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, 52262-53197 [2023-14624]
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52262
Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
wellness visit and Basic Health
Program.
DEPARTMENT OF HEALTH AND
HUMAN 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
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Proposed rule.
AGENCY:
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
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SUMMARY:
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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 https://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:
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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.
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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.
DATES:
Centers for Medicare & Medicaid
Services
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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
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
advancing access to behavioral health.
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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.
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
complex drug administration.
Laura Ashbaugh, (410) 786–1113,
Ariana Pitcher, ariana.pitcher@
cms.hhs.gov, Rasheeda Arthur, (410)
786–3434, or CLFS_Inquiries@
cms.hhs.gov for issues related to
Clinical Laboratory Fee Schedule.
Lisa Parker, (410) 786–4949, or
FQHC–PPS@cms.hhs.gov, for issues
related to FQHC payments.
Michele Franklin, (410) 786–9226, or
RHC@cms.hhs.gov, 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, ariana.pitcher@
cms.hhs.gov, or OTP_Medicare@
cms.hhs.gov, for issues related to
Medicare coverage of opioid use
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
disorder treatment services furnished by
opioid treatment programs.
Sabrina Ahmed, (410) 786–7499, or
SharedSavingsProgram@cms.hhs.gov,
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
SharedSavingsProgram@cms.hhs.gov,
for issues related to Shared Savings
Program beneficiary assignment and
benchmarking methodology.
Lucy Bertocci, (667) 290–8833, or
SharedSavingsProgram@cms.hhs.gov,
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
AmbulanceDataCollection@
cms.hhs.gov, 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).
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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: https://
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-ServicePayment/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
MedicarePhysicianFeeSchedule@
cms.hhs.gov.
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
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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.
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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.)
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• 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.)
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• 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).
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b. Indirect Practice Expense per Hour
Data
We use survey data on indirect PEs
incurred per hour worked, in
developing the indirect portion of the
PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty
that was obtained from the AMA’s
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
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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.
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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 crosswalked 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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-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
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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
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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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-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
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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
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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
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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.
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(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.
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• 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: Crosswalk the utilization associated with all
physical therapy services to the
specialty of physical therapy.
• Identify professional and technical
services not identified under the usual
TC and 26 modifiers: Flag the services
that are PC and TC services but do not
use TC and 26 modifiers (for example,
electrocardiograms). This flag associates
the PC and TC with the associated
global code for use in creating the
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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;
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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
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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
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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.
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(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
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in which the modifiers are applied.
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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.
We are not proposing any changes to
the equipment interest rates for CY
2024.
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
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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
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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 2017based 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 2017based 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
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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
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-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
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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
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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 RUCrecommended 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
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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
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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 https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-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.
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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, nonsterile 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
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these invoices are submitted in
conjunction with the RUCrecommended 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 PE_Price_Input_
Update@cms.hhs.gov.
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
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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
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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 fullyimplemented new pricing that we
finalized in the CY 2022 PFS final rule
is provided in Table 4.
(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).
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We did not receive new wage data or
other additional information for use in
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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
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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
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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.
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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
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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
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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
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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
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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.
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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
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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 Meritbased 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 (https://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
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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 (https://
www.medpac.gov/docs/default-source/
reports/march-2009-report-to-congressmedicare-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.
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• 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
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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
MedicarePhysicianFeeSchedule@
cms.hhs.gov, 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 Harvardvalued codes that had not yet been
reviewed, focusing first on high-volume,
low intensity codes. In the fourth FiveYear Review of Work RVUs proposed
rule (76 FR 32410, 32419), we requested
recommendations from the RUC to aid
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.
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in our review of Harvard-valued codes
with annual utilization of greater than
30,000 services. In the CY 2013 PFS
final rule with comment period, we
identified specific Harvard-valued
services with annual allowed charges
that total at least $10,000,000 as
potentially misvalued. In addition to the
Harvard-valued codes, in the CY 2013
PFS final rule with comment period we
finalized for review a list of potentially
misvalued codes that have stand-alone
PE (codes with physician work and no
listed work time and codes with no
physician work that have listed work
time). We continue each year to
consider and finalize a list of potentially
misvalued codes that have or will be
reviewed and revised as appropriate in
future rulemaking.
3. CY 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-ofservice, 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
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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.
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Specifically, the current nominee
recommends adding 4 rods of DilapanS 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.
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(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 × 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 nonfacility/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
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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
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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).
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.
support. We welcome comments on the
nomination of these codes as potentially
misvalued, or not.
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.
tkelley on DSK125TN23PROD with PROPOSALS2
(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
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(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
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(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
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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.
tkelley on DSK125TN23PROD with PROPOSALS2
(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
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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 × $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
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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.)
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We welcome comments as to whether
or not these codes are potentially
misvalued.
tkelley on DSK125TN23PROD with PROPOSALS2
(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 MACdetermined payment amounts have been
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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
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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.
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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 ×
CF $33.8872 = $14.57.
• CPT code 93010; total RVUs 0.24 ×
CF $33.8872 = $8.13.
• CPT code 99211; total RVUs 0.69 ×
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
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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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tkelley on DSK125TN23PROD with PROPOSALS2
(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
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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.
tkelley on DSK125TN23PROD with PROPOSALS2
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
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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
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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-GeneralInformation/Telehealth/.
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/.
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
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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,
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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
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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.
BILLING CODE 4120–01–P
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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
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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.
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(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
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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
(2) Cardiovascular and Pulmonary
co-occurring mental health disorder; or
Rehab
(3) monthly ESRD-related clinical
We received multiple requests to
assessments furnished to a beneficiary
permanently add the following CPT
who is receiving home dialysis,
codes to the Medicare Telehealth
beginning January 1, 2025. Therefore, in
Services List:
the absence of further action by
• 93797 (Physician or other qualified
Congress, CPT codes 93797 and 94626
health care professional services for
will not be able to be furnished via
outpatient cardiac rehabilitation;
telehealth to a beneficiary in the home
without continuous ECG monitoring (per beginning January 1, 2025. As such, we
session)); and
are not proposing to include these
• 94624 (Physician or other qualified
services permanently on the Medicare
health care professional services for
Telehealth Services List on a Category 1
outpatient pulmonary rehabilitation;
basis. We are instead proposing to
without continuous oximetry monitoring continue to include these services on
(per session)).
the Medicare Telehealth Services List
In the CY 2022 PFS final rule (86 FR
through CY 2024. We would then
65048), we explained that some services remove CPT codes 93797 and 94626
were added temporarily to the Medicare from the Medicare Telehealth Services
Telehealth Services List on an
List for CY 2025.
emergency basis to allow practitioners
(3) Deep Brain Stimulation
and beneficiaries to have access to
medically necessary care while avoiding
We received a request to permanently
both risk for infection and further
add the following CPT codes to the
burdening healthcare settings during the Medicare Telehealth Services List:
• 95970 (Electronic analysis of
PHE for COVID–19. In the same rule, we
implanted neurostimulator pulse
considered available evidence and
generator/transmitter (e.g., contact
noted that as evidence evolves on this
group[s], interleaving, amplitude, pulse
subject matter, we welcome further
width, frequency [Hz], on/off cycling,
discussions with interested parties on
burst, magnet mode, dose lockout,
the topic. In subsequent cycles of
patient selectable parameters,
annual rulemaking, we have continued
responsive neurostimulation, detection
conversations with interested parties
algorithms, closed loop parameters, and
that furnish, support, and use
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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 § 410.78.
Therefore, we are not proposing to add
this service to the Medicare Telehealth
Services List on a Category 1 basis.
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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
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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
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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
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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
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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/
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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, inperson 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
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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 wellbeing coaching face-to-face; individual,
initial assessment);
• CPT code 0592T (Health and wellbeing coaching face-to-face; individual,
follow-up session, at least 30 minutes);
and
• CPT code 0593T (Health and wellbeing 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 prepublication 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 metaanalyses 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
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coaching only requires a few hours of
training, and few articles submitted to
CMS discuss the intensity of health
coach training at all. The prepublication 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
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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
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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
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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
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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 § 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
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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
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-GeneralInformation/Telehealth/Addition.
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code, that is equivalent to an in-person
service.
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 CMS_
telehealthreview@cms.hhs.gov 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
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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/MedicareGeneral-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 § 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
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diagnostic imaging tests, and certain
care management services). Other
examples include virtual check-ins, evisits, 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 § 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
§ 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
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clinical actions, or patient interaction,
would not be of similar content as an inperson 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 inperson 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
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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
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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
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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.
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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
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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
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and provisional status. We do not assign
provisional status when it is improbable
that the code would ever achieve
permanent status.
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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 speechlanguage 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
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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 inperson 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
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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 inperson 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
§ 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
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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 § 410.78(b)(3).
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(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
§ 410.78(b)(2) to add new paragraphs
(xi) and (xii) to specify that a marriage
and family therapist as described in
proposed § 410.53 and a mental health
counselor as described in proposed
§ 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
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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 nonfacility 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
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52299
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 inperson. 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
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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 nonfacility 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
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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
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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:
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
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physicians-and-other-clinicians-cms-flexibilitiesfight-covid-19.pdf.
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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.
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2. Other Non-Face-to-Face Services
Involving Communications Technology
Under the PFS
a. Direct Supervision via Use of TwoWay 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 § 410.26) and many
diagnostic tests (see § 410.32), direct
supervision is required. Additionally,
for pulmonary rehabilitation services
(see § 410.47) and for cardiac
rehabilitation and intensive cardiac
rehabilitation services (see § 410.49),
direct supervision by a physician, PA,
NP, or CNS is required (see also
§ 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 inperson, 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
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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 realtime 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
§ 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
§ 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
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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 realtime 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 § 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
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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
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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 3way 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,
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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-cmswaivers-flexibilities-and-end-covid-19public-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 atrisk 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.
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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);
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• 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.
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(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 16day 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 30day 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
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• 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 30day 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
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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.
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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
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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
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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.
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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.
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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-
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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 § 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
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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
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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-questionscms-waivers-flexibilities-and-end-covid19-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
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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.
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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
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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
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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 longestablished 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
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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
× 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
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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 RUCrecommended 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 RUCrecommended 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
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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/).
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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 RUCrecommended 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.
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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
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-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.
tkelley on DSK125TN23PROD with PROPOSALS2
(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
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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
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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
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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 codespecific 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
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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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-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 computerassisted imaging services, including Xray, 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
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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
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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.
tkelley on DSK125TN23PROD with PROPOSALS2
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
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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 RUCrecommended 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 RUCrecommended 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 RUCrecommended 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
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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 RUCrecommended 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 intraservice 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
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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 RUCrecommended 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 RUCrecommended 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
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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 RUCrecommended 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
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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 RUCrecommended 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 intraservice 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 intraservice work time is decreasing by 43
percent and the total work time is
decreasing by 27 percent but the RUCrecommended 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 RUCrecommended 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
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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 RUCrecommended 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 RUCrecommended 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
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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 RUCrecommended 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.
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(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 RUCrecommended 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 procedurespecific needles and an injection kit.
CPT code 6X000 replaces temporary
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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 FDAapproved medication to treat macular
edema associated with uveitis which is
reported separately with HCPCS J-code
J3299 triamcinolone acetonide
(Xipere®).
We are proposing the RUCrecommended work RVU of 1.53 for
CPT code 6X000. We are also proposing
the RUC-recommended direct PE inputs
for the code without refinement.
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(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 RUCrecommended work RVU of 25.75 for
CPT code 619X1 (Insertion of skullmounted 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 RUCrecommended 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
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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.
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We are proposing the remaining RUCrecommended 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
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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.
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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
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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 RUCrecommended 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 softtissue 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
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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 rereviewed 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 RUCrecommended 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 RUCrecommended 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
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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,
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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 RUCrecommended 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
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be reflected in decreases to work RVUs.
We disagree with the RUCrecommended 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 RUCrecommended work RVU of 0.60 and
work times of 5 minutes of preevaluation 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 RUCrecommended work times for CPT codes
7X001 and 7X002 of 10 minutes of preevaluation 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
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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 RUCrecommended 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
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documentation (2D) (with or without Mmode 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 Mmode 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
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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
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code family was referred to the CPT
Editorial Panel for restructuring for the
CY 2025 cycle.
We are proposing the RUCrecommended 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 RUCrecommended work RVU of 1.25 for
CPT code 926X1 and 0.33 for CPT
926X2. We are also proposing the RUCrecommended 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,
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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
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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 oneto-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
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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
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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
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time, work RVUs, or direct PE inputs for
these services for CY 2024.
We are proposing the RUCrecommended 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 RUCrecommended direct PE inputs for these
codes without refinement.
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(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 RUCrecommended 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.
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(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-
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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 twohour 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 RUCrecommended 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 60minute 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 15minute 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
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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
tkelley on DSK125TN23PROD with PROPOSALS2
a. Background
In CY 2022, we received AMA RUC
recommendations for a new code family
of two codes (CPT code 96202 (Multiplefamily 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-
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face with multiple sets of parent(s)/
guardian(s)/caregiver(s); initial 60
minutes) and CPT code 96203 (Multiplefamily 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-toface 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,
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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://
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www.whitehouse.gov/briefing-room/
presidential-actions/2023/04/18/
executive-order-on-increasing-access-tohigh-quality-care-and-supportingcaregivers/) 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-advisorycouncil), 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.
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(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-andeducation/outreach/partnerships/
caregiver#:∼:text=Caregivers%20are%
20broadly%20defined%20as,chronic
%20illness%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
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52323
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 postoperative 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.
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(3) Reasonable and Necessary CTS
We believe CTS could be reasonable
and necessary when furnished based on
an established individualized, patientcentered 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.
tkelley on DSK125TN23PROD with PROPOSALS2
(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
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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-toface 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
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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 pretime, 60 minutes intra-time, and 20
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tkelley on DSK125TN23PROD with PROPOSALS2
minutes post-time for a total time of 90
minutes. For CPT code 96203, the 15minute 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 RUCrecommended 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-toface; 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
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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 RUCrecommended 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 RUCrecommended 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.
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(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
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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
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
4 CMS
Strategic Plan | 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 | The White
House https://www.whitehouse.gov/briefing-room/
statements-releases/2022/02/02/fact-sheetpresident-biden-reignites-cancer-moonshot-to-endcancer-as-we-know-it/.
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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).
Physicians and NPPs are generally
trained to obtain a patient’s social and
family history, in support of patientcentered 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
6 2021
CPT Codebook, p. 16.
CPT Codebook, p. 14.
8 See for example Patient-Centered
Communication: Basic Skills | AAFP; https://
www.aafp.org/about/policies/all/socialdeterminants-health-family-medicine-positionpaper.html; https://doi.org/10.7326/M17-2441;
https://nam.edu/social-determinants-of-health-201for-health-care-plan-do-study-act/; https://
www.ama-assn.org/system/files/2021-05/amaequity-strategic-plan.pdf; https://edhub.amaassn.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/.
7 2021
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medically necessary care, such as
appropriate treatment or diagnostic
services after an office visit or following
discharge from a facility.
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.
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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 § 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
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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-andguidance/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
§ 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)
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52327
presence is not required during the
performance of the service
(§ 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
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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 goalsetting 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 communitybased social services (e.g., housing,
utilities, transportation, food assistance)
to address the SDOH need(s).
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• 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
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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 § 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,
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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.
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 communitybased 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
9 https://chwtraining.org/c3-project-chw-skills/.
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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 inperson. 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
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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 communitybased 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 Statefunded 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
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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
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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 StandAlone G Code
i. Background
As previously discussed, there is
increasing recognition within the health
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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
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
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/cmsframework-health-equity-2022.pdf.
13 https://www.aafp.org/about/policies/all/socialdeterminants-health-family-medicine-positionpaper.html.
14 https://doi.org/10.7326/M17-2441.
15 https://nam.edu/social-determinants-of-health201-for-health-care-plan-do-study-act/.
16 https://www.ama-assn.org/system/files/202105/ama-equity-strategic-plan.pdf.
17 https://edhub.ama-assn.org/steps-forward/
module/2702762.
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performed by physicians and
practitioners in support of patientcentered 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.
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
18 https://health.gov/healthypeople/tools-action/
browse-evidence-based-resources/types-evidencebased-resources.
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domains of food insecurity, housing
insecurity, transportation needs, and
utility difficulties.
++ 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
Given the multifaceted nature of
unmet SDOH needs, appropriate followup is critical for mitigating the effects of
the identified, unmet SDOH needs on a
person’s health. An SDOH risk
assessment without appropriate followup 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 communitybased 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.
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
19 https://innovation.cms.gov/files/worksheets/
ahcm-screeningtool.pdf.
20 https://www.nachc.org/research-and-data/
prapare/.
21 CMS–10825.
22 https://www.cms.gov/files/document/z-codesdata-highlight.pdf.
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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
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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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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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
24 https://pubmed.ncbi.nlm.nih.gov/29125784/.
25 https://www.ajmc.com/view/serious-illness-ahigh-priority-for-accountable-care.
26 https://www.ajmc.com/view/serious-illness-ahigh-priority-for-accountable-care.
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lived experience or training in the
specific condition being addressed.
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 § 410.26. We would not
require an initiating E/M visit every
month that PIN services are billed, but
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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-andguidance/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
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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 § 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 (§ 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
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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, highrisk 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
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community-based service providers; and
caregiver (if applicable).
++ Communication with
practitioners, home-, and communitybased 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 communitybased 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
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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 § 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
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
27 https://resumecat.com/blog/patient-navigatorcertifications.
28 https://peerrecoverynow.org/product/
comparative-analysis-of-state-requirements-forpeer-support-specialist-training-and-certificationin-the-us/ and https://store.samhsa.gov/sites/
default/files/pep23-10-01-001.pdf.
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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.
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 inperson 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, inperson, using audio-video, using twoway 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
29 https://view.ons.org/3hjHjc and https://
www.accc-cancer.org/docs/projects/pdf/patientnavigation-guide; https://chwtraining.org/c3project-chw-skills/; and https://
peerrecoverynow.org/wp-content/uploads/
Comparative-Analysis_Jan.31.2022-003.pdf; https://
www.samhsa.gov/sites/default/files/nationalmodel-standards-for-peer-supportcertification.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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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
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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 Statefunded 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
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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
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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;
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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
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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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F. Evaluation and Management (E/M)
Visits
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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
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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
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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
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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 decisionmaking (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
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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 Medicarespecific 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
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52351
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).
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,
30 https://www.cms.gov/files/document/
physician-fee-schedule-pfs-paymentofficeoutpatient-evaluation-and-management-emvisits-fact-sheet.pdf.
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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
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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
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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
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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
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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 addon code G2211 to be reported when the
O/O E/M service is reported with a
payment modifier, such as the modifier25, 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).
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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 followup, 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
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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 resourcebased 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
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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
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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 nonphysician 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
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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
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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 § 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
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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-Feefor-Service-Payment/
PhysicianFeeSched/.
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;
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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 MSAbased 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 MSAbased 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
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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 phasein 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 afterthe-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 BeachAnaheim 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
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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 FranciscoOakland-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-OaklandBerkeley 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-OaklandBerkeley (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 BeachAnaheim (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 BeachAnaheim MSA, containing Orange
County and Los Angeles County, by one
unique locality number, 18, and the San
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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.
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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
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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
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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 costgathering 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
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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.
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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).
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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 §§ 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 §§ 410.59 and 410.60 last
year for OTPPs and PTPPs, we are
proposing to establish an RTM-specific
general supervision policy at
§§ 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 §§ 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
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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 §§ 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 §§ 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
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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 §§ 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
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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 §§ 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 speechlanguage 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-butone 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?
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• 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
§§ 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
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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 × 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.
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
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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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 § 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, §§ 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
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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 § 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 § 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 multidisciplinary 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.
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Consequently, we propose to amend
the regulation at § 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 § 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.
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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 subregulatory 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
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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-toface 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 § 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 § 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-andGuidance/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,
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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 inperson 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
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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
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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 assignmentrelated 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.
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 § 410.53 and § 410.54 to
codify the coverage provisions for MFTs
and MHCs, respectively.
Specifically, we are proposing to
define a marriage and family therapist at
§ 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
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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
§ 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
§ 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 § 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
§ 410.53(b)(2) that the following services
do not fall under the Medicare Part B
benefit category for MFT services:
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• 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 § 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 § 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
§ 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 § 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 § 410.54(b)(2)
that the following services do not fall
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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 § 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 § 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, § 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 § 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 § 414.53 the payment amounts
authorized under section 1833(a)(1)(FF)
for MFT and MHC services.
Additionally, we are proposing to codify
at § 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
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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
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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 § 424.510, a
provider or supplier must complete,
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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 nonphysician practitioner types, be subject
to limited-risk screening under
§ 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 §§ 410.53 and
410.54 as finalized, would enroll in
Medicare via the Form CMS–855I
application (Medicare Enrollment
Application—Physicians and NonPhysician 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/providerenrollment-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
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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,
§ 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 § 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 § 412.2(c)(5), or for
services furnished via telehealth under
§ 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 § 414.22(b)(5)(i)(B), the nonfacility 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 nonfacility 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
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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 nonfacility 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 nonfacility 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
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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
§ 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.
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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
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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
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
33 https://www.cms.gov/medicare-coveragedatabase/view/
article.aspx?articleid=57754&ver=12&=.
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.
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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.
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
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.
36 https://www.kff.org/coronavirus-covid-19/
issue-brief/the-implications-of-covid-19-for-mentalhealth-and-substance-use/.
37 https://bhw.hrsa.gov/sites/default/files/bureauhealth-workforce/data-research/behavioral-health2013-2025.pdf.
38 https://bhw.hrsa.gov/sites/default/files/bureauhealth-workforce/data-research/behavioral-health2013-2025.pdf.
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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
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 nonfacility 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
39 Health Resources and Services Administration,
Health Workforce Shortage Areas, https://
data.hrsa.gov/topics/health-workforce/shortageareas.
40 https://bhw.hrsa.gov/sites/default/files/bureauhealth-workforce/data-research/bh-workforceprojections-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/s11414-01909679-z.
42 https://store.samhsa.gov/sites/default/files/
SAMHSA_Digital_Download/pep22-06-02-005.pdf.
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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 personto-person interactions with
beneficiaries, particularly those services
that are comprised of conversational
interactions rather than physical
interactions, because these services
require minimal equipment and
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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.
The dynamic described by the Urban
Institute report can lead to systemic
undervaluation for some kinds of timebased 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
43 https://www.urban.org/sites/default/files/
publication/87771/2001123-collecting-empiricalphysician-time-data-piloting-approach-forvalidating-work-relative-value-units_0.pdf.
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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, oneon-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.
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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
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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 4year 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 oneon-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
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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 addon 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
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would implement this change over a 4year 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
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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.
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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.
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
44 https://www.cms.gov/cms-behavioral-healthstrategy.
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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
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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,
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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
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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
tkelley on DSK125TN23PROD with PROPOSALS2
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 § 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
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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
§ 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
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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 report47
regarding dental services and the link
between medical services is available at
https://effectivehealthcare.ahrq.gov/
products/receiving-chemotherapycancer/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 post45 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/cancerterms.
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.
https://dx.doi.org/10.20517/2573–0002.2017.03.
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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.
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
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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 lifethreatening) 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
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
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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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
§ 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)
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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
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receptor (CAR) T-cell therapy, bonemodifying 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 Tcell 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 bonemodifying 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
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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
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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
MedicarePhysicianFeeSchedule@
cms.hhs.gov. Interested parties should
include the words ‘‘dental
recommendations for CY 2025 review’’
in the subject line of their email
submission to facilitate processing. We
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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
§ 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,
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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 bonemodifying agents (antiresorptive
therapy) when used in the treatment of
cancer.
As such, we propose to amend our
regulation at § 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 Medicarecovered: 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 bonemodifying 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 § 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
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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
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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
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.
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52375
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
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-2021140675. 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.
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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
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
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 alphahemolytic 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].
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 alphahemolytic streptococcal infection in patients
undergoing autologous bone marrow
transplantation for hematologic malignancies.
Cancer 1998;82(11):2275–2281. [PubMed: 9610710].
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prior to initiation of cancer treatment,
further complicating the totality of
services a patient received to treat their
cancer.69
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
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
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.
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.
https://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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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.
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)
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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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
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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
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scenarios under which payment can be
made for certain dental services in our
regulation at § 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 Tcell 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-
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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
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 Tcell 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
76 Wudhikarn K, Palomba ML, Pennisi M, GarciaRecio 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, Dahllo¨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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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 § 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
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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
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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 BoneModifying Agents (Antiresorptive
Therapy) When Used in the Treatment
of Cancer
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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 bonemodifying 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
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.
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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 bonemodifying 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.
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 bonemodifying 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 § 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
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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52379
a comprehensive workup in either the
inpatient or outpatient setting prior to
Medicare-covered the administration of
Medicare-covered high-dose bonemodifying 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 bonemodifying 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 § 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 § 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 § 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
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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
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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 treatmentinduced 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
§ 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, Medicarecovered 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 § 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 § 411.15(i)(3)(i) to allow for
payment under Medicare Parts A and
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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 § 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, noneradicated 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).
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
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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tkelley on DSK125TN23PROD with PROPOSALS2
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
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
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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.
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 § 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.
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.
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.
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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.
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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 wellbeing, and overall quality of life.
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
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.
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, Llina´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
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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
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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 § 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,
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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
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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
§ 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
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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 § 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 § 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
§ 411.15(i)(3). We will maintain this
policy and continue to contractor price
the dental services for which payment is
made under § 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
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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-servicepayment/physicianfeesched/pfsrelative-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 § 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
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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 (§§ 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
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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.
In addition, two provisions (among
others in the IRA) make statutory
changes that affect beneficiary out-ofpocket 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 inflationadjusted 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.
• 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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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 § 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,
94 https://www.cms.gov/files/document/
r11496cp.pdf.
95 https://www.cms.gov/medicare/medicare-feefor-service-part-b-drugs/mcrpartbdrugavgsalesprice.
96 https://www.cms.gov/files/document/medicarepart-b-inflation-rebate-program-initialguidance.pdf.
97 https://www.congress.gov/bill/117th-congress/
house-bill/5376/text.
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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
§ 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
§ 414.904. Specifically, we are
proposing to revise paragraph (e)(4) at
§ 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
§ 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.
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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 § 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 § 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
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-servicepart-b-drugs/mcrpartbdrugavgsalesprice.
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In this proposed rule, we propose to
add definitions of ‘‘applicable 5-year
period’’ and ‘‘qualifying biosimilar
biological product’’ at § 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 § 414.904 (j) by adding
paragraphs (j)(1) and (2).
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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/inflationreduction-act-and-medicare/inflationrebates-medicare.
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
99 https://www.cms.gov/files/document/medicarepart-b-inflation-rebate-program-initialguidance.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://
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inflation-adjusted payment amount for
such quarter (hereafter, the inflationadjusted 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 § 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 § 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
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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.
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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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 § 489.30 by adding paragraph
(b)(7) and the adjustment to the provider
payment at § 410.152 by adding
paragraph (n). In addition, we propose
to codify at § 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 selfadministered.’’ 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
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the drugs that are subject to the selfadministered 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 nonchemotherapeutic 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
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52387
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 nonchemotherapeutic 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
(§§ 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
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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 § 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 patientspecific 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).
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
103 https://www.cms.gov/medicare/medicare-feefor-service-payment/hospitaloutpatientpps/
downloads/jw-modifier-faqs.pdf.
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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
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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 § 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
104 https://www.cms.gov/files/document/
medicare-part-b-inflation-rebate-program-initialguidance.pdf.
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calendar quarters in CY 2023 and CY
2024 until September 30, 2025.105
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
105 https://www.cms.gov/files/document/
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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 § 414.902 and to revise
§ 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
§ 414.940(b), which requires
manufacturers to pay refunds in 12month 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 § 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
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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 § 414.940(b)(2),
whichever is later. We propose to revise
§ 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
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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 § 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 § 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
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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
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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.
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
106 https://www.cms.gov/files/document/
medicare-part-b-inflation-rebate-program-initialguidance.pdf.
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be as follows:
(3,000)(23.81%)($50)¥(21,000)(10%)
(23.81%)($50) = refund amount of
$10,714.50.
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 § 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.
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
(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 patientspecific characteristics (§ 414.490(d)(1)).
We have identified only one drug,
Jelmyto® (mitomycin for pyelocalyceal
solution), with such unique
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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 § 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 FDAlabeled 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
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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
§ 414.902 and define a low volume dose
to be a labeled dose (based on FDAapproved 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 § 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
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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.
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.
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 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® (triamcinolone
acetonide injection, suspension) and
Xipere® (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® (collagenase clostridium
histolyticum) and Kimmtrak®
(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
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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 postmarketing. 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
109 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-discarded-drug-units.
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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.
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 orphandrug 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
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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 § 414.940(e)).
We propose to codify these applicable
percentages at § 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
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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) FDAapproved 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
§ 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®
(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® 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.
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.
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
110 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/optimizing-dosagehuman-prescription-drugs-and-biological-productstreatment-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.
114 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-discarded-drug-units.
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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.
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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.
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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, § 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.
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 singledose 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
115 https://www.cms.gov/medicare/medicare-feefor-service-payment/hospitaloutpatientpps/
downloads/jw-modifier-faqs.pdf.
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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 pervisit payment.
RHCs generally are paid an allinclusive 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.
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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.
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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 § 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
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services are furnished in-person. In
addition, we revised the regulation
under § 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
§ 405.2469, FQHC supplemental
payments, to state that a supplemental
payment required under this section is
made to the FQHC when a covered faceto-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 § 405.2463.
At § 405.2469, we also revised
paragraph (d) to describe the same inperson visit requirement referenced in
§ 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
§§ 405.2463 and 405.2469 again to
reflect these provisions.
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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
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 inperson 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
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 § 405.2463, ‘‘What
constitutes a visit,’’ we are proposing to
amend paragraph (b)(3) and, at
§ 405.2469 ‘‘FQHC supplemental
payments,’’ we are proposing to amend
paragraph (d) to include the delay of the
in-person requirements for mental
116 https://www.cms.gov/files/document/ruralhealth-clinics-and-federally-qualified-healthcenters-cms-flexibilities-fight-covid-19.pdf.
117 https://www.hhs.gov/coronavirus/covid-19public-health-emergency/.
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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 TwoWay 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 (§ 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
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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
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
118 https://www.govinfo.gov/content/pkg/FR2020-04-06/pdf/2020-06990.pdf.
119 https://www.cms.gov/files/document/
03092020-covid-19-faqs-508.pdf.
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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-toface 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
(§ 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
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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 §§ 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
§ 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
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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 § 405.2401, Scope and
definitions, we propose to amend the
section to add definitions for MFT and
MHC;
• At § 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 § 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 § 405.2446, Scope of services, we
propose to amend the section to include
MFT and MHC services to the scope of
services;
• At § 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 § 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 § 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 § 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 § 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
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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
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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 §§ 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 § 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.
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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 nonface-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-faceto-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
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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 lowincome 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 nonfacility 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
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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 nonfacility 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 nonfacility 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 nonface-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/CareManagement.html and on the CMS RHC
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and FQHC web pages at https://
www.cms.gov/Center/Provider-Type/
Rural-Health-Clinics-Center.html and
https://www.cms.gov/Center/ProviderType/Federally-Qualified-HealthCenters-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 patientcentered 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.
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.
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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
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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 nonface-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 patientphysician 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
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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
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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
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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 goalsetting 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
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discharges from hospitals, skilled
nursing facilities or other health care
facilities.
++ Facilitating access to communitybased 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
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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 lowincome 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, highrisk 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
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department visit; or follow-up after
discharges from hospitals, skilled
nursing facilities or other health care
facilities.
++ Facilitating access to communitybased 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.
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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.
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 nonfacility 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
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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.
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.
EP07AU23.033
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
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As demonstrated by comparing Table
22 to Table 23, using the current method
of calculating the average of the nonfacility 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 nonfacility 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.
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
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G0511 annually based on current data
available in the PFS.
We propose revisions at § 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.
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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
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
121 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFeeSched/CareManagement.
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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
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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
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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.
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(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
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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
§ 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 (§ 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
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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
§ 491.2, Definitions, we propose adding
a definition of MFTs and MHCs by
cross-referencing the definitions
proposed at §§ 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 § 491.2, Definitions, and
cross-reference the definitions
established in the payment
requirements at § 410.77(a), § 410.71(d),
§ 410.73(a) respectively.
We propose revising the existing
‘‘nurse practitioner’’ (NP) definition at
§ 491.2. The current definition sets forth
education and certification
requirements. The current requirement
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at § 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 § 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 § 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
122 https://www.aanp.org/advocacy/advocacyresource/position-statements/nurse-practitionersin-primary-care#:∼:text=
Millions%20of%20Americans
%20choose%20a,of%20all%20ages%20and%
20backgrounds.
123 https://www.aanp.org/student-resources/npcertification.
124 American Association of Nurse Practitioners
(2020). The Path to Becoming a Nurse Practitioner
(NP). https://www.aanp.org/news-feed/explore-thevariety-of-career-paths-for-nursepractitioners#:∼:text=To%20become%20an%20NP
%2C%20one,national%20NP
%20board%20certification%20exam.
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provides alternative certification and
education requirements an NP can meet
to furnish services in an RHC or FQHC
if (1) is not met.
We are soliciting comments regarding
the current definition of NPs at
§ 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 fastestgrowing 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.
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
125 https://www.bls.gov/careeroutlook/2020/
article/careers-for-nurses-opportunities-andoptions.htm.
126 https://www.medpac.gov/wp-content/uploads/
2022/03/Mar22_MedPAC_ReportToCongress_Ch4_
v2_SEC.pdf.
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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: adultgerontology 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.
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 § 491.2.
b. Staffing and Staff Responsibilities
(§ 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
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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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 § 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
§ 491.8, Staffing and staff
responsibilities. Currently, at
§ 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
§ 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, § 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
§ 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
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52409
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
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
129 https://www.cms.gov/files/document/cmsgeographic-framework.pdf.
130 https://www.jstor.org/stable/pdf/
26554276.pdf?refreqid=excelsior%3A3437750
e2633ee53aa5c0afe8caae6ea&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%3A3437750
e2633ee53aa5c0afe8caae6ea&ab_segments=&origin
=&initiator=&acceptTC=1.
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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.
D. Clinical Laboratory Fee Schedule:
Revised Data Reporting Period and
Phase-In of Payment Reductions
1. Background on the Clinical
Laboratory Fee Schedule
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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.
136 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC1851736/.
137 https://aspe.hhs.gov/sites/default/files/202107/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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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
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 § 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.
140 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ClinicalLabFeeSched/
Downloads/2017-March-Announcement.pdf.
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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 § 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
§ 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
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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
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 3year 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 § 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
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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
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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
§ 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 § 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
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§ 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 § 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
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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
§ 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
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proposing to revise § 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 § 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 § 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
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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 §§ 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 § 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 § 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
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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 § 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 §§ 410.47 and 410.49 as
described below.
a. Definitions
We are proposing to add a new term,
nonphysician practitioner (NPP), to
§§ 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 §§ 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 § 410.47(a) and the
definitions for cardiac rehabilitation and
intensive cardiac rehabilitation (ICR)
program at § 410.49(a) to specify that
these are physician- or NPP-supervised
programs.
b. Setting
We are proposing to amend
§ 410.47(b)(3)(ii)(A) and
§ 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.
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c. Supervising Practitioner Standards
We are proposing to amend language
at §§ 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
(§§ 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
§§ 410.47(a) and 410.49(a) by crossreference 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 §§ 410.47 and 410.49.
We believe these proposed amendments
to §§ 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 UseDisorder 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
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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 nondrug 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 addon 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 § 410.67(b) to allow OTPs to furnish
individual and group therapy and
substance use counseling using audioonly telephone calls rather than twoway 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 takehome 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
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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 twoway 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 § 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 audiovideo communication technology
during the PHE for the COVID–19 if
beneficiaries do not have access to twoway 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 audioonly 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
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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 § 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 twoway 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 § 410.67(b) to provide that
periodic assessments (HCPCS code
G2077) must be furnished during a faceto-face encounter, which includes
services furnished via two-way
interactive audio-video communication
technology, as clinically appropriate,
provided all other applicable
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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 audioonly 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 audioonly 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
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-usetelehealth-visits-early-data-start-covid-19pandemic.
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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 § 410.67(b) of the
regulations to reflect these changes.
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 inperson 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 audioonly 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.
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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 audioonly communication technology
following the end of CY 2024 for
patients who are receiving treatment via
buprenorphine, methadone, and/or
naltrexone at OTPs.
Accordingly, we are proposing to
revise paragraph (vii) of the definition of
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/medicareand-telehealth-coverage-and-use-during-the-covid19-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/FCC20-50A1.pdf; https://www.cms.gov/files/document/
aian-telehealthwebinar.pdf; https://
www.sciencedirect.com/science/article/pii/
S0749379721000921?via%3Dihub.
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‘‘Opioid treatment services’’ at
§ 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
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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
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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
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
147 Refer to CMS, Shared Savings Program Fast
Facts—As of January 1, 2023, available at https://
www.cms.gov/files/document/2023-shared-savingsprogram-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-andbeneficiaries-benefiting-coordinated-careaccountable.
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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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 communitybased 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
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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 claimsbased 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;
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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 UseDisorder 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;
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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 twosided 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
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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
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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).
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++ Update the definition of primary
care services used in beneficiary
assignment at § 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
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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
§ 425.226(a)(1) or § 425.400(a)(4)(ii) in
subpart G of the regulations, correct
typographical errors in the definitions
in § 425.20, and update certain
terminology used in § 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 threeway 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 10year period 2024 through 2033. These
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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
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52419
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
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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
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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-prodcontent.s3.amazonaws.com/uploads/
2179/APP%20Guidance%20
Document%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
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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 § 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
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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
§ 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
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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 feefor-service beneficiaries, instead of its
all payer/all patient population. We are
proposing to define a beneficiary
eligible for Medicare CQM at § 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 § 425.20)
who—
++ Meets the criteria for a beneficiary
to be assigned to an ACO described at
§ 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
§ 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 § 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 § 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
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52421
CQMs. For example, we define primary
care services as the set of services
identified by the HCPCS and revenue
center codes designated under
§ 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
§ 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
§ 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 § 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:
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• 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
§ 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 § 414.1370.
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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
§ 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 § 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 § 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 populationbased 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 § 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 § 425.20:
++ Demographic data such as
enrollment status.
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++ 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;
• Quality ID#: 134 Preventive Care
and Screening: Screening for Depression
and Follow-Up Plan; and
• Quality ID#: 236 Controlling High
Blood Pressure.
In section IV.A.4. e. of this proposed
rule, we are proposing to add these
measures as Medicare CQMs to the APP
measure set for Shared Savings Program
ACOs beginning with performance year
2024 and subsequent performance years.
ACOs may report the 3 Medicare CQMs,
or a combination of eCQMs/MIPS
CQMs/Medicare CQMs, to meet the
Shared Savings Program quality
reporting requirement at § 425.510(b)
and the quality performance standard at
§ 425.512(a)(5).
As a result, in order to meet the
Shared Savings Program reporting
requirements:
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• For performance year 2024, an ACO
would be required to report the 10
measures under the CMS web interface
measures, or the 3 eCQMs/MIPS CQMs/
Medicare CQMs. In addition, an ACO
would be required to administer the
CAHPS for MIPS Survey, and CMS will
calculate the two claims-based
measures.
• For performance year 2025 and
subsequent performance years, an ACO
would be required to report the 3
eCQMs/MIPS CQMs/Medicare CQMs. In
addition, an ACO would be required to
administer the CAHPS for MIPS Survey,
and CMS will calculate the two claimsbased measures.
ACOs may still report via the APP
using the all payer/all patient eCQM/
MIPS CQM collection types and may
report different collection types for each
measure.
In conjunction with the proposed
changes to § 425.512(a)(2), as described
in section III.G.2.j. of this proposed rule,
we propose to incorporate Medicare
CQMs into the existing quality
performance standard policies for new
ACOs at § 425.512(a)(2)(i), (ii), and (iii).
Accordingly, we propose that for the
first performance year of an ACO’s first
agreement period under the Shared
Savings Program, if the ACO reports
data via the APP and meets MIPS data
completeness requirement at § 414.1340
and receives a MIPS Quality
performance category score under
§ 414.1380(b)(1), the ACO will meet the
quality performance standard under the
Shared Savings Program, if:
• For performance year 2024. The
ACO reports the 10 CMS Web Interface
measures or the 3 eCQMs/MIPS CQMs/
Medicare CQMs, and administers a
CAHPS for MIPS survey under the APP.
• For performance year 2025 and
subsequent performance years. The
ACO reports the 3 eCQMs/MIPS CQMs/
Medicare CQMs and administers a
CAHPS for MIPS survey under the APP.
Additionally, we propose to
incorporate Medicare CQMs into the
existing policies at § 425.512(a)(5)(iii)
for when an ACO would not meet the
quality performance standard or the
alternative quality performance
standard. Accordingly, we propose that
an ACO would not meet the quality
performance standard or the alternative
quality performance standard if:
• For performance year 2024, if an
ACO (1) does not report any of the 10
CMS Web Interface measures or any of
the three eCQMs/MIPS CQMs/Medicare
CQMs and (2) does not administer a
CAHPS for MIPS survey under the APP.
• For performance year 2025 and
subsequent performance years, if an
ACO (1) does not report any of the three
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eCQMs/MIPS CQMs/Medicare CQMs
and (2) does not administer a CAHPS for
MIPS survey under the APP.
We are not proposing to add Medicare
CQMs to the eCQM/MIPS CQM
reporting incentive described at
§ 425.512(a)(5)(i)(A)(2) for performance
year 2024. The eCQM/MIPS CQM
reporting incentive intends to provide
an incentive to ACOs to report the all
payer/all patient eCQMs/MIPS CQMs
while allowing them time to gauge their
performance on the all payer/all patient
eCQMs/MIPS CQMs before full
reporting of these measures is required
beginning in performance year 2025.
Under the goals of the CMS National
Quality Strategy, CMS is moving
towards a building-block approach to
streamline quality measure across CMS
quality programs for the adult and
pediatric populations. This ‘‘Universal
Foundation’’ of quality measure will
focus provider attention, reduce burden,
identify disparities in care, prioritize
development of interoperable, digital
quality measures, allow for crosscomparisons across programs, and help
identify measurement gaps. Following
in the proposals under MIPS, we intend
to propose future policies aligning the
APP measure set for Sharing Savings
Program ACOs with the quality
measures under the ‘‘Universal
Foundation’’ beginning in performance
year 2025. These Universal Foundation
measures are proposed to be adopted
into the existing the Value in Primary
Care MVP as discussed in Table B.11 of
Appendix 3: MVP Inventory to this
proposed rule. By creating alignment
with the Universal Foundation in the
Value in Primary Care MVP and the
APP measure set by 2025, primary care
clinicians would develop familiarity
with the same quality measures that are
reported in the APP while in MIPS. We
expect this alignment would reduce the
barriers to participation in the Shared
Savings Program.
(3) Benchmarking Policy for Medicare
CQMs
As the Shared Savings Program
adopted the APP (see, for example,
§ 425.512(a)(3)(i)), benchmarks for
quality measures used by the program
are those established under the MIPS
policies at § 414.1380(b)(1)(ii). We
propose that new benchmarks for
scoring ACOs on the Medicare CQMs
under MIPS would be developed in
alignment with MIPS benchmarking
policies. As historical Medicare CQM
data would not be available at the time
this proposal is finalized (if this
proposal is finalized), we propose for
performance year 2024 and 2025 to
score Medicare CQMs using
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performance period benchmarks.
Similarly, as quality performance data
are submitted via Medicare CQM and
baseline period data become available to
establish historical benchmarks, we
propose for performance year 2026 and
for subsequent performance years to
transition to using historical
benchmarks for Medicare CQMs when
baseline period data are available to
establish historical benchmarks in a
manner that is consistent with the MIPS
benchmarking policies at
§ 414.1380(b)(1)(ii).
(4) Expanding the Health Equity
Adjustment to Medicare CQMs
In the CY 2023 PFS final rule (87 FR
69838 through 69858), for performance
year 2023 and subsequent performance
years, we finalized a health equity
adjustment to upwardly adjust the MIPS
Quality performance score for ACOs
that report eCQMs/MIPS CQMs, are
high performing on quality, and serve a
higher proportion of underserved
beneficiaries. As we stated in the CY
2023 PFS final rule, the goals of the
health equity adjustment include
rewarding ACOs serving a high
proportion of underserved beneficiaries
and supporting ACOs with the
transition to eCQMs/MIPS CQMs (87 FR
69841).
Consistent with the goal of supporting
ACOs in their transition to all payer/all
patient eCQMs/MIPS CQMs, we are
proposing that ACOs that report
Medicare CQMs would be eligible for
the health equity adjustment to their
quality performance category score
when calculating shared savings
payments. We are proposing to revise
§ 425.512(b) to specify that, for
performance years 2024 and subsequent
performance years, we would calculate
a health equity adjusted quality
performance score for an ACO that
reports the three Medicare CQMs or a
combination of eCQMs/MIPS CQMs/
Medicare CQMs in the APP measure set,
meeting the data completeness
requirement at § 414.1340 for each
measure, and administers the CAHPS
for MIPS survey (except as specified in
§ 414.1380(b)(1)(vii)(B)). This proposal
would advance equity within the
Shared Savings Program by supporting
ACOs that deliver high quality care and
serve a high proportion of underserved
individuals. Applying the health equity
adjustment to an ACO’s quality
performance category score when
reporting Medicare CQMs would
encourage ACOs to treat underserved
populations.
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(5) Summary of Proposals
In Table 25 of this proposed rule we
summarize the proposed changes to the
regulation at § 425.512(a)(4) and (5) to
reflect the proposed changes to the
quality reporting requirements and
quality performance standard for
performance year 2024 and subsequent
performance years. Performance
benchmarks for performance year 2024
used to determine the 10th, 30th, and
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40th percentiles for purposes of
evaluating the eCQM/MIPS CQM
reporting incentive described at
§ 425.512(a)(5)(i)(A)(2) will be posted on
the Quality Payment Program Resource
Library website at https://qpp.cms.gov/
resources/resource-library. We direct
readers to the MIPS measure
benchmarking policies described at
§ 414.1380(b)(1)(ii) and to both the
quality benchmark and performance
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period benchmark documentation
posted on the Quality Payment Program
Resource Library website at https://
qpp.cms.gov/resources/resource-library
for more details. Performance
benchmarks differ by collection type
(that is, eCQM, MIPS CQM, Medicare
CQM (as proposed), CMS Web Interface)
and are updated for each performance
year.
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c. Proposed APP Measure Set
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(1) Background
We refer readers to Table 26, which
lists the measures included in the final
APP measure set that will be reported
by Shared Savings Program ACOs for
performance year 2023 and subsequent
performance years. These are the same
measures finalized in the CY 2023 PFS
final rule (87 FR 69862); however, we
note that the Collection Type for each
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measure has been updated. As finalized
in the CY 2023 PFS final rule (87 FR
69863), we included the measure type
in Table 26 for each measure in the
measure set to provide ACOs a list of
the outcome measures for purposes of
meeting the quality performance
incentive for reporting eCQMs/MIPS
CQMs. This information is also relevant
to the alternative quality performance
standard under which ACOs that fail to
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meet the quality performance standard
to qualify for the maximum sharing rate,
but that achieve a quality performance
score at the 10th percentile on 1 of the
4 outcome measures in the APP measure
set, may be eligible to share in savings
on a sliding scale (87 FR 69861). We
noted inclusion of this information does
not change any of the measures in the
measure set.
(2) Proposed Revisions
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Table 27 includes the proposed
eCQM/MIPS CQM measure set for
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performance year 2024 for the Shared
Savings Program and outlines the
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measure types, which is relevant for
ACOs that may elect to report on eCQM/
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MIPS CQMs in order to qualify for the
incentive under § 425.512(a)(4)(i)(B).
The CMS Web Interface collection
type under the APP includes 10
measures. We refer readers to Table
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Group E of Appendix 1 of this proposed
rule for the proposed substantive
changes to measure specifications for 9
out of 10 CMS Web Interface measures
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starting with performance year 2024. As
proposed, the changes would update
measures and align the CMS Web
Interface measures with the practice
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Table 28 identifies the preliminary
measures for the Universal Foundation’s
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workflows of the MIPS CQM collection
type.
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d. Proposals To Modify the Health
Equity Adjustment Underserved
Multiplier
(1) Background
Consistent with our goal of rewarding
ACOs that include a higher proportion
of underserved beneficiaries while
delivering high quality care, we
finalized in the CY 2023 PFS final rule
(87 FR 69836 through 69857) the
application of a health equity
adjustment that adds up to 10 bonus
points to an ACO’s MIPS Quality
performance category score based on
certain criteria. The health equity
adjustment is applied to an ACO’s MIPS
quality performance category score
when the ACO reports the three allpayer eCQMs/MIPS CQMs in
performance year 2023 and, as proposed
in section III.G.2.b.(2) of this proposed
rule, the three eCQMs/MIPS CQMs/
Medicare CQMs starting in performance
year 2024. To qualify for the health
equity adjustment, the ACO must also
meet the data completeness requirement
at § 414.1340 and administer the CAHPS
for MIPS survey (except as specified in
§ 414.1380(b)(1)(vii)(B)). The health
equity adjustment is conditional on (1)
high quality measure performance and
(2) providing care for a proportion of
underserved populations greater than or
equal to a predetermined floor.
The goal of the health equity
adjustment is to reward ACOs with high
performance scores on quality measures
and that serve a high proportion of
underserved beneficiaries.
Correspondingly, the health equity
adjustment bonus points are calculated
by multiplying the ACO’s performance
scaler by the ACO’s underserved
multiplier. An ACO’s performance
scaler is designed to identify top
performance among ACOs reporting allpayer eCQMs/MIPS CQMs in
performance year 2023 and, as proposed
in section III.G.2.b.(2) of this proposed
rule, eCQMs/MIPS CQMs/Medicare
CQMs in performance year 2024. The
performance scaler is an aggregated
value across all eCQM/MIPS CQM
measures and is determined based on if
the ACO’s measure performance was in
the top, middle, or bottom third of ACO
performance for that performance year.
We refer readers to section III.G.4.b.(7).c
of the CY 2023 PFS final (87 FR 69843
through 69845) for more details on the
performance scaler calculation. The
underserved multiplier is designed to
identify ACOs serving high proportions
of underserved beneficiaries. As
described in the CY 2023 PFS final rule
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(87 FR 69845 through 69849), the
underserved multiplier is a proportion
ranging from zero to one of the ACO’s
assigned beneficiary population for the
performance year that is considered
underserved based on the highest of: (1)
the proportion of the ACO’s assigned
beneficiaries residing in a census block
group with an Area Deprivation Index
(ADI) national percentile rank of at least
85; or (2) the proportion of the ACO’s
assigned beneficiaries who are enrolled
in Medicare Part D low-income subsidy
(LIS) or are dually eligible for Medicare
and Medicaid. The use of both the ADI
and Medicare and Medicaid dual
eligibility or LIS status to assess
underserved populations in the health
equity adjustment allows CMS to
consider both broader neighborhood
level characteristics and individual
characteristics among CMS
beneficiaries.
The CY 2023 PFS final rule did not
state how CMS intended to compute the
proportion of beneficiaries with an ADI
national percentile rank of at least 85
with respect to beneficiaries for whom
a numeric national percentile rank value
is not available. We do not believe it is
appropriate to assign a zero to the
beneficiaries without an ADI national
percentile rank in the calculation. Doing
so would unfairly disadvantage ACOs
with such beneficiaries vis-a`-vis those
ACOs with beneficiaries that all have an
ADI national percentile rank by
lowering their scores. The CY 2023 PFS
final rule (87 FR 69846) stated that the
proportion of the ACO’s assigned
beneficiaries residing in a census block
group with an ADI national percentile
rank of at least 85 is computed using the
number of assigned beneficiaries. A
footnote stated that in computing the
proportion of beneficiaries dually
eligible for Medicare and Medicaid, we
would use for each beneficiary the
fraction of the year (referred to as person
years) in which they were eligible for
the aged/dual eligible enrollment type
or for which they were eligible for the
ESRD or disabled enrollment type and
dually eligible for Medicare and
Medicaid. In response to public
comment, we finalized the proposal to
include LIS as a modification to the
calculation of the underserved
multiplier (87 FR 69849). In calculating
the LIS proportion, CMS uses the same
methodology it adopted for calculating
dually eligible beneficiaries: person
years.
(2) Proposed Revisions
We propose to revise the underserved
multiplier calculation to specify the
calculations in more detail and bring
greater consistency between the
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calculation of the proportion of ACOs’
assigned beneficiaries residing in a
census block group with an ADI
national percentile rank of at least 85
and the proportion of ACOs’ assigned
beneficiaries who are enrolled in
Medicare Part D LIS or are dually
eligible for Medicare and Medicaid.
Specifically, we propose to remove
beneficiaries who do not have a numeric
national percentile rank available for
ADI from the health equity adjustment
calculation for performance year 2023
and subsequent performance years.
Beneficiaries without a national
percentile ADI rank would appear
neither in the numerator nor in the
denominator of the proportion.
While we established a policy for the
treatment of aligned beneficiaries for
whom an ADI national percentile rank
could not reasonably be calculated for
use in the advance investment payments
risk factors-based score (87 FR 69796
through 69797), we neither proposed
nor finalized a policy for such
beneficiaries with respect to the
calculation of the health equity
adjustment underserved multiplier—nor
do we believe the policy we finalized
for AIP is appropriate for calculating the
health equity adjustment. In the CY
2023 PFS final rule (87 FR 69800), we
finalized the use of imputing a value of
50 for the ADI national percentile rank
if there is insufficient data to match a
beneficiary to an ADI national
percentile rank for calculating AIP risk
factors-based scores. There are
important differences in the
implications of using an imputed value
of 50 for calculating the AIP risk factorsbased scores and for calculating the
underserved multiplier. The imputed
ADI ranking of 50 corresponds to the
average national ADI ranking and would
be the most neutral imputed value and
would avoid biasing an ACO’s payments
in either direction for risk factor-based
scores in the AIP calculation. The use of
an ADI ranking of 50 in the underserved
multiplier, however, would result in
that beneficiary not counting in the
numerator of the underserved multiplier
proportion because only beneficiaries
with an ADI of at least 85 are counted
in the numerator. Therefore, we are
proposing to exclude beneficiaries
without a national percentile ADI rank
from the health equity adjustment
underserved multiplier. This approach
is more equitable because it will remove
a beneficiary without an ADI rank from
the denominator and the numerator of
the calculation of an ACO’s underserved
multiplier instead of penalizing ACOs
that have such beneficiaries.
It is in the public interest to apply this
change starting with performance period
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2023. Section 1871(e)(1)(A)(ii) of the Act
authorizes the Secretary to retroactively
apply a substantive change in Medicare
regulations if the Secretary determines
that failure to apply the change
retroactively would be contrary to the
public interest. Here, applying this
change starting with performance period
2023 is in the public interest because,
absent further specification of how to
treat beneficiaries without a national
percentile ADI rank current policy may
unfairly penalize ACOs for reasons
beyond their control. Current policy
counts beneficiaries with missing ADI
ranks in the underserved multiplier
denominator and contributes zero to the
numerator, thereby reducing the health
equity adjustment for ACOs with such
beneficiaries and harming their ability
to meet the quality performance
standard and receive shared savings.
Separately, we propose to modify the
calculation of the proportion of assigned
beneficiaries dually eligible for
Medicare and Medicaid and the
calculation of the proportion of assigned
beneficiaries enrolled in LIS to use the
number of beneficiaries rather than
person years for calculating the
proportion of the ACO’s assigned
beneficiaries who are enrolled in LIS or
who are dually eligible for Medicare and
Medicaid starting in performance year
2024. For example, when calculating the
underserved multiplier component of
the health equity adjustment to an
ACO’s quality performance score for
ACOs that report the three eCQMs/MIPS
CQMs/Medicare CQMs, the proportion
would be equal to the number of
assigned beneficiaries with any months
enrolled in LIS or dually eligible for
Medicare and Medicaid divided by total
number of assigned beneficiaries. We
are not proposing to alter the calculation
of the proportion of beneficiaries
residing in a census block group with an
ADI national percentile rank of at least
85, which is already based on the
number of assigned beneficiaries.
Person years would continue to be used
in financial calculations where
beneficiary experience is stratified into
by Medicare enrollment type (ESRD,
disabled, aged/dual eligible, and aged
non/dual eligible) and it is important to
account for partial year enrollment to
ensure accuracy. The proposed policy
change would bring greater consistency
between the two proportions used in
determining the underserved multiplier.
It also acknowledges that beneficiaries
with partial year as compared to full
year LIS enrollment or dual eligibility
are also socioeconomically vulnerable
and strengthens incentives for ACOs to
serve this population. Further, inclusion
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of beneficiaries with partial year LIS
enrollment in the underserved
multiplier provides increased incentive
for ACOs to help facilitate LIS
enrollment for beneficiaries who meet
eligibility criteria.
We seek comment on these proposals.
e. Proposal To Use Historical Data To
Establish the 40th Percentile MIPS
Quality Performance Category Score
(1) Background
In the CY 2023 PFS final rule (87 FR
69858), we finalized that beginning
performance year 2024, one of the ways
for an ACO to meet the Shared Savings
Program quality performance standard
and share in savings at the maximum
rate under its track (or payment model
within a track) is for the ACO to achieve
a health equity adjusted quality
performance score that is equivalent to
or higher than the 40th percentile across
all MIPS Quality performance category
scores, excluding entities/providers
eligible for facility based-scoring.
In the CY 2022 PFS proposed and
final rules (86 FR 39274 and 86 FR
65271), we stated that, for a given
performance year, the 30th or 40th
percentile across all MIPS Quality
performance category scores would be
calculated after MIPS final scoring is
complete based on the distribution
across all MIPS Quality performance
category scores, excluding entities/
providers eligible for facility-based
scoring. Therefore, we are not able to
provide performance rate information
prior to or during the performance year.
Nevertheless, we stated that we believe
that publicly displaying prior year
performance scores that equate to the
30th and 40th percentile across all MIPS
Quality performance category scores for
the applicable performance year would
still provide helpful information for
ACOs to determine what level of quality
performance they would need to meet in
order to satisfy the quality performance
standard under the Shared Savings
Program. We stated that we would
release this historical information on the
Shared Savings Program website when
it becomes available.
In the CY 2022 PFS proposed rule (86
FR 39274), we also explained that
interested parties have expressed
concerns regarding the lack of
information on the level of quality
performance that would equate to the
30th or 40th percentile MIPS Quality
performance category score and that
would enable an ACO to be eligible to
share in savings or to avoid maximum
shared losses, if applicable. We noted
that interested parties have expressed
concern that these data are not publicly
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available prior to the start of a
performance year and that they do not
believe that ACOs have a way of
determining what quality score they
would need to achieve to meet the
quality performance standard.
In the CY 2022 PFS proposed rule (86
FR 39274), we also solicited comment
on whether publicly displaying prior
year performance scores that equate to
the 30th or 40th MIPS Quality
performance category scores would help
to address ACOs’ concerns regarding the
lack of advance information regarding
the quality performance score they must
meet in order to satisfy the quality
performance standard under the Shared
Savings Program. Several commenters
supported publicly displaying prior year
performance scores that equate to the
30th or 40th percentile across all MIPS
Quality category performance scores,
and one commenter expressed concern
that publicly displaying prior year
performance scores is not the optimal
way to address concerns of interested
parties and indicated that performance
is volatile and the 30th (or 40th)
percentile may change significantly
from year to year depending upon
changes in quality performance in MIPS
(86 FR 65271).
We clarified in the CY 2023 PFS
proposed rule (87 FR 46148) and final
rule (87 FR 69867) that we use the
submission-level MIPS Quality
performance category scores
(unweighted distribution of scores) to
determine the 30th percentile and 40th
percentile MIPS Quality performance
category scores for purposes of
establishing the applicable quality
performance standard under the Shared
Savings Program. In light of public
comments and concerns about the
predictability of the 40th percentile
MIPS Quality performance category
score due to changes in MIPS scoring
policies over time—including MIPS
scoring changes impacting measures
that lack a benchmark or case minimum
as described at § 414.1380(b)(1)(i)(A),
measure achievement points as
described at paragraph (b)(1)(i), new
measures (years 1 and 2 of a measure’s
use) as described at paragraph
(b)(1)(i)(C), new sub-group reporting
option as described at § 414.1318(a), and
MIPS High Priority and End to End
Bonus Points as described at
§ 414.1380(b)(1)(v)—and as a result of
the concerns expressed by ACOs and
other interested parties and as we gain
experience with aligning Shared
Savings Program reporting and scoring
policies with MIPS, we believe that a
revised methodology is needed to
calculate the 40th percentile MIPS
Quality performance category score for
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the quality performance standard for
performance year 2024 and subsequent
performance years.
As MIPS scoring policies evolve over
time, changes in MIPS scoring policy
have the potential to adjust the year-toyear comparability of MIPS Quality
performance category scores. Between
performance years 2022 and 2023, there
were MIPS policy changes to measures
that lack a benchmark or case minimum
as described at § 414.1380(b)(1)(i)(A),
measure achievement points as
described at paragraph (b)(1)(i), new
measures (years 1 and 2 of a measure’s
use) as described at paragraph
(b)(1)(i)(C), and a new sub-group
reporting option as described at
§ 414.1318(a). Additionally, MIPS High
Priority and End to End Bonus Points
were sunset in performance year 2022 as
described at § 414.1380(b)(1)(v). The
projected 40th percentile MIPS Quality
performance category score for
performance year 2023 does not reflect
these proposed methodological changes.
To minimize reliance on a single year of
performance data, the use of multiple
years of historical data could be used to
‘‘smooth’’ out the impact of MIPS
scoring policy changes on the quality
performance standard in any one year.
At the same time, using too many years
of data to average scores might include
a greater number of years that don’t
reflect current policies.
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(2) Proposed Revisions
For performance year 2024 and
subsequent performance years, we
propose to use historical submissionlevel MIPS Quality performance
category scores to calculate the 40th
percentile MIPS Quality performance
category score. Specifically, we propose
to use a rolling 3-performance year
average with a lag of 1 performance year
(for example, the 40th percentile MIPS
Quality performance category score
used for the quality performance
standard for performance year 2024
would be based on averaging the 40th
percentile MIPS Quality performance
category scores from performance years
2020 through 2022). We believe that our
proposal to use a 3-year historical
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average is consistent with the proposal
under section IV.A.4.h.(2) of this
proposed rule that would permit, for
purposes of establishing a performance
threshold as identified in § 414.1405(b),
a time span of up to three consecutive
performance periods for performance
year 2024 and subsequent performance
years.
We would provide ACOs with the
performance score that equates to the
40th percentile MIPS Quality
performance category score that would
be used as the quality performance
standard for a given performance year
prior to the start of the performance year
(for example, the 40th percentile MIPS
Quality performance category score
based on historical data and applicable
for performance year 2024 would be
released on the Shared Savings Program
website in December 2023).
The use of 3 historical base years
would mitigate issues that may arise
from using a single year historical
reference such as scoring, policy, and/
or performance anomalies, such as a
pandemic, specific to the historical base
year. Additionally, the use of historical
data would allow additional time for
data availability and limit the potential
impact of MIPS Targeted Review as
described at § 414.1385 and other MIPS
scoring corrections. This approach is
also responsive to the concerns ACOs,
and other interested parties have with
the predictability of the current method
of calculating the 40th percentile MIPS
Quality performance category score.
However, we acknowledge that by using
historical benchmarks, the benchmark
would not reflect the most recent
policies, measure specifications, and
scores. For example, the historical base
years are 2–4 years removed from the
performance year and could reflect data
that may have anomalies specific to the
base year that would render those data
inconsistent with the performance
year’s quality performance.
Additionally, changes to measure
specifications for measures included in
the APP measure set may result in the
historical base period including
measures that are different than the
corresponding measures that were
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applicable during the performance year.
This could further reduce the
comparability of historic base year data
with the performance year’s quality
performance data.
Table 29 shows the 40th percentile
MIPS Quality performance category
scores for performance years 2018
through 2021 based on the current
methodology as published in the CY
2023 PFS final rule (87 FR 69868). The
proposed methodology would be
effective for performance year 2024 and
subsequent performance years. We have
added to Table 29 the projected 40th
percentile MIPS Quality performance
category scores for performance years
2022 and 2023 based on the proposed
methodology for illustrative purposes.
The projected 40th percentile MIPS
Quality performance category score
used for the quality performance
standard for performance year 2022 is
based on the average of the 40th
percentile MIPS Quality performance
category scores from performance years
2018 through 2020, and the projected
40th percentile MIPS Quality
performance category score used for the
quality performance standard for
performance year 2023 is based on the
average of the 40th percentile MIPS
Quality performance category scores
from performance years 2019 through
2021. The years are averaged at equal
weights. For example, we would
calculate the projected 40th percentile
MIPS Quality performance category
score used for the quality performance
standard for performance year 2022 by
first summing the 2018 (70.80), 2019
(70.82), and 2020 (75.59) 40th percentile
Quality performance category score
values to arrive at a value of 217.21
[70.80 + 70.82 + 75.59 = 217.21]. We
would then divide the value of 217.21
by three (the number of years included
in the historical reference period) to
arrive at a projected 40th percentile
MIPS Quality performance category
score of 72.40 for 2022 [217.21 ÷ 3 =
72.40]. Note that this example illustrates
averaging the 2018, 2019, and 2020 40th
percentile MIPS Quality performance
category score values.
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We seek comment on our proposal to
use a 3-performance year rolling average
with a lag of 1-performance year to
calculate the 40th percentile MIPS
Quality performance category score
used for the quality performance
standard for performance year 2024 and
subsequent performance years. Using a
1-year lag would help ensure the
availability of base period data by
limiting the possibility that data
availability is negatively impacted by
scoring, policy, and/or performance
anomalies from the prior performance
year. In the development of our
proposal to use a 3-performance year
rolling average with a lag of 1performance year to calculate the 40th
percentile MIPS Quality performance
category score used for the quality
performance standard for performance
year 2024 and subsequent performance
years, we considered another alternative
methodology, which was to establish a
historical quality performance standard
based on the year immediately prior to
the performance year’s quality
performance score across all MIPS
Quality performance category scores,
excluding entities/providers eligible for
facility-based scoring. We also seek
comment on other alternative
methodologies we should consider to
calculate the 40th percentile MIPS
Quality performance category score for
the quality performance standard.
f. Proposal To Apply a Shared Savings
Program Scoring Policy for Excluded
APP Measures
(1) Background
In the CY 2021 PFS final rule (85 FR
84720 through 84734), we finalized an
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approach that aligns the Shared Savings
Program quality performance scoring
methodology with the MIPS scoring
methodology. We also stated that for
each quality measure that an ACO
submits that has significant changes, the
total available measure achievement
points are reduced by 10 points under
the APP under current MIPS scoring
policy (§ 414.1380(b)(1)(vii)(A)) (85 FR
84725)). In the CY 2021 PFS final rule
(85 FR 84901), we finalized policies at
§ 414.1380(b)(1)(vii)(A) to provide that
for each measure under MIPS that is
submitted, if applicable, and impacted
by significant changes, performance is
based on data for 9 consecutive months
of the applicable CY performance
period. If such data are not available or
may result in patient harm or
misleading results, the measure is
excluded from a MIPS eligible
clinician’s total measure achievement
points and total available measure
achievement points. We stated that
‘‘significant changes’’ means changes to
a measure that are outside the control of
the clinician and its agents and may
result in patient harm or misleading
results. Significant changes include, but
are not limited to, changes to codes
(such as ICD–10, CPT, or HCPCS codes),
clinical guidelines, or measure
specifications. As described at
§ 414.1380(b)(1)(vii)(A), measures that
are excluded due to significant changes
are excluded from a MIPS eligible
clinician’s total measure achievement
points and total available measure
achievement points.
In performance year 2022, two of the
eCQMs/MIPS CQMs that are part of the
APP measure set were excluded from
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MIPS measure achievement points and
total available measure achievement
points for the MIPS Quality
performance category under
§ 414.1380(b)(1)(vii)(A). Specifically, the
eCQM version of the Preventive Care
and Screening: Screening for Depression
and Follow-up Plan measure (Quality ID
#134) and the Controlling High Blood
Pressure measure (Quality ID #236)
were excluded. Thus, under MIPS
scoring policies, ACOs reporting one or
both of these measures had their total
measure achievement points and total
available measure achievement points
reduced by 10 (for reporting one
measure) or 20 (for reporting both
measures) points, respectively. Under
the APP, these ACOs were still required
to report all 6 measures; however, their
performance year 2022 MIPS Quality
performance category score was based
on the 4 or 5 non-excluded measures
(depending on whether the ACO
reported one or both excluded
measures) in the APP measure set.
