are proposing that we will issue the second
annual refund report to manufacturers no later than September 30, 2025,
and once annually thereafter no later than September 30 for every year
thereafter. Accordingly, we are proposing to require manufacturers to
pay refunds specified in each report (beginning with the second report)
no later than December 31 of the year in which the report is sent,
except in circumstances where a report is under dispute. In cases in
which a manufacturer disputes a report, beginning with the initial
refund report, any manufacturer liability determined upon the
resolution of the dispute would be due by the above stated due date or
30 days following the resolution, as described in Sec. 414.940(b)(2),
whichever is later. We propose to revise Sec. 414.940(b)(1) to reflect
these dates.
d. Refund Amount
(1) Calculation of Refund Amounts for Updated Quarters
As discussed in section III.A.3.b. of this proposed rule, we are
proposing to include information for lagged claims data in all reports
other than the initial report. In addition, we propose that such
additional lagged JW modifier data, if any, will be used to calculate
revisions to the manufacturer refund amount. Specifically, we propose
to calculate the refund with updated data in the same manner as was
finalized in the 2023 PFS final rule (87 FR 69727) and subtract the
refund amount that already paid for such refundable drug for such
quarter to determine the updated quarter refund amount. We propose that
the refund amount owed
[[Page 52390]]
by a manufacturer, with respect to a refundable drug assigned to a
billing and payment code for an updated refund quarter 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 amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter.
Exceeds the difference of:
++ 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; and
++ The refund amount previously paid for such refundable drug for
the given quarter.
We propose that if the resulting refund calculation for an updated
quarter is a negative number, then it will be netted out of the any
refund owed for other updated quarters or new quarters.
We propose to revise Sec. [thinsp]414.940 by adding new paragraphs
(c)(2) and (3) to reflect the above proposed method of calculation of
revisions to the refund amount owed for quarters in the year that is
two calendar years prior.
(2) Calculation of Refund for a Drug When There Are Multiple
Manufacturers
In the CY 2023 PFS final rule (87 FR 69727 through 69731),
consistent with section 1847A(h)(3) of the Act, we adopted regulations
at Sec. 414.940(c) specifying the manner in which the refund amount
will be calculated with respect to a refundable drug of a manufacturer
assigned to a billing and payment code for a calendar quarter beginning
on or after January 1, 2023. 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 amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter;
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.
We stated we will estimate the total allowed charges during the
quarter by multiplying the drug's payment 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 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 drug paid 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.
Because refundable drugs are single source drugs or biologicals,
they typically will have one manufacturer. However, a refundable drug
could have more than one manufacturer, for example, in the circumstance
where a refundable drug is produced by one manufacturer, and also by
one or more manufacturer(s) that is a repackager or relabeler. Multiple
manufacturers of a refundable drug could also occur in the case of one
or more authorized generic products that are marketed under the same
FDA-approval as the original FDA applicant. In such cases, the National
Drug Codes (NDCs) for the drug typically are assigned to the same
billing and payment code, and each manufacturer is responsible for
reporting ASP data to CMS, which includes sales volume. In the CY 2023
PFS final rule (87 FR 69724 through 69726), we stated that we would
identify the manufacturer responsible for the provision of refunds by
the labeler code of the refundable drug.
Therefore, there is a need to establish a method for apportioning
billing units of a refundable drug sold during a calendar quarter in
situations where there are multiple manufacturers of a refundable drug.
When calculating the refund amount owed by manufacturers for a
refundable drug that has more than one manufacturer, we propose to
identify such refundable drugs using the ASP sales data reported for
the calendar quarter for which a refund amount is calculated.
Furthermore, we propose to apportion financial responsibility for the
refund amount among each manufacturer in the following manner: by
dividing the sum of the individual manufacturer's billing units sold
during the refund quarter for all the manufacturer's NDCs assigned to
the billing and payment code (as reported in the ASP data submissions),
by the sum of all manufacturers' billing units sold during the refund
quarter for all NDCs of the refundable drug assigned to the billing and
payment code (as reported in the ASP data submissions).
This calculation approach is consistent with the approach for
apportioning inflation rebate obligations discussed in section 50.13 of
the Medicare Part B Drug Inflation Rebates Paid by Manufacturers:
Initial Memorandum, Implementation of Section 1847A(i) of the Social
Security Act, and Solicitation of Comments,\106\ released on February
9, 2023.
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\106\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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We propose to apportion the discarded drug refund when there is
more than one manufacturer for a refundable drug, using the proportion
of billing unit sales, expressed as a percentage, attributed to each
NDC (at the NDC-11 level) assigned to the billing and payment code for
such refund quarter. The number of billing unit sales for each NDC
would be the reported number of NDCs sold (as submitted in the ASP
report to CMS each quarter) multiplied by the billing units per package
for such NDC. We propose that the refund amount attributed to such NDCs
for which the manufacturer is liable would be 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;
++ The percentage of billing unit sales of the applicable code
attributed to the NDC; and
++ The amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter;
Exceeds an amount equal to the product of:
++ The applicable percentage of the estimated total allowed charges
for such a drug (less the amount paid for packaged drugs) during the
quarter; and
++ The percentage of billing unit sales of the applicable code
attributed to the NDC.
For example, if a billing and payment code for a refundable drug
includes three NDCs, each from a different manufacturer as shown below
in Table 18, there were 3,000 units discarded during the refund
quarter, the payment limit amount for the refundable drug was $50.00
per billing unit, the applicable percentage was 10 percent, and the
estimated total allowed charges for the refundable drug during the
refund quarter was $1.05 million, the proposed calculation for the
refund amount owed by Manufacturer 1 would
[[Page 52391]]
be as follows: (3,000)(23.81%)($50)-(21,000)(10%)(23.81%)($50) = refund
amount of $10,714.50.
[GRAPHIC] [TIFF OMITTED] TP07AU23.028
The report to manufacturers described in section 1847A(h)(1) of the
Act and discussed in the previous section III.A.3.b. of this proposed
rule, in the case that there are multiple manufacturers for a
refundable drug, would include: (1) the total number units of the
billing and payment code of such drug attributed to the manufacturer's
NDC assigned to the billing and payment code of the refundable drug
that were discarded during such quarter, if any; and (2) the refund
amount that the manufacturer of that NDC is liable for pursuant to
section 1847A(h)(3) of the Act. We propose that this method of
calculation apply beginning with calendar quarters in CY 2023 included
in the initial refund report, which we propose to be sent no later than
December 31, 2024. We propose that this method of calculation would be
done for new refund quarters and updated refund quarters.
We propose to revise Sec. [thinsp]414.940 by adding a new
paragraph (c)(4) to reflect the above proposed method of calculation of
the refund amount attributed to a NDC when there are multiple
manufacturers.
(3) 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 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. In the CY 2023
PFS final rule (87 FR 69727 through 69731), we adopted an increased
applicable percentage of 35 percent for drugs reconstituted with a
hydrogel and with variable dosing based on patient-specific
characteristics (Sec. 414.490(d)(1)). We have identified only one
drug, Jelmyto[supreg] (mitomycin for pyelocalyceal solution), with such
unique circumstances. We stated in that final rule that we recognize
that there are drug products that may indeed have other unique
circumstances, and that an increased applicable percentage for these
products would have to be determined through future notice and comment
rulemaking, as required by the statutory provision. We stated that we
planned to collect additional information about drugs that may have
unique circumstances along with potential increased applicable
percentages that might be appropriate for such drugs, and to collect
additional information about a process to identify unique circumstances
based on manufacturer input. We explained that we would revisit
additional increased applicable percentages for drugs that have unique
circumstances, and a process to identify such circumstances, through
future notice and comment rulemaking. To that end, we hosted a town
hall meeting on February 1, 2023 to discuss what criteria would be
appropriate to determine whether a refundable drug has unique
circumstances, and whether a categorical approach (that is, unique
circumstances that apply to more than one drug), drug-by-drug approach,
or a hybrid of these two approaches should be used for determining
drugs for which an increased applicable percentage is appropriate.
After considering input from interested parties provided at the
town hall and in subsequent meetings, in this proposed rule, we are
proposing a hybrid approach to determining when it is appropriate to
increase the applicable percentage for a drug with unique
circumstances. First, we are proposing two categorical unique
circumstances along with proposed increased applicable percentages and,
secondly, we are proposing an application process so manufacturers may
request that CMS consider whether an increased applicable percentage
would be appropriate for a particular drug in light of its unique
circumstances (and if an increased applicable percentage is considered
appropriate it would then be proposed in future notice-and-comment
rulemaking).
As discussed in the CY 2023 PFS final rule and further discussed at
the town hall, many interested parties requested CMS increase
applicable percentages (defined at Sec. [thinsp]414.940(c)(3) as 10
percent, except where an increased applicable percentage is applied in
paragraph (d) of that section) for drugs packaged with small vial fill
amounts or low-volume products (generally, those with a fill amount
less than 1 mL). These parties stated that, for certain drugs, the
small volume of drug contained in the vial (as identified on the
package or FDA labeling) often represents the minimum volume necessary
to safely and effectively prepare and administer the prescribed dose.
Certain labeled amounts that are unused and discarded include amounts
remaining in the syringe hub, amounts remaining in the syringe that are
not part of the prescribed dose, amounts left in the vial that cannot
be removed (such as drug adhering to the side of the vial or pooling
around the vial stopper), and amounts left in the vial when it contains
enough drug for two administration attempts.
We agree that such drugs have unique circumstances, because certain
FDA-labeled amounts on the vial or package are unused and discarded
after administration of the labeled dose, and these amounts are not
available to be administered. The unique circumstances described for
such drugs are similar to loss of product from filtration described in
section 1847A(h)(8)(B)(ii) of the Act because in both circumstances,
such amounts lost are amounts that are not part of the recommended dose
and are not available to be administered to the patient (one being loss
due to labeled amounts remaining in the filter and the other due to
labeled amounts remaining
[[Page 52392]]
in other areas such as the vial or syringe).
Since not all drugs with small fill volumes have certain labeled
amounts that are unused and discarded, we believe more specific
criteria are required to identify certain drugs with unique
circumstances in this case. For example, if a drug is available as 0.8
mL in a prefilled syringe, the total volume in the presentation is
small, however, the entire labeled amount in the syringe may be
administered to the patient as part of a labeled dose; the unique
circumstances described above only occur when the volume of the labeled
dose that is withdrawn from a vial or container is very small and there
is a labeled amount that is unused and discarded and not available for
administration, (based on drugs currently available in the market, we
have observed this to occur with doses contained within less than 0.4
mL). Therefore, we propose an increased applicable percentage for drugs
with a ``low volume dose.'' We consider a low volume dose to be a dose
of a drug for which the volume removed from the vial containing the
labeled dose does not exceed 0.4 mL (which is about 8 drops of liquid).
We propose to revise Sec. 414.902 and define a low volume dose to be a
labeled dose (based on FDA-approved labeling) that is contained within
no more than 0.4 mL when removed from the vial or container. For
example, if a labeled dose is 4 mg and a vial contains a suspension
with a concentration of 40 mg/mL, the labeled dose would be contained
in 0.1 mL, which would not exceed 0.4 mL and would, therefore, be
considered a low volume dose. We propose that this definition of low
volume dose apply even if the drug is further diluted after removal
from the vial and prior to administration because, even if the dose is
further diluted, a dose withdrawn from the vial and diluted would still
have the same physical constraints as a dose that was not diluted, and
those constraints would necessitate the loss of product as described in
the previous paragraph. In addition, we propose that for a drug to meet
these unique circumstances, all labeled doses of the drug would be low
volume doses. As proposed, this definition would not affect the
determination of units as defined at section 1847A(b)(2)(B) of the Act
and codified at Sec. 414.802, and we note that the statutory
definition of unit is exclusive of any diluent without reference to
volume measures pertaining to liquids. The proposed definition of low
volume dose would only be applied for the determination of whether a
higher applicable percentage is warranted for a drug.
We propose a two-tiered increased applicable percentage for drugs
with low volume doses, because the percentage that is unused and
discarded for these drugs decreases as the volume of the dose
increases. We propose that, for drugs with labeled doses contained
within 0.1 mL or less when removed from the vial or container, the
applicable percentage be increased to 90 percent. We are proposing 90
percent applicable percentage for this tier because certain drugs with
low volume doses of 0.1 mL or less have up to 90 percent of the labeled
amount that is unused and discarded and not part of the labeled dose
available to be administered.107 108 We are not proposing to
add an additional 10 percent to this number as we did in the case of
hydrogel, as discussed in the CY 2023 final rule (see 87 FR 69729),
because, generally, we do not believe it would be appropriate for any
product to have an applicable percentage of 100 percent. Such an
applicable percentage would, in effect, exclude drugs from the refund
liability altogether. We believe it would be inappropriate to
effectively expand the list of exclusions described in section
1847A(h)(8)(B) of the Act by proposing an increased applicable
percentage of 100 percent to drugs not expressly excluded in statute.
However, we considered whether some additional percentage might be
appropriate in this case. We solicit comment on whether an additional
percentage above 90 percent (but less than 100 percent) is warranted
for drugs with low volume doses of 0.1 mL or less.
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\107\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950Orig1s000correctedlbl.pdf.
\108\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf.
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In the second tier of the low volume dose unique circumstances, we
propose that for drugs with labeled doses contained within 0.11-0.4 mL,
the applicable percentage be increased to 45 percent. Certain drugs
currently marketed that fall into this category have up to 35.6 percent
of the labeled amount that is unused and discarded and not part of the
labeled dose to be administered. In the same manner as the applicable
percentage for the hydrogel finalized in the CY 2023 PFS final rule, we
propose to add the discarded amount percentage to the applicable
percentage of 10 percent that is used for drugs without unique
circumstances (that is, 35.6 percent plus 10 percent), and we propose
to round that number to an applicable percentage of 45 percent for this
tier.
In summary, we propose to increase the applicable percentages for
drugs with a low volume dose (a dose of a drug for which the volume
removed from the vial or container containing the labeled dose does not
exceed 0.4 mL). Specifically, we propose that:
Refundable drugs with labeled doses that are contained
within 0.1 mL or less when removed from the vial or container have an
increased applicable percentage of 90 percent and;
Refundable drugs with labeled doses that are contained
within 0.11--0.4 mL when removed from the vial or container have an
increased applicable percentage of 45 percent.
To date, we have identified certain drugs that would meet the
proposed criteria for such unique circumstances and would have a
proposed increased applicable percentage of 90 percent, including
Triesence[supreg] (triamcinolone acetonide injection, suspension) and
Xipere[supreg] (triamcinolone acetonide injection, suspension), along
with some other ophthalmic drugs with such low volume doses that do not
include all of the target fill volume in the labeled amount (that is,
those that are labeled such that the low volume dose is equal to the
labeled amount). We also note that, although SusvimoTM
(ranibizumab injection, solution) would qualify for the proposed 90
percent applicable percentage, it is excluded from the definition of
refundable drug due to filtration requirements as discussed in the 2023
PFS final rule (87 FR 69723 through 69724). To date, we have identified
certain drugs that would meet the proposed criteria for such unique
circumstances and would have a proposed increased applicable percentage
of 45 percent, including Xiaflex[supreg] (collagenase clostridium
histolyticum) and Kimmtrak[supreg] (tebentafusp injection, solution,
concentrate).
The second categorical unique circumstances we are proposing is for
orphan drugs administered to a low volume of unique beneficiaries,
which we propose to be fewer than 100 unique Medicare fee-for-service
beneficiaries per calendar year (hereafter referred to as rarely
utilized orphan drugs); we propose an increased applicable percentage
of 26 percent for drugs with these unique circumstances. There is a
higher probability that the percentage of discarded amounts for rarely
utilized orphan drugs may not have a normal statistical distribution
from quarter to quarter, which could disproportionately affect
manufacturers of such drugs by resulting in highly variable refund
amounts as compared with the variability of drugs administered to a
[[Page 52393]]
higher number of beneficiaries. This is evidenced by our analysis of
quarterly discarded drug data reported using the JW modifier of 30
refundable drugs identified in the 2021 Medicare Part B Discarded Drug
Units data with greater than 10 percent units discarded,\109\ three of
which were orphan drugs furnished to a patient population of less than
100 unique fee-for-service Medicare beneficiaries in CY 2021: J9262
(omacetaxine mepesuccinate); J9269 (tagraxofusp-erzs); and J0223
(givosiran). This analysis of JW modifier data for quarters in 2021 and
2022 showed that the average standard deviation of the percentage of
units discarded across quarters for the rarely utilized orphan drugs is
6.21 percent, compared with an average standard deviation for all other
refundable drugs (with a percentage of discarded units over 10 percent
in 2021) of 2.35 percent. In other words, the standard deviation from
the mean discarded drug percentage for rarely utilized orphan drugs is
2.64 times greater than that of the group of refundable drugs with
larger patient populations and claims volume. In addition, based on the
2021 Medicare Part B Discarded Drug Units data for the three
aforementioned drugs, the most historical public data is associated
with J9262, which shows that the percent discarded units for J9262 was
23.65 percent, 19.96 percent, and 30.98 percent in 2019, 2020, and
2021, respectively. Because of this substantial statistical variation
from quarter to quarter for such drugs, we believe it would be
difficult to optimize the presentation of the drug to consistently
minimize the discarded amounts to less than 10 percent given the small
number of patients receiving the drug. We consider the higher
percentage of unused and discarded amounts from such drugs as
unavoidable loss due to both the low volume of unique beneficiaries
receiving the drug contributing statistically higher variability in
discarded amounts. Also, due to the low numbers of patients available
to study for rare disease, it may be more difficult to determine the
most efficient vial size for the patient population who receive the
drug post-marketing. This is similar to the loss of product due to
filtration described in section 1847A(8)(B)(ii) of the Act because the
loss is unavoidable in both circumstances. In the case of filtration
described in statute, the loss is unavoidable because certain amounts
of product will be left within the filter and unavailable for
administration; in the case of rarely utilized orphan drugs, the loss
is unavoidable because of the variability of potential doses (and low
number of patients receiving the drug) leading to an inability to
develop a package size that will result in a consistent average
percentage of discarded units (as evidenced in the analysis above in
this section). In contrast, drugs administered to a larger number of
beneficiaries per year do have a more consistent average percentage
discarded from quarter to quarter, as evidenced by the lower standard
deviation in our analysis, and we believe manufacturers are able to
develop availability of the drug accordingly to minimize discarded
amounts.
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We propose that unique circumstances of rarely utilized orphan
drugs have the following characteristics: (1) a drug designated under
section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a
drug for a rare disease or condition; and (2) that is furnished to
fewer than 100 unique Medicare fee-for-service beneficiaries per
calendar year. We propose that the number of beneficiaries receiving
such drug in the calendar year would correspond with the refund
quarter. For example, for refund quarters in 2023, we would use the
number of beneficiaries receiving the drug in the 2023 calendar year to
determine if the unique circumstances and increased applicable
percentage would apply. Data of number of beneficiaries would be
analyzed at the same time as the JW modifier data for the given
calendar quarters. To meet these unique circumstances, we propose that
the drug be designated an orphan-drug under section 526 of the FD&C Act
for a rare disease or condition (or diseases or conditions) and be
approved by the FDA-only for one or more indications within such
designated rare disease or condition (or diseases or conditions). That
is, all FDA-labeled indications for the drug must be orphan
indications. In addition, we propose that the drug would meet these
unique circumstances and that the increased applicable percentage would
apply for as long as the drug meets these conditions, even after any
orphan-drug exclusivity end date.
The increased applicable percentage of 26 percent that we are
proposing is appropriate because the standard deviation from the mean
discarded drug percentage for rarely utilized orphan drugs is 2.64
times greater than that of the larger group of refundable drugs, and
multiplying the applicable percentage referenced in paragraph
(h)(3)(B)(i)(II) by how many times greater the variance is (in other
words, 10 percent times 2.64) equals 26.4 percent, which we propose to
round to the nearest percentage.
We propose that CMS would identify drugs that have unique
circumstances of low volume doses and rarely utilized orphan drugs in
the report sent to manufacturers and apply the proposed increased
applicable percentages based on these categorical unique circumstances
proposals. If a manufacturer believes that the incorrect applicable
percentage was applied to the refund calculation, the manufacturer may
submit a dispute regarding the calculation by submitting an error
report (see Sec. [thinsp]414.940(e)).
We propose to codify these applicable percentages at Sec.
[thinsp]414.940(d). Specifically, we propose to add applicable
percentages for low volume doses by creating new paragraphs (d)(3) and
(4); and we propose to add applicable percentage for orphan drugs
administered to fewer than 100 unique beneficiaries per calendar year
in new paragraph (d)(5). We propose that these applicable percentages
apply beginning with the initial refund report that we propose to be
sent no later than December 31, 2024.
We solicit comments on the proposed categorical unique
circumstances. Specifically, we solicit comment on the proposed volume
(mL) tiers for drugs with low volume doses along with the proposed
increased applicable percentages and whether an additional percentage
above 90 percent (but less than 100 percent) is warranted for drugs
with low volume doses of 0.1 mL or less. We also solicit comment on the
increased applicable percentage of 26 percent for rarely utilized
orphan drugs.
(4) Proposed Application Process for Individual Drugs
In addition to the two proposed categorical unique circumstances,
we propose to establish an application process through which
manufacturers may request that we consider an individual drug to have
unique circumstances for which an increased applicable percentage is
appropriate. We believe manufacturers would benefit from a formal
process through which they can provide information, including that
which may not be publicly available, and therefore, not known to us, in
order to request an increase in their refundable drug's applicable
percentage and provide justification for why the drug has unique
circumstances for which such an increase is appropriate, including in
the case of a drug with an applicable percentage that has already been
increased by virtue of
[[Page 52394]]
its inclusion in categorical unique circumstances.
We propose that, to request CMS consider increasing the applicable
percentage of a particular refundable drug, a manufacturer must submit
the following: (1) a written request that a drug be considered for an
increased applicable percentage based on its unique circumstances; (2)
FDA-approved labeling for the drug; (3) justification for the
consideration of an increased applicable percentage based on such
unique circumstances; and (4) justification for the requested increase
in the applicable percentage. Such justification could include
documents, such as (but not limited to) a minimum vial fill volume
study or a dose preparation study. We propose that in evaluating
requests for increased applicable percentages, we would review the
documentation referenced above for evidence that amounts of drug
identified in the FDA-approved package or labeling has similar loss of
product as that described in paragraph section 1847A(8)(B)(ii) of the
Act.
Section 1847(h)(3)(B)(ii) of the Act requires that any increase to
applicable percentages for refundable drugs to be made through notice-
and-comment rulemaking. Therefore, we propose that applications for
individual applicable percentage increases be submitted in a form and
manner specified by CMS by February 1 of the calendar year prior to the
year the increased applicable percentage would apply (for example,
applications for increased applicable percentages effective January 1,
2025 would be due to CMS by February 1, 2024). We propose to discuss
our analyses of applications in the PFS rulemaking immediately
following the application period, and to communicate in the proposed
rule whether we consider the drug to have unique circumstances that
warrant an increased applicable percentage. We would also include
proposals, if any, for increased applicable percentages, along with a
summary of any applications for which we determined not to propose an
increase in the applicable percentage. We propose to codify this
application process for individual unique circumstances in new
paragraph Sec. 414.940(e).
We do not consider the following to be unique circumstances
warranting an increased applicable percentage at this time: weight-
based doses, BSA-based doses, varying surface area of a wound, loading
doses, escalation or titration doses, tapering doses, and dose
adjustments for toxicity because we believe manufacturers can optimize
the availability of products for these circumstances to limit the
percentage of discarded units for a drug, unlike the circumstances of
manufacturers of drugs that require filtration during the preparation
process, as described in section 1847A(h)(8)(B)(ii) of the Act. FDA
draft guidance, titled ``Optimizing the Dosage of Human Prescriptions
Drugs and Biological Products for the Treatment of Oncologic
Diseases'',\110\ states: ``Various dose strengths should be available
to allow multiple dosages to be evaluated in clinical trials. Perceived
difficulty in manufacturing multiple dose strengths is an insufficient
rationale for not comparing multiple dosages in clinical trials.''
Although optimization of dosage and available product formulations most
often occurs prior to marketing a drug, we also observe several
instances where the drug formulation availability has been changed and
subsequently resulted in a decreased percentage of discarded amounts.
For example, Kyprolis[supreg] (carfilzomib), which is cross-walked to
the billing and payment code J9047, was available in only one 60-mg
single-dose vial size when first approved in 2012.\111\ Subsequently, a
second 30-mg vial size was approved in 2016,\112\ and a third 10-mg
vial size was approved in June of 2018.\113\ We observe in discarded
drug data, based on the JW modifier, that the percentage of discarded
units for J9047 was 14.27, 12.68, 5.95, 4, and 3.09 percent in 2017,
2018, 2019, 2020, and 2021, respectively. There is a sharp drop in the
percent of discarded units after 2018, which correlates with the
introduction of the 10-mg vial. The labeled dose of Kyprolis[supreg] is
based on the patient's BSA, there is a dose escalation, there are two
different dosage schedules (once weekly and twice weekly) each with
differing doses, there are dosage modifications for toxicity that
involve dose reductions, and there is a dose reduction for patients
with hepatic impairment. With these dose variations taken into
consideration, the available vial sizes of the drug allow for the
percentage of discarded units to remain well below 10 percent after the
introduction of the third vial size.
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\110\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases.
\111\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf.
\112\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf.
\113\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf.
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In addition, we observe that, based on the 2021 discarded drug
data,\114\ as the number of available package sizes increases, the
percent discarded decreases (see Table 19). This example is indicative
of ways in which manufacturers can optimize package sizes to reduce the
percentage of discarded units in the circumstances listed above.
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\114\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
[GRAPHIC] [TIFF OMITTED] TP07AU23.029
We solicit comments from interested parties on the application
process for individual drug unique circumstances. Specifically, we
solicit comment on what factors we should use in a framework for
considering these
[[Page 52395]]
applications, what factors we should use to assess appropriate
increases to applicable percentages, as well as what types of
additional or alternative documentation may help us analyze
justifications for increased applicable circumstances.
e. Clarification for the Definition of Refundable Drug
As discussed in the CY 2023 PFS final rule (87 FR 69650 through
69655), CMS aims to create a consistent coding and payment approach for
the suite of products currently referred to as skin substitutes. On
January 18, 2023, we held a Town Hall to discuss this issue further and
to provide an opportunity to further engage interested parties on this
matter and is soliciting additional comments about skin substitutes in
this proposed rule. We anticipate addressing coding and payment for
skin substitutes in future rulemaking. While we consider making changes
to the Medicare Part B payment policies for such products, we propose
that billing and payment codes that describe products currently
referred to as skin substitutes not be counted for purposes of
identifying refundable drugs for calendar quarters during 2023 and
2024. We plan to revisit discarded drug refund obligations for skin
substitutes in future rulemaking.
f. Clarification for the Determination of Discarded Amounts and Refund
Amounts
Section 1847A(h) of the Act specifies that discarded amounts of
refundable 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. In the CY 2023 PFS final rule (87 FR
69718 through 69719), we finalized our previously existing policy that
required billing providers report the JW modifier for all separately
payable drugs with discarded drug amounts from single use vials or
single use packages payable under Part B, beginning January 1, 2023.
Since the JW modifier, the mechanism described in section 1847A(h) of
the Act, is not required in Medicare Advantage claims for drugs payable
under Medicare Part B and there is not a similar mechanism to identify
discarded units of such drugs that are billed to Medicare Advantage
plans, we are clarifying that the JW modifier requirement does not
apply to units billed to Medicare Advantage plans and that the refund
amount calculations under section 1847A(h)(3) of the Act will not
include units billed to Medicare Advantage plans.
g. Technical Changes
In the CY 2023 PFS final rule (87 FR 70227) we finalized the
regulation text for the calculation of the manufacturer refund
requirement. That text contained an error in two places, Sec.
414.940(c)(3) and (d), which incorrectly referenced paragraph
(c)(1)(ii) of that section in reference to the applicable percentage,
rather than paragraph (c)(2). We propose to correct the textual
reference in both paragraphs and make additional technical changes to
streamline the text. See section III.A.3.d.(1) of this proposed rule
for discussion of additional proposed revisions to these provisions.
h. Use of the JW Modifier and JZ Modifier Policy
In the CY 2023 PFS final rule (87 FR 69723), we discussed the
applicability of the JW and JZ modifier policy to drugs that are not
administered by the billing supplier, including drugs furnished through
a covered item of DME that may be administered by the beneficiary. In
such cases, suppliers who dispense drugs payable under Medicare Part B
do not actually administer the drug, as the claim is typically
submitted prior to the administration of the drug, and the billing
provider or supplier is not at the site of administration to measure
discarded amounts. We stated that since we do not believe it would be
appropriate to collect data about discarded amounts from beneficiaries,
the reporting requirement does not apply to drugs that are self-
administered by a patient or caregiver in the patient's home. In the
updated FAQ for the JW/JZ modifier policy \115\ released on January 5,
2023, we reiterated that suppliers who dispense but do not actually
administer a separately payable drug are not expected to report the JW
modifier.
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\115\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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Beginning October 1, 2023, we will begin editing for correct use of
both the JW and JZ modifiers for billing and payment codes for drugs
from single-dose containers (87 FR 69719). However, because currently
there is no claims modifier to designate that a drug was dispensed, but
not administered, by the billing supplier, the policy finalized last
year exempting self-administered drugs from the JW/JZ modifier policy
may result in claims rejections absent a modification. Therefore, as we
continue to believe it is unreasonable to collect discarded drug data
from beneficiaries, we propose to require that drugs separately payable
under Part B from single-dose containers that are furnished by a
supplier who is not administering the drug be billed with the JZ
modifier.
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 of our regulations, RHC
and FQHC visits generally are defined as 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 verified as having
shortage of home health agencies. We note, as discussed in section
III.B.2.b. of this proposed rule, effective January 1, 2024 RHC and
FQHC practitioners can also be licensed marriage and family therapists
or mental health counselors. 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.
[[Page 52396]]
Beginning on that date, in accordance with section 1834(o) of the Act
(as added by section 10501(i)(3) of the Patient Protection and
Affordable Care Act (Pub. L. 111-148), FQHCs 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 at
the individual level for the complexity of individual patient health
care needs, the length of an individual visit, or the number or type of
practitioners involved in the patient's care. Instead for RHCs, all
costs for the facility over the course of the year are aggregated and
an AIR is derived from these aggregate expenditures. The FQHC PPS base
rate is updated annually by the percentage increase in the FQHC market
basket less a productivity adjustment.
2. Implementation of the Consolidated Appropriations Act (CAA), 2023
a. Section 4113 of the Consolidated Appropriations Act, 2023
In the CY 2022 PFS final rule with comment (86 FR 65211), we
revised 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/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. We also noted
that 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 revised 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 revised 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 revised
paragraph (d) to describe the same in-person visit requirement
referenced in Sec. 405.2463.
As discussed in the CY 2023 PFS final rule (87 FR 69738), the
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022) included the extension of a number of Medicare
telehealth flexibilities established during the public health emergency
(PHE) for COVID-19 for a limited 151-day period beginning on the first
day after the end of the PHE for COVID-19. Specifically, Division P,
Title III, 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 until the 152nd day
after the end of the PHE for COVID-19. Therefore, in the CY 2023 PFS
final rule (87 FR 69737), we revised the regulations under Sec. Sec.
405.2463 and 405.2469 again to reflect these provisions.
The CAA, 2023 (Pub. L. 117-328, December 29, 2022) extends the
Medicare telehealth flexibilities enacted in the CAA, 2022 for a period
beginning on the first day after the end of the PHE for COVID-19 and
ending on December 31, 2024, if the PHE ends prior to that date.
Specifically related to RHCs and FQHCs, section 4113(c) of the CAA,
2023 amends section 1834(m)(8) of the Act to extend payment for
telehealth services furnished by FQHCs and RHCs for the period
beginning on the first day after the end of the COVID-19 PHE and ending
on December 31, 2024 if the PHE ends prior to that date. Payment
continues 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.
Rather, we used our authority in section 4113(h) of the CAA, 2023 to
issue program instructions or other subregulatory guidance to
effectuate this provision to ensure a smooth transition after the
PHE.\116\
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\116\ https://www.cms.gov/files/document/rural-health-clinics-and-federally-qualified-health-centers-cms-flexibilities-fight-covid-19.pdf.
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Section 4113(d) of the CAA, 2023 also continues to delay 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. That is, for RHCs
and FQHCs, in-person visits will not be required until January 1, 2025
or, if later, the first day after the end of the PHE for COVID-19.
Therefore, we continue to apply the delay of the in-person requirements
under Medicare for mental health services furnished by RHCs and FQHCs.
We note, the Department of Health and Human Services declared an end to
the Federal PHE for COVID-19 under section 319 of the Public Health
Service Act on May 11, 2023.\117\
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\117\ https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.
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We are proposing to make conforming regulatory text changes based
on CAA, 2023 to the applicable RHC and FQHC regulations in 42 CFR part
405, subpart X, specifically, at Sec. 405.2463, ``What constitutes a
visit,'' we are proposing to amend paragraph (b)(3) and, at Sec.
405.2469 ``FQHC supplemental payments,'' we are proposing to amend
paragraph (d) to include the delay of the in-person requirements for
mental
[[Page 52397]]
health visits furnished by RHCs and FQHCs through telecommunication
technology under Medicare beginning January 1, 2025. We note that we
are not revising the regulation text to reflect ``or, if later, the
first day after the end of the PHE for COVID-19'' as the legislation
states since the end of the PHE was May 11, 2023.
In the CY 2023 PFS final rule (87 FR 69738), we listed the several
other provisions of the CAA, 2022 that apply to telehealth services
(those that are not mental health visits) furnished by RHCs and FQHCs.
For details on the other Medicare telehealth provisions in the CAA,
2022, see section II.D. of this proposed rule. The CAA, 2023 extends
the telehealth policies mentioned above and enacted in the CAA, 2022
through December 31, 2024 if the PHE ends prior to that date.
b. Direct Supervision via Use of Two-Way Audio/Video Communications
Technology
As discussed in section II.D.2.a of this proposed rule, under
Medicare Part B, certain types of services are required to be furnished
under specific minimum levels of supervision by a physician or
practitioner. For RHCs and FQHCs, services and supplies furnished
incident to physician's services are limited to situations in which
there is direct physician supervision of the person performing the
service, except for certain care management services which may be
furnished under general supervision (Sec. 405.2415(a)(5)). The
``incident to'' policy for RHCs and FQHCs is discussed in Pub. 100-02,
chapter 13, section 120.1. Similar to physician services paid under the
PFS, outside the circumstances of the PHE, direct supervision of RHC
and FQHC services does not require the physician to be present in the
same room. However, the physician must be in the RHC or FQHC and
immediately available to provide assistance and direction throughout
the time the incident to service or supply is being furnished to a
beneficiary.
During the COVID-19 PHE, the modifications that we made to the
regulatory definition of direct supervision for services paid under the
PFS were also applicable to RHCs and FQHCs. We explained in the April
6, 2020 IFC that given the circumstances of the PHE for the COVID-19
pandemic, we recognized that in some cases, the physical proximity of
the physician or practitioner might present additional exposure risks,
especially for high risk patients isolated for their own protection or
cases where the practitioner has been exposed to the virus but could
otherwise safely supervise from another location using
telecommunications technology. We believed that the same concerns
existed for RHCs and FQHCs. In the April 6, 2020 IFC, we allowed the
supervising professional to be immediately available through virtual
presence using two-way, real time audio-visual technology, instead of
requiring their physical presence (85 FR 19245 and 19246).\118\ When
discussing direct supervision in RHCs and FQHCs, we noted that in
general, CMS had modified the requirements for direct supervision to
include the use of a virtual supervisory presence through the use of
interactive audio and video telecommunications technology.\119\
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\118\ https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf.
\119\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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We believe that extending this definition of direct supervision for
RHCs and FQHCs through December 31, 2024, would align the timeframe of
this policy with many of the previously discussed PHE-related
telehealth policies that were extended under provisions of the CAA,
2023 and we are concerned about an abrupt transition to the pre-PHE
policy of requiring the physical presence of the supervising
practitioner beginning after December 31, 2023, given that RHCs and
FQHCs have established new patterns of practice during the PHE for
COVID-19. We also believe that RHCs and FQHCs will need time to
reorganize their practices established during the PHE to reimplement
the pre-PHE approach to direct supervision without the use of audio/
video technology. For RHCs and FQHCs, we are proposing to continue to
define ``immediate availability'' as including real-time audio and
visual interactive telecommunications through December 31, 2024.