Consequently, the resulting MIPS
Quality performance category score for
an ACO that would have performed well
on the excluded quality measures would
be lower than it otherwise would have
been if those measures were not
excluded. Alternatively, if an ACO
would have performed poorly on the
excluded quality measures, then the
resulting MIPS Quality performance
category score would be higher than it
otherwise would have been if those
measures were not excluded. In either
scenario, an ACO is required to report
quality performance for all measures
under the APP and has no control over
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whether and which measures are
excluded.
(2) Proposed Revisions
Given that the Shared Savings
Program does not determine which
quality measures are excluded and that
ACOs do not have a choice of measures
they can report under the APP, we do
not want to adversely impact shared
savings determinations for events
outside the ACOs’ control, such as in
the event a measure is excluded.
Therefore, we are proposing that, for
performance year 2024 and subsequent
performance years, if (1) an ACO reports
all required measures under the APP
and meets the data completeness
requirement at § 414.1340 for all
required measures and receives a MIPS
Quality performance category score
under § 414.1380(b)(1), and (2) the
ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score for the performance year
is reduced due to measure exclusion
under § 414.1380(b)(1)(vii)(A), then we
would use the higher of the ACO’s
health equity adjusted quality
performance score or the equivalent of
the 40th percentile MIPS Quality
performance category score across all
MIPS Quality performance category
scores, excluding entities/providers
eligible for facility-based scoring, to
determine whether the ACO meets the
quality performance standard required
to share in savings at the maximum rate
under its track (or payment model
within a track), for the relevant
performance year. This policy aims to
alleviate the potential adverse impacts
to shared savings determinations that
may arise in the event that one or more
of the quality measures required under
the APP is excluded. We are also
proposing to make conforming changes
to the regulation text § 425.512 by
revising paragraph (a)(5)(i) and adding
paragraph (a)(7).
We finalized in the CY 2023 PFS final
rule (87 FR 69845) that unscored
measures are removed from the
calculation of an ACO’s health equity
adjustment, effectively receiving a
performance scaler of 0 for those
measures. However, we inadvertently
did not codify this policy in the Code
of Federal Regulations. Therefore, in
this proposed rule, we are proposing to
codify this policy by revising
§ 425.512(b)(3)(ii)(B) to state that CMS
assigns a value of 0 for each measure
that CMS does not evaluate because the
measure is unscored. We propose that
the regulation text changes would be
effective for performance year 2023 and
subsequent performance years as the
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policy was finalized in the CY 2023 PFS
final rule to calculate the health equity
adjustment for performance year 2023
and subsequent performance years.
We are also proposing that quality
measures impacted by the MIPS policy
at § 414.1380(b)(1)(vii)(A) are unscored
measures for the purposes of calculating
the health equity adjustment; therefore,
excluded measures would not render an
ACO ineligible for the health equity
adjustment as long as the ACO reports
all required measures under the APP
and meets the data completeness
requirement at § 414.1340 for all
required measures and receives a MIPS
Quality performance category score
under § 414.1380(b)(1).
As discussed in section
IV.A.4.g.(1)(c)(i) of this proposed rule,
we are proposing a change to the MIPS
policy to remove the 10 percent
threshold for changes to codes, clinical
guidelines, or measure specifications for
all measure types. We believe that our
proposal to apply a floor to an ACO’s
Quality performance category score in
determining the ACO’s quality
performance standard in the event that
the ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score for the performance year
is reduced under
§ 414.1380(b)(1)(vii)(A) functions in
concert with our proposal under section
IV.A.4.g.(1)(c)(i) of this proposed rule.
We refer readers to section
IV.A.4.g.(1)(c)(i) of this proposed rule
for further discussion of our proposal to
change the MIPS scoring policy.
adds additional survey administration
cost to the organization.
g. Proposal To Require Spanish
Language Administration of the CAHPS
for MIPS Survey
h. Proposals To Align CEHRT
Requirements for Shared Savings
Program ACOs With MIPS
(1) Background
(1) Background
CMS has created official translations
of the CAHPS for MIPS survey in 7
languages, including Spanish,
Cantonese, Korean, Mandarin,
Portuguese, Russian, and Vietnamese
(81 FR 77386), in addition to the
required administration of English
survey. However, use of these
translations is mostly voluntary, with
the exception of a requirement to
administer the Spanish translation of
the CAHPS for MIPS Survey for patients
residing in Puerto Rico. Organizations
(groups, virtual groups, subgroups, and
APM entities) that elect CAHPS for
MIPS must contract with a CMSapproved survey vendor to administer
the survey and must request survey
translations for the vendor to administer
the survey in an optional language.
Generally, the use of survey translations
Many of our programs require the use
of certified electronic health record
(EHR) technology (CEHRT), including
the Quality Payment Program, Shared
Savings Program, and other value-based
payment initiatives. With respect to the
Shared Savings Program, section
1899(b)(2)(G) of the Act requires
participating ACOs to define processes
to report on quality measures and
coordinate care, such as through the use
of telehealth, remote patient monitoring,
and other such enabling technologies. In
addition, section 1899(b)(3)(D) of the
Act authorizes the Secretary to
incorporate reporting requirements and
incentive payments from section 1848 of
the Act into the Shared Savings
Program, such as requirements and
payments related to electronic
prescribing and electronic health
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(2) Proposed Revisions
As discussed in section
IV.A.4.f.(1)(c)(ii) of this proposed rule,
we are proposing to require Spanish
language administration of the CAHPS
for MIPS survey for MIPS eligible
clinicians reporting MIPS. Specifically,
we are proposing to require MIPS
eligible clinicians to contract with a
CMS-approved survey vendor that, in
addition to administering the survey in
English, will administer the Spanish
survey translation to Spanish-preferring
patients using the procedures detailed
in the CAHPS for MIPS Quality
Assurance Guidelines beginning with
2024 survey administration. This should
better ensure that we are assessing the
experience of patients who are Spanishspeaking and with limited English
proficiency, and is part of our efforts to
advance health equity. We refer readers
to section IV.A.4.f.(1)(c)(ii) of this
proposed rule for further discussion of
our proposal related to the CAHPS for
MIPS survey. In addition, we are
interested in gathering information
directly from organizations that
administer the CAHPS for MIPS Survey
on whether they consider to request the
vendor to administer the survey in one
or more of the available survey
translations based on the language
preferences of patients. We are also
interested in learning about the factors
that more or less likely affect the
administration of survey translations
where there is need for one or more of
the available translations.
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records, including using alternative
criteria for determining whether to make
such incentive payments. Pursuant to
these authorities, we have incorporated
reporting requirements related to the
adoption and use of CEHRT in our
regulations, including specifically crossreferencing the Quality Payment
Program’s definition of CEHRT (42 CFR
414.1305) in our regulatory definition of
CEHRT at § 425.20. For the Shared
Savings Program and Quality Payment
Program, CEHRT currently is defined at
§ 414.1305 as EHR technology (which
could include multiple technologies)
certified by the Office of the National
Coordinator for Health Information
Technology (ONC) under the ONC
Health IT Certification Program as
meeting the 2015 Edition Base EHR
definition, set forth at 45 CFR 170.102,
and a designated set of the 2015 Edition
health information technology (IT)
certification criteria as further provided
therein.
The Health Information Technology
for Economic and Clinical Health Act
(HITECH Act), sections 13001 through
13424 of the American Recovery and
Reinvestment Act of 2009 (ARRA) (Pub.
L. 111–5, February 17, 2009),
established ONC under the Department
of Health and Human Services,
authorizing ONC to adopt standards for
certifying health IT. ONC has codified
its standards, implementation
specifications, certification criteria, and
certification program for health IT under
45 CFR part 170. Specifically, ONC has
codified its certification criteria for
health IT, including EHRs, at 45 CFR
170.315. Currently referred to as the
‘‘2015 Edition health IT certification
criteria.’’ For more information
regarding ONC’s current policies,
standards, and certification
requirements for health IT, please refer
to 45 CFR part 170, particularly
§ 170.315, and the ONC Certification of
Health IT website at: https://
www.healthit.gov/topic/certificationehrs/certification-health-it.
In the CY 2019 PFS final rule (83 FR
59982 through 59988), we adopted three
key requirements related to ACOs use of
CEHRT, beginning with the performance
years starting on January 1, 2019.
First, ACOs must certify annually, at
the end of each performance year, that
the percentage of eligible clinicians
participating in the ACO who use
CEHRT to document and communicate
clinical care to their patients or other
health care providers meets or exceeds
the applicable percentage during the
current performance year. The ACO’s
eligible clinicians must use CEHRT that
meets the definition in our regulation at
§ 425.20, which provides that CEHRT
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has the same meaning as under the
Quality Payment Program at § 414.1305.
Specifically, we updated our regulations
at § 425.506(f) to reflect that, beginning
with the performance years starting on
January 1, 2019:
• ACOs in a track that does not meet
the financial risk standard to be an
Advanced APM, which includes ACOs
participating under BASIC track Levels
A through D, must certify annually that
at least 50 percent of the eligible
clinicians participating in the ACO use
CEHRT to document and communicate
clinical care to their patients or other
health care providers.
• ACOs in a track that meets the
financial risk standard to be an
Advanced APM, which includes ACOs
participating under BASIC track Level E
or the ENCHANCED track, must certify
annually that the percentage of eligible
clinicians participating in the ACO that
use CEHRT to document and
communicate clinical care to their
patients or other health care providers
meets or exceeds the threshold
established under the Quality Payment
Program at § 414.1415(a)(1)(i). Under
this requirement, for Performance
Periods beginning in 2019, 75 percent of
eligible clinicians must use CEHRT to
document and communicate clinical
care to their patients or health care
providers.
Second, we also revised the Shared
Savings Program requirements for data
submission and certifications at
§ 425.302(a)(3)(iii) to require the ACO to
certify at the end of each performance
year, that the percentage of eligible
clinicians participating in the ACO that
use CEHRT to document and
communicate clinical care to their
patients or other health care providers
meets or exceeds the applicable
percentage specified by CMS at
§ 425.506(f).
Finally, we updated our regulations at
§ 425.20 to incorporate the definition of
CEHRT at § 414.1305 that applies under
the Quality Payment Program. The
Quality Payment Program’s regulation at
§ 414.1305 defines CEHRT as EHR
technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that meets the 2015 Edition Base EHR
definition at 45 CFR 170.102 and has
been certified as meeting certain other
criteria set forth in ONC’s 2015 Edition
health IT certification criteria at 45 CFR
170.315 as further described in
§ 414.1305. Applying the Shared
Savings Program’s definition at § 425.20,
ACOs under the Shared Savings
Program must use EHR technology
meeting the Quality Payment Program’s
definition of CEHRT at § 414.1305to
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meet the requirements set forth in our
regulation at § 425.506(f). As discussed
in section III.R. of this proposed rule, in
the Health Data, Technology, and
Interoperability: Certification Program
Updates, Algorithm Transparency, and
Information Sharing proposed rule (88
FR 23758), which appeared in the April
18, 2023 Federal Register, ONC has
proposed to discontinue the yearthemed ‘‘editions,’’ which ONC first
adopted in 2012, to distinguish between
sets of health IT certification criteria
finalized in different rules. ONC is
proposing to instead maintain a single
set of ‘‘ONC Certification Criteria for
Health IT,’’ which would be updated in
an incremental fashion in closer
alignment to standards development
cycles and regular health information
technology (IT) development timelines
(88 FR 23750). As further discussed in
section III.R. of this proposed rule, we
are proposing to modify the Quality
Payment Program’s definition of CEHRT
at § 414.1305 to flexibly incorporate any
changes by ONC to its definition of Base
EHR and its certification criteria for
Health IT.
(2) Removing CEHRT Use Threshold
Requirements and Requiring Reporting
of the MIPS Promoting Interoperability
Performance Category
In order to streamline CEHRT
threshold requirements for ACOs and
align with the Quality Reporting
Program’s Merit-Based Incentive
Payment System (MIPS), we propose to
sunset the Shared Savings Program
CEHRT threshold requirements and
modify our regulations at § 425.506(f) to
indicate that they will be applicable
only through performance year 2023.
We further propose, for performance
years beginning on or after January 1,
2024, unless otherwise excluded, to
require that all MIPS eligible clinicians,
Qualifying APM Participants (QPs), and
Partial Qualifying APM Participants
(Partial QPs) (each as defined at
§ 414.1305 of this subchapter)
participating in the ACO, regardless of
track, satisfy all of the following:
• Report the MIPS Promoting
Interoperability (PI) performance
category measures and requirements to
MIPS according to 42 CFR part 414
subpart O as either of the following—
++ All MIPS eligible clinicians, QPs,
and partial QPs participating in the
ACO as an individual, group, or virtual
group; or
++ The ACO as an APM entity.
• Earn a MIPS performance category
score for the MIPS Promoting
Interoperability performance category at
the individual, group, virtual group, or
APM entity level.
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A MIPS eligible clinician, QP, Partial
QP, or ACO as an APM entity may be
excluded from the requirements
proposed at § 425.507(a) if the MIPS
eligible clinician, QP, Partial QP, or
ACO as an APM entity—
• Does not exceed the low volume
threshold set forth at
§ 414.1310(b)(1)(iii);
• Is an eligible clinician as defined at
§ 414.1305 who is not a MIPS eligible
clinician and has opted to voluntarily
report measures and activities for MIPS
as set forth in § 414.1310(b)(2); or
• Has not earned a performance
category score for the MIPS Promoting
Interoperability performance category
because the MIPS Promoting
Interoperability performance category
has been reweighted in accordance with
applicable policies set forth at
§ 414.1380(c)(2).
We propose to codify this new
requirement at § 425.507.
Specifically, we propose that any
requirements applicable to MIPS
eligible clinicians reporting on
objectives and measures specified by
CMS for the MIPS PI category would
apply to MIPS eligible clinicians, QPs,
and Partial QPs participating in an ACO
at § 425.507(a). We further propose that
if any of these requirements for a MIPS
eligible clinician reporting for the MIPS
PI category, including objectives and
measures, are amended through
rulemaking (such as adoption,
modification, or removal of an objective
or measure), then the new or modified
requirements will also be applicable to
MIPS eligible clinicians, QPs, and
Partial QPs participating in an ACO
under § 425.507. For instance, in section
IV.A.4.f.(4) of this proposed rule, we are
proposing several modifications to the
MIPS PI performance category’s
requirements, including modifying the
performance period at § 414.1320 as
well as specific measures such as the
High Priority Safety Assurance Factors
for EHR Resilience (SAFER) Guides
measure. To the extent these or other
policies are finalized through
rulemaking, then these requirements
would also be applicable to ACO
participants as provided by our proposal
here.
To further align with applicable
requirements for the MIPS Promoting
Interoperability performance category,
we are proposing that MIPS eligible
clinicians, QPs, Partial QPs, and ACOs
as APM entities may be exempt from
our proposed regulation at § 425.507(a)
if the MIPS eligible clinician, QP, Partial
QP, or ACO as an APM entity: (1) does
not exceed the low volume threshold set
forth at § 414.1310(b)(1)(iii); (2) is an
eligible clinician as defined at
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§ 414.1305 who is not a MIPS eligible
clinician and has opted to voluntarily
report measures and activities for MIPS
as set forth in § 414.1310(b)(2); or (3) has
not earned a performance category score
for the MIPS Promoting Interoperability
performance category because the MIPS
Promoting Interoperability performance
category has been reweighted in
accordance with applicable policies set
forth at § 414.1380(c)(2). However, if
such MIPS eligible clinicians, QPs, and
Partial QPs do report the MIPS PI
performance category as an individual,
group, or virtual group or the ACO
reports MIPS PI performance category as
an APM entity, the MIPS eligible
clinicians, QPs, and Partial QP the
exemption would not apply for
purposes of satisfying our proposed
regulation at § 425.507.
Exclusions to MIPS eligible clinicians
described at § 414.1310(b)(1)(iii) include
eligible clinicians who do not exceed
the MIPS low volume threshold. Eligible
clinicians who are not MIPS eligible
clinicians have the option to voluntarily
report measures and activities for MIPS
as described at § 414.1310(b)(2).
Federally Qualified Health Centers
(FQHC) or Rural Health Clinics (RHC)
who provide services that are billed
exclusively under the FQHC or RHC
payment methodologies may voluntarily
report the MIPS PI performance category
as a group, virtual group, or APM entity.
MIPS eligible clinicians, QPs, and
Partial QPs practicing in FQHCs or
RHCs who provide services that are
billed exclusively under FQHC or RHC
payment methodologies may voluntarily
report the MIPS PI performance category
as an individual, group, virtual group,
or APM entity. It is important to note
that exclusions to MIPS eligible
clinicians as described at
§ 414.1310(b)(1)(i) and (ii) are not
applicable to our proposal at § 425.507
because QPs and Partial QPs are
required to report MIPS PI performance
category for purposes of satisfying the
Shared Savings Program proposal at
§ 425.507. Examples of applicable
exclusions under § 414.1380(c)(2) for
reweighting of the MIPS PI performance
category include, but are not limited to,
the following:
• MIPS eligible clinicians, QPs, and
Partial QPs participating in the ACO
who are granted a hardship exception
under § 414.1380(c)(2)(i)(C) at the
individual, group, virtual group, or
APM entity level.
• MIPS eligible clinicians, QPs, and
Partial QPs that are eligible for
reweighting of the PI performance
category at the individual, group, virtual
group, or APM entity level as described
at § 414.1380(c)(2)(i)(A)(4).
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• MIPS eligible clinicians, QPs, and
Partial QPs that are eligible for
reweighting of the PI performance
category as described at
§ 414.1380(c)(2)(i)(A)(4).
We believe that incorporating MIPS PI
performance category’s requirements
into the Shared Savings Program will
alleviate the burden that the current
policy creates for ACOs. Because the
Shared Savings Program CEHRT
attestation requirement and the MIPS PI
category requirements are not the same,
ACOs have the burden of managing
compliance with two different CEHRT
program requirements. In finalizing the
Shared Savings Program CEHRT
attestation in the CY 2019 PFS, we
stated our desire to continue to promote
and encourage CEHRT use by ACOs and
their ACO participants and ACO
providers/suppliers, and our desire to
better align with the goals of the Quality
Payment Program and the criteria for
participation in certain alternative
payment models tested by the
Innovation Center (83 FR 59983). Given
our unified goal and vision for the use
of CEHRT, we believe our proposal at
§ 425.507 will allow ACOs to focus on
a unified set of program requirements
for the use of CEHRT and reduce the
administrative burden of managing
compliance with a different set of
program requirements with the same
aim.
While ACOs would be able to report
the MIPS PI category at the individual,
group, virtual group, or APM entity
level for purposes of satisfy our
proposal at § 425.507, we encourage
ACOs to evaluate reporting the MIPS PI
performance category at the APM entity
level for purposes of satisfying the
Shared Savings Program regulation
proposed at § 425.507. In the CY 2023
PFS final rule, we finalized a policy to
introduce a voluntary reporting option
for APM entities to report the MIPS PI
performance category at the APM entity
level beginning with the CY 2023
performance period (87 FR 70033). For
purposes of MIPS scoring and payment
adjustments, if the ACO reports the
MIPS PI performance category at the
APM entity level, the APM entity PI
performance category score would be
used to generate the APM entity level
score for purposes of scoring the MIPS
PI performance category. If the ACO
does not report PI at APM entity level,
the ACO’s individual and group scores
would be calculated as a weighted
average up to the APM entity level to
generate the APM entity level score for
purposes of scoring the MIPS PI
performance category. If an eligible
clinician reports PI at the individual or
group level under traditional MIPS or
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the APM Performance Pathway (APP) in
addition to reporting the MIPS PI
performance at the APM entity level via
the APP, for purposes of MIPS scoring
and payment adjustments, that eligible
clinician would receive the higher of
their individual, group, or APM entity
PI performance category score. For more
information about reporting the PI
performance category at the APM entity
level, we direct readers to the MIPS
Promoting Interoperability User Guide,
which is updated each performance
year, in the QPP Resource library
https://qpp.cms.gov/resources/resourcelibrary. We anticipate releasing subregulatory guidance for ACOs that
participate in the Shared Savings
Program about voluntarily reporting the
MIPS PI performance category at the
APM entity level in future performance
years.
We are seeking public comment on
our proposal that, for performance years
beginning on or after January 1, 2024,
unless otherwise excluded, to require
that all MIPS eligible clinicians,
Qualifying APM Participants (QPs), and
Partial Qualifying APM Participants
(Partial QPs) (each as defined at
§ 414.1305) participating in the ACO,
regardless of track, satisfy all of the
following:
• Report the MIPS Promoting
Interoperability (PI) performance
category measures and requirements to
MIPS according to 42 CFR part 414
subpart O as either of the following—
++ All MIPS eligible clinicians, QPs,
and partial QPs participating in the
ACO as an individual, group, or virtual
group; or
++ The ACO as an APM entity.
• Earn a MIPS performance category
score for the MIPS Promoting
Interoperability performance category at
the individual, group, virtual group, or
APM entity level.
A MIPS eligible clinician, QP, Partial
QP, or ACO as an APM entity may be
excluded from the requirements
proposed at § 425.507(a) if the MIPS
eligible clinician, QP, Partial QP, or
ACO as an APM entity—
• Does not exceed the low volume
threshold set forth at
§ 414.1310(b)(1)(iii);
• Is an eligible clinician as defined at
§ 414.1305 who is not a MIPS eligible
clinician and has opted to voluntarily
report measures and activities for MIPS
as set forth in § 414.1310(b)(2); or
• Has not earned a performance
category score for the MIPS Promoting
Interoperability performance category
because the MIPS Promoting
Interoperability performance category
has been reweighted in accordance with
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applicable policies set forth at
§ 414.1380(c)(2).
We propose to codify this new
requirement at § 425.507.
We are also seeking public comment
on an alternative proposal to narrow the
proposal to require that ACOs to report
the measures and requirements under
the MIPS PI performance category, in
accordance with our regulations at 42
CFR part 414 subpart O, at the APM
entity level. This alternative proposal
would remove the option for MIPS
eligible clinicians, Qualifying APM
Participants (QPs), and Partial
Qualifying APM Participants (Partial
QPs) (each as defined at § 414.1305)
participating in the ACO to report the
MIPS PI performance category at the
individual, group, or virtual group level
for purposes of satisfying our proposal
at § 425.507.
(3) Updating Public Reporting
Requirements
As described in the CY 2019 final rule
(80 FR 32813 through 32815), we
believe that one important aspect of
patient-centered care is patient
engagement and transparency, which
can be achieved by the public reporting
of ACO quality and cost performance.
Public reporting helps to hold ACOs
accountable and may improve a
beneficiary’s ability to make informed
health care choices as well as facilitate
an ACO’s ability to improve the quality
and efficiency of its care. To ensure our
public reporting requirements reflect
our proposal to require reporting of
objectives, measures, and activities
under the MIPS PI performance category
as discussed above, we also are
proposing to require ACOs to publicly
report the number of MIPS eligible
clinicians, Qualifying APM Participants
(QPs), and Partial Qualifying APM
Participants (Partial QPs) (each as
defined at § 414.1305) participating in
the ACO that earn a MIPS performance
category score for the MIPS Promoting
Interoperability performance category at
the individual, group, virtual group, or
APM entity level as proposed at
§ 425.507. We are proposing to codify
this requirement at § 425.308(b)(9).
We are proposing that MIPS eligible
clinicians, QPs, and Partial QPs who
would be excluded from reporting
under the proposed regulation at
§ 425.507(b) as discussed previously
may be excluded from the number of
MIPS eligible clinicians, QPs, or Partial
QPs that the ACO publicly reports
under our proposed regulation at
§ 425.308(b)(9). However, if such MIPS
eligible clinicians, QPs, and Partial QPs
do report the MIPS PI performance
category as an individual, group, or
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virtual group or the ACO reports the
MIPS PI performance category as an
APM entity, the MIPS eligible
clinicians, QPs, and Partial QPs should
be included in the number of MIPS
eligible clinicians, QPs, and Partial QPs
that the ACO publicly reports under our
proposed regulation at § 425.308(b)(9).
(4) Updating Annual Certification
Requirements
As noted in section III.G.2.h.(2) of this
proposed rule, we believe that
incorporating MIPS PI performance
category’s requirements will alleviate
confusion for ACOs and the use of
CEHRT under the Shared Savings
Program. Additionally, we find that the
MIPS PI performance category’s
reporting requirements are more
comprehensive and better address the
key functions that facilitate better care
coordination and quality measurement
for ACOs. This change would further
align the Shared Savings Program with
the MIPS program and allow for greater
insight into CEHRT use among ACO
clinicians.
Currently, under § 425.302(a)(3)(iii),
at the end of each performance year,
ACOs must certify that the percentage of
eligible clinicians participating in the
ACO that use CEHRT to document and
communicate clinical care to their
patients or other health care providers
meets or exceeds the applicable CEHRT
threshold percentage specified at
§ 425.506(f). As discussed in section
III.G.2.h.(4). of this proposed rule, we
are proposing to sunset the Shared
Savings Program CEHRT threshold
requirements and modify § 425.506(f) to
indicate that they will end with
performance year 2023.
To ensure our certification
requirements align with our proposal in
section III.G.2.h.(2) of this proposed
rule, we also propose to revise our
regulation at § 425.302(a)(3)(iii) to make
the current Shared Savings Program
Annual Certification requirement
applicable for only performance years
2019 through 2023. That is, we are
proposing to sunset the CEHRT
certification requirement in the Shared
Savings Program by amending
regulations to no longer require ACO
clinicians to report the percentage of
eligible clinicians participating in the
ACO that use CEHRT to document and
communicate clinical care to their
patients or other health care providers
meets or exceeds the applicable
percentage specified at § 425.506(f).
We are seeking public comment on
our proposal to sunset the CEHRT
certification requirement in the Shared
Savings Program at §§ 425.302(a)(3)(iii)
and 425.506(f) and to add new
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requirements at § 425.507, for
performance years beginning on or after
January 1, 2024, unless otherwise
excluded, to require that all MIPS
eligible clinicians, Qualifying APM
Participants (QPs), and Partial
Qualifying APM Participants (Partial
QPs) (each as defined at § 414.1305)
participating in the ACO, regardless of
track, satisfy all of the following:
• Report the MIPS Promoting
Interoperability (PI) performance
category measures and requirements to
MIPS according to 42 CFR part 414
subpart O as either of the following—
++ All MIPS eligible clinicians, QPs,
and partial QPs participating in the
ACO as an individual, group, or virtual
group; or
++ The ACO as an APM entity.
• Earn a MIPS performance category
score for the MIPS Promoting
Interoperability performance category at
the individual, group, virtual group, or
APM entity level.
A MIPS eligible clinician, QP, Partial
QP, or ACO as an APM entity may be
excluded from the requirements
proposed at § 425.507(a) if the MIPS
eligible clinician, QP, Partial QP, or
ACO as an APM entity—
• Does not exceed the low volume
threshold set forth at
§ 414.1310(b)(1)(iii);
• Is an eligible clinician as defined at
§ 414.1305 who is not a MIPS eligible
clinician and has opted to voluntarily
report measures and activities for MIPS
as set forth in § 414.1310(b)(2); or
• Has not earned a performance
category score for the MIPS Promoting
Interoperability performance category
because the MIPS Promoting
Interoperability performance category
has been reweighted in accordance with
applicable policies set forth at
§ 414.1380(c)(2).
We also seek comment on our
proposal to add a new requirement for
public reporting in § 425.308(b)(9),
requiring that the ACO must publicly
report the number of MIPS eligible
clinicians, Qualifying APM Participants
(QPs), and Partial Qualifying APM
Participants (Partial QPs) (each as
defined at § 414.1305) participating in
the ACO that earn a MIPS performance
category score for the MIPS Promoting
Interoperability performance category at
the individual, group, virtual group, or
APM entity level as proposed at
§ 425.507.
i. MIPS Value Pathway (MVP) Reporting
for Specialists in Shared Savings
Program ACOs—Request for Information
(RFI)
In the CY 2021 PFS proposed rule (85
FR 50232 and 50233), we proposed that
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for performance year 2021 and
subsequent performance years, ACOs
would be assessed on a measure set
under the APP for Shared Savings
Program ACOs. As part of finalizing the
APP measure set (85 FR 34727), we
stated that the transition to the APP
measure set was intended to reduce
reporting burden and eliminate
differences in the way ACOs are scored
compared to their MIPS eligible
clinicians, while also moving toward a
more outcome-based, primary care
focused measure set. Additionally, we
stated that we selected the measures to
be included because they are broadly
applicable for the primary care
population and population health goals
that are associated with the Shared
Savings Program.
We received public comments raising
concerns about the challenges and
applicability of these measures to
specialists that are part of their ACOs
(85 FR 34727). Commenters provided
feedback that: reducing the number of
ACO quality measures would make
specialists less likely to participate in
the Shared Savings Program; the
proposed measures are not relevant to
ophthalmology specialty practices and
suggested that the same measure sets
used in MIPS be permitted for reporting
through the APP or a protocol be put in
place to determine if the measures are
relevant to the clinicians reporting
under the APP; CMS should work with
interested parties to refine the current
set of measures to make it more
appropriate for ACOs, which are
responsible for total cost of care for the
populations they serve; CMS should
clarify if the outcome measures selected
are representative of all of the different
types of populations that ACOs treat
and recommended that CMS take
patient compliance and case mix into
consideration when selecting measures
because some patients may take longer
to achieve health goals and ACOs may
not have the same relative volume of
patients with diagnoses such as diabetes
and hypertension.
In the CY 2022 PFS proposed rule (86
FR 39270), we solicited comments on
reporting options for specialist
providers within an ACO. Specifically,
we stated that we have heard from
interested parties that the population
health/primary care focused measures
in the APP are not applicable for
specialist providers within an ACO. We
noted in the final rule that we may
consider feedback we received to inform
future rulemaking (86 FR 65264).
In the CY 2022 PFS final rule (86 FR
65376), MVPs were finalized to be
available for reporting beginning with
the CY 2023 performance period of
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52437
MIPS, with the notion that MVPs will be
implemented through notice and
comment rulemaking over the next few
years to offer clinically relevant quality
reporting for specialists and more
granular specialty data (through
subgroup reporting) for patients to make
informed decisions about the care they
receive. In the CY 2022 PFS final rule
(86 FR 65376), MVPs were finalized to
be available for reporting beginning
with the CY 2023 performance period of
MIPS, with the notion that MVPs will be
implemented through notice and
comment rulemaking over the next few
years to offer clinically relevant quality
reporting for specialists and more
granular specialty data (through
subgroup reporting) for patients to make
informed decisions about the care they
receive. Building upon our commitment
to align quality measures across CMS,150
we direct readers to section IV.A.4.a. of
this proposed rule where we propose to
create a primary care MVP. We note that
the primary care MVP would create
continuity between the primary care
measures assessed under MIPS and the
measures providers would be
accountable for in the Medicare Shared
Savings Program.
In light of the public comments
described above and the finalization and
continued development of the MVPs,
we believe we need incentives for
specialists in Shared Savings Program
ACOs to report clinically relevant
quality measures and to allow patients,
referring clinicians, and ACOs to have
more information regarding specialists
involved in patient care. We believe that
encouraging specialists to report on
MVPs will lead to increased specialty
engagement in the Shared Savings
Program, thereby holding specialists
accountable for quality improvement.
Beginning in CY 2023, specialists that
report under MIPS, including specialists
that participate in Shared Savings
Program ACOs, have the option to
register to report MVPs for the
applicable CY performance period as
described at § 414.1365(b) as a group,
subgroup, or individual and to report on
relevant MVP quality measures as
described at § 414.1365(c). In this
proposed rule, we are soliciting
comments on scoring incentives that
would be applied to an ACO’s health
equity adjusted quality performance
score beginning in performance year
2025 when specialists who participate
150 Jacobs D, Schreiber M, Seshamani M, Tsai D,
Fowler E, Fleisher L. Aligning Quality Measures
across CMS—The Universal Foundation. New
England Journal of Medicine, March 2, 2023,
available at https://www.nejm.org/doi/full/10.1056/
NEJMp2215539.
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in the ACO report quality MVPs as
described at § 414.1365(c)(1).
Similar to the health equity
adjustment finalized in the CY 2023 PFS
final rule (87 FR 69838), we are
considering bonus points for ACOs with
specialists reporting quality MVPs as
described at § 414.1365(c)(1) that would
be applied after MIPS scoring is
complete. ACOs may receive up to a
maximum of 10 additional points added
to their ACO’s health equity adjusted
quality performance score if they meet
the data completeness requirement at
§ 414.1340 and receives a MIPS Quality
performance category score under
§ 414.1380(b)(1), in addition to
administering the CAHPS for MIPS
survey. In addition to specialists that
participate in the ACO reporting quality
MVPs described at § 414.1365(c)(1), an
ACO would be required to report all
measures in the APP measure set, meet
the data completeness requirement at
§ 414.1340 and receives a MIPS Quality
performance category score under
§ 414.1380(b)(1) to be eligible for bonus
points.
Our overarching intent is to have
specialists participate in ACOs in a
meaningful way and to collect quality
data that is comparable to data reported
by other specialty providers in quality
MVPs. We are seeking feedback on our
overall approach to align quality
measures in the Adult Universal
Foundation with measures used for
evaluation in the Medicare Shared
Savings Program. We are also seeking
feedback on the following aspects of
MVP reporting for specialists in Shared
Savings Program ACOs:
• In order to highlight specialty
clinical practice within ACOs, how
should we encourage specialist
reporting of MVPs?
• How should we encourage the
reporting of MVPs to collect quality data
that is comparable to data reported by
other specialty providers in quality
MVPs and to address clinician concerns
over measure appropriateness?
• How should we consider
encouraging specialists to report the
MVP that is most relevant to their
clinical practice?
• How should we distinguish bonus
points for ACOs that report on a larger
volume of patients through MVPs?
• How should we provide ACOs with
bonus points to their health equity
adjusted quality performance score
when an ACO’s specialty clinicians
report MVPs?
• What concerns and considerations
should we be aware of when assessing
ACOs for quality performance based on
reporting quality measures within
MVPs?
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• Would incentivizing specialty
MVPs create a disincentive for ACOs to
report primary care focused APP and/or
MVP measures?
• In the event that MIPS quality
measures in MVPs are excluded under
§ 414.1380(b)(1)(vii)(A), should we
apply the proposed Shared Savings
Program scoring policy for excluded
APP measures as described in section
III.G.2.f. of this proposed rule?
• As noted above, providing ACOs
with bonus points to their health equity
adjusted quality performance score
when ACOs’ specialty clinicians report
MVPs serves to encourage reporting of
MVPs. Therefore, we do not intend to
establish bonus points as a permanent
policy. We seek comment on how long
we should have bonus points in place
in order to incentivize MVP reporting.
• Once specialists are reporting
MVPs, overall aggregate specialty
performance within an ACO could be
assessed. We seek comment on if and
how CMS should consider assessing
overall specialty performance as part of
the APP in the future.
We note that in section IV.A.1.b.(2) of
this proposed rule, we included an RFI
on how we can leverage MIPS policies
to enable more Medicare beneficiaries to
benefit from accountable care
relationships within APMs and provide
rigorous performance standards for
those clinicians who report MVPs and
remain in MIPS.
j. Proposal To Revise the Requirement
To Meet the Case Minimum
Requirement for Quality Performance
Standard Determinations
(1) Background
We require ACOs to meet the case
minimum requirement at § 414.1380 to
determine the quality performance
standard for ACOs in the first
performance year of their first
agreement period, for the eCQM/MIPS
CQM incentive for performance year
2024, and for the extreme and
uncontrollable circumstances policy
(§ 425.512(a)(2), (a)(5)(i)(A)(2), (c)(3)).
Section 414.1380 includes policies
related to all of MIPS scoring and is not
specific to the Quality performance
category. Further, the phrase ‘‘case
minimum’’ is mentioned in multiple
paragraphs at § 414.1380. The broad
reference to § 414.1380 under
§ 425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3)
does not specify which paragraph at
§ 414.1380 is applicable when applying
case minimum for purposes of
determining an ACO’s quality
performance standard. We believe that
the references to meeting the case
minimum requirement at § 414.1380 in
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the context of determining an ACO’s
quality performance standard under
§ 425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3)
is not sufficient in describing our
policy’s intent, which is to apply the
MIPS Quality performance category
scoring policies as described at
§ 414.1380(b)(1) in determining the ACO
quality performance standard.
(2) Proposed Revisions
In order to alleviate confusion
regarding the reference to case
minimum in determining the ACO
quality performance standard, for
performance year 2024 and subsequent
performance years, we propose to
replace the references to meeting the
case minimum requirement at
§ 414.1380 from § 425.512(a)(2),
(a)(5)(i)(A)(2), and (c)(3) with the
requirement that the ACO must receive
a MIPS Quality performance category
score under § 414.1380(b)(1) in order to
meet the quality performance standard.
This proposal would correct the
purpose of our reference to case
minimums by incorporating all of the
applications of case minimums in the
MIPS Quality performance category
scoring policies in our policies to
determine an ACO’s quality
performance standard under the Shared
Savings Program. For example, under
current policy at
§ 414.1380(b)(1)(i)(A)(2)(ii) in
performance year 2024, if an ACO does
not meet the case minimum requirement
on an administrative claims-based
measure, that measure would be
excluded from the ACO’s MIPS Quality
performance category measure
achievement points (numerator) and
total available measure achievement
points (denominator). If the ACO in this
example meets the data completeness
requirement at § 414.1340 for the ten
CMS Web Interface measures or the
three eCQMs/MIPS CQMs/Medicare
CQMs and administers a CAHPS for
MIPS survey, the ACO would receive a
MIPS Quality performance category
score. The resulting MIPS Quality
performance category score in this
example would be used to determine
the ACO’s quality performance standard
under the Shared Savings Program.
All ACOs that participated in the
Shared Savings Program were affected
by an extreme and uncontrollable
circumstance as described at
§ 425.512(c)(1) for performance years
2021, 2022, and 2023 due to the
COVID–19 public health emergency. We
believe that any unintended impact of
meeting the case minimum requirement
at § 414.1380 in evaluating an ACO’s
quality performance standard for
performance years 2021, 2022, and 2023
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was mitigated by the application of the
extreme and uncontrollable
circumstance policy. Specifically, it is
not our intent to exclude an ACO who
received a MIPS Quality performance
category score, but reported less than 20
cases on any measure(s) in the APP
measure set from achieving the quality
performance standard under
§ 425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3),
if that ACO is otherwise eligible to meet
the quality performance standard.
Separately, we propose to address a
gap in the current rule regarding the
‘‘minimum beneficiary sampling
requirement’’ at § 414.1380(b)(1)(vii)(B).
This provision provides for a 10-point
reduction in the total available measure
achievement points for MIPS eligible
clinicians that submit five measures or
fewer and register for the CAHPS for
MIPS survey but do not meet the
minimum beneficiary sampling
requirement. As the case minimum is
not applicable to the CAHPS for MIPS
survey, we did not intend to preclude
ACOs that do not meet the minimum
beneficiary sampling requirement to
field a CAHPS for MIPS survey from
meeting the Shared Savings Program
quality performance standard or the
alternative quality performance
standard. We propose revisions to the
following regulation text sections:
• At § 425.512(a)(2)(ii) and (iii), we
propose to replace the phrase ‘‘case
minimum requirement at § 414.1380 of
this subchapter’’ with the phrase
‘‘receives a MIPS Quality performance
category score under § 414.1380(b)(1) of
this subchapter.’’
Additionally, we propose to replace
the phrase ‘‘CAHPS for MIPS survey’’
with the phrase ‘‘CAHPS for MIPS
survey (except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter).’’ To read as follows: For
the first performance year of an ACO’s
first agreement period under the Shared
Savings Program, the ACO would meet
the quality performance standard under
the Shared Savings Program, if:
++ For performance year 2024, the
ACO reports data via the APP and meets
the data completeness requirement at
§ 414.1340 of this subchapter on the ten
CMS Web Interface measures or the
three eCQMs/MIPS CQMs/Medicare
CQMs, and the CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter), and receives a MIPS
Quality performance category score
under § 414.1380(b)(1) of this
subchapter.
++ For performance year 2025 and
subsequent performance years, the ACO
reports data via the APP and meets the
data completeness requirement at
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§ 414.1340 of this subchapter on the
three eCQMs/MIPS CQMs/Medicare
CQMs and the CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter), and receives a MIPS
Quality performance category score
under § 414.1380(b)(1) of this
subchapter
• At § 425.512(a)(5)(i)(A)(2), we
propose to remove the phrase ‘‘and the
case minimum requirement at
§ 414.1380 of this subchapter.’’ As
follows: For performance year 2024,
under the eCQM/MIPS CQM reporting
incentive, the ACO would meet the
quality performance standard used to
determine eligibility for shared savings
and to avoid maximum shared losses, as
applicable, if the ACO: (1) meets the
data completeness requirement at
§ 414.1340 for all three eCQMs/MIPS
CQMs; (2) achieves a quality
performance score equivalent to or
higher than the 10th percentile of the
performance benchmark on at least one
of the four outcome measures in the
APP measure set and (3) achieves a
quality performance score equivalent to
or higher than the 40th percentile of the
performance benchmark on at least one
of the remaining five measures in the
APP measure set.
++ We are not including a
requirement under
§ 425.512(a)(5)(i)(A)(2) for the ACO to
receive a MIPS Quality performance
category score under § 414.1380(b)(1).
As described at § 414.1380(b)(1)(vii), the
MIPS Quality performance category
score is the sum of all the measure
achievement points divided by the sum
of total available measure achievement
points for the quality performance
category. Therefore, we do not believe
that it would be appropriate to require
an ACO to receive a MIPS Quality
performance category score in
determining whether the ACO met the
Shared Savings Program quality
performance standard based on
measure-level performance (such as in
the case of the eCQM/MIPS CQM
reporting incentive).
• At § 425.512(c)(3), we propose to
remove the phrase ‘‘case minimum’’ for
performance 2024 and subsequent
performance years and replace with the
phrase ‘‘receives a MIPS Quality
performance category score under
§ 414.1380(b)(1) of this subchapter.’’ To
read as follows: Under the extreme and
uncontrollable circumstances policy, for
performance year 2024 and subsequent
performance years, if the ACO reports
quality data via the APP and meets the
data completeness requirement at
§ 414.1340 of this subchapter and
receives a MIPS Quality performance
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52439
category score under § 414.1380(b)(1) of
this subchapter, CMS would use the
higher of the ACO’s health equity
adjusted quality performance score or
the equivalent of the 40th percentile
MIPS Quality performance category
score across all MIPS Quality
performance category scores, excluding
entities/providers eligible for facilitybased scoring, for the relevant
performance year.
We are proposing to revise
§ 425.512(a)(5)(iii)(A) and (B) to read as
follows:
• For performance year 2024, the
ACO does not report any of the ten CMS
Web Interface measures, any of the three
eCQMs/MIPS CQMs/Medicare CQMs
and does not administer a CAHPS for
MIPS survey (except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter) under the APP.
• For performance year 2025 and
subsequent years, the ACO does not
report any of the three eCQMs/MIPS
CQMs/Medicare CQMs and does not
administer a CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter) under the APP.
Additionally, we propose to add
clarifying language to the proposed
redesignated paragraph (b)(2) of
§ 425.512 on calculating an ACO’s
health equity adjusted quality
performance score as follows:
• For performance year 2024 and
subsequent performance years, CMS
will calculate the ACO’s health equity
adjusted quality performance score as
the sum of: the ACO’s MIPS Quality
performance category score for all
measures in the APP measure set, and
the ACO’s health equity adjustment
bonus points calculated in accordance
with paragraph (b)(3) of this section, to
which the sum of these values may not
exceed 100 percent, if the following
requirements are met: (1) The ACO
reports the three eCQMs/MIPS CQMs/
Medicare CQMs in the APP measure set;
(2) meets the data completeness
requirement at § 414.1340 for the three
eCQMs/MIPS CQMs/Medicare CQMs;
and (3) administers the CAHPS for MIPS
survey (except as specified in
§ 414.1380(b)(1)(vii)(B)).
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3. Determining Beneficiary Assignment
Under the Shared Savings Program
a. Proposed Modifications to the StepWise Assignment Methodology and
Approach To Identifying the Assignable
Beneficiary Population
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(1) Background
(a) Background on Assignment
Methodology
Section 1899(c)(1) of the Act, as
amended by the CURES Act and the
Bipartisan Budget Act of 2018, provides
that the Secretary shall determine an
appropriate method to assign Medicare
FFS beneficiaries to an ACO based on
their utilization of primary care services
provided by physicians in the ACO and,
in the case of performance years
beginning on or after January 1, 2019,
services provided by a FQHC or RHC.
As we have explained in earlier
rulemaking, the term ‘‘assignment’’ for
purposes of the Shared Savings Program
in no way implies any limits,
restrictions, or diminishment of the
rights of Medicare FFS beneficiaries to
exercise freedom of choice in the
physicians and other health care
practitioners from whom they receive
covered services. In the context of the
Shared Savings Program, ‘‘assignment’’
refers to an operational process by
which Medicare will determine whether
a beneficiary has chosen to receive a
sufficient level of certain primary care
services from physicians and other
health care practitioners associated with
a specific ACO so that the ACO may be
appropriately designated as exercising
basic responsibility for that beneficiary’s
care.151
The regulations governing the
assignment methodology under the
Shared Savings Program are in 42 CFR
part 425, subpart E. Under claims-based
assignment, we determine a Medicare
FFS beneficiary is assigned to an ACO
if the beneficiary meets the criteria in
§ 425.401(a) to be eligible for assignment
to an ACO, and the beneficiary’s
utilization of primary care services
meets the criteria established under the
assignment methodology specified in
§§ 425.402 and 425.404. Section 425.402
specifies a step-wise assignment
methodology for determining an ACO’s
assigned beneficiary population based
on beneficiaries’ use of primary care
services. In accordance with
§ 425.402(b)(1), as a ‘‘pre-step’’ in the
two-step claims-based assignment
process, CMS identifies all beneficiaries
who had at least one primary care
service furnished by a physician who is
151 See for example, 76 FR 67851, and 83 FR
67863.
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an ACO professional in the ACO and
who is a primary care physician as
defined under § 425.20 or has one of the
primary specialty designations specified
in § 425.402(c). This pre-step is
designed to satisfy the statutory
requirement under section 1899(c)(1) of
the Act that beneficiaries be assigned to
an ACO based on their use of primary
care services furnished by physicians
participating in the ACO. Beneficiaries
who meet the pre-step requirement are
then assigned to an ACO through either
one of two steps specified in
§ 425.402(b)(3) and (b)(4).
Under the first step of the assignment
process, a beneficiary who is eligible for
assignment and meets the pre-step
requirement is assigned to an ACO if the
allowed charges for primary care
services furnished to the beneficiary
during the assignment window by
primary care physicians, nurse
practitioners, physician assistants, and
clinical nurse specialists who are ACO
professionals in the ACO are greater
than the allowed charges for primary
care services furnished during the
assignment window by primary care
physicians, nurse practitioners,
physician assistants, or clinical nurse
specialists who are ACO professionals
in any other ACO, or not affiliated with
any ACO and identified by a Medicareenrolled billing TIN. The second step of
the assignment methodology applies to
the remainder of the beneficiaries who
are eligible for assignment and meet the
pre-step requirement, who have not had
a primary care service rendered during
the assignment window by any primary
care physician, nurse practitioner,
physician assistant, or clinical nurse
specialist, either inside or outside the
ACO. The beneficiary will be assigned
to an ACO if the allowed charges for
primary care services furnished to the
beneficiary during the assignment
window by physicians who are ACO
professionals with specialty
designations specified in § 425.402(c)
are greater than the allowed charges for
primary care services furnished during
the assignment window by physicians
with such specialty designations who
are ACO professionals in any other
ACO, or who are unaffiliated with an
ACO and are identified by a Medicareenrolled billing TIN.
The Shared Savings Program stepwise assignment process is offered in
two similar, but distinct, claims-based
assignment methodologies, prospective
assignment and preliminary prospective
assignment with retrospective
reconciliation. Consistent with the
requirements of section 1899(c)(2)(A) of
the Act, we offer all Shared Savings
Program ACOs the opportunity to select
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their assignment methodology annually,
starting with agreement periods
beginning on July 1, 2019. We use the
same step-wise assignment methodology
under § 425.402 to assign beneficiaries
to ACOs under prospective assignment
and ACOs under preliminary
prospective assignment with
retrospective reconciliation.
In the June 2015 final rule (80 FR
32699) we finalized the definition of
‘‘assignment window’’ under § 425.20
to mean the 12-month period used to
assign beneficiaries to an ACO. As
described in the December 2018 final
rule, the assignment window for ACOs
under prospective assignment is a 12month period offset from the calendar
year (for example, October through
September preceding the calendar year),
while for ACOs under preliminary
prospective assignment with
retrospective reconciliation, the
assignment window is the 12-month
period based on the calendar year (83
FR 67861). Operationally, in
determining beneficiary assignment for
each performance year and benchmark
year, we identify allowed charges for
services billed under the HCPCS and
CPT codes included in the applicable
definition of primary care services
under § 425.400(c), and according to the
step-wise assignment methodology
specified in subpart E of the Shared
Savings Program’s regulations, during
all months of the 12-month period of the
assignment window.
The step-wise assignment
methodology was initially established
with the November 2011 final rule and
was modified through subsequent
rulemaking. For instance, with the June
2015 final rule, we modified the
approach to include claims for primary
care services furnished by nonphysician practitioners (nurse
practitioners, physician assistants, and
clinical nurse specialists) in step one of
the assignment methodology rather than
in step two, and to exclude services
provided by certain physician
specialties from step two of the
assignment process. We refer readers to
the November 2011 final rule and the
June 2015 final rule for a discussion of
the relevant background and related
considerations (see 76 FR 67853 through
67858, and 80 FR 32748 through 32755).
Generally, as we have previously
explained in rulemaking, the step-wise
assignment methodology maintains the
statutory requirement to conduct
claims-based beneficiary assignment
based on beneficiaries’ utilization of
physician primary care services,
recognizing the necessary and
appropriate role of certain specialists in
providing primary care services, such as
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in areas with primary care physician
shortages (see, for example, 76 FR 67853
through 67855; see also 80 FR 32748
and 32754). Further, including services
furnished by nurse practitioners,
physician assistants, and clinical nurse
specialists in determining where a
beneficiary has received the plurality of
primary care services in step one of the
assignment methodology helps ensure
that a beneficiary is assigned to the ACO
whose ACO participants are actually
providing the plurality of primary care
for that beneficiary, and thus, should be
responsible for managing the patient’s
overall care, or is not assigned to any
ACO if the plurality of the beneficiary’s
primary care is furnished by
practitioners in a non-ACO entity (see,
for example, 80 FR 32748).
Various Shared Savings Program
operations are based on the ACO’s
assigned population, or consider the
size of the ACO’s assigned population,
which are summarized as follows:
• Within the Shared Savings
Program’s financial methodology:
++ CMS determines benchmark and
performance year expenditures based on
the ACO’s assigned population as
specified under subpart G of the
regulations.
++ CMS determines the counties to
include in the ACO’s regional service
area based on the ACO’s assigned
population (refer to definition of ACO’s
regional service area in § 425.20), and
uses the ACO’s assigned population in
determining the share of assignable
beneficiaries in the ACO’s regional
service area that are assigned to the
ACO (see §§ 425.601(a)(5)(v) and
425.652(a)(5)(v)) which is applied in
calculating the two-way blend of
national and regional growth rates used
to trend forward BY1 and BY2
expenditures to BY3 according to
§§ 425.601(a)(5)(iv) and 425.652(a)(5)(iv)
and as part of the blended growth rates
used to update the benchmark according
to §§ 425.601(b) and 425.652(b)(2). CMS
also uses the ACO’s regional service
area to determine the regional
adjustment to the ACO’s historical
benchmark according to § 425.656.
++ CMS considers the proportion of
the ACO’s assigned beneficiary
population that is dually eligible for
Medicare and Medicaid and the
difference between the ACO’s weighted
average prospective HCC risk score for
BY3 taken across the four Medicare
enrollment types and when calculating
the offset factor applied to negative
regional adjustments (see
§ 425.656(c)(4)).
++ CMS considers the size of the
ACO’s assigned population in
calculating the proration factor when
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determining the ACO’s eligibility for the
prior savings adjustment (see
§ 425.658(b)(3)) as well as in
determining the minimum savings rate
(MSR)/minimum loss rate (MLR) for
ACOs that select the option to have their
MSR/MLR calculated based on the
number of beneficiaries assigned to the
ACO (refer to § 425.605(b)(2)(i)(C)
(BASIC track) and § 425.610(b)(1)(iii)
(ENHANCED track)).
++ CMS determines average
prospective HCC risk scores for assigned
beneficiaries for purposes of adjusting
assigned beneficiary expenditures for
severity and case mix (refer to
§§ 425.601(a)(3), 425.601(a)(10),
425.605(a)(1), 425.610(a)(2),
425.652(a)(3), and 425.652(a)(10)),
adjusting for differences in severity and
case mix between the ACO’s assigned
beneficiary population and the
assignable beneficiary population for
the ACO’s regional service area
according to §§ 425.601(a)(8)(i)(C) and
425.656(b)(3), and adjusting the flat
dollar amount ACPT for differences in
severity and case mix between the
ACO’s BY3 assigned beneficiary
population and the national assignable
FFS population according to
§ 425.660(b)(4).
• In determinations related to an
ACO’s eligibility for participation for
the Shared Savings Program:
++ CMS determines expenditures
based on the ACO’s assigned population
when identifying if the ACO is a high
revenue or low revenue ACO (as defined
under § 425.20).
++ CMS considers whether an ACO
meets the requirement to have at least
5,000 Medicare FFS assigned
beneficiaries (see § 425.110).
++ CMS uses the ACO’s number of
assigned beneficiaries in calculating and
recalculating the amount of the
repayment mechanism required for
ACOs participating under a two-sided
model (see § 425.204(f)).
• For ACOs eligible to receive
advance investment payments (see
§ 425.630(b)), CMS considers the size of
the ACO’s assigned population and the
risk factors-based score of those
beneficiaries in determining the
quarterly payment amount (see
§ 425.630(f)).
• For ACOs that meet the reporting
requirements for receiving a health
equity adjusted quality performance
score (see § 425.512(b)), CMS considers
the proportion of the ACO’s assigned
beneficiary population that is
underserved in determining the ACO’s
health equity adjustment bonus points
(see § 425.512(b)(2)(iv)).
• For ACOs affected by an extreme
and uncontrollable circumstance, CMS
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52441
considers the proportion of the ACO’s
assigned beneficiaries residing in an
area identified under the Quality
Payment Program as being affected by
an extreme and uncontrollable
circumstance in determining the ACO’s
quality score (see § 425.512(c)(1)(i)).
CMS considers the percentage of the
ACO’s performance year assigned
beneficiary population affected by an
extreme and uncontrollable
circumstance in determining the
amount of shared losses owed by ACOs
under a two-sided model (refer to
§§ 425.605(f)(1) and 425.610(i)(1)).
• For ACOs that have established a
beneficiary incentive program,
beneficiaries assigned to an ACO who
receive a qualifying service are eligible
to receive an incentive payment (see
§ 425.304(c)(3)(ii) through (iv)).
• In accordance with the Shared
Savings Program regulations under
subpart H, CMS provides ACOs with
certain aggregate reports and
beneficiary-identifiable claims data on
the ACO’s assigned beneficiary
population.
Further, a non-claims-based process
for voluntary alignment applies to all
Shared Savings Program ACOs and is
used to supplement claims-based
assignment. Section 1899(c) of the Act,
as amended by section 50331 of the
Bipartisan Budget Act of 2018, requires
the Secretary to permit a Medicare FFS
beneficiary to voluntarily identify an
ACO professional as their primary care
provider for purposes of assignment to
an ACO. In the November 2018 final
rule (83 FR 59959 through 59964), we
finalized changes to the beneficiary
voluntary alignment policies CMS
previously established to implement the
requirements under section
1899(c)(2)(B) of the Act (refer to
§ 425.402(e), as revised). In the
November 2018 final rule (83 FR 59964),
we revised the requirements related to
primary care services and practitioner
specialties previously established for
the voluntary alignment process. As a
result of this change, a voluntarily
aligned beneficiary is no longer required
to receive a primary care service from an
ACO professional to be assigned to the
ACO in which the beneficiary’s
designated primary care clinician is
participating. Additionally, the revision
established that a beneficiary can be
voluntarily aligned to an ACO based on
their selection of any ACO professional
as their primary clinician, regardless of
the ACO professional’s specialty and
including nurse practitioners, physician
assistants, and clinical nurse specialists.
As specified in § 425.402(e)(1), and
subject to § 425.402(e)(2), assignment
under voluntary alignment supersedes
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any assignment that otherwise may have
occurred under claims-based
assignment.
(b) Background on Identification and
Uses of the Assignable Beneficiary
Population Under the Shared Savings
Program
To identify the assignable beneficiary
population, which is used in program
financial calculations, we apply a
similar logic as is used to identify the
Medicare beneficiaries who can be
assigned to an ACO in the pre-step to
the claims-based assignment
methodology (see, for example, 81 FR
5843, and 81 FR 37985). In the June
2016 final rule (81 FR 37950), we
finalized policies to use the assignable
beneficiary population (a subset of the
larger population of Medicare FFS
beneficiaries) as the basis of certain
calculations that had previously been
based on the overall Medicare FFS
population, including expenditures
used to trend and update ACOs’
historical benchmarks and to establish
the truncation thresholds used in
expenditure calculations. In the June
2016 final rule, we finalized the
definition of ‘‘assignable beneficiary’’
under § 425.20 to mean a Medicare FFS
beneficiary who receives at least one
primary care service with a date of
service during a specified 12-month
assignment window from a Medicareenrolled physician who is a primary
care physician or who has one of the
specialty designations included in
§ 425.402(c). We specified that the
assignable population used to calculate
national and regional benchmarking
factors was to be identified using the 12month calendar year assignment
window corresponding to the
benchmark or performance year for all
ACOs, regardless of assignment
methodology which applied to the ACO,
which at that time was determined by
an ACO’s track (see 81 FR 37985
through 37988). We explained our belief
that using assignable beneficiaries
across all program calculations based on
national and regional FFS expenditures
would result in factors that are generally
more comparable to ACO expenditures
than factors based on the overall
Medicare FFS population, which can
include non-utilizers of health care
services and other beneficiaries not
eligible for assignment (see, for
example, 81 FR 5843 and 5844).
In the CY 2023 PFS final rule (87 FR
69929 through 69932), we finalized a
modification to this policy, applicable
for agreement periods beginning on
January 1, 2024, and in subsequent
years, to calculate risk-adjusted regional
expenditures and the share of assignable
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beneficiaries assigned to an ACO using
county-level values based on the
assignable population identified using
an assignment window that is consistent
with the ACO’s assignment
methodology selection for the
applicable performance year. (Refer to
§§ 425.652(a)(5)(v)(A) and (b)(2)(iv)(A),
and 425.654(a)(1)(i).) Under this
approach, for ACOs selecting
prospective assignment, we will use an
assignable population of beneficiaries
that is identified based on the offset
assignment window (for example,
October through September preceding
the calendar year) and for ACOs
selecting preliminary prospective
assignment with retrospective
reconciliation, we will use an assignable
population of beneficiaries identified
based on the calendar year assignment
window (87 FR 69930). We also
specified in the CY 2023 PFS final rule
that we would continue to compute all
factors used in calculations that are
based on the national assignable FFS
population using an assignable
population identified based on the
calendar year assignment window.
(Refer to 87 FR 69931.) For ACOs
participating under agreement periods
beginning on or after July 1, 2019, and
before January 1, 2024, we will continue
to identify the assignable population
that is the basis for calculating national
and regional factors using the 12-month
period based on a calendar year, which
aligns with the assignment window for
preliminary prospective assignment
with retrospective reconciliation,
regardless of the ACO’s assignment
methodology. (See § 425.601. See also,
87 FR 69929, for a description of
relevant background.)
The assignable beneficiary population
is used in various calculations under the
Shared Savings Program, including the
following:
• CMS determines the 99th percentile
of national Medicare fee-for-service
expenditures for assignable beneficiaries
for purposes of truncating beneficiary
expenditures in order to minimize
variation from catastrophically large
claims (see §§ 425.601(a)(4) and (c)(3),
425.605(a)(3), 425.610(a)(4)(ii),
425.652(a)(4), and 425.654(a)(3)).
• CMS determines average county
fee-for-service expenditures based on
expenditures for the assignable
population of beneficiaries in each
county of an ACO’s regional service area
(see §§ 425.601(c) and 425.654(a)) for
purposes of calculating the ACO’s
regional fee-for-service expenditures
(see §§ 425.601(d) and 425.654(b)). CMS
also determines the share of assignable
beneficiaries in the ACO’s regional
service area that are assigned to the
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ACO (see §§ 425.601(a)(5)(v) and
425.652(a)(5)(v)). The ACO’s regional
fee-for-service expenditures and the
share of assignable beneficiaries in the
ACO’s regional service area that are
assigned to the ACO are used in the
following calculations:
++ Trend forward BY1 and BY2
expenditures to BY3 according to
§§ 425.601(a)(5) and 425.652(a)(5).
++ Determine the blended growth
rates used to update the benchmark
according to §§ 425.601(b) and
425.652(b)(2).
++ Determine the adjustment to the
ACO’s benchmark according to
§§ 425.601(a)(8) and 425.652(a)(8).
• CMS determines national per capita
fee-for-service expenditures for
assignable beneficiaries for purposes of
capping the regional adjustment to the
ACO’s historical benchmark according
to §§ 425.601(a)(8)(ii)(C) and
425.656(c)(3), capping the prior savings
adjustment according to
§ 425.652(a)(8)(iv), and determining a
flat dollar amount ACPT according to
§ 425.660(b)(3).
• CMS determines national growth
rates for assignable beneficiaries that are
used to trend forward BY1 and BY2
expenditures to BY3 according to
§§ 425.601(a)(5)(ii) and 425.652(a)(5)(ii)
and to determine the blended growth
rates used update the benchmark
according to §§ 425.601(b)(2) and
425.652(b)(2)(i).
• CMS determines average
prospective HCC risk scores for
assignable beneficiaries for purposes of
adjusting county fee-for-service
expenditures for severity and case mix
of assignable beneficiaries in the county
according to §§ 425.601(c)(4) and
425.654(a)(4), calculating the regional
adjustment to the historical benchmark
by adjusting for differences in severity
and case mix between the ACO’s
assigned beneficiary population and the
assignable beneficiary population for
the ACO’s regional service area
according to §§ 425.601(a)(8)(i)(C) and
425.656(b)(3), and adjusting the flat
dollar amount ACPT for differences in
severity and case mix between the
ACO’s BY3 assigned beneficiary
population and the national assignable
FFS population according to
§ 425.660(b)(4).
(c) Concerns About Beneficiaries
Excluded From the Current Assignment
Methodology Based on the Pre-Step
Requirement and Definition of an
Assignable Beneficiary
CMS has established a goal that 100
percent of beneficiaries enrolled in
Original Medicare be involved in a care
relationship with accountability for
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quality and total cost of care by 2030.152
CMS has also established health equity
as a top priority through our CMS
Framework for Health Equity (2022–
2032).153 However, CMS believes that
the assignment pre-step and definition
of assignable beneficiary may create
barriers for some beneficiaries otherwise
eligible for assignment to be assigned to
ACOs. Revising the pre-step and
definition of assignable beneficiary thus
represents an opportunity to expand the
assigned and assignable populations.
ACOs and other interested parties
have also raised concerns that the
current pre-step and definition of
assignable beneficiary create barriers for
some beneficiaries to be assigned to
ACOs. For example, in previous
proposed rules, we have received input
from commenters that the pre-step
requirement, as implemented in the
current assignment methodology,
systematically excludes from
assignment beneficiaries who only
received primary care from nurse
practitioners, physician assistants, and
clinical nurse specialists. In response to
the CY 2023 PFS proposed rule, a
commenter noted that the current
claims-based assignment methodology
creates a barrier for nurse practitioners
and their patients to participate in
ACOs.154
Additional analysis by CMS has
found that expanding the assignment
methodology to allow more
opportunities for beneficiaries to be
assignable based on their receipt of
primary care services provided by nurse
practitioners, physician assistants, or
clinical nurse specialists would reduce
the barriers for underserved
beneficiaries to be assigned to ACOs. As
described in section III.G.3.a.(2)(d) of
this proposed rule, we have observed
from initial modeling of expanding the
definition of an assignable beneficiary
that such an approach could add to the
national assignable population
identified under current Shared Savings
Program policies a population of
beneficiaries that are more likely to be
disabled, be enrolled in the Medicare
Part D low-income subsidy (LIS), and
152 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.
153 Centers for Medicare & Medicaid Services, The
CMS Framework for Health Equity 2022–2032
(April 2022), available at https://www.cms.gov/files/
document/cms-framework-health-equity.pdf.
154 See comment letter from American
Association of Nurse Practitioners, to Chiquita
Brooks-LaSure, Administrator, CMS (September 6,
2022), available at https://www.regulations.gov/
comment/CMS-2022-0113-21927.
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reside in areas with higher ADI scores.
The newly assignable population of
beneficiaries also had a lower average
prospective HCC risk score, lower total
per capita-year spending, higher hospice
utilization, and a higher mortality rate
than the national assignable population
under the current definition of an
assignable beneficiary. Therefore, we
believe that adjusting the assignment
methodology within the flexibility
available under the statute so that
additional beneficiaries can be included
in the population of beneficiaries
assigned to ACOs participating in the
Shared Savings Program, and modifying
the definition of assignable beneficiary
to include a broader population, would
make meaningful steps toward greater
health equity and align with priorities
recently emphasized in our CMS
Framework for Health Equity (2022–
2032).155
(2) Proposed Revisions
(a) Overview of Proposed Revisions To
Incorporate Use of an Expanded
Window for Assignment
Section 1899(c)(1)(A) of the Act
requires that claims-based assignment to
ACOs be based on beneficiaries’
utilization of primary care services
furnished by ACO professionals who are
physicians. We are proposing to use an
expanded window for assignment in a
new step three to the claims-based
assignment process to identify
additional beneficiaries for ACO
assignment (described in section
III.G.3.a.(2)(b). of this proposed rule),
and we are proposing to modify the
definition of ‘‘assignable beneficiary’’ to
be consistent with this use of an
expanded window for assignment to
identify additional beneficiaries to
include in the assignable population
after application of the existing
methodology (described in section
III.G.3.a.(2)(c). of this proposed rule).
We propose to add a new definition of
‘‘Expanded window for assignment’’ in
§ 425.20 to mean the 24-month period
used to assign beneficiaries to an ACO,
or to identify assignable beneficiaries, or
both that includes the applicable 12month assignment window (as defined
under § 425.20) and the preceding 12
months.
To follow is a brief summary of the
proposed uses of the expanded window
for assignment, described in greater
detail elsewhere within this section of
this proposed rule. First, the proposed
addition of a step three to the
155 Centers for Medicare & Medicaid Services, The
CMS Framework for Health Equity 2022–2032
(April 2022), available at https://www.cms.gov/files/
document/cms-framework-health-equity.pdf.
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52443
beneficiary assignment methodology
would occur after the current steps one
and two and would apply only to
beneficiaries who do not meet the prestep requirement but who received at
least one primary care service during
the proposed expanded window for
assignment with an ACO professional
who is a primary care physician or a
physician who has one of the specialty
designations included in § 425.402(c).
Beneficiaries qualifying for step three
would be assigned based on the
plurality of allowed charges for primary
care services during this expanded
window for assignment. Second, the
proposed revision to the definition of an
assignable beneficiary would similarly
include beneficiaries who receive at
least one primary care service during
the proposed expanded window for
assignment from a Medicare-enrolled
physician who is a primary care
physician or who has one of the
specialty designations included in
§ 425.402(c). In combination with using
the expanded window for assignment
for identifying beneficiaries who
received at least one primary care
service from a primary care physician or
a physician whose specialty designation
is used in assignment, under both the
proposed step three for assignment and
proposed revised definition of an
assignable beneficiary, we would
continue to consider whether
beneficiaries received at least one
primary care service during the 12month assignment window. We propose
that these changes would be effective for
the performance year beginning on
January 1, 2025, and subsequent
performance years.