In the absence of evidence that patient safety is compromised by
virtual direct supervision, we believe that an immediate reversion to
the pre-PHE definition of direct supervision may present a barrier to
access services, such as those furnished incident-to a physician's
service. Therefore, we are soliciting comment on whether we should
consider extending the definition of direct supervision to permit
virtual presence beyond December 31, 2024. When compared to
professionals paid under the PFS, RHCs and FQHCs have a different model
of care and payment structure. Therefore, we seek comment from
interested parties on potential patient safety or quality concerns when
direct supervision occurs virtually in RHCs and FQHCs; for instance, if
certain types of services are more or less likely to present patient
safety concerns, or if this flexibility would be more appropriate when
certain types of auxiliary personnel are performing the supervised
service. We are also interested in potential program integrity concerns
such as overutilization or fraud and abuse that interested parties may
have in regard to this policy.
c. Section 4121 of the CAA, 2023
Section 1861(aa) of the Act provides authority under Medicare Part
B to cover and pay for RHC and FQHC services. Section 1861(aa)(1) of
the Act defines these services as those furnished by physicians,
physician assistants, nurse practitioners, nurse-midwives, qualified
clinical psychologists, clinical social workers, and services and
supplies furnished incident to professional services of these
practitioners. As discussed in section III.B.1.a. of this proposed
rule, our conforming regulation text is provided in 42 CFR part 405,
subpart X where we define RHC and FQHC visits as 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.
Before passage of CAA, 2023, there was no separate benefit category
under the statute that recognized the professional services of licensed
marriage and family therapists (MFTs) or mental health counselors
(MHCs). As discussed in the CY 2023 PFS final rule (87 FR 69546),
payment for MFTs was only made under the PFS indirectly when an MFT or
MHC performed services as auxiliary personnel incident to the services
of a physician or other practitioner and under general supervision.
This is also true for RHCs and FQHCs, in that MFTs and MHCs were
considered auxiliary personnel and the services they provided were
considered incident to the services of the RHC or FQHC practitioner
(Sec. 405.2413).
Section 4121 of Division FF, Title IV, Subtitle C of the CAA, 2023,
entitled ``Coverage of Marriage and Family Therapist Services and
Mental Health Counselor Services under Part B of the Medicare
Program'', amended section 1861(s)(2) of the Act to establish coverage
of MFT and MHC services (section 1861(s)(2)(II) of the Act). We note
that section II.J of this proposed rule provides a detailed discussion
of the provisions in section 4121(a) of CAA, 2023 including the
authority for coverage of MFT and MHC services, definitions of these
professionals and
[[Page 52398]]
their services, and payment under the PFS. Section 4121(b) of CAA, 2023
amended section 1861(aa)(1)(B) of the Act by extending the scope of RHC
services to include those furnished by MFTs and MHCs as eligible for
payment, which is incorporated into FQHC services through section
1861(aa)(3)(A) of the Act. We are proposing to codify payment
provisions for MFTs and MHCs under 42 CFR part 405, subpart X beginning
January 1, 2024. That is, RHC and FQHCs would be paid under the RHC AIR
and FQHC prospective payment system (PPS), respectively, when MFTs and
MHCs furnished RHC and FQHC services defined in Sec. Sec. 405.2411 and
405.2446. As eligible RHC and FQHC practitioners, MFTs and MHCs would
follow the same policies and supervision requirements as a PA, NP, CNM,
CP, and CSW.
In addition, as discussed in section II.J of this proposed rule, we
are proposing to allow addiction counselors that meet all of the
applicable requirements of clinical supervised experience in mental
health counseling, and that are licensed or certified as MHCs, clinical
professional counselors, or professional counselors by the State in
which the services are furnished) to enroll in Medicare as MHCs.
Therefore, to remain consistent with payment policies for professionals
billing Medicare under the PFS, we propose that the definitions
established for MFTs and MHCs under the PFS would also apply for RHCs
and FQHCs. In the CY 2023 PFS final rule (87 FR 69735 through 69737),
we discussed the coding and payment for HCPCS code G0323 which
describes general BHI services performed by CPs and CSWs under the PFS.
We noted CPs and CSWs are statutorily authorized to furnish services in
RHCs and FQHCs under sections 1861(aa)(1) and (3) of the Act,
respectively, and as described by Sec. 405.2411(a)(6). We also
explained, the payment rate for HCPCS code G0323 is based on the
payment rate for the current general BHI code, 99484. Therefore, in the
CY 2023 PFS final rule (87 FR 69737) we clarified that when CPs and
CSWs provide the services described in HCPCS code G0323 in an RHC or
FQHC, the RHC or FQHC can bill HCPCS code G0511. We further stated RHCs
and FQHCs that furnish general BHI services are able to bill for this
service 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.
We note that in section II.J of this proposed rule, we are
proposing to revise the code descriptor for HCPCS code G0323 in order
to allow MFTs and MHCs, as well as CPs and CSWs, to be able to bill for
this monthly care integration service. Since MFTs and MHCs are
statutorily authorized to furnish services in RHCs and FQHCs effective
January 1, 2024, we are proposing to clarify that when MFTs and MHCs
provide the services described in HCPCS code G0323 in an RHC or FQHC,
the RHC or FQHC can bill HCPCS code G0511. We believe that this policy
aligns to our effort to be consistent with the new services that are
proposed for practitioners billing under the PFS.
We propose to make several conforming regulatory changes to
applicable RHC and FQHC regulations in 42 CFR part 405, subpart X,
specifically:
At Sec. 405.2401, Scope and definitions, we propose to
amend the section to add definitions for MFT and MHC;
At Sec. 405.2411, Scope of benefits, we propose to amend
the section to include MFT and MHC where other RHC and FQHC
practitioners are stated;
At Sec. 405.2415, Incident to services and direct
supervision, we propose to amend the section to include MFT and MHC
where other RHC and FQHC practitioners are stated;
At Sec. 405.2446, Scope of services, we propose to amend
the section to include MFT and MHC services to the scope of services;
At Sec. 405.2448, Preventive primary services, we propose
to amend the section to include MFT and MHC where other RHC and FQHC
practitioners are stated;
At Sec. 405.2450, Clinical psychologist and clinical
social worker services, we propose to amend the section title to add
MFT and MHC and include MFT and MHC where other RHC and FQHC
practitioners are stated;
At Sec. 405.2452, Services and supplies incident to
clinical psychologist and clinical social worker services, we propose
to amend the section title to add MFT and MHC and include MFT and MHC
where other RHC and FQHC practitioners are stated;
At Sec. 405.2463, What constitutes a visit, we propose to
amend the section to add MFT and MHC to the list of eligible
practitioners; and
At Sec. 405.2468, Allowable costs, we propose to amend
the section to add MFTs and MHCs where other RHC and FQHC practitioners
are listed.
d. Section 4124 of the Consolidated Appropriations Act, 2023
Section 4124 of Division FF of the CAA, 2023 establishes coverage
and payment under Medicare for the Intensive Outpatient Program (IOP)
benefit, effective January 1, 2024. IOP may be furnished by hospitals,
Community Mental Health Centers (CMHCs), FQHCs and RHCs. Payment for
IOP services furnished by RHCs and FQHCs is to be made at the same
payment rate as if it were furnished by a hospital.
In addition to existing mental health services furnished by RHCs
and FQHCs, this new provision establishes coverage for IOP services
furnished in RHCs and FQHCs and includes occupational therapy, family
counseling, beneficiary education, diagnostic services and individual
and group therapy.
Please see section VIII.F. of the CY 2024 Outpatient Prospective
Payment System proposed rule for discussion of the new IOP scope of
benefits, requirements, physician certification, and payment policies.
3. Updates to Supervision Requirements for Behavioral Health Services
Furnished at RHCs and FQHCs
In the CY 2023 PFS final rule (87 FR 69545 through 69548), we
amended the direct supervision requirement under the ``incident to''
regulations for services payable under the PFS to allow behavioral
health services to be furnished under the general supervision of a
physician or non-physician practitioner (NPP) when these services or
supplies are provided by auxiliary personnel incident to the services
of a physician or NPP. Several commenters expressed support for CMS
allowing behavioral health services to be furnished under general
supervision in the RHC and FQHC settings in addition to services paid
under the PFS. In response to the public comments, we noted that for CY
2023, the proposed change to the level of supervision for ``incident
to'' behavioral health services from direct to general was applicable
only to services payable under the PFS, as services furnished in the
RHC and FQHC settings were not addressed in the relevant proposal in
the CY 2023 PFS proposed rule (87 FR 46062 through 46068). We stated we
may consider changes to the regulations regarding services furnished at
RHCs and FQHCs in the future.
Currently, behavioral health services furnished in the RHC and FQHC
settings require direct supervision. However, in order to be more
consistent with applicable policies under the PFS, for CY 2024, we are
proposing to change the required level of supervision for behavioral
health services furnished ``incident to'' a physician or NPP's services
at RHCs and FQHCs to allow
[[Page 52399]]
general supervision, rather than direct supervision, consistent with
the policies finalized under the PFS for CY 2023. Accordingly, we are
proposing to revise the regulations at Sec. Sec. 405.2413 and 405.2415
to reflect that behavioral health services can be furnished under
general supervision of the physician (or other practitioner) when these
services or supplies are provided by auxiliary personnel incident to
the services of a physician (or another practitioner). Additionally, as
discussed in the CY 2023 PFS final rule (87 FR 69547), we note that at
Sec. 410.26(a)(1) we define ``auxiliary personnel'' as any individual
who is acting under the supervision of a physician (or other
practitioner), regardless of whether the individual is an employee,
leased employee, or independent contractor of the physician (or other
practitioner) or of the same entity that employs or contracts with the
physician (or other practitioner), has not been excluded from the
Medicare, Medicaid and all other Federally-funded health care programs
by the Office of Inspector General or had his or her Medicare
enrollment revoked, and meets any applicable requirements to provide
incident to services, including licensure, imposed by the State in
which the services are being furnished.
4. General Care Management Services in RHCs and FQHCs
a. Background
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 independently
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.
As we discussed in the CY 2016 PFS final rule (80 FR 71081 through
71088), to address the concern that the non-face-to-face care
management work involved in furnishing comprehensive, coordinated care
management for certain categories of beneficiaries is not adequately
paid for as part of an office visit, beginning on January 1, 2015,
practitioners billing under the PFS are paid separately for CCM
services when CCM service requirements are met. We explained that RHCs
and FQHCs cannot bill under the PFS for RHC or FQHC services and
individual practitioners working at RHCs and FQHCs cannot bill under
the PFS for RHC or FQHC services while working at the RHC or FQHC.
Although many RHCs and FQHCs pay for coordination of services within
their own facilities, and may sometimes help to coordinate services
outside their facilities, the type of structured care management
services that are now payable under the PFS for patients with multiple
chronic conditions, particularly for those who are transitioning from a
hospital or SNF back into their communities, are generally not included
in the RHC or FQHC payment. Therefore, separate payment was established
in the CY 2016 PFS final rule (80 FR 71080 through 71088) for RHCs and
FQHCs that furnish 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 (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. We
also initiated the use of HCPCS code G0511, 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 HCPCS code G0511 were CPT code 99490
(20 minutes or more of CCM services), CPT code 99487 (60 minutes or
more of complex CCM services), and CPT code 99484 (20 minutes or more
of BHI services).
We also explained that another CCM code was introduced for
practitioners billing under the PFS, CPT code 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 2021 PFS final rule (85 FR 84697 through 84699), we
explained that the requirements described by the codes for Principal
Care Management (PCM) services were similar to the requirements for the
services described by HCPCS code G0511; therefore, we added HCPCS codes
G2064 and G2065 to HCPCS code G0511 as general care management services
for RHCs and FQHCs. Consequently, effective January 1, 2021, RHCs and
FQHCs are paid when a minimum of 30 minutes of qualifying PCM services
are furnished during a calendar month. The payment rate for HCPCS code
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 codes G2064 and G2065). 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 payment rate
for HCPCS code G0511 was the average of the national non-facility PFS
payment rate for CPT codes 99490, 99487, 99484, 99491, 99424, and
99425).
Most recently, in the CY 2023 PFS final rule (87 FR 69735 through
69737), we included Chronic Pain Management (CPM) services described by
HCPCS code G3002 in the general care management HCPCS code G0511 when
at least 30 minutes of qualifying non-face-to-face CPM services are
furnished during a calendar month. We explained since HCPCS code G3002
is valued using a crosswalk to the PCM CPT code 99424, which is
currently one of the CPT codes that comprise HCPCS code G0511, there
was no change made to the average used to calculate the HCPCS code
G0511 payment rate to reflect CPM services.
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
[[Page 52400]]
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.
b. Remote Physiologic Monitoring (RPM) and Remote Therapeutic
Monitoring (RTM) Services Furnished in RHCs and FQHCs
In recent years under the PFS, we have finalized payment for five
CPT codes in the RPM code family. RPM services include the collection,
analysis, and interpretation of digitally collected physiologic data,
followed by the development of a treatment plan, and the managing of a
patient under the treatment plan (84 FR 62697). Within the suite of
services that comprise RPM, there is a CPT code that describes the
initial set-up and patient education on use of the equipment that
stores the physiologic data.
After analyzing and interpreting a patient's remotely collected
physiologic data, we noted that the next step in the process of RPM is
the development of a treatment plan that is informed by the analysis
and interpretation of the patient's data. It is at this point that the
physician or other practitioner develops a treatment plan with the
patient and/or caregiver (that is, develops a patient-centered plan of
care) and then manages the plan until the targeted goals of the
treatment plan are attained, which signals the end of the episode of
care.
[GRAPHIC] [TIFF OMITTED] TP07AU23.030
Remote Therapeutic Monitoring (RTM) is a family of five codes
finalized for Medicare payment in the CY 2022 PFS final rule (86 FR
65114 through 65117). The RTM codes include three practice expense
(PE)-only codes and two professional work, treatment management codes.
RTM services involve remote monitoring of respiratory system status,
musculoskeletal status, therapy adherence, or therapy response. There
is also a CPT code that describes the initial set-up and patient
education on use of the equipment that stores the physiologic data
within the suite of services that comprise RTM.
[[Page 52401]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.031
Currently, RPM and RTM services are not stand-alone billable visits
in RHCs and FQHCs. When these services are furnished incident to an RHC
or FQHC visit, payment is included in the RHC's AIR subject to a
payment-limit or the per visit payment under the FQHC PPS which is the
lesser of the PPS rate or the FQHC's actual charges.
In recent years, we have updated RHC and FQHC policies to improve
payment for care management and coordination. We have provided a
separate payment to RHCs and FQHCs in addition to the billable visit in
part for monthly care management and behavioral health integration
codes, as described in the general care management code, HCPCS code
G0511, because these are inherently non-face-to-face services that may
not be accounted for in the per-visit payment for an in-person
encounter.
RHCs and FQHCs have inquired about receiving a separate payment for
RTM and RPM services. They have stated that CMS should expand HCPCS
code G0511 to include RPM treatment management services to provide
Medicare beneficiaries in rural and underserved areas access to these
services or establish G-codes to reimburse RHCs and FQHCs for RPM set-
up and patient education on use of equipment (CPT code 99453) and
monthly data transmission (CPT code 99554) and do not believe that
these services are captured in the RHC AIR or FQHC PPS and as such are
impeding access to these services.
Upon further review and in line with our thinking about non-face-
to-face services previously, we are proposing to include the CPT codes
that are associated with the suite of services that comprise RPM and
RTM in the general care management HCPCS code G0511 when these services
are furnished by RHCs and FQHCs since the requirements for RPM and RTM
services are similar to the non-face-to-face requirements for the
general care management services furnished in RHCs and FQHCs. Allowing
a separate payment for RPM and RTM services in RHCs and FQHCs is
intended to reflect the additional resources necessary for the unique
components of these 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 in-person encounters may not
reflect all the services and resources required to furnish
comprehensive, coordinated care management. As RPM and RTM services are
described, particularly, collection and transmission of data and then
further analysis and interpretation of the data are happening outside
of the face-to-face visit. RPM and RTM also have principles which are
consistent with other care management principles, such as, an
established patient-physician relationship is required, patient consent
is required at the time that RPM services are furnished, and services
allow the monitoring of acute conditions and chronic conditions.
However, we note that under this proposal, RPM and RTM services must be
medically reasonable and necessary, meet all requirements, and not be
duplicative of services paid to RHCs and FQHCs under the general care
management code for an episode of care in a given calendar month.
Therefore, we propose that RHCs and FQHCs that furnish RPM and RTM
services 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, 2024.
c. Services Addressing Health-Related Social Needs: Community Health
Integration Services and Principal Illness Navigation Services
(1) Background
As discussed in section II.E.4.(27) of this proposed rule, in
recent years, we have sought to recognize significant changes in health
care practice and been engaged in an ongoing, incremental effort to
identify gaps in appropriate coding and payment for care management/
coordination and primary care services under the PFS. In congruence
with services paid under the PFS, we have similarly provided separate
payment for transitional care management services, chronic care
management services, and behavioral health care management services
(discussed above in section III.B.4.a. of the proposed rule) to improve
payment accuracy to better recognize resources involved in care
management and coordination for certain patient populations. In this
effort to improve payment accuracy for care coordination in RHCs and
FQHCs, we are exploring ways to better identify the resources for
[[Page 52402]]
helping patients with serious illnesses navigate the healthcare system
or removing health-related social barriers that are interfering with
their ability to execute a medically necessary plan of care. RHCs and
FQHCs sometimes obtain information about and help address, social
determinants of health (SDOH) that significantly impact their ability
to diagnose or treat a patient. The CPT E/M Guidelines defined SDOH as,
``Economic and social conditions that influence the health of people
and communities. Examples may include food or housing insecurity.