A number of factors informed our
consideration of the duration of the
expanded window for assignment. We
believe that a 24-month expanded
window for assignment, as opposed to
a longer period, would prioritize
primary care services that were
provided more recently. Through the
proposed modifications to the
assignment methodology and the
definition of assignable beneficiary, we
seek to better account for beneficiaries
who may be receiving their primary care
predominantly from non-physician
practitioners during the 12-month
assignment window, but who received
care from a physician in the preceding
12 months, in recognition of the
statutory requirement in section 1899(c)
of the Act that claims-based assignment
be based on receipt of primary care
services from physicians who are ACO
professionals. We believe that primary
care services furnished by nurse
practitioners, physician assistants, and
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clinical nurse specialists during the 12month assignment window could reflect
their work in clinical teams in
collaboration with and under the
supervision of physicians, and thereby
represent a continuation of the
beneficiary’s primary care relationship
with a physician from the previous year.
Furthermore, use of a 24-month
expanded window for assignment
would build on experience we have
gained and lessons learned from testing
Medicare ACO initiatives by the Center
for Medicare and Medicaid Innovation
(Innovation Center), specifically from
the use of a two-year beneficiary
alignment period in the ACO Realizing
Equity, Access, and Community Health
(REACH) Model and the Next
Generation ACO (NGACO) Model.156
We also believe it is timely to propose
modifications to the definition of
‘‘assignment window’’ under § 425.20
for improved clarity and consistency
with the programmatic applications of
the assignment window. Under the
existing definition, assignment window
means the 12-month period used to
assign beneficiaries to an ACO.
However, under existing Shared Savings
Program policies and under the
proposed changes described in this
section of this proposed rule, we use the
term assignment window in referencing
our identification of assignable
beneficiaries. Therefore, we are
proposing to modify the definition of
assignment window to mean the 12month period used to assign
beneficiaries to an ACO, or to identify
assignable beneficiaries, or both.
We seek comment on proposed
modifications to § 425.20, to revise the
definition of ‘‘assignable beneficiary,’’
‘‘assignment window,’’ and add a new
definition of ‘‘expanded window for
assignment’’.
156 See, for example, CMS, Center for Medicare &
Medicaid Innovation, ACO Realizing Equity,
Access, and Community Health (REACH) Model,
PY2023 Financial Operating Guide: Overview,
available at https://innovation.cms.gov/media/
document/aco-reach-py2023-financial-op-guide
(refer to Appendix B, Beneficiary Alignment
Procedures). See also, CMS, Center for Medicare &
Medicaid Innovation, Next Generation ACO Model
Benchmarking Methods (December 15, 2015),
available at https://innovation.cms.gov/files/x/
nextgenaco-methodology.pdf (refer to Appendix A,
Next Generation ACO Model Alignment
Procedures). In summary, under the ACO REACH
Model and NGACO Model the alignment period
consists of two alignment years. The first alignment
year is the 12-month period ending 18 months prior
to the start of the relevant performance year or base
year. The second alignment year is the 12-month
period ending 6 months prior to the start of the
relevant performance year or base year.
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(b) Proposed Revisions To Add a Step
Three to the Beneficiary Assignment
Methodology
For the performance year beginning
on January 1, 2025, and subsequent
performance years, we propose to revise
the step-wise beneficiary assignment
methodology, as described in § 425.402,
to include a step three, which would
utilize the proposed expanded window
for assignment to identify additional
beneficiaries for assignment among
Medicare FFS beneficiaries who were
not identified under the existing prestep. Specifically, step three would
identify all such beneficiaries not
identified by the pre-step criterion
specified in § 425.402(b)(1), who also
meet the following criteria:
(1) Received at least one primary care
service with a non-physician ACO
professional (nurse practitioner,
physician assistant, or clinical nurse
specialist) in the ACO during the
applicable 12-month assignment
window.
(2) Received at least one primary care
service with a physician who is an ACO
professional in the ACO and who is a
primary care physician as defined under
§ 425.20 or who has one of the primary
specialty designations included in
§ 425.402(c) during the applicable 24month expanded window for
assignment.
A beneficiary meeting the
aforementioned criteria would then be
assigned to the ACO if the allowed
charges for primary care services
furnished to the beneficiary by ACO
professionals in the ACO who are
primary care physicians, non-physician
ACO professionals, or physicians with
specialty designations included in
§ 425.402(c) during the applicable
expanded window for assignment are
greater than the allowed charges for
primary care services furnished by
primary care physicians, physicians
with specialty designations included in
§ 425.402(c), nurse practitioners (as
defined at § 410.75(b)), physician
assistants (as defined at § 410.74(a)(2)),
and clinical nurse specialists (as defined
at § 410.76(b)) who are ACO
professionals in any other ACO or not
affiliated with any ACO and identified
by a Medicare-enrolled billing TIN.
Further, in order to be assigned to an
ACO through the step-wise assignment
methodology, a Medicare FFS
beneficiary would continue to need to
meet the eligibility criteria in
§ 425.401(a) for the 12-month
assignment window, regardless of
whether the beneficiary is assigned to
an ACO in step one or two, or proposed
step three. Under the proposed
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approach, beneficiaries who do not
receive any primary care services during
the assignment window would continue
to be excluded from claims-based
assignment as they are under the current
assignment methodology. Beneficiaries
who meet the pre-step based on a 12month assignment window (as specified
in § 425.402(b)(1)) but are not assigned
to an ACO in steps one or two would
also continue to not be assigned to an
ACO as these beneficiaries would not be
considered for assignment in step three.
The proposed changes also would not
change beneficiary voluntary alignment,
which would continue to supersede
claims-based assignment, as specified in
§ 425.402(e).
As specified in § 425.400(a)(3)(ii),
beneficiaries who are prospectively
assigned to an ACO will remain
assigned to the ACO at the end of the
benchmark or performance year, unless
they meet any of the exclusion criteria
under § 425.401(b). As a result, under
claims-based assignment, a beneficiary
prospectively assigned to an ACO is not
eligible for assignment to a different
ACO for the same benchmark or
performance year.157 We propose to
continue to apply this approach for
beneficiaries prospectively assigned at
step one, step two, or proposed step
three. In other words, a beneficiary who
is assigned to an ACO based on
prospective assignment through step
one or two or proposed step three would
remain assigned to that ACO for the
benchmark or performance year (unless
they meet any of the exclusion criteria
under § 425.401(b)). Under this
approach, a beneficiary prospectively
assigned to an ACO for a benchmark or
performance year would not be assigned
to another ACO under prospective
assignment or to an ACO under
preliminary prospective assignment
with retrospective reconciliation, even if
the other ACO provides the plurality of
the beneficiary’s primary care services
during the relevant benchmark or
performance year.
The use of a 24-month expanded
window for assignment would also
require changes to the timeframe for
which we recognize additional primary
care service codes related to the COVID–
19 Public Health Emergency (PHE), as
outlined in § 425.400(c)(2). Under
§ 425.400(c)(2), we use certain
additional primary care service codes in
157 See, for example, Medicare Shared Savings
Program, Shared Savings and Losses, Assignment
and Quality Performance Standard Methodology
Specifications (version #11, January 2023), available
at https://www.cms.gov/files/document/medicareshared-savings-program-shared-savings-and-lossesand-assignment-methodology-specifications.pdf2(see section 2.3.2.2, ‘‘Prospective Assignment’’).
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determining beneficiary assignment
under § 425.400(c)(1) when the
assignment window for a benchmark or
performance year includes any month(s)
during the COVID–19 PHE (as defined
in § 400.200). In accordance with
§ 425.400(c)(2)(ii), the additional
primary care service codes are
applicable to all months of the
assignment window, when the
assignment window includes any
month(s) during the COVID–19 PHE,
with the exception of certain additional
CPT codes (99441, 99442, and 99443)
which we use in determining
assignment until they are longer payable
under Medicare FFS payment policies
(as specified under
§ 425.400(c)(2)(i)(A)(2)). We refer
readers to discussions in earlier
rulemaking for the development of this
policy, including 85 FR 84748 through
84755, 85 FR 84791 through 84793, and
86 FR 65276. We propose to modify the
regulations at § 425.400(c)(2)(i) and (ii)
to incorporate references to the
expanded window for assignment, such
that we would apply the additional
primary care service codes to all months
of the assignment window or applicable
expanded window for assignment when
the assignment window or applicable
expanded window for assignment
includes any month(s) during the
COVID–19 PHE. These proposed
changes are necessary to capture the
additional codes related to the COVID–
19 PHE when using the expanded
window for assignment in determining
assignment for a benchmark or
performance year.158
The proposed use of an expanded
window for assignment in an enhanced
step-wise assignment methodology
would result in a greater overall number
of beneficiaries assigned to ACOs. All
beneficiaries who are assigned to an
ACO under the current methodology
would continue to be assigned to an
ACO under the proposed methodology.
Under the proposed methodology, a
beneficiary who does not meet the
current pre-step requirement would also
be eligible to be assigned to an ACO if
they (a) received at least one primary
care service from a nurse practitioner,
158 See, for example, HHS Secretary Xavier
Becerra Statement on End of the COVID–19 Public
Health Emergency (May 11, 2023), available at
https://www.hhs.gov/about/news/2023/05/11/hhssecretary-xavier-becerra-statement-on-end-of-thecovid-19-public-health-emergency.html. See also
Letter to U.S. Governors from HHS Secretary Xavier
Becerra on renewing COVID–19 Public Health
Emergency (PHE), available at https://www.hhs.gov/
about/news/2023/02/09/letter-us-governors-hhssecretary-xavier-becerra-renewing-covid-19-publichealth-emergency.html (specifying the U.S.
Department of Health and Human Services is
planning for the COVID–19 PHE to end on May 11,
2023).
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physician assistant, or clinical nurse
specialist who is an ACO professional in
the ACO during the applicable
assignment window and (b) received at
least one primary care service from a
primary care physician or physician
with a specialty used in assignment who
is an ACO professional in the ACO
during the applicable expanded window
for assignment.
Under proposed changes, the 12month assignment window would
continue to represent the period used to
identify allowed charges for primary
care services received from ACO
professionals and analogous
practitioners not participating in an
ACO, for purposes of claims-based
beneficiary assignment during steps one
and two. Thus, most beneficiaries
currently assigned to an ACO under the
existing assignment methodology would
continue to be assigned to the same
ACO under the proposed changes. We
anticipate that only a very small share
of beneficiaries would be assigned to a
different ACO under the proposed
assignment methodology, and any
change in ACO assignment would be
due to the operational order in which
assignment is run and the precedence of
prospective assignment over
preliminary prospective assignment
with retrospective reconciliation.
Specifically, there may be a small share
of beneficiaries who would be
prospectively assigned to an ACO under
the proposed step three for prospective
assignment that differs from the
retrospective ACO the beneficiary is
currently assigned to under steps one or
two for preliminary prospective
assignment with retrospective
reconciliation. This precedence of
prospective assignment follows the
current assignment methodology, which
currently assigns beneficiaries via steps
one and two of prospective assignment
to an ACO that may be different than the
ACO to which the beneficiary would
have been assigned via steps one or two
if assigned to an ACO under preliminary
prospective assignment with
retrospective reconciliation. For the
average retrospective ACO, the share of
assigned beneficiaries affected by this
precedence of prospective assignment
has historically been very small,
approximately 1.3 percent from 2018
through 2021.
The proposed addition of step three
would add a population of otherwise
omitted beneficiaries by using the
expanded window for assignment to
identify the required physician visit
with an ACO professional and to
determine the plurality of allowed
charges for primary care services.
Functionally, the beneficiaries who
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would be newly assigned are
beneficiaries who received a primary
care service from an ACO professional
who is a primary care physician (as
defined under § 425.20) or who has one
of the specialty designations included in
§ 425.402(c) in the 12-month period
prior to the assignment window and
received a primary care service from a
nurse practitioner (as defined at
§ 410.75(b)), a physician assistant (as
defined at § 410.74(a)(2)), or a clinical
nurse specialist (as defined at
§ 410.76(b)) during the assignment
window. Notably, the proposed step 3
would continue to be consistent with
section 1899(c)(1)(A) of the Act, because
a beneficiary would have to have
received a primary care service from a
primary care physician or physician
with a specialty used in assignment who
is an ACO professional in the ACO
during the expanded window for
assignment to be eligible for assignment
to the ACO.
Similar to any other change that
affects beneficiary assignment, the
proposed use of an expanded window
for assignment in a step three could
impact downstream aspects of the
Shared Savings Program that rely on the
assigned population, including the
following potential effects:
• Larger populations of assigned
beneficiaries could contribute to more
ACOs meeting minimum size
requirements to participate in the
program.
• A larger assigned population would
result in lower minimum savings rates
for ACOs subject to a variable minimum
savings rate (that is, ACOs in a onesided risk model on the BASIC track’s
glide path or ACOs in a two-sided risk
model that elected a variable minimum
savings rate). Lower minimum savings
rates reflect a lower threshold for ACOs
to meet in order to share in savings.
Similarly, a larger assigned population
would result in a lower minimum loss
rate for ACOs in a two-sided risk model
with a variable minimum loss rate,
which reflects a lower threshold for
two-sided risk ACOs to meet before they
must share in losses.
• A larger assigned population would
enable higher performance payment
limits, which are based on a percentage
of an ACO’s total benchmark
expenditures. As an ACO’s assigned
beneficiary population increases, so too
do the ACO’s total benchmark
expenditures. Because the maximum
shared savings an ACO can earn is
determined as a percentage of total
benchmark expenditures, a larger
assigned population would result in a
higher performance payment limit.
Similarly, a larger assigned population
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would result in larger loss sharing limit
for ACOs in two-sided risk models
because loss sharing limits are also
determined as a percentage of aggregate
benchmarks.
• A larger assigned population could
affect an ACO’s revenue status as the
ACO’s ACO participants’ total Medicare
Parts A and B fee-for-service (FFS)
revenue would not change but the
ACO’s assigned beneficiary population’s
total Medicare Parts A and B FFS
expenditures would increase. In other
words, revenue-to-expenditure ratios
would decrease for ACOs that receive a
larger assigned beneficiary population.
Compared to the current assignment
methodology, the proposed assignment
methodology change could result in
some ACOs being identified as low
revenue instead of high revenue. As a
result, other program elements tied to
revenue status could then be affected by
the proposed changes, specifically an
ACO’s eligibility for Advance
Investment Payments.
• Changes in the assigned population
could directly affect ACOs’ average risk
scores, mix of beneficiaries across
enrollment types, regional service area,
and total expenditures during
benchmark and performance years.
Expected impacts on several other
program elements would depend on
differences in the changes observed for
beneficiaries added to the assignable
population versus beneficiaries added to
the ACO’s assigned beneficiaries. For
example, the impact of the proposed
change to the assignment methodology
on ACO performance would depend in
part on the difference in spending levels
and trends between those beneficiaries
added to the assignable population,
nationally and within an ACO’s regional
service area, versus those beneficiaries
added to the ACO’s assigned beneficiary
population. The data shared with ACOs
on their assignable and assigned
beneficiaries would change under the
proposed policy as the population of
assignable and assigned beneficiaries
changes.
We propose modifications to subpart
E of the Shared Savings Program
regulations to specify the revised
beneficiary assignment methodology.
We propose to specify the new step
three in a new provision at
§ 425.402(b)(5). We also propose
technical and conforming changes to
incorporate the revised methodology.
We propose to amend § 425.402(b)(1),
describing the existing pre-step of the
assignment methodology that would
remain applicable for step one and step
two, to refer to the identification of all
beneficiaries who had ‘‘at least one
primary care service during the
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applicable assignment window with a
physician who is an ACO professional
in the ACO and who is a primary care
physician as defined under § 425.20 or
who has one of the primary specialty
designations included in [§ 425.402(c)]’’
(emphasis added to reflect revised text).
In § 425.402(c), which indicates the
primary specialty designations used in
assignment, we propose to specify that
the listed specialties would be
considered for ACO professionals in
step two (as described in
§ 425.402(b)(4)) and the proposed step
three (which would become a new
provision at § 425.402(b)(5)) of the
assignment methodology. In
§ 425.400(a)(2)(ii), which generally
describes quarterly updates to
preliminary prospective assignment
with retrospective reconciliation, we
propose to specify that assignment
would be updated quarterly based on
the most recent 12 or 24 months of data,
as applicable, under the methodology
described in §§ 425.402 and 425.404.
Lastly, in § 425.400(a)(3)(i), which
generally describes prospective
assignment of beneficiaries to ACOs at
the beginning of each benchmark or
performance year, we propose to amend
the reference that specifies that we base
prospective assignment on the
beneficiary’s use of primary care
services in the most recent 12 months
for which data are available, to specify
instead the beneficiary’s use of primary
care services in the most recent 12
months or 24 months, as applicable, for
which data are available, using the
assignment methodology described in
§§ 425.402 and 425.404.
(c) Proposed Revisions to the Definition
of an Assignable Beneficiary
Consistent with the previously
described proposal to use an expanded
window for assignment in an enhanced
step-wise assignment methodology, we
are proposing to revise the definition of
Assignable beneficiary in § 425.20 to
include additional beneficiaries who
would be identified using the expanded
window for assignment. Under this
proposal, we would continue to utilize
the criterion in the existing definition,
under which assignable beneficiary
means a Medicare FFS beneficiary who
receives at least one primary care
service with a date of service during a
specified 12-month assignment window
from a Medicare-enrolled physician
who is a primary care physician or who
has one of the specialty designations
included in § 425.402(c). Further, for the
performance year beginning January 1,
2025 and subsequent performance years,
we propose that a Medicare fee-forservice beneficiary who does not meet
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this requirement but who meets both of
the following criteria would also be
considered an assignable beneficiary:
• Receives at least one primary care
service with a date of service during a
specified 24-month expanded window
for assignment from a Medicare-enrolled
physician who is a primary care
physician or who has one of the
specialty designations included in
§ 425.402(c).
• Receives at least one primary care
service with a date of service during a
specified 12-month assignment window
from a Medicare-enrolled practitioner
who is a nurse practitioner (as defined
at § 410.75(b)), physician assistant (as
defined at § 410.74(a)(2)), or a clinical
nurse specialist (as defined at
§ 410.76(b)).
The proposed use of an expanded
window for assignment would result in
a greater number of beneficiaries
included in the assignable population.
All beneficiaries who are currently
assignable would continue to be
assignable under the proposed revisions
to the definition of an assignable
beneficiary. Under the proposed
definition, beneficiaries who do not
receive any primary care services during
the assignment window would continue
to be excluded from the population of
assignable beneficiaries, just as they are
excluded in the current definition of an
assignable beneficiary. In other words,
the 12-month assignment window
would continue to represent the
timeframe within which beneficiaries
must receive at least one primary care
service to be identified as an assignable
beneficiary. Moreover, to identify a
broader assignable population under
this proposed approach, we believe it is
important to consider the criterion for
the beneficiary to have received a
primary care service during the 12month assignment window to be met
through a service furnished from a nonphysician practitioner (nurse
practitioner, physician assistant, and
clinical nurse specialist), or from a
primary care physician or a physician
who has one of the specialty
designations included in § 425.402(c)
(as is required under the current
definition).
The proposed approach to expanding
the assignable beneficiary population
could impact downstream aspects of the
Shared Savings Program that rely on the
assignable population, including the
following effects:
• Changes in the distribution of
expenditures among the national
assignable population could affect the
thresholds used to truncate
expenditures.
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• Changes in average per capita
expenditures and risk scores among
assignable beneficiaries in a given
benchmark year could affect the average
risk-adjusted spending within ACOs’
regional service areas, which could
affect regional adjustments.
• Differential changes in average per
capita expenditures and risk scores over
time could affect trend and update
factors that are based on changes in
expenditures for the national assignable
population and in the risk-adjusted
expenditures for the population of
assignable beneficiaries in an ACO’s
regional service area.
• Changes in average prospective
HCC risk scores for the national
assignable population could affect the
factors used to renormalize risk scores
each benchmark and performance year
and to risk-adjust the flat-dollar ACPT
amounts.
• Changes in the number of
assignable beneficiaries across ACO
regional service areas could affect
ACOs’ market shares, which determine
the weights used for blending the
national and regional benchmark trend
and update factors.
• Changes in the level of national feefor-service expenditures for the
assignable population could affect the
caps applied to the regional adjustment
and prior savings adjustment to the
historical benchmark and the
calculation of the flat-dollar ACPT
amount.
Under the current regulations, the
time period we use to identify the
assignable population that will be used
to calculate different factors used in
program financial calculations depends
on whether it is a national or regional
factor, the start date of an ACO’s
agreement period and, in some cases, an
ACO’s selected assignment
methodology. Under the proposed
revised definition of assignable
beneficiary, for all ACOs (regardless of
agreement period start date), for the
performance year beginning on January
1, 2025, and subsequent performance
years, for benchmark year and
performance year factors based on the
national assignable population, we
would identify the assignable
population using the 24-month
expanded window for assignment
comprised of the 12-month calendar
year assignment window, which aligns
with the assignment window for
preliminary prospective assignment
with retrospective reconciliation, and
the preceding 12 months. We note that
under this proposal we would also use
the 24-month expanded window for
assignment comprised of the 12-month
calendar year assignment window and
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the preceding 12 months when
identifying the assignable population for
regional factors for performance year
2025 and subsequent years for use in
calculations for ACOs that are
continuing in agreement periods that
began before January 1, 2024.
For ACOs participating in agreement
periods beginning on January 1, 2024,
and in subsequent years, for
performance year 2025 and in
subsequent years for regional factors, we
would identify the assignable
population using the 24-month
expanded window for assignment that is
consistent with the beneficiary
assignment methodology selected by the
ACO for the performance year according
to § 425.400(a)(4)(ii). That is, for ACOs
selecting preliminary prospective
assignment with retrospective
reconciliation, we would use the 24month expanded window for
assignment comprised of the 12-month
calendar year assignment window and
the preceding 12 months. For ACOs
selecting prospective assignment, the
24-month expanded window for
assignment would be comprised of the
12-month, offset assignment window
plus the preceding 12 months. For
example, we would use October 1, 2022,
to September 30, 2024, as the 24-month
expanded window for assignment to
identify the assignable population for
performance year 2025 for ACOs under
prospective assignment.
We propose technical and conforming
changes to provisions in subpart G of
the Shared Savings Program regulations
that refer to the assignment window
used to identify the assignable
beneficiary population in order to
incorporate references to the proposed
approach to using an expanded window
for assignment in identifying the
assignable population for performance
year 2025 and in subsequent years. The
regulations establishing the
benchmarking methodology for ACOs
with agreement periods beginning
before January 1, 2024, do not directly
reference the assignment window, and
thus would not require conforming
changes. However, there are
benchmarking methodology provisions
for ACOs with agreement periods
beginning on January 1, 2024, and in
subsequent years that directly refer to
the assignment window. Thus, we
propose to amend these provisions to
specify that the assignable population
would be identified for the relevant
benchmark year or the performance year
(as applicable) using the assignment
window or expanded window for
assignment that is consistent with the
beneficiary assignment methodology
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52447
selected by the ACO for the performance
year according to § 425.400(a)(4)(ii):
• In §§ 425.652(a)(5)(v)(A) and
(b)(2)(iv)(A), provisions on calculating
the county-level share of assignable
beneficiaries who are assigned to the
ACO for each county in the ACO’s
regional service area for purposes of
calculating the blended nationalregional growth rates used in trending
and updating the benchmark
(respectively).
• In the provision on redetermination
of the regional adjustment for the
second or each subsequent performance
year during the term of the agreement
period in § 425.652(a)(9)(ii).
• In the provision on the calculation
of average county FFS expenditures for
assignable beneficiaries in each county
in the ACO’s regional service area in
§ 425.654(a)(1)(i).
• In the provision on adjusting for
differences in severity and case mix
between the ACO’s assigned beneficiary
population for BY3 and the assignable
beneficiary population for the ACO’s
regional service area for BY3, in
calculating average per capita
expenditures for the ACO’s regional
service area, in § 425.656(b)(3).
Similarly, we also propose to specify
in the proposed new provision at
§ 425.655(b)(1) that the assignable
population that would be used to
calculate average county prospective
HCC and demographic risk scores for
purposes of calculating the proposed
regional risk score growth cap
adjustment factor (refer to section
III.G.4.b. of this proposed rule) would be
identified for the relevant benchmark
year or the performance year (as
applicable) using the assignment
window or expanded window for
assignment that is consistent with the
beneficiary assignment methodology
selected by the ACO for the performance
year according to § 425.400(a)(4)(ii).
We seek comment on our proposed
modifications to the definition of
assignable beneficiary in § 425.20. We
also seek comment on our proposed
technical and conforming changes to
references to the identification of
assignable beneficiaries in subpart G of
the Shared Savings Program regulations,
as well as in the proposed new
regulation at § 425.655 (on calculating
the regional risk score growth cap
adjustment factor), to incorporate the
use of the assignment window or
expanded window for assignment in
identification of the assignable
beneficiary population.
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To understand the potential impact of
using an expanded window for
assignment in a proposed step 3 of the
claims-based assignment methodology,
we simulated using the proposed
definition for an assignable beneficiary
and proposed step 3 using the set of
ACOs and data for performance year
(PY) 2021. To simplify the analysis, this
simulation used CY 2021 as the
assignment window. Thus, the
expanded window for assignment
spanned from January 1, 2020, through
December 31, 2021. We used a calendar
year basis because we do not expect the
impact of the proposed changes to
meaningfully differ between
retrospective and prospective
assignment windows, the latter of which
uses an offset window. In this analysis,
the national assignable population
included a total of 26.2 million
beneficiaries based on the current
methodology. The simulation applying
the proposed policies then added
762,156 newly assignable beneficiaries,
growing the national assignable
population by about 2.9 percent. For
additional analysis on estimated
impacts, we also refer commenters to
the Regulatory Impact Analysis in
section VII.E. of this proposed rule. We
seek comment on the proposed
approach discussed in this proposed
rule and the potential effects of the
proposed approach, including its effects
modeled in the aforementioned
simulation and its effects in other
scenarios that might be considered by
commenters. We anticipate continuing
additional simulations on the effect of
the proposed changes to the assignment
methodology to further inform our
understanding of the potential impacts
of the proposal, and we are planning to
publish results from such additional
simulations in the final rule.
Simulation results suggest that an
expanded window for assignment may
increase access to accountable care for
underserved beneficiaries. Relative to
the national assignable population as
determined under the current
assignment methodology, the group of
added beneficiaries from the expanded
window for assignment simulation had
a larger share of beneficiaries with
disabled Medicare enrollment type,
resided in areas with slightly higher
average Area Deprivation Index (ADI)
national percentile rank (a measure of
neighborhood socioeconomic
disadvantage), and had a larger share
with any months of Medicare Part D LIS
enrollment (refer to Table 30).
Simulation results also suggest that
using a 24-month expanded window for
assignment in proposed step 3 of the
claims-based assignment methodology
would increase access to accountable
care among beneficiaries with Medicare
coverage for part of a year (such as
beneficiaries who die during the
performance year). The group of added
assignable beneficiaries in the
simulation previously described had a
lower average prospective HCC risk
score, lower total per capita spending in
CY 2021, higher hospice utilization, and
a higher mortality rate when compared
to assignable beneficiaries determined
using the current definition of
assignable beneficiary and assignment
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(d) Simulations To Understand the
Potential Effect of Proposed Changes
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tkelley on DSK125TN23PROD with PROPOSALS2
methodology. These results suggest that
beneficiaries who would be added to the
assignable population under the
proposed changes may benefit from
greater care coordination through ACOs.
(e) Implementation of Proposed
Revisions
We are proposing that the expanded
window for assignment and revised
step-wise assignment methodology
would be applicable to all ACOs for the
performance year beginning on January
1, 2025, and in subsequent years. For
example, for a calendar year assignment
window that runs from January 1, 2025,
through December 31, 2025, the
expanded window for assignment
would run from January 1, 2024,
through December 31, 2025. For an
offset assignment window that runs
from October 1, 2023, through
September 30, 2024, the expanded
window for assignment would run from
October 1, 2022, through September 30,
2024. Consistent with how we have
implemented previous changes to the
Shared Savings Program assignment
methodology, we would use the new
methodology each time assignment is
determined for a given benchmark or
performance year and, as applicable, to
determine the eligibility of ACOs
applying to enter into or renew
participation in the Shared Savings
Program. For example, applicant
eligibility for PY 2024 will be
determined during CY 2023. We would
not be able to review public comments
and decide whether to finalize the
proposed changes in sufficient time to
apply the expanded window for
assignment and revised methodology for
PY 2024 applications. Additionally, we
anticipate that the proposed revised
approach, if finalized, would require
significant operational changes to the
Shared Savings Program assignment
methodology, which would take time to
prepare in advance of initial use of the
approach during the application
process. For these reasons, we would
not be able to apply the expanded
window for assignment and revised
step-wise beneficiary assignment
methodology for the performance year
starting on January 1, 2024, and we are
proposing to apply this change
beginning with the performance year
starting on January 1, 2025.
We would apply the proposed revised
approach to determining beneficiary
assignment and the revised definition of
assignable beneficiary in establishing,
adjusting, updating, and resetting
historical benchmarks for ACOs
entering new agreement periods
beginning on January 1, 2025, and
subsequent years. Also consistent with
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how we have implemented previous
changes to the assignment methodology,
we would adjust benchmarks for all
ACOs in agreement periods for which
performance year 2025 is a second or
subsequent performance year at the start
of performance year 2025, so that the
ACO benchmarks reflect the use of the
same assignment rules and definition of
assignable beneficiary as would apply in
the performance year (refer to
§§ 425.601(a)(9) and 425.652(a)(9)). We
believe that the expanded window for
assignment and proposed step three
represent a valuable change that would
fill an important gap in the current
assignment methodology. CMS has
outlined a renewed vision and strategy
for driving health system transformation
to achieve equitable outcomes through
high-quality, affordable, personcentered care for all beneficiaries.159 In
a January 2022 article, CMS stated our
goal that 100 percent of people with
Original Medicare will be in a care
relationship with accountability for
quality and total cost of care by 2030.160
Many Medicare FFS beneficiaries are
currently excluded from the assignable
and Shared Savings Program assigned
populations despite receiving primary
care from ACO professional nurse
practitioners, physician assistants, and
clinical nurse specialists during the
existing 12-month assignment window,
and these excluded beneficiaries tend to
come from populations characterized by
greater social risk factors. Specifically,
beneficiaries likely to be added to the
assignable population are more likely to
be disabled, be enrolled in the Medicare
Part D LIS, and reside in areas with
higher ADI scores (as described in
section III.G.3.a.(2)(d) of this proposed
rule). The proposed change to the
assignment methodology represents an
opportunity to not only grow the share
of Medicare beneficiaries involved in
accountable care relationships but to
also support efforts to improve health
equity in the Medicare program.
In summary, we seek comment on the
proposed changes to establish a new
defined term in § 425.20, expanded
window for assignment, for use in a
proposed additional step three in the
beneficiary assignment methodology
and in identifying the assignable
159 See, for example, CMS Innovation Center
‘‘Strategic Direction’’ web page, at https://
innovation.cms.gov/strategic-direction. See also,
CMS, Innovation Center Strategy Refresh, available
at https://innovation.cms.gov/strategic-directionwhitepaper.
160 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.
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52449
beneficiary population, revisions to the
definition of assignable beneficiary, as
well as proposed technical and
conforming changes to provisions of the
Shared Savings Program regulations,
including the definition of assignment
window under § 425.20, and provisions
within subpart E and subpart G. If
finalized, the proposed changes would
be applicable for the performance year
beginning on January 1, 2025, and
subsequent performance years. We
welcome comments on any aspects of
the proposed changes, including the
length of the expanded window for
assignment. We also seek comment on
additional policies that CMS should
consider for potential future rulemaking
on our assignment methodology, with
the goal of increasing the number of
Original Medicare fee-for-service
beneficiaries assigned to an ACO,
particularly in underserved
communities.
b. Proposed Revisions to the Definition
of Primary Care Services Used in Shared
Savings Program Beneficiary
Assignment
(1) Background
Section 1899(c)(1) of the Act, as
amended by the CURES Act and the
Bipartisan Budget Act of 2018, provides
that for performance years beginning on
or after January 1, 2019, the Secretary
shall assign beneficiaries to an ACO
based on their utilization of primary
care services provided by a physician
who is an ACO professional and all
services furnished by Rural Health
Clinics (RHCs) and Federally Qualified
Health Centers (FQHCs). However, the
statute does not specify a list of services
considered to be primary care services
for purposes of beneficiary assignment.
In the November 2011 final rule (76
FR 67853), we established the initial list
of services, identified by Current
Procedural Terminology (CPT) and
Healthcare Common Procedure Coding
System (HCPCS) codes, that we
considered to be primary care services.
In that final rule, we indicated that we
intended to monitor CPT and HCPCS
codes and would consider making
changes to the definition of primary care
services to add or delete codes used to
identify primary care services if there
were sufficient evidence that revisions
were warranted. We have updated the
list of primary care service codes in
subsequent rulemaking (refer to 80 FR
32746 through 32748; 80 FR 71270
through 71273; 82 FR 53212 and 53213;
83 FR 59964 through 59968; 85 FR
27582 through 27586; 85 FR 84747
through 84756; 85 FR 84785 through
84793; 86 FR 65273 through 65279; 87
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FR 69821 through 69825) to reflect
additions or modifications to the codes
that have been recognized for payment
under the PFS and to incorporate other
changes to the definition of primary care
services for purposes of the Shared
Savings Program.
For the performance year beginning
on January 1, 2023, and subsequent
performance years, we defined primary
care services in § 425.400(c)(1)(vii) for
purposes of assigning beneficiaries to
ACOs under § 425.402 as the set of
services identified by the following
HCPCS/CPT codes:
• CPT codes:
++ 96160 and 96161 (codes for
administration of health risk
assessment).
++ 99201 through 99215 (codes for
office or other outpatient visit for the
evaluation and management of a
patient).
++ 99304 through 99318 (codes for
professional services furnished in a
nursing facility; professional services or
services reported on an FQHC or RHC
claim identified by these codes are
excluded when furnished in a SNF).
++ 99319 through 99340 (codes for
patient domiciliary, rest home, or
custodial care visit).
++ 99341 through 99350 (codes for
evaluation and management services
furnished in a patient’s home).
++ 99354 and 99355 (add-on codes,
for prolonged evaluation and
management or psychotherapy services
beyond the typical service time of the
primary procedure; when the base code
is also a primary care service code
under this paragraph (c)(1)(vi)).
++ 99421, 99422, and 99423 (codes
for online digital evaluation and
management).
++ 99424, 99425, 99426, and 99427
(codes for principal care management
services).
++ 99437, 99487, 99489, 99490 and
99491 (codes for chronic care
management).
++ 99439 (code for non-complex
chronic care management).
++ 99483 (code for assessment of and
care planning for patients with cognitive
impairment).
++ 99484, 99492, 99493 and 99494
(codes for behavioral health integration
services).
++ 99495 and 99496 (codes for
transitional care management services).
++ 99497 and 99498 (codes for
advance care planning; services
identified by these codes furnished in
an inpatient setting are excluded).
• HCPCS codes:
++ G0402 (code for the Welcome to
Medicare visit).
++ G0438 and G0439 (codes for the
annual wellness visits).
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++ G0442 (code for alcohol misuse
screening service).
++ G0443 (code for alcohol misuse
counseling service).
++ G0444 (code for annual depression
screening service).
++ G0463 (code for services furnished
in ETA hospitals).
++ G0506 (code for chronic care
management).
++ G2010 (code for the remote
evaluation of patient video/images).
++ G2012 and G2252 (codes for
virtual check-in).
++ G2058 (code for non-complex
chronic care management).
++ G2064 and G2065 (codes for
principal care management services).
++ G0317, G0318, and G2212 (code
for prolonged office or other outpatient
visit for the evaluation and management
of a patient).
++ G2214 (code for psychiatric
collaborative care model).
++ G3002 and G3003 (codes for
chronic pain management).
• Primary care service codes include
any CPT code identified by CMS that
directly replaces a CPT code specified
in paragraph (c)(1)(vi)(A) of § 425.400 or
a HCPCS code specified in paragraph
(c)(1)(vi)(B) of § 425.400, when the
assignment window (as defined in
§ 425.20) for a benchmark or
performance year includes any day on
or after the effective date of the
replacement code for payment purposes
under FFS Medicare.
(2) Proposed Revisions
Based on feedback from ACOs and
our further review of the HCPCS and
CPT codes that are currently recognized
for payment under the PFS or that we
are proposing to recognize for payment
starting in CY 2024, we believe it would
be appropriate to amend the definition
of primary care services used in the
Shared Savings Program assignment
methodology to include certain
additional codes and to make other
technical changes to the definition of
primary care services for use in
determining beneficiary assignment for
the performance year starting on January
1, 2024, and subsequent performance
years, in order to remain consistent with
billing and coding under the PFS.
We propose to revise the definition of
primary care services used for
assignment in the Shared Savings
Program regulations to include the
following additions: (1) Smoking and
Tobacco-use Cessation Counseling
Services CPT codes 99406 and 99407;
(2) Remote Physiologic Monitoring CPT
codes 99457 and 99458; (3) Cervical or
Vaginal Cancer Screening HCPCS code
G0101; (4) Office-Based Opioid Use
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Disorder Services HCPCS codes G2086,
G2087, and G2088; (5) Complex
Evaluation and Management Services
Add-on HCPCS code G2211, if finalized
under Medicare FFS payment policy; (6)
Community Health Integration services
HCPCS codes GXXX1 and GXXX2, if
finalized under Medicare FFS payment
policy; (7) Principal Illness Navigation
(PIN) services HCPCS codes GXXX3 and
GXXX4, if finalized under Medicare FFS
payment policy; (8) SDOH Risk
Assessment HCPCS code GXXX5, if
finalized under Medicare FFS payment
policy; (9) Caregiver Behavior
Management Training CPT Codes 96202
and 96203, if finalized under Medicare
FFS payment policy; and (10) Caregiver
Training Services CPT codes 9X015,
9X016, and 9X017, if finalized under
Medicare FFS payment policy. The
following provides additional
information about the HCPCS codes that
we are proposing to add to the
definition of primary care services used
for purposes of beneficiary assignment:
• Smoking and tobacco-use cessation
counseling services CPT codes 99406
and 99407: Effective January 1, 2008,
CPT codes 99406 (Smoking and
tobacco-use cessation counseling visit;
intermediate, greater than 3 minutes up
to 10 minutes) and 99407 (Smoking and
tobacco-use cessation counseling visit;
intensive, greater than 10 minutes) were
implemented for billing for smoking and
tobacco-use cessation counseling
services. As described in Medicare
National Coverage Determinations
(NCD) Manual, Publication 100–3,
chapter 1, section 210.4.1, tobacco use
remains the leading cause of
preventable morbidity and mortality in
the U.S. and is a major contributor to
the nation’s increasing medical costs.
Despite the growing list of adverse
health effects associated with smoking,
more than 45 million U.S. adults
continue to smoke and approximately
1,200 die prematurely each day from
tobacco-related diseases. Since these are
recognized as preventive services,161
similar to other preventive services such
as alcohol misuse screening and
counseling (HCPCS codes G0442 and
G0443) which are currently included in
the definition of primary care services
for purposes of beneficiary assignment,
we believe it appropriate to include CPT
codes that identify counseling to
prevent tobacco use in the definition of
161 Medicare Learning Network (MLN006559,
May 2023) Medicare Preventive Services Quick
Reference Chart, available at: https://www.cms.gov/
Medicare/Prevention/PrevntionGenInfo/medicarepreventive-services/MPS-QuickReferenceChart1.html#TOBACCO.
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primary care services for purposes of
beneficiary assignment.
• Remote Physiologic Monitoring CPT
codes 99457 and 99458: Chronic care
remote physiologic monitoring (RPM)
services 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. In the CY 2020 PFS final
rule (84 FR 62697) we finalized a
revised CPT code 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; initial 20 minutes) and added
CPT code 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;
additional 20 minutes) to adopt the CPT
Editorial Panel revised structure for CPT
code 99457. The new code structure
retained CPT code 99457 as a base code
that describes the first 20 minutes of the
treatment management services, and
uses a new add-on code to describe
subsequent 20-minute intervals of the
service. We further designated CPT
codes 99457 and 99458 as care
management services because care
management services include
establishing, implementing, revising, or
monitoring treatment plans, as well as
providing support services, and because
RPM services include establishing,
implementing, revising, and monitoring
a specific treatment plan for a patient
related to one or more chronic
conditions that are monitored remotely.
Because these remote therapeutic
monitoring services are designated as
care management services 162 and
because we broadly include care
management services (for example, CPT
codes 99437, 99487, 99489, 99490 and
99491) in the Shared Savings Program
definition of primary care services for
purposes of beneficiary assignment, we
believe CPT codes 99457 and 99458
should also be included in the
definition of primary care services for
purposes of beneficiary assignment.
• Cervical or Vaginal Cancer
Screening Code HCPCS code G0101:
Section 4102 of the Balanced Budget
Act of 1997 provides for coverage of
162 Medicare
Physician Fee Schedule Care
Management Services Information, available at:
https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeeSched/CareManagement.
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screening pelvic examinations
(including a clinical breast examination)
for all female beneficiaries, subject to
certain frequency and other
limitations.163 Cervical and vaginal
cancer screening and clinical breast
examination are important preventive
health care services intended to detect
early cancer, precancers and sexually
transmitted infections. HCPCS code
G0101 (Cervical or vaginal cancer
screening; pelvic and clinical breast
examination) can be reimbursed by
Medicare Part B every 2 years. For
patients who are considered high risk, it
is allowed on an annual basis.
Obstetrics/gynecology and gynecology/
oncology are identified as physician
specialty designations for purposes of
identifying primary care services
furnished to beneficiaries used in
assignment operations according to
§ 425.402(c), so we believe it
appropriate to use wellness and
preventive care visits provided by these
specialists in our definition of primary
care services used in assignment. CMS
considers these to be a preventive health
service that can be provided in a
primary care setting 164 similar to the
annual wellness visit HCPCS codes
G0438 and G0439, which are already
included in the Shared Savings Program
definition of primary care services used
in assignment, so we believe that they
should be included in the definition of
primary care services for purposes of
beneficiary assignment.
• Office-Based Opioid Use Disorder
Services HCPCS Codes G2086, G2087,
and G2088: In the CY 2020 PFS final
rule (84 FR 62568) we finalized our
proposal to establish bundled payments
for the overall treatment of Opioid Use
Disorder (OUD), including management,
care coordination, psychotherapy, and
counseling activities HCPCS codes
G2086 (Office-based treatment for
opioid 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),
G2087 (Office-based treatment for
163 Medicare National Coverage Determination for
Screening Pap Smears and Pelvic Examinations for
Early Detection of Cervical or Vaginal Cancers (Pub.
No. 100–3, Manual Section 210.2), available at:
https://www.cms.gov/medicare-coverage-database/
view/ncd.aspx?NCDId=
185#:∼:text=Section%204102%20
of%20the%20Balanced%20Budget%20Act%20of,
beneficiaries%2C%20subject%20to%20
certain%20frequency%20and%
20other%20limitations.
164 Medicare Learning Network (MLN006559,
May 2023) Medicare Preventive Services Quick
Reference Chart, available at: https://www.cms.gov/
Medicare/Prevention/PrevntionGenInfo/medicarepreventive-services/MPS-QuickReferenceChart1.html#PELVIC.
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opioid use disorder, including care
coordination, individual therapy and
group therapy and counseling; at least
60 minutes in a subsequent calendar
month), and G2088 (Office-based
treatment for opioid use disorder,
including care coordination, individual
therapy and group therapy and
counseling; each additional 30 minutes
beyond the first 120 minutes (List
separately in addition to code for
primary procedure)). Refer to the CY
2020 PFS final rule (84 FR 62673) for
detailed, technical discussion regarding
the description, payment and utilization
of these HCPCS codes.
The bundled payment under the PFS
for office-based treatment for OUD was
intended to create an avenue for
physicians and other health
professionals to bill for a bundle of
services that is similar to the bundled
OUD treatment services benefit, but not
furnished by an Opioid Treatment
Program (OTP). By creating a separate
bundled payment for these services
under the PFS, we hoped to incentivize
increased provision of counseling and
care coordination for patients with OUD
in the office setting, thereby expanding
access to OUD care. We note that use of
these codes is limited to only
beneficiaries diagnosed with OUD and
these codes should not be billed for
beneficiaries who are receiving
treatment at an OTP, as we believe that
would be duplicative since the bundled
payments made to OTPs cover similar
services for the treatment of OUD.
Because the separately reportable
initiating visit requirement for the OUD
bundle HCPCS codes G2086, G2087 and
G2088 is similar to the separately
reportable initiating visit requirements
for chronic care management (CCM)
services, and behavioral health
integration services (BHI), as they
include overall management and care
coordination activities, we believe these
services should be considered primary
care services for purposes of beneficiary
assignment.165 Additionally, we
anticipate that the billing clinician,
likely an addiction medicine specialist,
would manage the patient’s overall OUD
care, as well as supervise any other
individuals participating in the
treatment, such as those billing incident
to services of the billing physician or
other practitioner, which is similar to
the requirements related to the
furnishing of psychiatric collaborative
care model (CoCM) services. CCM, BHI,
165 Medicare Physician Fee Schedule OfficeBased Opioid Use Disorder (OUD) Treatment
Billing Information, available at: https://
www.cms.gov/medicare/physician-fee-schedule/
office-based-opioid-use-disorder-oud-treatmentbilling.
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CoCM, and alcohol misuse screening
and counseling services are included in
our definition of primary care services,
so we believe that HCPCS codes G2086,
G2087 and G2088 are appropriate to be
included in the definition of primary
care services for purposes of beneficiary
assignment. For additional clarity,
incident to services are services
rendered to a patient by a provider other
than the physician treating the patient
more broadly, that are an integral,
although incidental, part of the patient’s
normal course of diagnosis or treatment
of an injury or illness. These services
are billed as Medicare Part B services,
as if the original physician personally
provided the care using that physician’s
NPI number. We anticipate that these
services would often be billed by
addiction specialty practitioners but
note that these codes are not limited to
use by any particular physician or nonphysician practitioner specialty.
Further, since addiction medicine is
identified as one of the physician
specialty designations for purposes of
identifying primary care services used
in assignment operations according to
§ 425.402(c)(13), we believe it would be
appropriate to include care coordination
services provided by these specialists in
our definition of primary care services
used for purposes of beneficiary
assignment.
We further recognize that OUD
bundle HCPCS codes G2086, G2087 and
G2088 are identified as codes for
alcohol and substance abuse-related
diagnoses that are excluded from Shared
Savings Program Claim and Claim Line
Feeds. Given this, we want to make
transparent that ACOs will not be able
to see the claims that may have been
used in assignment for beneficiaries
receiving OUD services, and possibly
not be able to identify why certain
beneficiaries were assigned to their ACO
related to these codes.
• Complex Evaluation and
Management Services Add-on HCPCS
Code G2211, if finalized under Medicare
FFS payment policy: As discussed in
section II.F. of this proposed rule,
HCPCS add-on 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. (Addon code, list separately in addition to
office/outpatient evaluation and
management visit, new or established))
can be reported in conjunction with
office/outpatient (O/O) evaluation and
management (E/M) visits to better
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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). Section
113 of Division CC of the Consolidated
Appropriations Act, 2021 (Pub. L. 116–
260, December 27, 2020) imposed a
moratorium on Medicare payment for
this service by prohibiting CMS from
making payment under the PFS for
inherently complex E/M visits described
by HCPCS code G2211 (or any successor
or substantially similar code) before
January 1, 2024. The moratorium on
Medicare payment under the PFS for
HCPCS code G2211 will end on
December 31, 2023, therefore we are
proposing to make HCPCS code G2211
separately payable effective January 1,
2024. Refer to section II.F. of this
proposed rule for detailed, technical
discussion regarding the description,
payment, and utilization of these
HCPCS codes.
Since G2211 is an add on code used
in conjunction with O/O E/M services
and such services are included in our
definition of primary care services, we
believe that the proposed inclusion of
HCPCS code G2211 is consistent with
our intent to encompass primary care
and wellness services in the definition
of primary care services used for
purposes of beneficiary assignment.
• Community Health Integration
Services HCPCS Codes GXXX1 and
GXXX2, if finalized under Medicare FFS
payment policies: In section II.E. of this
proposed rule, separate coding,
payment, service elements and
documentation requirements for the
following Community Health
Integration (CHI) services are being
proposed:
GXXX1—Community health
integration (CHI) 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 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,
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including understanding cultural and
linguistic factors.
++ Facilitating patient-driven goalsetting 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:
++ Coordination with practitioner;
home, and community-based service
providers; and caregiver (if applicable).
++ Communication with
practitioners, home- and communitybased 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 referrals 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 communitybased social services (e.g., housing,
utilities, transportation, food assistance)
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, 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
and treatment.
• Health care access/health system
navigation:
++ Helping the patient access care,
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
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to better meet diagnosis and treatment
goals.
GXXX2—Community health
integration services, each additional 30
minutes per calendar month (List
separately in addition to GXXX1).
As proposed in section II.E. of this
proposed rule, 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 § 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.166 A billing practitioner may
arrange to have CHI services provided
by auxiliary personnel 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. The payment policy
proposal explains that 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. Refer to section II.E. of
this proposed rule for detailed,
technical discussion regarding the
proposed description, payment and
utilization of these HCPCS codes.
Since the proposal described in
section II.E. of this proposed rule
proposes to designate CHI services as
care management services that may be
furnished under general supervision
under § 410.26(b)(5) and because we
broadly include care management
services in the definition of primary
care services used for purposes of
beneficiary assignment, we believe it
would be similarly appropriate to
include CHI services in the list of
primary care services used for purposes
of beneficiary assignment. Additionally,
since CHI services require an initiating
E/M visit and these services can be
billed as incident to by the billing
practitioner who bills for the CHI
initiating E/M visit, and E/M services
166 CHW Roles As Outlined In The C3 Project
available at: https://chwtraining.org/c3-project-chwskills/.
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are currently included in the list of
primary care services used for purposes
of beneficiary assignment, we believe it
would be similarly appropriate to
include CHI services in the list of
primary care services used for purposes
of beneficiary assignment.
• Principal Illness Navigation (PIN)
Services HCPCS codes GXXX3 and
GXXX4, if finalized under Medicare FFS
payment policies: In section II.E. of this
proposed rule, new coding for Principal
Illness Navigation (PIN) services is
being proposed. In considering the
appropriate patient population to
receive these services, 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.167
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, while
some measure serious illness by the
amount of urgent health care use (911
calls, emergency department visits,
repeated hospitalizations) and
polypharmacy.168 The navigation
services such patients need are similar
to CHI services, but Social Determinants
of Health (SDOH) need(s) may be fewer
or not present. Accordingly, a parallel
set of services focused on patients with
a serious, high-risk illness who may not
necessarily have SDOH-related needs is
being proposed. PIN services could be
furnished following an initiating E/M
visit addressing a single high-risk
disease.
The following codes would be
reported for PIN services:
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
167 Kelley AS, Bollens-Lund E. Identifying the
Population with Serious Illness: The
‘‘Denominator’’ Challenge. J Palliat Med. 2018
Mar;21(S2):S7–S16. doi: 10.1089/jpm.2017.0548.
Epub 2017 Nov 10. PMID: 29125784; PMCID:
PMC5756466. available at https://
pubmed.ncbi.nlm.nih.gov/29125784/.
168 Silver, Alison. Serious Illness: A High Priority
for Accountable Care. The American Journal of
Accountable Care. 2020;8(2):32–33. available at
https://www.ajmc.com/view/serious-illness-a-highpriority-for-accountable-care.
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52453
individualized context of the serious,
high-risk condition.
++ Conducting a person-centered
assessment to understand the patient’s
life story, needs, goals, preferences, and
desired outcomes, including
understanding cultural and linguistic
factors.
++ Facilitating patient-driven goal
setting and creating 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 communitybased service providers, hospitals, and
skilled nursing facilities (or other health
care facilities) regarding the patient’s
psychosocial strengths and needs,
functional deficits, goals, and
preferences, including cultural and
linguistic factors.
++ Coordination of care transitions
between and among health care
practitioners and settings, including
transitions involving referrals 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 communitybased social services (e.g., housing,
utilities, transportation, food assistance)
as needed to address SDOH need(s).
• Health education—Helping the
patients 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, identifying appropriate
practitioners or providers for clinical
care and helping secure appointments
with them.
• Facilitating behavioral change
necessary for meeting diagnosis and
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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 for the patient to
help the patient cope with the
condition, SDOH need(s), and adjust
daily routines to better meet diagnosis
or 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).
As discussed in section II.E. of this
proposed rule, 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. 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. Refer to section II.E. of this
proposed rule for detailed, technical
discussion regarding the description,
payment and utilization of these HCPCS
codes.
Since the proposal described in
section II.E. of this proposed rule
proposes to designate PIN services as
care management services that may be
furnished under general supervision
under § 410.26(b)(5) and because we
broadly include care management
services in the list of primary care
services used for purposes of beneficiary
assignment, we believe it would be
similarly appropriate to include PIN
services in the list of primary care
services used for purposes of beneficiary
assignment. Additionally, since these
services are meant to provide assistance
to the beneficiary through
communication and coordination with
practitioners, providers, including
referrals to other clinicians and followup after emergency or inpatient care, we
believe that these services can further
the ACO’s goal of care coordination and
the provision of value-based care and
should, therefore, be included in the
definition of primary care services for
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purposes of beneficiary assignment.
Further, since PIN services require an
initiating E/M visit and these services
can be billed as incident to by the
billing practitioner who bills for the PIN
initiating E/M visit, and E/M services
are currently included in the list of
primary care services used for purposes
of beneficiary assignment, we believe it
would be similarly appropriate to
include PIN services in the list of
primary care services used for purposes
of beneficiary assignment.
• SDOH Risk Assessment HCPCS
code GXXX5, if finalized under
Medicare FFS payment policies: In
section II.E. of this proposed rule, a new
stand-alone G code, GXXX5
(administration of a standardized,
evidence-based Social Determinants of
Health Risk Assessment tool, 5–15
minutes, at most every 6 months.) is
being proposed to identify and value the
work involved in the utilization of
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 enables comparisons across
populations. 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 treatment plan that
is established during the visit. Required
elements are described in detail in the
payment policy proposal described in
section II.E.
Under the proposal described in
section II.E. of this proposed rule, the
practitioner billing or furnishing the
SDOH risk assessment would be
required to have the ability to furnish
CHI or other care management services.
Given the multifaceted nature of SDOH
needs, ensuring adequate referral to
appropriate services and supports is
critical for addressing both the SDOH
need and the impact of that need on the
patient’s health. Refer to section II.E. of
this proposed rule for detailed,
technical discussion regarding the
description, payment and utilization of
these HCPCS codes.
Additionally, the proposal detailed in
section III.T of this proposed rule
proposes to add elements to the Annual
Wellness Visit (AWV) by adding a new
SDOH Risk Assessment as an optional,
additional element with an additional
payment. Under this proposal, the
SDOH Risk Assessment would be
separately payable with no beneficiary
cost sharing when furnished as part of
the same visit with the same date of
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service as the AWV, and would inform
the care the patient is receiving during
the visit, including taking a medical and
social history, applying health
assessments, and conducting prevention
services education and planning.
Since the proposals described in
sections II.E. and III.T. of this proposed
rule propose that these services would
be provided in conjunction with
professional services, such as E/M
visits, which can be provided in a
primary care setting, we believe it
would be appropriate to include these
services in the definition of primary
care services for purposes of beneficiary
assignment. Additionally, since these
are separately payable services when
provided with an AWV and the AWV is
included in the Shared Savings Program
definition of primary care services for
purposes of beneficiary assignment, we
believe it would be appropriate to
include SDOH risk assessment in the
definition of primary care services for
purposes of beneficiary assignment.
Further, since these services precede the
utilization of CHI, PIN, and Care
Management services, which are either
currently included or proposed to be
included in the definition of primary
care services for purposes of
assignment, we believe the inclusion of
the new SDOH risk assessment HCPCS
code would be appropriate as well.
• Caregiver Behavior Management
Training CPT Codes 96202 and 96203,
if finalized under Medicare FFS
payment policy: CPT code 96202
(Multiple-family group behavior
management/modification training for
guardians/caregivers of patients with a
mental or physical health diagnosis,
administered by physician or other
qualified health care professional
(without the patient present), face-toface with multiple sets of guardians/
caregivers; initial 60 minutes) and its
add-on code, CPT code 96203 (Multiplefamily group behavior management/
modification training for guardians/
caregivers of patients with a mental or
physical health diagnosis, administered
by physician or other qualified health
care professional (without the patient
present), face-to-face with multiple sets
of guardians/caregivers; each additional
15 minutes (List separately in addition
to code for primary service)) are two
new codes created by the CPT Editorial
Panel during its February 2021 meeting
used to report the total duration of faceto-face time spent by the physician or
other qualified health professional
providing group training to guardians or
caregivers of patients. Although the
patient does not attend the group
trainings, the goals and outcomes of the
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sessions focus on interventions aimed at
improving the patient’s daily life.
In section II.E. of this proposed rule,
an active payment status for CPT codes
96202 and 96203 (caregiver behavior
management/modification training
services) is being proposed for CY 2024.
These codes allow treating practitioners
to report 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. Caregiver
behavior management/modification
training services 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
caregiver behavior management/
modification training services
themselves need to be congruent with
the treatment plan in order to effectuate
the desired patient outcomes.
For purposes of caregiver behavior
management/modification training
services, the proposal requires that a
caregiver receiving behavior
management/modification training
services is a family member, friend, or
neighbor who provides unpaid
assistance to the patient, 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). In this context, caregivers
would be trained by the treating
practitioner in strategies and specific
activities that improve symptoms,
functioning, adherence to treatment,
and/or general welfare related to the
patient’s primary clinical diagnoses.
Under this proposal, caregiver behavior
management/modification training
services may be furnished directly by
the treating practitioner or provided by
auxiliary personnel incident to the
treating practitioner’s professional
services as specified in 42 CFR 410.26,
as applicable for the types of
practitioners whose covered services
include ‘‘incident to’’ services. Refer to
section II.E. of this proposed rule for
detailed, technical discussion regarding
the description, payment and utilization
of these HCPCS codes.
Since the proposal described in
section II.E. of this proposed rule
proposes that these services can be
billed as incident to by the billing
practitioner who could be a primary
care physician who also bills for an E/
M visit, and these services cannot
duplicate services provided in
conjunction with transitional care
management, chronic care management,
behavioral health integration services,
and virtual check-in services which are
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currently included in the list of primary
care services used for purposes of
beneficiary assignment, we believe that
these services should be included in the
definition of primary care services for
purposes of beneficiary assignment in
support of the Shared Savings mission
to give coordinated, high quality care to
an ACO’s Medicare beneficiaries.
• Caregiver Training Services CPT
codes 9X015, 9X016, and 9X017, if
finalized under Medicare FFS payment
policy: 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), 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 (ADLs). Activities of daily living
generally include ambulating, feeding,
dressing, personal hygiene, continence,
and toileting.
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 above, we believe
training furnished to a caregiver may be
reasonable and necessary when it is
integral to a patient’s overall treatment
and furnished after the treatment plan
(or therapy plan of care) is established.
The Caregiver Training Services (CTS)
themselves need to be congruent with
the treatment plan in order to effectuate
the desired patient outcomes, especially
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in medical treatment scenarios where
the caregiver receiving CTS is necessary
to ensure a successful treatment
outcome for the patient.
In section II.E., an active payment
status for CPT codes 9X015, 9X016, and
9X017 for CY 2024 under the PFS is
proposed. CTS may be furnished
directly by the treating practitioner or
provided by auxiliary personnel
incident to the treating practitioner’s
professional services as specified in 42
CFR 410.26, as applicable for the types
of practitioners whose covered services
include ‘‘incident to’’ services. Under
this proposal, 9X015, 9X016, and 9X017
are designated as ‘‘sometimes therapy’’.
This means that the services represented
by 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. Refer to section
II.E. of this proposed rule for detailed,
technical discussion regarding the
description, payment and utilization of
these HCPCS codes.
Since the proposal described in
section II.E. of this proposed rule
proposes that these services can be
billed as incident to by the billing
practitioner who could be a primary
care physician who also bills for an E/
M visit, and these services cannot
duplicate services provided in
conjunction with transitional care
management, chronic care management,
behavioral health integration services,
and virtual check-in services which are
currently included in the list of primary
care services used for purposes of
beneficiary assignment, and we believe
that these services are reported to
Medicare only when furnished in
conjunction with treatment for
particular conditions and reflected in a
plan of care, we believe they should be
included in the definition of primary
care services for purposes of beneficiary
assignment in support of the Shared
Savings Program mission to give
coordinated, high quality care to an
ACO’s Medicare beneficiaries.
We propose to specify a revised
definition of primary care services in a
new provision of the Shared Savings
Program regulations at
§ 425.400(c)(1)(viii) to include the list of
HCPCS and CPT codes specified in
§ 425.400(c)(1)(vii) along with the
proposed additional CPT codes 99406
and 99407, and 99457 and 99458, 96202
and 96203, if finalized under Medicare
FFS payment policy; and 9X015, 9X016,
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and 9X017, if finalized under Medicare
FFS payment policy and HCPCS codes
G0101; G2086, G2087, and G2088;
G2211, if finalized under Medicare FFS
payment policy; GXXX1 and GXXX2, if
finalized under Medicare FFS payment
policy; GXXX3 and GXXX4, if finalized
under Medicare FFS payment policy;
and GXXX5, if finalized under Medicare
FFS payment policy; as discussed in the
preceding paragraphs. We propose that
the new provision at § 425.400(c)(1)(viii)
would be applicable for use in
determining beneficiary assignment for
the performance year starting on January
1, 2024, and subsequent performance
years.
We seek comment on these proposed
changes to the definition of primary care
services used for assigning beneficiaries
to Shared Savings Program ACOs for the
performance year starting on January 1,
2024, and subsequent performance
years. We also welcome comments on
any other existing HCPCS or CPT codes
and new HCPCS or CPT codes proposed
elsewhere in this proposed rule that we
should consider adding to the definition
of primary care services for purposes of
assignment in future rulemaking.
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4. Benchmarking Methodology
a. Overview
In this section of the proposed rule,
we are proposing modifications to the
benchmarking methodology under the
Shared Savings Program. We propose a
combination of modifications to the
Shared Savings Program’s
benchmarking methodology to
encourage sustained participation by
ACOs in the program. Specifically, we
are proposing to revise the
benchmarking methodology by
modifying the existing calculation of the
regional update factor used to update
the historical benchmark between
benchmark year (BY) 3 and the
performance year (section III.G.4.b. of
this proposed rule). We are additionally
proposing to further mitigate the impact
of the negative regional adjustment to
the historical benchmark (section
III.G.4.c. of this proposed rule). We are
also proposing refinements to the prior
savings adjustment calculation
methodology (section III.G.4.d. of this
proposed rule), that would apply in the
establishment of benchmarks for
renewing ACOs and re-entering ACOs
entering an agreement period beginning
on January 1, 2024, and in subsequent
years, to account for the following: a
change in savings earned by the ACO in
a benchmark year due to compliance
action taken to address avoidance of atrisk beneficiaries or a change in the
amount of savings or losses for a
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benchmark year as a result of issuance
of revised initial determination under
§ 425.315. Finally, we propose to
specify in the regulations an approach
to calculating prospective HCC risk
scores used in Shared Savings Program
benchmark calculations, applicable for
agreement periods beginning on January
1, 2024, and in subsequent years, in
which we would use the CMS–HCC risk
adjustment model(s) applicable to the
calendar year corresponding to the
performance year to calculate a
Medicare FFS beneficiary’s prospective
HCC risk score for the performance year,
and for each benchmark year of the
ACO’s agreement period (section
III.G.4.e. of this proposed rule). Our
specific proposals are discussed in
detail in the following sections.
b. Proposal To Cap Regional Service
Area Risk Score Growth for Symmetry
With ACO Risk Score Cap
(1) Background
In the June 2016 final rule (81 FR
37977 through 37981), we established a
policy of utilizing a regional growth rate
to update the benchmark annually. In
that rule, we finalized a policy that, for
ACOs in their second or subsequent
agreement period whose rebased
historical benchmark incorporates an
adjustment to reflect regional
expenditures, the annual update to the
benchmark would be calculated as a
growth rate that reflects growth in risk
adjusted regional per beneficiary FFS
spending for the ACO’s regional service
area, for each of the following
populations of beneficiaries: ESRD,
disabled, aged/dual eligible, aged/nondual eligible (refer to § 425.603(d)).
In proposing and finalizing the
regional growth rate policy, we
explained that incorporating regional
expenditures in the benchmark would
make the ACO’s cost target more
independent of its historical
expenditures and more reflective of FFS
spending in its region. We also
explained that the use of regional trend
factors to trend forward BY1 and BY2 to
BY3 in resetting ACO benchmarks and
regional growth rates used to update the
historical benchmark to the performance
year annually would likely result in
relatively higher benchmarks for ACOs
that are low growth relative to their
region compared to benchmarks for
ACOs that are high growth relative to
their region (refer to 81 FR 37955).
In the December 2018 final rule (83
FR 68013 through 68031), we finalized
a proposal to use a blend of national and
regional trend factors to trend forward
BY1 and BY2 to BY3 when determining
the historical benchmark and a blend of
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national and regional update factors to
update the historical benchmark to the
performance year for all agreement
periods beginning on or after July 1,
2019 (refer to § 425.601(a) and (b)).
Under this policy, the national
component of the blended trend and
update factors receives a weight equal to
the share of assignable beneficiaries in
the regional service area that are
assigned to the ACO, computed by
taking a weighted average of countylevel shares. The regional component of
the blended trend and update factors
receives a weight equal to 1 minus the
national weight. Calculations are made
separately for each Medicare enrollment
type. In the December 2018 final rule
(83 FR 68024), we acknowledged that,
for an ACO that serves a high proportion
of beneficiaries in select counties
making up its regional service area
(referred to herein as having ‘‘high
market share’’), a purely regional trend
would be more influenced by the ACO’s
own expenditure patterns, making it
more difficult for the ACO to
outperform its benchmark and
conflicting with our goal to move ACOs
away from benchmarks based solely on
their own historical costs. Incorporating
national trends that are more
independent of an ACO’s own
performance was therefore intended to
reduce the influence of the ACO’s
assigned beneficiaries on the ultimate
blended trend and update factors
applied.
In the CY 2023 PFS final rule (87 FR
69881 through 69899), we finalized a
policy for agreement periods starting on
or after January 1, 2024, under which
we will update the historical benchmark
between BY3 and the performance year
for each year of the agreement period
using a three-way blend calculated as a
weighted average of a two-way blend of
national and regional growth rates
determined after the end of each
performance year and a fixed projected
growth rate determined at the beginning
of the ACO’s agreement period called
the Accountable Care Prospective Trend
(ACPT) (refer to § 425.652(b)). Under
this policy, we will make separate
calculations for expenditure categories
for each Medicare enrollment type. We
explained that incorporating this
prospective trend in the update to the
benchmark would insulate a portion of
the annual update from any savings
occurring as a result of the actions of
ACOs participating in the Shared
Savings Program and address the impact
of increasing market penetration by
ACOs in a regional service area on the
existing blended national-regional
growth factor.
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For ACOs in agreement periods
beginning on July 1, 2019, and in
subsequent years, we account for
changes in severity and case mix of the
ACO’s assigned beneficiary population
when establishing the benchmark for an
agreement period and also in adjusting
the benchmark for each performance
year during the agreement period. In
accordance with § 425.601(a)(3) and
§ 425.652(a)(3), in establishing the
benchmark, we adjust expenditures for
changes in severity and case mix using
CMS Hierarchical Condition Category
(CMS–HCC) prospective risk scores
(herein referred to as prospective HCC
risk scores). Pursuant to § 425.601(a)(10)
and § 425.652(a)(10), we further adjust
the ACO’s historical benchmark at the
time of reconciliation for a performance
year to account for changes in severity
and case mix for the ACO’s assigned
beneficiary population between BY3
and the performance year (refer to
§ 425.605(a)(1), (a)(2); § 425.610(a)(2),
(a)(3)). In performing this risk
adjustment, we make separate
adjustments for the population of
assigned beneficiaries in each Medicare
enrollment type used in the Shared
Savings Program (ESRD, disabled, aged/
dual eligible, aged/non-dual eligible).