Additionally, RHCs and FQHCs sometimes help newly diagnosed cancer
patients and other patients with similarly serious, high-risk illnesses
navigate their care, such as helping them understand and implement the
plan of care, and locate and reach the right practitioners and
providers to access recommended treatments and diagnostic services,
considering the personal circumstances of each patient. Payment for
these activities, to the extent they are reasonable and necessary for
the diagnosis and treatment of the patient's illness or injury, is
currently included in the RHC AIR or under the FQHC PPS payment amount
for visits and some care management services. Medical practice has
evolved to increasingly recognize the importance of these activities,
and we believe RHCs and FQHCs are performing them more often.
However, this work is not explicitly identified in current coding,
and as such, we believe it is underutilized and undervalued.
Accordingly, we are proposing to create new coding to expressly
identify and value these services for PFS payment, and distinguish them
from current care management services. Therefore, we are considering
the new coding for purposes of payment to RHCs and FQHCs.
(2) Payment for Community Health Integration (CHI) Services in RHCs and
FQHCs
Consistent with the discussion in section II.E.4.(27).b. of this
proposed rule, there are two new HCPCS codes proposed to describe CHI
services performed by certified or trained auxiliary personnel, which
may include a CHW, incident to the professional services and under the
general supervision of the billing practitioner. The requirements for
the proposed CHI services, as stated in section II.E.4.(27) of this
proposed rule, are similar to the requirements for the general care
management services furnished by RHCs and FQHCs. As such, we believe
the level of care coordination resources required in addressing the
particular SDOH need(s) that are interfering with, or presenting a
barrier to, diagnosis or treatment of the patient's problem(s)
addressed in the CHI initiating visit are 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. Payment for office visits may not
reflect all the services and resources involved with CHI as described
in the HCPCS code below, for example, coordination of care,
facilitation of access to services, communication between settings.
GXXX1 Community health integration services performed by certified
or trained auxiliary personnel, including a community health worker,
under the direction of a physician or other practitioner; 60 minutes
per calendar month, in the following activities to address social
determinants of health (SDOH) need(s) that are significantly limiting
ability to diagnose or treat problem(s) addressed in an initiating E/M
visit:
Person-centered assessment, performed to better understand
the individualized context of the intersection between the SDOH need(s)
and the problem(s) addressed in the initiating E/M visit.
++ Conducting a person-centered assessment to understand patient's
life story, strengths, needs, goals, preferences and desired outcomes,
including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal-setting and establishing an
action plan.
++ Providing tailored support to the patient as needed to
accomplish the practitioner's treatment plan.
Practitioner, Home-, and Community-Based Care
Coordination.
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if
applicable).
++ Communication with practitioners, home- and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) to address the
SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, and preferences, in the context of the SDOH
need(s), and educating the patient on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services addressing the SDOH need(s), in ways that are
more likely to promote personalized and effective diagnosis or
treatment.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care and helping
secure appointments with them.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the problem(s) addressed in the initiating
visit, the SDOH need(s), and adjust daily routines to better meet
diagnosis and treatment goals.
Leveraging lived experience when applicable to provide
support, mentorship, or inspiration to meet treatment goals.
GXXX2--Community health integration services, each additional 30
minutes per calendar month (List separately in addition to GXXX1).
(3) Payment for Principal Illness Navigation (PIN) Services in RHCs and
FQHCs
Consistent with the discussion in section II.E.4.(27).e. of this
proposed rule, there are two new HCPCS codes proposed to describe PIN
services. That is when certified or trained auxiliary personnel under
the direction of a billing practitioner, which may include a patient
navigator or certified peer specialist, are involved in the patient's
health care navigation as part of the treatment plan for a serious,
high-risk disease expected to last at least 3 months, that places the
patient at significant risk of hospitalization or
[[Page 52403]]
nursing home placement, acute exacerbation/decompensation, functional
decline, or death. The requirements for the proposed PIN services are
also similar to the requirements for the general care management
services furnished by RHCs and FQHCs.
As such, we believe the resources required to provide the level of
care coordination needed for individualized help to the patient (and
caregiver, if applicable) to identify appropriate practitioners and
providers for care needs and support, and access necessary care timely
are 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.
Payment for office visits may not reflect all the services and
resources involved with PIN as described in the HCPCS code below.
GXXX3 Principal Illness Navigation services by certified or trained
auxiliary personnel under the direction of a physician or other
practitioner, including a patient navigator or certified peer
specialist; 60 minutes per calendar month, in the following activities:
Person-centered assessment, performed to better understand
the individual context of the serious, high-risk condition.
++ Conducting a person-centered assessment to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal setting and establishing an
action plan.
++ Providing tailored support as needed to accomplish the
practitioner's treatment plan.
Identifying or referring patient (and caregiver or family,
if applicable) to appropriate supportive services.
Practitioner, Home, and Community-Based Care Coordination.
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; home- and community-based
service providers; and caregiver (if applicable).
++ Communication with practitioners, home-, and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) as needed to
address SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, preferences, and SDOH need(s), and educating
the patient (and caregiver if applicable) on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services (as needed), in ways that are more likely to
promote personalized and effective treatment of their condition.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care, and helping
secure appointments with them.
++ Providing the patient with information/resources to consider
participation in clinical trials or clinical research as applicable.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the condition, SDOH need(s), and adjust
daily routines to better meet diagnosis and treatment goals.
Leverage knowledge of the serious, high-risk condition
and/or lived experience when applicable to provide support, mentorship,
or inspiration to meet treatment goals.
GXXX4--Principal Illness Navigation services, additional 30 minutes
per calendar month (List separately in addition to GXXX3).
Allowing a separate payment for CHI and PIN services in RHCs and
FQHCs is intended to reflect the additional time and resources
necessary for the unique components of care coordination services. 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 PIN services in the general care management HCPCS code G0511
when these services are provided by RHCs and FQHCs.
We note that under the proposals to expand the billable services
under HCPCS code G0511 to include CHI and PIN, each of these services
must be medically reasonable and necessary, meet all requirements, and
not be duplicative of services paid to RHCs and FQHCs under the general
care management code for an episode of care in a given calendar month.
We expect that our proposal to add the new codes for CHI and PIN to the
general care management code would also support the CMS pillars \120\
for equity, inclusion, and access to care for the Medicare population,
and improve patient outcomes, including for underserved and low-income
populations where there is a disparity in access to quality care.
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\120\ CMS Strategic Plan. https://www.cms.gov/cms-strategic-plan.
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d. Proposed Revision to the Calculation of the Payment Amount for the
General Care Management HCPCS Code G0511
Currently, HCPCS code G0511 is based on the PFS national average
non-facility payment rate for each of the services identified as
billable general care management services. Then we add each payment
rate and divide by the total number of codes to arrive at the payment
amount for HCPCS code G0511. This payment amount is a flat rate that is
not subsequently adjusted for locality. As we noted in the CY 2023 PFS
final rule (87 FR 69735), when determining which services are billable
under HCPCS code G0511, we do not include the add-on HCPCS codes
payable under the PFS because RHCs and FQHCs do not pay their
practitioners based on additional minutes spent by practitioners.
Instead we generally include the base codes. In the CY 2023 PFS final
rule (87 FR 69736), we mentioned that we may consider other approaches
for calculating the payment rate for HCPCS code G0511 as the number of
services included in the general care management code is growing each
year and provided examples. We thought to consider in the future
valuing 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 welcomed comments on
potential methodologies, but noted we did not receive any comments.
As we discuss above, 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
[[Page 52404]]
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 in-person
encounters may not reflect all the services and resources required to
furnish comprehensive, coordinated care management. Through the last
few payment rules, we have expanded the general care management
services billable using the HCPCS code G0511 to be consistent with the
policies implemented under the PFS.
In section III.B.4.b and c. of this proposed rule, we are proposing
to expand the billable services under HCPCS code G0511 to include RPM,
RTM, CHI, and PIN. If we continue to calculate HCPCS code G0511 using
our current approach, we believe that the value may no longer be
appropriate payment for those services since we are simply dividing by
the number of codes that comprise HCPCS code G0511 and as that number
of services with lower payment rates increases, the value diminishes.
Therefore, we are proposing to revise our method for calculating HCPCS
code G0511 so that payment for general care management is more
appropriate. Below, we compare our current method to the proposed
revised approach.
Based on the current methodology for HCPCS code G0511 as shown in
Table 22, general care management services are paid at the average of
the national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, 99491, 99424 and 99426.
[GRAPHIC] [TIFF OMITTED] TP07AU23.032
As shown in Table 23, when we include RPM and RTM services in the
national non-facility average as discussed above, the payment rate for
HCPCS code G0511 is reduced to $64.13 based on the national non-
facility PFS payment rates for CY 2023.
[GRAPHIC] [TIFF OMITTED] TP07AU23.033
[[Page 52405]]
As demonstrated by comparing Table 22 to Table 23, using the
current method of calculating the average of the non-facility rates but
adding in RPM and RTM services base codes would result in a lower
payment amount for HCPCS code G0511 compared to the current payment
amount. We believe that while the policy may address providing a
payment for furnishing non-face-to-face services, the magnitude of the
value may not appropriately account for the costs. Therefore, we
considered and are proposing a revised methodology for the calculation
by looking at the actual utilization of the services. That is, we are
proposing to use a weighted average of the services that comprise HCPCS
code G0511. In order to use a weighted average, there needs to be data
on the utilization of the services. We do not have data on utilization
of the services that comprise HCPCS code G0511 for RHCs and FQHCs since
HCPCS code G0511 accounts for a variety of services. Therefore, we
would use the most recently available utilization data from the
services paid under the PFS, that is, in the physician office setting.
We believe that the physician office setting provides an appropriate
proxy for utilization of these services in the absence of actual data
because this setting most closely aligns with the types of services
furnished in RHCs and FQHCs since they typically furnish primary care.
In order to analyze utilization for services paid under the PFS and
to ensure we accounted for payments accurately, we would use CY 2021
claims data to look at utilization of the base code for the service and
any applicable add-on codes used in the same month as well as any base
codes reported alone in a month for all of the services encompassing
general care management, that is the array of services that make up
HCPCS code G0511. We believe we need to account for the payment
associated with the base code along with an applicable add-on code in
our calculation as this demonstrates a complete encounter. Until actual
utilization becomes available, RHCs and FQHCs that furnish CPM, GBHI,
CHI and PIN services would report HCPCS code G0511 when those services
are furnished; however, they would not be included in the weighted
average at this time. Once more data is available, we will revisit the
valuation of HCPCS code G0511 to include CPM, GBHI, CHI, and PIN as
necessary.
Table 24 shows the payment amount using this calculation. The
national non-facility payment rate associated with each code that
comprises HCPCS code G0511 can be found in Addendum B of this proposed
rule. We note that the revised methodology does reduce the payment rate
for HCPCS code G0511 from its current rate for CY 2023, although not
significantly.
[GRAPHIC] [TIFF OMITTED] TP07AU23.034
Therefore, we propose to take the weighted average of the base code
and add-on code pairs, in addition to the individual base codes for all
of the services that comprise HCPCS code G0511 by using the CY 2021 PFS
utilization to calculate the payment rate for the general care
management services furnished in RHCs and FQHCs on or after January 1,
2024. The number on the right side of Table 24 is a weighted average
which grants more relative weight to the codes in proportion to their
utilization in 2021 claims data. To calculate the weighted average, we
multiple the non-facility payment rate times the non-facility
utilization for each code, sum this total, then divide by the summed
non-facility utilization for the codes included in the average. In an
effort to be consistent with practitioners billing under the PFS and to
account for the additional time spent in care coordination, we
determined that this approach was more accurate representation of the
payment. We would also update HCPCS code
[[Page 52406]]
G0511 annually based on current data available in the PFS.
We propose revisions at Sec. 405.2464(c) to reflect the revised
methodology for calculating the payment amount for general care
management services beginning January 1, 2024 which would be based on a
weighted average of the services that comprise HCPCS code G0511 using
the most recently available PFS utilization data. We welcome comments
on this proposed methodology.
e. Chronic Care Management Services and Virtual Communication Services
Requirement for Obtaining Beneficiary Consent
(1) Chronic Care Management Services
RHCs and FQHCs have been authorized to bill for Chronic Care
Management (CCM) services since January 1, 2016. The RHC and FQHC
requirements for billing CCM services have generally followed the
requirements for practitioners billing under the PFS, with some
adaptations based on the RHC and FQHC payment methodologies. In fact,
in the CY 2017 PFS final rule (81 FR 80256-80257) to assure that CCM
requirements for RHCs and FQHCs were not more burdensome than those for
practitioners billing under the PFS, we finalized revisions to the
requirements for CCM services furnished by RHCs and FQHCs similar to
revisions to the requirements for CCM services finalized under the PFS
(81 FR 80243 through 80251). Information regarding CCM services is
available on the CMS Care Management Site.\121\
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\121\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
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In the CY 2022 PFS proposed rule (86 FR 39175), we solicited public
comment on the standard practice used by practitioners to obtain
beneficiary consent for CCM services. We stated that we have received
questions from interested parties regarding the consent requirements
for CCM services. We explained that these questions may have arisen
because of the many flexibilities allowed in response to the PHE for
COVID-19. In particular, during the PHE for COVID-19, we allowed
interested parties to obtain beneficiary consent for certain services
under general supervision (85 FR 19230, April 6, 2020). We noted that
before the PHE for COVID-19, we required that beneficiary consent be
obtained either by or under the direct supervision of the primary care
practitioner. We noted that this requirement was consistent with the
conditions of payment for this service under the PFS. We stated that as
we consider what policies implemented during the PHE for COVID-19
should remain in effect beyond the PHE, we were interested in
understanding how billing practitioners furnishing CCM at different
service sites (for example, physician office settings, RHCs, FQHCs)
have been obtaining beneficiary consent over the past year and how
different levels of supervision impact this activity. We welcomed
public comment on the issue, specifically on what levels of supervision
are necessary to obtain beneficiary consent when furnishing CCM
services and said that we will consider such comments in future
rulemaking.
We received 52 comments regarding the standard practice used by
practitioners to obtain beneficiary consent for CCM services from a
variety of interested parties. For example, we received comments from
hospitals, physicians, RHCs, FQHCs, software companies, care management
companies.
All comments received expressed support for obtaining consent for
care management under general supervision. Many commenters requested
that CMS make this supervision level permanent after the expiration of
the COVID-19 PHE. They stated that their practice would be unable to
maintain its current CCM program without the assistance of a third-
party partner. CCM vendors have trained enrollment staff which are
vital to obtaining proper consent from their patients. Their staff are
able to educate and inform our patients regarding the CCM program as
they have been specifically trained to explain the benefits of CCM.
They explained that vendors have the capacity to call patients and
receive calls when it is convenient for the patient. They expressed
concern that they could not replicate these services using only their
employed staff and that allowing a third party to obtain consent from
their patients for CCM under general supervision is vital to their CCM
program.
One commenter explained that CCM programs are a challenging and
heavy lift for all providers, regardless of size and available
resources, and the providers that offer CCM services to their patient
populations do so because they recognize and value CCM's capacity to
improve patient outcomes. The commenter stated that they have seen the
administrative burdens of successful and compliant CCM programs fall
hardest upon RHCs and FQHCs and noted if CMS were to establish general
supervision as the guideline for beneficiary consent, this would ease
those burdens. The commenter noted that CCM codes describing clinical
staff activities are assigned general supervision and if CMS were to
carve out beneficiary consent from the rest of CCM and impose a
heightened administrative burden by imposing direct supervisions, RHCs
and FQHCs that service the most vulnerable and underserved patient
populations, would encounter challenges that could have negative
consequence for their existing CCM programs.
Several commenters stated that they believed an efficient Medicare
system requires CCM services to leverage the potential of non-face-to-
face modalities, such as EHR systems, patient portals, texting/SMS
services, chatbot technologies, interactive mobile medical apps, and
direct patient calls. The commenters explained that while they
understood CMS' concerns, it is long past due that CMS do away with the
requirement for a provider to directly obtain consent. Virtual
modalities more than adequately enable a patient to gain an
understanding of what they are consenting to at the same level or
better than an in-person consent process, making the direct consent
requirement outdated and overburdensome. The commenters strongly
encouraged CMS to permanently allow providers to obtain beneficiary
consent under general supervision.
We note that, for the purposes of CCM services furnished under the
PFS, we require that practitioners obtain informed consent before
furnishing a beneficiary with CCM services. During the COVID-19 PHE,
CMS clarified its existing policy about how practitioners could obtain
beneficiary consent. We explained that practitioners could obtain
beneficiary consent either at the required initiating visit for CCM
(many of which Medicare allows to be furnished virtually), or at the
same time that the CCM service is initiated by auxiliary staff who work
to furnish the CCM services. When the beneficiary's consent is
separately obtained, it may be obtained under the general supervision
of the billing practitioner and may be verbal as long as it is
documented in the medical record and includes notification of the
required information. Now that the COVID-19 PHE has ended, we expect
that practitioners will continue to appropriately obtain informed
consent before they start furnishing CCM services to a beneficiary.
For purposes of CCM services furnished by RHCs and FQHCs, we are
proposing to clarify the policy of how RHC and FQHC practitioners can
obtain beneficiary consent. That is, while we have stated our intent
since allowing
[[Page 52407]]
RHCs and FQHCs to furnish CCM services, is to assure that CCM
requirements for RHCs and FQHCs were not more burdensome than those for
practitioners billing under the PFS, we believe our guidance could be
clearer. After a review of commenters' concerns, we propose to clarify
when, how and by whom beneficiary consent for CCM services can be
obtained. Specifically, informed consent to receive CCM services must
be obtained prior to the start of CCM services. Consent does not have
to be obtained at the required initiating visit for CCM that must be
performed by the RHC or FQHC practitioner, but it can be obtained at
that time. Since the RHC or FQHC practitioner discusses CCM with the
beneficiary during the initiating visit, if consent is separately
obtained, it may be obtained under general supervision, and can be
verbal as long as it is documented in the medical record and includes
notification of the required information. That is, beneficiary consent
can be obtained at the same time that the CCM service is initiated by
auxiliary staff who work to furnish the CCM services. Further, there
need not be an employment relationship between the person obtaining the
consent and the RHC or FQHC practitioner. That is, the clinical staff
obtaining the verbal or written consent can be under contract with the
RHC or FQHC.