As finalized in the CY 2023 PFS final
rule (87 FR 69932 through 69946), for
agreement periods beginning on or after
January 1, 2024, we will use prospective
HCC risk scores to adjust the historical
benchmark for changes in severity and
case mix for all assigned beneficiaries
between BY3 and the performance year,
with positive adjustments subject to a
cap equal to the ACO’s aggregate growth
in demographic risk scores between BY3
and the performance year plus 3
percentage points (herein referred to as
the ‘‘aggregate demographics plus 3
percent cap’’) (refer to
§ 425.605(a)(1)(ii); § 425.610(a)(2)(ii)).
This cap applies only if the ACO’s
aggregate growth in prospective HCC
risk scores between BY3 and the
performance year across all of the
Medicare enrollment types (ESRD,
disabled, aged/dual eligible, aged/nondual eligible) exceeds this cap. If the cap
is determined to apply, the value of the
cap is the maximum increase in
prospective HCC risk scores (expressed
as a ratio of the ACO’s performance year
risk score to the ACO’s BY3 risk score)
for the applicable performance year,
such that any positive adjustment
between BY3 and the performance year
cannot be larger than the value of the
aggregate demographics plus 3 percent
cap for any of the Medicare enrollment
types. This cap is applied separately for
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the population of beneficiaries in each
Medicare enrollment type.
In the CY 2023 PFS final rule, we
further explained that we were
finalizing the aggregate demographics
plus 3 percent cap to address concerns
with the prior approach to risk
adjustment, which used prospective
HCC risk scores to adjust the historical
benchmark for changes in severity and
case mix for all assigned beneficiaries
between BY3 and the performance year,
subject to a cap of positive 3 percent for
the agreement period that was applied
separately by Medicare enrollment type
(referred to herein as the ‘‘3 percent
cap’’) (refer to § 425.605(a)(1)(i);
§ 425.610(a)(2)(i)). The 3 percent cap
was finalized through the December
2018 final rule (83 FR 68013) and is
applicable to ACOs in agreement
periods beginning on or after July 1,
2019, and prior to January 1, 2024.
We believe that the aggregate
demographics plus 3 percent cap
addresses several concerns raised by
interested parties 169 about the 3 percent
cap by: accounting for higher volatility
in prospective HCC risk scores for
certain Medicare enrollment types due
to smaller sample sizes; allowing for
higher benchmarks than the prior risk
adjustment methodology for ACOs that
care for larger proportions of
beneficiaries in aged/dual eligible,
disabled and ESRD enrollment types
(which are frequently subject to the 3
percent cap); and continuing to
safeguard the Trust Funds by limiting
returns from coding initiatives.
However, the demographics plus 3
percent cap does not address concerns
from certain interested parties that the
current policy places a cap on an ACO’s
risk score growth between BY3 and the
performance year but does not place a
cap on the regional prospective HCC
risk score growth between BY3 and the
performance year, which is reflected in
the regional growth rate used to
calculate the update factor (pursuant to
§ 425.652(b)(2)(ii)).170
Under the methodology finalized in
CY 2023 PFS final rule, as described in
§ 425.652(b), we express the regional
update factor, used to update the
historical benchmark to the performance
year, as the ratio of an ACO’s
performance year regional service area
risk adjusted expenditures to its BY3
169 For summaries of these concerns of interested
parties, refer to the CY 2022 PFS final rule (86 FR
65302 through 65306), CY 2023 PFS final rule (87
FR 69932 through 69934).
170 For summaries of these concerns of interested
parties, refer to the CY 2021 PFS final rule (85 FR
84783 through 84785), the CY 2022 PFS final rule
(86 FR 65302 through 65306), and the CY 2023 PFS
final rule (87 FR 66942 and 69943).
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regional service area risk adjusted
expenditures for each Medicare
enrollment type. Table 31 provides a
numeric example of the current
methodology for calculating the regional
update factor for the ESRD Medicare
enrollment type for a hypothetical ACO
with a regional service area that
includes counties A, B, C, and D.
Pursuant to § 425.654, an ACO’s
regional expenditures are calculated
using risk adjusted county FFS
expenditures. The counties included in
the ACO’s regional service area are
based on the ACO’s assigned beneficiary
population for the applicable
benchmark or performance year. We
determine average county FFS
expenditures based on expenditures for
the assignable population 171 of
beneficiaries in each county in the
ACO’s regional service area. We make
separate calculations for each Medicare
enrollment type. We adjust these
county-level FFS expenditures (refer to
Table 31, rows [A] and [F]) for severity
and case mix of assignable beneficiaries
in the county using county-level
prospective HCC risk scores (refer to
Table 31, rows [B] and [G]). The
adjustment is made by dividing the
county-level FFS expenditures for the
Medicare enrollment type by countylevel prospective HCC risk scores for the
Medicare enrollment type, resulting in
risk adjusted county-level FFS
expenditures shown in Table 31 rows
[C] and [H].
We then calculate an ACO’s regional
expenditures for each Medicare
enrollment type by weighting these risk
adjusted county-level FFS expenditures
according to the ACO’s proportion of
assigned beneficiaries 172 in the county
for that Medicare enrollment type (refer
to Table 31, rows [D] and [I]),
determined by the number of the ACO’s
171 Assignable beneficiary expenditures are
calculated using the payment amounts included in
Parts A and B FFS claims with dates of service in
the 12-month calendar year that corresponds to the
relevant benchmark or performance year, using a 3month claims run out with a completion factor.
These expenditure calculations exclude IME and
DSH payments, and the supplemental payment for
IHS/Tribal hospitals and Puerto Rico hospitals; and
consider individually beneficiary identifiable final
payments made under a demonstration, pilot or
time limited program. Refer to § 425.654(a)(2). The
assignable population of beneficiaries is identified
for the assignment window corresponding to the
relevant benchmark or performance year that is
consistent with the assignment window that applies
under the beneficiary assignment methodology
selected by the ACO for the performance year
according to § 425.400(a)(4)(ii). Refer to
§ 425.654(a)(1)(i). We refer readers to the discussion
of the proposed changes to the methodology for
identifying the assignable beneficiary population in
section III.G.3.a of this proposed rule.
172 Proportions are calculated using beneficiary
person years.
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assigned beneficiaries in the applicable
population (according to Medicare
enrollment type) residing in the county
in relation to the ACO’s total number of
assigned beneficiaries in the applicable
population (according to Medicare
enrollment type) for the relevant
benchmark or performance year. We
then aggregate those values for each
population of beneficiaries (according to
Medicare enrollment type) across all
counties within the ACO’s regional
service area 173 (refer to Table 31, rows
[E] and [J]).
We then calculate the regional update
factor as the ratio of an ACO’s
performance year expenditures to BY3
regional expenditures. This calculation
is performed separately for each
Medicare enrollment type. Refer to
Table 31, row [K] for an example of how
the regional update factor would be
calculated for the ESRD Medicare
enrollment type. This calculation would
then be repeated for each of the other
Medicare enrollment types.
While the regional expenditures for
BY3 and the performance year are risk
adjusted, as described previously in this
section, there is currently no cap on
prospective HCC risk score growth in an
ACO’s regional service area between
BY3 and the performance year. As
discussed previously in this section,
ACOs and other interested parties have
expressed concerns that the program’s
current cap on ACO risk score growth
between BY3 and the performance year
does not account for risk score growth
in the ACO’s regional service area and
that there is not an equivalent cap on
regional risk score growth. High
prospective HCC risk score growth in an
ACO’s regional service area between
BY3 and the performance year has the
effect of decreasing the regional update
factor, resulting in a lower updated
benchmark for the ACO than if the
regional risk score growth were capped
(assuming that the risk score growth was
high enough to be capped). In past
rulemaking, some commenters have
encouraged CMS to adopt a policy of
applying a cap on ACO risk score
growth after accounting for regional
increase in risk scores.174 Others have
suggested more generally that CMS align
the use of a risk adjustment cap for the
ACO and its region by applying a
consistent capping policy to both.175
In the CY 2022 PFS proposed rule (86
FR 39294 through 39295), we sought
comment on an alternate approach to
capping ACO prospective HCC risk
score growth between BY3 and the
performance year in relation to the
prospective HCC risk score growth in
the ACO’s regional service area. The
option we presented was to allow an
ACO’s risk score growth cap to increase
above 3 percent by a percentage of the
difference between the 3 percent cap
and risk score growth in the AC’’s
regional service area for a given
Medicare enrollment type. In this
alternate approach (herein referred to as
the ‘‘3 percent cap plus regional
difference’’), the percentage applied
would be equal to 1 minus the ACO’s
regional market share for the Medicare
enrollment type. For example, if
regional risk score growth for a
particular Medicare enrollment type
was 5 percent and the ACO’s regional
market share was 20 percent, we would
increase the cap on the ACO’s risk score
growth for that Medicare enrollment
type by an amount equal to the
difference between the regional risk
173 Refer to the Medicare Shared Savings Program,
Shared Savings and Losses, Assignment and
Quality Performance Standard Methodology
Specifications (version #11, January 2023), sections
4.1.1 ‘‘Determining Regional FFS Expenditures’’
and 4.1.4 ‘‘Risk Adjusting and Updating the
Historical Benchmark’’, available at https://
www.cms.gov/files/document/medicare-sharedsavings-program-shared-savings-and-losses-andassignment-methodology-specifications.pdf-2.
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174 Refer
to CY 2021 PFS final rule (85 FR 84784).
to CY 2021 PFS final rule (85 FR 84784)
and CY 2023 PFS final rule (87 FR 69943).
175 Refer
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score growth and the 3 percent cap (2
percent) multiplied by one minus the
ACO’s regional market share (80
percent). Thus, the ACO would face a
cap for this Medicare enrollment type
equal to 4.6 percent instead of 3 percent
(3 percent + (2 percent × 80 percent)).
This approach would raise the 3 percent
cap while limiting the ability for ACOs
with high market share to increase their
cap by engaging in coding intensity
initiatives that raise the regional
prospective HCC risk score. As
discussed in the CY 2022 PFS final rule,
a few commenters noted their support
for this 3 percent cap plus regional
difference methodology.176 MedPAC,
however, expressed concern that
increasing the cap beyond 3 percent
could effectively reward ACOs for
greater coding intensity in their region,
particularly for those with higher
market share.177 178
In the CY 2023 PFS final rule (87 FR
69932 through 69946), we indicated that
we had considered the 3 percent cap
plus regional difference methodology
described in the CY 2022 PFS proposed
rule. However, we opted not to propose
this policy and instead proposed, and
ultimately finalized, the aggregate
demographics plus 3 percent cap. One
reason we did not propose the 3 percent
cap plus regional difference was that a
relatively small share of ACOs affected
by the 3 percent cap operated in
regional service areas where regional
risk score growth was greater than 3
percent, indicating that this was not a
widespread issue impacting ACO
performance. Additionally, we
explained that we still had concerns
that allowing the cap on an ACO’s risk
score growth to increase with regional
risk score growth could incentivize
ACOs, particularly those with high
market share, to engage in coding
behavior that would increase their cap,
even if this incentive would be
mitigated to some degree by limiting the
allowable increase in the cap based on
the ACO’s market share. Under the 3
percent cap, ACOs with high market
share have a disincentive to engage in
coding initiatives, as it could increase
risk score growth in their regional
service area and potentially decrease the
value of the regional component of their
update factor. We noted that raising the
3 percent cap based on risk score growth
176 Refer
to 86 FR 65304.
to 86 FR 65303 through 65305.
178 Refer to Letter from MedPAC to Chiquita
Brooks-LaSure, Administrator, CMS (September 9,
2021), regarding File code CMS–1751–P (pages 16–
18 ‘‘Risk adjustment methodology’’), available at
https://www.medpac.gov/wp-content/uploads/
2021/10/09092021_PartB_CMS1751_MedPAC_
Comment_V2_SEC.pdf.
177 Refer
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in an ACO’s regional service area could
change these incentives and encourage
ACOs to engage in coding initiatives. In
addition to finalizing the aggregate
demographics plus 3 percent cap, in the
CY 2023 PFS final rule, we noted that
we declined to consider an approach
that would impose a direct cap on risk
score growth in an ACO’s regional
service area (87 FR 69932 through
69947). As with the 3 percent cap plus
regional difference, we were concerned
that such an approach would create
adverse incentives for coding behavior,
especially for ACOs with high market
share.
In response to the discussion of the
cap on prospective HCC risk score
growth in the CY 2023 PFS proposed
rule, commenters took the opportunity
to reiterate their concerns that the
program’s current cap on ACO risk score
growth between BY3 and the
performance year does not account for
risk score growth in the ACO’s regional
service area and suggested ways to
incorporate a cap on regional risk score
growth. A couple of commenters
requested that the risk score cap be
allowed to further increase for ACOs in
regions where risk score growth exceeds
the cap, with one stating that a flat
percentage cap will always disadvantage
ACOs in regions where risk score
growth exceeds the cap and another
stating that this additional flexibility
would ensure ACOs are not
disadvantaged by operating in
underserved communities.
Additionally, many commenters
supported capping regional risk score
growth in addition to capping ACO risk
score growth. Several of those
commenters stated that it was critical
that, whatever policy CMS adopted for
capping ACOs’ risk score growth, the
same policy must also apply to regional
risk score growth. Several commenters
noted that CMS should not apply
adjustments to only one side of the
equation, that is, capping ACO risk
ratios without capping regional risk
ratios, with many commenters saying
this would lead to unintended
consequences and another commenter
saying it would have inequitable results.
Several commenters stated that not
capping increases in regional risk scores
would stifle growth in exactly the areas
CMS wants growth the most. A few
commenters explained that lack of
regional risk score growth caps
incentivizes ACOs not to grow in places
with certain types of populations, such
as those with increasing health burdens,
higher needs, or higher numbers of
aged/dual and disabled enrollees.179 In
179 Refer
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response to these comments, we
indicated that we would continue to
monitor the impacts of regional risk
score growth and may propose further
refinements to our risk adjustment
policies in future rulemaking.180
(2) Proposed Revisions
Since the publication of the CY 2023
PFS final rule, we have performed
further analysis on prospective HCC risk
score growth in ACOs’ regional service
area between BY3 and the performance
year and considered ways in which we
could reduce impacts to ACOs in
regions with high risk score growth,
particularly when such growth is not
due to the ACO’s own complete and
accurate coding, while also limiting the
impact from coding initiatives,
particularly among ACOs with high
market share. Based on this additional
analysis, which is detailed later in this
section, we are proposing to modify the
calculation of the regional update factor
used to update the historical benchmark
between BY3 and the performance year.
The proposed approach would cap
prospective HCC risk score growth in an
ACO’s regional service area between
BY3 and the performance year by
applying an adjustment factor to the
regional update factor. This cap on
regional risk score growth would be
applied independently of the cap on an
ACO’s own prospective HCC risk score
growth between BY3 and the
performance year, meaning that this
proposed cap on prospective HCC risk
score growth in an ACO’s regional
service area would be applied whether
or not the ACO’s prospective risk score
growth was capped when updating the
benchmark between BY3 and the
performance year. Applying these caps
independently would be more equitable
to ACOs serving high risk patients in
regions with high risk score growth, and
avoid creating incentives for ACOs to
avoid high risk and more medically
complex patients. Adjusting the regional
service area risk score growth cap based
on the percentage of original Medicare
fee-for-service beneficiaries the ACO
serves in the region would help to
mitigate the impact an ACO’s own
coding initiatives have on risk score
growth in the ACO’s regional service
area, particularly when the ACO has a
greater influence on its regional service
area risk score growth rate.
To determine the cap on prospective
HCC risk score growth in an ACO’s
regional service area we propose to
follow a similar methodology as the one
adopted in the CY 2023 PFS final
180 Refer
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rule 181 for capping ACO risk score
growth, codified at § 425.605(a)(1)(ii)
and § 425.610(a)(2)(ii), while
additionally accounting for an ACO’s
aggregate market share. The effect of the
regional risk score growth cap would be
to increase the regional component of
the update factor for ACOs in regions
with aggregate regional prospective HCC
risk score growth above the cap, with
ACOs with higher aggregate market
shares seeing smaller increases, all else
being equal. ACOs in regions with
aggregate regional prospective HCC risk
score growth below the cap would not
be affected by the proposed policy.
By symmetrically limiting risk score
growth within both an ACO’s assigned
beneficiary population and its region,
this proposed approach is expected to
improve the accuracy of the regional
update factors for ACOs operating in
regional service areas with high risk
score growth, particularly in later years
of the 5-year agreement period where
the difference between an ACO’s BY3
and performance year regional risk
scores is expected to be the greatest. We
believe capping regional risk score
growth will strengthen incentives for
ACOs to form or continue to operate in
regions with high risk score growth and
thereby incentivize ACOs to care for
higher risk beneficiaries. This approach
would also offer an incentive for
potential applicant ACOs that may be
examining recent risk score growth in
their region and making the decision
whether to participate in the Shared
Savings Program. Additionally, by
adjusting the regional risk score growth
cap based on ACO market share, this
proposal would also maintain a
disincentive against coding intensity for
ACOs with high market share.
To implement the new cap on
regional risk score growth, we would
multiply the original regional update
factor used to update the historical
benchmark between BY3 and the
performance year (determined in
accordance with § 425.652(b)(2)(ii)) by a
regional risk score growth cap
adjustment factor. The regional risk
score growth cap adjustment factor
would be calculated as follows:
• Step 1: Calculate county-level risk
scores. We would calculate county-level
prospective HCC and demographic risk
scores by Medicare enrollment type for
both BY3 and the performance year. To
do this for a given benchmark or
performance year, we would first
determine the renormalized, prospective
HCC and demographic risk score for
181 87
FR 69932 through 69946.
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each assignable beneficiary 182 in each
county in the ACO’s regional service
area. For both HCC and demographic
risk scores, we would then compute the
weighted average risk score for each
county for each Medicare enrollment
type by multiplying each assignable
beneficiary’s risk score for that Medicare
enrollment type by the beneficiary’s
person years enrolled in that Medicare
enrollment type, summing these
weighted risk scores across all
assignable beneficiaries for that
Medicare enrollment type in the county,
and then dividing by total person years
for that Medicare enrollment type
among assignable beneficiaries in the
county. Note that this approach would
be similar to the approach that is
currently used to determine countylevel prospective HCC risk scores as an
intermediate step in calculating risk
adjusted regional expenditures under
the current methodology.183
• Step 2: Calculate regional risk
scores. We would calculate regionallevel BY3 and performance year
prospective HCC and demographic risk
scores as a weighted average of countylevel HCC and demographic risk scores
for the Medicare enrollment type
(calculated in step 1), with weights
reflecting the proportion of the ACO’s
assigned beneficiaries 184 in the county.
This proportion is determined by the
number of the ACO’s assigned
beneficiaries (by Medicare enrollment
type) residing in each county in relation
to the ACO’s total number of assigned
beneficiaries for that Medicare
enrollment type for the relevant
benchmark or performance year. These
would be the same weights as used to
calculate regional expenditures under
§ 425.654(b).
• Step 3: Determine aggregate growth
in regional risk scores. To calculate
aggregate growth in regional risk scores,
we would first calculate growth in
prospective HCC and demographic risk
scores between BY3 and the
182 Consistent with our proposal to revise the
definition of an assignable beneficiary (refer to
section III.G.3.a of this proposed rule), we propose
that the assignable population of beneficiaries for a
benchmark or performance year would be identified
using the assignment window or expanded window
for assignment that is consistent with the
beneficiary assignment methodology selected by the
ACO for the applicable performance year according
to § 425.400(a)(4)(ii).
183 Refer to the Medicare Shared Savings Program,
Shared Savings and Losses, Assignment and
Quality Performance Standard Methodology
Specifications (version #11, January 2023), section
4.1.1 ‘‘Determining Regional FFS Expenditures’’,
available at https://www.cms.gov/files/document/
medicare-shared-savings-program-shared-savingsand-losses-and-assignment-methodologyspecifications.pdf-2.
184 Proportions are calculated using beneficiary
person years.
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performance year for each Medicare
enrollment type, expressed as the ratio
of the performance year regional risk
score for a Medicare enrollment type
(calculated in step 2) to the BY3
regional risk score for that enrollment
type (calculated in step 2). We would
next take a weighted average of the
regional prospective HCC or
demographic risk ratios, as applicable,
across the four Medicare enrollment
types, where the weight applied to the
growth in risk scores for each Medicare
enrollment type would be the ACO’s
performance year assigned beneficiary
person years for the Medicare
enrollment type multiplied by the
ACO’s regionally adjusted historical
benchmark expenditures for the
Medicare enrollment type.185
• Step 4: Determine the cap on
regional risk score growth. We would
first calculate the non-market share
adjusted cap on the ACO’s regional risk
score growth as the sum of the aggregate
growth in regional demographic risk
scores (calculated in step 3) and 3
percentage points.186
We would next adjust the cap to
reflect the ACO’s aggregate market
share. We would calculate an ACO’s
aggregate market share as a weighted
average of the ACO’s market share
across the four Medicare enrollment
types. An ACO’s market share for each
Medicare enrollment type would be
equal to the weight that is applied to the
national component of the blended
update factor in the two-way blend that
is calculated as the share of assignable
beneficiaries in the ACO’s regional
service area that are assigned to the
ACO for the applicable performance
year (refer to § 425.652(b)(2)(iv)). The
weights for each Medicare enrollment
type used to compute the weighted
average would be the ACO’s
performance year assigned person years
for the Medicare enrollment type.
We would adjust the cap on regional
risk score growth to reflect the ACO’s
aggregate market share by adding to the
non-market share adjusted cap the
product of:
++ The ACO’s aggregate market
share, and
++ The difference (subject to a floor
of zero) between:
185 These are the same weights that are to be used
when calculating weighted average ACO
prospective HCC and demographic risk ratios under
the risk adjustment methodology adopted in the CY
2023 PFS final rule (87 FR 69932 through 69946)
and codified in §§ 425.605(a)(1)(ii)(C) and
425.610(a)(2)(ii)(C).
186 This is similar to the calculation of the cap on
ACO prospective HCC risk score growth finalized
in the CY 2023 PFS (87 FR 69932 through 69946)
and codified in §§ 425.605(a)(1)(ii)(A) and
425.610(a)(2)(ii)(A).
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-- The aggregate regional prospective
HCC risk score growth (calculated in
step 3), and
-- The non-market share adjusted cap
(calculated first in this step).
This adjustment of the cap on regional
risk score growth using the ACO’s
aggregate market share creates a sliding
scale. Assuming that an ACO has
aggregate regional prospective HCC risk
score growth above the non-market
share adjusted cap, an ACO with close
to 0 percent aggregate market share
would receive a market share adjusted
cap on regional risk score growth close
to the aggregate growth in regional
demographic risk scores plus 3
percentage points and an ACO with 100
percent aggregate market share would
receive a market share adjusted cap on
regional risk score growth equal to the
aggregate regional prospective HCC risk
score growth calculated in step 3 (which
is effectively no cap at all). Under this
approach, as an ACO’s aggregate market
share increases, so does the cap on the
ACO’s regional risk score growth,
ultimately limiting the potential
increase to the regional update factor for
ACOs with high market share.
• Step 5: Determine the regional risk
score growth cap adjustment factor.
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First, we would determine if the ACO’s
regional risk score growth is subject to
a cap by comparing the ACO’s aggregate
regional prospective HCC risk score
growth (calculated in step 3) to the
market share adjusted cap on regional
risk score growth (calculated in step 4).
++ If the aggregate regional
prospective HCC risk score growth does
not exceed the cap on regional risk score
growth, the ACO’s regional risk score
growth would not be subject to the cap.
For these ACOs we would set the risk
score growth cap adjustment factor
equal to 1 for each Medicare enrollment
type (which is effectively no
adjustment).
++ If the aggregate regional
prospective HCC risk score growth
exceeds the market share adjusted cap,
the ACO’s regional risk score growth is
subject to the cap. For these ACOs we
would next determine whether the cap
on regional risk score growth applies for
each Medicare enrollment type. To do
this, we would compare regional
prospective HCC risk score growth for
each Medicare enrollment type
(calculated in step 3) with the market
share adjusted cap (calculated in step 4).
If the regional risk score growth for a
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Medicare enrollment type does not
exceed the cap, the enrollment type is
not subject to the cap and the regional
risk score growth cap adjustment factor
for that Medicare enrollment type is set
equal to 1 (effectively no adjustment).
Otherwise, the Medicare enrollment
type is subject to the cap and we would
set the adjustment factor for the
Medicare enrollment type equal to the
regional prospective HCC risk score
growth for the Medicare enrollment type
(calculated in step 3) divided by the
market share adjusted cap calculated in
step 4. In this case, the adjustment
factor for the Medicare enrollment type
would represent a measure of how far
above the cap the regional prospective
HCC risk score growth is.
Table 32 provides a numeric example
of the calculation of the regional risk
score growth cap adjustment factor for
a hypothetical ACO that is determined
to be subject to the market share
adjusted cap. Table 32 begins at the end
of step 2 of the calculation, and
therefore only reflects regional-level
calculations and does not include the
county-level calculations:
BILLING CODE 4120–01–P
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In this example, the hypothetical ACO
was in a regional service area with
aggregate prospective HCC risk score
growth (a weighted average risk ratio of
1.039, refer to row [H]) above the market
share adjusted cap of 1.021 (refer to row
[N]). The ACO’s regional prospective
HCC risk score growth (shown in row
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[E]) was above this cap for three of the
four Medicate enrollment types (all but
the aged/dual eligible Medicare
enrollment type). Therefore, the regional
risk score growth cap adjustment factor
(refer to row [Q]) calculated for those
three capped Medicare enrollment types
was above one, and the regional risk
score growth cap adjustment factor
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calculated for the one uncapped
Medicare enrollment type was equal to
one. Once the regional risk score growth
cap adjustment factors are multiplied by
the original regional update factors used
to update the historical benchmark
between BY3 and the performance year,
the regional update factor would
increase for the three capped Medicare
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enrollment types. For example, if the
original regional update factor for the
ESRD Medicare enrollment type was
0.976, then the final regional ESRD
update factor after the application of the
regional risk score growth cap
adjustment factor would be 1.000 (the
product of 0.976 and the regional risk
score growth cap adjustment factor of
1.025). There would be no change to the
original regional update factor for the
uncapped aged/dual eligible Medicare
enrollment type as it would be
multiplied by one. Because of the
increase in original regional update
factor for the three capped Medicare
enrollment types, this hypothetical ACO
would have a higher updated
benchmark under this proposed policy
than under current policy.
However, if an ACO was in a regional
service area with aggregate prospective
HCC risk score growth that was not
above the regional risk score growth
cap, the regional risk score growth cap
adjustment factor for all Medicare
enrollment types would be equal to one,
thus resulting in no change to the
original regional update factor for any
Medicare enrollment type and therefore
no change to the ACO’s updated
benchmark compared to current policy.
We believe this proposed policy
would help increase the accuracy of the
regional update factor for ACOs
operating in regional service areas with
high risk score growth, including those
serving more medically complex
beneficiaries, therefore increasing
incentives for ACOs to form or continue
participation in such areas. At the same
time, we believe that incorporating the
market share adjustment helps to
mitigate concerns related to coding
intensity for ACOs with high market
share and thus a relatively high level of
influence over risk scores in the ACOs
regional service area as discussed in
section III.G.4.b.(1) of this proposed rule
and would therefore protect the Trust
Funds by continuing to limit incentives
for this behavior.
We simulated the impact of the
proposed policy using PY 2021 financial
reconciliation data for ACOs in
agreement periods beginning on or after
July 1, 2019. This simulation found that
38 of the 332 ACOs (11 percent) would
have been subject to the cap on regional
risk score growth determined in step 4
of the proposed methodology and
therefore would have had a higher
regional update factor than under
current policy for at least one Medicare
enrollment type. Thirty-six of those 38
ACOs were subject to the 3 percent cap
on their own risk score growth for at
least one enrollment type in actual PY
2021 results. Table 33 shows the
percentage of ACOs determined to be
subject to the cap on regional risk score
growth for each Medicare enrollment
type and the average increase in the
regional update factor for that
enrollment type among those ACOs.
While this modeling shows that only
a small proportion of ACOs would have
benefitted from this policy in PY 2021,
our analyses have also shown that this
proportion is predicted to increase as
more ACOs advance farther into their 5year agreement period. This is
supported by the finding that ACOs in
the simulation were significantly more
likely to be impacted if their agreement
period started in 2019 with a BY3 of
2018 (16 percent) than if their
agreement period started in 2020 with a
BY3 of 2019 (6 percent).187 Because the
analysis of PY 2021 data demonstrates
that circumstances like the PHE for
COVID–19 and progression along a 5year agreement period can interact to
increase the share of ACOs in regional
service areas with aggregate regional
risk score growth above the cap, we
have determined that our initial
concerns about creating adverse
incentives for coding behavior by
capping regional risk score growth, as
discussed in section III.G.4.b.(1) of this
proposed rule, are outweighed by the
potential harm to ACOs in regions with
high risk score growth, particularly
when such growth is not due to the
ACO’s own coding activities.
Additionally, we believe the market
share adjustment to the cap on regional
risk score growth will limit overly
advantaging ACOs with high market
share if they participate in coding
initiatives.
Table 34 displays information on the
impact of the market share adjustment
on the cap on regional risk score growth
within our simulation of the proposed
policy in PY 2021 for the ACOs with the
minimum, median, and maximum
aggregate market share that were found
to be subject to the cap on regional risk
score growth.
187 While analysis of average FFS risk score
changes at the hospital referral region (HRR) level
further supports the assumption that more ACOs
would be impacted toward the end of their 5-year
agreement period, such analysis also indicates that
variation from the PHE for COVID–19 likely
accentuated this phenomenon in the simulation on
PY2021 data. For this reason, the finding in the
PY2021 simulation that 16 percent of 2019 starters
were impacted is likely indicative of an upper
bound for the share of ACOs potentially impacted
by PY5 in agreement periods that start in 2024 or
later (that is, where the impact of the PHE for
COVID–19 is minimal in BY3 relative to the BY3s
in this simulation).
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Based on this data in Table 34, the
majority of ACOs found to be impacted
in this simulation had a relatively small
aggregate market share, with a median
of about 13 percent. Because of this, the
median increase to the cap on regional
risk score growth from the market share
adjustment was small (0.001). (This is
both the median increase among all 38
impacted ACOs and the increase for the
impacted ACO with the median market
share). Further analysis showed that
results were similar among both rural
and urban ACOs. Of the 38 impacted
ACOs, 34 were classified as urban and
had a median aggregate market share of
about 12 percent. The remaining four
impacted ACOs were rural ACOs with a
median aggregate market share of about
24 percent. While the market share was
higher on average among rural ACOs,
average market share for both types of
ACOs was under 25 percent and both
groups had only a small median
increase to the cap on regional risk score
growth from the market share
adjustment of 0.001.188
ACOs with a larger aggregate market
share received a larger increase in the
cap on regional risk score growth due to
the market share adjustment. For
example, in Table 34, the ACO with the
highest market share of 53.6 percent (an
ACO that has a regional service area in
an urban area), had a 20 percent
increase in its cap from the market share
adjustment, going from a non-market
share adjusted cap of 1.008 to an
adjusted cap of 1.028. We believe that,
188 For this analysis, ACOs were classified as
rural if the plurality of their assigned beneficiaries
resided in either micropolitan or noncore counties
and urban if the plurality of their assigned
beneficiaries resided in either large central metro,
large fringe metro, medium metro, or small metro
counties as defined by The United States Census
Bureau and the Office of Management and Budget
(OMB).
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while the impact of the market share
adjustment on the cap on regional risk
score growth will be small for the
majority of ACOs, this market share
adjustment is important to address both
our own concerns related to incentives
for coding intensity and the similar
concerns raised by MedPAC in the CY
2023 PFS final rule, as discussed in
section III.G.4.b.(1) of this proposed
rule. The market share adjustment to the
cap limits the adverse coding incentives
that can arise when allowing larger
benchmark increases when an ACO
increases its coding, especially for ACOs
with high market share. Specifically,
ACOs with high market share will still
have a disincentive to engage in coding
initiatives, as these initiatives could
increase risk score growth in their
regional service area and potentially
decrease the value of the regional
component of their update factor.
Apart from the market share
adjustment, the calculation of the
proposed cap on regional risk score
growth between BY3 and the
performance year is calculated in the
same way as the aggregate demographics
plus 3 percent cap on ACO risk score
growth under §§ 425.605(a)(1)(ii)(A) and
425.610(a)(2)(ii)(A). Specifically, the cap
is calculated as the aggregate growth in
regional demographic risk scores
between BY3 and the performance year
plus 3 percentage points, prior to
application of the market share
adjustment. Additionally, as a result of
incorporating the risk adjustment into
the regional update factor at the county
level, the current methodology does not
directly calculate a regional risk ratio
that can be directly modified. The
proposed approach of modifying the
regional update factor by multiplying by
an adjustment factor achieves the goal of
reducing the impact of regional risk
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score growth while leaving the existing
methodology for calculating riskadjusted regional expenditures intact.
As we have explained in earlier
rulemaking (see 87 FR 69887 and
69888), we have used our authority
under section 1899(i)(3) of the Act to
adopt a three-way blended benchmark
update factor (weighted one-third
ACPT, and two-thirds national-regional
blend) for agreement periods beginning
on January 1, 2024, and in subsequent
years, in place of an update factor based
on the projected absolute amount of
growth in national per capita
expenditures for Parts A and B services
under the original FFS program as
called for in section 1899(d)(1)(B)(ii) of
the Act. Therefore, the proposed
changes to the regional component of
the three-way blended update factor
described in this section of this
proposed rule would similarly require
continued use of our statutory authority
under section 1899(i)(3) of the Act.
Section 1899(i)(3) of the Act grants the
Secretary the authority to use other
payment models, including payment
models that use alternative
benchmarking methodologies, if the
Secretary determines that doing so
would improve the quality and
efficiency of items and services
furnished under the Medicare program
and program expenditures under the
alternative methodology would be equal
to or lower than those that would result
under the statutory payment model. We
believe the changes to the methodology
for updating the benchmark that we are
proposing pursuant to section 1899(i)(3)
of the Act would improve the quality
and efficiency of items and services
furnished under the Medicare Program.
More specifically, we believe that the
proposed changes to the regional
component of the update factor would—
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in the context of the downward effects
on the benchmark resulting from
elevated variation in regional average
prospective HCC risk score growth as
shown in the PY 2021 analysis—
reinforce the incentive for ACOs to enter
and remain in the Shared Savings
Program, particularly in regions with
changing populations. Moreover, we
believe that the proposed approach, by
encouraging ACOs to enter and continue
participation in the Shared Savings
Program, would lead to improvement in
the quality of care furnished to
Medicare FFS beneficiaries because
participating ACOs have an incentive to
perform well on quality measures in
order to maximize the shared savings
they may receive. In addition, as
discussed in the Regulatory Impact
Analysis (section VII.E.10. of this
proposed rule), we believe the proposed
changes to the regional component of
the three-way blended update factor, in
combination with the other proposals
for which we must use our authority
under section 1899(i)(3) of the Act,
would result in a marginal impact that
is estimated to result in $330 million in
lower net spending over the 10-year
projection window, which supports our
finding that the relatively minor
changes to program spending resulting
from these proposed changes would not
violate the requirements of section
1899(i)(3)(B) 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 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.
We propose to revise the Shared
Savings Program regulations governing
the calculation of the regional growth
rate when updating the historical
benchmark between BY3 and the
performance year at § 425.652(c) to
incorporate a regional risk score growth
cap adjustment factor. We also propose
to add a new section to the regulations
at § 425.655 to describe the calculation
of the adjustment factor.
We seek comment on the proposed
changes to calculation of the regional
component of the update factor for
agreement periods beginning on or after
January 1, 2024.
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c. Mitigating the Impact of the Negative
Regional Adjustment on the Benchmark
To Encourage Participation by ACOs
Caring for Medically Complex, HighCost Beneficiaries
(1) Background
In earlier rulemaking we have
discussed our use of the Secretary’s
discretion under section
1899(d)(1)(B)(ii) of the Act to adjust the
historical benchmark by ‘‘such other
factors as the Secretary determines
appropriate’’ in order to adjust ACO
historical benchmarks to reflect FFS
expenditures in the ACO’s regional
service area (81 FR 37962). We initially
established a regional adjustment in a
benchmark rebasing methodology that
applied to ACOs entering a second
agreement period beginning on January
1, 2017, January 1, 2018, or January 1,
2019 (§ 425.603(c) through (g)), before
modifying our policy to apply this
adjustment program wide beginning
with agreement periods starting on July
1, 2019, and in subsequent years
(§ 425.601(a)(8)). In the CY 2023 PFS
final rule (87 FR 69915 through 69923)
we modified the way we would
calculate the regional adjustment for
ACOs in agreement periods starting on
January 1, 2024, and in subsequent
years (§ 425.656). We also finalized a
policy that would modify the way we
would apply the regional adjustment to
the benchmark that would also take into
account a new adjustment for prior
savings that would be available to
eligible ACOs (§ 425.652(a)(8)).
In accordance with § 425.601(a)(8), for
ACOs in agreement periods beginning
on or after July 1, 2019 and before
January 1, 2024, we adjust historical
benchmark expenditures by Medicare
enrollment type (ESRD, disabled, aged/
dual eligible Medicare and Medicaid
beneficiaries, aged/non-dual eligible
Medicare and Medicaid beneficiaries)
by a percentage of the difference
between the average per capita
expenditure amount for the ACO’s
regional service area and the average per
capita amount of the ACO’s historical
benchmark (referred to herein as the
‘‘regional adjustment’’). The percentage
applied in calculating the regional
adjustment depends on whether the
ACO has lower or higher spending
compared to the ACO’s regional service
area and the agreement period for which
the ACO is subject to the regional
adjustment, according to the phase-in
schedule of applicable weights. We cap
the per capita dollar amount of the
regional adjustment for each Medicare
enrollment type at a dollar amount
equal to positive or negative 5 percent
of national per capita FFS expenditures
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for Parts A and B services under the
original Medicare FFS program in
benchmark year (BY) 3 for assignable
beneficiaries (as defined in § 425.20) in
that Medicare enrollment type
identified for the 12-month calendar
year corresponding to BY3
(§ 425.601(a)(8)(ii)(C)) (referred to herein
as positive or negative 5 percent of
national per capita FFS expenditures for
assignable beneficiaries, and as the
‘‘symmetrical cap,’’ terms which we
consider to be synonymous). We then
apply the capped regional adjustment
for each Medicare enrollment type by
adding it to the historical benchmark
expenditure for that enrollment type. A
positive regional adjustment for a given
Medicare enrollment type increases the
benchmark for that enrollment type,
whereas a negative regional adjustment
decreases the benchmark for that
enrollment type.
With the policies finalized in the CY
2023 PFS final rule (87 FR 69915
through 69923), we sought to reduce the
impact of negative regional adjustments
in several ways for agreement periods
beginning on January 1, 2024, and
subsequent years. First, we finalized a
policy that replaced the negative 5
percent cap on the negative regional
adjustment with a negative 1.5 percent
cap. Under this policy, we would
continue to cap positive adjustments for
each Medicare enrollment type at a
dollar amount equal to 5 percent of
national per capita FFS expenditures for
assignable beneficiaries for that
enrollment type but would cap negative
adjustments for each enrollment type at
a dollar amount equal to negative 1.5
percent of national per capita FFS
expenditures for assignable beneficiaries
for that enrollment type. Additionally,
after applying the negative 1.5 percent
cap, we would apply an offset factor
that would gradually decrease the
negative regional adjustment amount for
a given Medicare enrollment type as an
ACO’s proportion of dually eligible
Medicare and Medicaid beneficiaries
increases or its weighted average
prospective HCC risk score increases.
Finally, for an ACO eligible for the prior
savings adjustment for which the
regional adjustment expressed as a
single value (based on taking a person
year weighted average across the four
Medicare enrollment types) is negative,
we would further offset the regional
adjustment by the prior savings
adjustment. In the CY 2023 PFS final
rule (87 FR 69919) we expressed our
belief that by reducing the impact of
negative regional adjustments, these
policies would incentivize ACOs that
serve high-cost beneficiaries to join or
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continue to participate in the Shared
Savings Program.
These policies to reduce the impact of
negative regional adjustments are
reflected in several new sections of the
regulations. Section 425.652 is the main
provision that describes the
methodology for establishing, adjusting,
and updating the benchmark for
agreement periods beginning on January
1, 2024, and in subsequent years,
including the interaction of the regional
adjustment and the prior savings
adjustment. Sections 425.656 and
425.658 provide additional detail on the
calculations of the regional adjustment
and the prior savings adjustment,
respectively.
Table 35 illustrates how the caps to
the regional adjustment would be
calculated and applied to positive and
negative regional adjustments at the
Medicare enrollment type level under
the policy finalized in the CY 2023 PFS
final rule. Note that the uncapped
regional adjustment values would be
calculated using the applicable
percentage phase-in weight based on
whether the ACO has lower or higher
spending as compared to its regional
service area and the ACO’s agreement
period subject to a regional adjustment
as described in § 425.656(d). For
example, if an ACO is considered to
have lower spending compared to the
ACO’s regional service area, and it is the
ACO’s first agreement period subject to
the regional adjustment, we would use
a weight of 35 percent when applying
the regional adjustment. If an ACO is
considered to have higher spending
compared to the ACO’s regional service
area, and it is the ACO’s first agreement
period subject to the regional
adjustment, we would use a weight of
15 percent when applying the regional
adjustment.
The hypothetical ACO in this
example has a mix of positive and
negative regional adjustments across the
four enrollment types. The ACO’s
uncapped aged/non-dual eligible
adjustment is outside the negative 1.5
percent cap and thus changes from
¥$307 to ¥$166 when the cap is
applied. The ACO’s adjustments for the
other three enrollment types are all
within the applicable positive or
negative caps and are thus unaffected.
The ACO’s overall weighted average
regional adjustment (calculated by
multiplying the adjustment for each
enrollment type by the corresponding
enrollment type proportion and then
summing across the four enrollment
types) changes from ¥$209 to ¥$111
when the negative regional adjustment
cap is applied, reducing the per capita
impact of the negative regional
adjustment by $98.
Under the methodology adopted in
the CY 2023 PFS final rule (87 FR 69917
and 69920), after we apply the caps, we
next apply an offset factor to any
negative regional adjustments at the
enrollment type level. The offset factor
is based on the following: [A] the ACO’s
overall proportion of BY3 assigned
beneficiaries that are dually eligible for
Medicare and Medicaid (including
dually eligible ESRD, disabled, and aged
beneficiaries) 189 and [B] the ACO’s
weighted average prospective HCC risk
score for BY3 taken across the four
Medicare enrollment types.190 Before
taking this weighted average, the risk
score for each enrollment type is first
renormalized by dividing by the
national mean risk score for the
assignable FFS population for that
enrollment type identified for the
calendar year corresponding to BY3.
Specifically, the offset factor is
calculated as:
Offset factor = [A] + ([B]¥1)
We apply the offset factor, which is
subject to a minimum of zero and a
maximum of one, by subtracting its
value from 1 and multiplying this
difference by the negative regional
adjustment for each Medicare
enrollment type, calculated as:
Final regional adjustment = Negative
regional adjustment × (1¥Offset
factor)
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189 In computing this proportion, we use for each
beneficiary the fraction of the year (referred to as
person years) in which they were eligible for the
aged/dual eligible enrollment type or for which
they were eligible for the ESRD or disabled
enrollment type and dually eligible for Medicare
and Medicaid.
190 In computing this weighted average, we apply
a weight to the risk score for BY3 for an enrollment
type that is equal to the product of the ACO’s BY3
per capita expenditures for that enrollment type
and the ACO’s BY3 person years for that enrollment
type.
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The higher an ACO’s proportion of
dually eligible beneficiaries or the
higher its risk score, the larger the offset
factor would be and the larger the
reduction to the overall negative
regional adjustment. If the offset factor
is equal to the maximum value of one,
the ACO would not receive a negative
regional adjustment for any enrollment
type, because each negative adjustment
would be multiplied by a value of 1
minus the offset factor, or 0. For these
ACOs, the overall weighted average
regional adjustment would either be 0
(if the ACO had negative adjustments
for all four enrollment types prior to the
application of the offset factor) or
positive (if the ACO had a mix of
positive and negative adjustments at the
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enrollment type level prior to the
application of the offset factor). If the
offset factor is equal to the minimum
value of zero, the ACO would receive no
benefit from the offset factor.
To illustrate how the offset factor
would be calculated and applied,
assume that the hypothetical ACO from
Table 35 had a proportion of dually
eligible beneficiaries of 0.130 and a
weighted average prospective HCC risk
score for BY3 of 1.240. The offset factor
for this ACO would be calculated as:
Here, the offset factor is applied to the
regional adjustments for the disabled
and aged/non-dual eligible populations,
as both are negative, but not to the
regional adjustments for the ESRD and
aged/dual eligible populations, which
are both positive. Taking the weighted
average across the enrollment types
following application of the offset factor
shows that the ACO’s overall weighted
regional adjustment changes from
¥$111 before the offset to ¥$55 after
the offset, further reducing the per
capita impact of the negative regional
adjustment by $56. The overall per
capita impact of both the cap and offset
factor for this ACO would be $154.
In the CY 2023 PFS final rule (87 FR
69918 and 69921) we presented
simulations of the combined impact of
the cap and offset factor relative to the
symmetrical positive and negative 5
percent cap then in place for ACOs in
agreement periods beginning on July 1,
2019, and in subsequent years. The
results of these simulations, which used
data from PY 2020 historical
benchmarks for ACOs in agreement
periods starting on or after July 1, 2019,
and from PY 2022 historical
benchmarks for ACOs starting an
agreement period on January 1, 2022,
found the negative regional adjustment
for almost every ACO that had an
overall negative regional adjustment in
the PY 2020 and PY 2022 data under the
symmetrical cap would have been
reduced (or eliminated), with an average
per capita impact of approximately $114
for PY 2020 and $48 for PY 2022. ACOs
with higher weighted average BY3
prospective HCC risk scores and higher
proportions of dually eligible Medicare
and Medicaid beneficiaries had overall
greater reductions in their negative
regional adjustments. Four ACOs in the
PY 2020 simulation and one in the PY
2022 simulation had an offset factor of
1, meaning they would have received a
full offset to their negative regional
adjustments.
Under a separate policy also finalized
in the CY 2023 PFS final rule, an ACO
beginning an agreement period on
January 1, 2024, and in subsequent
years that is a renewing or re-entering
ACO may be eligible to receive an
adjustment to its benchmark to account
for savings generated in performance
years that correspond to the benchmark
years of its new agreement period. A full
discussion of this policy can be found
in that earlier rulemaking (87 FR 69899
through 69915). The policy was
designed such that an eligible ACO
would receive the higher of its overall
positive regional adjustment or its prior
savings adjustment, or a combination of
the two if its overall regional adjustment
is negative and it had prior savings.
ACOs ineligible for the prior savings
adjustment would receive the regional
adjustment (computed as described
earlier in this section applying a 5
percent cap on positive regional
adjustments and a ¥1.5 percent cap and
offset factor on negative regional
adjustments). Specifically, if the
regional adjustment, expressed as a
single value, is positive, the ACO would
receive a final adjustment equal to the
higher of the regional adjustment or an
adjustment based on the ACO’s prior
savings (see § 425.652(a)(8)(iii)(B)). If
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Offset factor = 0.130 + (1.240¥1) =
0.370
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52467
This factor would be applied as
illustrated in Table 36 by multiplying
the negative regional adjustment for
each applicable Medicare enrollment
type by 1 minus the offset factor or
0.630.
the regional adjustment, expressed as a
single value, is negative, we would
calculate the final adjustment as
described in § 425.652(a)(8)(iii)(A), with
the ACO receiving either a smaller
negative regional adjustment or a
positive adjustment for prior savings
depending on the relative size of the
negative regional adjustment and the
ACO’s pro-rated prior savings.
Based on further consideration, we
believe it is important and timely to
revisit the policy that allows for
negative adjustments to be applied in
establishing the benchmark for ACOs.
While we did not consider eliminating
negative regional adjustments programwide in CY 2023 PFS rulemaking, one
commenter noted that there is an
argument for doing so. We believe
further mitigating the impact of the
negative regional adjustment for ACOs
with high-cost populations, thereby
resulting in higher benchmarks for
ACOs compared to the recently
finalized methodology, could further
bolster the business case for Shared
Savings Program participation by such
ACOs.
As we discussed in the CY 2023 PFS
proposed rule (87 FR 46161), there is
evidence that certain aspects of the
program’s benchmarking methodology,
notably the regional adjustment to the
benchmark, may deter participation
among ACOs with spending above their
regional service area including those
serving medically complex, high-cost
populations. High-cost ACOs are
underrepresented in the Shared Savings
Program, with around 86 percent of all
participating ACOs receiving an overall
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positive regional adjustment in PY 2022
indicating that a majority of ACOs are
lower spending than their regional
service area. We also observed that
ACOs that received an overall negative
regional adjustment for PY 2022 were
less likely to continue participation in
the program in PY 2023 than were ACOs
that received an overall positive
regional adjustment, with 22 percent of
ACOs with a negative overall
adjustment leaving the program
compared to 12 percent of ACOs with a
positive overall adjustment. Since PY
2017 the overall annual average share of
ACOs that leave the program has been
12 percent. A recent academic study
also found evidence suggesting selective
participation among ACOs in response
to the original adoption of a regional
adjustment in 2017, with the
composition of ACOs between 2017 to
2019 increasingly shifting to providers
with lower preexisting levels of
spending.191 The authors attributed
these changes to a combination of the
entry of new ACOs with lower baseline
spending, the exit of higher-spending
ACOs, and the reconfiguration of ACO
participant lists to favor lower-spending
practices among ACOs continuing
participation in the program.
Relatedly, we have observed that
negative regional adjustments may make
it more difficult for ACOs to succeed in
the program financially. Between PY
2017, when regional adjustments were
first introduced in the Shared Savings
Program, and PY 2021, ACOs that
received negative regional adjustments
have been consistently less likely to
share in savings than ACOs that
received positive regional adjustments.
For example, in PY 2021 we observed
that 37 percent of ACOs that received a
negative regional adjustment shared in
savings compared to 63 percent among
those with a positive adjustment.
We believe that eliminating the
possibility that an ACO will receive an
overall negative regional adjustment to
its benchmark in combination with the
other elements of the benchmarking
methodology finalized in the CY 2023
PFS final rule, would work together to
further our efforts to ensure
sustainability of the benchmarking
methodology. More specifically, we
believe this policy change would further
encourage continued participation
among high-cost ACOs that serve
medically complex beneficiaries by
eliminating the potential of a lower
191 Lyu P, Chernew M, McWilliams J.
Benchmarking Changes And Selective Participation
In The Medicare Shared Savings Program. Health
Affairs. May 1, 2023. Available at https://
www.healthaffairs.org/doi/10.1377/
hlthaff.2022.01061.
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benchmark due to an overall negative
regional adjustment. It may also
encourage ACOs serving such
populations that may have otherwise
been discouraged from participating in
the Shared Savings Program by the idea
of a lower benchmark to join. The
implementation of this policy would
allow ACOs to serve the most
vulnerable populations while lessening
the concern of how this may affect their
performance in the program. We believe
that program participation by ACOs
serving these populations has the
potential, over time, to produce cost
savings for the Medicare Trust funds by
improving care coordination and quality
of care for such beneficiaries.
Additionally, we believe that
eliminating overall negative regional
adjustments could further incentivize
greater participation among ACOs
whose ACO participants have
historically been less efficient than
other providers and suppliers in their
regions. Such ACOs may have the
greatest potential to generate cost
savings for the Medicare Trust Funds by
adopting more efficient practices,
therefore we believe that their
participation in the program should not
be discouraged.
(2) Proposed Revisions
In light of these considerations, we
are proposing to modify the policies we
adopted in the CY 2023 PFS final rule
so as to prevent any ACO from receiving
an adjustment that would cause its
benchmark to be lower than it would
have been in the absence of a regional
adjustment. Specifically, we are
proposing the following approach to
calculate and apply the regional
adjustment, or the regional adjustment
in combination with the prior savings
adjustment, if applicable, for ACOs in
agreement periods starting on January 1,
2024, and in subsequent years:
• We would continue to calculate the
original uncapped regional adjustment
by Medicare enrollment type using the
applicable percentage phase-in weight
based on whether the ACO has lower or
higher spending compared to its
regional service area and the ACO’s
agreement period subject to a regional
adjustment as described in § 425.656(d).
• We would continue to apply the 5
percent cap on positive regional
adjustments and the ¥1.5 percent cap
and offset factor on negative regional
adjustments at the enrollment type
level, as finalized in the CY 2023 PFS
final rule and described in § 425.656(c).
For the performance year beginning on
January 1, 2025, and subsequent
performance years, the national
assignable fee-for-service population
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used to calculate the caps would reflect
the revised definition of assignable
beneficiary that incorporates the
expanded window for assignment as
proposed in section III.G.3.a of this
proposed rule, if finalized.
• After applying the cap and offset
factor (if applicable), we would express
the regional adjustment as a single per
capita value by calculating a person year
weighted average of the Medicare
enrollment type-specific regional
adjustment values.
• If the ACO’s regional adjustment
amount (expressed as a single per capita
value) is positive, the ACO would
receive a regional adjustment, according
to the approach we finalized in the CY
2023 PFS final rule. That is, we would
apply the enrollment type-specific
regional adjustment amounts separately
to the historical benchmark
expenditures for each Medicare
enrollment type. If the ACO is also
eligible for a prior savings adjustment,
the ACO would receive the higher of the
two adjustments. If the regional
adjustment amount (expressed as a
single per capita value) is higher, we
would apply the enrollment typespecific regional adjustment amounts
separately to the historical benchmark
expenditures for each Medicare
enrollment type. If the prior savings
adjustment is higher, we would apply
the adjustment in the manner finalized
in the CY 2023 PFS final rule as a flat
dollar amount applied separately to the
historical benchmark expenditures for
each Medicare enrollment type.
• If the ACO’s regional adjustment
amount (expressed as a single per capita
value) is negative, the ACO would
receive no regional adjustment to its
benchmark for any enrollment type. If
the ACO is eligible for a prior savings
adjustment, it would receive the prior
savings adjustment as its final
adjustment, without any offsetting
reduction for the negative regional
adjustment.
Under the proposed approach, ACOs
that would face a negative overall
adjustment to their benchmark based on
the methodology adopted in the CY
2023 PFS final rule would benefit, as
they would now receive no downward
adjustment. Additionally, ACOs that
have a negative regional adjustment
amount (expressed as a single value)
and are eligible for prior savings
adjustment under the policy adopted in
the CY 2023 PFS final rule (§ 425.658)
would also be expected to benefit from
the proposed policy. Specifically, these
ACOs could receive a larger positive
adjustment to their benchmark or a
positive adjustment instead of a
negative adjustment, as we would no
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longer offset the prior savings amount
by the negative regional adjustment
amount when determining the final
adjustment that would apply to the
ACO’s benchmark as described in the
current regulations in
§ 425.652(a)(8)(iii)(A).192 We believe
that by increasing the potential benefit
of the prior savings adjustment in this
manner, our proposed policy would be
responsive to the comments discussed
in the CY 2023 PFS final rule
recommending that CMS make the prior
savings adjustment more favorable,
particularly for ACOs serving high-risk
populations (see 87 FR 69910 through
69914).
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192 For examples of the calculation of the final
adjustment when an ACO is eligible for a prior
savings adjustment and the overall regional
adjustment is negative under the policy adopted in
the CY 2023 PFS final rule, please refer to Tables
65 and 66 of the CY 2023 PFS final rule (87 FR
69904 and 69905). In Table 65 the hypothetical
ACO receives a positive final adjustment and in
Table 66 a negative final adjustment.
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Importantly, no ACO would be made
worse off under the proposed policy.
ACOs that have an overall positive
regional adjustment amount would
continue to receive the same adjustment
to their benchmark as they would under
the methodology finalized in the CY
2023 PFS final rule calculated and
applied as described in the current
regulations at §§ 425.656 and
425.652(a)(8), respectively. For these
ACOs, the regional adjustment would
continue to reflect the percentage phasein weight based on whether the ACO
has lower or higher spending compared
to its regional service area and the
ACO’s agreement period subject to a
regional adjustment as described in
§ 425.656(d) and we would continue to
allow negative adjustments to be
applied at the enrollment type level for
those ACOs that receive a positive
overall regional adjustment. We believe
this is appropriate because these ACOs
would continue to receive a positive
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overall adjustment to their benchmark
and thus should already have greater
incentive to join or continue
participation in the program than ACOs
that might otherwise face an adjustment
that reduces their benchmark.
Tables 37 and 38 present hypothetical
examples to demonstrate how we would
determine the final adjustment to an
ACO’s benchmark under the proposed
policy. Both tables include two
hypothetical ACOs. The first ACO, ACO
A, is the same hypothetical ACO as
illustrated in Tables 35 and 36 within
this section and has an overall negative
regional adjustment. The second ACO,
ACO B, has an overall positive regional
adjustment. Table 37 assumes that both
ACOs are ineligible for a prior savings
adjustment, whereas Table 38 shows
how the calculation would change if
both ACOs were eligible for such an
adjustment.
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In Table 37, because ACO A had an
overall negative regional adjustment and
was not eligible for a prior savings
adjustment, the ACO ultimately receives
no adjustment, upward or downward, to
its benchmark. For ACO B, whose
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overall regional adjustment is positive,
the final adjustment is the regional
adjustment, which is applied by adding
the regional adjustment specific to each
enrollment type (reflecting the
percentage weight determined for the
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ACO and after the application of the cap
and offset factor, if applicable) to the
ACO’s pre-adjustment historical
benchmark expenditures for that
enrollment type.
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In Table 38, both ACO A and ACO B
are eligible for a prior savings
adjustment. Because ACO A has a
negative overall regional adjustment, its
final adjustment is automatically set
equal to the prior savings adjustment of
$58. The adjustment is applied as flat
dollar amount by adding the $58 to the
ACO’s historical benchmark
expenditures (row [A]) for each
enrollment type. For ACO B, by
contrast, the final adjustment is
determined by comparing the regional
adjustment amount (expressed as a
single value) to the prior savings
adjustment amount and using the higher
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of the two. In this case the ACO would
receive a final adjustment equal to the
prior savings adjustment of $239. Like
with ACO A, this would be applied to
the ACO’s historical benchmark
expenditures for each enrollment type
as a flat dollar amount.
In revisiting simulations done with
PY 2020 data described earlier in this
section, there were 36 ACOs (of the 43
ACOs with a negative regional
adjustment under the policy with the
symmetrical cap) simulated to have a
negative overall regional adjustment
after the application of the cap and
offset factor. Among these, 31 would not
have been eligible for a prior savings
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adjustment and would have had this
negative regional adjustment applied to
their benchmark under the policy
adopted in the CY 2023 PFS final rule.
Under the new proposed policy, these
ACOs would receive no adjustment to
their benchmark. The average per capita
benefit of eliminating the downward
adjustment would be $30.
The remaining five ACOs would have
been eligible for the prior savings
adjustment. These ACOs would have
received a positive final adjustment to
their benchmark under the methodology
adopted in the CY 2023 PFS final rule
but would receive a larger positive
adjustment under the new proposed
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policy, with an average per capita
increase of $26. This is because we
would no longer be offsetting the prior
savings amount by the negative regional
adjustment as part of determining the
final adjustment to the ACO’s
benchmark as would happen under the
methodology finalized in the CY 2023
PFS final rule and codified at
§ 425.652(a)(8)(iii)(A).
In the PY 2022 simulation described
earlier in this section, there were 26
ACOs (of the 27 ACOs with a negative
regional adjustment under the policy
with the symmetrical cap) that would
have had a negative regional
adjustment, expressed as a single per
capita value, after the application of the
policy adopted in the CY 2023 PFS final
rule. Among these, 14 ACOs would not
have been eligible for a prior savings
adjustment and would have their full
negative regional adjustment eliminated
under the new proposed policy, with an
average impact of $66. The remaining 12
ACOs that would have been eligible for
a prior savings adjustment would see a
larger positive adjustment under the
proposed policy, with an average
increase of $14.
Overall, we believe that the proposed
changes to the calculation and
application of the regional adjustment,
including its interaction with the prior
savings adjustment, would strengthen
incentives for participation among
ACOs that might otherwise be subject to
a downward adjustment to their
benchmark due to the negative regional
adjustment. The proposed policy, if
finalized, would not adversely impact
any ACO’s benchmark relative to the
policy that was finalized in CY 2023
PFS final rule, all else being equal, but
would tend to increase benchmarks for
ACOs that have historically had higher
spending than their regional service
area. Based on our simulations using
data from PY 2020 and PY 2022, the
estimated average increase to the overall
benchmark would be between 0.2 and
0.4 percent but could be larger in future
years when more ACOs would be
subject to higher phase-in weights for
calculating the negative regional
adjustment that would apply (alone or
in combination with the prior savings
adjustment) under the policy adopted in
the CY 2023 PFS final rule. ACOs that
would benefit from the proposed policy
are likely to include those that serve
high-cost, medically complex patients
or those whose ACO participants have
historically been less efficient than their
regional counterparts but may have the
potential to generate the greatest savings
to Medicare through their participation
in the Shared Savings Program.
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We propose to implement the changes
described in this section through
revisions to §§ 425.652, 425.656, and
425.658. Specifically, within § 425.652,
which is the section that sets forth the
methodology for establishing, adjusting,
and updating the benchmark for
agreement periods beginning on January
1, 2024, and in subsequent years, we
propose revisions to § 425.652(a)(8). As
revised, this provision would describe
how we would determine and apply the
adjustment to an ACO’s benchmark
depending on whether the ACO is
eligible for a prior savings adjustment
and whether the ACO’s regional
adjustment, expressed as a single value,
is positive or negative. This provision
would also establish that if an ACO is
not eligible to receive a prior savings
adjustment and has a regional
adjustment, expressed as a single value
that is negative or zero, the ACO will
not receive an adjustment to its
benchmark.
We propose to revise § 425.656
(which describes the calculation of the
regional adjustment) and § 425.658
(which describes the calculation of the
prior savings adjustment) to include
certain elements of each calculation that
were previously described in
§ 425.652(a)(8). Specifically, we propose
to revise § 425.656 to redesignate
paragraphs (d) and (e) as paragraphs (e)
and (f) (respectively) and to specify in
a new paragraph (d) that we would
express the regional adjustment as a
single value, and use this value in
determining whether a regional
adjustment or a prior savings
adjustment would be applied to the
ACO’s benchmark in accordance with
§ 425.652(a)(8) (as revised under this
proposed rule). We also propose
modifications to update certain crossreferences within § 425.656 for accuracy
and consistency with the proposed
revisions to the section.
We propose to revise § 425.658 to
redesignate paragraph (c) as paragraph
(d). We propose to add a new paragraph
(c) under § 425.658 specifying that we
would calculate the per capita savings
adjustment as the lesser of 50 percent of
the pro-rated average per capita savings
amount (computed as described in
§ 425.658(b)(3)(ii)) and the cap equal to
5 percent of national per capita FFS
expenditures for assignable beneficiaries
for BY3 expressed as a single value by
taking a person-year weighted average of
the Medicare enrollment-type specific
values. We propose to revise newly
redesignated paragraph (d) of § 425.658
to specify CMS would compare the per
capita prior savings adjustment with the
regional adjustment, expressed as a
single value as described in
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§ 425.656(d), to determine the
adjustment, if any, that would be
applied to the ACO’s benchmark in
accordance with § 425.652(a)(8).
Additionally, we propose to make the
following conforming changes:
• In § 425.600(f)(4)(ii), we propose to
remove the reference ‘‘425.656(d)’’ and
add in its place the reference
‘‘425.656(e)’’.
• In § 425.611(c)(2)(iii), we propose to
remove the reference
‘‘§ 425.652(a)(8)(iv)’’ and add in its
place the reference ‘‘§ 425.658(c)(1)(ii)’’.
• In § 425.652(a)(9)(v), we propose to
remove the wording that references
CMS redetermining the adjustment to
the benchmark based on ‘‘a combination
of’’ the redetermined regional
adjustment and the prior savings
adjustment.
• In § 425.658(b)(3)(i), which
specifies that the ACO is not eligible to
receive an adjustment for prior savings
if the average per capita amount
computed in § 425.658(b)(2) is less than
or equal to zero, we propose to remove
the sentence: ‘‘The ACO will receive the
regional adjustment to its benchmark as
described in § 425.656.’’
We seek comment on these proposed
changes.
d. Proposal To Modify the Prior Savings
Adjustment
(1) Background
Under section 1899(d)(1)(B)(ii) of the
Act, an ACO’s benchmark must be reset
at the start of each agreement period
using the most recent available 3 years
of expenditures for Parts A and B
services for beneficiaries assigned to the
ACO. Section 1899(d)(1)(B)(ii) of the Act
provides the Secretary with discretion
to adjust the historical benchmark by
‘‘such other factors as the Secretary
determines appropriate.’’ Pursuant to
this authority, as described in the CY
2023 PFS final rule (87 FR 69898
through 69915), we established a prior
savings adjustment that will apply when
establishing the benchmark for ACOs
entering a second agreement period
beginning on January 1, 2024, or in
subsequent years, to account for the
average per capita amount of savings
generated during the ACO’s prior
agreement period.
The prior savings adjustment adopted
in the CY 2023 PFS final rule is
designed to adjust an ACO’s benchmark
to account for the average per capita
amount of savings generated by the ACO
across the 3 performance years prior to
the start of its current agreement period
for new and renewing ACOs. In the final
rule, we explained that reinstituting a
prior savings adjustment would be
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broadly in line with our interest in
addressing dynamics to ensure
sustainability of the benchmarking
methodology. Specifically, such an
adjustment would help to mitigate the
rebasing ratchet effect on an ACO’s
benchmark by returning to an ACO’s
benchmark an amount that reflects its
success in lowering growth in
expenditures while meeting the
program’s quality performance standard
in the performance years corresponding
to the benchmark years for the ACO’s
new agreement period. We also
explained our belief that a prior savings
adjustment could help address an
ACO’s effects on expenditures in its
regional service area that result in
reducing the regional adjustment added
to the historical benchmark.
In the CY 2023 PFS final rule, we
explained that, in order to mitigate the
potential for rebased benchmarks for
ACOs that are lower-spending compared
with their regional service area and that
achieved savings in the benchmark
period to become overinflated, we
believed that adjusting an ACO’s
benchmark based on the higher of either
the prior savings adjustment or the
ACO’s positive regional adjustment
would be appropriate. Additionally, we
believed it would be appropriate to use
a prior savings adjustment to offset
negative regional adjustments for ACOs
that are higher spending compared to
their regional service area. We noted
that this would permit ACOs that are
subject to a negative regional
adjustment, but that have generated
savings in prior years, to receive a
relatively higher benchmark.
Under the methodology finalized in
the CY 2023 PFS final rule and codified
at § 425.658 of the regulations, the prior
savings adjustment that will apply in
the establishment of benchmarks for
renewing ACOs and re-entering ACOs
entering an agreement period beginning
on January 1, 2024, and in subsequent
years, is calculated as follows:
• Step 1: Calculate total per capita
savings or losses in each performance
year that constitutes a benchmark year
for the current agreement period. For
each performance year we will
determine an average per capita amount
reflecting the quotient of the ACO’s total
updated benchmark expenditures minus
total performance year expenditures
divided by performance year assigned
beneficiary person years. CMS will
apply the following requirements in
determining the amount of per capita
savings or losses for each performance
year:
++ The per capita savings or losses
will be set to zero for a performance
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year if the ACO was not reconciled for
the performance year.
++ If an ACO generated savings for a
performance year but was not eligible to
receive a shared savings payment for
that year due to noncompliance with
Shared Savings Program requirements,
the per capita savings for that year will
be set to zero.
++ For a new ACO that is identified
as a re-entering ACO, per capita savings
or losses will be determined based on
the per capita savings or losses of the
ACO in which the majority of the ACO
participants in the re-entering ACO
were participating.
• Step 2: Calculate average per capita
savings. Calculate an average per capita
amount of savings by taking a simple
average of the values for each of the 3
performance years as determined in
Step 1, including values of zero, if
applicable. CMS will use the average
per capita amount of savings to
determine the ACO’s eligibility for the
prior savings adjustment as follows:
++ If the average per capita value is
less than or equal to zero, the ACO will
not be eligible for a prior savings
adjustment. The ACO will receive the
regional adjustment to its benchmark.
++ If the average per capita value is
positive, the ACO will be eligible for a
prior savings adjustment.
• Step 3: Apply a proration factor to
the per capita savings calculated in Step
2 equal to the ratio of the average person
years for the 3 performance years that
immediately precede the start of the
ACO’s current agreement period
(regardless of whether these 3
performance years fall in one or more
prior agreement periods), and the
average person years in benchmark
years for the ACO’s current agreement
period, capped at 1. If the ACO was not
reconciled for one or more of the 3 years
preceding the start of the ACO’s current
agreement period, the person years from
that year (or years) will be excluded
from the averages in the numerator and
the denominator of this ratio. For a new
ACO that is identified as a re-entering
ACO, the person years of the ACO in
which the majority of the ACO
participants of the re-entering ACO were
participating will be used in the
numerator of the calculation. This ratio
will be redetermined for each
performance year during the agreement
period in the event of any changes to the
number of average person years in the
benchmark years as a result of changes
to the ACO’s certified ACO participant
list, a change to the ACO’s beneficiary
assignment methodology selection, or
changes to the beneficiary assignment
methodology.
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• Step 4: Determine final adjustment
to benchmark. Compare the pro-rated
positive average per capita savings from
Step 3 with the ACO’s regional
adjustment, determined as specified in
the regulation at § 425.656, expressed as
a single per capita value by taking a
person-year weighted average of the
Medicare enrollment type-specific
regional adjustment values.
++ If the regional adjustment,
expressed as a single value, is negative
or zero, calculate the sum of the regional
adjustment value and the pro-rated
positive average per capita savings value
and determine the final adjustment as
follows:
-- If the sum is positive, the ACO will
receive a prior savings adjustment in
place of the negative regional
adjustment equal to the lesser of 50
percent of the sum of the pro-rated
average per capita savings and the
regional adjustment and 5 percent of
national per capita FFS expenditures for
Parts A and B services under the
original Medicare FFS program in BY3
for assignable beneficiaries identified
for the 12-month calendar year
corresponding to BY3. The adjustment
will be applied as a flat dollar amount
to the historical benchmark
expenditures for each of the following
populations of beneficiaries: ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries.
--If this sum is negative, this will
constitute the amount of the negative
regional adjustment applied to the
ACO’s historical benchmark. The
adjustment will be applied as a flat
dollar amount to the historical
benchmark expenditures for the
following populations of beneficiaries:
ESRD, disabled, aged/dual eligible
Medicare and Medicaid beneficiaries,
and aged/non-dual eligible Medicare
and Medicaid beneficiaries.
++ If the regional adjustment,
expressed as a single value, is positive,
the ACO will receive an adjustment to
the benchmark equal to the higher of the
following:
-- The positive regional adjustment
amount. The adjustment will be applied
separately to the historical benchmark
expenditures for each of the following
populations of beneficiaries in
accordance with § 425.656(c): ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries.
-- A prior savings adjustment equal to
the lesser of 50 percent of the pro-rated
positive average per capita savings value
and 5 percent of national per capita FFS
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expenditures for Parts A and B services
in BY3 for assignable beneficiaries
identified for the 12-month calendar
year corresponding to BY3. The
adjustment will be applied as a flat
dollar amount to the historical
benchmark expenditures for each of the
following populations of beneficiaries:
ESRD, disabled, aged/dual eligible
Medicare and Medicaid beneficiaries,
and aged/non-dual eligible Medicare
and Medicaid beneficiaries.
As we explained in the CY 2023 PFS
final rule (87 FR 69900) in calculating
an ACO’s average per capita prior
savings over the 3 performance years
immediately preceding the start of its
agreement period, we believe that a
safeguard is needed to ensure that ACOs
that achieved savings for a performance
year that serves as a benchmark year for
the current agreement period, but were
ineligible to receive a shared savings
payment due to noncompliance with
Shared Savings Program requirements,
are not subsequently eligible to have a
portion of those savings included in
their historical benchmark. Without
such a safeguard, we would be
rewarding an ACO, despite its
noncompliance, through a higher
benchmark in its subsequent agreement
period. This would conflict with the
sanction imposed on the ACO for its
noncompliance during the performance
year(s) of its prior agreement period.
Accordingly, under the prior savings
adjustment policy we finalized in the
CY 2023 PFS final rule, if an ACO was
ineligible to share in savings for any
performance year in the 3 performance
years immediately preceding the start of
its agreement period due to
noncompliance with Shared Savings
Program requirements, we will set at
zero the per capita amount of savings for
the affected performance year(s) when
calculating the prior savings adjustment.
There are a variety of reasons that
could result in an ACO’s ineligibility to
receive a shared savings payment due to
noncompliance. In accordance with
§§ 425.605(c)(2), and 425.610(c)(2), an
ACO does not qualify to receive shared
savings for a performance year if it
failed to meet the quality performance
standard as specified under § 425.512 or
otherwise did not maintain its eligibility
to participate in the Shared Savings
Program. Furthermore, an ACO will not
receive any shared savings payments
during the time it is under a corrective
action plan (CAP) for avoidance of atrisk beneficiaries and is not eligible to
receive shared savings for the
performance year attributable to the
time that necessitated the CAP (the time
period during which the ACO avoided
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at-risk beneficiaries) (refer to
§ 425.316(b)(2)(ii)(B) and (C)).
In the CY 2023 PFS rulemaking to
establish the current prior savings
adjustment, we did not describe how we
would account for certain circumstances
where there could be changes to the
values used in calculating the prior
savings adjustment. Such changes could
occur as a result of changes in savings
earned by ACOs in accordance with
§ 425.316(b)(2)(ii)(B) or (C) as a result of
a compliance action to address
avoidance of at-risk beneficiaries or
issuance of a revised initial
determination of financial performance
under § 425.315. If CMS determines that
an ACO, its ACO participants, any ACO
providers/suppliers, or other
individuals or entities performing
functions or services related to the
ACO’s activities avoids at-risk
beneficiaries and requires the ACO to
submit a CAP, the ACO will not receive
any shared savings payments during the
time it is under the CAP
(§ 425.316(b)(2)(ii)(B)), and it will not at
any time be eligible to receive shared
savings for the performance year
attributable to the time that necessitated
the CAP (§ 425.316(b)(2)(ii)(C)). Upon
completion of an ACO’s CAP for
avoidance of at-risk beneficiaries, CMS
may release shared savings payments
withheld from an ACO during the time
it was under a CAP under
§ 425.316(b)(2)(ii)(B), so long as the
shared savings are not attributable to the
time that necessitated the CAP (that is,
the time period during which the ACO
avoided at-risk beneficiaries). Thus,
depending on the timing of compliance
actions undertaken by CMS, the amount
of savings eligible for inclusion in the
prior savings adjustment under
§ 425.658(b)(1), may change as a result
of the compliance action. For instance,
the total savings eligible for inclusion in
the prior savings adjustment may
increase after the completion of a CAP
and release of shared savings payment
withheld under § 425.316(b)(2)(ii)(B).
Further, if an initial determination of
financial performance was already made
and shared savings payments
distributed and then the ACO was found
to have avoided at-risk beneficiaries and
therefore ineligible to receive a shared
savings payment for the performance
year, CMS would recoup the shared
savings for the time period during
which the ACO avoided at-risk
beneficiaries. This latter scenario would
result in a decrease in the total amount
of savings eligible for inclusion in the
prior savings adjustment calculation.
Further, if CMS determines that the
amount of shared savings due to the
ACO or the amount of shared losses
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owed by the ACO has been calculated
in error, under § 425.315 CMS may
reopen its prior determination and issue
a revised initial determination: (1) at
any time in the case of fraud or similar
fault as defined in § 405.902; or (2) not
later than 4 years after the date of the
notification to the ACO of the initial
determination of savings or losses for
the relevant performance year, for good
cause. If these situations—changes in
the amount of shared savings for a prior
performance year under
§ 425.316(b)(2)(ii)(B) or (C) as a result of
a compliance action due to the
avoidance of at-risk beneficiaries, or the
issuance of a revised initial
determination based on a reopening of
ACO shared savings or shared losses
under § 425.315—impact one of the 3
years prior to the start of the ACO’s
current agreement period, it is possible
that the prior savings adjustment would
no longer reflect the savings or losses
achieved by the ACO during the
applicable years. In the CY 2023 PFS
rulemaking we did not adopt a
mechanism to account for these changes
in the prior savings adjustment, but
rather focused on changes to the prior
savings adjustment related to changes in
an ACO’s participant list, changes to the
ACO’s assignment methodology
selection, or changes to beneficiary
assignment methodology under the
Shared Savings Program as a whole.
(2) Proposed Revisions
We are proposing refinements to the
prior savings adjustment calculation
methodology, specified in 42 CFR part
425, subpart G, that would apply in the
establishment of benchmarks for
renewing ACOs and re-entering ACOs
entering an agreement period beginning
on January 1, 2024, and in subsequent
years, to account for circumstances
where the amount of savings or losses
for a performance year used in the prior
savings adjustment calculation changes
retroactively. Specifically, we are
proposing to modify the list of
circumstances for adjusting the
historical benchmark in § 425.652(a)(9)
to include two additional scenarios: a
change in savings earned by an ACO in
a benchmark year in accordance with
§ 425.316(b)(2)(ii)(B) or (C) due to
compliance action to address avoidance
of at-risk beneficiaries, or a change in
the amount of savings or losses for a
benchmark year as a result of a
reopening of a prior determination of
ACO shared savings or shared losses
and the issuance of a revised initial
determination under § 425.315. In these
situations, the amount of savings or
losses that an ACO may have generated
in the 3 performance years prior to the
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start of the current agreement period
and that would have been eligible for
inclusion in the calculation of the prior
savings adjustment may change. The
refinements we are proposing would
allow for the prior savings adjustment to
be recalculated and the historical
benchmark to be adjusted to reflect the
any change in the amount of savings
earned or losses incurred by the ACO in
the 3 performance years prior to its
current agreement period that are
eligible for inclusion in the calculation
of the prior savings adjustment.
We are proposing to modify the
process currently described in
§ 425.652(a)(9) for adjusting the
historical benchmark. Currently, an
ACO may receive an adjusted historical
benchmark because of changes in the
ACO’s assigned beneficiary population
in the benchmark years of the ACO’s
current agreement period due to the
addition and removal of ACO
participants or ACO providers/suppliers
in accordance with § 425.118(b), a
change to the ACO’s beneficiary
assignment methodology selection
under § 425.226(a)(1),193 or changes to
the beneficiary assignment methodology
specified in 42 CFR part 425, subpart E.
We are proposing to modify
§ 425.652(a)(9) to indicate that an ACO
would receive an adjusted historical
benchmark for changes in values used
in benchmark calculations in
accordance with § 425.316(b)(2)(ii)(B) or
(C) due to compliance action to address
avoidance of at-risk beneficiaries or as a
result of issuance of a revised initial
determination under § 425.315. More
specifically, an ACO would receive an
adjusted benchmark for the following
reasons: (1) a change in the amount of
savings calculated for any of an ACO’s
three benchmark years eligible for
inclusion in the prior savings
adjustment in accordance with
§ 425.316(b)(2)(ii)(B) or (C) due to
compliance action taken to address
avoidance of at-risk beneficiaries, or (2)
CMS issues a revised initial
determination under § 425.315 that
impacts the amount of savings or losses
calculated for one of the ACO’s
benchmark years. We note that a
compliance action taken to address
avoidance of at-risk beneficiaries may
lead to a change in the amount of
savings earned by an ACO for a previous
performance year when CMS releases
savings previously withheld under
§ 425.316(b)(2)(ii)(B) for a time period
other than the time period during which
193 Refer to section III.G.7.a of this proposed rule
for the proposal to revise the current reference to
§ 425.400(a)(4)(ii) in § 425.652(a)(9)(iv) to a
reference to § 425.226(a)(1).
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the ACO avoided at-risk beneficiaries
following completion of a CAP or CMS
recoups shared savings previously
disbursed to an ACO under
§ 425.316(b)(2)(ii)(C) for a time period
during which the ACO is later
determined to have avoided at-risk
beneficiaries.
Only ACOs whose current benchmark
includes a prior savings adjustment or
whose benchmark would include an
adjustment for prior savings following a
change in the amount of savings earned
for a previous performance year that is
a benchmark year for the ACO’s current
agreement period would receive an
adjusted benchmark under these
proposed changes. Furthermore, we
propose to modify the process currently
described in § 425.652(a)(9) to indicate
that if either of these two conditions
occur after the ACO has already
received its historical benchmark for the
first performance year of its agreement
period, an ACO could receive an
adjusted historical benchmark for the
first year of its agreement period.
We are also proposing to add a new
paragraph (e) to § 425.658 to indicate
that, when either of the two
aforementioned scenarios occurs, the
prior savings adjustment itself would be
recalculated. Without this addition
there is currently no mechanism for
recalculating the prior savings
adjustment to address changes in ACO’s
savings or losses for a performance year
within an agreement period. Further, we
are proposing that, absent any other
triggers for receiving an adjusted
benchmark, an ACO would only receive
an adjusted historical benchmark due to
a change in the ACO’s savings or losses
for a performance year under §§ 425.315
or 425.316(b)(2)(ii)(B) or (C) if the
change would result in a change to the
prior savings adjustment as determined
under § 425.652(a)(8). In other words,
the ACO would not receive an adjusted
historical benchmark following
recalculation of the prior savings
adjustment if the recalculation of the
prior savings adjustment would not
result in a change to the historical
benchmark.
We believe that, in order to issue
adjusted benchmarks and complete
financial reconciliation in a timely
fashion, a need exists to establish a
timing cutoff for when the
determination to issue an adjusted
historical benchmark for these two
additional reasons would be made. Each
of the two scenarios for which we are
proposing to recalculate the prior
savings adjustment may occur at any
point during any performance year of
the ACO’s agreement period as well as
after the end of that agreement period.
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We are proposing that for an adjusted
benchmark due to the two conditions
being considered to be used in financial
reconciliation for a performance year,
any determination that changes the
amount of the ACO’s savings or losses
in any of the benchmark years under
§§ 425.315 or 425.316(b)(2)(ii)(B) or (C)
must be issued no later than the date of
the initial determination of shared
savings or shared losses through
financial reconciliation for the relevant
performance year under § 425.605(e) or
§ 425.610(h). Note that if we are aware
of a potential change under
§ 425.316(b)(2)(ii)(B) or (C) in the
savings earned in a benchmark year by
an ACO eligible for the prior savings
adjustment or an upcoming revised
initial determination under § 425.315
that could impact the determination of
the ACO’s savings or losses for a
benchmark year, we may delay the
initial determination of shared savings
or shared losses for the ACO for the
relevant performance year beyond when
initial determinations would otherwise
be issued in order to assess whether the
ACO should receive an adjusted
historical benchmark. Under this
framework, changes to savings or losses
for a benchmark year that are finalized
after notification to the ACO of the
initial determination of shared savings
or shared losses for a given performance
year would be reflected in the adjusted
benchmark applied to the subsequent
performance year during the relevant
agreement period but would not be
retroactively applied to completed
performance years in the agreement
period.
We considered several alternatives to
the timing of when we could
incorporate new information about a
change in savings earned by an ACO in
accordance with § 425.316(b)(2)(ii)(B) or
(C) or a revised initial determination
under § 425.315 into the prior savings
adjustment. The two primary
alternatives we considered were: (1)
requiring information about a change to
the amount of savings calculated for a
previous year in accordance with
§ 425.316(b)(2)(ii)(B) or (C) or a revised
initial determination under § 425.315 to
become available by December 31st of
the year prior to the performance year;
and (2) considering this information at
any time it becomes available. An
advantage of the former option of
requiring information by December 31st
is that it would allow us to issue the
adjusted benchmark in March of the
performance year, consistent with when
adjusted benchmarks are otherwise
issued to ACOs. A disadvantage of this
approach is that it would provide less
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flexibility for when new information
impacting savings or losses in the
benchmark years could be applied to the
benchmark used in financial
reconciliation for a given performance
year. An advantage of the latter
approach of considering such
information at any time that it becomes
available is that an ACO could receive
an adjusted benchmark and a revised
initial determination of shared savings
or shared losses even after receiving its
initial determination for a performance
year. However, a disadvantage of this
approach is that it would generate
significant operational complexities. If,
for instance, information becomes
available during performance year four
of an ACO’s agreement period that
would potentially impact financial
reconciliation results in the first 3
performance years of the agreement
period, we would need to
simultaneously issue adjusted
benchmarks and revised initial
determinations for several performance
years. On balance, we believe it would
be appropriate to consider new
information that could impact the prior
savings adjustment up to the point at
which an ACO receives its initial
determination for a particular
performance year. We note that we are
continuing to consider the complexities
surrounding reopening initial
determinations for multiple prior
performance years throughout the
program’s benchmarking and financial
reconciliation methodologies and may
address this issue in future rulemaking.
We recognize that under
§ 425.658(b)(1)(iii), for a new ACO
identified as re-entering ACO, the prior
savings adjustment is based on the prior
savings or losses of the ACO in which
the majority of the ACO’s ACO
participants were participating.
Accordingly, in the case of a re-entering
ACO, we propose to consider whether
this prior ACO is impacted by the
following when determining whether to
issue an adjusted benchmark: (1) a
change in the amount of savings
calculated for any of the ACO’s
benchmark years eligible for inclusion
in the prior savings adjustment in
accordance with § 425.316(b)(2)(ii)(B) or
(C) due to compliance action to address
avoidance of at-risk beneficiaries; or (2)
a revised initial determination issued
under § 425.315 that impacts the
determination of the ACO’s savings or
losses for one of the benchmark years.
In this case, other aspects of this
proposal would apply similarly,
including the timing cutoff for issuing
an adjusted benchmark and issuing an
adjusted benchmark only if the change
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in savings or losses determined for the
applicable benchmark year would result
in a change to the prior savings
adjustment as determined under
§ 425.652(a)(8).
Below are two examples that illustrate
how an ACO could receive an adjusted
historical benchmark that incorporates
additional savings as a result of the
changes we are proposing.
• Example 1: An ACO renews to
begin a new agreement period on
January 1, 2025 but is under a corrective
action plan under § 425.316(b) for
avoidance of at-risk beneficiaries during
performance year 2023. In accordance
with § 425.316(b)(2)(ii)(B) the ACO did
not receive a shared savings payment for
performance year 2024, which
represents the third benchmark year of
its new agreement period. Therefore, the
ACO’s prior savings adjustment for its
new agreement period would be
calculated by setting the gross savings
and losses for the third benchmark year
equal to 0 as described in
§ 425.658(b)(1)(ii). However, in
November of 2026 the corrective action
plan for avoidance of at-risk
beneficiaries is closed and CMS
determines that the ACO is eligible to
receive payment for shared savings for
performance year 2024. In this example,
the ACO would have previously
received notification of the initial
determination of shared savings or
shared losses for performance year 2025.
Because the change in the status of the
corrective action plan occurred after the
ACO received its initial determination
of shared savings and shared losses for
performance year 2025, savings from the
ACO’s third benchmark year would be
included in the calculation of the prior
savings adjustment beginning with the
benchmark used to determine financial
performance for performance year 2026.
That is, the ACO would receive an
adjusted historical benchmark for
performance year 2026 reflecting the
recalculated prior savings adjustment,
and financial reconciliation for
performance year 2026 and subsequent
performance years of the ACO’s current
agreement period would reflect that
adjusted historical benchmark.
However, financial reconciliation for
performance year 2025 would not be
reopened to reflect savings from the
third benchmark year in the calculation
of the prior savings adjustment because
the corrective action plan was not lifted
until after the ACO received its initial
determination of shared savings or
shared losses for that performance year.
• Example 2: An ACO begins a new
agreement period on January 1, 2026,
and receives its historical benchmark,
which includes a prior savings
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adjustment. In February of 2027,
information is identified that leads to a
revised initial determination of shared
savings and shared losses for benchmark
year 2 of the ACO’s new agreement
period. Because the issue was identified
in February of the second performance
year of the new agreement period,
which is prior to the ACO receiving an
initial determination of its shared
savings and shared losses for
performance year 2026, the ACO would
receive an adjusted historical
benchmark for performance year 2026.
Shared savings and shared losses
calculations for performance year 2026
would reflect the recalculated prior
savings adjustment included in this
adjusted benchmark. All subsequent
performance years in the agreement
period would also reflect the
recalculated prior savings adjustment.
In summary, we are proposing
revisions to § 425.652(a)(9) to indicate
that we would adjust the benchmark for
changes in values used in benchmark
calculations in accordance with
§ 425.316(b)(2)(ii)(B) or (C) due to
compliance action to address avoidance
of at-risk beneficiaries or as a result of
the issuance of a revised initial
determination under § 425.315. We are
also proposing to add new paragraph (e)
to § 425.658 to specify that the ACO’s
prior savings adjustment is recalculated
for changes to the ACO’s savings or
losses for a performance year used in
the prior savings adjustment calculation
in accordance with § 425.316(b)(2)(ii)(B)
or (C) due to compliance action to
address avoidance of at-risk
beneficiaries or as a result of issuance of
a revised initial determination under
§ 425.315. Further, the new provision
§ 425.658(e) would also establish that
for new re-entering ACOs, the prior
savings adjustment will be recalculated
for changes in savings or losses for a
performance year used in the prior
savings adjustment for the ACO in
which a majority of the new ACO’s ACO
participants were previously
participating.
We seek comment on this proposal to
adjust the historical benchmark to
reflect changes in savings or losses for
a performance year that constitutes a
benchmark year for an ACO’s current
agreement period. These changes would
be applicable for agreement periods
beginning on or after January 1, 2024.
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e. Proposal To Update How Benchmarks
Are Risk Adjusted
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(1) Overview of Risk Adjustment Within
Shared Savings Program Benchmark
Calculations
When establishing, adjusting, and
updating an ACO’s historical
benchmark, CMS makes certain
adjustments to account for the severity
and case mix of, and certain
demographic factors for, the ACO’s
assigned beneficiary population and the
assignable beneficiary population. We
use prospective HCC risk scores and (as
applicable) demographic risk scores to
perform this risk adjustment.
To follow is a summary of the
calculations in which we will account
for the severity and case mix of the
ACO’s assigned beneficiary population
or the assignable beneficiary population
when establishing, adjusting, and
updating the historical benchmark, for
agreement periods beginning on January
1, 2024, and in subsequent years,
including as proposed elsewhere in this
proposed rule.
• We risk adjust benchmark year
expenditures used to establish the
historical benchmark for changes in
severity and case mix using prospective
HCC risk scores, in accordance with
§ 425.652(a)(3). In making this
adjustment, we account for changes in
severity and case mix in the ACO’s
assigned beneficiary population
between the first and third benchmark
years and between the second and third
benchmark years.194
• We calculate the ACO’s regional
FFS expenditures using risk adjusted
county-level FFS expenditures, which
are determined in accordance with
§ 425.654(a)(4) by adjusting FFS
expenditures for severity and case mix
of assignable beneficiaries in the county
using prospective HCC risk scores and
by making separate expenditure
calculations for populations of
beneficiaries by Medicare enrollment
type (ESRD, disabled, aged/dual eligible
Medicare and Medicaid beneficiaries,
and aged/non-dual eligible Medicare
and Medicaid beneficiaries). The ACO’s
risk adjusted regional FFS expenditures
are utilized in determining the regional
adjustment to the historical benchmark
(in accordance with § 425.656), the
regional component of the nationalregional blended trend factor (in
194 See, for example, Medicare Shared Savings
Program, Shared Savings and Losses, Assignment
and Quality Performance Standard Methodology
Specifications (version #11, January 2023), available
at https://www.cms.gov/files/document/medicareshared-savings-program-shared-savings-and-lossesand-assignment-methodology-specifications.pdf-2
(see section 3.6, ‘‘Risk Adjustment Policies’’).
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accordance with § 425.652(a)(5)), and
the regional component of the three-way
blended benchmark update factor (in
accordance with § 425.652(b)(2)).
• We calculate the regional
adjustment to the historical benchmark
in accordance with § 425.656, including
the following calculations to account for
severity and case mix:
++ We adjust for differences in
severity and case mix between the
ACO’s assigned beneficiary population
for BY3 and the assignable population
of beneficiaries for the ACO’s regional
service area for BY3 in accordance with
§ 425.656(b)(3).
++ In calculating the negative
regional adjustment, we apply an offset
factor based on the ACO’s overall
proportion of BY3 assigned beneficiaries
who are dually eligible for Medicare and
Medicaid (including dually eligible
ESRD, disabled, and aged beneficiaries)
and the ACO’s weighted average
prospective HCC risk score for BY3
taken across the four Medicare
enrollment types, in accordance with
§ 425.656(c)(4).
• We adjust the ACO’s historical
benchmark to account for changes in
severity and case mix in the ACO’s
assigned beneficiary population
between BY3 and the performance year
in accordance with §§ 425.652(a)(10),
425.605(a)(1) and (2) (BASIC track), and
425.610(a)(2) and (3) (ENHANCED
track), at the time of financial
reconciliation for a performance year.
We use prospective HCC risk scores to
adjust the historical benchmark for
changes in severity and case mix for all
assigned beneficiaries between BY3 and
the performance year, with positive
adjustments subject to a cap equal to the
ACO’s aggregate growth in demographic
risk scores between BY3 and the
performance year plus 3 percentage
points (refer to §§ 425.605(a)(1)(ii) and
425.610(a)(2)(ii), and section III.G.4.b.(1)
of this proposed rule).
• In calculating the regional
component of the three-way blended
update factor, we are proposing to cap
prospective HCC risk score growth in an
ACO’s regional service area between
BY3 and the performance year by
applying an adjustment factor, as
discussed in section III.G.4.b.(2) of this
proposed rule and the proposed new
provision at § 425.655.
• We adjust the flat dollar amounts of
the ACPT component of the three-way
blended update factor for each
performance year, for differences in
severity and case mix between the
ACO’s BY3 assigned beneficiary
population and the national assignable
FFS population for each Medicare
enrollment type identified for the 12-
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month calendar year corresponding to
BY3, in accordance with § 425.660(b)(4).
(2) Background on Calculation of
Prospective HCC Risk Scores Used To
Risk Adjust Shared Savings Program
Benchmark Calculations
(a) Historical Practices
We have detailed how CMS performs
Shared Savings Program risk adjustment
calculations in programmatic material,
including publicly available
specifications documents. See, for
example, Medicare Shared Savings
Program, Shared Savings and Losses,
Assignment and Quality Performance
Standard Methodology Specifications
(version #11, January 2023), available at
https://www.cms.gov/files/document/
medicare-shared-savings-programshared-savings-and-losses-andassignment-methodologyspecifications.pdf-2 (see section 3.6,
‘‘Risk Adjustment Policies’’). While we
have specified the details of these
practices in guidance, we have not
previously codified these practices in
regulation.
More generally, CMS maintains the
CMS–HCC risk adjustment models for
the Medicare Advantage (MA) program.
CMS maintains CMS–HCC risk
adjustment models for populations of
beneficiaries based on age, disability
status, gender, institutional status,
eligibility for Medicaid, and health
status (see section 1853(a)(1)(C)(i) of the
Act), including a separate MA risk
adjustment model for the ESRD
population, and a Part D risk adjustment
model (known as the RxHCC model).
Over time, CMS has implemented
revised versions of the CMS–HCC risk
adjustment models (also referred to
generally as the ‘‘CMS–HCC model’’).
Historically, transitions to a revised
version of the CMS–HCC model have
been gradually phased-in over time by
blending the old risk adjustment model
and the revised risk adjustment model.
CMS specifies the CMS–HCC risk
adjustment models applicable for a
calendar year in the annual MA Rate
Announcement (see sections
1853(a)(1)(C) and (b)(1) of the Act). Prior
to doing so, CMS solicits comment on
the CMS–HCC risk adjustment
methodology (see section 1853(b)(2) of
the Act). Using the specified model, or
blend of models (if applicable), CMS
calculates prospective HCC risk scores
for all Medicare beneficiaries, including
FFS beneficiaries. These prospective
HCC risk scores are then used to set MA
capitation rates and Part C and D
payment policies for the applicable
calendar year.
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To perform risk adjustment
calculations for the Shared Savings
Program, we calculate prospective HCC
risk scores for Medicare FFS
beneficiaries for the relevant benchmark
year or performance year. In doing so,
we use the CMS–HCC risk adjustment
model(s) that are applicable for the
particular calendar year corresponding
to the benchmark or performance year to
identify a Medicare FFS beneficiary’s
prospective HCC risk score for that
benchmark or performance year.
Prospective HCC risk scores used in
financial calculations for the Shared
Savings Program have the MA coding
pattern adjustment of 5.90 percent
removed, if applicable.195 Additionally,
all prospective HCC risk scores are
renormalized by Medicare enrollment
type based on a national assignable FFS
population to ensure that the mean risk
score among assignable beneficiaries is
equal to one. Renormalization helps to
ensure consistency in risk scores from
year to year, given changes made to the
underlying risk score models. All risk
adjustment calculations for the Shared
Savings Program, including risk score
renormalization, are performed
separately for each Medicare enrollment
type for the following populations of
beneficiaries: ESRD, disabled, aged/dual
eligible for Medicare and Medicaid,
aged/non-dual eligible for Medicare and
Medicaid.196
Under the Shared Savings Program,
we calculate demographic only risk
scores using a separate model than those
used to calculate prospective HCC risk
scores. For agreement periods beginning
on January 1, 2024 and subsequent
years, CMS will use demographic risk
scores to determine the cap on risk score
growth between BY3 and the
performance year. Demographic risk
scores consider only certain specified
patient demographic factors, such as
age, sex, Medicaid status, and the basis
for Medicare entitlement (that is, age,
disability, or ESRD), without
incorporating diagnostic information.
195 The MA risk adjustment models used for
beneficiaries classified as ESRD for the Shared
Savings Program (that is, beneficiaries in long-term
dialysis or transplant status, no more than three
months post-graft) do not currently employ a coding
intensity adjustment, therefore no adjustment is
currently removed from risk scores for beneficiaries
in the ESRD enrollment type.
196 A beneficiary’s final risk score for each month
is the risk score determined for that beneficiary
based on the beneficiary’s risk adjustment model
status for that month. There are risk adjustment
models for MA subpopulations (for example,
community model versus institutional model versus
new enrollee model for aged/non-dual eligible
beneficiaries), and the risk scores used by the
Shared Savings Program for beneficiaries in a
Medicare enrollment type may be derived from
more than one risk adjustment model.
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As such, demographic risk scores are
not subject to changes in coding
intensity or coding accuracy in the same
way that prospective HCC risk scores
are. We note that while the Shared
Savings Program uses the same
demographic factors as those used in
MA, Shared Savings Program
demographic factor coefficients are
calibrated based on the entire Medicare
FFS population instead of new
Medicare enrollees as is used by MA.
Currently, when establishing,
adjusting, and updating the benchmark,
we account for changes in severity and
case mix between benchmark years or
between BY3 and the performance year
by multiplying the expenditures for the
applicable year by a quotient of two
ACO-level renormalized risk scores,
known as the risk ratio. For example, to
risk adjust the expenditures for an
ACO’s assigned beneficiary population
to account for changes in case mix and
severity from the first benchmark year to
the third, we multiply BY1 expenditures
by a risk ratio equal to the mean
renormalized risk score among the
ACO’s assigned beneficiaries in BY3
divided by the mean renormalized risk
score among the ACO’s assigned
beneficiaries in BY1 for each Medicare
enrollment type. For instance, a one
percent rate of growth in renormalized
risk scores between these benchmark
years would be expressed by a risk ratio
of 1.010. This ratio reflects growth in
risk for the ACO’s assigned beneficiary
population relative to that of the
national assignable population. Because
the risk ratios used in benchmarking
calculations may be determined using
risk scores calculated from different
underlying CMS–HCC risk adjustment
models, depending on the CMS–HCC
risk adjustment model(s) applicable to
the corresponding benchmark or
performance year, this approach allows
for the possibility that differences in
risk models between the benchmark
years and the performance year could
impact an ACO’s financial performance.
Since the inception of the Shared
Savings Program in 2012, there have
been several CMS–HCC model changes.
Several factors reduce the impact of
using different risk adjustment models
to calculate prospective HCC risk scores
for benchmark and performance years
when performing Shared Savings
Program risk adjustment calculations.
One factor is that the Shared Savings
Program renormalizes prospective HCC
risk scores by Medicare enrollment type,
which ensures that the mean risk score
for the national assignable FFS
population for each enrollment type is
equal to one. If a new CMS–HCC model
leads to a shift in the mean of the
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distribution of prospective HCC risk
scores for the national assignable FFS
population for a particular Medicare
enrollment type, then renormalizing the
risk scores would counterbalance this
effect. Because renormalization factors
are calculated across the assignable
beneficiary population for each
enrollment type, any adverse or
beneficial impact for an ACO from a
change in CMS–HCC model would
derive from the mean risk score for the
ACO’s assigned beneficiaries within a
given enrollment type being impacted in
a systematically different way than the
mean for the national assignable
population for that enrollment type.
A second factor is that risk scores are
used in multiple ways that balance their
effects when establishing, adjusting or
updating a benchmark. Risk scores are
used to adjust ACO expenditures and
also to adjust regional expenditures
used in calculating the regional
adjustment to the benchmark and
regional growth rates in benchmark
calculations. Any impact of a new
CMS–HCC model that could increase or
decrease an ACO’s risk scores used to
establish, adjust or update a benchmark
may differ directionally from the impact
that risk scores for the assignable FFS
population in an ACO’s regional service
area might have on risk-adjusted
regional expenditure calculations. For
example, if a new CMS–HCC model
lowers the risk ratio between BY3 and
the PY and therefore lowers the
benchmark for an ACO, all else equal,
then the new risk adjustment model
may also lower the risk scores for the
ACO’s regional service area assignable
beneficiary population, which would
increase risk-adjusted regional
expenditures.197 This would put
upward pressure on the benchmark by
increasing the regional update factor.
Any changes to the ACO’s risk ratio may
be thus reduced by changes to the
ACO’s regional update factor. This
would reduce the impact of CMS–HCC
model changes on ACO financial
performance.
A third factor is that CMS–HCC model
transitions have been gradually phasedin over time by blending the old risk
adjustment model and the new risk
adjustment model, thereby constraining
the magnitude of any change in risk
ratios resulting from differences in the
risk adjustment models used to
calculate prospective HCC risk scores.
197 For each county and Medicare enrollment type
(ESRD, disabled, aged/dual eligible, and aged/nondual eligible) in the ACO’s regional service area,
CMS divides average per capita county-level FFS
expenditures by the county average renormalized
CMS–HCC risk score to obtain risk-adjusted county
expenditures.
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That is, as a result of this blending, the
risk ratios used to adjust expenditures
between BY3 and the PY may have
some degree of overlap in underlying
risk adjustment models used to
calculate both the numerator and
denominator of the risk ratios.
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(b) Introduction of the 2024 CMS–HCC
Risk Adjustment Model, Version 28
On March 31, 2023, CMS released the
Announcement of CY 2024 MA
Capitation Rates and Part C and Part D
Payment Policies,198 which finalized the
transition to a revised CMS–HCC risk
adjustment model. The revised 2024
CMS–HCC risk adjustment model,
Version 28 (V28), has the same structure
as the 2020 CMS–HCC risk adjustment
model currently used for payment in
that it has eight model segments as first
implemented for payment for CY 2017
and condition count variables as first
implemented for payment for CY 2020.
It incorporates the following technical
updates: (1) updated data years used for
model calibration, (2) updated
denominator year used in determining
the average per capita predicted
expenditures to create relative factors in
the model, and (3) a clinical
reclassification of the hierarchical
condition categories (HCCs) using the
International Classification of Diseases,
Tenth Revision, Clinical Modification
(ICD–10–CM) codes. In addition, as part
of the clinical reclassification, CMS
conducted an assessment on conditions
that are coded more frequently in MA
relative to FFS. This assessment is
consistent with Principle 10 of CMS’s
longstanding model principles,
described in more detail initially in the
December 2000 report titled,
‘‘Diagnostic Cost Group Hierarchical
Condition Category Models for Medicare
Risk Adjustment (Final Report)’’
(available at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/Reports/
downloads/pope_2000_2.pdf). As a
result of this assessment, in addition to
the technical updates, the revised model
includes additional constraints and the
removal of several HCCs in order to
reduce the impact on risk score
variation in coding between MA and
FFS.199
198 For more details, refer to Announcement of
Calendar Year (CY) 2024 Medicare Advantage (MA)
Capitation Rates and Part C and Part D Payment
Policies (March 31, 2023) (herein CY 2024 Rate
Announcement), available at https://www.cms.gov/
files/document/2024-announcement-pdf.pdf.
199 See Advance Notice of Methodological
Changes for Calendar Year (CY) 2024 for Medicare
Advantage (MA) Capitation Rates and Part C and
Part D Payment Policies (February 1, 2023),
available at https://www.cms.gov/files/document/
2024-advance-notice-pdf.pdf.
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For CY 2024, MA risk scores will be
calculated as a blend of 67 percent of
the risk scores calculated under the
2020 CMS–HCC risk adjustment model,
Version 24 (V24), and 33 percent of the
risk scores calculated with the 2024
CMS–HCC risk adjustment model (V28).
CMS expects that for CY 2025, MA risk
scores will be calculated using a blend
of 33 percent of the risk scores
calculated with V24 and 67 percent of
the risk scores calculated with V28, and
for CY 2026, 100 percent of risk scores
will be calculated with V28.200
With the transition to the use of the
V28 CMS–HCC model beginning in CY
2024 in MA, it is timely to revisit how
we apply the CMS–HCC risk adjustment
model(s) to calculate risk scores used in
Shared Savings Program calculations.
As summarized in the CY 2024 Rate
Announcement, some commenters
questioned if the updated MA risk
adjustment model will affect lines of
business outside of Medicare Advantage
such as the ACO REACH Model and
Medicare Shared Savings Program. In
response to these comments, we
explained that we were considering the
implications of these changes to the
CMS–HCC risk adjustment model for
these initiatives.201
In section III.G.4.e.(3) of this proposed
rule, we discuss our initial analysis of
the impact of the V28 CMS–HCC model
on Shared Savings Program
calculations, including modeling of an
alternative approach to calculating
benchmark year risk scores. We propose
a modified approach to making such
calculations for agreement periods
beginning on January 1, 2024, and in
subsequent years, in section III.G.4.e.(4)
of this proposed rule.
(3) Initial Analysis of the Impact of Risk
Adjustment Model Changes on Shared
Savings Program Calculations and
Modeling of an Alternative Approach to
Calculating Benchmark Year Risk Scores
To further evaluate the potential
impact of the V28 CMS–HCC model
transition on Shared Savings Program
ACOs, we analyzed the following:
• Our current approach in which we
apply the CMS–HCC risk adjustment
model(s) applicable for a particular
calendar year to calculate a Medicare
FFS beneficiary’s prospective HCC risk
score for the corresponding benchmark
or performance year. This approach
could lead to different CMS–HCC risk
adjustment models being used to
calculate prospective HCC risk scores
200 See CY 2024 Rate Announcement, available at
https://www.cms.gov/files/document/2024announcement-pdf.pdf at 3.
201 See id. at 97.
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for the benchmark years as compared to
a particular performance year of the
ACO’s agreement period when there is
a transition to a new CMS–HCC risk
adjustment model between one or more
benchmark years and the performance
year.
• An alternative approach in which
we would use the CMS–HCC risk
adjustment model(s) applicable to the
calendar year corresponding to the
performance year to calculate a
Medicare FFS beneficiary’s prospective
HCC risk score for the performance year,
and for each benchmark year of the
ACO’s agreement period.202 This
approach ensures consistency between
the CMS–HCC risk adjustment
methodology used to calculate the
prospective HCC risk scores for the
benchmark years relative to a particular
performance year.
To conduct this analysis, we
calculated prospective HCC risk scores
and risk ratios for CY 2018 (treated as
BY3) and CY 2021 (treated as the PY) for
all 275 ACOs that participated in both
PY 2018 and PY 2021. Risk ratios
between BY3 and the PY were
calculated under the current approach,
in which we used the V24 CMS–HCC
model to calculate BY3 prospective HCC
risk scores and the V28 CMS–HCC
model to calculate PY prospective HCC
risk scores, and under the alternative
approach of calculating both BY and PY
prospective HCC risk scores using
V28.203
CMS performed this analysis to
roughly estimate how V28 would have
impacted payment to ACOs in PY 2021
using weighted average risk scores
calculated across the three non-ESRD
Medicare enrollment types (disabled,
aged/dual eligible, aged/non-dual
eligible). The analysis provides insight
into the impact of a fully phased-in V28,
which is expected to occur in PY 2026
(particularly for ACOs that would at that
point have a BY3 prior to 2024). For the
275 ACOs in the sample, combined PY
2021 shared savings payments would
have been about 11 percent lower than
actual payments if V28 had been fully
phased-in for the performance year,
202 A similar approach was suggested by
commenters in earlier rulemaking for the Shared
Savings Program. See, for example, the December
2018 final rule (83 FR 68013), in which we
summarize commenters’ recommendation that CMS
modify the current methodology to use the same
CMS–HCC risk score model to calculate risk scores
for both the benchmark years and the performance
year.
203 The V24 CMS–HCC model was not applicable
to CY 2018 but was used in this analysis to
calculate BY3 prospective HCC risk scores under
the current approach in order to measure the impact
of the transition from V24 to V28 on Shared Savings
Program ACOs.
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when using V24 to calculate BY3
prospective HCC risk scores (reflecting
the current approach to applying CMS–
HCC risk adjustment models).
Alternatively, combined shared savings
payments would have been about 2
percent higher than actual if V28 were
used for BY3 calculations as well as for
PY 2021 calculations (reflecting the
alternative approach to applying CMS–
HCC risk adjustment models).
Table 39 compares the estimated
impact on PY 2021 shared savings of the
current approach, and the alternative
approach to calculating BY3 and PY
prospective HCC risk scores.
Estimated decreases in PY 2021
shared savings payments are more
extreme at the tail of the distribution
when using the current approach. Over
10 percent of ACOs showed more than
1.4 percent in reduced shared savings
payments relative to benchmark under
the modeling of the current approach, in
which we used V24 to calculate BY3
prospective HCC risk scores and V28 to
calculate PY prospective HCC risk
scores. In contrast, about 3 percent of
ACOs showed declines of such
magnitude in shared savings payments
relative to the benchmark using the
alternative approach to calculating
prospective HCC risk scores for BY3 and
PY 2021 with the V28 CMS–HCC model.
Compared to the alternative approach,
the current approach is estimated to
result in a reduction in shared savings
of about 0.2 percent per ACO on
average, relative to benchmark. These
impacts would be smaller, potentially
one-third of the magnitude, if the use of
V24 in BY3 was compared to the blend
of 33 percent V28 and 67 percent V24
for the PY (reflecting the blend
applicable for CY 2024).
Table 40 compares the estimated
impact on PY 2021 shared savings of the
current approach, and the alternative
approach to calculating BY3 and PY risk
scores (expressed as percentage of
benchmark), based on the following
ACO characteristics: ACO average
renormalized prospective HCC risk
scores for aged/disabled beneficiaries,
ACO participation in performance-based
risk, and year of entry into the Shared
Savings Program. We observed that the
current approach would have the
greatest adverse effect on ACOs with the
highest average risk scores (calculated
with the V24 CMS–HCC model), ACOs
participating in two-sided models, and
ACOs that have been in the Shared
Savings Program longer. ACOs that
would not have been harmed by the
current approach had an average
renormalized risk score for their nonESRD populations roughly equal to 1.00.
The 5 percent of ACOs in the modeling
with the most adverse impact from the
current approach had an average
renormalized risk score for their nonESRD populations of 1.22. For ACOs
with the highest average risk scores, the
modeling showed the current approach
would have resulted in reduced shared
savings of about 2 percent (relative to
benchmark) per ACO, as compared to
the alternative approach. The most
adversely impacted ACOs in the
modeling also were roughly 40 percent
more likely to participate in a two-sided
model and to have participated in the
Shared Savings Program nearly 2 years
longer than ACOs not harmed. The
modeling demonstrates that the
alternative approach would reduce the
negative impact that the current
approach shows for ACOs with high risk
scores, with earlier entry dates into the
Shared Savings Program, and with
participation in a two-sided model.
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In the context of the transition to the
V28 CMS–HCC model, the results of this
analysis show that the current approach
to calculating prospective HCC risk
scores is expected to adversely impact
ACO financial performance, particularly
for ACOs that serve a high-risk
beneficiary population, when compared
to the stated alternative approach. The
factors discussed in section III.G.4.e.(2)
of this proposed rule—renormalizing
risk scores to the national assignable
FFS population, risk-adjusted regional
expenditures providing a
counterbalance to how risk ratios
impact the benchmark, and the phased
transition from V24 to V28 by means of
a blended risk model—will reduce the
impact of a risk adjustment model
transition. However, these factors will
be insufficient to prevent adverse effects
on ACO financial performance due to
the larger impact from the transition to
V28 relative to prior CMS–HCC model
transitions. The alternative policy under
which CMS would apply the same
CMS–HCC risk adjustment model used
in the performance year to calculate
prospective HCC risk scores for all
benchmark years would strengthen risk
adjustment in the Shared Savings
Program and consistently apply the
CMS–HCC model in the Shared Savings
Program context as it is applied in MA.
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(4) Proposed Revisions
The adoption of the alternative
approach to calculating prospective
HCC risk scores for the performance
year and each benchmark year of an
ACO’s agreement period would allow us
to more accurately measure the change
in severity and case mix for an ACO’s
assigned beneficiary population or the
assignable beneficiary population.
Under such an approach, there would
be no potential for distortion from using
different CMS–HCC risk adjustment
models in calculating prospective HCC
risk scores for benchmark years and the
performance year that could occur
under the current policy. For this
reason, we propose to modify our
current use of the CMS–HCC risk
adjustment model and adopt the
alternative approach to calculating
prospective HCC risk scores for a
performance year and the relevant
benchmark years for agreement periods
beginning on January 1, 2024, and in
subsequent years.
We propose to add a new section to
our regulations at § 425.659, which
would codify our existing framework for
calculating risk scores used in Shared
Savings Program benchmark
calculations and adopt the alternative
approach to calculating prospective
HCC risk scores for a performance year
and the relevant benchmark years
discussed in this section of this
proposed rule. We propose in paragraph
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(a) of § 425.659 to codify our current
practice of accounting for differences in
severity and case mix of the ACO’s
assigned beneficiaries and assignable
beneficiaries (as defined under § 425.20)
in calculations used in establishing,
adjusting and updating the ACO’s
historical benchmark.
We propose to set forth in paragraph
(b) of § 425.659 our approach to
determining Medicare FFS beneficiary
prospective HCC risk scores for Shared
Savings Program benchmark and
performance year calculations. In
paragraph (b)(1) of § 425.659, we
propose to codify our current policy
under which CMS specifies the CMS–
HCC risk adjustment methodology used
to calculate prospective HCC risk scores
for Medicare FFS beneficiaries (as
defined under § 425.20) for use in
Shared Savings Program calculations.
Additionally, we propose:
• To codify our current practice of
calculating risk scores for Medicare FFS
beneficiaries for a performance year,
which provides that CMS uses the
CMS–HCC risk adjustment methodology
applicable for the corresponding
calendar year.
• To codify our current practice for
agreement periods beginning before
January 1, 2024, of applying the CMS–
HCC risk adjustment methodology for
the calendar year corresponding to
benchmark year in calculating risk
scores for Medicare FFS beneficiaries
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for each benchmark year of the
agreement period.
• For agreement periods beginning on
January 1, 2024, and in subsequent
years, CMS would apply the CMS–HCC
risk adjustment methodology for the
calendar year corresponding to the
performance year in calculating risk
scores for Medicare FFS beneficiaries
for each benchmark year of the
agreement period.
We propose at § 425.659(b)(2) to
codify our current practices for
calculating prospective HCC risk scores
for a benchmark or performance year.
Specifically, in calculating prospective
HCC risk scores, we would remove the
MA coding intensity adjustment, if
applicable. Further, we would
renormalize prospective HCC risk scores
by Medicare enrollment type (ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries) based on a
national assignable FFS population for
the relevant benchmark or performance
year. We would calculate the average
prospective HCC risk score by Medicare
enrollment type (ESRD, disabled, aged/
dual eligible Medicare and Medicaid
beneficiaries, and aged/non-dual
eligible Medicare and Medicaid
beneficiaries) in order to risk adjust
benchmark calculations also performed
by Medicare enrollment type.
We note that at this time we are not
proposing to modify the current
approach to calculating demographic
risk scores under the Shared Savings
Program, as described in section
III.G.4.e.(1) of this proposed rule.
We also propose to adjust the
benchmark to account for CMS–HCC
risk adjustment model changes during
the term of the agreement period to
maintain uniformity between the
calculation of prospective HCC risk
scores for the performance year and
each benchmark year. We propose to
revise the list of circumstances for
adjusting the historical benchmark for
the second and each subsequent
performance year during the term of the
agreement period at § 425.652(a)(9) to
include a change in the CMS–HCC risk
adjustment methodology used to
calculate prospective HCC risk scores
under proposed, new § 425.659. We
further propose to add a new paragraph
(a)(9)(vi) to § 425.652 to specify that we
would redetermine factors based on
prospective HCC risk scores calculated
for benchmark years by calculating the
prospective HCC risk scores using the
CMS–HCC risk adjustment methodology
that applies for the calendar year
corresponding to the applicable
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performance year in accordance with
proposed § 425.659(b)(1).
We also propose a technical and
conforming change to § 425.650(a),
which generally describes the
organization of the sections on the
benchmarking methodology within
subpart G of the Shared Savings
Program regulations. In the description
of the benchmarking methodology
applicable for agreement periods
beginning before January 1, 2024, we
propose to update the list of referenced
sections to include the proposed new
§ 425.659.
This proposed policy would address
the concerns of ACOs and other
interested parties regarding the
transition to the V28 CMS–HCC model
or other similar future changes to CMS–
HCC risk adjustment methodology that
could occur during the term of an ACO’s
agreement period. Under this proposal,
both the numerator and denominator in
the PY/BY3 risk ratio would be
calculated using a consistent risk model,
and any distributional impacts should,
on average, be balanced. This would
prevent distortion to historical
benchmarks resulting from model
changes. This conclusion is informed by
the data analysis described in section
III.G.4.e.(3) of this proposed rule, which
shows that on average ACOs would
have earned roughly 0.2 percent in
additional PY 2021 shared savings
payments relative to benchmark when
both benchmark year and performance
year prospective HCC risk scores are
calculated under V28 compared to
calculations under both V24 and V28.
Our analysis shows that ACOs with
high risk scores would benefit from
using the proposed approach to
calculate BY and PY prospective HCC
risk scores relative to the current policy.
This proposal would therefore help the
Shared Savings Program retain ACOs
serving the highest risk beneficiaries.
This is a priority for CMS as high risk
beneficiaries may benefit the most from
better care coordination and quality
improvement activities, particularly by
ACOs with above average duration of
participation in the program. Similarly,
the proposed approach would support
potential participation from new ACOs
that would consider whether risk
adjustment calculations in the Shared
Savings Program benchmarking
methodology would be adequate for
beneficiaries with the highest risk.
This proposal would not affect how
prospective HCC risk scores are
calculated for ACOs in agreement
periods that began prior to January 1,
2024, consistent with our historical
practice of incorporating changes to the
benchmarking methodology only at the
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start of an ACO’s agreement period.
ACOs in an existing agreement period
that includes performance year 2024,
2025 or 2026 may benefit from the
factors discussed in section III.G.4.e.(2)
of this proposed rule—renormalizing
risk scores to the national assignable
FFS population, risk-adjusted regional
expenditures providing a
counterbalance to how risk ratios
impact the benchmark, and the phased
transition from V24 to V28 by means of
a blended risk model. These factors
would diminish adverse effects of using
the new CMS–HCC risk adjustment
methodology in Shared Savings Program
calculations.
If we finalize the proposed approach
for agreement periods beginning on
January 1, 2024, and in subsequent
years, we note that an ACO in an
existing agreement period may choose
to terminate its participation agreement
early in order to early renew under a
new participation agreement to be under
the revised approach. For instance, an
ACO under an existing agreement
period with the current methodology
(with a 2022 or 2023 start date) could
apply to early renew with the
application cycle for the January 1, 2025
agreement period start date, which
would occur during CY 2024. For an
existing ACO that applied to early
renew and enters a new agreement
period beginning on January 1, 2024, the
proposed policy, if finalized, would
apply to the ACO’s new agreement
period. Any ACO that early renews
would have its benchmark rebased at
the start of the new agreement period.
The following examples, based on the
first three years of a 5-year agreement
period beginning on January 1, 2024,
illustrate the applicability of the current
approach to calculating BY and PY
prospective HCC risk scores using
different CMS–HCC risk adjustment
model(s), as compared to the proposed
approach to calculating both BY and PY
prospective HCC risk scores using the
same CMS–HCC risk adjustment
model(s). Under the current policy an
ACO beginning a new agreement period
on January 1, 2024, would have its
prospective HCC risk scores for BY1
(2021) calculated using a blend of 25
percent under the 2014 CMS–HCC
model, Version 22 (V22), and 75 percent
V24,204 and for BY2 (2022) and BY3
(2023) calculated using V24.205 206 For
204 For more details, refer to Announcement of
Calendar Year (CY) 2021 Medicare Advantage (MA)
Capitation Rates and Part C and Part D Payment
Policies (April 6, 2020), available at https://
www.cms.gov/files/document/2021announcement.pdf.
205 For more details, refer to Announcement of
Calendar Year (CY) 2022 Medicare Advantage (MA)
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PY1 (2024), prospective HCC risk scores
would be calculated using a blend of 67
percent V24 and 33 percent V28. For
PY2 (2025), prospective HCC risk scores
are expected to be calculated using a
blend of 33 percent V24 and 67 percent
V28. For PY3 (2026), prospective HCC
risk scores are expected to be calculated
using V28. Under the current
methodology, the risk ratios used to risk
adjust expenditures would have the
numerator and denominator calculated
using different underlying CMS–HCC
risk adjustment models. Specifically, to
risk adjust BY1 expenditures to BY3
when establishing or adjusting the
ACO’s historical benchmark, the risk
ratio would include risk scores
calculated under V24 (BY3) and a blend
of 25 percent V22 and 75 percent V24
(BY1). To risk adjust BY3 expenditures
to the performance year when updating
the historical benchmark during
financial reconciliation, risk ratios
would include risk scores calculated
under V24 (as applicable to BY3) and
either a blend of V24 and V28 (for PY1
and as expected for PY2) or fully
calculated with V28 (as expected for
PY3).
Under the proposed approach, BY and
PY prospective HCC risk scores would
be calculated under the CMS–HCC risk
adjustment model(s) applicable to the
calendar year corresponding to the
relevant performance year. For an ACO
beginning a new agreement period on
January 1, 2024, in PY1 (2024) all
benchmark year and PY1 prospective
HCC risk scores would be calculated
using a blend of 67 percent V24 and 33
percent V28. In PY2 (2025), all
benchmark year and PY2 prospective
HCC risk scores are expected to be
calculated using a blend of 33 percent
V24 and 67 percent V28. In PY3 (2026),
all benchmark year and performance
year prospective HCC risk scores are
expected to be calculated using V28. In
the case of an ACO in an existing
agreement period that early renews for
a new agreement period beginning on
January 1, 2025, the calculations
described in this paragraph regarding
the blend of V24 and V28 for 2025 and
the fully phased-in V28 CMS–HCC
model for 2026 would be expected to
apply for the ACO’s first and second
performance years (respectively).
Capitation Rates and Part C and Part D Payment
Policies (January 15, 2021), available at https://
www.cms.gov/files/document/2022announcement.pdf.
206 For more details, refer to Announcement of
Calendar Year (CY) 2023 Medicare Advantage (MA)
Capitation Rates and Part C and Part D Payment
Policies (April 4, 2022), available at https://
www.cms.gov/files/document/2023announcement.pdf.
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We seek comment on these proposals
regarding the prospective HCC risk
scores to be used in risk adjustment for
purposes of benchmark calculations
under the Shared Savings Program.
5. Proposed Modifications to Advance
Investment Payments Policies
a. Overview
In the CY 2023 PFS final rule (87 FR
69782 through 69805), we finalized a
new payment option for eligible Shared
Savings Program ACOs entering
agreement periods beginning on or after
January 1, 2024, to receive advance
shared savings payments. This payment
option is referred to as advance
investment payments (AIP) and the
payments themselves are referred to as
advance investment payments.
In that final rule, we explained that
section 1899(i) of the Act authorizes the
Secretary to use other payment models
instead of the one-sided model
described in section 1899(d) of the Act
so long as the Secretary determines that
the other payment model would
improve the quality and efficiency of
items and services furnished to
Medicare beneficiaries without
additional program expenditures (87 FR
69783 and 69784). In accordance with
section 1899(i) of the Act, we
determined that making advance
investment payments to certain ACOs
participating in the Shared Savings
Program would improve the quality and
efficiency of items and services
furnished to Medicare beneficiaries by
enhancing the accessibility of the
Shared Savings Program (Id.).
We established standards for an
ACO’s receipt and use of advance
investment payments within the Shared
Savings Program regulations at
§ 425.630 and also specified
requirements in connection with AIP in
other sections within 42 CFR part 425.
Such standards include: eligibility
criteria to limit AIP to new, low revenue
ACOs that are inexperienced with
performance-based risk; application
procedures and contents, including
submission of a spend plan; policies
governing use and management of
payments; amount and frequency of
advance investment payments, which
are comprised of a one-time $250,000
upfront payment and up to 8 quarterly
payments; the methodology for
calculation of the quarterly payment
amount based on the ACO’s assigned
population; termination of advance
investment payments, as well as
recoupment and recovery of advance
investment payments; policies to
monitor ACO eligibility for AIP; and
ACO public reporting requirements
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regarding the use of advance investment
payments.
Within this section of this proposed
rule, we propose modifications to refine
AIP policies to better prepare for initial
implementation of AIP beginning with
ACOs entering agreement periods on
January 1, 2024. In summary, we are
proposing to better support ACOs that
are prepared to progress to performancebased risk by allowing ACOs to advance
to two-sided model Levels within the
BASIC track’s glide path beginning in
PY3 of the agreement period in which
they receive advance investment
payments (section III.G.5.b of this
proposed rule). We are also proposing to
recoup advance investment payments
from shared savings for ACOs that wish
to early renew to continue their
participation in the Shared Savings
Program (section III.G.5.c of this
proposed rule). We propose to specify
that CMS would terminate advance
investment payments for future quarters
to ACOs that elect to terminate their
participation in the Shared Savings
Program (section III.G.5.d. of this
proposed rule). We propose to require
ACOs to report spend plan updates and
actual spend information to CMS in
addition to publicly reporting such
information (section III.G.5.e. of this
proposed rule). We propose to codify
that ACOs receiving advance investment
payments may seek reconsideration
review of all payment calculations
(section III.G.5.f. of this proposed rule).
If finalized, these policies would be
effective beginning January 1, 2024.
b. Proposal To Modify AIP Eligibility
Requirements To Allow ACOs To
Advance to Performance-Based Risk
During the 5-Year Agreement Period
(1) Background
The policies we finalized with the CY
2023 PFS final rule require an ACO to
remain under a one-sided model for the
duration of its agreement period in
which it receives advance investment
payments to remain compliant with AIP
requirements. The ACO would
otherwise face potential compliance
action and may be required to repay all
advance investment payments within 90
days of receiving written notification
from CMS. This limits an ACO’s ability
to select participation options that
include progression along the BASIC
track’s glide path to a performancebased two-sided risk model. This policy
arises from the interaction of numerous
standards.
First, an ACO is eligible to receive
advance investment payments if CMS
determines that all of the following
criteria are met: (1) the ACO is not a
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renewing or a re-entering ACO; (2) the
ACO has applied to participate in the
Shared Savings Program under any level
of the BASIC track’s glide path and is
eligible to participate in the Shared
Savings Program; (3) the ACO is
inexperienced with performance-based
risk Medicare ACO initiatives; and (4)
the ACO is a low revenue ACO
(§ 425.630(b)). An eligible ACO will
receive a one-time upfront payment of
$250,000 and quarterly payments each
quarter for the first 2 performance years
of the ACO’s 5-year agreement period,
totaling no more than 8 quarterly
payments (§ 425.630(f)).
Second, under § 425.630(h), CMS will
terminate an ACO’s advance investment
payments in accordance with
§ 425.316(e) if the ACO is no longer
inexperienced with performance-based
risk Medicare ACO initiatives or is no
longer a low revenue ACO. Section
425.316(e) specifies that if CMS
determines during any performance year
of the agreement period that an ACO
receiving advance investment payments
is experienced with performance-based
risk Medicare ACO initiatives or is a
high revenue ACO, and the ACO
remains experienced with performancebased risk Medicare ACO initiatives or
a high revenue ACO after a deadline
specified by CMS pursuant to
compliance action, the ACO must repay
all advance investment payments it
received.
An eligible ACO that joins the Shared
Savings Program in Level A of the
BASIC track and opts to receive advance
investment payments will be eligible for
all 8 quarterly payments to be paid over
PY1 and PY2, so long as the ACO
remains in Level A (or progresses to
Level B) in PY2 and remains
inexperienced with performance-based
risk Medicare ACO initiatives and a low
revenue ACO. An ACO that joins the
Shared Savings Program at Levels B
through E of the BASIC track, however,
will not be eligible to receive all 8
quarters of advance investment
payments because current program
regulations require that an ACO remain
inexperienced with performance-based
risk Medicare ACO initiatives while
receiving advance investment payments
(§ 425.630(h)(2)). More specifically, if an
ACO receiving advance investment
payments elects to participate at Level
B of the BASIC track in PY1 progresses
along the glide path to Level C for PY2,
CMS would determine that the ACO is
experienced with performance-based
risk in PY2 and the ACO would no
longer be eligible to receive advance
investment payments during PY2.
In the CY 2023 final rule (87 FR
69787), we stated that advance
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investment payments were intended to
assist smaller, community-based
providers in forming high-performing
ACO networks by providing muchneeded startup capital that can be used
to attract and maintain staffing,
purchase healthcare delivery
infrastructure and IT systems, and
develop and implement a strategy to
address the health needs of underserved
communities. It is for this reason we
restricted AIP eligibility to those ACOs
that are inexperienced with
performance-based risk. ACOs that are
experienced with performance-based
risk generally would not need advance
investment payments to successfully
participate in the Shared Savings
Program as they have previously
participated in the Shared Savings
Program or certain Innovation Center
models or CMS programs in which the
ACO accepted risk for shared losses. In
this proposed rule, we propose to
modify program regulations to permit an
ACO to progress to two-sided risk along
the BASIC track’s glide path within the
agreement period while the ACO
continues to benefit from advance
investment payments.
(2) Proposed Revisions
We propose to modify AIP eligibility
requirements to allow an ACO receiving
advance investment payments to
transition to two-sided risk within its 5year agreement period under the BASIC
track’s glide path. Specifically, we
propose to modify § 425.630(b)(2) and
(3) to allow an eligible ACO receiving
advance investment payments to
advance to performance-based risk (by
advancing from Level A or B to Level C,
D, or E of the BASIC track’s glide path)
beginning in PY3 of the ACO’s
agreement period. We also propose to
modify § 425.316(e)(2) to specify that
CMS would cease payment of advance
investment payments if CMS determines
that an ACO approved for AIP became
experienced with performance-based
risk Medicare ACO initiatives during
the first or second performance year of
its agreement period or became a high
revenue ACO during any performance
year of the agreement period in which
it received advance investment
payments. Pursuant to
§ 425.316(e)(2)(ii), CMS may take
compliance action against such ACOs.
We also propose to modify
§ 425.316(e)(2)(i) to specify that CMS
will cease payment of advance
investment payments no later than the
quarter after the ACO became
experienced with performance-based
risk Medicare ACO initiatives or became
a high revenue ACO.
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Under the proposed approach, ACOs
may choose to move into a two-sided
risk participation option within the
Shared Savings Program’s BASIC track
beginning in PY3 (and in subsequent
performance years). These ACOs would
still be required to repay advance
investment payments through earned
shared savings over the remaining
performance years of its agreement
period as prescribed in § 425.630(g). We
propose that this policy would be
effective January 1, 2024. Under this
proposal, an ACO could not use
advance investment payments to fund
repayment mechanisms or repay shared
losses. This limitation also reduces the
risk that ACOs stretch themselves
beyond their financial capacity while
receiving advance investment payments
by taking on large amounts of risk.
Unlike other ACOs, ACOs receiving
advance investment payments will have
the additional financial obligation of
repaying the advance investment
payments if they misjudge their appetite
for risk and leave the program mid
performance period after incurring
shared losses. These policies are
intended to align with our goal to
support the creation of new ACOs that
need time and resource assistance to
develop the infrastructure to operate an
ACO that effectively manages patient
care and lowers costs.
After 2 years of participation, new
ACOs may have sufficient experience to
be capable of taking on the smaller
amounts of downside risk available in
levels C–E of the BASIC track. Given
that the option to receive advance
investment payments was designed for
ACOs that are new to the Shared
Savings Program, low revenue, and
inexperienced with risk, it does not
align with broader program goals to
permit ACOs of such size or
capitalization to take on the high levels
of downside risk in the ENHANCED
track during their first agreement period
in the Shared Savings Program. As
proposed, these modifications balance
the risk of a new ACO taking on too
much risk too quickly while allowing
them to take on moderate risk as they
develop more experience with the
program.
Specifically, we propose to amend the
eligibility criteria specified in
§ 425.630(b) as follows. We propose to
revise the eligibility criterion at
§ 425.630(b)(2) to remove language
stating that the ACO has applied to
participate in the Shared Savings
Program ‘‘under any level of the BASIC
track’s glide path’’; the revised
provision would simply state that ‘‘CMS
has determined that the ACO is eligible
to participate in the Shared Savings
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Program.’’ Further, we propose to
amend the criterion in § 425.630(b)(3) to
specify that the ACO must be
inexperienced with performance-based
risk Medicare ACO initiatives during its
first 2 performance years but may
participate in Levels of the BASIC track
that would make them experienced with
performance-based risk Medicare ACO
initiatives starting with the third year of
its first agreement period. Specifically,
we propose to specify in revisions to
§ 425.630(b)(3), that the ACO may
participate in the Levels of the BASIC
track’s glide path as follows during the
agreement period in which the ACO
receives advance investment payments:
• For performance year 1, the ACO
must participate in Level A of the
BASIC track’s glide path.
• For performance year 2, the ACO
may participate in Level A of the BASIC
track’s glide path (in accordance with
§ 425.600(a)(4)(i)(C)(3)) or Level B.
• For performance years 3 through 5,
the ACO may participate in Level A of
the BASIC track’s glide path (in
accordance with
§ 425.600(a)(4)(i)(C)(3)), or Levels B
through E.
To illustrate the proposed policy,
consider an ACO entering an agreement
period beginning on January 1, 2024,
that applies for and is determined to be
eligible to receive advance investment
payments. The ACO must participate in
Level A for PY1. In PY2, the ACO may
remain under Level A for all subsequent
years of the agreement period in
accordance with § 425.600(a)(4)(i)(C)(3)
or may move to Level B. The ACO
would receive advance investment
payments for PY1 and PY2, receiving
the one-time payment of $250,000 and
the 8 quarterly payments. If the ACO
remained at Level A for PY2, it could
then transition to a higher level of risk
and potential reward within the glide
path for PY3 (that is, Levels B, C, D, or
E) in accordance with
§ 425.600(a)(4)(i)(C)(3)(iii). If the ACO
participated in Level B for PY2, it could
automatically progress for PY3 to Level
C (in accordance with
§ 425.600(a)(4)(i)(C)(2)) or elect to
transition to Level D (in accordance
with § 425.600(a)(4)(i)(C)(2)(i) and
§ 425.226(a)(2)(i)) or Level E (in
accordance with § 425.600(h)(2)(i) and
§ 425.226(a)(2)(i)) beginning with PY3.
Under this proposed modification,
CMS would continue to recoup from
future shared savings. In contrast to
what is required under existing
§ 425.316(e)(3), the ACO would not be
immediately obligated to repay all
advance investment payments it
received by virtue of its transition to a
two-sided model in its third
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performance year or any subsequent
performance year. We note that under
our proposal if an ACO opts to progress
to a two-sided risk model (BASIC track’s
glide path Levels C through Level E) in
PY2, CMS would terminate the ACO’s
advance investment payments, the ACO
may be subject to compliance actions
specified in §§ 425.216 and 425.218,
and CMS may seek repayment of
advance investment payments as set
forth at § 425.316(e).