It is important to reiterate that the importance of obtaining
advance beneficiary consent to receive CCM services is to ensure the
beneficiary is informed, educated about CCM services, and is aware of
applicable cost sharing. In addition, querying the beneficiary about
whether another practitioner is already providing CCM services helps to
reduce the potential for duplicate provision or billing of the
services. We require the beneficiary be informed on the availability of
CCM services; that only one practitioner can furnish and be paid for
these services during a calendar month; and of the right to stop the
CCM services at any time (effective at the end of the calendar month).
Again, we believe that it is important that the beneficiary grant the
consent at the onset of CCM services to have the opportunity to
understand what services are being billed and note it is important for
CMS to take a balanced approach between administrative burden and
potential program integrity concerns. That being said, we are
clarifying that we understand that the sequencing and mode of consent
can take various forms since the beneficiary is given notice and
verbally consents.
(2) Virtual Communication Services
In the April 6, 2020 IFC (85 FR 19253 through 19254), we
implemented on an interim final basis the expansion of services that
can be included in the payment for virtual communications in RHCs and
FQHCs. We explained that in order to minimize risks associated with
exposure to COVID-19, and to provide the best care possible during the
PHE for the COVID-19 pandemic, we believed that RHCs and FQHC
practitioners, like many other health care providers, should explore
the use of interactive communications technology in the place of
services that would have otherwise been furnished in person and
reported and paid under the established methodologies.
In order to ensure these services would be available to
beneficiaries who otherwise would not have access to clinically
appropriate in-person treatment, we placed in our interim final rule a
provision stating that all virtual communication services billed by
HCPCS code G0071 would be available to new patients not seen by the RHC
or FQHC within the previous months and modified requirements regarding
when patient consent was required for these services, in order to
promote timely provision of care. Specifically, we allowed consent to
be obtained when the services were furnished instead of prior to the
service being furnished and before the services were billed. Consent
could also be acquired by staff under the general supervision of the
RHC or FQHC practitioner for the virtual communication codes during the
COVID-19 PHE.
We received several comments on these policies and subsequently
finalized the provisions of the April 6, 2020 IFC without modification.
However, we stated that when the COVID-19 PHE ended, beneficiary
consent for these services would revert back to direct supervision and
clarified this in the CY 2023 PFS final rule with comment period (87 FR
70127 through 70128).
Similar to the discussion above regarding obtaining consent for
CCM, we believe the same philosophy applies to consent for virtual
communications. In an effort to continue promoting access to timely,
quality care for Medicare beneficiaries and to align with the PFS, we
propose to clarify that the consent from the beneficiary to receive
virtual communication services can be documented by auxiliary staff
under general supervision, as well as by the billing practitioner.
While we continue to believe that beneficiary consent is necessary so
that the beneficiary is notified of cost sharing when receiving these
services, we do not believe that the timing or manner in which
beneficiary consent is acquired should interfere with the provision of
one of these services.
C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs) Conditions for Certification or Coverage (CfCs)
1. Summary of the Provisions
Section III.C. of this proposed rule outlines changes to the RHC
and FQHC CfCs as required in section 4121 of division FF of the
Consolidated Appropriations Act (Pub. L. 117-328, December 29, 2022)
(CAA 2023). Specifically, we must implement provisions that would
modify the existing RHC and FQHC CfCs at Sec. 491.8(a)(3) to include
marriage and family therapists (MFTs) and mental health counselors
(MHCs) as part of the collaborative team approach to provide services
under Medicare Part B. We also propose to include definitions of other
healthcare professionals who are already eligible to provide services
at RHCs and FQHCs.
2. Proposed Changes to the RHC Conditions for Certification and FQHC
Conditions for Coverage
a. Definitions (Sec. 491.2)
According to House Report No. 95-548 (Vol. I), the Rural Health
Clinic Services Act of 1977 was established to address an inadequate
supply of physicians available to serve Medicare and Medicaid
beneficiaries in rural and shortage areas. The establishment of RHCs
addressed this problem by allowing physicians and certain other
practitioners in qualifying clinics in rural, medically underserved
communities to furnish outpatient services to Medicare and Medicaid
beneficiaries. The Rural Health Clinic Services Act of 1977 (Pub. L.
95-210, enacted December 13, 1977) enacted section 1861(aa) of the Act
to extend Medicare entitlement and payment for primary care services
furnished at an RHC by physicians and certain other practitioners and
for services and supplies incidental to their services. Other
practitioners included nurse practitioners (NPs) and physician
assistants (PAs). Subsequent legislation extended the definition of
covered RHC services to include the services of clinical psychologists
(CPs), clinical social workers (CSWs), and certified nurse midwives
(CNMs).
Section 4161(a)(2) of the Omnibus Budget Reconciliation Act (OBRA)
of
[[Page 52408]]
1990 added the definition of ``FQHC services'' to section 1861(aa) of
the Act as ``services described in section 1861(aa)(l)(A) through (C)
of the Act,'' which, are RHC services generally provided by physicians,
NPs, PAs, CPs, CSWs, and CNMs. FQHCs were established to provide
primary care and preventive services in underserved rural or urban
areas designated as either a shortage area or an area with a medically
underserved population, regardless of the patient's ability to pay.
Section 4121 of division FF of the CAA, 2023 amended section 1861
of the Act to add a new subsection (lll) and corresponding revisions to
subsection (s)(2) of such section that establish a new benefit category
for MFT services and MHC services. Section 4121(b)(1) of the CAA, 2023
amended section 1861(aa)(1)(B) of the Act to add MFT and MHC services
as services that can be furnished by RHCs, which is incorporated into
FQHC services through section 1861(aa)(3) of the Act.
Section 1861 of the Act authorizes the Secretary to establish the
requirements that an RHC and FQHC must meet to participate in the
Medicare Program. These requirements are codified in regulations at 42
CFR part 491. For an RHC and FQHC to receive Medicare payment for
services, it must meet the requirements at part 491, which are intended
to promote the health and safety of care provided to RHC and FQHC
patients.
In order to reflect the statute, we propose adding conforming
changes to the CfCs to include MFT and MHC services as proposed in
section III.B. of this proposed rule to indicate that RHC and FQHCs can
offer these services under their Medicare certification. At Sec.
491.2, Definitions, we propose adding a definition of MFTs and MHCs by
cross-referencing the definitions proposed at Sec. Sec. 410.53 and
410.54.
Previously enacted laws extended the definition of covered RHC
services to include the services of CPs (section 4077(a) of OBRA '87),
CNMs (section 6213(a) of OBRA '89), and CSWs (section 6213(b) of OBRA
'89). Note that the CfCs do not currently define CPs, CSWs, or CNMs
whose services are covered when furnished in an RHC and FQHC, so we
also propose to add these professionals to Sec. 491.2, Definitions,
and cross-reference the definitions established in the payment
requirements at Sec. 410.77(a), Sec. 410.71(d), Sec. 410.73(a)
respectively.
We propose revising the existing ``nurse practitioner'' (NP)
definition at Sec. 491.2. The current definition sets forth education
and certification requirements. The current requirement at Sec.
491.2(1) states that an NP must be certified as a primary care NP by
the American Nurses Association and the National Board of Pediatric
Nurse Practitioners and Associates. The National Board of Pediatric
Nurse Practitioners and Associates has changed the organization's name
since this requirement was first implemented. The American Association
of Nurse Practitioners (AANP), examined NP graduates from 2019 to 2020
by certification exam and discovered that 88 percent of licensed NPs in
the U.S. are educated and prepared in primary care.\122\ The AANP
considers primary care providers with a population focus on family,
adult gerontology primary care, psych mental health, pediatric primary
care, and women's health. We believe that removing specific certifying
boards from Sec. 491.2(1) will ensure that the requirements reflect
the breadth of currently available certifications. For awareness,
examples of certifying boards that focus on an area the AANP considers
primary care are the American Academy of Nurse Practitioners
Certification Board (AANPCB), American Nurses Credentialing Center
(ANCC) Certification Program, Pediatric Nursing Certification Board
(PNCB), and the National Certification Corporation (NCC).\123\ We
propose revising the definition of NP at Sec. 491.2(1) to require that
an NP, be certified as a primary care nurse practitioner at the time of
provision of services by a recognized national certifying body that has
established standards for nurse practitioners and possess a master's
degree in nursing or a Doctor of Nursing Practice (DNP) doctoral
degree. We have proposed adding the education requirement to clause (1)
of the definition because the American Nurses Association has stated
that for someone to become an NP, one must be a registered nurse or
have a bachelor of science in nursing (BSN), complete an NP-focused
master's or doctoral nursing program, and pass the National NP
Certification Board Exam.\124\ We propose to retain paragraphs (2) and
(3) of the current NP definition, which provides alternative
certification and education requirements an NP can meet to furnish
services in an RHC or FQHC if (1) is not met.
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\122\ https://www.aanp.org/advocacy/advocacy-resource/position-
statements/nurse-practitioners-in-primary-
care#:~:text=Millions%20of%20Americans%20choose%20a,of%20all%20ages%2
0and%20backgrounds.
\123\ https://www.aanp.org/student-resources/np-certification.
\124\ American Association of Nurse Practitioners (2020). The
Path to Becoming a Nurse Practitioner (NP). https://www.aanp.org/
news-feed/explore-the-variety-of-career-paths-for-nurse-
practitioners#:~:text=To%20become%20an%20NP%2C%20one,national%20NP%20
board%20certification%20exam.
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We are soliciting comments regarding the current definition of NPs
at Sec. 491.2(1). Specifically, we are interested in feedback on
whether the definition of NPs should specify that an NP's certification
be in the area of primary care, or whether this distinction should be
removed. This would allow all NPs who are certified by a national
certifying body and meet other applicable requirements to furnish
services in an RHC or FQHC. We recognize that NPs are one of the
fastest-growing provider groups to provide primary care, and the number
of Medicare beneficiaries who receive primary care services from NPs is
increasing.125 126 According to the March 2023 Medicare
Payment Policy report, a larger percentage of Medicare beneficiaries
and privately insured persons living in rural or low-income areas have
revealed that they rely on NPs or PAs for most, if not all, of their
healthcare needs. This indicates that NPs and PAs play a crucial role
in ensuring that underserved populations have access to quality
healthcare services, despite the challenges of living in areas with
limited healthcare professionals and resources. The latest report from
AANP indicates that a significant proportion of NP graduates are
currently certified in primary care; however, during the 2019-2020
academic year, approximately 12.9 percent or 45,795 NP graduates
received certification in non-primary care specialties, including Adult
Acute Care, Neonatal, and Pediatric Acute Care.\122\ The precise number
of non-primary care-certified NPs who would furnish their services at
RHCs and FQHCs if the primary care certification requirement was
removed remains uncertain at this time.
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\125\ https://www.bls.gov/careeroutlook/2020/article/careers-for-nurses-opportunities-and-options.htm.
\126\ https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_Ch4_v2_SEC.pdf.
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With the increasing number of NPs and their crucial role in
providing quality care, the Consensus Model was developed to tackle the
issue of inconsistent standards in education, regulation, and practice
for advanced practice RNs (APRNs) by providing guidance for states to
adopt uniformity in the regulation of APRN roles, licensure,
accreditation, certification and education. The aim of the Consensus
Model is to promote patient safety while providing greater access to
[[Page 52409]]
care by standardizing education, certification, accreditation and
licensure requirements for APRNs, including NPs.\127\ In order to
practice in specialized nursing roles, individuals must possess
specialized knowledge and skills. Therefore, the Consensus Model
mandates that Advanced Practice Registered Nurses (APRNs) have
congruent education, certification, and licensure in terms of
population foci. NPs are required to select between two population foci
tracks: adult-gerontology and pediatric foci. These foci are further
distinguished as either primary care or acute care. Although the focus
of practice centers around the patient's needs rather than the setting,
NPs possess comprehensive educational training and practical experience
to cater to patients in primary or acute care.\128\ Primary care NPs
are trained to offer comprehensive, continuous care for patients with
most health needs, including chronic conditions. In contrast, acute
care NPs are equipped to provide restorative care, which involves
addressing rapidly changing clinical conditions in patients with
unstable, chronic, and complex acute and critical conditions.
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\127\ https://www.ncbi.nlm.nih.gov/books/NBK209870/.
\128\ https://www.aacn.org/~/media/aacn-website/certification/
advanced-practice/adultgeroacnpcompetencies.pdf.
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The NP scope of practice allows them to provide care to patients
based on the acuity of the patient's needs, rather than the setting in
which the services are administered. This implies that an acute care NP
can offer their services to patients within their scope of practice in
RHCs and FQHCs, and other settings. NPs increasingly provide services
to Medicare beneficiaries; however, the scope of benefits between
primary care and acute care may be different. We seek comments on
whether the specification of requiring NPs to be certified in primary
care should remain in the definition at Sec. 491.2.
b. Staffing and Staff Responsibilities (Sec. 491.8)
Section 1861(aa) of the Act extends Medicare and Medicaid
entitlement and payment for primary and emergency care services
furnished at an RHC by physicians and other practitioners and for
services and supplies incidental to their services. Other practitioners
include NPs, PAs, CPs, CSWs, and CNMs. Section 4121(b)(1) of the CAA,
2023, Coverage of Certain Mental Health Services Provided in Certain
Settings Rural Health Clinics and Federally Qualified Health Centers
amends section 1861(aa)(1)(B) of the Act by including MFT and MHCs to
the list of other practitioners whose services, when provided in RHCs
and FQHCs, are entitled to payment under the Medicare program. To
implement these changes, we propose modifying our CfCs to include MFT
and MHCs as recognized staff for RHC and FQHCs.
The current requirements at Sec. 491.8, Staffing and staff
responsibilities, establish staffing requirements for RHC and FQHCs,
details of physician responsibilities, PA and NP responsibilities, and
COVID-19 vaccination requirements for staff. We propose revising the
requirements at Sec. 491.8, Staffing and staff responsibilities.
Currently, at Sec. 491.8(a)(3), the PA, NP, CNM, CSW, or CP may be the
owner, employee, or furnish services under contract with the clinic
(RHC) or center (FQHC). In the case of a clinic, at least one PA or NP
must be an employee of the clinic. At Sec. 491.8(a)(3), we propose to
add MFT and MHC to the list, allowing them to be the owner, employee,
or furnish services under contract to the clinic or center.
Additionally, Sec. 491.8(a)(6) requires that a physician, PA, NP, CNM,
CSW, or CP is available to furnish patient care services at all times
the clinic or center operates. Furthermore, for RHCs, an NP, PA, or CNM
is available to furnish patient care services at least 50 percent of
the time the RHC operates. We propose adding MFTs and MHCs to the list
of other practitioners who can provide services when the clinic or
center is open and operating. We are also proposing to update Sec.
491.8(a)(6) to include MFTs and MHCs to the list of other practitioners
who are eligible to furnish services and who can provide services,
within the scope of practice, when the clinic or center is open and
operating.
Section 1861(aa)(2) and (4) of the Act require that RHC and FQHC
staff include one or more physicians, and RHCs are also required to
employ at least one PA or NP. There are no requirements for an RHC or
FQHC to employ a CNM, CSW, CP, MHC, or MFT; however, we expect clinics
and centers to ensure that the needs of the patient population they
serve are met. We acknowledge that there are similarities and
differences between CSWs, MHCs, and MFTs, ranging from offered services
to experience to scope of practice. CSWs, MHCs, and MFTs have similar
roles and responsibilities as they relate to counseling and can assist
patients with the challenges they are facing; however, MHCs and MFTs
may have a larger emphasis on human development and psychological
approaches, whereas CSWs often focus on a person's overall social and
socioeconomic circumstance. Some other services social workers can
provide are psychosocial assessments, identifying and providing
community resources to patients, and assisting with communicating with
other members of their healthcare team. As rural areas are increasingly
diverse, have significant strengths and unique challenges, and are
essential in providing care to residents of medically underserved
communities, RHCs and FQHCs play a key role in identifying the needs of
their patients and employing mental health professionals. In November
2022, we published a framework for advancing health care in rural,
tribal, and geographically isolated communities.\129\ Priorities
related to rural health included in the framework are advancing health
equity by addressing health disparities, expanding access to care, and
engaging with partners and communities. To reduce health disparities
and achieve positive physical, mental, and behavioral health outcomes,
providers must address access to affordable and quality food,
education, employment, housing, and access to the physical and mental
care they need.\130\ People living in rural areas have less access to
healthcare and social services, higher unemployment rates, and higher
poverty rates than urban areas, which impacts a person's physical and
mental well-being.131 132 133 To meet an individual's
medical, behavioral, and social service needs, it's important to have
high-quality staff to address those issues.\134\ A team of diverse
professionals can address a patient's physical and mental health
through counseling, case management, and provide resources and
information to address social determinants of health.\135\
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\129\ https://www.cms.gov/files/document/cms-geographic-framework.pdf.
\130\ https://www.jstor.org/stable/pdf/26554276.pdf?refreqid=excelsior%3A3437750e2633ee53aa5c0afe8caae6ea&ab_segments=&origin=&initiator=&acceptTC=1.
\131\ https://apps.who.int/iris/bitstream/handle/10665/112828/9789241506809_eng.pdf.
\132\ https://onlinelibrary.wiley.com/doi/10.1111/jmft.12202.
\133\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4102288/.
\134\ https://www.chcs.org/media/INSIDE_ICTs_for_Medicare-Medicaid_Enrollees-012216.pdf.
\135\ https://www.jstor.org/stable/pdf/26554276.pdf?refreqid=excelsior%3A3437750e2633ee53aa5c0afe8caae6ea&ab_segments=&origin=&initiator=&acceptTC=1.
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Individuals living in rural areas face multiple barriers that
prevent people from accessing physical and mental health services,
including but not limited to provider shortages and
[[Page 52410]]
transportation difficulties.\136\ A study from 2015 surveyed mental
health specialists in nonmetropolitan areas and found that rural
counties had less than half as many mental health professionals as
proportional to the population compared to urban areas.\137\ The
shortage of mental health providers in rural areas also puts a strain
on generalist providers to diagnose and care for patients seeking care
for mental health.\138\ In 2017, general practice physicians (including
NPs and PAs) were the predominant source for treating depression in
adults living in rural communities.\139\ Of the same population, less
than 20 percent received treatment from mental health professionals,
and 32 percent received no treatment. If MFTs and MHCs can provide
reimbursable services under the Medicare program, the pool of mental
health professionals who can help address practitioner shortages in
rural communities can expand.
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\136\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1851736/.