We seek comment on our proposals to
amend AIP policies and require that all
AIP ACOs be inexperienced with
performance-based risk Medicare ACO
initiatives while the ACO receives
advance investment payments—that is,
during PY1 and PY2 of the agreement
period—and to allow ACOs to progress
to performance-based risk under the
BASIC track’s glide path beginning with
PY3 of the same agreement period.
c. Proposal To Modify AIP Recoupment
and Recovery Policies for Early
Renewing ACOs
(1) Background
In the CY 2023 PFS final rule (87 FR
69803 through 69805), CMS finalized
program policies regarding recoupment
and recovery of advance investment
payments. In accordance with
§ 425.630(g)(4), if an ACO terminates its
participation agreement during the
agreement period in which it received
an advance investment payment, the
ACO must repay all advance investment
payments it received. CMS will provide
written notification to the ACO of the
amount due and the ACO must pay such
amount no later than 90 days after the
receipt of such notification.
Paragraph (2) of the definition of
‘‘renewing ACO’’ at § 425.20 includes an
ACO that continues its participation in
the Shared Savings Program for a
consecutive agreement period, without a
break in participation, because it is an
ACO that terminated its current
participation agreement under § 425.220
and immediately enters a new
agreement period to continue its
participation in the program. In prior
rulemaking (see, for example, 83 FR
67885 through 67890), we have referred
to this provision as allowing for an
‘‘early renewal’’ option. In developing
the AIP policies in the PFS rulemaking
for CY 2023, we did not address the
potential interactions between the
policy on recovery of advance
investment payments specified in
§ 425.630(g) and a voluntary termination
of the participation agreement by an
ACO that is seeking to early renew.
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(2) Proposed Revisions
We propose to amend § 425.630(g)(4)
to create a limited exception to CMS’s
policy of recovering advance investment
payments from an ACO that voluntarily
terminates its participation agreement
for the agreement period during which
it received advance investment
payments. Under this proposal, we
would not seek to collect all advance
investment payments received from an
ACO in accordance with § 425.630(g)(4)
if the ACO voluntarily terminates its
participation agreement at the end of
PY2 or later during the agreement
period in which it received advance
investment payments, provided that the
ACO immediately enters into a new
participation agreement with CMS
under any level of the BASIC track’s
glide path or the ENHANCED track.
Rather, we would carry forward any
remaining balance of advance
investment payments owed by the early
renewing ACO into the ACO’s new
agreement period.
We propose to allow an ACO
approved for AIP to early renew its
participation agreement before the
expiration of its current agreement, as
long as the ACO terminates its current
participation agreement effective on or
after December 31 of the ACO’s second
performance year. By requiring the ACO
to maintain its current agreement period
for the first 2 years, the ACO will
receive all of its advance investment
payments prior to renewing its
participation agreement. We further
propose that in such circumstances, the
early renewing ACO must continue to
repay the advance investment payments
through shared savings earned in the
subsequent agreement period. If an ACO
early renews prior to PY3, it will no
longer comply with the eligibility
requirements for receiving payments in
§ 425.630(b)(1) and may be subject to
compliance actions under §§ 425.216
and 425.218.
Section 425.630(e)(3) specifies that an
ACO may spend an advance investment
payment over its entire agreement
period and must repay to CMS any
unspent funds remaining at the end of
the ACO’s agreement period. We
propose to amend § 425.630(e)(3) to
permit an early renewing ACO to spend
advance investment payments in its
second agreement period so long as the
advance investment payments are spent
within 5 performance years of when it
began to receive advance investment
payments. If the ACO does not spend all
of the advance investment payments
received by the end of the fifth
performance year, the ACO must repay
any unspent funds to CMS. The
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duration of spending advance
investment payments was discussed in
the CY 2023 PFS final rule (87 FR
69801).
We believe these policy proposals
would be most relevant to an ACO that
is receiving advance investment
payments and seeks to early renew to
enter a new participation agreement to
participate under modified Shared
Savings Program policies that are not
applicable to the ACO’s current
agreement period. For such an ACO, any
remaining balance of advance
investment payments owed would
continue to be recouped from any
shared savings the ACO earns in its new
agreement period. Further, such an ACO
would continue its participation in the
Shared Savings Program without a lapse
in participation and would be required
to continue to adhere to all AIP
requirements. We believe continued
program participation aligns with our
goals to improve the quality and
efficiency of care. These policies
provide ACOs the flexibility to
participate in the Shared Savings
Program in a manner that may work best
for their structure and patient
population without having to choose
between immediately paying back the
advance investment payment funds they
received and being able to enter a new
agreement with the Shared Savings
Program. Some policy changes are
applicable to new agreement periods,
and we believe ACOs approved for AIP
should have the opportunity to enter a
new agreement to experience those
changes. This proposed modification, if
finalized, would be effective January 1,
2024.
We seek comment on the proposed
changes to § 425.630(e)(3) and
§ 425.630(g)(4).
d. Proposal To Amend Termination
Policies To Allow CMS To Cease
Distribution of Advance Investment
Payments Following an ACO’s
Notification of Voluntary Termination
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(1) Background
In the CY 2023 PFS final rule (87 FR
69803), we finalized policies for
termination of advance investment
payments at § 425.630(h). Section
425.630(h)(1) specifies that CMS may
terminate an ACO’s advance investment
payments if the ACO fails to comply
with the requirements of § 425.630 or
meets any of the grounds for ACO
termination set forth in § 425.218(b).
However, we did not address the
termination of advance investment
payments if an ACO voluntarily
terminates its participation agreement in
accordance with § 425.220(a). This
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created ambiguity regarding whether
CMS would continue to make quarterly
advance investment payments to an
ACO that voluntarily terminates its
participation agreement in accordance
with § 425.220(a) and does not
immediately enter a new agreement
period. We are concerned that the
continued payment of advance
investment payments in such a case
would not serve the purpose for which
CMS is making such payments and
would create unnecessary program
integrity risks for the Shared Savings
Program. In such a case, CMS would be
knowingly paying funds to an ACO that
will need to be repaid upon termination.
(2) Proposed Revisions
We propose to permit CMS to
terminate advance investment payments
for future quarters to an ACO that has
provided CMS with notice of
termination in accordance with
§ 425.220(a) if the ACO will not
immediately enter a new agreement
period. This avoids distributing advance
investment payments to an ACO from
which CMS would subsequently need to
recover such payments. Specifically, we
propose to add § 425.630(h)(1)(iii),
which allows CMS to terminate an
ACO’s advance investment payments
when the ACO voluntarily terminates its
participation agreement in accordance
with § 425.220(a). We are also proposing
conforming changes to the punctuation
of the list of factors in paragraphs
(h)(1)(i) and (ii) of § 425.630. If
finalized, these proposed changes
would be effective January 1, 2024.
In summary, if finalized, CMS will
cease paying advance investment
payments to an ACO that voluntarily
terminates its participation in the
Shared Savings Program if the ACO will
not immediately enter a new agreement
period. In accordance with
§ 425.630(g)(4), the ACO would still be
obligated to repay all advance
investment payments within the 90days after receiving notice of the
amount due to CMS. We seek comment
on this proposal.
e. Proposal To Require ACOs To Report
to CMS Spend Plan Updates and Use of
Advance Investment Payments
In the CY 2023 PFS final rule (87 FR
69786 through 69788), CMS finalized
program policies to require ACOs that
receive advance investment payments to
submit a spend plan to CMS as a part
of their Shared Savings Program
application (§ 425.630(d)(1)). In
accordance with § 425.630(d)(3), CMS
may review an ACO’s spend plan at any
time and require the ACO to modify its
spend plan to comply with the spend
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plan requirements specified at
§ 425.630(d)(2) and the requirements for
use and management of advance
investment payments at § 425.630(e).
In the CY 2023 PFS final rule (87 FR
69801 and 69802), we also finalized
requirements at § 425.308(b)(8) that an
ACO receiving advance investment
payments must publicly report
information, updated annually, about
the ACO’s use of advance investment
payments for each performance year,
including the following:
• The ACO’s spend plan.
• The total amount of any advance
investment payments received from
CMS.
• An itemization of how advance
investment payments were spent during
the year, including expenditure
categories, the dollar amounts spent on
the various categories, any changes to
the spend plan submitted under
§ 425.630(d), and such other
information as may be specified by
CMS.
These provisions do not require an
ACO to submit this same information to
CMS. To support CMS’s ability to
monitor AIP efficiently, we propose that
an ACO must report to CMS the same
information about its use of advance
investment payments that it is required
to publicly report under § 425.308(b)(8).
To ensure that § 425.630 sets forth the
complete requirements applicable to an
ACO’s obligation to report information
on its receipt and use of advance
investment payments, we propose to
add a new provision at § 425.630(i)
specifying that an ACO must (1)
publicly report information about the
ACO’s use of advance investment
payments for each performance year in
accordance with § 425.308(b)(8); and (2)
in a form and manner and by a deadline
specified by CMS, report to CMS the
same information it is required to
publicly report in accordance with
§ 425.308(b)(8).
We believe that these proposed
changes would help ensure that CMS
efficiently obtains information in a
consistent manner from all ACOs
receiving advance investment payments
and thereby support CMS’s monitoring
and analysis of the use of advance
investment payments. CMS believes that
these proposed changes will impose
little to no administrative burden on
participating ACOs, which are already
required to publicly report this
information by § 425.308(b)(8). Further,
CMS expects to use the submitted data
as the template that ACOs can use to
populate their public reporting web
page early in each performance year to
minimize administrative burden for
ACOs.
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If finalized, these proposed changes
would be effective January 1, 2024. We
seek comment on these proposals.
f. Proposal To Permit Reconsideration
Review of Quarterly Payment
Calculations
(1) Background
In the CY 2023 PFS final rule (87 FR
69795 and 69796), we specified that an
ACO can request a reconsideration
review if CMS does not make an
advance investment payment to the
ACO pursuant to subpart I of part 425
(§ 425.630(f)). However, we did not
specify that an ACO could request
reconsideration of the advance
investment payment amount received.
(2) Proposed Revisions
We propose to permit an ACO to
request a reconsideration review for all
advance investment payment quarterly
payment calculations, not just instances
where no payments are distributed. We
propose to revise § 425.630(f) to provide
that CMS would notify in writing each
ACO of its determination of the amount
of advance investment payment it will
receive and that such notice would
inform the ACO of its right to request
reconsideration review in accordance
with the procedures specified under
subpart I of the regulations. We seek
comment on this proposal.
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6. Shared Savings Program Eligibility
Requirements
a. Overview
We are proposing two modifications
to the Shared Savings Program
eligibility requirements that, if finalized,
would be implemented on January 1,
2024. Specifically, we propose the
following, which are discussed in more
detail in sections (b) and (c) below:
• 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 or will be included on
a participant list used in financial
reconciliation for a performance year
under performance-based risk during
the 5 most recent performance years.
b. Shared Governance Requirement
(1) Background
In the November 2011 final rule (76
FR 67819), we finalized policies that
require an ACO to establish and
maintain a governing body with
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adequate authority to execute the
statutory functions of an ACO, and we
codified the governing body policies at
§ 425.106. Specifically, § 425.106(c)(3)
mandates that at least 75 percent control
of an ACO’s governing body must be
held by ACO participants. An ACO’s
governing body is responsible for
providing ACO leadership, strategic
direction, and oversight for operational
management towards meeting the goals
of the ACO, including better care,
healthy communities, and reduced
spending. This responsibility
incorporates not only the delivery of
improved healthcare, but also the
promotion of evidence-based healthcare
practices, improved engagement of
patients and caregivers, reporting on
quality and cost, provision of highquality care to beneficiaries, and the
distribution of shared savings, among
other functions. In the November 2011
final rule (76 FR 67819), we indicated
our belief that this requirement allowed
for Medicare-enrolled entities that
directly provide health care services to
beneficiaries to drive decision-making,
while recognizing that partnerships
with non-Medicare enrolled entities
outside this 75 percent composition
allow these participants access to
capital and infrastructure needed for an
ACO. This physician-driven leadership
is balanced by the remaining percentage
of the governing body that is made up
of patient advocates, accounting, legal
and other professionals that support
administrative duties and other
functions of the ACO.
We affirmed in the November 2011
final rule (76 FR 67820) our belief that
the 75 percent participant control
requirement is necessary to ensure that
ACOs are provider-driven, innovative in
care delivery and strike an appropriate
balance to incentivize and empower
ACO participants to be accountable for
the success of the ACO’s operations and
improve the health outcomes of their
beneficiaries. Previously, commenters
expressed concern that the 75 percent
participant control threshold is overly
prescriptive and may hinder operations,
conflict with IRS and State tax laws, and
restrict access to capital for the ACO.
ACOs requested flexibility to develop
their own governing body composition
to meet the unique leadership needs of
the ACO. In response to these
comments, CMS granted an exception
process for an ACO that wishes to
structure its governing body in a manner
that does not meet the 75 percent
participant control threshold as required
under § 425.106(c)(3). Under the
exception process defined at
§ 425.106(c)(5), an ACO must describe
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why it seeks to differ from the 75
percent participant control threshold
and how the ACO will involve ACO
participants in innovative ways in ACO
governance. If the exception is granted
by CMS, an ACO can form a governing
body with less than 75 percent
participant control.
In the December 2014 Medicare
Shared Savings Program proposed rule
(79 FR 72776) we proposed to revise
§ 425.106(c)(5) to remove the flexibility
for ACOs to deviate from the
requirement that at least 75 percent
control of an ACO’s governing body
must be held by ACO participants. We
stated that, through program
implementation, we learned that ACO
applicants do not have difficulty
meeting the requirements under
§ 425.106(c)(3) that ACO participants
maintain 75 percent control of the
governing body. We also noted that
since CY 2012, we had not denied
participation to any ACO applicants
solely based on failure to comply with
this requirement and no exceptions
have been granted by CMS under
§ 425.106(c)(5). Furthermore, we
affirmed the 75 percent participant
control requirement to be ‘‘necessary
and protective of the ACO participant’s
interests’’ and thus, that there was no
reason to continue to offer an exception
to the rule.
During the public comment period for
the December 2014 Medicare Shared
Savings Program proposed rule, several
commenters advocated for retaining the
flexibility offered at § 425.106(c)(5),
stating that an ACO may elect to utilize
the exception in the future. In our
response, we noted that our program
experience thus far had not suggested
that commenters’ concerns that laws
concerning the composition of taxexempt or State-licensed entities would
interfere with their ability to meet the
75 percent participant control threshold
would impact their compliance with
this requirement. However, since
implementation of the requirement
remained in the early stages and we had
limited applicability with ACOs in twosided risk tracks, we declined to finalize
the proposal in the June 2015 final rule
(80 FR 32719) and elected to retain the
flexibility at § 425.106(c)(5). In the final
rule, we noted that we anticipated
granting such exceptions only in limited
circumstances (that is, an ACO being
unable to meet the 75 percent
participant control requirement because
it conflicts with other laws) and might
revisit this issue in future rulemaking.
(2) Proposed Revisions
We continue to believe that ACO
participants should drive ACO
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leadership to move toward improved
quality of care and patient outcomes,
and that this is a key component of ACO
success and ability to earn shared
savings. The 75 percent participant
control threshold is critical to ensuring
that governing bodies are participant-led
and best positioned to meet program
goals, while allowing for partnership
with non-Medicare enrolled entities to
provide needed capital and
infrastructure for ACO formation and
administration.
Over the years, a few ACOs have
requested an exception to form a
governing body with less than 75
percent participant control. CMS
discussed the exemption requests with
the interested ACOs and ultimately the
ACOs made adjustments to comply with
the 75 percent participant control
requirement. To date, CMS has not
granted an ACO an exception to this
requirement, despite the flexibility
provided in current regulation.
Accordingly, we believe that there is no
reason to continue to offer an exception
to the requirement, as ACOs have
demonstrated that they can
appropriately meet the 75 percent
participant control requirement without
utilizing this flexibility since its
establishment in the November 2011
final rule. Thus, we propose to remove
the option under § 425.106(c)(5) for
ACOs to request an exception to the
requirement specified in § 425.106(c)(3)
that 75 percent control of the ACO’s
governing body must be held by ACO
participants. Additionally, we propose a
corresponding revision to
§ 425.204(c)(3) to remove the option for
ACOs to request an exception to the 75
percent control requirement under
§ 425.106(c)(3) as part of their Shared
Savings Program applications.
We are seeking public comments on
the appropriateness of our proposed
policy refinement and elimination of the
exception process. If finalized, our
proposed modification to § 425.106(c)
would make no changes to paragraphs
(c)(2), (3) and (4). CMS would amend
§ 425.106(c)(5) to remove reference to
paragraph (c)(3) and the procedure for
submitting a request for an exception to
the 75 percent requirement.
Specifically, the revised regulation text
would state: ‘‘In cases in which the
composition of the ACO’s governing
body does not meet the requirements of
paragraph (c)(2) of this section, the ACO
must describe why it seeks to differ
from these requirements and how the
ACO will provide meaningful
representation in ACO governance by
Medicare beneficiaries.’’ Additionally,
CMS would amend § 425.204(c)(3) to
remove references to § 425.106(c)(3) and
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the procedure for submitting a request
for an exception to the 75 percent
requirement. Specifically, the revised
regulation text would state: ‘‘If an ACO
requests an exception to the governing
body requirement in § 425.106(c)(2), the
ACO must describe—(i) Why it seeks to
differ from the requirement; and (ii)
How the ACO will provide meaningful
representation in ACO governance by
Medicare beneficiaries.’’ If finalized,
this policy would be effective beginning
January 1, 2024.
c. Identifying ACOs Experienced With
Risk Based on TINs’ Prior Participation
(1) Background
In the December 2018 final rule, we
added a new paragraph (d) under
§ 425.600 to set forth the participation
options for ACOs that are experienced
or inexperienced with ‘‘performancebased risk Medicare ACO initiatives’’
(which is defined at § 425.20 to include
certain Innovation Center ACO models
as well as two-sided risk tracks of the
Shared Savings Program). We also
finalized the definitions of ‘‘experienced
with performance-based risk Medicare
ACO initiatives’’ and ‘‘inexperienced
with performance-based risk Medicare
ACO initiatives’’ (83 FR 68062). These
definitions classify ACOs by experience
level based on the percentage of ACO
participant TINs that participated in
performance-based risk Medicare ACO
initiatives during a 5-year lookback
period. However, current regulation text
does not specify how CMS determines
whether an ACO participant TIN has
‘‘participated’’ in a performance-based
risk Medicare ACO initiative. To
improve clarity of the regulations, we
propose to codify our existing program
policy under which an ACO participant
TIN is considered to have participated
in a performance-based risk Medicare
ACO initiative if it was or will be
included in financial reconciliation for
a performance year under such initiative
during any of the 5 most recent
performance years.
Under the December 2018 final rule,
an ACO is ‘‘inexperienced with
performance-based risk Medicare ACO
initiatives’’ (and therefore eligible to
enter an agreement period under the
BASIC track’s glide path), if less than 40
percent of its ACO participants has
participated in a performance-based risk
Medicare ACO initiative in ‘‘each’’ of
the 5 most recent performance years
prior to its Shared Savings Program
agreement start date, and the ACO legal
entity has not participated in any
performance-based risk Medicare ACO
initiative (83 FR 67895). Similarly, an
ACO is ‘‘experienced with performance-
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based risk Medicare ACO initiatives’’ if
40 percent or more of its ACO
participants has participated in a
performance-based risk Medicare ACO
initiative in ‘‘any’’ of the 5 most recent
performance years prior to its Shared
Savings Program agreement start date
(83 FR 67895). Thus, if 40 percent or
more of the entities on an ACO
participant list participated in a
performance-based risk Medicare ACO
initiative in a single performance year
within the 5 most recent performance
years, we would determine that the
ACO meets the definition of
‘‘experienced with performance-based
risk Medicare ACO initiatives.’’
Conversely, we would determine that an
ACO satisfies the definition of
‘‘inexperienced with performance-based
risk Medicare ACO initiatives’’ only if it
is below the 40 percent threshold in all
of the 5 most recent performance years
prior to the ACO’s agreement start date.
In other words, an ACO is
inexperienced with performance-based
risk Medicare ACO initiatives as long as
it does not meet the definition of
‘‘experienced with performance-based
risk Medicare ACO initiatives’’ in any of
the five most recent performance years
prior to the ACO’s agreement start date.
We chose to use a 5-year lookback
period for determining whether an ACO
is experienced or inexperienced with
performance-based risk Medicare ACO
initiatives for a number of reasons,
including that it could reduce the
incentive for organizations to wait out
the period in an effort to establish a new
legal entity with the same or very
similar composition of ACO participants
for purposes of gaming program
policies.
We recognize that some ACOs or TINs
in performance-based risk Medicare
ACO initiatives participate for only part
of a performance year, but our current
regulation text does not specify the
duration of participation required for
CMS to determine that an ACO
participant TIN has participated in a
performance-based risk Medicare ACO
initiative.
(2) Proposed Revisions
We propose to codify the current
operational approach for determining
whether an ACO participant has
participated in a performance-based risk
Medicare ACO initiative. Under our
current operational approach, an ACO
participant is considered to have
participated in a performance-based risk
Medicare ACO initiative if its TIN was
or will be used to calculate financial
reconciliation for the entity
participating in such ACO initiative
(‘‘Initiative ACO’’). In general, if an ACO
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participant was included on an
Initiative ACO’s participant list for a
performance year during the 5 most
recent performance years before the
ACO’s agreement start date, and the
Initiative ACO is, or will be, financially
reconciled for that performance year,
the ACO participant will be considered
to have participated in the Initiative
ACO. This will generally be true
regardless of whether the entity leaves
the Initiative ACO mid-performance
year, because its claims experience
would still be used in the Initiative
ACO’s alignment and financial
reconciliation for that performance year.
If the ACO participant was included on
an Initiative ACO’s participant list for a
performance year during the lookback
period, but the ACO voluntarily
terminates before the deadline for
reconciliation or is otherwise not
eligible for reconciliation, the ACO
participant will not be considered to
have experience with risk because its
claims experience would not be used for
financial reconciliation.
Except for determinations made
regarding AIP ACOs for purposes of
§ 425.316(e)(2), we determine whether
an ACO is experienced with
performance-based risk Medicare ACO
initiatives prior to the start of an ACO’s
agreement start date. At the time we
make these determinations, the ACO
may be in the middle of a PY for which
reconciliation has not yet occurred.
Nevertheless, we believe that at the time
we make these determinations, we have
the information necessary to determine
whether an ACO or ACO participant
TIN will be included in financial
reconciliation for a PY in the relevant
Medicare ACO initiative because this
issue is addressed in the terms of each
Medicare ACO initiative. For example,
as outlined in § 425.221(b)(2)(ii)(A), if
an ACO in a two-sided model
terminates from the Shared Savings
Program after June 30th of a PY, they
will be held responsible for a pro-rated
share of any shared losses determined
for the performance year during which
the termination becomes effective. Any
ACO participant TIN that was included
on the participant list for that
performance year will have been
included in beneficiary alignment and
their claims experience used to
calculate the benchmark and
performance year expenditures. For
other Medicare ACO initiatives, the
terms of the participation agreement
specify when the ACO is subject to
reconciliation and which TINs will be
included in reconciliation.
We propose to modify the existing
definitions for ‘‘experienced with
performance-based risk Medicare ACO
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initiatives’’ and ‘‘inexperienced with
performance-based risk Medicare ACO
initiatives’’ at § 425.20 to include the
following new sentence at the end of
each definition: ‘‘An ACO participant is
considered to have participated in a
performance-based risk Medicare ACO
initiative if the ACO participant TIN
was or will be included in financial
reconciliation for a performance year
under such initiative during any of the
5 most recent performance years.’’ We
also propose a technical correction to
remove the language ‘‘as defined under
this section’’ from both definitions. We
propose that these amendments would
become effective on January 1, 2024.
We seek comments on the proposed
regulation text.
7. Proposed Technical Changes to
References in Shared Savings Program
Regulations
a. References to an ACO’s Assignment
Methodology Selection
Section 1899(c)(2)(A) of the Act, as
amended by the Bipartisan Budget Act
of 2018, provides all ACOs with a
choice of prospective assignment for
agreement periods beginning on or after
January 1, 2020. In the December 2018
final rule (83 FR 67859 through 67863),
we finalized modifications to the Shared
Savings Program’s regulations, to
separate the choice of beneficiary
assignment methodology from the
choice of participation track (financial
model). We also added a new section of
the Shared Savings Program regulations
at § 425.226 to govern annual
participation elections. In accordance
with § 425.226, before the start of a
performance year an ACO may make
elections related to its participation in
the Shared Savings Program, including
selection of its beneficiary assignment
methodology, which will be effective at
the start of the applicable performance
year and for the remaining years of the
agreement period, unless superseded by
a later election. Section 425.226(a)(1)
specifies that an ACO may select the
assignment methodology that CMS
employs for assignment of beneficiaries
under subpart E of the Shared Savings
Program regulations. An ACO may
select either of the following: (i)
preliminary prospective assignment
with retrospective reconciliation, as
described in § 425.400(a)(2); or (ii)
prospective assignment, as described in
§ 425.400(a)(3).
For consistency, in the December
2018 final rule (83 FR 67991), we also
finalized conforming changes to
regulations that previously identified
assignment methodologies according to
program track. Among other changes to
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the Shared Savings Program regulations,
we added § 425.400(a)(4)(ii) to establish
that for agreement periods beginning on
July 1, 2019, and in subsequent years,
the ACO may select the assignment
methodology CMS employs for the
assignment of beneficiaries. As specified
in § 425.400(a)(4)(ii)(B), this selection of
assignment methodology is made prior
to the start of each agreement period,
and may be modified prior to the start
of each performance year as specified in
§ 425.226 (83 FR 67863).
Although §§ 425.226(a)(1) and
425.400(a)(4)(ii) both reference
assignment methodology selection,
there are key differences in the purpose
each section serves in directing action
from the ACO versus action that CMS
initiates. Section 425.226 states that the
initial selection of, and any annual
selection for a change in, beneficiary
assignment methodology by an ACO,
must be made in the form and manner,
and according to the timeframe, that we
establish. Therefore, § 425.226(a)(1) is
the relevant regulation for referencing
the ACO’s option to select and to change
its selection of assignment methodology.
That is, § 425.226 describes actions for
which the ACO is responsible because
the ACO is selecting the assignment
methodology that will be effective at the
beginning of the ACO’s agreement
period or making a change to the ACO’s
prior assignment methodology selection
that will become effective at the
beginning of the next performance year.
In comparison, § 425.400 outlines
how we employ the assignment
methodology described in §§ 425.402
and 425.404 for purposes of
benchmarking, preliminary prospective
assignment (including quarterly
updates), retrospective reconciliation,
and prospective assignment. Therefore,
§ 425.400(a)(4)(ii) is the relevant
regulation for referencing how we
determine the assignment methodology
to be used in the referenced program
operations or program calculations. That
is, § 425.400(a)(4)(ii) governs actions
undertaken by us because we are
applying the ACO’s selected assignment
methodology when determining
benchmarking, preliminary prospective
assignment, retrospective reconciliation,
and prospective assignment.
Throughout the current Shared
Savings Program regulations text, there
are various references to § 425.226(a)(1)
or § 425.400(a)(4)(ii). We conducted a
review of the Shared Savings Program
regulations text to determine whether
the existing twelve references to either
§ 425.226(a)(1) or § 425.400(a)(4)(ii)
align with provisions’ intended
purposes. We also considered the
intended purposes of the provisions in
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identifying the appropriate crossreference to include in the proposed
new regulation at § 425.655, which is
described in section III.G.4.b. of this
proposed rule.
We believe the following five
references to § 425.400(a)(4)(ii) are
consistent with the intended purpose of
§ 425.400(a)(4)(ii), in referring to how
we determine the ACO’s chosen
assignment methodology for purposes of
determining beneficiary assignment or
performing certain program
calculations: § 425.609(c)(1);
§ 425.652(a)(5)(v)(A);
§ 425.652(b)(2)(iv)(A); § 425.654(a)(1)(i);
and § 425.656(b)(3).
We believe the following two
references to § 425.226(a)(1) are
consistent with the intended purpose of
§ 425.226(a)(1) because the references
are used when referring to the ACO’s
option to change its selection of
assignment methodology:
§ 425.601(a)(9) introductory text; and
§ 425.652(a)(9) introductory text.
We identified five inconsistencies in
references to §§ 425.226(a)(1) and
425.400(a)(4)(ii) that we are proposing
to revise in this proposed rule. To
follow is a description of the five
references we are proposing to revise
and the proposed technical changes to
the applicable provisions in 42 CFR part
425, subpart G to ensure that the
appropriate assignment selection
reference is being cited for clarity and
consistency.
For performance years starting on
January 1, 2019, and subsequent
performance years, CMS adds
beneficiaries to an ACO’s list of
assigned beneficiaries based on a
beneficiary’s designation of an ACO
professional as the provider or supplier
they consider responsible for
coordinating their overall care, if certain
conditions are satisfied, including the
conditions specified in
§ 425.402(e)(2)(ii)(A). In accordance
with § 425.402(e)(2)(ii)(A), the
beneficiary must meet the eligibility
criteria established at § 425.401(a) and
must not be excluded by the criteria at
§ 425.401(b). Further, the provision
specifies that the exclusion criteria at
§ 425.401(b) apply for purposes of
determining beneficiary eligibility for
alignment to an ACO based on the
beneficiary’s designation of an ACO
professional as responsible for
coordinating their overall care under
§ 425.402(e), regardless of the ACO’s
assignment methodology selection
under § 425.400(a)(4)(ii). The reference
to § 425.400(a)(4)(ii) in
§ 425.402(e)(2)(ii)(A) is not consistent
with the intended purpose of the
reference the ACO’s selected assignment
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methodology. Therefore, we are
proposing to amend
§ 425.402(e)(2)(ii)(A) by removing the
reference to § 425.400(a)(4)(ii) and
adding in its place a reference to
§ 425.226(a)(1), for clarity and
consistency.
The introductory text of § 425.601(a)
(applicable to agreement periods
beginning on or after July 1, 2019, and
before January 1, 2024) and § 425.652(a)
(applicable to agreement periods
beginning on January 1, 2024, and in
subsequent years) specifies that in
computing an ACO’s historical
benchmark for its first agreement period
under the Shared Savings Program, CMS
determines the per capita Parts A and B
fee-for-service expenditures for
beneficiaries that would have been
assigned to the ACO in any of the 3
most recent years prior to the start of the
agreement period using the ACO
participant TINs identified before the
start of the agreement period as required
under § 425.118(a) and the beneficiary
assignment methodology selected by the
ACO for the first performance year of
the agreement period as required under
§ 425.226(a)(1). Accordingly, the
introductory text of § 425.601(a) and
§ 425.652(a) is describing how we will
compute expenditures for beneficiaries
that would have been assigned to the
ACO based on the assignment
methodology selected by the ACO. This
provision is referring to how we
determine the assignment methodology
to be used to identify the beneficiary
population that would have been
assigned in the three benchmark years,
not to the ACO’s act of selecting the
assignment methodology. Therefore, we
are proposing to amend the introductory
text of § 425.601(a) and § 425.652(a) by
removing the reference to
§ 425.226(a)(1) and adding in its place a
reference to § 425.400(a)(4)(ii), for
clarity and consistency.
Section 425.652(a)(9)(ii) specifies that
for agreement periods beginning on
January 1, 2024, and in subsequent
years, when adjusting the benchmark for
certain changes during the agreement
period, we redetermine the regional
adjustment amount under § 425.656
according to the ACO’s assigned
beneficiaries for BY3, and based on the
assignable population of beneficiaries
identified for the assignment window
corresponding to BY3 that is consistent
with the assignment window that
applies under the beneficiary
assignment methodology selected by the
ACO for the performance year according
to § 425.226(a)(1). In § 425.652(a)(9)(ii)
the reference to § 425.226(a)(1) is not
consistent with the intended purpose of
the reference, which is to specify how
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we determine the assignment
methodology that will be used to
identify the assigned beneficiary and
assignable beneficiary populations
which are in turn used to redetermine
the regional adjustment in the event the
ACO changes its selected assignment
methodology. Therefore, we are
proposing to amend § 425.652(a)(9)(ii)
by removing the reference to
§ 425.226(a)(1) and adding in its place
the reference to § 425.400(a)(4)(ii), for
clarity and consistency.
Section 425.652(a)(9)(iv) describes
that for agreement periods beginning on
January 1, 2024, and in subsequent
years, when adjusting the benchmark for
certain changes during the agreement
period, we redetermine the proration
factor used in calculating the prior
savings adjustment under
§ 425.658(b)(3)(ii) to account for changes
in the ACO’s assigned beneficiary
population in the benchmark years of
the ACO’s current agreement period due
to the addition and removal of ACO
participants or ACO providers/suppliers
in accordance with § 425.118(b), a
change to the ACO’s beneficiary
assignment methodology selection
under § 425.400(a)(4)(ii), or changes to
the beneficiary assignment methodology
under 42 CFR part 425, subpart E. In
§ 425.652(a)(9)(iv) the reference to
§ 425.400(a)(4)(ii), is not consistent with
the intended purpose of provision,
which is to specify that we will
redetermine the proration factor used in
calculating the prior savings adjustment
if the ACO changes its beneficiary
assignment methodology selection.
Therefore, we are proposing to amend
§ 425.652(a)(9)(iv) by removing the
reference to § 425.400(a)(4)(ii) and
adding in its place a reference to
§ 425.226(a)(1), for clarity and
consistency.
We seek comments on these proposed
technical changes.
b. Definition of Rural Health Clinic
In the November 2011 final rule, we
established a definition for the term
‘‘Rural health center (RHC)’’ for the
Shared Savings Program at § 425.20.207
The definition of ‘‘Rural health center
(RHC)’’ at § 425.20 states that this term
has the same meaning given to this term
under § 405.2401(b). The term ‘‘Rural
health clinic (RHC)’’ is defined at
§ 405.2401(b) to mean a facility that
has—
• Been determined by the Secretary to
meet the requirements of section
207 See, for example, 76 FR 67930 through 67932
(discussion of our proposal to define FQHCs and
RHCs as these terms are defined in § 405.2401(b)),
and 76 FR 67974 and 67975 (finalized regulations
text for § 425.20).
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1861(aa)(2) of the Act and 42 CFR part
491 concerning RHC services and
conditions for approval; and
• Filed an agreement with CMS that
meets the requirements in § 405.2402 to
provide RHC services under Medicare.
This inconsistency between § 425.20,
which inaccurately uses the word
‘‘center,’’ and § 405.2401(b), which
accurately uses the word ‘‘clinic,’’
recently came to our attention. We note
that the term ‘‘rural health clinic’’ was
in use and defined at § 405.2401(b)
when we established the term and
definition for ‘‘Rural health center
(RHC)’’ under part 425 with the
November 2011 final rule. Furthermore,
in the November 2011 final rule (76 FR
67803) we separately established an
acronym ‘‘RHCs’’ for ‘‘Rural Health
Clinics’’ in the acronyms list reflecting
the accurate term.
To ensure clarity and accuracy, we are
proposing to correct the error in the
definition for ‘‘Rural health center
(RHC)’’ at § 425.20 by replacing the
word ‘‘center’’ with the word ‘‘clinic’’.
We would like to clarify that all uses of
the acronym ‘‘RHC’’ or ‘‘RHCs’’
throughout Part 425—including in the
definition of ‘‘primary care physician’’
in § 425.20 as well as in §§ 425.102 and
425.304 and throughout 42 CFR part
425, subpart E—have been interpreted
to refer to ‘‘rural health clinic’’ or ‘‘rural
health clinics’’ as defined at
§ 405.2401(b). Further, we propose to
revise the definition of rural health
center in § 425.20 to specify that the
referenced provision at § 405.2401(b) is
within Title 42, Chapter IV of the Code
of Federal Regulations. We seek
comments on these proposed technical
changes.
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c. Definition of At-Risk Beneficiary
In the November 2011 final rule (see
76 FR 67974), we established the
definition of ‘‘At-risk beneficiary’’ at
§ 425.20, the meaning of which
includes, but is not limited to, a
beneficiary who—
• Has a high risk score on the CMS–
HCC risk adjustment model;
• Is considered high cost due to
having two or more hospitalizations or
emergency room visits each year;
• Is dually eligible for Medicare and
Medicaid;
• Has a high utilization pattern;
• Has one or more chronic
conditions;
• Has had a recent diagnosis that is
expected to result in increased cost;
• Is entitled to Medicaid because of
disability; or
• Is diagnosed with a mental health
or substance abuse disorder.
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In finalizing modifications to the
proposed definition of at-risk
beneficiary, we explained that we
agreed with commenters that our
proposed definition should be expanded
to include patients who are entitled to
Medicare (emphasis added) because of
disability (see 76 FR 67950). However,
in codifying the relevant regulation text
at § 425.20, we inadvertently referred to
patients who are entitled to Medicaid
because of disability (emphasis added).
We note that an individual who is
entitled to Medicare because of
disability and who is also entitled to
Medicaid, would be included under the
category ‘‘Is dually eligible for Medicare
and Medicaid.’’
We are proposing to correct the
typographical error in the definition for
‘‘At-risk beneficiary’’ at § 425.20 by
replacing the word ‘‘Medicaid’’ in
paragraph (7) with the word
‘‘Medicare’’. We also propose to adjust
inaccurate punctuation in the list of
paragraphs within this definition by
replacing the period at the end of
paragraphs (5) and (6) with a semicolon. We seek comment on these
proposed changes.
d. Updating Terminology in Regulations
on Data Sharing With ACOs
It has come to our attention that
certain terminology that is used in the
data sharing regulations for the Shared
Savings Program in 42 CFR part 425,
subpart H is outdated or inconsistent
with the terminology used elsewhere in
the Medicare program and in the HIPAA
regulations in 45 CFR part 164. We are
proposing technical and conforming
changes to § 425.702(c)(1)(ii)(A)(3) and
§ 425.702(c)(1)(ii) for clarity and
consistency.
In accordance with the Medicare
Access and CHIP Reauthorization Act of
2015 (MACRA), CMS discontinued the
use of Social Security Number-based
Health Insurance Claim Numbers
(HICNs) as the beneficiary identifier on
Medicare cards and replaced that
identifier type with Medicare
Beneficiary Identifiers (MBIs) by April
2019. MBIs are now used for Medicare
transactions like billing, eligibility
status, and claim status. All claims with
a date of service on or after January 1,
2020, must use the beneficiary’s MBI,
rather than the HICN.208 209 To
208 CMS, MLN Matters, ‘‘New Medicare
Beneficiary Identifier (MBI) Get It, Use It’’. Article
number SE18006, revised March 19, 2020.
Available at https://www.cms.gov/outreach-andeducation/medicare-learning-network-mln/
mlnmattersarticles/downloads/se18006.pdf.
209 CMS.gov website, Medicare Beneficiary
Identifiers (MBIs), at https://www.cms.gov/
Medicare/New-Medicare-Card.
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accommodate this change from HICN to
MBI, starting in PY 2018 we revised
Shared Savings Program reports
providing beneficiary-identifiable
information under § 425.702, and claim
and claim line feed files with
beneficiary identifiable claims data
provided under § 425.704, to include a
field for the beneficiary’s MBI. By the
end of PY 2019 we discontinued
populating data in the HICN fields.
However, when we made this
operational update we did not make
conforming changes to the regulations
text at § 425.702(c)(1)(ii)(A) to revise the
list of the four data elements we provide
to ACOs on their fee-for-service
beneficiary population: (1) beneficiary
name; (2) date of birth; (3) HICN; and (4)
sex. Therefore, because CMS has
discontinued use of the HICN, we
propose to revise
§ 425.702(c)(1)(ii)(A)(3) to refer to
‘‘Beneficiary identifier’’ instead of
‘‘Health Insurance Claim Number
(HICN).’’ This change to the regulations
text will not change the information that
is provided to ACOs pursuant to
§ 425.702(c)(1)(ii).
Further, we propose to revise the list
of purposes in § 425.702(c)(1)(ii) for
which an ACO may request certain
beneficiary-identifiable data for
purposes of population-based activities
to better align with the terminology
used in the first paragraph of the
definition of health care operations at 45
CFR 164.501. Specifically, we propose
to remove the reference to ‘‘process
development’’ and to add in its place a
reference to ‘‘protocol development.’’ In
prior rulemaking, we indicated that
ACOs could request beneficiaryidentifiable data under
§ 425.702(c)(1)(ii) for purposes of
carrying out population-based activities,
including process development, and
referred to care coordination processes
and required process development
under § 425.112 (see 80 FR 32734 and
32735). We do not believe the revision
we are proposing would impact ACOs’
ability to request data for these types of
process development. Rather, activities
related to care coordination processes
and the development of required
processes under § 425.112 would
continue to fall within the populationbased activities listed in
§ 425.702(c)(1)(ii) for which an ACO
may request data, including protocol
development (as added by this proposed
revision) and care coordination. This
proposed revision would also ensure
that the terminology used in
§ 425.702(c)(1)(ii) is consistent with the
language of the proposed new provision
at § 425.702(c)(1)(iii) discussed in
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section III.G.2.b.(2) of this proposed
rule.
We seek comment on these proposed
changes.
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8. Seeking Comments on Potential
Future Developments to Shared Savings
Program Policies
a. Background
In an article published on the New
England Journal of Medicine’s website
on April 27, 2022,210 CMS lays out a
vision for how Accountable Care
Organizations (ACOs) participating in
the Shared Savings Program and in
Center for Medicare and Medicaid
Innovation (Innovation Center) models
can help CMS achieve its goal of having
all beneficiaries in the traditional
Medicare program cared for by health
care providers who are accountable for
costs and quality of care by 2030. This
article describes a vision for the Shared
Savings Program and new Innovation
Center models to expand participation
in ACOs, strengthen incentives for
savings for participants and for
Medicare, and make access to ACOs
more equitable, including: (1) aligning
features of new Center for Medicare and
Medicaid Innovation (Innovation
Center) models and features in the
Shared Savings Program; (2) adopting
lessons from the ACO Investment Model
to help provide upfront investments for
small ACOs that lack experience with
performance-based risk; (3) examining
benchmarking approaches that could
support increased participation,
including among organizations serving
patients with high costs of care and
address the effects of rebasing and
regional benchmark adjustments; and
(4) examining the use of incentives to
recruit health care providers that care
for underserved populations to join
ACOs, with the goal of closing gaps in
outcomes, and asking health care
providers to consider beneficiaries’
social needs in care plans.
CMS adopted several policies as part
of the CY 2023 PFS final rule to advance
these goals, including providing
advance shared savings payments in the
form of advance investment payments to
certain new, low-revenue ACOs that
they can use to build the infrastructure
needed to succeed in the Shared
Savings Program and promote equity by
holistically addressing beneficiary
needs, including social needs;
reinstating a sliding scale reflecting an
ACO’s quality performance for use in
210 Jacobs D, Rawal P, Fowler L, Seshamani M.
Expanding Accountable Care’s Reach among
Medicare Beneficiaries. NEJM.org, April 27, 2022,
available at https://www.nejm.org/doi/full/10.1056/
NEJMp2202991.
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determining shared savings for ACOs
and shared losses for ENHANCED track
ACOs; modifying the benchmarking
methodology to strengthen financial
incentives for long-term participation by
reducing the impact of ACOs’
performance and market penetration on
their benchmarks; support the business
case for ACOs serving high-risk and a
high proportion of dually eligible
populations to participate; and mitigate
bias in regional expenditure
calculations for ACOs electing
prospective assignment; and expanding
opportunities for certain low-revenue
ACOs participating in the BASIC track
to share in savings.
CMS has also continued to receive
significant input from interested parties
regarding opportunities to increase
participation in ACO initiatives. One
such option would be to identify ways
that the Shared Savings Program can
support ACOs’ efforts to strengthen
primary care, such as by providing
prospective payments for primary care
that would reduce reliance on fee-forservice payments and support
innovations in care delivery that better
meet beneficiary needs and increase
access to primary care in underserved
communities. Empirical data support
the notion that primary care serves as
the foundation of high-performing
ACOs. ACO performance results have
indicated that ACOs comprised of 75
percent or more of primary care
clinicians share in savings at almost
twice the rate of those ACOs comprised
of less than 75 percent primary care
clinicians.211 Another option would be
to offer a higher risk track in the Shared
Savings Program, on which CMS
requests input below.
b. Incorporating a Higher Risk Track
Than the ENHANCED Track
Over time, CMS has considered a
higher risk Shared Savings Program
track under which the shared savings/
loss rate would be somewhere between
80 percent and 100 percent (that is, a
rate higher than that currently offered
under the ENHANCED track) that builds
on the experience of the Next
Generation ACO (NGACO) and ACO
Realizing Equity, Access, and
Community Health (ACO REACH)
Models. ‘‘Higher risk’’ sharing provides
a higher level of potential reward which
may encourage ACOs that would not
otherwise have participated in the
211 Refer to ‘‘Medicare Shared Savings Program
Saves Medicare More Than $1.6 Billion in 2021 and
Continues to Deliver High-quality Care’’—As of
August 30, 2022, available at https://www.cms.gov/
newsroom/press-releases/medicare-shared-savingsprogram-saves-medicare-more-16-billion-2021-andcontinues-deliver-high.
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Shared Savings Program because of
current limitations on potential upside
to consider participating. Also, a higher
risk sharing model may incentivize
participating ACOs to take on more risk
(and potential reward) and incentivize
ACOs to improve performance in the
program, which may result in reduced
healthcare costs for Medicare, and more
effective, efficient care for beneficiaries.
In addition, higher risk sharing may
incentivize ACOs to develop new care
delivery strategies, such as a focus on
specialty care integration and reduced
care fragmentation. Offering a higher
risk sharing track may also help CMS
reach our goal of having all beneficiaries
in the traditional Medicare program in
a care relationship with a health care
provider who is accountable for the
costs and quality of their care by 2030
by encouraging efficient ACOs to
continue participation in the Shared
Savings Program.
Currently, under the Shared Savings
Program, ACOs may enter participation
agreements under one of two tracks—
the BASIC track or the ENHANCED
track. The BASIC track allows eligible
ACOs to begin under a one-sided model
and incrementally transition to higher
levels of risk and potential reward
through the BASIC track’s glide path.
The ENHANCED track is a two-sided
model that represents the highest level
of risk and potential reward currently
offered under the Shared Savings
Program. The rules governing the
participation options available to ACOs
and the progression from lower to
higher risk for ACOs entering the
program are described in § 425.600 of
the regulations.
Under the BASIC track, eligible ACOs
operate under either a one-sided model
or a two-sided model, either sharing
savings only or sharing both savings and
losses with the Medicare program.
Under the BASIC track’s glide path, the
level of risk and potential reward phases
in over the course of an agreement
period with the ACO beginning
participation under a one-sided model
and progressing to incrementally higher
levels of risk and potential reward,
unless the ACO chooses to begin under
a two-sided model and/or progress more
quickly than the glide path would
require.212 The glide path includes five
levels (Levels A through E). Levels A
and B are one-sided models (shared
savings only); 213 and Levels C, D, and
E are two-sided models (shared savings
and shared losses) that provide for
212 Refer
to § 425.600(a)(4)(i).
to §§ 425.600(a)(4)(i)(A)(1),
425.605(d)(1)(i) (Level A); §§ 425.600(a)(4)(i)(A)(2),
425.605(d)(1)(ii) (Level B).
213 Refer
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incrementally higher performance-based
risk.214 An ACO in the ENHANCED
track operates under a two-sided model,
sharing both savings and losses with the
Medicare program, for all 5 performance
years of the agreement period.
To qualify for a shared savings
payment, an ACO must meet a
minimum savings rate (MSR)
requirement, meet the quality
performance standard or alternative
quality performance standard
established under § 425.512, and
otherwise maintain its eligibility to
participate in the Shared Savings
Program under 42 CFR part 425.215 For
ACOs meeting the applicable quality
performance standard established under
§ 425.512(a)(2) or § 425.512(a)(4)(i) (for
PY 2022 and PY 2023) or
§ 425.512(a)(5)(i) (for PY 2024 and
subsequent performance years), the final
shared savings rate is equal to the
maximum sharing rate specific to the
ACO’s track/level of participation as
follows: 40 percent for ACOs
participating in Level A or Level B of
the BASIC track,216 50 percent for ACOs
participating in Levels C, D, or E of the
BASIC track,217 and 75 percent for
ACOs participating in the ENHANCED
track.218 Beginning in PY 2023, ACOs
meeting the MSR requirement that do
not meet the applicable quality
performance standard established under
§ 425.512(a)(2) or § 425.512(a)(4)(i) or
§ 425.512(a)(5)(i), as applicable, but
meet the alternative quality performance
standard described in § 425.512(a)(4)(ii)
(for PY 2023) or § 425.512(a)(5)(ii) (for
PY 2024 and subsequent performance
years) will have the opportunity to share
in savings at a lower rate that is scaled
by the ACO’s quality performance.
Additionally, beginning in PY 2024,
certain ACOs participating in the BASIC
track that do not meet the MSR have the
opportunity to share in savings at a rate
that is equal to half of the rate to which
they would have otherwise been
entitled had they met the MSR.219 CMS
computes an ACO’s shared savings
payment by applying the final sharing
rate to the ACO’s savings on a first
dollar basis (meaning the final sharing
rate is applied to the ACO’s full total
savings amount), with the payment
subject to a cap that is equal to 10
214 Refer to §§ 425.600(a)(4)(i)(A)(3),
425.605(d)(1)(iii) (Level C); §§ 425.600(a)(4)(i)(A)(4),
425.605(d)(1)(iv) (Level D); §§ 425.600(a)(4)(i)(A)(5),
425.605(d)(1)(v) (Level E).
215 Refer to §§ 425.100(b), 425.604(c), 425.605(c),
425.606(c), 425.610(c).
216 Refer to § 425.605(d)(1)(i)(A), (d)(1)(ii)(A).
217 Refer to § 425.605(d)(1)(iii)(A), (d)(1)(iv)(A),
(d)(1)(v)(A).
218 Refer to § 425.610(d).
219 Refer to § 425.605(h).
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percent of the updated benchmark for
an ACO in the BASIC track or 20
percent of the updated benchmark for
an ACO in the ENHANCED track.220
ACOs that operate under a two-sided
model and have losses that meet or
exceed a minimum loss rate (MLR) must
share losses with the Medicare
program.221 Once this MLR is met or
exceeded, the ACO will share in losses
at a rate determined according to the
ACO’s track/level of participation, up to
a loss recoupment limit (also referred to
as the loss sharing limit).222 In
determining shared losses, ACOs
participating in Level C, D, or E of the
BASIC track are subject to a fixed shared
loss rate (also referred to as the loss
sharing rate) of 30 percent.223
ENHANCED track ACOs are subject to a
loss rate that is scaled by the ACO’s
quality performance, subject to a
minimum of 40 percent and a maximum
of 75 percent.224
For agreement periods beginning
before January 1, 2024, certain ACOs
were only allowed to enter the program
in the ENHANCED track, and ACOs
entering the program in the BASIC track
were limited in how many agreement
periods they could participate in the
BASIC track before being required to
transition to the ENHANCED track.
Based on changes finalized in the CY
2023 PFS final rule, for agreement
periods starting on January 1, 2024, and
in subsequent years, participation in the
ENHANCED track will be optional (see
87 FR 69818).
In the NGACO Model, NGACOs were
offered the choice between two risk
arrangements, partial risk or full risk.
Under both arrangements, the NGACO
was responsible for 100 percent of
performance year expenditures, for
services rendered to the NGACO’s
aligned beneficiaries.225 Under the
220 Refer
to § 425.605(d); § 425.610(e).
to § 425.100(c).
222 Refer to § 425.605(d); § 425.610(f), (g).
223 Refer to § 425.605(d)(1)(iii)(C), (d)(1)(iv)(C),
(d)(1)(v)(C).
224 Refer to § 425.610(f).
225 In 2020, due to the impacts of the COVID–19
pandemic, NGACOs were offered an optional
amendment to the Participation Agreement (PA) for
2020 (PY5). For NGACOs that signed the
amendment, CMS removed all beneficiary
experience associated with COVID–19 related
admissions and retrospectively updated the
prospective trend with a regional observed trend.
For 2021, CMS modified the NGACO financial
methodology to provide financial protection to all
NGACOs continuing in the model for PY6. PY6
financial protections included: adoption of an
extreme and uncontrollable circumstances policy,
under which any shared losses were prorated based
on the number of months during the PHE and the
number of beneficiaries residing in an impacted
area, and all expenses associated with COVID–19
related admissions were removed from both PY
expenditures and retrospective trend.
221 Refer
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52493
partial risk arrangement, the NGACO
could receive or owe up to 80 percent
of savings/losses, whereas under the full
risk arrangement, the NGACO could
receive or owe up to 100 percent of
savings/losses. To mitigate the ACO’s
risk of large shared losses, as well as to
protect the Medicare Trust Funds
against paying out excessive shared
savings, NGACOs were required to
choose a cap on gross savings/losses.
The cap, expressed as a percentage of
the benchmark, ranged from 5 percent to
15 percent. The risk arrangement chosen
by the NGACO (80 or 100 percent) was
applied to gross savings or losses after
the application of the cap. In PYs 1–3,
a discount was applied to the NGACO’s
benchmark that was set at a standard 3
percent, with various adjustments, that
allowed the final discount to vary from
0.5 percent to 4.5 percent. In PYs 4–6,
a discount of 0.5 percent was applied to
the benchmark under the partial risk
arrangement, and a discount of 1.25 was
applied to the benchmark under the full
risk arrangement. The purpose of the
discount was to ensure that CMS
received a financial benefit from any
savings achieved by the NGACOs
participating in the model.
Under the ACO REACH Model,
REACH ACOs are offered the choice of
participating under the Global or the
Professional Risk Options. As in the
NGACO Model, under both risk sharing
options, the ACO REACH ACO is
responsible for 100 percent of
performance year expenditures for
services rendered to aligned
beneficiaries. Because ACOs electing the
Global Risk Option retain up to 100
percent of the savings/losses, a discount
is applied to the benchmark to ensure
savings are also generated for CMS.
Consequently, for ACOs in the Global
Risk Option, the benchmark is reduced
by a fixed percentage based on the
performance year.226 The benchmark for
ACOs participating in the Professional
Option does not include this discount,
and these ACOs are only eligible to
retain 50 percent of savings or owe 50
percent of any losses.
When considering including a higher
risk track in the Shared Savings
Program, we must balance several
factors to protect beneficiaries, ACOs,
and the Medicare trust funds. One factor
to consider is that there may be selective
participation with regard to which
ACOs would choose to participate in a
226 For more details, refer to CMS, ACO Realizing
Equity, Access, and Community Health (REACH)
Model, PY2023 Financial Settlement Overview,
available at: https://innovation.cms.gov/media/
document/aco-reach-py2023-fncl-settlement (see
Table 4: Schedule of Discounts by Risk
Arrangement).
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higher risk track, if offered. For
example, Shared Savings Program ACOs
that have a history of high levels of
shared savings or have received a
favorable high regional adjustment to
their benchmark may be more likely
than other ACOs to switch to the higher
risk track upon renewing or early
renewing their participation in the
program so they can receive additional
benefit from the higher levels of
potential reward offered in a higher risk
track. Section 1899(i)(3) of the Act,
grants the Secretary the authority to use
other payment models, if the Secretary
determines that doing so would improve
the quality and efficiency of items and
services furnished under Medicare and
the alternative methodology would
result in program expenditures equal to
or lower than those that would result
under the statutory payment model
under section 1899(d). We have
concerns that introducing a higher risk
track would lead to only select ACOs
participating, creating benefits limited
almost entirely to those ACOs and
limited to no benefits gained for
beneficiaries or CMS.
Another consideration is that ACOs in
a higher risk track could have an
increased incentive (relative to existing
Shared Savings Program risk models) to
avoid high-cost beneficiaries in the
performance year in order to maximize
their potential shared savings payment
or avoid or reduce potential shared
losses. The Shared Savings Program
truncates individual beneficiary
expenditures at the 99th percentile of
national Medicare fee-for-service
expenditures by enrollment type, which
can help to protect ACOs from the
impact of expenditure outliers (i.e.,
prevent a small number of extremely
costly beneficiaries from significantly
affecting the ACO’s per capita
expenditures) and reduce the incentive
for ACOs to avoid high-cost
beneficiaries. As described earlier in
this section of this proposed rule, the
Shared Savings Program also caps the
amount of shared savings an ACO may
receive or the amount of shared losses
it may owe, which can further
discourage beneficiary selection. If
introducing a higher risk-track to the
program, we would need to consider
whether the program’s existing
approach to expenditure truncation and
capping shared savings and shared
losses would be sufficient in curbing
incentives for ACOs to engage in
beneficiary selection in light of the
higher potential risk and reward, while
ensuring that the new risk model will
still be attractive to ACOs and improve
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the quality and efficiency of the care
their assigned beneficiaries receive.
When considering a higher risk track,
CMS would need to balance the
incentives for ACOs to transition to
higher levels of risk and potential
reward only when they are very
confident it is in their financial interest
to do so, with the benefits of increasing
ACO participation in the Shared
Savings Program and in two-sided
accountable care tracks, all while
ensuring sufficient financial safeguards
against inappropriately large shared
losses for ACOs coordinating and
improving quality of care for high-cost
beneficiaries. We are seeking comment
on the following: (1) policies/model
design elements that could be
implemented so that a higher risk track
could be offered without increasing
program expenditures; (2) ways to
protect ACOs serving high-risk
beneficiaries from expenditure outliers
and reduce incentives for ACOs to avoid
high-risk beneficiaries; and (3) the
impact that higher sharing rates could
have on care delivery redesign, specialty
integration, and ACO investment in
health care providers and practices.
c. Increasing the Amount of the Prior
Savings Adjustment
Under section 1899(d)(1)(B)(ii) of the
Act, an ACO’s benchmark must be reset
at the start of each agreement period
using the most recent available 3 years
of expenditures for Parts A and B
services for beneficiaries assigned to the
ACO. Section 1899(d)(1)(B)(ii) of the Act
provides the Secretary with discretion
to adjust the historical benchmark by
‘‘such other factors as the Secretary
determines appropriate.’’ Pursuant to
this authority, as described in the CY
2023 PFS final rule (87 FR 69898
through 69915), we established a prior
savings adjustment that will apply when
establishing the benchmark for eligible
ACOs entering an agreement period
beginning on January 1, 2024, or in
subsequent years, to account for the
average per capita amount of savings
generated during the ACO’s prior
agreement period.
The prior savings adjustment adopted
in the CY 2023 PFS final rule is
designed to adjust an ACO’s benchmark
to account for the average per capita
amount of savings generated by the ACO
across the 3 performance years prior to
the start of its current agreement period
for re-entering and renewing ACOs. In
the final rule, we explained that
reinstituting a prior savings adjustment
would be broadly in line with our
interest in addressing dynamics to
ensure sustainability of the
benchmarking methodology.
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Specifically, such an adjustment would
help to mitigate the rebasing ratchet
effect on an ACO’s benchmark by
returning to an ACO’s benchmark an
amount that reflects its success in
lowering growth in expenditures while
meeting the program’s quality
performance standard in the
performance years corresponding to the
benchmark years for the ACO’s new
agreement period. We also explained
our belief that a prior savings
adjustment could help address an
ACO’s effects on expenditures in its
regional service area that result in
reducing the regional adjustment added
to the historical benchmark.
In the CY 2023 PFS final rule (87 FR
69899), we explained that, in order to
mitigate the potential for rebased
benchmarks for ACOs that are lowerspending compared with their regional
service area and that achieved savings
in the benchmark period to become
overinflated, we believed that adjusting
an ACO’s benchmark based on the
higher of either the prior savings
adjustment or the ACO’s positive
regional adjustment would be
appropriate. We also note that
elsewhere in this proposed rule, we
have proposed to further mitigate the
impacts of the negative regional
adjustment when the overall adjustment
to an ACO’s historical benchmark is
negative; however, the negative regional
adjustments by enrollment type would
continue to be factored in when the
overall regional adjustment is positive.
In the CY 2023 PFS final rule (87 FR
69902), we finalized a policy to apply a
50 percent scaling factor to the pro-rated
positive average per capita prior savings
because we believed it would be
important to consider a measure of the
sharing rate used in determining the
shared savings payment the ACO earned
in the applicable performance years
under its prior agreement period(s). In
response to discussion of this policy in
the CY 2023 PFS proposed rule, ACOs
and other interested parties commented
that we should consider using a higher
scaling factor that may more closely
match the maximum shared savings rate
from an ACO’s prior agreement period.
However, in the CY 2023 PFS final rule,
we reiterated our belief that a 50 percent
scaling factor would be appropriate
because it represents a middle ground
between the maximum sharing rate of
75 percent under the ENHANCED track
and the lower sharing rates available
under the BASIC track (e.g., 40 percent).
Additionally, we noted that if we were
to finalize a scaling factor that would
more closely match the average shared
savings rate from an ACO’s prior
agreement period, many ACOs would
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have a scaling factor below 50 percent,
which would be less advantageous than
the policy that we finalized.
In the CY 2023 PFS final rule (87 FR
69902), we also finalized a policy to
calculate the final adjustment to the
benchmark by adding the pro-rated
average per capita prior savings to the
ACO’s negative regional adjustment for
ACOs that are higher spending relative
to their regional service area. Under this
policy, we apply the 50 percent scaling
factor after offsetting the negative
regional adjustment to maximize the
portion of the pro-rated average per
capita savings that would be added to
the negative regional adjustment in
determining the final adjustment to the
benchmark and strengthen incentives
for ACOs to remain in the program.
MedPAC commented on the CY 2023
PFS proposed rule that while the prior
savings adjustment is a reasonable
policy for mitigating ratcheting effects,
implementing both the prior savings
adjustment and the regional adjustment
policies together would be duplicative.
MedPAC also expressed concern that
the prior savings adjustment and the
regional adjustment could interact in a
way that would perpetuate a
programmatic bias towards ACOs
receiving a positive regional adjustment.
In MedPAC’s view, many ACOs would
receive an inflated prior savings
adjustment because the prior savings
adjustment would be based on savings
achieved using benchmarks already
inflated by the regional adjustment.
However, we explained in the CY 2023
PFS final rule (87 FR 69913) that
because for most ACOs, the positive
regional adjustment would exceed the
prior savings adjustment, our policy of
applying the larger of the regional
adjustment and the prior savings
adjustment potentially mitigates this
concern.
We are seeking comment on potential
changes to the 50 percent scaling factor
used in determining the prior savings
adjustment such as using an average of
the ACO’s shared savings rates from the
3 years prior to the start of its agreement
period, increasing to 75 percent of
shared savings achieved if the ACO
participated in the ENHANCED track in
the 3 years prior to the start of the
agreement period, or another value
corresponding to the maximum shared
savings rate the ACO was eligible to
earn in the 3 years prior to the start of
the agreement period. We are also
seeking comment on potential changes
to the positive regional adjustment to
reduce the possibility of inflating the
benchmark while still mitigating
potential ratchet effects on ACO
benchmarks.
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d. Expanding the ACPT Over Time and
Addressing Overall Market-Wide
Ratchet Effects
As described in the December 2018
final rule (83 FR 68024 through 68030),
we used our statutory authority under
section 1899(i)(3) of the Act to adopt the
policy under which we update the
historical benchmark using a blend of
national and regional growth rates. In
accordance with § 425.601(b), for
agreement periods beginning on July 1,
2019, and before January 1, 2024, we
update the historical benchmark for an
ACO for each performance year using a
blend of national and regional growth
rates between BY3 and the performance
year.
In the CY 2023 PFS final rule (87 FR
69902), we finalized a policy for
agreement periods beginning on January
1, 2024, and in subsequent years to
incorporate a prospectively projected
administrative growth factor, a variant
of the United States Per Capita Cost
(USPCC) that we refer to as the
Accountable Care Prospective Trend
(ACPT), into a ‘‘three-way’’ blend with
national and regional growth rates to
update an ACO’s historical benchmark
for each performance year in the ACO’s
agreement period. The three-way blend
is calculated as the weighted average of
the ACPT (one-third weight) and the
existing national-regional ‘‘two-way’’
blend (two-thirds weight). The ACPT
will be projected for an ACO’s entire
agreement period near the start of that
agreement period, providing a degree of
certainty to ACOs.
We explained in the CY 2023 PFS
final rule that the ACPT will insulate a
portion of the annual benchmark update
from any savings occurring as a result of
the actions of ACOs participating in the
Shared Savings Program and address the
impact of increasing market penetration
by ACOs in a regional service area on
the existing blended national-regional
growth factor. Because the ACPT is
prospectively set at the outset of an
agreement period, any savings generated
by ACOs during the agreement period
would not be reflected in the ACPT
component of the three-way blend.
Accordingly, incorporation of the ACPT
may allow benchmarks to increase
beyond actual spending growth rates as
ACOs slow spending growth. By
limiting ACOs’ ability to slow spending
growth for purposes of their own
benchmarks, we noted that we believed
the use of this three-way blend to
update ACOs’ benchmarks would
incentivize greater savings by ACOs and
greater program participation.
Additionally, because incorporating the
ACPT into the update would reduce the
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52495
degree to which an ACO’s savings
negatively impact its benchmark
through the regional trend component of
the update, we also stated our belief that
this change to the update methodology
would help to address concerns raised
by ACOs and other interested parties
regarding the disproportionate impact of
an ACO’s savings on the benchmark
update for ACOs with high market
share.
In the final rule, we noted that it was
possible that incorporating the ACPT
into a three-way blended update factor
would have the potential for mixed
effects. For example, it may also lower
an ACO’s benchmark relative to the twoway blend if external factors lead to
higher program spending growth than
originally projected at the start of an
ACO’s agreement period. Consequently,
we finalized that if an ACO generates
losses for a performance year that meet
or exceed its MLR (for two-sided model
ACOs) or negative MSR (for one-sided
model ACOs) under the three-way
blend, we would recalculate the ACO’s
updated benchmark using the two-way
blend and the ACO would receive
whichever benchmark update
minimizes shared losses. However, the
ACO would not be eligible to share in
savings resulting from use of the twoway blend in updating the benchmark.
We also finalized that if unforeseen
circumstances such as an economic
recession, pandemic, or other factors
cause actual expenditure trends to
significantly deviate from projections,
we would retain discretion to decrease
the weight applied to the ACPT in the
three-way blend.
In their comments on the proposal to
adopt the three-way blend in the CY
2023 PFS proposed rule, ACOs and
other interested parties expressed
concern that the three-way blend
effectively increases the proportion of
the benchmark update that is based
upon national trends, as opposed to
regional trends, noting that the blend
may not adequately account for
geographic variation in spending growth
that is outside of an ACO’s control. Over
a 5-year agreement period, we recognize
some ACOs may be disadvantaged or
advantaged in the short term by
benchmark updates that give greater
weight to a national update factor.
However, as we stated in the CY 2023
PFS final rule (87 FR 69891), we believe
that the net impact of these deviations
will be modest in the context of
offsetting considerations. For example,
the three-way blend only incorporates
the ACPT at a one-third weight and
maintains the current two-way blend for
the majority weight of the benchmark
trend calculation, allowing for a
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significant proportion of the benchmark
update to reflect expenditure growth in
an ACO’s regional service area. The
ACPT itself is also expected to project
spending above realized spending as
ACOs generate savings, thereby
providing a stable, predictable
component of the update factor that will
be beneficial for ACOs.
Interested parties who commented on
the proposal in the CY 2023 PFS
proposed rule to incorporate the ACPT
as part of a three-way blend suggested
modifications to the three-way blend to
further mitigate potential ratchet effects
and to better reflect regional variation in
spending. These included modifications
such as: (1) keeping a two-way nationalregional blend and substituting the
national component of the two-way
blend with the ACPT (see 87 FR 69890);
and (2) adjusting the weight of the
ACPT in the three-way blend to reflect
each ACO’s market penetration, as is
done with the national component of
the two-way blend (see 87 FR 69893).
CMS declined to implement these
suggestions in the CY 2023 PFS final
rule.