\137\ https://aspe.hhs.gov/sites/default/files/2021-07/rural-health-rr.pdf.
\138\ https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1013&context=ruhrc_reports.
\139\ https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1013&context=ruhrc_reports.
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D. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and
Phase-In of Payment Reductions
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)
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 for failure to report applicable information with
respect to the initial data reporting period.\140\
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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 plan payments
under Part C from the denominator of the Medicare revenues threshold
calculation to broaden the types of laboratories qualifying as an
applicable laboratory. 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
original provisions enacted by section 216(a) of PAMA, for the first 3
years after implementation (CY 2018 through CY 2020), the reduction
could not be more than 10 percent per year. For the next 3 years after
implementation (CY 2021 through CY 2023), section 216(a) of PAMA stated
that the reduction could not be more than 15 percent per year. Under
sections 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 were to 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 originally scheduled to take place from January 1,
2020, through March 31, 2020, with the next update to the Medicare
payment rates for those tests based on that reported applicable
information scheduled to take effect on 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
[[Page 52411]]
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.
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.\141\
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3. Previous Statutory Revisions to the Data Reporting Period and Phase-
In of Payment Reductions
Beginning in 2019, Congress passed a series of legislation to
modify the statutory requirements for the data reporting period and
phase-in of payment reductions under the CLFS. First, section 105(a)(1)
of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L.
116-94, December 20, 2019) (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, instead of January 1, 2020, through March 30,
2020. 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 Coronavirus Aid, Relief, and
Economic Security Act, 2020 (CARES Act) (Pub. L. 116-136, March 27,
2020) 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.
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 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 instead of CY 2023. 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 would apply for CYs 2022 through 2024, instead of
CYs 2021 through 2023. In the CY 2021 PFS rulemaking (85 FR 50210
through 50211; 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.
Section 4 of the Protecting Medicare and American Farmers from
Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, 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 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, 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 did 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) would continue to be based on
the data collection period of January 1, 2019, through June 30, 2019,
as defined in Sec. 414.502.
Section 4 of PMAFSCA 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 2025. It further amended 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 amended section
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of
15 percent would apply for CYs 2023 through 2025, instead of CYs 2022
through 2024.
In the CY 2023 PFS rulemaking (87 FR 46068 through 46070; 87 FR
69741 through 69744, 70225), in accordance with section 4 of PMAFSCA,
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, 2023, through March 31,
2023, the data collection period is January 1, 2019, through June 30,
2019. We also revised
[[Page 52412]]
Sec. 414.504(a)(1) to indicate that initially, data reporting begins
January 1, 2017, and is required every 3 years beginning January 1,
2023. In addition, we finalized conforming changes to our requirements
for the phase-in of payment reductions to reflect the PMAFSCA
amendments. Specifically, we finalized revisions to 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.
As a result of the statutory revisions under the FCAA, CARES Act,
and PMAFSCA, there have only been two data collection periods for CDLTs
that are not ADLTs to date. The first data collection period for these
tests occurred from January 1, 2016, through June 30, 2016, and the
second occurred from January 1, 2019, through June 30, 2019. Thus far,
there has been only one data reporting period for these tests, which
took place from January 1, 2017, through March 31, 2017. We have
established CLFS payment rates for these tests using the methodology
established in PAMA only one time, effective January 1, 2018, based on
the applicable information collected by applicable laboratories during
the 2016 data collection period and reported to CMS during the 2017
data reporting period.
Additionally, we have applied the phase-in of payment reductions
for the first 3 years of PAMA implementation, CY 2018 through CY 2020,
whereby reduction of payment rates could not be more than 10 percent
per year as compared to the amount established the prior year. However,
the phase-in of payment reductions set forth in PAMA for years 4
through 6 of PAMA implementation, whereby payment cannot exceed 15
percent per year as compared to the amount established the prior year,
has not yet occurred.
4. Additional Statutory Revisions to the Data Reporting Period and
Phase-In of Payment Reductions
Section 4114 of the Consolidated Appropriations Act of 2023 (CAA,
2023) (Pub. L. 117-328, enacted December 29th, 2022) made further
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 4114(b) of the
CAA, 2023 amended the data reporting requirements in section
1834A(a)(1)(B) of the Act to delay the next data reporting period for
CDLTs that are not ADLTs by one year, so that data reporting would be
required during the period of January 1, 2024, through March 31, 2024,
instead of the data reporting period of January 1, 2023 through March
31, 2023 established under the PMAFSCA. The 3-year data reporting cycle
for CDLTs that are not ADLTs would resume after that data reporting
period. As amended by section 4114(b) of the CAA, 2023, 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, 2023; (ii) reporting is required during the period
beginning January 1, 2024, and ending March 31, 2024; and (iii)
reporting is required every 3 years after the period described in
clause (ii).
Section 4114 of the CAA, 2023 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, 2024, through March 31, 2024) will continue
to be based on the data collection period of January 1, 2019, through
June 30, 2019, as defined in Sec. 414.502.
Section 4114(a) of the CAA, 2023 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 2026. It further amends section
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent
for CY 2023 is 0 percent, meaning that the payment amount determined
for a CDLT for CY 2023 shall not result in any reduction in payment as
compared to the payment amount for that test for CY 2022. Section
4114(a) of the CAA, 2023 further amends section 1834A(b)(3)(B)(iii) of
the Act to state that the applicable percent of 15 percent will apply
for CYs 2024 through 2026.
5. Proposed Conforming Regulatory Changes
In accordance with section 4114 of the CAA, 2023, 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, 2024, through March
31, 2024, 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 2024. 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 4114(a)
of the CAA, 2023. Specifically, we are proposing to revise Sec.
414.507(d) to indicate that for CY 2023, payment may not be reduced by
more than 0.0 percent as compared to the amount established for CY
2022, and for CYs 2024 through 2026, 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 2023 and 2024 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 2025 through CY 2027 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, 2024, through March 31,
2024.
E. Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation Expansion of Supervising Practitioners
Conditions of coverage for pulmonary rehabilitation (PR), cardiac
rehabilitation (CR) and intensive cardiac rehabilitation (ICR) are
codified at 42 CFR 410.47 and 410.49. We are proposing revisions to the
PR and CR/ICR regulations to codify the statutory changes made in
section 51008 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123,
February 9, 2018) (BBA of 2018) which permit other specific
practitioners to supervise the items and services effective January 1,
2024.
1. Statutory Authority
Section 144(a) of the Medicare Improvements for Patients and
Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA) amended
title XVIII to add new section 1861(eee) of the Act to provide coverage
of CR and ICR under Medicare part B, as well as new section 1861(fff)
of the Act to provide coverage of PR under Medicare
[[Page 52413]]
part B. The statute specified certain conditions for coverage of these
services and an effective date of January 1, 2010. Conditions of
coverage for PR, CR and ICR consistent with the statutory provisions of
section 144(a) of the MIPPA were codified in Sec. Sec. 410.47 and
410.49 respectively through the CY 2010 PFS final rule with comment
period (74 FR 61872 through 61886 and 62002 through 62003 (PR) 62004
through 62005 (CR/ICR)). Section 51008 of the BBA of 2018, entitled
``Allowing Physician Assistants, Nurse Practitioners, and Clinical
Nurse Specialists to Supervise Cardiac, Intensive Cardiac and Pulmonary
Rehabilitation Programs,'' amended sections 1861(eee) and (fff) of the
Act, effective January 1, 2024. The amendment directs us to add to the
types of practitioners who may supervise PR, CR and ICR programs to
also include a physician assistant (PA), nurse practitioner (NP), or
clinical nurse specialist (CNS).
2. Background
Under Sec. 410.47(b), Medicare part B covers PR for beneficiaries
with moderate to very severe chronic obstructive pulmonary disease
(COPD) (defined as GOLD classification II, III and IV), when referred
by the physician treating the chronic respiratory disease and allows
additional medical indications to be established through a national
coverage determination (NCD). We have not added additional medical
indications for PR using the NCD process; however, we used notice and
comment rulemaking through the CY 2022 PFS final rule (86 FR 64996) to
establish coverage of PR for beneficiaries who have had confirmed or
suspected COVID-19 and experience persistent symptoms that include
respiratory dysfunction for at least 4 weeks. In the same final rule,
we also updated language to improve consistency and accuracy across PR
and CR/ICR conditions of coverage and removed a PR requirement for
direct physician-patient contact.
Under Sec. 410.49(b), Medicare part B covers CR and ICR for
beneficiaries who have experienced one or more of the following: (1) an
acute myocardial infarction within the preceding 12 months; (2) a
coronary artery bypass surgery; (3) current stable angina pectoris; (4)
heart valve repair or replacement; (5) percutaneous transluminal
coronary angioplasty (PTCA) or coronary stenting; (6) a heart or heart-
lung transplant; (7) stable, chronic heart failure defined as patients
with left ventricular ejection fraction of 35 percent or less and New
York Heart Association (NYHA) class II to IV symptoms despite being on
optimal heart failure therapy for at least 6 weeks, on or after
February 18, 2014, for cardiac rehabilitation and on or after February
9, 2018, for intensive cardiac rehabilitation; or (8) other cardiac
conditions as specified through an NCD. The NCD process may also be
used to specify non-coverage of a cardiac condition for ICR if coverage
is not supported by clinical evidence.
In 2014, we established coverage of CR through the NCD process (NCD
20.10.1, Cardiac Rehabilitation Programs for Chronic Heart Failure
(Pub. 100-03) to beneficiaries with stable, chronic heart failure.
Section 51004 of the BBA of 2018, amended section 1861(eee)(4)(B) of
the Act to expand coverage of ICR to include patients with stable,
chronic heart failure. Section 410.49 was updated to codify this
expansion through the CY 2020 PFS final rule (84 FR 62897 through 62899
and 63188). The CY 2022 PFS final rule (86 FR 64996) updated language
in Sec. 410.49 to improve consistency and accuracy across PR and CR/
ICR conditions of coverage.
3. Proposals for Implementation
Consistent with the amendments made by section 51008 of the BBA of
2018 to section 1861(eee) and (fff) of the Act, we propose additions
and revisions to language in Sec. Sec. 410.47 and 410.49 as described
below.
a. Definitions
We are proposing to add a new term, nonphysician practitioner
(NPP), to Sec. Sec. 410.47(a) and 410.49(a), which would be defined as
a PA, NP, CNS as those terms are defined in section 1861(aa)(5)(A) of
the Act.
We are proposing to amend the term supervising physician at
Sec. Sec. 410.47(a) and 410.49(a) to supervising practitioner and
amend the definition to mean a physician or NPP.
Finally, we are proposing to amend the definition for pulmonary
rehabilitation at Sec. 410.47(a) and the definitions for cardiac
rehabilitation and intensive cardiac rehabilitation (ICR) program at
Sec. 410.49(a) to specify that these are physician- or NPP-supervised
programs.
b. Setting
We are proposing to amend Sec. 410.47(b)(3)(ii)(A) and Sec.
410.49(b)(3)(ii) to specify that all settings must have a physician or
NPP immediately available and accessible for medical consultations and
emergencies at all times when items and services are being furnished
under the programs.
c. Supervising Practitioner Standards
We are proposing to amend language at Sec. Sec. 410.47(d) and
410.49(e) by specifying that these sections include supervising
practitioner standards, rather than just supervising physician
standards. We are also removing the third standard in each section
(Sec. Sec. 410.47(d)(3) and 410.49(e)(3)) because specifying that a
physician or NPP is licensed to practice medicine in the state where a
PR/CR/ICR program is offered, or any corresponding reference to a NPP
being licensed or authorized to practice, is redundant to the
definition for each practitioner type in the Act. Since the physicians
and NPPs that may supervise PR/CR/ICR are defined at Sec. Sec.
410.47(a) and 410.49(a) by cross-reference to the Act, we believe
repeating part of that definition in these sections is unnecessary.
4. Summary
We are proposing additions and revisions that are necessary to
implement the amendments to section 1861(eee) and (fff) of the Act set
forth in section 51008 of the BBA of 2018, which expand the types of
practitioners that may supervise PR, CR and ICR. This includes changes
to the regulatory language in the definitions, settings and supervising
practitioner standards sections under Sec. Sec. 410.47 and 410.49. We
believe these proposed amendments to Sec. Sec. 410.47 and 410.49 would
serve to implement the provisions in the BBA of 2018 regarding the
types of practitioners that may supervise PR, CR and ICR beginning
January 1, 2024. All other provisions of these regulations would remain
unchanged.
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 (SUPPORT) for Patients and Communities
Act (SUPPORT Act) (Pub. L. 115-271, October 24, 2018) established a new
Medicare Part B benefit 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 also
[[Page 52414]]
established in the CY 2020 PFS final rule new codes 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 paragraphs (iii) and (iv) in the definition of ``Opioid
disorder treatment service'' at Sec. 410.67(b) 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 public health
emergency (PHE) for COVID-19 in cases where audio/video communication
technology is not available to the beneficiary, provided all other
applicable requirements are met (86 FR 65342).
More recently, CMS made further modifications and expansions to
covered services for the treatment of OUD by OTPs in the CY 2023 PFS
final rule (87 FR 69768 through 69777). Specifically, we revised our
methodology for pricing the drug component of the methadone weekly
bundle and the add-on code for take-home supplies of methadone by using
the payment amount for methadone for CY 2021 updated by the PPI for
Pharmaceuticals for Human Use (Prescription) to better reflect the
changes in methadone costs for OTPs over time. Additionally, we
finalized a modification to the payment rate for individual therapy in
the non-drug component of the bundled payment for an episode of care to
base the payment rate on the rate for longer therapy sessions that
better account for the greater severity of needs for patients with an
OUD and receiving treatment in the OTP setting. Moreover, for the
purposes of the geographic adjustment, we clarified that services
furnished via OTP mobile units will be treated as if the services were
furnished in the physical location of the OTP 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 Substance
Abuse and Mental Health Services Administration (SAMHSA) and Drug
Enforcement Administration (DEA) guidance. We believe that this policy
enables OTPs to better serve Medicare beneficiaries living in
underserved areas by providing access to many of the same OUD treatment
services offered at the brick and mortar location of the OTP. We are
continuing to monitor utilization of OUD treatment services furnished
by OTPs to ensure that Medicare beneficiaries have appropriate access
to care. For CY 2024, we are proposing several modifications to the
policies governing Medicare coverage and payment for OUD treatment
services furnished by OTPs.
2. Additional Flexibilities for Periodic Assessments Furnished via
Audio-Only Telecommunications
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 paragraphs (iii) and (iv) in the definition of
opioid use disorder treatment service at Sec. 410.67(b) 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 audio
and video communication 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 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. More recently in the
CY 2023 PFS final rule (87 FR 69775 through 69777), we further extended
telecommunication flexibilities for the initiation of treatment with
buprenorphine outside of the COVID-19 PHE. Specifically, we allowed 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 also permitted the use of audio-only communication technology to
initiate treatment with buprenorphine in cases where audio-video
technology is not available to the beneficiary, provided all other
applicable requirements are met.
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 paragraph (vii) in the definition of ``Opioid
use disorder treatment service'' at Sec. 410.67(b) on an interim final
basis to allow periodic assessments to be furnished during the PHE for
COVID-19 via two-way interactive audio-video telecommunication
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 paragraph
(vii) in the definition of ``Opioid use disorder treatment service'' at
Sec. 410.67(b) 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
[[Page 52415]]
requirements are met, on a permanent basis.
Furthermore, in the CY 2023 PFS proposed rule (87 FR 46093), we
sought 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.
In response, several commenters advocated for CMS to continue to allow
periodic assessments to be furnished audio-only when video is not
available after the end of the PHE. Commenters highlighted that making
audio-only flexibilities permanent would further promote equity for
individuals who are economically disadvantaged, live in rural areas,
are racial and ethnic minorities, lack access to reliable broadband or
internet access, or do not possess devices with video capability.
Additionally, a commenter cited a 2020 HHS Issue Brief indicating
higher utilization of audio-only visits for older adults. Specifically,
evidence suggests that the proportion of telephonic audio-only visits
increases with the age of the patient, with ``17 percent of visits
delivered via audio-only interaction for patients 41-60 years of age,
30 percent for patients 61-80 years of age, and 47 percent of visits
for patients over 81.'' \142\ One commenter stated that periodic
assessments are no less complex than intake/initial assessments, and
thus are equally appropriate for audio-video and audio-only care.
Lastly, several commenters expressed support for the use of
telecommunications in circumstances when the provider and patient have
together determined that the patient would individually benefit from
telehealth services and a high quality of care is maintained. They
encouraged CMS to expand flexibilities to furnish substance use
disorder (SUD) services via telecommunications to allow providers and
patients to decide collaboratively the best modality for individualized
care. After considering these comments, CMS determined that it would be
appropriate to allow periodic assessments to be furnished audio-only
when video is not available through the end of CY 2023, to the extent
that it is authorized by SAMHSA and DEA at the time the service is
furnished and, in a manner consistent with all applicable requirements.
We stated our belief that this modification would allow continued
beneficiary access to these services for the duration of CY 2023 in the
event the PHE terminated before the end of 2023 and that it would also
grant additional time for CMS to further consider telecommunication
flexibilities associated with periodic assessments. Accordingly, we
revised the requirements related to the periodic assessment services in
paragraph (vii) in the definition of ``Opioid use disorder treatment
services'' at Sec. 410.67(b) of the regulations to reflect these
changes.
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\142\ HHS ASPE Issue Brief: Medicare beneficiary use of
telehealth visits: Early Data from the Start of the COVID-19
Pandemic (July 27, 2020). https://aspe.hhs.gov/reports/medicare-beneficiary-use-telehealth-visits-early-data-start-covid-19-pandemic.
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Section 4113 of Division FF, Title IV, Subtitle A of the
Consolidated Appropriations Act of 2023 (CAA, 2023) (Pub. L. 117-328,
December 29, 2022) extended the telehealth flexibilities enacted in the
Consolidated Appropriations Act of 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022). Specifically, it amended sections 1834(m), 1834(o),
and 1834(y) of the Act to delay the requirement for an in-person visit
prior to furnishing certain mental health services via
telecommunications technology by physicians and other practitioners,
Rural Health Clinics (RHCs), and Federally Qualified Health Centers
(FQHCs) until dates of service on or after January 1, 2025 if the
COVID-19 PHE ends prior to that date. Additionally, it extended the
flexibilities available during the PHE that allow for certain Medicare
telehealth services defined in section 1834(m)(4)(F)(i) of the Act to
be furnished via an audio-only telecommunications system through
December 31, 2024 if the PHE for COVID-19 ends prior to that date. The
PHE for COVID-19, which was declared under section 319 of the Public
Health Service Act, expired at the end of the day on May 11, 2023, so
the aforementioned flexibilities will be extended through the end of CY
2024 or CY 2025, as applicable.