We seek comment on the following
potential refinements to the ACPT and
the three-way blended benchmark
update factor as CMS works toward
broad implementation of administrative
benchmarks: (1) replacing the national
component of the two-way blend with
the ACPT; and (2) scaling the weight
given to the ACPT in a two-way blend
for each ACO based on the collective
market share of multiple ACOs within
the ACO’s regional service area.
e. Promoting ACO and CBO
Collaboration
Section 1899(b)(2)(G) of the Act
requires an ACO to define processes to
promote evidence-based medicine and
patient engagement; report on quality
and cost measures; and coordinate care,
such as through the use of telehealth,
remote patient monitoring, and other
enabling technologies. In the November
2011 final rule (76 FR 67827), we
finalized policies to require that a
participating Shared Savings Program
ACO provide documentation in its
application describing its plans to: (1)
promote evidence-based medicine; (2)
promote beneficiary engagement; (3)
report internally on quality and cost
metrics; and (4) coordinate care. We
emphasized our belief that ACOs should
retain the flexibility to establish
processes that are best suited to their
practice and patient population. As part
of these required processes, we
explained that ACOs should adopt a
focus on patient-centeredness, which
could include such activities as: a
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process for evaluating the needs of the
ACO’s population, including
consideration of diversity in its patient
populations, and a plan to address the
needs of this population, including how
the ACO intends to partner with other
interested parties in the community to
improve the health of its population; a
plan to engage in shared decision
making with beneficiaries; and a plan to
implement individualized care plans,
including taking into account the
community resources available to the
individual beneficiary.
When establishing these required
processes and patient centeredness
criteria in the November 2011 final rule
(76 FR 67826), we stated that as we
learn more about successful strategies in
these areas, and as we gain more
experience assessing specific critical
elements for success, the Shared
Savings Program eligibility
requirements under section
1899(b)(2)(G) of the Act may be revised.
For example, in subsequent rules we
underscored the importance of health
information technology development
and infrastructure within care
coordination. In the June 2015 final
rule, we finalized two modifications to
the care coordination processes required
of ACOs under § 425.112(b)(4): (1)
adding a new eligibility requirement
under § 425.112(b)(4)(ii)(C), which
required an ACO to describe in its
application how it will encourage and
promote the use of enabling
technologies for improving care
coordination for beneficiaries, and (2)
adding a new provision at
§ 425.112(b)(4)(ii)(D), which required
the applicant to describe how the ACO
intends to partner with long-term and
post-acute care providers to improve
care coordination for the ACO’s
assigned beneficiaries (80 FR 32725). In
the CY 2018 PFS final rule (82 FR
53222), we shifted from requiring an
ACO to submit documents detailing
how it would meet the requirements of
§ 425.112 as a narrative in its Shared
Savings Program application to instead
requiring it to certify at the time of
application that it has defined the
required processes and patient
centeredness criteria consistent with the
requirements specified in section
§ 425.112 and to furnish such
documentation upon request—thereby
reducing ACO burden while
maintaining CMS’s flexibility to obtain
additional documentation when
necessary (see § 425.204(c)(ii)).
Additionally, in previous rulemaking
(80 FR 32722), we specified that the care
coordination processes under § 425.112
could include coordination with CBOs
that provide services that address social
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determinants of health. This
coordination could include a plan to
partner with interested parties of the
community, a plan to engage in shared
decision making with beneficiaries, and
a plan to implement individualized care
plans. In that rulemaking (80 FR 32722),
we also confirmed our understanding
that ACOs differ in their ability to adopt
the appropriate health information
exchange technologies, but we
continued to underscore the importance
of robust health information exchange
tools in effective care coordination.
We are seeking comment on ways to
improve and incentivize collaboration
between ACOs and interested parties in
the community or CBOs. As explained
in the CY 2023 PFS final rule (87 FR
69790), where we refer to CBOs, 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, or other non-profits
that apply for grants to perform social
services. They may receive grants from
other agencies in the U.S. Department of
Health and Human Services, including
Federal grants administered by the
Administration for Children and
Families (ACF), Administration for
Community Living (ACL), or the Centers
for Disease Control, or from Statefunded grants to provide social services.
Generally, we believe such
organizations are trusted entities that
know the populations they serve and
their communities, want to be engaged,
and may have the infrastructure or
systems in place to help coordinate
supportive services that address social
determinants of health or serve as a
trusted source to share information.227
We recognize that ACOs wishing to
address social needs may want to make
investments in goods or social services
that would enable their ACO
participants and ACO providers/
suppliers to work with CBOs that have
expertise in identifying and providing
the types of social services that the
ACO’s beneficiary population requires.
It is important to note that the Shared
Savings Program does not prohibit
ACOs from partnering with CBOs.
Currently, if a CBO is enrolled in
Medicare, it may already be an ACO
participant or an ACO provider/
supplier. We believe CBOs could play
227 U.S. Department of Health & Human Services,
Office of the Assistant Secretary for Preparedness
and Response, Community-Based Organizations
during COVID–19, available at https://
www.phe.gov/emergency/events/COVID19/atrisk/
returning-to-work/Pages/default.aspx.
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an important role in identifying and
addressing gaps in health equity. As we
stated in the CY 2023 PFS final rule, we
hope to encourage more ACOs to
partner with CBOs whether they
provide items and services reimbursed
by Medicare or not. We recognized that
Federal and other sources of grant
funding for social services may be
insufficient to fully address the demand
for services within a community or
broader geography. As we noted in that
final rule, contractual arrangements
between the health care sector and
CBOs providing social services have
increased in recent years to meet this
demand.
We are seeking comment on
approaches, generally, for encouraging
or incentivizing increased collaboration
between ACOs and CBOs, including any
policies specifically designed to
encourage ACOs to partner with CBOs
and address unmet health-related social
needs. We are also seeking comment on
potential changes CMS could make to
the patient-centered care requirements
in § 425.112 to strengthen partnerships
between ACOs and interested parties in
the community, including CBOs, to
address unmet health-related social
needs.
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H. Medicare Part B Payment for
Preventive Vaccine Administration
Services (§§ 410.10, 410.57, 410.152)
1. Statutory Background
Under section 1861(s)(10) of the Act,
Medicare Part B currently covers both
the vaccine and vaccine administration
for the specified preventive vaccines—
the pneumococcal, influenza, hepatitis
B and COVID–19 vaccines. Section
1861(s)(10)(B) of the Act specifies that
the hepatitis B vaccine and its
administration is only covered for those
who are at high or intermediate risk of
contracting hepatitis B, as defined at
§ 410.63. Under sections 1833(a)(1)(B)
and (b)(1) of the Act, respectively, there
is no applicable beneficiary
coinsurance, and the annual Part B
deductible does not apply for these
vaccines or the services to administer
them. Per section 1842(o)(1)(A)(iv) of
the Act, payment for these vaccines is
based on 95 percent of the Average
Wholesale Price (AWP) for the vaccine
product, except where furnished in the
settings for which payment is based on
reasonable cost, such as a hospital
outpatient department (HOPD), rural
health clinic (RHC), or Federally
qualified health center (FQHC). Some
other preventive vaccines, such as the
zoster vaccine for the prevention of
shingles, not specified for Medicare Part
B coverage under section 1861(s)(10) of
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the Act are instead covered and paid for
under Medicare Part D.
of publication of the CY 2024 PFS final
rule.
2. Medicare Part B Payment for the
Administration of Preventive Vaccines
b. COVID–19 Vaccine Administration
In the CY 2022 PFS final rule (86 FR
65181 and 65182), we provide a detailed
history regarding the determinations of
the initial payment rates for the
administration of the COVID–19
vaccines, and how the payment policy
evolved to a rate of $40 per dose. We
note that in the CY 2022 PFS proposed
rule (86 FR 39220 through 39224), we
included a comment solicitation
requesting information that specifically
identifies the resource costs and inputs
that should be considered when
determining payment rates for
preventive vaccine administration. As
part of the comment solicitation, we
requested feedback specifically related
to the circumstances and costs
associated with furnishing COVID–19
vaccines, in order to ensure that we took
these into consideration when
determining our payment policy. In the
CY 2022 PFS final rule (86 FR 65185),
we stated that, after consideration of all
the comments received, it was
appropriate to establish a single,
consistent payment rate for the
administration of all four Part B
preventive vaccines in the long term,
but to pay a higher, $40 payment rate for
administration of COVID–19 vaccines in
the short term, while pandemic
conditions persisted (86 FR 65185).
In the CY 2023 PFS final rule (87 FR
69988 through 69993), we stated that in
light of the timing distinctions between
a PHE declared under section 319 of the
Public Health Service (PHS) Act and an
Emergency Use Authorization (EUA)
declaration under section 564 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), we reconsidered the
policies finalized in the CY 2022 PFS
final rule in light of our goal to promote
broad and timely access to COVID–19
vaccines. We explained that our goal
would be better served if our policies
with respect to payment for these
products, as addressed in the November
2020 IFC and CY 2022 PFS final rule,
continue until the EUA declaration for
drugs and biological products with
respect to COVID–19 (see 85 FR 18250)
is terminated. Therefore, we finalized
that we would maintain the current
payment rate of $40 per dose for the
administration of COVID–19 vaccines
through the end of the calendar year in
which the March 27, 2020 EUA
declaration under section 564 of the
FD&C Act (EUA declaration) for drugs
and biological products ends. Effective
January 1 of the year following the year
in which the EUA declaration ends, the
COVID–19 vaccine administration
a. Pneumococcal, Influenza and
Hepatitis B Vaccine Administration
In the CY 2022 PFS final rule (86 FR
65186), we finalized a uniform payment
rate of $30 for the administration of a
pneumococcal, influenza or hepatitis B
vaccine covered under the Medicare
Part B preventive vaccine benefit. We
explained that since the administration
of the preventive vaccines described
under section 1861(s)(10) of the Act are
finalized independent of the PFS, these
payment rates will be updated as
necessary, independent of the valuation
of any specific codes under the PFS.
(Please see COVID–19 vaccine
administration payment information in
the next section.) The CY 2022 PFS final
rule (86 FR 65180 through 65182)
provides a detailed discussion on the
history of the valuation of the three
Level II Healthcare Common Procedure
Coding System (HCPCS) codes, G0008,
G0009, and G0010, which describes the
services to administer an influenza,
pneumococcal, and hepatitis B vaccine,
respectively.
In the CY 2023 PFS final rule (87 FR
69984), we finalized an annual update
to the payment amount for the
administration of Part B preventive
vaccines based upon the percentage
increase in the Medicare Economic
Index (MEI). Additionally, we finalized
the use of the PFS Geographical
Adjustment Factor (GAF) to adjust the
payment amount to reflect cost
differences for the geographic locality
based upon the fee schedule area where
the preventive vaccine is administered.
These adjustments and updates apply to
HCPCS codes G0008, G0009, G0010,
and to Level I Current Procedural
Terminology (CPT) codes that describe
the service to administer COVID–19
vaccines, which we discuss in the next
section.228
The current payment rates for G0008,
G0009, and G0010, as finalized in the
CY 2023 PFS final rule, can be found on
the CMS Seasonal Influenza Vaccines
Pricing website under Downloads.229
The payment rates for these services
with the annual update applied for CY
2024, will be made available at the time
228 https://www.cms.gov/medicare/medicare-partb-drug-average-sales-price/covid-19-vaccines-andmonoclonal-antibodies.
229 https://www.cms.gov/medicare/medicare-feefor-service-part-b-drugs/
mcrpartbdrugavgsalesprice/vaccinespricing.
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payment would be set at a rate to align
with the payment rate for the
administration of other Part B
preventive vaccines, that is, $30 per
dose. As mentioned above, we also
finalized that, beginning January 1,
2023, we would annually update the
payment amount for the administration
of all Part B preventive vaccines based
upon the percentage increase in the
MEI, and that we would use the PFS
GAF to adjust the payment amount to
reflect cost differences for the
geographic locality based upon the fee
schedule area where the vaccine is
administered.
The current payment rates for the CPT
codes that describe the service to
administer COVID–19 vaccines, as
finalized in the CY 2023 PFS final rule,
can be found on the CMS COVID–19
Vaccines and Monoclonal Antibodies
website.230 The payment rates for these
services with the annual update applied
for CY 2024, will be made available at
the time of publication of the CY 2024
PFS final rule.
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3. In-Home Additional Payment for
Administration of COVID–19 Vaccines
a. Background
In the CY 2022 PFS final rule (86 FR
65187 and 65190), we provide a detailed
discussion on the payment policy for
COVID–19 vaccine administration in the
home. In summary, providers and
suppliers that administer a COVID–19
vaccine in the home, under certain
circumstances, can bill Medicare for one
of the existing COVID–19 vaccine
administration CPT codes 231 along with
HCPCS code M0201 (COVID–19 vaccine
administration inside a patient’s home;
reported only once per individual home
per date of service when only COVID–
19 vaccine administration is performed
at the patient’s home). In CY 2022, the
Medicare Part B payment amount paid
to providers and suppliers
administering a COVID–19 vaccine in
the home was $75.50 dollars per dose
($40 for COVID–19 vaccine
administration and $35.50 for the
additional payment for administration
in the home). These payment amounts
were then geographically adjusted using
PFS GPCIs (as discussed in the CY 2023
PFS final rule at 87 FR 69980 through
69983).
Since announcing the add-on
payment for in-home COVID–19 vaccine
administration in June 2021, we noted
230 https://www.cms.gov/medicare/medicare-partb-drug-average-sales-price/covid-19-vaccines-andmonoclonal-antibodies.
231 https://www.cms.gov/medicare/medicare-partb-drug-average-sales-price/covid-19-vaccines-andmonoclonal-antibodies.
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that we established these policies on a
preliminary basis to ensure access to
COVID–19 vaccines during the public
health emergency and that we would
continue to evaluate the needs of
Medicare patients and these policies. In
the CY 2022 PFS proposed rule (86 FR
39224 through 39226), we included a
comment solicitation to collect feedback
on these policies and potential future
changes. As part of the comment
solicitation, we requested feedback
related to our definition of ‘‘home,’’
program integrity concerns, changes that
we should consider, costs associated
with administering COVID–19 vaccines
in the home, and whether outside of a
PHE there is a need to vaccinate people
in the home rather than going to a
health care provider or supplier. In the
CY 2022 PFS final rule (86 FR 65188
through 65190), we discussed the
feedback received, and we noted that
commenters overwhelmingly
recommended that we continue making
the additional payment for COVID–19
vaccines administered in the home
beyond the end of the PHE. Many
commenters also supported extending
the payment to other preventive
vaccines, either permanently or until
the end of the PHE. Commenters
emphasized the importance of
increasing vaccination rates and making
vaccines available to underserved
homebound beneficiaries who face
barriers including chronic illness,
financial and social precarity, and lack
of access to digital resources. We agreed
with commenters that the added costs
and compelling needs required CMS to
adopt the in-home add-on payment rate
for COVID–19 vaccine administration.
In addition, we stated that since we did
not expect those needs or costs to
diminish immediately with the end of
the PHE, we believed it would be
appropriate to leave the in-home add-on
payment rate in place through the end
of the calendar year in which the PHE
ends. We explained that this extension
of payment past the end of the PHE
would also afford CMS the opportunity
to monitor vaccine uptake data (86 FR
65189). We note that in section III.H.3.c.
of this proposed rule, we are proposing
revisions to § 410.152 that relate to this
payment policy.
In the CY 2023 PFS final rule (87 FR
69984 through 69986), we discussed
that we had received many comments
and requests from interested parties that
the in-home add-on payment be applied
more broadly to all preventive vaccines.
Commenters also expressed concerns
that discontinuation of the in-home
additional payment would negatively
impact access to the COVID–19 vaccine
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for underserved homebound
beneficiaries. We noted that while we
agreed with these concerns, we also
believed that we need to learn more
about the populations served through
the current in-home add-on payment,
and other potential populations that
may not have been able to access a
COVID–19 vaccine despite the
availability of the in-home add-on
payment, in order to understand the
barriers in receiving vaccinations in
their home versus in the community.
We also noted the need to consider
potential program integrity concerns.
Therefore, we finalized that we would
continue the additional payment of
$35.50 when a COVID–19 vaccine is
administered in a beneficiary’s home,
under the certain circumstances
described in section III.H.3.b of the final
rule, only for the duration of CY 2023.
We explained that we were continuing
the additional payment for at-home
COVID–19 vaccinations for another year
in order to provide us time to track
utilization and trends associated with
its use, in order to inform the Part B
preventive vaccine policy on payments
for in-home vaccine administration for
CY 2024.
We also finalized the policy to adjust
this payment amount for geographic
cost differences as we do the payment
for the preventive vaccine
administration service, that is, based
upon the fee schedule area where the
COVID–19 vaccine is administered, by
using the PFS GAF. In addition, we
finalized an update to the $35.50
payment amount by the CY 2023 MEI
percentage increase, consistent with the
policy finalized for the other preventive
vaccine administration services. We
note that in the CY 2023 PFS final rule
(87 FR 69688 through 69710), we
rebased and revised the MEI to a 2017
base year. Therefore, we finalized (87
FR 69986) that for CY 2023, the in-home
additional payment amount for COVID–
19 vaccine administration described by
HCPCS code M0201 was $36.85 ($35.50
× 1.038 = $36.85), and we established
that payment for these services is
adjusted for geographic cost differences
using the relevant PFS GAF. We note
that in section III.H.3.c. of this proposed
rule, we are proposing revisions to
§ 410.152 that relate to these policies.
b. Conditions for Billing HCPCS Code
M0201
In establishing the additional
payment for COVID–19 vaccine
administration in the home, we also
established certain conditions for the
add-on payment described by HCPCS
code M0201. In the CY 2022 PFS final
rule, we provide a detailed discussion
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on how we established the certain
conditions under which the code can be
used, and the situations we
contemplated to arrive at our final
payment policy (86 FR 65187 and
65188).
For purposes of this add-on payment
for in-home COVID–19 vaccine
administration, the following
requirements apply when billing for
HCPCS code M0201: 232 233
• The patient has difficulty leaving
the home to get the vaccine, which
could mean any of these:
++ They have a condition, due to an
illness or injury, that restricts their
ability to leave home without a
supportive device or help from a paid or
unpaid caregiver;
++ They have a condition that makes
them more susceptible to contracting a
pandemic disease like COVID–19; or
++ They are generally unable to leave
the home, and if they do leave home, it
requires a considerable and taxing
effort.
• The patient is hard-to-reach because
they have a disability or face clinical,
socioeconomic, or geographical barriers
to getting a COVID–19 vaccine in
settings other than their home. These
patients face challenges that
significantly reduce their ability to get
vaccinated outside the home, such as
challenges with transportation,
communication, or caregiving.
• The sole purpose of the visit is to
administer the COVID–19 vaccine.
Medicare will not pay the additional
amount if the provider or supplier
furnished another Medicare covered
service in the same home on the same
date.
• A home can be:
++ A private residence, temporary
lodging (for example, a hotel or motel,
campground, hostel, or homeless
shelter);
++ An apartment in an apartment
complex or a unit in an assisted living
facility or group home (including
assisted living facilities participating in
the CDC’s Pharmacy Partnership for
Long-Term Care Program when their
residents are vaccinated through this
program);
++ A patient’s home that is made
provider-based to a hospital during the
PHE for COVID–19; or
++ Communal spaces of a multi-unit
or communal living arrangement.
• A home cannot be:
++ An institution that meets the
requirements of sections 1861(e)(1),
232 https://www.cms.gov/medicare/covid-19/
medicare-covid-19-vaccine-shot-payment.
233 https://www.cms.gov/files/document/vaccinehome.pdf.
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1819(a)(1), or 1919(a)(1) of the Act,
which includes hospitals and skilled
nursing facilities (SNFs), as well as most
nursing facilities under Medicaid.234
The COVID–19 vaccine must be
administered inside an individual’s
home. For this purpose, an individual
unit in a multi-dwelling building is
considered a home. For example, an
individual apartment in an apartment
complex or an individual bedroom
inside an assisted living facility or
group home is considered a home.
HCPCS code M0201, as noted in the
code descriptor, can be billed only once
per individual home per date of service.
Medicare pays the additional payment
amount for up to a maximum of 5
vaccine administration services per
home unit or communal space within a
single group living location; but only
when fewer than 10 Medicare patients
receive a COVID–19 vaccine dose on the
same day at the same group living
location.
c. Proposals for CY 2024 and
Subsequent Years
Over the past several months, CMS
has engaged in an in-depth analysis of
the use of HCPCS billing code M0201,
which specifically indicates that a
COVID–19 vaccine was furnished in the
home on a Medicare claim. The analysis
found that data for in-home COVID–19
vaccinations among Medicare fee-forservice beneficiaries from June 2021 to
June 2022 show the payment code was
used at a disproportionately high rate by
underserved populations, including
persons who are dual eligible for both
Medicare and Medicaid and those of
advanced age. The data reflect that,
between June 2021-June 2022, those 85
years of age and older were over 3 times
more likely than younger beneficiaries
to have received an in-home COVID–19
vaccination, and persons who are dual
eligible for both Medicare and Medicaid
were over 2 times more likely than those
who are not dual eligible to have
received a COVID–19 vaccine provided
in their home. The data also showed
higher usage of the in-home payment
code among those with some common
chronic conditions.235
In light of the results of our study, we
concluded that the in-home additional
payment improved healthcare access to
vaccines for these often-underserved
Medicare populations. From an analysis
of the data, it is clear that the in-home
additional payment is being billed
significantly more frequently for
234 42
CFR 409.42(a).
chronic conditions as identified by
the CMS Chronic Conditions Data Warehouse,
https://www2.ccwdata.org/web/guest/home/.
235 Common
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beneficiaries that are harder to reach
and that may be less likely to otherwise
receive these preventive benefits.
Therefore, we propose to maintain the
in-home additional payment for
COVID–19 vaccine administration
under the Part B preventive vaccine
benefit. In addition, since our statutory
authority at section 1861(s)(10) of the
Act to regulate Part B preventive
vaccine administration is identical for
all four preventive vaccines, and since
the payment has been shown to
positively impact health equity and
healthcare access, we propose to extend
the additional payment to the
administration of the other three
preventive vaccines included in the Part
B preventive vaccine benefit—the
pneumococcal, influenza, and hepatitis
B vaccines. We propose to provide the
additional payment for pneumococcal,
influenza, hepatitis B and COVID–19
vaccine administrations in the home,
when the conditions described in
section III.H.3.b of this proposed rule
are met. We note that several of the
conditions we established for the inhome additional payment, discussed
previously in this section of the
proposed rule, refer specifically to
COVID–19. If we finalize the proposal to
expand the in-home additional payment
to the other preventive vaccines, we
would broaden the conditions for the
payment to reflect preventive vaccines
for the other diseases.
Further, since expanding this policy
could mean that multiple vaccines are
administered during the same visit to
the home, we propose to limit the
additional payment to one payment per
home visit, even if multiple vaccines are
administered during the same home
visit. We emphasize that every vaccine
dose that is furnished would still
receive its own unique vaccine
administration payment. We intend to
continue to monitor utilization of the
M0201 billing code for the in-home
additional payment, and we plan to
revisit the policy should we observe
inappropriate use or abuse of the code.
We propose to modify the regulations at
§ 410.152(h) to reflect these policies.
We seek comment on the policy
condition mentioned in section III.H.3.b
of this proposed rule regarding
Medicare payment of the in-home
additional payment amount for up to a
maximum of 5 vaccine administration
services per home unit or communal
space within a single group living
location, but only when fewer than 10
Medicare patients receive a COVID–19
vaccine dose on the same day at the
same group living location. We invite
feedback on the applicability of this
policy to the proposed policy to make
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the in-home additional payment
available for the administration of all
four Part B preventive vaccines.
If finalized as proposed, the in-home
additional payment for the
administration of pneumococcal,
influenza, and hepatitis B vaccines
would be effective January 1, 2024, to
join the current additional payment for
the in-home administration of COVID–
19 vaccines that is now being extended.
That is, providers and suppliers would
continue to bill Medicare Part B for the
additional payment for the in-home
administration of COVID–19 vaccines,
and beginning January 1, 2024, they
would also be able to bill Medicare Part
B for the in-home administration of
pneumococcal, influenza, and hepatitis
B vaccines. In addition, like the current
in-home additional payment for
COVID–19 vaccine administration, the
proposed in-home additional payment
for the administration of Part B
preventive vaccines that would be
effective beginning for CY 2024, if
finalized, would be geographically
adjusted based on the PFS GAF, and
annually updated by the CY 2024 MEI
percentage increase. For CY 2024, the
proposed growth rate of the 2017-based
MEI is estimated to be 4.5 percent,
based on the IHS Global, Inc. (IGI) first
quarter 2023 forecast with historical
data through fourth quarter 2022.
Therefore, we would multiply the CY
2023 in-home additional payment
amount for Part B preventive vaccine
administration of $36.85 by the
proposed CY 2024 percentage increase
in the MEI of 4.5 percent, which would
result in a proposed CY 2024 in-home
additional payment for Part B
preventive vaccine administration of
$38.51 ($36.85 x 1.045 = $38.51). We are
also proposing that if more recent data
are subsequently available (for example,
a more recent estimate of the MEI
percentage increase), we would use
such data, if appropriate, to determine
the CY 2024 MEI percentage increase in
the CY 2024 PFS final rule; we would
apply that new MEI percentage increase
to update last year’s $36.85 CY 2023 inhome additional payment amount for
Part B preventive vaccine
administration.
Therefore, in this proposed rule, we
propose to amend the Part B payment
for preventive vaccine administration
regulations at § 410.152(h) to reflect the
following:
• Effective January 1, 2022, the
Medicare Part B additional payment
amount paid to providers and suppliers
administering a COVID–19 vaccine in
the home, under certain circumstances,
is $35.50. For COVID–19 vaccines
administered in the home January 1,
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2022 through December 31, 2022, the
additional payment amount under
Medicare Part B is adjusted to reflect
geographic cost variations using the PFS
GPCIs.
• Effective January 1, 2023, the
additional payment amount for the
administration of a COVID–19 vaccine
in the home is annually updated based
upon the percentage change in the MEI.
For COVID–19 vaccines administered in
the home January 1, 2023 through
December 31, 2023, the payment
amount is adjusted to reflect geographic
cost variations using the PFS GAF.
• Effective January 1, 2024, the
payment policy allowing for additional
payment for the administration of a
COVID–19 vaccine in the home would
be extended to include the other three
preventive vaccines included in the Part
B preventive vaccine benefit, and the
payment amount for all four vaccines
would be identical. That is, beginning
January 1, 2024, the Medicare Part B
will pay the same additional payment
amount to providers and suppliers that
administer a pneumococcal, influenza,
hepatitis B, or COVID–19 vaccine in the
home, under certain circumstances.
This additional payment amount would
be annually updated using the
percentage increase in the MEI and
adjusted to reflect geographic cost
variations using the PFS GAF.
We solicit comment on these
proposals and the proposed
amendments to the regulation text.
4. Other Amendments to Regulation
Text
In CY 2023 PFS final rule (87 FR
69987 through 69993), we finalized
changes to our policies regarding Part B
coverage and payment for COVID–19
monoclonal antibody products and their
administration. In that final rule (87 FR
69987), we discussed that all COVID–19
monoclonal antibody products and their
administration are covered and paid for
under the Part B preventive vaccine
benefit through the end of year in which
the Secretary terminates the EUA
declaration for drugs and biological
products with respect to COVID–19. In
addition, we explained that, under the
authority provided by section 3713 of
the CARES Act, we have established
specific coding and payment rates for
the COVID–19 vaccine, as well COVID–
19 monoclonal antibodies and their
administration, through technical
direction to Medicare Administrative
Contractors (MACs) and information
posted publicly on the CMS website (87
FR 69987). At 87 FR 69983, we listed
the unique payments rates for the
administration of COVID–19
monoclonal antibodies in Table 85. We
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note that at the time of the publication
of this proposed rule, there are no
COVID–19 monoclonal antibodies
approved or authorized for use against
the dominant strains of COVID–19 in
the United States.
In the CY 2023 PFS final rule, we also
established a policy to continue
coverage and payment for monoclonal
antibodies that are used for preexposure prophylaxis (PreP) of COVID–
19 under the Part B preventive vaccine
benefit, if they meet applicable coverage
requirements (87 FR 69992). We
explained that we would continue to
pay for these products and their
administration even after the EUA
declaration for drugs and biological
products is terminated, so long as after
the EUA declaration is terminated, such
products have market authorization.
Additionally, we established that
payments for the administration of
monoclonal antibodies that are used for
PreP of COVID–19 would be adjusted
for geographic cost variations using the
PFS GAF. However, we did not codify
these policies in our regulations. We
now propose revisions to the relevant
regulations to include monoclonal
antibodies that are used for PreP of
COVID–19 under the Part B preventive
vaccine benefit. Specifically, we
propose to revise the following
regulations to reflect policies for
monoclonal antibodies for PreP of
COVID–19 that we finalized in the CY
2023 PFS final rule:
• At § 410.10, in paragraph (l), we
propose to add a phrase regarding
monoclonal antibodies used for preexposure prophylaxis of COVID–19, and
their administration.
• At § 410.57, in paragraph (c), we
propose to add a phrase regarding
monoclonal antibodies used for preexposure prophylaxis of COVID–19, and
their administration.
We note again that at the time of the
publication of this proposed rule, there
are no COVID–19 monoclonal
antibodies approved or authorized for
use against the dominant strains of
COVID–19 in the United States.
Therefore, we are not proposing any
payment regulations regarding
monoclonal antibodies for PreP of
COVID–19 at this time. If and when a
new monoclonal antibody for PreP of
COVID–19 becomes authorized for use,
we would use the authority provided by
section 3713 of the CARES Act, as
discussed in the CY 2023 PFS Final
Rule (87 FR 69987), to establish specific
coding and payment rates for the
administration of that product through
technical direction to MACs and
information posted publicly on the CMS
website. We would subsequently
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propose coding and payment rates for
the administration of that product via
rulemaking.
We also note that, for the purposes of
the in-home additional payment
discussed above in section III.H.3.c. of
this proposed rule, that additional
payment is not applicable to the
administration of monoclonal
antibodies for PreP of COVID–19. With
regard to monoclonal antibodies for
PreP of COVID–19, as displayed in
Table 85 of the CY2023 PFS final rule
(87 FR 69983), we set the coding and
payment rates for the administration of
COVID–19 monoclonal antibodies in the
home to be higher than those in other
health care settings, and therefore such
amounts already account for the higher
costs of administering the product in the
home. More information on our coding
and payment policies for COVID–19
monoclonal antibodies is available at
https://www.cms.gov/monoclonal.
Also, in the CY 2023 PFS final rule,
we codified our payment rates for all
four Part B preventive vaccines, and we
finalized that the vaccine administration
payment rates for all four Part B
preventive vaccines would be annually
updated by the MEI and geographically
adjusted by the PFS GAF. We included
these policies in regulation text at
§ 410.152(h). However, we neglected to
include the effective date for the MEI
policy in the regulation text. We are
proposing the following correction, and
we are reorganizing other elements of
the regulation text at § 410.152(h) as we
codify the in-home additional payment:
• At § 410.152, at paragraph (h)(5), we
propose to add that the paragraph is
effective beginning January 1, 2023.
• At § 410.152, we propose to
combine the existing paragraph (h)(2)
and (h)(3) into a new paragraph (h)(2),
with subparagraphs (h)(2)(i) and
(h)(2)(ii)
• At § 410.152, at a revised paragraph
(h)(3), we propose new regulations
regarding the in-home additional
payment for preventive vaccine
administration, as described in this
section of the proposed rule in section
III.H.3.c.
I. Medicare Diabetes Prevention
Program (MDPP)
The Centers for Medicare & Medicaid
Services’ (CMS) Medicare Diabetes
Prevention Program Expanded Model
(hereafter, ‘‘MDPP’’ or ‘‘expanded
model’’) is an evidence-based behavioral
intervention that aims to prevent or
delay the onset of type 2 diabetes for
eligible Medicare beneficiaries
diagnosed with prediabetes. MDPP is an
expansion in duration and scope of the
Diabetes Prevention Program (DPP)
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model test, which was initially tested by
CMS through a Round One Health Care
Innovation Award (2012–2016). MDPP
was established in 2017 as an
‘‘additional preventive service’’ covered
by Medicare and not subject to
beneficiary cost-sharing, in addition to
being available once per lifetime to
eligible beneficiaries. To facilitate
delivery of MDPP in a non-clinical
community setting (to align with the
certified DPP model test) by non-clinical
providers, CMS created through
rulemaking in the CY 2017 PFS final
rule, a new MDPP supplier type, in
addition to requiring organizations that
wish to participate in MDPP enroll in
Medicare separately, even if they are
already enrolled in Medicare for other
purposes.
MDPP is a non-pharmacological
behavioral intervention consisting of no
fewer than 22 intensive sessions using
a Centers for Disease Control and
Prevention (CDC) approved National
Diabetes Prevention Program (National
DPP) curriculum. Sessions are furnished
over 12 months by a trained Coach who
provides training on topics that include
long-term dietary change, increased
physical activity, and behavior change
strategies for weight control and
diabetes risk reduction. Suppliers may
use the CDC-developed PreventT2
curriculum 236 or an alternate CDCapproved curriculum when delivering
MDPP. The primary goal of the
expanded model is to help Medicare
beneficiaries reduce their risk for
developing type 2 diabetes by achieving
at least 5 percent weight loss.
Eligible organizations seeking to
furnish MDPP began enrolling in
Medicare as MDPP suppliers on January
1, 2018 and began furnishing MDPP on
April 1, 2018. Through the National
DPP Diabetes Prevention Recognition
Program (DPRP), the CDC administers a
national quality assurance program
recognizing eligible organizations that
furnish the National DPP through its
evidence-based DPRP Standards,237
which are updated every 3 years. The
CDC established the DPRP in 2012 and
possesses significant experience
assessing the quality of program
delivery by organizations throughout
the United States, applying a
comprehensive set of national quality
standards. For further information on
the DPP model test, the CDC’s National
DPP, and DPRP Standards, please refer
236 https://www.cdc.gov/diabetes/prevention/
resources/curriculum.html.
237 Centers for Disease Control & Prevention
Diabetes Prevention Recognition Program:
Standards and Operating Procedures. May 1, 2021.
https://www.cdc.gov/diabetes/prevention/pdf/dprpstandards.pdf.
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to the CY 2017 238 and CY 2018 PFS 239
final rules and the following websites:
https://Innovation.cms.gov/initiatives/
Health-Care-Innovation-Awards/;
https://www.cdc.gov/diabetes/
prevention/; and https://
www.cdc.gov/diabetes/prevention/pdf/
dprp-standards.pdf.
We are proposing to amend
§ 410.79(b) to remove the definition for
the core maintenance session interval
while adding definitions for the
following terms: Combination delivery,
Distance learning, Extended flexibilities,
Extended flexibilities period, Full-Plus
CDC DPRP recognition, Online delivery,
and Virtual sessions. In addition, we
propose to amend § 410.79(c)(2)(i)(A)
and (B) to update the maximum number
of payable sessions during the MDPP
core services period. We also propose to
amend § 410.79(e)(2) to extend certain
flexibilities established through
rulemaking as a result of the recent
COVID–19 public health emergency
(PHE) for a period of 4 years.
Furthermore, we propose to amend
§ 414.84 to streamline the MDPP
payment structure by adding servicebased attendance payments, while still
retaining the diabetes risk reduction
performance payments for 5 percent and
9 percent weight loss. We also propose
to amend § 424.205(a) and (c) to remove
‘‘MDPP interim preliminary
recognition’’ and replace it with ‘‘CDC
preliminary recognition’’.
1. Proposed Changes to § 410.79 by
Amending Paragraphs (b), (c)(2)(i) and
(e)(2)
The MDPP expanded model was
implemented through the rulemaking
process in two phases in the CY 2017
PFS final rule 240 and in the CY 2018
PFS final rule.241 Through this proposed
rule, we are proposing to amend the
MDPP expanded model to revise certain
238 Centers for Medicare & Medicaid Services.
Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2017; Medicare
Advantage Bid Pricing Data Release; Medicare
Advantage and Part D Medical Loss Ratio Data
Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes
Prevention Program Model; Medicare Shared
Savings Program Requirements. 81 FR 80471.
Accessed March 12, 2023. https://www.govinfo.gov/
content/pkg/FR–2016–11–15/pdf/2016–26668.pdf.
239 Centers for Medicare & Medicaid Services.
Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2018; Medicare Shared
Savings Program Requirements; and Medicare
Diabetes Prevention Program. 82 FR 52976. https://
www.govinfo.gov/content/pkg/FR–2018–11–23/pdf/
2018–24170.pdf.
240 https://www.govinfo.gov/content/pkg/FR–
2016–11–15/pdf/2016–26668.pdf.
241 https://www.govinfo.gov/content/pkg/FR–
2017–11–15/pdf/2017–23953.pdf.
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MDPP policies adopted through
previous rulemaking. We are proposing
to amend § 410.79(b) to remove the
definition for the core maintenance
session interval while adding
definitions for Combination delivery,
Distance learning and Online delivery
modalities, among other definitions.
The core maintenance session interval,
as defined in the CY 2018 PFS, means
one of the two consecutive 3-month
time periods during months 7 through
12 of the MDPP services period, during
which an MDPP supplier offers an
MDPP beneficiary at least one core
maintenance session per month. The
core maintenance session interval
represents a performance interval for
attendance-based payments in the
current payment structure. Given that
we are proposing that beneficiary
attendance be paid on a fee-for-service
basis, we propose removing the core
maintenance session interval to make
the payment structure less confusing.
In prior rulemaking, we did not
formally define the MDPP delivery
modalities that are considered virtual.
In this proposed rule, we propose
adding definitions for distance learning
and online delivery modalities in
§ 410.79(b) to better clarify which
virtual modalities can be used in the
proposed Extended flexibilities period.
We are also proposing to modify the
definitions for Make-up session, MDPP
services period, and MDPP session as
defined in § 410.79(b) to remove most
references to ongoing maintenance
sessions. In the CY 2022 PFS, we
removed eligibility for the Ongoing
Maintenance Sessions for those
beneficiaries who started the Set of
MDPP services on or after January 1,
2022. Given that the 2-year MDPP
services period for those beneficiaries
who started MDPP on or before
December 31, 2022 will end on or before
December 30, 2024, eligibility for
ongoing maintenance services will end
December 31, 2023 for all beneficiaries.
The core services period, as defined
in § 410.79(c)(2)(i)(A) and (B), consists
of at least 16 core sessions offered at
least one week apart during the months
1 through 6 of the MDPP services
period, and two 3-month core
maintenance session intervals offered
during months 7 through 12 of the
MDPP services period. In order to
conform to the proposed revisions to the
payment structure in § 414.84, we are
proposing to amend the expanded
model regulations to allow for fee-forservice payments for beneficiary
attendance during the core services
period.
MDPP’s performance-based payment
structure was established in the CY
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2018 PFS to pay for the Set of MDPP
services that makes up the periodic
performance payments to MDPP
suppliers during the MDPP services
period. The aggregate of all MDPP
performance payments constitutes the
total performance-based payment
amount for the Set of MDPP services.
Although beneficiaries may currently
attend at least 16 weekly sessions in
months 1–6 and at least 6 monthly
sessions in months 7–12, MDPP
suppliers are only paid five times for
beneficiary attendance: after a
beneficiary attends the 1st, 4th and 9th
sessions in months 1–6, and after
attending the second core maintenance
session in months 7–9 and in months
10–12.
Since this payment structure went
into effect in 2018, we received
feedback from suppliers and interested
parties that the MDPP performancebased payment structure is confusing to
suppliers, including those new to
Medicare and existing Medicareenrolled suppliers. Confusion with
claims submission has been due in part
to the MDPP payment structure, which
pays for attendance and diabetes riskreduction performance-based milestones
instead of paying for an individual
service. Paying for an individual service
delivery is typical in Medicare. Public
comments in response to the CY 2018
PFS proposed rule have indicated that
CMS should modify its payment
structure such that it allows for an
adequate and predictable payment
stream to cover the cost of providing
services as long as beneficiaries attend
sessions.
After 5 years of testing the current
performance-based payment structure,
we have determined that the
attendance-based performance
payments are not working. For example,
there are currently five attendancebased performance payments over the
12-month MDPP service period, with a
potential 4 to 5-month lag between the
third payment and the fourth payment.
Our monitoring data show that
attendance sharply drops after the first
quarter of the expanded model, which is
likely after the 9th weekly session has
been attended. We believe that our
current payment structure does not
incentivize beneficiary retention. As a
result, we are proposing fee-for-service
payments for beneficiary attendance,
allowing for up to 22 attendance-based
payments versus the five that are
currently in place. Thus, we propose
allowing beneficiaries to attend a
maximum of 22 sessions during the core
services period, including up to 16
sessions in months 1–6 and up to 6
sessions in months 7–12.
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We are proposing to amend the MDPP
expanded model to revise certain MDPP
policies finalized in the CY 2021 PFS
final rule. We are proposing to extend
the flexibilities allowed under the
COVID–19 Public Health Emergency for
a period of 4 years until December 31,
2027. These Extended flexibilities are
described in § 410.79(e)(3)(iii), and (iv)
of this paragraph. The MDPP regulations
provide for the following flexibilities
during the PHE or an applicable 1135
waiver event:
• Alternatives to the requirement for
in-person weight measurement
(§ 410.79(e)(3)(iii)). Section
410.79(e)(3)(iii) permits an MDPP
supplier to obtain weight measurements
for MDPP beneficiaries for the baseline
weight and any weight loss-based
performance achievement goals in the
following manner: (1) via digital
technology, such as scales that transmit
weights securely via wireless or cellular
transmission; or (2) via self-reported
weight measurements from the at-home
digital scale of the MDPP beneficiary.
We stated that self-reported weights
must be obtained during live,
synchronous online video technology,
such as video chatting or video
conferencing, wherein the MDPP Coach
observes the beneficiary weighing
themselves and views the weight
indicated on the at-home digital scale.
Alternatively, the MDPP beneficiary
may self-report their weight by
submitting to the MDPP supplier a datestamped photo or video recording of the
beneficiary’s weight, with the
beneficiary visible in their home. The
photo or video must clearly document
the weight of the MDPP beneficiary as
it appears on the digital scale on the
date associated with the billable MDPP
session. This flexibility allows suppliers
to bill for participants achieving weight
loss performance goals.
• Elimination of the maximum
number of virtual services
(§ 410.79(e)(3)(iv): The virtual session
limits described in § 410.79 (d)(2), and
(d)(3)(i) and (ii) do not apply, and MDPP
suppliers may provide all MDPP
sessions virtually during the PHE as
defined in § 400.200 of this chapter or
applicable 1135 waiver event. MDPP
suppliers were permitted to provide the
Set of MDPP services virtually during
the COVID–19 PHE, as long as the
virtual services are furnished in a
manner that is consistent with the CDC
DPRP standards for virtual sessions,
follow the CDC-approved National DPP
curriculum requirements, and the
supplier has an in-person DPRP
organizational code.
We are proposing that during the
Extended flexibilities period, MDPP
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suppliers may provide virtual services
as long as they are provided in a manner
consistent with the CDC DPRP
standards for distance learning. The
proposed extension of these flexibilities
under § 410.79(e)(3)(v) will allow
beneficiaries to obtain the Set of MDPP
services either in-person, through
distance learning, or through a
combination of in-person and distance
learning for a proposed period of 4
years.
In the May 2, 2023 Federal Register
(88 FR 27413), we published a notice
extending COVID–19 PHE flexibilities
for MDPP suppliers, providing them the
opportunity to deliver the Set of MDPP
services either virtually or in-person (or
a combination of both) from May 12,
2023 through December 31, 2023. As a
result, MDPP suppliers can continue
delivering the Set of MDPP services on
a virtual basis during this period to
allow MDPP suppliers additional time
to resume in-person services. For more
information on the Federal Register
Notice, please see https://
www.federalregister.gov/d/2023–09188.
For more information on the flexibilities
that MDPP suppliers were permitted to
implement during the PHE, please see
https://www.cms.gov/files/document/
participants-medicare-diabetesprevention-program-cms-flexibilitiesfight-covid-19.pdf.
The CDC’s 2021 DPRP Standards
allow two types of virtual delivery
modalities: ‘‘Distance learning’’ and
‘‘online’’ delivery. According to CDC,
Distance learning involves ‘‘a yearlong
National DPP lifestyle change program
delivered 100 percent by trained
Lifestyle Coaches via remote classroom
or telehealth. The Lifestyle Coach
provides live (synchronous) delivery of
session content in one location and
participants call-in or video-conference
from another location.’’ Although
‘‘telehealth’’ is included in CDC’s
definition of distance learning, CMS
stated in the CY 2017 PFS final rule (82
FR 52976) that MDPP services delivered
via a telecommunications system or
other remote technologies do not qualify
as telehealth services.242
Additionally, CDC defines online
delivery as a yearlong National DPP
lifestyle change program delivered
online for all participants. One hundred
242 Centers for Medicare & Medicaid Services.
Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2017; Medicare
Advantage Pricing Data Release; Medicare
Advantage and Part D Medical Low Ratio Data
Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes
Prevention Program Model. 82 FR 52976, November
15, 2017. https://www.govinfo.gov/content/pkg/FR–
2017–11–15/pdf/2017–23953.pdf.
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percent of the program is experienced
through the internet via phone, tablet,
laptop, in an asynchronous classroom
where participants are experiencing the
content on their own time without a live
Lifestyle Coach teaching the content.
However, live Lifestyle Coach
interaction should be provided to each
participant no less than once per week
during the first 6 months and once per
month during the second 6 months.
Emails and text messages can count
toward the requirement for live coach
interaction as long as there is bidirectional communication between
coach and participant.243
In the CY 2021 PFS final rule (85 FR
84472),244 we established that virtual
sessions performed under flexibilities
finalized in that rule could only be
performed by suppliers who offered inperson services. For the proposed
Extended flexibilities period, CMS
proposes to limit virtual delivery to the
CDC DPRP definition of ‘‘distance
learning.’’ This proposal is based on the
data we have obtained to date from the
PHE, including anecdotal, monitoring,
evaluation, claims, and CDC DPRP data,
suggesting that the majority of the
MDPP virtual sessions delivered during
the COVID–19 PHE 1135 waiver event
were distance learning sessions.
MDPP was certified and established
as an in-person service. However, in
response to the COVID–19 PHE, we
established and implemented policies
that allowed MDPP suppliers to provide
MDPP services virtually during the PHE,
as long as the virtual services: were
furnished in a manner that is consistent
with the CDC DPRP standards for virtual
sessions, the curriculum furnished
243 Centers for Disease Control & Prevention
Diabetes Prevention Recognition Program:
Standards and Operating Procedures. May 1, 2021.
https://www.cdc.gov/diabetes/prevention/pdf/dprpstandards.pdf.
244 Centers for Medicare & Medicaid Services.
Medicare Program; CY 2021 Payment Policies
Under the Physician Fee Schedule and Other
Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Medicaid
Promoting Interoperability Program Requirements
for Eligible Professionals; Quality Payment
Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare
Enrollment of Opioid Treatment Programs;
Electronic Prescribing for Controlled Substances for
a Covered Part D Drug; Payment for Office/
Outpatient Evaluation and Management Services;
Hospital IQR Program; Establish New Code
Categories; Medicare Diabetes Prevention Program
(MDPP) Expanded Model Emergency Policy; Coding
and Payment for Virtual Check-in Services Interim
Final Rule Policy; Coding and Payment for Personal
Protective Equipment (PPE) Interim Final Rule
Policy; Regulatory Revisions in Response to the
Public Health Emergency (PHE) for COVID–19; and
Finalization of Certain Provisions from the March
31st, May 8th and September 2nd Interim Final
Rules in Response to the PHE for COVID–19. (85
FR 84472), December 28, 2020. https://
www.federalregister.gov/d/2020–26815.
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during the virtual sessions addressed
the same curriculum topics as the CDCapproved National DPP curriculum, the
supplier had an in-person DPRP
organizational code, and other
requirements specified at
§ 410.79(e)(3)(iv) were satisfied. We
believe that distance learning allows for
a similar live group experience for
beneficiaries, but delivered only in a
synchronous virtual manner through
telephonic or video conference.
Through utilizing distance learning,
participants may still interact with their
Coach and other participants in their
cohort in real-time, allowing for
relationship building and peer support,
unlike online delivery which is
delivered asynchronously. Therefore,
the proposed Extended flexibilities do
not include online delivery (or
asynchronous virtual), as defined in the
CDC DPRP Standards through the
‘‘online’’ modality, including virtual
make-up sessions.
We previously stated that the MDPP
expanded model was certified for
expansion by the Chief Actuary of CMS,
based on a model test that used inperson delivery. Given the 3-year
duration of the COVID–19 PHE and the
feedback received from MDPP suppliers,
beneficiaries, MA plans, interested
parties, and comments submitted during
the CY 2022 rulemaking, there is
interest in extending the flexibilities
offered during the PHE to reduce the
burden of traveling to an in-person class
on a weekly basis, as beneficiaries
experienced transportation as well as
child/elder care challenges with inperson delivery. Additionally, we have
heard interest in a hybrid or
combination delivery option where
participants could attend some inperson classes as well as virtual classes.
As a result of this feedback, we are
proposing to extend the flexibilities
allowed under § 410.79(e)(3)(iii)
(regarding use of alternative methods for
obtaining weight measurements during
virtual services) and § 410.79(e)(3)(iv)
(regarding elimination of the maximum
number of virtual services) for 4 years,
to give us time to test and evaluate the
distance learning delivery of MDPP.
Since MDPP was established in the
CY 2017 PFS final rule, CMS and
interested parties have considered
whether fully virtual services could be
included as part of the expanded model.
For example, in the CY 2017 PFS
proposed rule, CMS proposed that
MDPP suppliers be allowed to provide
MDPP services via remote technologies,
even though the majority of CDC DPRP
organizations provided in-person
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delivery at that time.245 However, we
also recognized that the virtual delivery
of the Set of MDPP services may
introduce additional risk of fraud and
abuse. CMS stated that if that provision
was to be finalized, we would propose
specific policies in future rulemaking to
mitigate these risks. In the CY 2017 PFS
final rule (81 FR 80459), CMS deferred
establishing policies related to
organizations delivering the Set of
MDPP services virtually.
In the subsequent CY 2018 PFS
proposed rule, we explained our
rationale for proposing not to allow
fully virtual delivery of MDPP, but did
propose to allow, consistent with CDC
DPRP Standards, a limited number of
virtual make-up sessions for
participants who missed a regularly
scheduled session. ‘‘Virtual make-up
session’’ was defined in § 410.79(d)(2)
as a make-up session that is not
furnished in-person and that is
furnished in a manner consistent with
the requirements in paragraph
§ 410.79(d)(1). In the CY 2018 PFS final
rule, we finalized that the Set of MDPP
services would be primarily delivered
in-person, in a classroom-based setting,
and within an established timeline.
We prioritized establishing a service
that, when delivered within this
framework, would create the least risk
of fraud, waste, and abuse, increase the
likelihood of success for beneficiaries,
and maintain the integrity of data.
Furthermore, we believed at that time
that in-person administration of
beneficiaries’ weight measurements was
the most reliable and appropriate
approach to monitoring beneficiarylevel progress toward the 5 percent
weight loss programmatic goal.
However, circumstances have
changed since the start of the expanded
model. We have received comments
from interested parties in response to
the CY 2018 PFS proposed rule and
thereafter regarding increasing the
limited virtual delivery of MDPP.
Commenters noted that increased
virtual options could expand access to
MDPP for beneficiaries in rural areas,
beneficiaries who are homebound or
who lack transportation options, as well
as increase beneficiary choice of
delivery modality and flexibility of
location. Commenters also noted that
245 Centers for Medicare & Medicaid Services.
Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2017; Medicare
Advantage Pricing Data Release; Medicare
Advantage and Part D Medical Low Ratio Data
Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes
Prevention Program Model. Federal Register,
81(136): July 15, 2016. https://www.govinfo.gov/
content/pkg/FR–2016–07–15/pdf/2016–16097.pdf.
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virtual National DPP delivery has been
successful in reaching beneficiaries in
certain locations. Ultimately, we
finalized our policy that suppliers could
offer no more than four virtual makeup
sessions during months 1–6 and two
virtual makeup sessions during months
7–12.
On March 13, 2020, less than 2 years
after MDPP went into effect, COVID–19
was declared a national emergency by
Proclamation 9994.246 By mid-March
2020, MDPP suppliers were largely
unable to deliver in-person classes due
to national and local restrictions
resulting from the national emergency.
On April 6, 2020, CMS established
MDPP PHE-related flexibilities in the
first Interim Final Rule with Comment
(IFC–1),247 to allow for temporary
flexibilities that prioritized availability
and continuity of services for MDPP
suppliers and MDPP beneficiaries
impacted by extreme and uncontrollable
circumstances during the COVID–19
PHE. These flexibilities allowed an
unlimited number of virtual sessions,
waived the once-per-lifetime limit for
those participating in MDPP when the
PHE started, and waived the 5 percent
weight loss requirement to continue
with ongoing maintenance sessions.
However, we did not waive the
requirement for in-person weigh-ins at
that time, leaving suppliers unable to
obtain the 5 percent weight loss
performance payment given the local
and State restrictions and stay-at-home
orders during the initial months of the
PHE. This prevented suppliers from
collecting an in-person weight from
beneficiaries at each MDPP session as
described in § 424.205(g)(2)(v) to
document the 5 percent weight loss.
In the CY 2021 PFS final rule, we
finalized the MDPP Emergency Policy
and updated the PHE flexibilities
established in the IFC–1 in the
following ways: allowing for virtual
weigh-ins and new cohorts to begin
virtually; reinstating the 5 percent
weight loss requirement during an 1135
waiver event; and reinstating the onceper-lifetime limit during an 1135 waiver
event starting with beneficiaries who
246 https://www.whitehouse.gov/briefing-room/
presidential-actions/2023/02/10/notice-on-thecontinuation-of-the-national-emergencyconcerning-the-coronavirus-disease-2019-covid-19pandemic-3/#:∼:text=On%20March%2013%2C
%202020%2C%20by,(COVID%2D19)
%20pandemic.
247 Centers for Medicare & Medicaid Services,
HHS. Medicare and Medicaid Programs; Policy and
Regulatory Revisions in Response to the COVID–19
Public Health Emergency. (85 FR 19230, Monday,
April 6, 2020) https://www.federalregister.gov/
documents/2020/04/06/2020–06990/medicare-andmedicaid-programs-policy-and-regulatory-revisionsin-response-to-the-covid-19-public.
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started the Set of MDPP services in 2021
or thereafter. These changes sought to
address interruptions in services caused
by CMS not waiving the in-person
weigh-in in IFC–1, which prevented
MDPP suppliers from starting new
cohorts and getting reimbursed for
participants who achieved and
maintained the 5 percent weight loss
goals. Additionally, beneficiaries who
began sessions on or before December
31, 2020, were able to re-start MDPP
sessions at a later date. Similarly, we
allowed suppliers to pause, then resume
MDPP sessions at a later date.
During the COVID–19 PHE, we
allowed full virtual delivery of MDPP.
In making that policy change in the CY
2021 PFS final rule, we stated that
‘‘Because MDPP services are covered
under Medicare only when they are
furnished at least in-part in-person, a
supplier that does not have an
organizational code authorizing inperson services (‘‘virtual-only
suppliers’’) may not provide MDPP
services, either virtually or in-person.’’
We indicated that it is not appropriate
to permit virtual-only suppliers, such as
suppliers with CDC DPRP recognition in
the distance learning, online, or
combination only modalities, to furnish
MDPP services when the Emergency
Policy is in effect. This is due to the
requirement that MDPP suppliers
remain prepared to resume in-person
delivery of the Set of MDPP services to
start new cohorts and to serve
beneficiaries who wish to return to inperson services when the Emergency
Policy is no longer in effect.
As stated earlier, we propose to
extend the flexibilities allowed during
the COVID–19 PHE under
§ 410.79(e)(3)(iii), and (iv) for 4 years, or
through December 31, 2027. We are
proposing that the Extended flexibilities
under § 410.79(e)(3)(iii) and (iv)
continue to apply only to MDPP
suppliers that have and maintain CDC
DPRP in-person recognition. We
recognize that organizations and
interested parties may be disappointed
that we are not proposing to allow
organizations with CDC recognition in
distance learning delivery modalities to
participate in MDPP unless they also
have and maintain their in-person CDC
recognition. In the CY 2021 PFS final
rule, we stated that virtual only
suppliers are not permitted to provide
the Set of MDPP services because MDPP
beneficiaries may elect to return to inperson services after the PHE for
COVID–19 or other applicable 1135
waiver event ends, and MDPP suppliers
need to be able to accommodate their
request.
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MDPP was established as an in-person
service since the original DPP test and
data used in the certification were based
on in-person delivery. During the
COVID–19 PHE, we were able to allow
greater use of virtual sessions, but the
virtual delivery was primarily furnished
as a virtual classroom. We are also
proposing that suppliers may offer a
combination delivery of MDPP,
including both in-person and distance
learning. We believe that after almost 4
years of having the option to deliver the
Set of MDPP services through distance
learning, between the COVID–19 PHE
and the Federal Register Notice to
extend the PHE flexibilities through
December 31, 2023, allowing MDPP
suppliers to have the option to continue
delivering the Set of MDPP services in
the same manner will be the least
disruptive to both suppliers and
beneficiaries. We are also proposing that
MDPP suppliers may no longer suspend
the Set of MDPP services as described
in paragraph (e)(3)(v) in this section on
or after January 1, 2024. We believe we
have given MDPP suppliers ample time,
through the Federal Register Notice to
extend the PHE flexibilities through
December 31, 2023, to adequately
prepare to resume MDPP services from
an operational perspective.
Furthermore, we also believe that our
proposal to extend the PHE flexibilities
for 4 years, or through December 31,
2027, will make MDPP more equitable
and accessible for all eligible
beneficiaries by providing both
suppliers and beneficiaries more
flexibility in how the Set of MDPP
services are delivered, including inperson, distance learning, or a
combination of in-person and distance
learning. For an example, allowing
virtual sessions will make MDPP more
accessible to beneficiaries who reside in
rural communities and who may have
transportation and other barriers to
attending in-person classes. We
anticipate that the combination of a
simplified payment structure in
addition to more flexibilities regarding
how MDPP is delivered will encourage
more organizations to engage in and
deliver MDPP, making MDPP more
accessible to more beneficiaries.
Additionally, extending the COVID–
19 PHE flexibilities for 4 years would
provide CMS an opportunity to evaluate
the impact of the Extended flexibilities
over a longer period of time. To better
track the use of distance learning
through claims, we are proposing the
creation of a new HCPCS G-code
specific to ‘‘distance learning,’’ that will
more accurately track sites from which
distance learning occurs, the number of
MDPP sessions delivered by distance
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learning, monitor the expanded model
for fraud, waste, or abuse, and evaluate
the impact of distance learning and inperson delivery modalities of MDPP
relative to cost-savings and diabetes risk
reduction among participants.
In previous rulemaking, we received
comments about how to best monitor
the use of virtual make-up sessions, and
whether CMS would use an additional
HCPCS code or modifier to indicate
virtual sessions since there was a limit
to the number of virtual make-up
sessions a beneficiary can attend.248 In
response, we finalized the use of the
virtual make-up sessions in
§ 410.79(d)(2) and stated that MDPP
suppliers must include the virtual
modifier (VM) on claims to indicate the
use of the virtual make-up session. As
part of the MDPP flexibilities
established in response to the COVID–
19 PHE, we eliminated the maximum
number of virtual make-up sessions that
could be delivered by MDPP suppliers,
described in § 410.79(d)(2) and (d)(3)(i)
and (ii), but still required MDPP
suppliers to use the VM to indicate
when a beneficiary received MDPP
virtually.
Given the inconsistent use of the
virtual modifier as it was described in
the CY 2018 PFS final rule to document
the virtual make-up sessions allowed
during the PHE as described in
§ 410.79(e)(2)(iii), we propose to add a
HCPCS code for distance learning to
better track the synchronous virtual
delivery of the Set of MDPP services to
be used instead of the VM when
submitting MDPP claims, including
claims for make-up sessions since we
are not permitting online (asynchronous
virtual) delivery of the Set of MDPP
services. At this time, we are not
proposing to remove use of the VM
entirely in-case we need it in future
rulemaking, for example, should we
allow online make-up sessions in future
rulemaking.
MDPP supplier locations have
traditionally clustered proximate to
large metropolitan areas, leaving
significant gaps throughout rural
communities. Given that the MDPP
curriculum consists of no fewer than 16
weekly sessions in months 1–6, and 6
monthly sessions in months 7–12
months, the participation commitment
248 Centers for Medicare & Medicaid Services.
Medicare Program; Revisions to Payment Policies
Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2017; Medicare
Advantage Pricing Data Release; Medicare
Advantage and Part D Medical Low Ratio Data
Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes
Prevention Program Model. 82 FR 52976, November
15, 2017. https://www.govinfo.gov/content/pkg/FR–
2017–11–15/pdf/2017–23953.pdf.
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may pose significant challenges to
beneficiaries with limited mobility or
access to reliable transportation. Based
on findings from the 2nd evaluation
report of the MDPP expanded model,249
we believe that in-person requirements
have contributed to significant MDPP
under-utilization, not only for those
who reside in rural communities, but
also populations that experience
excessive diabetes related disparities,
including populations of color, lowincome beneficiaries, those living in
Tribal and rural communities, and the
disabled.
To date, beneficiary uptake of MDPP
has been low, with 4,848 beneficiaries
participating as of December 31, 2021,
and approximately half of those
participants were Medicare FFS
beneficiaries. White women account for
the majority of MDPP participants to
date, with the both the National DPP
and MDPP having enrolled a similar
high proportion of non-Hispanic white
women. RTI estimated that 97 percent of
participants travel less than 25 miles to
attend in-person services, with the
average distance to the nearest MDPP
supplier location being 5 to 7 miles.
At the time of the second annual
evaluation report, which was released in
November, 2022 and includes data
through December 31, 2021, 39 percent
of all Medicare beneficiaries live more
than 25 miles from the nearest MDPP
location. Extending the PHE flexibilities
to allow distance learning will make
MDPP more accessible to beneficiaries
who live more than 25 miles from the
nearest MDPP location or lack
transportation.10
Additionally, the 2nd evaluation
report (p. 32) noted that suppliers tried
to make MDPP services accessible to
Medicare beneficiaries by scheduling
sessions at locations that were most
convenient to Medicare beneficiaries. It
was also noted that while beneficiary
engagement and connection tend to be
stronger with in-person cohorts, moving
to distance learning delivery reduced
participant barriers (p. 34). While some
suppliers and beneficiaries experienced
initial challenges migrating to fully
virtual delivery, the report noted an
overwhelming support from MDPP
suppliers for the continued opportunity
to administer MDPP through distance
learning or a combination of in-person
and synchronous virtual delivery.
Therefore, by proposing the use of
synchronous virtual delivery as an
acceptable modality for MDPP delivery,
249 RTI International. Evaluation of the Medicare
Diabetes Prevention Program: Second Evaluation
Report. November 2022. https://
innovation.cms.gov/data-and-reports/2022/mdpp2ndannevalrpt.
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our goal is to use the Extended
Flexibilities period to increase
beneficiary access to and uptake of
MDPP while demonstrating that the
beneficiaries receiving the Set of MDPP
services through distance learning
experience similar or better outcomes
compared to in-person delivery
concerning attendance, achievement of
the 5 percent weight loss goal, and cost
savings.
Through the CY 2018 PFS final rule,
we established important MDPP
payment policies and program integrity
safeguards in order to mitigate the risk
of fraud, waste, and abuse in MDPP that
included the creation of supplier
enrollment requirements and
compliance standards. MDPP
monitoring activities are performed
primarily through an independent
monitoring contractor, with referrals
sent to CMS for further investigation or
enforcement action, as appropriate. We
will continue to implement, adapt, and
scale the current monitoring strategy for
indications of fraud, waste, and abuse
for both in-person and the proposed
distance learning modalities. Should we
identify excessive indicators of fraud,
waste, and/or abuse of the synchronous
virtual delivery of the Set of MDPP
services during the extended PHE
flexibilities period, we may opt to
discontinue these flexibilities through
subsequent rulemaking.
With these safeguards in-place, we
anticipate the proposed programmatic
updates will boost supplier enrollment,
with the goal of increasing beneficiary
participation and retention due to
increased access to the Set of MDPP
services. Moreover, we believe that
extending the PHE flexibilities will
especially increase equitable access to
diabetes preventive services among
rural and at-risk populations. For
example, for beneficiaries with
transportation challenges or child/elder
care obligations, the ability to
participate in MDPP through a live
virtual classroom, or distance learning,
may encourage uptake and retention
among those participants. Also, for
beneficiaries living in rural areas or
regions with a limited number of MDPP
suppliers, the distance learning option
will allow beneficiaries to enroll in
programs further away from their
homes, making MDPP accessible to
more beneficiaries. Finally, we believe
that increased participation in the Set of
MDPP services through distance
learning may provide data necessary to
conduct an impactful evaluation of the
synchronous virtual delivery of MDPP.
We propose to amend § 410.79(b), (c),
and (d) to remove most references to,
and requirements of, the Ongoing
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Maintenance phase described in these
sections. In the CY 2022 PFS, CMS
removed eligibility for the Ongoing
Maintenance Sessions for those
beneficiaries who started the Set of
MDPP services on or after January 1,
2022. Eligibility for these services will
end December 31, 2023.
We are proposing to amend
§ 410.79(b), (c)(2)(i) and (e)(2), and seek
comment on these proposals.
2. Proposed Changes to § 414.84
Although MDPP has over 300
suppliers representing over 1,000
locations across the US, based on feefor-service claims analysis, only onethird of them have submitted claims
since MDPP launched in April 2018. We
have heard anecdotally from suppliers,
CDC, and interested parties that our
payment structure is complex, which
has created barriers to organizations
wanting to participate in MDPP. As a
result, the lack of suppliers has
contributed to limited beneficiary access
to the preventive services offered under
this expanded model. Challenges
inherent in the current payment
structure include irregular flow of
operating funds due to the performancebased payment structure, claims denials
due to the complicated payment
structure, and a lack of incentive to
retain participants after the 9th core
session due to the potential 4 to 5month payment lag between the 9th
session attended and the 2nd session
attended in months 7–9. Consistent with
this last challenge, our monitoring data
show a sharp drop in claims after the
first quarter.
We propose to update the payment
structure from a performance-based
attendance and weight loss structure to
a hybrid structure that pays for
attendance on a fee-for-service basis and
diabetes risk reduction (that is, weight
loss), on a performance basis. MDPP, as
defined in § 410.79(b), consists of up to
16 sessions offered during the core
sessions phase (Months 1–6) and 6
monthly maintenance sessions offered
during the core maintenance sessions
phase (Months 7–12), (collectively the
‘‘core sessions phase’’). In the current
payment structure, suppliers must
submit a claim after a participant
completes the first, fourth, and ninth
sessions during the first 6 months, then
following the second core maintenance
session in months 7–9 and in months
10–12 in the core maintenance sessions
phase. Depending on the timing of the
ninth session attended and the second
core maintenance session attended by
the beneficiary in months 7 to 9,
suppliers may have a 4- to 5-month gap
between attendance-based performance
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payments in the current MDPP payment
structure.
Given consistent supplier and
interested party feedback regarding the
complexity of this payment structure
and necessary up-front costs incurred by
suppliers, we propose to simplify the
payment structure and pay for
attendance on a fee-for-service basis. We
propose creating an Attendance
Payment, which we propose to define as
a payment that is made to an MDPP
supplier for furnishing services to an
MDPP beneficiary when the MDPP
beneficiary attends an MDPP core or
core maintenance session. We also
propose that suppliers may receive an
Attendance Payment after they submit a
claim for each MDPP session, starting
with the first core session, using a new
HCPCS G-code, Behavioral counseling
for diabetes prevention, in-person,
group, 60 minutes, or Behavioral
counseling for diabetes prevention,
distance learning, 60 minutes, for MDPP
dates of service on or after January 1,
2024.
This proposed payment structure
aligns closely to that of similar benefits
such as the Intensive Behavioral
Counseling for Obesity (IBTO) and
Diabetes Self-Management Training
(DSMT), and also allows suppliers to
receive regular payments for service for
up to a year during a 12-month MDPP
service period. We propose paying for
up to 22 sessions, either in-person or
distance learning, or a combination of
in-person and distance learning, for
MDPP dates of services within a 12month MDPP services period. In months
1 to 6, payments are allowed for one inperson or distance learning session
every week up to a maximum of 16
sessions. During months 7 to 12,
payments are allowed for one in-person
or distance learning session every
month up to a maximum 6 sessions.