To better align coverage for periodic assessments furnished by OTPs
with the telehealth flexibilities described in section 4113 of the CAA,
2023, we are proposing to extend the audio-only flexibilities for
periodic assessments furnished by OTPs through the end of CY 2024.
Under this proposal, we would allow periodic assessments to be
furnished audio-only when video is not available to the extent that use
of audio-only communications technology is permitted under the
applicable SAMHSA and DEA requirements at the time the service is
furnished and all other applicable requirements are met. We believe
extending this flexibility would promote continued beneficiary access
to these services following the end of the PHE and for the duration of
CY 2024. During the COVID-19 pandemic, substance use disorder treatment
facilities increased telemedicine offerings by 143 percent, and as of
2021, almost 60 percent of SUD treatment facilities offer
telehealth.\143\ Notably, telephone-based (that is, audio-only) therapy
and recovery support services provided by SUD programs have been found
to be one of the most common modes of telehealth for treatment of
opioid use disorder.\144\ Therefore, extending these audio-only
flexibilities for an additional year may minimize disruptions
associated with the conclusion of the PHE. Additionally, evidence has
shown that Medicare beneficiaries who are older than 65 years-old,
racial/ethnic minorities, dual-enrollees, or living in rural areas, or
who experience low broadband access, low-income, and/or not speaking
English as their primary language, are more likely to be offered and
use audio-only telemedicine services than audio-video services.\145\
Other evidence also suggests that while Tribal populations, including
American Indian and Alaska Natives, have the highest rates of OUD
prevalence among Medicare beneficiaries, one-third of these populations
do not have adequate access to high-speed broadband and continue to
rely on audio-only visits.\146\ Therefore, minimizing disruptions to
care for beneficiaries currently receiving audio-only periodic
assessments may further promote health equity and minimize disparities
in access to care. Lastly, extending these flexibilities another year
will allow CMS time to further consider this issue, including whether
periodic assessments should continue to be furnished using audio-only
communication technology following the end of CY 2024 for patients who
are receiving treatment via buprenorphine, methadone, and/or naltrexone
at OTPs.
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\143\ https://pubmed.ncbi.nlm.nih.gov/34407631/.
\144\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250742/.
\145\ https://pubmed.ncbi.nlm.nih.gov/33471458/; https://www.kff.org/medicare/issue-brief/medicare-and-telehealth-coverage-and-use-during-the-covid-19-pandemic-and-options-for-the-future/;
https://journals.lww.com/lww-medicalcare/Fulltext/2021/11000/Disparities_in_Audio_only_Telemedicine_Use_Among.10.aspx.
\146\ https://docs.fcc.gov/public/attachments/FCC-20-50A1.pdf;
https://www.cms.gov/files/document/aian-telehealthwebinar.pdf;
https://www.sciencedirect.com/science/article/pii/S0749379721000921?via%3Dihub.
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Accordingly, we are proposing to revise paragraph (vii) of the
definition of
[[Page 52416]]
``Opioid treatment services'' at Sec. 410.67(b) of the regulations to
state that through the end of CY 2024, in cases where a beneficiary
does not have access to two-way audio-video communications technology,
periodic assessments can be furnished using audio-only telephone calls
if all other applicable requirements are met.
3. Intensive Outpatient Program (IOP) Services Provided by OTPs
In the CY 2023 PFS proposed rule, we solicited comments on
intensive outpatient mental health treatment (87 FR 45943 through
45944). Commenters emphasized the importance of ensuring access to
intensive outpatient program (IOP) services in OTP settings and that
these services are valuable to those with SUDs (for example, OUD),
including individuals who cannot stabilize at a lower level of care or
require more care than can be provided in office settings and
individuals who have stabilized biomedical conditions and the need for
close monitoring but no longer require a higher level of care for SUD
treatment, such as partial hospitalization or inpatient care.
Please see the CY 2024 Outpatient Prospective Payment System
proposed rule for the full policy discussion and additional details
regarding Medicare payment for IOP services provided by OTPs.
G. Medicare Shared Savings Program
1. Executive Summary and Background
a. Purpose
Eligible groups of providers and suppliers, including physicians,
hospitals, and other healthcare providers, may participate in the
Medicare Shared Savings Program (Shared Savings Program) by forming or
joining an accountable care organization (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 (FFS) 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.
As of January 1, 2023, 10.9 million people with Medicare receive
care from one of the 573,126 health care providers in the 456 ACOs
participating in the Shared Savings Program, the largest value-based
care program in the country.\147\ While the Shared Savings Program
experienced a decrease in the number of ACOs and assigned beneficiaries
for 2023, the policies finalized in the CY 2023 PFS final rule (87 FR
69777 through 69968) are expected to grow participation in the program
for 2024 and beyond, when many of the new policies are set to go into
effect. These policies are expected to drive growth in participation,
particularly in rural and underserved areas, promote equity, advance
alignment across accountable care initiatives, and increase the number
of beneficiaries assigned to ACOs participating in the program by up to
four million over the next several years.\148\ Accordingly, we expect
these recently finalized changes will support CMS in achieving its goal
of having 100 percent of people with Original Medicare in a care
relationship with accountability for quality and total cost of care by
2030.\149\
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\147\ Refer to CMS, Shared Savings Program Fast Facts--As of
January 1, 2023, available at https://www.cms.gov/files/document/2023-shared-savings-program-fast-facts.pdf.
\148\ See CMS Press Release, ``CMS Announces Increase in 2023 in
Organizations and Beneficiaries Benefiting from Coordinated Care in
Accountable Care Relationship'', January 17, 2023, available at
https://www.cms.gov/newsroom/press-releases/cms-announces-increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable.
\149\ Ibid. See also, Seshamani M, Fowler E, Brooks-LaSure C.
Building On The CMS Strategic Vision: Working Together For A
Stronger Medicare. Health Affairs. January 11, 2022. Available at
https://www.healthaffairs.org/do/10.1377/forefront.20220110.198444.
CMS, Innovation Center Strategy Refresh, available at https://innovation.cms.gov/strategic-direction-whitepaper (Innovation Center
Strategic Objective 1: Drive Accountable Care, pages 13-17).
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Section III.G. of this proposed rule addresses changes to the
Shared Savings Program regulations to further advance Medicare's
overall value-based care strategy of growth, alignment, and equity, and
to respond to concerns raised by ACOs and other interested parties. We
propose changes to the quality performance standard and reporting
requirements under the Alternative Payment Model (APM) Performance
Pathway (APP) within the Quality Payment Program (QPP) that would
continue to move ACOs toward digital measurement of quality and align
with the QPP. Further, the policy proposals would add a third step to
the step-wise beneficiary assignment methodology under which we would
use an expanded period of time to identify whether a beneficiary has
met the requirement for having received a primary care service from a
physician who is an ACO professional in the ACO to allow additional
beneficiaries to be eligible for assignment, as well as to propose
related changes to how we identify assignable beneficiaries used in
certain Shared Savings Program calculations. Additionally, we are
proposing updates to the definition of primary care services used for
purposes of beneficiary assignment to remain consistent with billing
and coding guidelines. We also propose refinements to the financial
benchmarking methodology for ACOs in agreement periods beginning on
January 1, 2024, and in subsequent years to cap the risk score growth
in an ACO's regional service area when calculating regional trends used
to update the historical benchmark at the time of financial
reconciliation for symmetry with the cap on ACO risk score growth;
apply the same CMS-HCC risk adjustment methodology applicable to the
calendar year corresponding to the performance year in calculating risk
scores for Medicare FFS beneficiaries for each benchmark year; further
mitigate the impact of the negative regional adjustment on the
benchmark to encourage participation by ACOs caring for medically
complex, high-cost beneficiaries; and specify the circumstances in
which CMS would recalculate the prior savings adjustment for changes in
values used in benchmark calculations due to compliance action taken to
address avoidance of at-risk beneficiaries, or as a result of the
issuance of a revised initial determination of financial performance
for a previous performance year following a reopening of ACO shared
savings and shared losses calculations. We are also proposing to refine
our policies for the newly established advance investment payments
(AIP) and make updates to other programmatic areas including the
program's eligibility requirements and make timely technical changes to
the regulations for clarity and consistency. Lastly, we seek comment on
potential future developments to Shared Savings Program policies,
including with respect to incorporating a new track that would offer a
higher level of risk and potential reward than currently available
under the ENHANCED track, refining the three-way blended benchmark
update factor and the prior savings adjustment, and promoting ACO and
community-based organization (CBO) collaboration.
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
[[Page 52417]]
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 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 that 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
[[Page 52418]]
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. For
summaries of certain policies finalized in prior PFS rules, refer to
the CY 2020 PFS proposed rule (84 FR 40705), the CY 2021 PFS final rule
(85 FR 84717), the CY 2022 PFS final rule (86 FR 65253 and 65254), and
the CY 2023 PFS final rule (87 FR 69779 and 69780). In the CY 2023 PFS
final rule (87 FR 69777 through 69968), we finalized changes to Shared
Savings Program policies, including to: provide advance shared savings
payments in the form of advance investment payments to certain new, low
revenue ACOs that can be used to support their participation in the
Shared Savings Program; provide greater flexibility in the progression
to performance-based risk; establish a health equity adjustment to an
ACO's Merit-based Incentive Payment System (MIPS) quality performance
category score used to determine shared savings and losses to recognize
high quality performance by ACOs serving a higher proportion of
underserved populations; incorporate a sliding scale reflecting an
ACO's quality performance for use in determining shared savings for
ACOs, and revise the approach for determining shared losses for
ENHANCED track ACOs; modify the benchmarking methodology to strengthen
financial incentives for long term participation by reducing the impact
of ACOs' performance and market penetration on their benchmarks, and to
support the business case for ACOs serving high risk and high dually
eligible populations to participate, as well as mitigate bias in
regional expenditure calculations for ACOs electing prospective
assignment; expand opportunities for certain low revenue ACOs
participating in the BASIC track to share in savings; make changes to
policies within other programmatic areas, including the program's
beneficiary assignment methodology, requirements related to marketing
material review and beneficiary notifications, the SNF 3-day rule
waiver application, and data sharing requirements.
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 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.7. of this proposed rule, we
propose modifications to the Shared Savings Program's policies, and
describe comment solicitations. As a general summary, we are proposing
the following changes to Shared Savings Program policies to:
Revise the quality reporting and the quality performance
requirements (section III.G.2. of this proposed rule), including the
following:
++ Allow Shared Savings Program ACOs the option to report quality
measures under the APP on only their Medicare beneficiaries through
Medicare CQMs (section III.G.2.b. of this proposed rule).
++ Update the APP measure set for Shared Savings Program ACOs
(section III.G.2.c. of this proposed rule).
++ Revise the calculation of the health equity adjustment
underserved multiplier (section III.G.2.d. of this proposed rule).
++ Use historical data to establish the 40th percentile MIPS
Quality performance category score used for the quality performance
standard (section III.G.2.e. of this proposed rule).
++ Apply a Shared Savings Program scoring policy for suppressed APP
measures (section III.G.2.f. of this proposed rule).
++ Require Spanish language administration of the CAHPS for MIPS
survey (section III.G.2.g. of this proposed rule).
++ Align CEHRT requirements for Shared Savings Program ACOs with
MIPS (section III.G.2.h. of this proposed rule).
++ Solicit comments on MIPS Value Pathway reporting for specialists
in Shared Savings Program ACOs (section III.G.2.i. of this proposed
rule).
++ Revise the requirement to meet the case minimum requirement for
quality performance standard determinations (section III.G.2.j. of this
proposed rule).
Revise the policies for determining beneficiary assignment
(section III.G.3 of this proposed rule).
++ Modify the step-wise beneficiary assignment methodology and
approach to identifying the assignable beneficiary population (section
III.G.3.a of this proposed rule).
++ Update the definition of primary care services used in
beneficiary assignment at Sec. 425.400(c) (section III.G.3.b of this
proposed rule).
Revise the policies on the Shared Savings Program's
benchmarking methodology (section III.G.4 of this proposed rule).
++ Modify the calculation of the regional update factor used to
update the historical benchmark between benchmark year (BY) 3 and the
performance year by capping an ACO's regional service area risk score
growth through use of an adjustment factor to provide more equitable
treatment for ACOs and for symmetry with the cap on ACO risk score
growth (section III.G.4.b of this proposed rule).
++ Further mitigate the impact of the negative regional adjustment
on the benchmark to encourage participation by ACOs caring for
medically complex, high-cost beneficiaries (section III.G.4.c of this
proposed rule).
++ Specify the circumstances in which CMS would recalculate the
prior savings adjustment for changes in values used in benchmark
calculations due to compliance action taken to address avoidance of at-
risk beneficiaries, or as a result of the issuance of a revised initial
determination of financial performance for a previous performance year
(section III.G.4.d of this proposed rule).
++ Specify use of the CMS-HCC risk adjustment methodology
applicable to the calendar year corresponding to the performance year
in calculating prospective HCC risk scores for Medicare FFS
beneficiaries for the performance year, and for each benchmark year of
the ACO's agreement period (section III.G.4.e. of this proposed rule).
Refine AIP policies, including the following (section
III.G.5 of this proposed rule):
++ Modify AIP eligibility requirements to allow an ACO to elect to
advance to a two-sided model level of the BASIC track's glide path
beginning with the third performance year of the 5-year agreement
period in which the ACO receives advance investment payments.
++ Modify AIP recoupment and recovery polices to forgo immediate
collection of advance investment payments from an ACO that terminates
its participation agreement early in order to early renew under a new
participation agreement to continue their participation in the Shared
Savings Program.
++ Modify termination policies to specify that CMS would
immediately terminate advance investment payments
[[Page 52419]]
to an ACO for future quarters if the ACO voluntarily terminates from
the Shared Savings Program.
++ Modify ACO reporting requirements to require ACOs to submit
spend plan updates to CMS in addition to publicly reporting spend plan
updates.
++ Modify AIP requirements to permit ACOs to seek reconsideration
review of all quarterly payment calculations.
Update Shared Savings Program eligibility requirements,
including the following (section III.G.6 of this proposed rule):
++ Remove the option for ACOs to request an exception to the shared
governance requirement that 75 percent control of an ACO's governing
body must be held by ACO participants.
++ Codify the existing Shared Savings Program operational approach
to specify that CMS determines that an ACO participant TIN participated
in a performance-based risk Medicare ACO initiative if it was included
on a participant list used in financial reconciliation for a
performance year under performance-based risk during the five most
recent performance years.
Make technical changes to references in Shared Savings
Program regulations (section III.G.7 of this proposed rule), including
to update assignment selection references to either Sec. 425.226(a)(1)
or Sec. 425.400(a)(4)(ii) in subpart G of the regulations, correct
typographical errors in the definitions in Sec. 425.20, and update
certain terminology used in Sec. 425.702.
In addition, we are soliciting comment on potential future
developments to Shared Savings Program policies (section III.G.8. of
this proposed rule), including: incorporating a track with higher risk
and potential reward than the ENHANCED track; modifying the amount of
the prior savings adjustment through potential changes to the 50
percent scaling factor used in determining the adjustment, as well as
considerations for potential modifications to the positive regional
adjustment to reduce the possibility of inflating the benchmark;
potential refinements to the ACPT and the three-way blended benchmark
update factor over time to further mitigate potential ratchet effects
within the update factor; and policies to promote ACO and CBO
collaboration.
In combination, the Shared Savings Program proposals are
anticipated to improve the incentive for ACOs to sustainably
participate and earn shared savings in the program. On net, total
program spending is estimated to decrease by $330 million over the 10-
year period 2024 through 2033. These changes are anticipated to support
the goals outlined in the CY 2023 PFS final rule for growing the
program with a particular focus on including underserved beneficiaries.
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: the proposed
modifications to the calculation of regional component of the three-way
blended update factor to cap regional service area risk score growth
for symmetry with the ACO risk score growth cap, as described in
section III.G.4.b of this proposed rule and the refinements to AIP
policies as described in section III.G.5. of this proposed rule.
Further, certain existing policies adopted under the authority of
section 1899(i)(3) of the Act that depend on use of the assigned
population and assignable beneficiary populations would be affected by
the proposed addition of a new third step of the beneficiary assignment
methodology and the proposed revisions to the definition of assignable
beneficiary described in section III.G.3. of this proposed rule,
including the following: the amount of advance investment payments;
factors used in determining shared losses for ACOs under two-sided
models (including calculation of the variable MSR/MLR based on the
ACO's number of assigned beneficiaries, and the applicability of the
extreme and uncontrollable circumstances policy for mitigating shared
losses for two-sided model ACOs); and calculation of the ACPT, regional
and national components of the three-way blended benchmark update
factor. 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 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. Quality Performance Standard and Other Reporting Requirements
a. Background
Section 1899(b)(3)(C) of the Act states that the Secretary shall
establish quality performance standards to assess the quality of care
furnished by ACOs and seek to improve the quality of care furnished by
ACOs over time by specifying higher standards, new measures, or both
for purposes of assessing such quality of care. As we stated in the
November 2011 final rule establishing the Shared Savings Program (76 FR
67872), our principal goal in selecting quality measures for ACOs has
been to identify measures of success in the delivery of high-quality
health care at the individual and population levels. In the November
2011 final rule, we established a quality measure set spanning four
domains: patient experience of care, care coordination/patient safety,
preventative health, and at-risk population (76 FR 67872 through
67891). We have subsequently updated the measures that comprise the
quality performance measure set for the Shared Savings Program through
rulemaking in the CY 2015, 2016, 2017, 2019, and 2023 PFS final rules
(79 FR 67907 through 67921, 80 FR 71263 through 71269, 81 FR 80484
through 80488, 83 FR 59707 through 59715, 87 FR 69860 through 69763,
respectively).
b. Proposal for Shared Savings Program ACOs To Report Medicare CQMs
(1) Background
In the CY 2021 PFS final rule, CMS finalized modifications to the
Shared Savings Program quality reporting requirements and quality
performance standard for performance year 2021 and subsequent
performance years (85 FR 84720). For performance year 2021 and
subsequent years, ACOs are required to report quality data via the
Alternative Payment Model (APM) Performance Pathway (APP). Pursuant to
policies
[[Page 52420]]
finalized under the CY 2022 and CY 2023 PFS (86 FR 65685; 87 FR 69858),
to meet the quality performance standard under the Shared Savings
Program through performance year 2024, ACOs must report the ten CMS Web
Interface measures or the three eCQMs/MIPS CQMs, and the CAHPS for MIPS
survey. In performance year 2025 and subsequent performance years, ACOs
must report the three eCQMs/MIPS CQMs and the CAHPS for MIPS survey.
Since the CY 2021 PFS final rule was issued, interested parties
have continued to express concerns about requiring ACOs to report all
payer/all patient eCQMs/MIPS CQMs via the APP due to the cost of
purchasing and implementing a system wide infrastructure to aggregate
data from multiple ACO participant TINs and varying EHR systems (86 FR
65257). In the CY 2022 PFS, commenters supported our acknowledgement of
the complexity of the transition to all payer/all patient eCQM/MIPS
CQMs (86 FR 65259). Additionally, one commenter questioned how data
completeness standards could be met, given the issues of de-duplication
and patients adding or moving insurance coverage (87 FR 65260). In
public comment to the CY 2023 PFS proposed rule, some commenters
expressed multiple concerns regarding the requirement to report all
payer/all patient eCQMs/MIPS CQMS beginning in performance year 2025,
such as issues related to meeting all payer data requirements, data
completeness requirements, data aggregation and deduplication issues,
and interoperability issues among different EHRs (87 FR 69837). In the
CY 2023 PFS final rule, we explained these comments went beyond the
scope of our proposals. These comment letters included details of the
commenters' concerns. Specifically, some commenters, which included
ACOs, noted the financial burden of aggregating, deduplicating, and
exporting eCQM data across multiple TINs and EHRs. Commenters,
including ACOs, expressed concerns that the requirement to report all
payer measures ties performance to patients that the ACO does not
actively manage, increases the difficulty of meeting data completeness,
and may negatively impact an ACO's performance by including patients
seen by specialists. We also acknowledged that as the transition to
reporting all-payer eCQMs/MIPS CQMs continues, the health equity
adjustment which we finalized in the CY 2023 PFS final rule (87 FR
69842) will support ACOs that may experience challenges with the new
quality reporting requirement and will provide an incentive for ACOs to
serve underserved populations during the transition to reporting eCQMs/
MIPS CQMs. In the CY 2023 PFS final rule, we stated that we are
continuing to monitor the impact of these policies as we gain more
experience with ACOs reporting all payer/all patient eCQMs/MIPS CQMs
and, further, that we are exploring how to address some of the concerns
related to data aggregation and the all payer requirement and may
revisit these and related issues in future rulemaking based on lessons
learned (87 FR 69833).
Consistent with our goal to support ACOs in the transition to all
payer/all patient eCQMs/MIPS CQMs, in the CY 2023 final rule we
extended the eCQM/MIPS CQM reporting incentive through PY 2024 to
provide an incentive to ACOs to report the eCQMs/MIPS CQMs, while
allowing them time to gauge their performance on the eCQMs/MIPS CQMs
before full reporting of these measures is required beginning in
performance year 2025 (87 FR 69835). Building on our goal to provide
technical support to ACOs and to help ACOs build the skills necessary
to aggregate and match patient data to report all payer/all patient
eCQMs/MIPS CQMS, in December 2022, we hosted a webinar to support ACOs
in the transition to reporting all payer/all patient eCQMs/MIPS CQMs
and released a guidance document on the topic. Resources from the
``Reporting MIPS CQMs and eCQMs in the APM Performance Pathway''
webinar are available at https://qpp.cms.gov/resources/webinars. The
guidance document, entitled ``Medicare Shared Savings Program:
Reporting MIPS CQMs and eCQMs in the Alternative Payment Model
Performance Pathway (APP)'' is available in the Quality Payment Program
Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2179/APP%20Guidance%20Document%20for%20ACOs.pdf. We are
committed to continuing to support ACOs in the transition to all payer/
all patient eCQMs/MIPS CQMs and in the transition to digital quality
measurement reporting.
(2) Reporting the Medicare CQMs
In light of the concerns raised by ACOs and other interested
parties and our commitment to supporting ACOs in the transition to
digital quality measure reporting, for performance year 2024 and
subsequent performance years as determined by CMS, we are proposing in
section IV.A.4.f.(1)(b) of this proposed rule to establish the Medicare
CQMs for Accountable Care Organizations Participating in the Medicare
Shared Savings Program (Medicare CQMs) as a new collection type for
Shared Savings Program ACOs reporting on the Medicare CQMs (reporting
quality data on beneficiaries eligible for Medicare CQMs as defined at
Sec. 425.20) within the APP measure set and administering the CAHPS
for MIPS Survey as required under the APP. Medicare CQMs would serve as
a transition collection type to help some ACOs build the
infrastructure, skills, knowledge, and expertise necessary to report
all payer/all patient MIPS CQMs and eCQMs by defining a population of
beneficiaries that exist within the all payer/all patient MIPS CQM
Specifications and tethering that population to claims encounters with
ACO professionals with specialties used in assignment. Specifically, we
believe that Medicare CQMs would address the concern raised by ACOs
that--for ACOs with a higher proportion of specialty practices and/or
multiple EHR systems--the broader all payer/all patient eligible
population would capture beneficiaries with no primary care
relationship to the ACO. Further, we believe that ACOs, particularly
ACOs with a higher proportion of specialty practices and/or multiple
EHRs, would be able utilize Medicare Part A and B claims data to help
identify the ACO's eligible population and to validate the ACO's
patient matching and deduplication efforts. For these reasons, we
believe that it is appropriate to establish Medicare CQMs as a new
collection type for Shared Savings Program ACOs only.
We recognize that Medicare CQMs might not be the suitable
collection type for some ACOs, particularly ACOs with a single-EHR
platform, a high proportion of primary care practices, and/or ACOs
composed of participants with experience reporting all payer/all
patient measures in traditional MIPS. We encourage ACOs to evaluate all
quality reporting options to determine which collection type is most
appropriate based on the ACO's unique composition and technical
infrastructure. In addition to this proposal to report quality data
utilizing the Medicare CQMs collection type, in performance year 2024,
ACOs would have the option to report quality data utilizing the CMS Web
Interface measures, eCQMs, and/or MIPS CQMs collection types. Under
this proposal, in performance year 2025 and subsequent performance
years as determined by CMS, ACOs would have the option to
[[Page 52421]]
report quality data utilizing the eCQMs, MIPS CQMs, and/or Medicare
CQMs collection types.
Our long-term goal continues to be to support ACOs in the adoption
of all payer/all patient measures. We would monitor the reporting of
quality data utilizing the Medicare CQMs collection type. For example,
one indicator to evaluate Medicare CQMs would be to assess if there are
any Medicare CQMs topped out as described at Sec. 414.1380(b)(1)(iv).
Therefore, in the 4th year the measure could be removed and would no
longer be available for reporting during the performance period (83 FR
59761). Once the measure has reached an extremely topped out status
(for example, a measure with an average mean performance within the
98th to 100th percentile range), we may propose the measure for removal
in the next rulemaking cycle, regardless of whether or not it is in the
midst of the topped out measure lifecycle, due to the extremely high
and unvarying performance where meaningful distinctions and improvement
in performance can no longer be made, after taking into account any
other relevant factors (83 FR 59763). Separately, we may specify higher
standards, new measures, or both--up to and including proposing to
sunset the Medicare CQM collection type in future rulemaking--to ensure
that Medicare CQMs conform to the intent of section 1899(b)(3)(C) of
the Act and the priorities established in the CMS National Quality
Strategy.
We also remain steadfast in our commitment to support providers in
the transition from traditional MIPS to APMs and Advanced APMs. As
mentioned above, we acknowledge that Medicare CQMs may not be the
preferred collection type for all ACOs. ACOs that are composed of
participants with experience reporting all payer/all patient measures
in traditional MIPS would continue to have the option to report all
payer/all patient measures under this proposal. In supporting providers
in the transition from traditional MIPS to APMs and Advanced APMs we
also recognize the corresponding need to support ACOs in the transition
to all payer/all patient reporting. In addition to the technical
support we would continue to provide ACOs, we believe that the Medicare
CQM collection type would aid some ACOs in the transition to all payer/
all patient measures by allowing ACOs to focus patient matching and
data aggregation efforts on ACO professionals with specialties used in
assignment while the ACO builds the infrastructure necessary to report
on a broader eligible population.
To facilitate the reporting of Medicare CQMs, we are proposing to
amend the definition of ``Collection Type'' in section IV.A.4.f.(1)(b)
of this proposed rule to include the Medicare CQM as an available
collection type in MIPS for ACOs that participate in the Shared Savings
Program. We note that the Medicare CQMs collection type would serve as
a transition collection type and be available as determined by CMS.
Additionally, we are proposing to establish data submission and
completeness criteria pertaining to the Medicare CQMs for the MIPS
quality performance category as discussed in sections
IV.A.4.f.(1)(c)(i) and IV.A.4.f.(1)(d)(ii) of this proposed rule.
A Medicare CQM for Accountable Care Organizations Participating in
the Medicare Shared Savings Program (Medicare CQM) is essentially a
MIPS CQM reported by an ACO under the APP on only the ACO's Medicare
fee-for-service beneficiaries, instead of its all payer/all patient
population. We are proposing to define a beneficiary eligible for
Medicare CQM at Sec. 425.20 as a beneficiary identified for purposes
of reporting Medicare CQMs for ACOs participating in the Medicare
Shared Savings Program (Medicare CQMs) who is either of the following:
A Medicare fee-for-service beneficiary (as defined at
Sec. 425.20) who--
++ Meets the criteria for a beneficiary to be assigned to an ACO
described at Sec. 425.401(a); and
++ Had at least one claim with a date of service during the
measurement period from an ACO professional who is a primary care
physician or who has one of the specialty designations included in
Sec. 425.402(c), or who is a PA, NP, or CNS.
A Medicare fee-for-service beneficiary who is assigned to
an ACO in accordance with Sec. 425.402(e) because the beneficiary
designated an ACO professional participating in an ACO as responsible
for coordinating their overall care.
While this definition refers to beneficiaries that have been
assigned to an ACO, it nonetheless differs from our basic assignment
methodology described under subpart E and from the concept of
assignable beneficiary defined at Sec. 425.20. Specifically, the use
of the terms of ``claim'' (instead of primary care services) and
``measurement period'' (instead of assignment window) in the definition
are synchronous with the application of all payer/all patient MIPS CQM
Specifications in reporting Medicare CQMs. For example, we define
primary care services as the set of services identified by the HCPCS
and revenue center codes designated under Sec. 425.400(c). Each all
payer/all patient MIPS CQM Specification identifies eligible encounters
that, in part, identify patients that should be included in the
measure's eligible population.
Our proposed definition for beneficiary eligible for Medicare CQMs
is intended to create alignment with the all payer/all patient MIPS CQM
Specifications. The HCPCS and revenue center codes designated under
Sec. 425.400(c) as primary care services for purposes of assignment
under the Shared Savings Program only partially over-lap with the codes
designated as eligible encounters used to identify the eligible
population in all payer/all patient MIPS CQM Specifications. Applying
primary care service codes or deferring to the basic assignment
methodology under subpart E to identify the beneficiaries eligible for
Medicare CQMs would have the unintended result of limiting the codes
used to identify eligible encounters in the Medicare CQM Specification
to only the codes that overlap with primary care services. Similarly,
we define the assignment window as the 12-month period used to assign
beneficiaries to the ACO. In a manner that is identical to the all
payer/all patient MIPS CQM Specifications, the Medicare CQM
Specifications would identify the measurement period applicable to each
measure. Applying the 12-month period used in assignment or deferring
to the basic assignment methodology under Subpart E to identify the
beneficiaries eligible for Medicare CQMs would have the unintended
result of reducing the beneficiaries eligible for Medicare CQMs to only
patients that had an eligible encounter during the overlap of the
assignment window as defined at Sec. 425.20 and the measurement period
as defined in the Medicare CQM Specifications.
In section IV.A.4.f.(1)(d)(ii)of this proposed rule, we are
proposing to establish the data completeness criteria threshold for the
Medicare CQM collection type, in which a Shared Savings Program ACO
that meets the reporting requirements under the APP would submit
quality measure data for Medicare CQMs on the APM Entity's applicable
beneficiaries eligible for the Medicare CQM, as proposed at Sec.
425.20, who meet the measure's denominator criteria. In section
IV.A.4.f.(1)(d)(ii) of this proposed rule, we are proposing the
following data completeness criteria thresholds for Medicare CQMs:
[[Page 52422]]
At least 75 percent for the CY 2024, CY 2025, and CY 2026
performance periods/2026, 2027, and 2028 MIPS payment years.
At least 80 percent for the CY 2027 performance period/
2029 MIPS payment year.
With the Medicare CQMs collection type serving as a transition
collection type under the APP and would be available as determined by
CMS, we are proposing to establish the aforementioned data completeness
criteria thresholds in advance of the applicable performance periods.
We recognize that it is advantageous to delineate the expectations for
ACOs as they prepare to meet the quality reporting requirements for the
Medicare CQMs collection type under the APP. We will assess the
availability of the Medicare CQM as a collection type under the APP
during the initial years of implementation and determine the timeframe
to sunset the Medicare CQM as a collection type in future rulemaking.
An ACO that reports Medicare CQMs in an applicable performance year
would aggregate patient data for beneficiaries who are eligible for
Medicare CQMs, as proposed at Sec. 425.20, across all ACO
participants. The ACO would then match the aggregated patient data with
each Medicare CQM Specification to identify the eligible population for
each measure. The ACO's aggregated ACO submission must account for 100
percent of the eligible and matched patient population across all ACO
participants. Data completeness is calculated based on submitted data.
We believe that the proposal to establish the Medicare CQM collection
type would address the concerns from ACOs regarding the capability of
meeting the data completeness requirement for all payer data.
Specifically, our proposal to define Beneficiaries eligible for
Medicare CQMs aims to focus ACOs' reporting efforts on beneficiaries
with an encounter with an ACO professional with a specialty used in
assignment and thereby reduce the potential for missing or un-matched
patient data. It is important to note that ACOs that include or are
composed solely of FQHCs or RHCs must report quality data on behalf of
the FQHCs or RHCs that participate in the ACO. To clarify, while FQHCs
and RHCs that provide services that are billed exclusively under FQHC
or RHC payment methodologies are exempt from reporting traditional
MIPS, FQHCs and RHCs that participate in APMs, such as the Shared
Savings Program, are considered APM Entity groups described at Sec.
414.1370.
To facilitate population-based activities related to improving
health through quality measurement of Medicare CQMs and to aid ACOs in
the process of patient matching and data aggregation necessary to
report Medicare CQMs, we would provide ACOs a list of beneficiaries who
are eligible for Medicare CQMs within the ACO. As set forth in our
regulations at Sec. 425.702, we share certain aggregate reports with
ACOs under specific conditions, and this information includes
demographic data that represents the minimum data necessary for ACOs to
conduct health care operations work, which includes demographic and
diagnostic information necessary to report quality data. We anticipate
the list of beneficiaries eligible for Medicare CQMs to be shared once
annually, at the beginning of the quality data submission period. Since
we would not have full run-out on performance year claims data prior to
the start of the quality data submission period, the list of
beneficiaries eligible for Medicare CQMs would not be a complete list
of beneficiaries that should be included on an ACO's Medicare CQMs
reporting. ACOs would have to ensure that all beneficiaries that meet
the applicable Medicare CQM Specification and also meet the definition
of a beneficiary eligible for Medicare CQMs proposed under Sec. 425.20
are included in the ACO's eligible population/denominator for reporting
each Medicare CQM. We are proposing to add new paragraph (c)(1)(iii) to
Sec. 425.702 as follows:
For performance year 2024 and subsequent performance years, at the
beginning of the quality submission period, CMS, upon the ACO's request
for the data for purposes of population-based activities relating to
improving health or reducing growth in health care costs, protocol
development, case management, and care coordination, provides the ACO
with information about its fee-for-service population.
The following information is made available to ACOs
regarding beneficiaries eligible for Medicare CQMs as defined at Sec.
425.20:
++ Beneficiary name.
++ Date of birth.
++ Beneficiary identifier.
++ Sex.
Information in the following categories, which represents
the minimum data necessary for ACOs to conduct health care operations
work, is made available to ACOs regarding beneficiaries eligible for
Medicare CQMs as defined at Sec. 425.20:
++ Demographic data such as enrollment status.
++ Health status information such as risk profile and chronic
condition subgroup.
++ Utilization rates of Medicare services such as the use of
evaluation and management, hospital, emergency, and post-acute
services, including the dates and place of service.
The list of beneficiaries eligible for Medicare CQMs shared by CMS
would aim to help ACOs aggregate, and match and deduplicate patient
data. We anticipate including the minimum data necessary to facilitate
the reporting of Medicare CQMs including beneficiary identifier,
gender, date of birth and death (if applicable), chronic condition
subgroup, and the NPIs of the top three frequented providers in the
ACO. We propose to include health status information such as risk
profile and chronic condition subgroup to the extent that such data
would aid ACOs in identifying patients that meet the denominator
criteria for the Medicare CQM Specifications. We would also provide
technical assistance to ACOs when reporting the Medicare CQMs,
including providing technical resource documents. Our proposal to
create Medicare CQMs is intended to support ACOs through the transition
to reporting the all payer/all patient eCQMs/MIPS CQMs and to
facilitate quality assessment improvement activities (as described in
the definition of health care operations at 45 CFR 164.501) since we
would provide ACOs with a list of beneficiaries eligible for Medicare
CQM reporting to aid in patient matching and data deduplication.
In the CY 2021 PFS final rule (85 FR 84733), we finalized the
following 3 all payer/all patient eCQMs/MIPS CQMs under the APP for
performance year 2021 and subsequent performance years:
Quality ID#: 001 Diabetes: Hemoglobin A1c (HbA1c) Poor
Control;