We proposing to update the
performance goal to mean a weight loss
goal that an MDPP beneficiary must
achieve during the MDPP services
period for an MDPP supplier to be paid
a performance payment, and removing
the performance-based payments for
attendance from the performance goal.
We are retaining the diabetes riskreduction performance payments, which
include payments for 5 percent and 9
percent weight loss because we want to
continue to pay for outcomes, and the
MDPP certification includes a diabetes
risk-reduction component (that is,
achievement of 5 percent weight loss
from baseline). Although we are
proposing to remove the attendancebased performance goal and pay for
attendance on a fee-for-service basis, we
want to continue rewarding suppliers
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submitting a claim for the enhanced
payment in months 7 to 12 for
maintaining the 5 percent weight loss.
Additionally, suppliers must continue
to submit a claim when 9 percent
weight loss from baseline weight is
achieved per § 414.84(b)(7), so they may
receive a one-time payment for this
claim.
This proposed payment structure
increases the maximum attendancebased payments a supplier may receive
in the first 6 months by $56 per MDPP
beneficiary, while allowing for similar
maximum attendance payments in
months 7–12 and maintaining the
maximum total payment of $768 per
person during the MDPP services
period. Also, this proposed payment
structure takes into consideration the
Extended flexibilities, by adding a
distance learning HCPCS G-code. The
new structure simplifies the claims
submission process because it no longer
requires that suppliers submit 11 to 15
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G-codes for different attendance-based
sessions at irregular intervals.
This proposed payment structure
allows suppliers to submit one of two Gcodes (depending on whether the MDPP
session was delivered in person or via
distance learning) for each session. In
months 7–12, suppliers may also add
the proposed maintenance of the 5
percent weight loss from baseline Gcode to their claim once the 5 percent
weight loss has been achieved. The
proposed payment structure allows
suppliers to indicate which sessions
were held via distance learning without
needing to provide additional
information in the claim submission
process. The proposed new payment
structure reduces complexity by
reducing the number of G-codes from 15
to 6.
Table 41 displays the proposed MDPP
payment structure and Table 42
indicates the current CY 2023
performance payments.
BILLING CODE 4120–01–P
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for successful outcomes for beneficiaries
(weight loss), and motivating them to
not only retain participants, but also
deliver a high-quality program that
achieves better outcomes.
As part of the performance payments,
MDPP suppliers must still submit a
claim when 5 percent weight loss from
baseline weight is achieved and will
receive a one-time payment for this
claim (weight loss G-code). We are
proposing to create a new HCPCS Gcode, ‘‘Maintenance of 5 percent weight
loss from baseline, months 7–12’’ to be
submitted along with the monthly
session claim for beneficiaries who have
met the 5 percent weight loss
performance goal, for whom the onetime claim for 5 percent weight loss has
been submitted. This maintenance of 5
percent weight loss code replaces the
attendance plus 5 percent weight loss
HCPCS G-codes, G9878 and G9879, in
months 7–12.
The one-time claim for 5 percent
weight loss must be submitted prior to
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BILLING CODE 4120–01–C
In previous rulemaking, we received
comments regarding how to best
monitor the use of virtual make-up
sessions, and whether we would use an
additional HCPCS code or modifier to
indicate virtual sessions since there is a
limit to the number of virtual make-up
sessions a beneficiary can attend. In
response, we finalized the use of the
virtual make-up sessions in
§ 410.79(d)(2) and stated in the
preamble to the CY 2018 PFS final rule
that MDPP suppliers must include the
virtual modifier on claims to indicate
the use of the virtual make-up session.
As part of the flexibilities established in
response to the COVID–19 PHE, we
eliminated the maximum number of
virtual make-up sessions that could be
delivered by MDPP suppliers, described
in § 410.79(d)(2) and (d)(3)(i) and (ii),
but still required MDPP suppliers to use
the virtual modifier to indicate when a
beneficiary received MDPP virtually.
We are proposing to amend
§ 414.84(a), (b), (c), and newly
redesignated paragraphs (d)(1) and (e).
We seek comment on these proposals.
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3. Changes to § 424.205 (a), (b)(1), (c),
and Newly Designated (c)(1), (d)(14),
(f)(2)(i), (g)(1)(i)(C)
The Centers for Disease Control and
Prevention (CDC), which administers
the Diabetes Prevention Recognition
Program (DPRP), is responsible for
implementing the quality assurance
function of the National DPP at the
national level, including for MDPP. The
DPRP awards four categories of
recognition: Pending, preliminary, full,
and full-plus. Organizations may
participate in MDPP with preliminary,
full, or full-plus CDC recognition.
Organizations may advance in CDC
DPRP recognition by demonstrating
their ability to effectively deliver the
behavioral change program
(preliminary) and achieve the outcomes
shown to prevent or delay type 2
diabetes (full and full-plus). To achieve
full CDC recognition, organizations
must demonstrate a reduction in risk of
developing type 2 diabetes among
completers in the evaluation cohort by
showing that at least 60 percent of all
completers achieved at least one of the
following outcomes:
• At least 5 percent weight loss 12
months after the cohort began; or
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• At least 4 percent weight loss and
at least 150 minutes/week on average of
physical activity 12 months after the
cohort began; or
• At least a 0.2 percent reduction in
HbA1C.
Organizations are granted an
additional 2 years of full recognition
(full-plus), for a total of 5 years if, at the
time full recognition is achieved,
organizations meet the following
retention criteria:
• A minimum of 50 percent at the
beginning of the fourth month since the
cohorts held their first sessions;
• A minimum of 40 percent at the
beginning of the seventh month since
the cohorts held their first sessions; and
• A minimum of 30 percent at the
beginning of the tenth month since the
cohorts held their first sessions.
In the CY 2017 PFS final rule, we
indicated that we would align the CDC’s
DPRP and MDPP to the greatest extent
possible. When the CY 2018 PFS went
into effect on January 1, 2018, CDC’s
2018 DPRP Standards had neither been
publicly released nor gone into effect.
For these reasons, we had to establish
an interim MDPP preliminary
recognition so that eligible organizations
could begin enrolling in Medicare to
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become MDPP suppliers starting
January 1, 2018, and approved suppliers
could start serving Medicare
beneficiaries on April 1, 2018.
When the CY 2018 PFS final rule was
issued, the CDC 2015 DPRP Standards
were still in effect, and CDC only
recognized organizations with pending
or full DPRP recognition. Consequently,
CMS and CDC developed an interim
solution that would allow organizations
that met the MDPP interim preliminary
recognition standard, which went into
effect on January 1, 2018, to become
eligible to enroll in Medicare as an
MDPP supplier.
Because CMS and CDC understood
that there would be a 2 to 4-month gap
between when the CY 2018 PFS went
into effect for MDPP (January 1, 2018)
and when the CDC 2018 DPRP
Standards would be cleared and go into
effect, we worked with CDC to establish
an interim solution so that eligible
organizations with MDPP interim
preliminary or CDC DPRP full
recognition could apply to Medicare to
become MDPP suppliers before the
CDC’s 2018 Standards went into effect
on March 1, 2018. The CY 2018 PFS
final rule at § 424.205(c)(2)(ii)
established that CDC-recognized
organizations with pending CDC DPRP
recognition could meet additional
criteria for an ‘‘interim preliminary
recognition’’ standard and enroll as
MDPP suppliers. With the MDPP new
supplier type going into effect on
January 1, 2018, and beneficiary
enrollment starting on April 1, 2018, we
wanted suppliers to be able to enroll in
Medicare to become MDPP suppliers in
time for the April 1 MDPP launch.
Now that the CDC DPRP Standards for
preliminary recognition are in effect, we
propose to remove § 424.205(c) and
retire the MDPP ‘‘interim preliminary
recognition’’ standard. We also propose
to amend § 424.59(a)(1) (redesignated
§ 424.205(b)(1)) to require that, at the
time of enrollment, organizations have
preliminary, full, or full-plus CDC DPRP
recognition. As described in the CY
2018 PFS final rule, MDPP suppliers
who received MDPP interim
preliminary recognition during the 4month time period between when the
CY 2018 PFS final rule was published
and when the CDC 2018 standards went
into effect, have achieved at least CDC
preliminary recognition.
To maintain compliance with the
current CDC DPRP Standards,
organizations that enrolled in Medicare
as MDPP suppliers based on their MDPP
interim preliminary recognition
between January 1, 2018 and February
28, 2018 would have had at least two
CDC DPRP evaluations given the 5-year
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time lapse. Per CDC DPRP Standards,
organizations are required to submit
data to CDC every 6 months, and
undergo evaluation every 12 to 18
months, depending upon the timing of
new cohorts.
Since the CDC DPRP Standards were
updated in 2018 and 2021 and are due
to be updated in Spring 2024, suppliers
are required to meet the most current
CDC DPRP Standards for preliminary,
full, or full-plus recognition to maintain
their eligibility to enroll and participate
in MDPP as MDPP suppliers.
Organizations that are interested in
enrolling in Medicare as MDPP
suppliers should refer to the CDC
DPRP’s most current standards 1 to
understand how to obtain preliminary,
full, or full-plus CDC recognition, and
consult § 424.205 for all other
enrollment conditions that need to be
met, in advance of submitting their
application to become a MDPP supplier.
We propose to amend § 424.205
newly designated paragraphs (c) and (f)
to remove reference to, and
requirements of, the Ongoing
Maintenance phase described in these
sections with the exception of § 424.205
newly designated paragraph (d)(14),
which we are retaining for historical
recordkeeping and crosswalk purposes.
In the CY 2022 PFS, CMS removed
eligibility for the Ongoing Maintenance
Sessions for those beneficiaries who
started the Set of MDPP services on or
after January 1, 2022. Eligibility for
these services will end December 31,
2023.
We are proposing to amend § 424.205
(a), (b)(1), newly redesignated
paragraphs (c)(1) and (g)(1)(i)(C). We
seek comment on these proposals.
4. Proposed Changes to § 424.210(b) and
(d)
We propose to amend § 424.210(b)
and (d) to remove reference to, and
requirements of, the Ongoing
Maintenance phase described in these
sections. In the CY 2022 PFS final rule,
CMS removed eligibility for the Ongoing
Maintenance Sessions for those
beneficiaries who started the Set of
MDPP Services on or after January 1,
2022. Eligibility for these services will
end December 31, 2023.
We are proposing to amend its
regulation at § 424.210 by amending
paragraphs (b) and (d). We seek
comment on these proposals.
J. Appropriate Use Criteria for
Advanced Diagnostic Imaging
Section 1834(q) of the Act, as added
by section 218(b) of the Protecting
Access to Medicare Act (Pub. L. 113–93,
April 1, 2014) (PAMA), directs CMS to
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establish a program to promote the use
of appropriate use criteria (AUC) for
advanced diagnostic imaging services.
Since the bill was passed, we have taken
steps to implement this program and
codified the AUC program in our
regulations at 42 CFR 414.94. In CY
2020, we began conducting an
educational and operations testing
period for the claims-based reporting of
AUC consultation information and the
program currently operates in this
phase.
1. Background
AUC are evidence-based guidelines
that assist clinicians in selecting the
imaging studies most likely to improve
health outcomes for patients based on
their individual clinical presentation.
AUC present information in a manner
that links a specific clinical condition or
presentation; one or more services; and
an assessment of the appropriateness of
the service(s). For purposes of this
program, AUC are a set or library of
individual AUC. Each individual
criterion is an evidence-based guideline
for a particular clinical scenario based
on a patient presenting symptoms or
condition. Under this program, any
clinician who orders an advanced
diagnostic imaging service must consult
AUC for the imaging service ordered.
Examples of advanced diagnostic
imaging services include computed
tomography, positron emission
tomography, nuclear medicine and
magnetic resonance imaging.
To consult AUC, clinicians use
clinical decision support mechanisms
(CDSMs). CDSMs are the electronic
portals through which clinicians access
the AUC during the patient workup.
They can be standalone applications
that require direct entry of patient
information, but may be more effective
when they are integrated into electronic
health records (EHRs). Ideally,
clinicians would interact directly with
the CDSM through their primary user
interface, thus minimizing interruption
to the clinical workflow.
Under the AUC program, clinicians
and facilities that furnish the imaging
service are responsible for reporting
information about the ordering
clinician’s AUC consultation on the
imaging service claim. The furnishing
clinician and facility are not paid if the
ordering clinician fails to consult and/
or if the consultation information is not
correctly included on the imaging
service claim.
2. Statutory Authority
Section 218(b) of the PAMA added a
new section 1834(q) of the Act entitled,
‘‘Recognizing Appropriate Use Criteria
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for Certain Imaging Services,’’ which
directed the Secretary to establish a
program to promote the use of AUC.
Section 1834(q)(4) of the Act requires
ordering professionals to consult with
specified applicable AUC through a
qualified CDSM for applicable imaging
services furnished in an applicable
setting and paid for under an applicable
payment system; and payment for such
service may only be made if the claim
for the service includes information
about the ordering professional’s
consultation of specified applicable
AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
and Implementation
There are four major components of
the AUC program under section 1834(q)
of the Act, and each component has its
own implementation date: (1)
establishment of AUC by November 15,
2015 (section 1834(q)(2) of the Act); (2)
identification of mechanisms for
consultation with AUC by April 1, 2016
(section 1834(q)(3) of the Act); (3) AUC
consultation by ordering professionals,
and reporting on AUC consultation by
January 1, 2017 (section 1834(q)(4) of
the Act); and (4) annual identification of
outlier ordering professionals (based on
low adherence to AUC) for services
furnished after January 1, 2017 (section
1834(q)(5) of the Act). These four
components are precursors to the
requirement that, beginning for CY
2017, we establish mandatory prior
authorization procedures for outlier
ordering professionals when ordering
advanced diagnostic imaging services
(section 1834(q)(6) of the Act).
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a. Establishment of AUC
We addressed the first component of
the Medicare AUC program under
section 1834(q)(2) of the Act,
establishment of AUC, in the CY 2016
PFS final rule with comment period (80
FR 70886). With this rule, we began to
codify the statutory requirements in our
regulations at 42 CFR 414.94. We also
defined provider-led entity (PLE) as
well as additional definitions under
section 1834(q)(1) of the Act in our
regulations at § 414.94(b). In
§ 414.94(c)(1) and (2), respectively, we
set forth the requirements and process
by which PLEs become qualified by
CMS to develop, modify or endorse
AUC. We qualified the first group of
PLEs under the AUC program and
posted them to the CMS website in June
2016 at which time their AUC libraries
became specified applicable AUC for
purposes of section 1834(q)(2)(A) of the
Act.
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b. Identification of Mechanisms for
Consultation With AUC
We addressed the second component
under section 1834(q)(3) of the Act,
identification of mechanisms for
consultation with AUC, in the CY 2017
PFS final rule (81 FR 80170). In this rule
we defined clinical decision support
mechanism (CDSM) in § 414.94(b). In
§ 414.94(g)(1) and (2), respectively, we
set forth the requirements CDSMs must
meet and established a process by
which CDSMs may become qualified by
CMS in accordance with the statutory
requirements under section
1834(q)(3)(B)(ii). We qualified the first
group of CDSMs under the AUC
program and posted them to the CMS
website in July 2017.
c. AUC Consultation and Reporting
We addressed the third component
under section 1834(q)(4) of the Act,
AUC consultation by ordering
professionals, and reporting on AUC
consultation, primarily in the CY 2018
PFS final rule (82 FR 53190).
Additionally, in the CY 2017 PFS final
rule, we defined terms in § 414.94(b) (81
FR 80405 and 80406) and identified
exceptions to the AUC consultation and
reporting requirements under section
1834(q)(4) in § 414.94(i) (81 FR 80422
through 80424) which are pertinent to
the third component. We also continued
to revise the regulation at § 414.94 as
needed and in response to comments
from interested parties in subsequent
rulemaking cycles. These updates,
revisions and clarifications, which
continued through annual PFS
rulemaking for CYs 2018, 2019, and
2020, are discussed throughout this
section as they directly relate to the
AUC consultation requirement under
section 1834(q)(4)(A) of the Act and
reporting requirement under section
1834(q)(4)(B) of the Act.
In the CY 2017 PFS final rule we
defined applicable payment systems
consistent with section 1834(q)(4)(D) of
the Act to include the PFS established
under section 1848(b) of the Act, the
prospective payment system for hospital
outpatient department services under
section 1833(t) of the Act, and the
ambulatory surgical center payment
system under section 1833(i) of the Act
(81 FR 80406). In the CY 2016 PFS final
rule with comment period we defined
applicable setting consistent with
section 1834(q)(1)(D) of the Act to
include a physician’s office, a hospital
outpatient department (including an
emergency department), and an
ambulatory surgical center (80 FR
71105). We later added independent
diagnostic testing facility (IDTF) to the
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definition of applicable setting in the
CY 2019 PFS final rule (83 FR 59690
and 59691).
Also in the CY 2017 PFS final rule,
consistent with section 1834(q)(4)(C) of
the Act, we identified exceptions to the
AUC consultation and reporting
requirements under section 1834(q)(4)
of the Act in the case of: a service
ordered for an individual with an
emergency medical condition, a service
ordered for an inpatient and for which
payment is made under Medicare Part
A, and a service ordered by an ordering
professional for whom the Secretary
determines that consultation with
applicable AUC would result in a
significant hardship (81 FR 80422
through 80424). The significant
hardship exception criteria and process
under § 414.94(i)(3) was later updated in
the CY 2019 PFS final rule (83 FR 59697
through 59700).
In the CY 2018 PFS final rule, we
established a voluntary period from July
2018 through the end of 2019 during
which ordering professionals who were
ready to participate in the AUC program
could consult specified applicable AUC
through qualified CDSMs and
communicate the results to furnishing
professionals (82 FR 53193 through
53195). Furnishing professionals who
were ready to do so could report AUC
consultation information on the claim.
To incentivize early use of qualified
CDSMs for consulting AUC, we
established in the CY 2018 Updates to
the Quality Payment Program; and
Quality Payment Program: Extreme and
Uncontrollable Circumstances Policy for
the Transition Year final rule with
comment period and interim final rule
a high-weight improvement activity for
ordering professionals who consult
specified AUC using a qualified CDSM
for the Merit-based Incentive Payment
System (MIPS) performance period that
began January 1, 2018 (82 FR 54193).
In addition, in the CY 2018 PFS final
rule, we established the start date of
January 1, 2020, for the Medicare AUC
program for advanced diagnostic
imaging services in § 414.94(j)(1) (82 FR
53189 through 53195). Specifically, for
services ordered on and after January 1,
2020, we established that ordering
professionals must consult specified
applicable AUC using a qualified CDSM
when ordering applicable imaging
services in § 414.94(j), and furnishing
professionals must report AUC
consultation information on the
Medicare claim in § 414.94(k). In the CY
2019 PFS final rule, we specified under
§ 414.94(j)(2) that when delegated by the
ordering professional, clinical staff
under the direction of the ordering
professional may perform the AUC
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consultation with a qualified CDSM. In
the CY 2018 PFS final rule, we further
specified that the AUC program,
including the claims denial payment
penalty phase, would begin on January
1, 2020, with a year-long educational
and operations testing period for CY
2019 during which AUC consultation
information was expected to be reported
on claims, but claims would not be
denied for failure to include proper
AUC consultation information (82 FR
53193 through 53195). As discussed in
further detail below, the educational
and operations testing period was
subsequently extended multiple times
and the program currently operates in
the educational and operations testing
period.
In the CY 2018 PFS final rule and
consistent with section 1834(q)(4)(B) of
the Act, we established in § 414.94(k)
that the following information must be
reported on Medicare claims for
advanced diagnostic imaging services:
(1) the qualified CDSM consulted by the
ordering professional; (2) whether the
service ordered would or would not
adhere to specified applicable AUC, or
whether the specified applicable AUC
consulted was not applicable to the
service ordered; and (3) the NPI of the
ordering professional (if different from
the furnishing professional) (82 FR
53190 through 53193). Section
1834(q)(4)(B) of the Act specifies that
payment for advanced diagnostic
imaging service claims under the AUC
program may only be made if the claim
submitted by the furnishing professional
(of which there can be more than one if
the professional component is furnished
by a different entity than the technical
component) includes this information
about the ordering professional’s AUC
consultation. This statutory requirement
establishes a real-time claims-based
reporting requirement whereby payment
for the imaging service is contingent
upon specific information being present
on the claim. We worked to
operationalize the real-time claimsbased reporting requirement by
announcing our intention to use
G-codes and HCPCS modifiers to report
AUC consultation information on the
Medicare claims in the CY 2019 PFS
final rule.
In the CY 2022 PFS final rule (86 FR
64996), we provided further
clarification around the scope of the
AUC program specifically pertaining to
updates or modifications to orders for
advanced diagnostic imaging services
(86 FR 65227 through 65229), the
extreme and uncontrollable
circumstances significant hardship
exception (86 FR 65229 and 65230) and
specified claims processing solutions,
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including creation and use of a new
HCPCS modifier intended to accurately
identify claims that are and are not
subject to the AUC program
requirements. We also discussed special
circumstances related to: services
furnished by a critical access hospital
(CAH) (86 FR 65231 and 65232),
services paid under the Maryland Total
Cost of Care Model (86 FR 65232 and
65233), inpatients converted to
outpatients (86 FR 65233 and 65234),
Medicare as the secondary payer (86 FR
65234 and 65235), and imaging services
ordered prior to the start of the claims
denial payment penalty phase but
furnished on or after the start of the
payment penalty phase (86 FR 65235).
We addressed where to identify the
ordering professional on practitioner
claims for imaging services (86 FR
65231) (we addressed where to identify
ordering professionals on institutional
claims in educational materials
following the CY 2019 PFS final rule
claims-based reporting discussion (83
FR 59696)) and confirmed that claims
that do not properly append AUC
consultation information will be
returned for correction and
resubmission, rather than denied, when
the payment penalty phase begins (86
FR 65234). We did not specify how long
claims would be returned before the
payment penalty phase would shift to
claim denials. Finally, we established
that the payment penalty phase would
begin on the later of January 1, 2023, or
the January 1 that follows the declared
end of the PHE for COVID–19. Under
this specification and with the declared
end of the PHE for COVID–19 on May
11, 2023, the payment penalty phase
would have been scheduled to begin on
January 1, 2024. However, as announced
via the AUC website in 2022 and
discussed further below in this section
of the proposed rule, the educational
and operations testing period will
continue until further notice. We did
not include provisions pertaining to the
AUC program in the CY 2023 PFS final
rule (87 FR 69404).
d. Identification of Outlier Ordering
Professionals
We began to address the fourth
component under section 1834(q)(5) of
the Act, identification of outlier
ordering professionals, in the CY 2017
PFS final rule by finalizing the first list
of priority clinical areas (PCAs) in
§ 414.94(e)(5) (81 FR 80406 through
80412) which were intended to
ultimately guide identification of outlier
ordering professionals who would
eventually be subject to prior
authorization when ordering advanced
diagnostic imaging services. Section
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1834(q)(5) of the Act directs CMS to: (1)
determine on an annual basis no more
than 5 percent of total ordering
professionals who are outlier ordering
professionals; and (2) base the
determination of an outlier ordering
professional on low adherence to AUC
which may be based on comparisons to
other ordering professionals and include
data for ordering professionals for
whom prior authorization applies; and
(3) use 2 years of data to identify outlier
ordering professionals; and (4) consult
with physicians, practitioners and other
interested parties in developing
methods to identify outlier ordering
professionals. To date, we have not
proposed or codified the methods for
identifying outlier ordering
professionals as prescribed by section
1834(q)(5) of the Act, and thus, we have
not subjected any ordering professionals
to prior authorization when ordering
advanced diagnostic imaging services as
prescribed by section 1834(q)(6) of the
Act.
4. Timeline
As evident from the description of our
regulatory activities to date, we have not
met the statutory implementation time
frame for the AUC program components.
The educational and operations testing
period began January 1, 2020, and the
AUC program continues to operate in
this phase currently. In this phase, there
are no payment penalties for advanced
diagnostic imaging service claims that
do not append AUC consultation
information. The provisions in section
1834(q) of the Act repeatedly stress the
importance of engagement with
interested parties in developing the
Medicare AUC program. Throughout
our implementation activities, we have
intentionally taken a diligent, stepwise
implementation approach to maximize
the opportunity for public comment and
engagement with interested parties, and
allow for adequate advance notice to
physicians and practitioners,
beneficiaries and other AUC interested
parties of any programmatic changes or
updates. These efforts to maximize
engagement included speaking and
answering live questions at multiple
CMS Open Door Forums, participating
in external meetings sponsored by and
at the request of interested parties like
medical specialty societies and health
care practitioners, and meeting in
person and virtually with interested
parties upon request to receive feedback
and answer questions to the best of our
ability and within the context of already
publicly available information. All of
these interactions were critical to inform
our proposals during each round of
notice and comment rulemaking. This
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approach has allowed us to be
comprehensive in our assessment of
implementation options and regulatory
proposals, responsive to concerns
expressed by interested parties, and
agile in reacting to unexpected events,
like the PHE for COVID–19. Since the
CY 2022 PFS final rule was released, we
have used the AUC website 250 to
publicly announce updates to the AUC
program. In July 2022, we updated the
AUC website to inform interested
parties that the payment penalty phase
of the AUC program would not begin on
January 1, 2023 even if the PHE for
COVID–19 ended in 2022. This update
also stated that the educational and
operations testing period would
continue and that we are not able to
forecast when the payment penalty
phase will begin. In October 2022, we
updated the AUC website again to
announce that applications for CDSM
and PLE initial qualification and requalification would not be accepted for
the 2023 application cycle and that all
CDSMs and PLEs qualified as of July
2022 would remain qualified through
this cycle.
5. Proposal To Pause Program for
Reevaluation
Since 2015, we have taken a
thoughtful, stepwise approach that
maximized engagement and
involvement of interested parties to
implement the statutory provisions set
forth in section 1834(q), as added by
section 218(b) of the PAMA, using
notice and comment rulemaking. As
discussed previously in this section of
the proposed rule, we established the
first two components of the AUC
statutory requirements—establishment
of AUC and mechanisms for
consultation. We began to build the
parameters for the fourth component,
outlier identification, leading to prior
authorization, by establishing the PCAs.
And we began implementing the third
component, the AUC consultation and
reporting requirement, using the
ongoing educational and operations
testing period. At this time, however,
we have exhausted all reasonable
options for fully operationalizing the
AUC program consistent with the
statutory provisions as prescribed in
section 1834(q)(B) of the Act directing
CMS to require real-time claims-based
reporting to collect information on AUC
consultation and imaging patterns for
advanced diagnostic imaging services to
ultimately inform outlier identification
and prior authorization. As a result, we
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propose to pause implementation of the
AUC program for reevaluation, and
rescind the current AUC program
regulations from § 414.94. We expect
this to be a hard pause to facilitate
thorough program reevaluation and, as
such, we are not proposing a time frame
within which implementation efforts
may recommence.
a. Real-Time Claims-Based Reporting
Section 1834(q)(4)(A) of the Act
requires ordering professionals to
consult AUC using a qualified CDSM.
Section 1834(q)(4)(B) of the Act requires
furnishing professionals to report
information about the ordering
professional’s AUC consultation with a
qualified CDSM on the Medicare claim
for the advanced diagnostic imaging
service the ordering professional
ordered. This section dictates that
payment to the furnishing professional
is contingent on reporting the ordering
professional’s AUC consultation
information, which must include the
ordering professional’s NPI, the
qualified CDSM that was consulted, and
whether the service ordered adheres or
does not adhere to the AUC consulted,
or if there were no AUC applicable to
the order available for consultation via
the qualified CDSM that was consulted
as described above.
While each component of the
statutory requirements has presented
unique challenges to implement, the
greatest challenge has been in fully
implementing and operationalizing the
real-time claims-based reporting
requirement consistent with section
1834(q)(4)(B) of the Act so as to ensure
accurate reporting, claims processing
and, ultimately, outlier identification
and prior authorization. We formally
solicited public comment and feedback
from interested parties in notice and
comment rulemaking in the CY 2017
PFS rulemaking cycle, and have
welcomed and encouraged feedback and
information from interested parties less
formally throughout the duration of our
implementation efforts in each
successive year. In the CY 2017 PFS
final rule, we discussed the importance
of developing and operationalizing a
meaningful solution for collecting AUC
consultation information on Medicare
claims. We explained that ‘‘we must
diligently evaluate our options taking
into account the vast number of claims
impacted and the limitations of the
legacy claims processing system.’’ We
further noted that ‘‘[m]oving too quickly
to satisfy the reporting requirement
could inadvertently result in technical
and operational problems that could
cause delays in payments’’ (81 FR
80420). In addition to consulting with
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claims processing experts outside of and
between rulemaking cycles, we
continued to clearly and intentionally
solicit feedback and suggestions from
interested parties to assist us in
developing workable claims processing
edits and solutions to operationalize the
AUC reporting requirement consistent
with section 1834(q)(4)(B) of the Act in
rulemaking cycles for the CY 2018, 2019
and 2022 PFS.
Having considered many rounds of
input from interested parties, including
internal and external experts, and
diligent exploration of options, we have
come to believe that the real-time
claims-based reporting requirement
prescribed by section 1834(q)(4)(B) of
the Act presents an insurmountable
barrier for CMS to fully operationalize
the AUC program. To properly apply the
statutory provisions of the AUC
program, including specifications
around settings in which services are
furnished and payment systems under
which Medicare payments are made, it
is critical that claims are accurately
identified in the Medicare claims
processing system and accurately
subjected to system’s edits to ensure
AUC consultation information is
properly reported on the claim. Equally
important is ensuring that claims not
subject to the AUC program are not
inappropriately subjected to claims
system’s edits. We consider a process
where the Medicare claims processing
system properly and accurately
identifies only claims for services
subject to the AUC program
requirements, without manual action by
practitioners/facilities that submit
claims, to be a fully automated process.
The existing Medicare claims processing
system does not have the capacity to
fully automate the process for
distinguishing between advanced
diagnostic imaging claims that are or are
not subject to the AUC program
requirement to report AUC consultation
information as prescribed by section
1834(q)(4)(B) of the Act. This means that
the Medicare claims processing system
is not able to ensure that claims for
services that are not subject to the AUC
consultation information reporting
requirement will not be improperly
denied for failure to append AUC
consultation information. We note here
that our intention, as announced in the
CY 2022 PFS final rule, was to begin the
payment penalty phase of the AUC
program by returning, rather than
denying, claims for advanced diagnostic
imaging services that do not contain
AUC consultation information for
correction and resubmission; however,
section 1834(q)(4)(B) of the Act specifies
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that payment for advanced diagnostic
imaging services under the AUC
program may only be made if the claim
for the imaging service includes specific
AUC consultation information.
Consequently, the payment penalty
phase would eventually need to shift
from returning claims for correction and
resubmission to denying claims. As
such, and without the practicable
capacity to fully automate the process
for editing claims to ensure only
appropriate claims are edited for AUC
consultation information, there is a
significant risk that full implementation
of the penalty phase of the AUC
program would result in inappropriate
claims denials.
To avoid these inappropriate denials,
we considered requiring claims to
include certain modifiers that would
identify them as not being subject to the
AUC consultation and reporting
requirements under section
1834(q)(4)(A) and (B) of the Act.
However, this would add an extra layer
of burden on furnishing professionals,
including freestanding and hospitalbased imaging facilities, requiring them
to append information to the claims
even for services that are not subject to
the AUC consultation and reporting
requirement in order to allow us to
identify which imaging services are and
are not subject to the AUC consultation
and reporting requirements under
section 1834(q)(4)(A) and (B) of the Act,
and allow us to appropriately process
claims.
Additionally, the AUC program is
designed to target a subset of advanced
diagnostic imaging services furnished in
specific settings and paid under specific
payment systems, as opposed to, for
example, all Medicare part B advanced
diagnostic imaging service claims, and
includes multifaceted criteria for
identifying which services are subject to
the program. As such, ordering
professionals would need to know, at
the time of the order, where each
imaging service will be furnished and
under which payment system the claim
will be paid to determine whether AUC
consultation, and transmission of AUC
consultation information with the order,
is required. Furnishing professionals,
including freestanding and hospitalbased imaging facilities, would need to
be able to delineate which orders
received without AUC consultation
information are not subject to the AUC
program from those that are subject to
the program and its requirements. If
they are able to confirm that a service
is not subject to the AUC program, then
they would need to identify the
appropriate modifier to append to the
claim so it can be processed and be paid
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without AUC consultation information.
Alternatively, if they find that the order
is subject to the AUC program, they
would need to take steps to obtain AUC
consultation information from the
ordering professional, decline to furnish
the service, or risk denial of the claim
for a furnished service.
An example that highlights the
practical complexity and unwieldiness
of the AUC program is the, not
uncommon, scenario where an
advanced diagnostic imaging service is
furnished in two settings—only one of
which is an applicable setting. For
example, this occurs when the technical
component (TC) of an imaging service is
furnished in a setting, like a critical
access hospital (CAH), that is not an
applicable setting. As we discussed in
the CY 2022 PFS final rule, because the
service was not furnished in an
applicable setting, the entirety of the
service (both the technical and
professional component (PC)), is not
subject to the AUC consultation
requirement. Therefore, neither of the
separate claims for the TC and PC for
the service are required to include AUC
consultation information. However,
there is no way in real-time claims
processing for us to identify that the PC
claim is for an imaging service that was
not furnished in an applicable setting.
For the claim to process and be paid
when it does not include AUC
consultation information, the furnishing
professional for the PC would need to
append a modifier to the claim to
identify it as not being subject to the
AUC consultation and reporting
requirement.
b. Accuracy of Claims Data
Because, as noted above, the CMS
claims processing system is unable to
fully automate editing advanced
diagnostic imaging claims, risks around
reporting accuracy are inherent to the
AUC program prescribed by section
1834(q)(4)(B) of the Act. These risks
directly impact furnishing professionals,
including free-standing and hospitalbased facilities, by affecting payment for
advanced diagnostic imaging services
they furnish, in some cases based on
conduct of ordering professionals with
whom they have little or no affiliation.
Beyond the potential for inappropriate
claims denials as discussed above, by
manually appending information to
their claims as supplied by ordering
professionals, furnishing professionals
are attesting to the credibility and
accuracy of that information and may
find themselves subject to audits or
post-pay review. Considering that the
AUC program ultimately involved the
identification of outlier ordering
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professionals and imposing a prior
authorization procedure for them as
prescribed in sections 1834(q)(5) and (6)
of the Act, reliance on manual reporting
by one party of information supplied by
another party presents a serious risk to
data accuracy and integrity. Since
section 1834(q)(5) of the Act directs
CMS to use these data from claimsbased AUC consultation information
collection to identify outlier ordering
professionals, and section 1834(q)(6) of
the Act directs CMS to require prior
authorization for outlier ordering
professionals, the quality and accuracy
of the data used to make these
determinations is critical to ensure the
AUC program leads to appropriate
application of prior authorization for
advanced diagnostic imaging services.
c. Effect on Medicare Beneficiaries
We recognize that a program to
promote the use of AUC for advanced
diagnostic imaging could improve
imaging utilization patterns for
Medicare beneficiaries. Ideally,
beneficiaries would undergo fewer and
more appropriate imaging procedures to
inform more efficient treatment plans
and address medical conditions more
quickly and without unnecessary tests.
In the CY 2019 PFS final rule, we
estimated how adding AUC consultation
to an ordering professional’s workload
would directly impact a Medicare
beneficiary based on the additional
office visit time needed for consultation
and ordering. We estimated this impact
by calculating the cost to beneficiaries
associated with the additional
consultation time to be $68,001,000
annually (83 FR 60040). In the CY 2022
PFS final rule we updated this estimate
based on Medicare claims data and
changes in wage estimates to
$54,789,518 annually. We estimated
that potential savings would offset this
cost by $27,394,759 annually based on
process efficiencies that may be
implemented over time by ordering
professionals (86 FR 65626). In the CY
2019 PFS final rule, we estimated other
impacts associated with the AUC
program including potential savings to
the Medicare program. We estimated
potential savings of $700,000,000
annually by extrapolating savings from
a clinical decision support pilot project
performed by the Institute for Clinical
Systems Improvement in Bloomington,
Minnesota 251 (83 FR 60043). Since this
estimate was based on information from
previous clinical decision support
experiences and not Medicare claims
251 Miliard, M. Nuance, ICSI aim to prevent
unnecessary imaging tests. Healthcare IT News.
November 10, 2010.
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data or wage estimates, we did not
update this estimate in the CY 2022 PFS
final rule.
While the incorporation of any new
process into workflows can be expected
to impart burden that eventually
lessens, we have additional concerns
about risks for beneficiaries stemming
from the real-time claims-based
reporting requirement prescribed by
section 1834(q)(4)(B) of the Act. Beyond
the burden of adding to the workload of
the ordering and furnishing
professionals for advanced diagnostic
imaging services, the AUC consultation
program can produce risk to
beneficiaries in receiving timely
imaging services, and potentially being
financially liable for advanced
diagnostic imaging service claims
denied by the Medicare program,
whether properly or due to omissions or
errors in conveying AUC consultation
information on claims. Beneficiaries
may experience delays in scheduling
and receiving imaging if AUC
information is not properly provided
with the order from the ordering
professional to furnishing professionals/
facilities. This may happen, even if the
imaging service is not subject to the
AUC program requirements, in any
circumstance where the furnishing
professional/facility is unclear whether
the AUC consultation and reporting
requirements apply (for example if
Medicare is the secondary payer, or
under other circumstances as discussed
in the CY 2022 PFS final rule). Section
1834(q) of the Act does not separately
establish protections to Medicare
beneficiaries from financial liability for
advanced diagnostic imaging service
claims not paid by Medicare as required
under the AUC program. As discussed
above, because the Medicare claims
processing system cannot fully automate
a process to ensure only claims for
advanced diagnostic imaging services
subject to the AUC program reporting
requirement under section 1834(q)(4)(B)
of the Act are edited as such, there is a
risk of inappropriate claims denials.
Additionally, in the event that an
ordering professional fails to consult
AUC or neglects to communicate AUC
consultation information (or relevant
exception information) to the furnishing
professional/facility and the furnishing
professional/facility proceeds with
furnishing the imaging service despite
the absence of this information, the
beneficiary may incur unwarranted
financial liability for the imaging
service.
d. Summary
Taken together and, in particular, due
to the inability of the Medicare claims
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processing system to automate claims
processing edits that ensure only claims
subject to the AUC program
requirements as prescribed in section
1834(q) of the Act will be processed as
such, returned or denied accordingly,
we believe the inherent risks in terms of
data integrity and accuracy, beneficiary
access, and potential beneficiary
financial liability for advanced
diagnostic imaging services render the
AUC program impracticable, and have
led us to our proposal to pause efforts
to implement the AUC program for
reevaluation and rescind current
regulations. Working within the
parameters prescribed under section
1834(q) of the Act, we have not
identified any practical way to move the
AUC program forward beyond the
educational and operations testing
period. Further, without a way forward
to fully implement the AUC program,
we believe there is no utility in
continuing the educational and
operations testing period. We will
continue efforts to identify a workable
implementation approach and will
propose to adopt any such approach
through subsequent rulemaking. We
note, and discuss further below in this
section of the proposed rule, that
clinical decision support tools can be
beneficial in assisting with clinical
decision making and we encourage
continued use of clinical decision
support in a manner that best serves and
assists clinicians.
6. Summary of Other Quality Initiatives
As discussed above, section 218(b) of
the PAMA of 2014 entitled ‘‘Promoting
Evidence-Based Care’’ established the
Medicare AUC program. The statute was
designed to promote the use of AUC for
advanced diagnostic imaging services
with enforcement through immediate
non-payment of claims for which there
was no AUC consultation and,
eventually, prior authorization for
‘‘outliers’’ that more frequently neglect
to consult AUC. Promoting the use of
AUC in clinical practice is an activity
that encourages the use of evidencebased information/guidelines/
recommendations to guide patient care
thus resulting in improved value and
quality. Subsequent to PAMA, the
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
(Pub. L. 114–10, April 16, 2015)
established the Quality Payment
Program, which is an incentive program
to tie Medicare PFS payment to
performance by rewarding high-value,
high-quality care. After enactment of
these laws, CMS worked to implement
both programs by successfully
establishing and fully operationalizing
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the Quality Payment Program (both the
Merit-based Incentive Payment System
(MIPS) and Advanced Alternative
Payment Models (APMs)) and, as
discussed above, taking steps to
implement each component of the AUC
program up to and through the ongoing
educational and operations testing
period. We have developed outreach
and educational materials and made all
AUC program-related information
available on the CMS AUC website.252
We believe that many goals of the AUC
program have been met by the QPP and
other more comprehensive accountable
care initiatives such as the Medicare
Shared Savings Program, advances in
electronic clinical quality measures
(eCQMs) and Interoperability
requirements of Certified Electronic
Health Record Technology (CEHRT),
and new Innovation Center models such
as ACO REACH and Kidney Care
Choices where physicians and other
health care providers join together to
take responsibility for both the quality
of care and total cost of care their
patients experience. These quality and
value-based care programs are designed
to achieve quality of care goals by
addressing issues of utilization, cost and
quality holistically instead of via claimby-claim examination and improvement
initiatives for specific types of services.
While these initiatives, including the
Shared Savings Program, do not
specifically target advanced diagnostic
imaging, we expect that this more global
approach to improving quality and
accountable care would broadly affect
all services, including advanced
diagnostic imaging utilization. Both
ACO participation and episode of care
payment models promote accountability
for beneficiary cost of care as well as
improving or maintaining quality of care
according to applicable quality
measures. Similarly, the MIPS ties
together quality and costs by measuring
and scoring performance in four
performance categories: quality, cost,
improvement activities, and promoting
interoperability. MIPS uses measures
and activities in each of these
categories, such as the Total Per Capita
Cost (TPCC) specialty measure, which
focuses on effective primary care
management to support Medicare
savings. While also not specific to
advanced diagnostic imaging,
improvements in primary care
management including ordering of
diagnostic tests may involve
consideration of appropriate imaging
orders.
252 https://www.cms.gov/medicare/qualityinitiatives-patient-assessment-instruments/
appropriate-use-criteria-program.
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More specific to advanced diagnostic
imaging, MIPS includes 10 specific
quality measures pertaining to imaging
or under the ‘‘Diagnostic Radiology’’
Specialty Measure Set. Additionally, the
Meaningful Measures 2.0 Framework
includes a priority area for safety with
the goal of ‘‘Reduced Preventable Harm’’
(https://edit.cms.gov/files/document/
cascade-meaningful-measuresframework.xlsx). An objective under
this goal is ‘‘Diagnostic Accuracy/Error’’
which includes a cascade measure
concept/family of ‘‘Appropriate use of
radiology and lab testing.’’ An example
of an existing measure within this
concept is ‘‘Appropriate Follow-up
Imaging for Incidental Abdominal
Lesions’’ (https://www.cms.gov/files/
document/cascade-measures.xlsx).
While a standalone program
specifically requiring AUC consultation
when ordering advanced diagnostic
imaging services would directly target
goals of improving advanced diagnostic
imaging ordering patterns, our
experience in recent years has
demonstrated that the goals of
appropriate, evidence based,
coordinated care can be achieved more
effectively, efficiently and
comprehensively through other CMS
quality initiatives.
making in clinical practice and improve
quality of care. Resources on clinical
decision support are available on HHS
Agency websites including the
following:
• Office of the National Coordinator—
https://www.healthit.gov/topic/safety/
clinical-decision-support.
• Agency for Healthcare Research and
Quality—https://www.ahrq.gov/cpi/
about/otherwebsites/clinical-decisionsupport/.
• Centers for Disease Control and
Prevention—https://www.cdc.gov/
opioids/healthcare-admins/ehr/clinicaldecision-support.html.
7. Proposal To Rescind § 414.94
To execute this proposal and provide
clarity to interested parties, we propose
to amend our regulations to rescind the
current regulations by removing the text
of § 414.94 and reserve it for future use.
This section contains the entirety of the
regulations we adopted in the course of
implementing elements of section
1834(q) of the Act. We believe the
removal of these regulations is
consistent with our proposal to pause
efforts to implement the AUC program
for reevaluation, and would avoid the
potential confusion that could result if
we were merely to retain or amend the
regulation text at § 414.94.
We want to acknowledge and
emphasize the value of clinical decision
support to bolster efforts to improve the
quality, safety, efficiency and
effectiveness of health care. We
welcome and encourage the continued
voluntary use of AUC and/or clinical
decision support tools in a style and
manner that most effectively and
efficiently fits the needs and workflow
of the clinician user. Across many
specialties and services, not just
advanced diagnostic imaging, clinical
decision support predates the enactment
of the PAMA and, given its utility when
accessed and used appropriately, we
expect it to continue being used to
streamline and enhance decision
a. Background
Section 1866(j)(1)(A) of the Act
requires the Secretary to establish a
process for the enrollment of providers
and suppliers into the Medicare
program. The overarching purpose of
the enrollment process is to help
confirm that providers and suppliers
seeking to bill Medicare for services and
items furnished to Medicare
beneficiaries meet all applicable Federal
and State requirements to do so. The
process is, to an extent, a ‘‘gatekeeper’’
that prevents unqualified and
potentially fraudulent individuals and
entities from entering and
inappropriately billing Medicare. Since
2006, we have undertaken rulemaking
efforts to outline our enrollment
procedures. These regulations are
generally codified in 42 CFR part 424,
subpart P (currently §§ 424.500 through
424.575 and hereafter occasionally
referenced as subpart P). They address,
among other things, requirements that
providers and suppliers must meet to
obtain and maintain Medicare billing
privileges.
As outlined in § 424.510, one such
requirement is that the provider or
supplier must complete, sign, and
submit to its assigned Medicare
Administrative Contractor (MAC) the
appropriate enrollment form, typically
the Form CMS–855 (OMB Control No.
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8. Summary
In conclusion, we are proposing to
pause efforts to implement the AUC
program for reevaluation and to rescind
the current AUC program regulations at
§ 414.94. We are not proposing a time
frame within which implementation
efforts may recommence. We will
continue efforts to identify a workable
implementation approach and will
propose to adopt any such approach
through subsequent rulemaking.
K. Medicare and Medicaid Provider and
Supplier Enrollment
1. Medicare Enrollment
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0938–0685). The Form CMS–855, which
can be submitted via paper or
electronically through the internetbased Provider Enrollment, Chain, and
Ownership System (PECOS) process
(SORN: 09–70–0532, PECOS), collects
important information about the
provider or supplier. Such data
includes, but is not limited to, general
identifying information (for example,
legal business name), licensure and/or
certification data, and practice
locations. The application is used for a
variety of provider enrollment
transactions, including the following:
• Initial enrollment—The provider or
supplier is—(1) enrolling in Medicare
for the first time; (2) enrolling in another
Medicare contractor’s jurisdiction; or (3)
seeking to enroll in Medicare after
having previously been enrolled.
• Change of ownership—The
provider or supplier is reporting a
change in its ownership.
• Revalidation—The provider or
supplier is revalidating its Medicare
enrollment information in accordance
with § 424.515. (Suppliers of durable
medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) must
revalidate their enrollment every 3
years; all other providers and suppliers
must do so every 5 years.)
• Reactivation—The provider or
supplier is seeking to reactivate its
Medicare billing privileges after it was
deactivated in accordance with
§ 424.540.
• Change of information—The
provider or supplier is reporting a
change in its existing enrollment
information in accordance with
§ 424.516.
After receiving the provider’s or
supplier’s initial enrollment
application, CMS or the MAC reviews
and confirms the information thereon
and determines whether the provider or
supplier meets all applicable Medicare
requirements. We believe this screening
process has greatly assisted CMS in
executing its responsibility to prevent
Medicare fraud, waste, and abuse.
As previously mentioned, over the
years we have issued various final rules
pertaining to provider enrollment.
These rules were intended not only to
clarify or strengthen certain components
of the enrollment process but also to
enable us to take further action against
providers and suppliers: (1) engaging (or
potentially engaging) in fraudulent or
abusive behavior; (2) presenting a risk of
harm to Medicare beneficiaries or the
Medicare Trust Funds; or (3) that are
otherwise unqualified to furnish
Medicare services or items. Consistent
with this, and as we discuss in this
section III.K. of this proposed rule, we
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propose several changes to our existing
Medicare provider enrollment
regulations.
(We note that section III.K.2 of this
proposed rule addresses a proposed
change to one of our Medicaid provider
enrollment provisions.)
b. Legal Authorities
There are two principal categories of
legal authorities for our proposed
Medicare provider enrollment
provisions:
• Section 1866(j) of the Act furnishes
specific authority regarding the
enrollment process for providers and
suppliers.
• Sections 1102 and 1871 of the Act
provide general authority for the
Secretary to prescribe regulations for the
efficient administration of the Medicare
program.
c. Medicare Provider Enrollment
Provisions
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i. Revocation and Denial Reasons and
Revisions to Other Revocation Policies
(A) Revocations
Under § 424.535(a), CMS may revoke
a Medicare provider’s or supplier’s
enrollment for any of the reasons
specified within that paragraph. (The
revocation grounds are currently
identified as § 424.535(a)(1) through
(22), with paragraphs (a)(15) and (16)
designated as reserved.) These reasons
include, for instance, the provider’s or
supplier’s: (i) failure to adhere to
Medicare enrollment requirements; (ii)
exclusion by the HHS Office of
Inspector General (OIG); (iii) felony
conviction within the previous 10 years;
(iv) pattern of improper or abusive
billing, prescribing of Part B or Part D
drugs, or ordering/referring/certifying of
Medicare services or items; and (v)
termination by another Federal health
care program. A revocation is designed
to safeguard the Medicare program, the
Trust Funds, and beneficiaries by
removing from (and preventing payment
to) Medicare providers and suppliers
that have engaged in problematic or
otherwise non-compliant behavior.
When a provider or supplier is revoked,
they are generally barred from
reenrolling in Medicare for a period of
1 to 10 years. The length of this
‘‘reenrollment bar’’ is determined based
upon the severity of the basis of the
revocation. The maximum reenrollment
bar is typically restricted to egregious
acts of misconduct.
We have previously finalized a
number of regulations adding new
revocation reasons to § 424.535(a) to
address particular program integrity
vulnerabilities and types of provider or
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supplier behavior. We have also used
rulemaking to refine other policies
regarding revocations, such as the
reenrollment bar and the effective dates
of certain revocations. Given our
continuing obligation to assess potential
vulnerabilities and establish payment
safeguard measures, we believe that
several additions and revisions to our
revocation policies in § 424.535(a) are
necessary at this time.
(1) Non-Compliance Revocation Ground
(§ 424.535(a)(1))
Existing § 424.535(a)(1), in part,
permits revocation if the provider or
supplier is determined to not be in
compliance with the enrollment
requirements described in subpart P or
in the enrollment application applicable
to its provider or supplier type. We
propose to change the language therein
that reads ‘‘described in this subpart P
or in the enrollment application’’ to
‘‘described in this title 42, or in the
enrollment application . . .’’ This is
because there are enrollment
requirements located outside of 42 CFR
part 424, subpart P; for instance, certain
enrollment requirements pertaining to
opioid treatment programs are in
§ 424.67(b). All enrollment
requirements, regardless of their
placement in title 42, must be adhered
to, which is why we believe the scope
of § 424.535(a)(1) should be expanded.
(2) Misdemeanor Convictions
As already alluded to, a provider or
supplier can be revoked under
§ 424.535(a)(3)(i) if the provider,
supplier, or any owner, managing
employee, officer, or director of the
provider or supplier was, within the
preceding 10 years, convicted of a
Federal or State felony that CMS
determines is detrimental to the best
interests of the Medicare program and
its beneficiaries. Section
424.535(a)(3)(ii) lists examples of such
felonies, though they are not limited in
scope and severity to these offenses.
Section 424.535(a)(3) does not include
misdemeanor convictions, and there
currently is no regulatory authority to
revoke a provider or supplier based
solely on a misdemeanor. However, we
have become aware of and increasingly
concerned about providers and
suppliers convicted of misdemeanors
for conduct that could endanger the
Trust Funds’ integrity and Medicare
beneficiaries’ health and safety. One
case, for instance, involved a physician
who wrote and filled prescriptions in
fictitious patients’ names to obtain
Schedule II controlled substances for
personal use. The physician pled guilty
to a reduced misdemeanor charge for
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attempting to obtain controlled
substances by fraud. In another
situation, an owner of a provider was
charged with felony assault with a
dangerous weapon; the court reduced it
to a misdemeanor as part of a guilty plea
and sentenced the defendant to 2 years
of probation.
We believe that our responsibility in
overseeing the Medicare program
requires that we have the ability to take
protective action in such instances. To
this end, we propose in new
§ 424.535(a)(16)(i) that CMS may revoke
a provider’s or supplier’s enrollment if
they, or any owner, managing employee
or organization, officer, or director
thereof, have been convicted (as that
term is defined in 42 CFR 1001.2) of a
misdemeanor under Federal or State law
within the previous 10 years that CMS
deems detrimental to the best interests
of the Medicare program and its
beneficiaries. Proposed
§ 424.535(a)(16)(ii) would state that
offenses under § 424.535(a)(16) include,
but are not limited in scope or severity
to, the following:
• Fraud or other criminal misconduct
involving the provider’s or supplier’s
participation in a Federal or State health
care program or the delivery of services
or items thereunder.
• Assault, battery, neglect, or abuse of
a patient (including sexual offenses).
• Any other misdemeanor that places
the Medicare program or its
beneficiaries at immediate risk, such as
a malpractice suit that results in a
conviction of criminal neglect or
misconduct. (This example mirrors that
in § 424.535(a)(3)(ii)(C) regarding
felonies.)
Our proposal accounts for the fact that
some States may classify a particular
crime as a misdemeanor while others
may deem it a felony; in other words,
the misdemeanors included in proposed
§ 424.535(a)(16) may be treated as
felonies in certain States. This reflects
our concern about the seriousness of
these actions. Indeed, merely because
particular State statutes may designate
the aforementioned actions as
misdemeanors does not, in our view,
lessen the risk the latter can pose to
Medicare and its beneficiaries. It is, in
short, the action itself, rather than its
specific classification under State law,
that is of principal concern to us.
We are soliciting comments on this
proposal. We specifically are seeking
feedback on: (1) whether there are any
potential unintended consequences of
our proposal that we are not
considering; or (2) any guardrails we
should consider so as not to create
unintended consequences for persons
with misdemeanor convictions.
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(3) False Claims Act Civil Judgments
The False Claims Act (FCA) (31 U.S.C.
3729–3733) is the Federal government’s
principal civil remedy for addressing
false or fraudulent claims for Federal
funds. Section 3729(a)(1) of the FCA
lists specific actions that can result in
an FCA judgment against a defendant.
These include the following:
• Knowingly presenting, or causing to
be presented, a false or fraudulent claim
for payment or approval.
• Knowingly making, using, or
causing to be made or used, a false
record or statement material to a false or
fraudulent claim.
• Conspiring to violate any of the
provisions in section 3729(a)(1) of the
FCA.
• Having possession, custody, or
control of property or money used, or to
be used, by the government and
knowingly delivering, or causing to be
delivered, less than all of that money or
property.
• Being authorized to make or deliver
a document certifying receipt of
property used, or to be used, by the
government and, intending to defraud
the Government, making or delivering
the receipt without completely knowing
that the information on the receipt is
true.
• Knowingly buying, or receiving as a
pledge of an obligation or debt, public
property from an officer or employee of
the government, or a member of the
Armed Forces, who lawfully may not
sell or pledge property.
• Knowingly making, using, or
causing to be made or used, a false
record or statement material to an
obligation to pay or transmit money or
property to the government, or
knowingly concealing or knowingly and
improperly avoiding or decreasing an
obligation to pay or transmit money or
property to the government.
Under section 3729(a)(1), a party that
is liable under the FCA must pay a civil
penalty of between $5,000 and $10,000
for each false claim (though these
amounts are periodically revised for
inflation) and triple the amount of the
government’s damages.
Although the FCA’s scope is not
restricted to the health care arena and
applies to all types of Federal
government programs, the FCA has
proven effective in helping to stem
Medicare fraud. However, an FCA civil
judgment against a provider or supplier
does not, in and of itself, impact the
latter’s Medicare enrollment. Even if, for
example, a provider is found to have
knowingly submitted fraudulent claims
and is liable for $100,000 in damages,
we have no ability to revoke the
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provider’s enrollment on this basis. This
concerns us, for the actions identified in
section 3729(a)(1) of the FCA involve
serious misbehavior. We believe we
must address this vulnerability to
protect the Medicare program and its
beneficiaries.
We accordingly propose in
§ 424.535(a)(15) that CMS could revoke
the enrollment of a provider or supplier
if the provider or supplier, or any
owner, managing employee or
organization, officer, or director thereof,
has had a civil judgment under the FCA
imposed against them within the
previous 10 years. (Strictly for purposes
of (a)(15), however, the term ‘‘civil
judgment’’ would not include FCA
settlement agreements. The provision
would require a judgment against the
provider or supplier.) Recognizing that
the specific facts and circumstances of
each case will differ, we would consider
the following factors in our decision:
• The number of provider or supplier
actions that the judgment incorporates
(for example, the number of false claims
submitted).
• The types of provider or supplier
actions involved.
• The monetary amount of the
judgment.
• When the judgment occurred.
• Whether the provider or supplier
has any history of final adverse actions
(as that term is defined in § 424.502).
• Any other information that CMS
deems relevant to its determination.
We note that we would include FCA
civil judgments against owners,
managing employees and organizations,
and officers and directors (as those
terms are defined in § 424.502) of the
provider or supplier within the scope of
this revocation basis. This is consistent
with our approach to several other
revocation reasons in § 424.535(a) and
reflects our recognition that certain
owning and managing parties exercise
great influence over the provider or
supplier organization and its daily
operations. Should such a party have an
FCA civil judgment against them, this
could present a program integrity risk.
We therefore believe that
§ 424.535(a)(15) should encompass such
situations, though we would consider
the degree of the owning or managing
party’s control over the provider or
supplier (for example, percentage of
ownership, scope of day-to-day
operational authority) as a factor in our
determination.
(4) Violation of Provider and Supplier
Standards
Section 410.33(g) lists detailed
enrollment standards that independent
diagnostic testing facilities (IDTFs) must
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meet to enroll and maintain enrollment
in Medicare. Likewise, § 424.57(c)
identifies 30 enrollment standards that
DMEPOS suppliers must meet as
conditions of enrollment. These IDTF
and DMEPOS standards address matters
such as the maintenance of liability
coverage, solicitation of patients, and
customer service requirements. In
addition, §§ 424.67(b) and (e), 424.68(c)
and (e), and 424.205(b) and (d) contain
enrollment standards and conditions
for, respectively, opioid treatment
programs (OTPs), home infusion
therapy (HIT) suppliers, and Medicare
diabetes prevention programs (MDPPs).
The standards and conditions in
§§ 410.33(g), 424.57(c), 424.67(b) and
(e), 424.68(c) and (e), and 424.205(b)
and (d) are in addition to, and not in
lieu of, the more general enrollment
requirements in 42 CFR part 424,
subpart P with which IDTFs, DMEPOS
suppliers, OTPs, HIT suppliers, MDPPs,
and all other provider and supplier
types must comply.
We propose to add new paragraph
(a)(23) to § 424.535 that would permit
CMS to revoke an IDTF’s, DMEPOS
supplier’s, OTP’s, HIT supplier’s, or
MDPP’s enrollment based on a violation
of any standard or condition in,
respectively, §§ 410.33(g), 424.57(c),
424.67(b) or (e), 424.68(c) or (e), or
424.205(b) or (d). No revocation reason
in existing § 424.535(a) specifically
references these regulatory paragraphs
or violations thereof. Although we have
sometimes applied a comparatively
broad revocation basis in § 424.535(a)(1)
to certain non-compliant IDTFs,
DMEPOS suppliers, OTPs, HIT
suppliers, and MDPPs (for example, an
invalid practice location under
§ 424.535(a)(5)), we believe a narrower
approach that allows us to target
violations of the aforementioned
standards and conditions is preferable.
That is, our proposal would more
directly tie these regulatory paragraphs
to § 424.535(a) by establishing a new
revocation reason restricted to noncompliance with any of them.
(5) Scope of § 424.535(a)(17)
Under § 424.535(a)(17), we may
revoke enrollment if the provider or
supplier has an existing debt that CMS
appropriately refers to the United States
Department of Treasury. In determining
whether a revocation is appropriate,
CMS considers the six factors outlined
in § 424.535(a)(17)(i) through (vi); these
include, for instance, the reason for the
provider’s or supplier’s failure to pay
the debt. Section 424.535(a)(17)’s
purpose is to spur providers and
suppliers to repay their financial
obligations to Medicare; in our view,
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their failure to do so raises doubts as to
whether the provider or supplier can be
a reliable partner of the Medicare
program.
We have received inquiries from
interested parties concerning the scope
of this provision, such as whether
paragraph (a)(17) applies to debts that
are no longer being collected or are
being appealed. We propose to revise
paragraph (a)(17) to address these
issues.
First, and to help accommodate our
revisions, existing § 424.535(a)(17)(i)
through (vi) would be re-designated as
paragraphs (a)(17)(i)(A) through (F).
Second, in new paragraph (a)(17)(ii),
we propose to exclude from paragraph
(a)(17)(i)’s purview those cases where:
(1) the provider’s or supplier’s Medicare
debt has been discharged by a
bankruptcy court; or (2) the
administrative appeals process
concerning the debt has not been
exhausted or the timeline for filing such
an appeal, at the appropriate appeal
level, has not expired. In our view, the
debts in these two situations have not
been finally and fully adjudicated for
purposes of paragraph (a)(17)(i)’s
applicability. For this reason, we believe
basic fairness to the provider or supplier
justifies revised paragraph (a)(17)(ii).
Third, in § 424.535(a)(17)(i) we would
change the term ‘‘existing debt’’ to
‘‘failure to repay a debt’’. This would
allow us to potentially use our
revocation authority even if collection
action has ceased and the debt was
ultimately terminated as a result, since
the provider or supplier had still failed
to repay it. Our central concern is more
with the provider’s or supplier’s
inaction in fulfilling its financial
obligations to Medicare than with the
particular status or result of CMS’
collection efforts. In other words, and as
with all of our revocation reasons in
§ 424.535(a), the issue is the provider’s
or supplier’s conduct, which, in the case
of § 424.535(a)(17), involves the
provider’s or supplier’s failure to repay
monies it owed to the Federal
government. Simply because the debt
could not be collected and was
subsequently ‘‘written off’’ does not
negate the fact that the provider or
supplier did not meet its responsibility
to repay it in the first place. Although
the financial obligation may no longer
constitute a debt because it was ‘‘written
off’’, the core point is that it was a debt
at one time but the provider did not
repay it. Again, it is the provider’s nonpayment of the debt when it was current
rather than whether said debt still exists
that is critical, hence our proposed
move away from ‘‘existing debt’’ to a
status that better reflects the provider’s
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inaction irrespective of the timing of the
debt. In our view, a provider’s failure to
fulfill its financial obligations to the
Medicare program: (1) constitutes a
potential vulnerability to the program;
and (2) could well increase the
likelihood that any of the provider’s or
supplier’s future Medicare debts, too,
may not be repaid. Our obligation to
safeguard the Trust Funds, we believe,
requires us to have authority to take
action to help prevent the latter
occurrence. For these reasons, we
believe our proposed change is
warranted.
Nevertheless, we recognize that our
proposed revision to § 424.535(a)(17)(i)
might cause concern within the
provider community, for there could be
numerous reasons behind the ‘‘writing
off’’ of a Medicare debt. For example, a
provider may have been unable to repay
a particular debt (that was later written
off) because of a severe local emergency
or natural disaster. While we would
retain the authority to revoke under
paragraph (a)(17)(i), we emphasize that
we would still apply the
aforementioned six factors in all
potential revocation cases under
paragraph (a)(17). Indeed, one of these
factors is the ‘‘reason(s) for the failure to
fully repay the debt (to the extent this
can be determined)’’, and we will
continue to carefully consider the
factual circumstances behind the
repayment failure so as to ensure
fairness to the provider or supplier.
(B) Reasons for Denial
As already discussed, we are
proposing new revocation authorities in
§ 424.535(a)(15), (16), and (23). We
believe the rationales for these
revocation reasons are equally
applicable to newly enrolling providers
and suppliers. Our program integrity
concerns are the same regardless of
whether the provider or supplier is
already enrolled or is attempting to
enroll; in either case, we must protect
the Trust Funds and beneficiaries from
problematic parties. Consequently, we
propose to largely duplicate these new
revocation reasons and establish
concomitant grounds in § 424.530 for
denying enrollment as follows.
First, § 424.530(a)(1), like
§ 424.535(a)(1), addresses the need for
compliance with subpart P’s enrollment
requirements. We propose to change
this reference from subpart P to title 42.
As already noted, several sections of
title 42 contain enrollment requirements
outside of those in subpart P and to
which the provider or supplier must
adhere.
Second, we propose in new
§ 424.530(a)(16)(i) that CMS may deny a
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provider’s or supplier’s enrollment
application if they, or any owner,
managing employee or organization,
officer, or director thereof, has been
convicted (as that term is defined in 42
CFR 1001.2) of a misdemeanor under
Federal or State law within the previous
10 years that CMS deems detrimental to
the best interests of the Medicare
program and its beneficiaries. (Section
424.530(a)(16)(ii) would mirror
proposed § 424.535(a)(16)(ii).) Our
concern is that we currently have no
legal authority to deny enrollment based
on misdemeanor convictions for
behavior that could endanger the Trust
Funds or Medicare beneficiaries.
Third, new § 424.530(a)(17) would
permit CMS to deny a provider’s or
supplier’s enrollment application if the
provider or supplier, or any owner,
managing employee or organization,
officer, or director thereof, has had a
civil judgment under the FCA imposed
against them within the previous 10
years. The same factors for
consideration in § 424.535(a)(15) would
be included in § 424.530(a)(17). Given
our previously stated view that the
actions identified in section 3729(a)(1)
of the FCA involve serious misbehavior,
we believe proposed § 424.530(a)(17)
would help protect the integrity of the
Medicare program.
Fourth, and for the same reasons we
are proposing new § 424.535(a)(23), we
would duplicate the latter in new denial
reason § 424.530(a)(18). We must strive
to ensure that enrolling IDTFs, DMEPOS
suppliers, OTPs, HIT suppliers, and
MDPPs are legitimate providers and
suppliers, as evidenced in part by their
compliance with the standards and
conditions applicable to them.
(C) Effective Date of Revocation
Section 424.535(g) addresses
revocation effective dates. It states that
a revocation becomes effective 30 days
after CMS or the contractor mails notice
of its determination to the provider or
supplier. Yet there are exceptions. If the
revocation is based on a Federal
exclusion or debarment, felony
conviction, license suspension or
revocation, or non-operational practice
location, the revocation is effective with
the date of exclusion or debarment,
felony conviction, license suspension or
revocation, or the date that CMS or its
contractor determined that the provider
or supplier was non-operational. The
purpose of these exceptions is to
prevent payment to a provider or
supplier while it is out of compliance
with Medicare enrollment requirements.
To illustrate, assume a supplier’s license
is revoked on June 1. CMS learns of this
and mails a revocation notice to the
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supplier on June 15. If we applied the
aforementioned ‘‘30 days after mailing’’
policy, the supplier could bill and be
paid for services furnished between
June 1 and July 15 while unlicensed. Per
existing § 424.535(g), however, the
revocation would be effective June 1,
meaning all services furnished after that
date would be ineligible for payment.
We view § 424.535(g)’s four
exceptions as an important program
integrity protection against improper
payments. We do not believe providers
and suppliers should be paid for
services furnished during a period of
non-compliance. With this principle in
mind, we propose a number of policy
and organizational changes to
§ 424.535(g).
First, we would split existing
§ 424.535(g) into several paragraphs.
Paragraph (g)(1) would include the
previously mentioned 30-day effective
date policy, though with the following
language at its beginning, ‘‘Except as
described in paragraphs (g)(2) and (g)(3)
of this section’’. New paragraph (g)(2)
would list the four retroactive
revocation situations in existing
§ 424.535(g). Each situation (and its
associated revocation effective date)
would be incorporated into a separate
sub-paragraph to make paragraph (g)(2)
clearer and more readable.
Second, paragraph (g)(2) would
include the following additional
situations where a retroactive effective
date would be warranted:
• Revocations under proposed
§ 424.535(a)(16) (regarding
misdemeanor convictions): the effective
date would be the date of the
misdemeanor conviction.
• Revocations based on a State
license surrender in lieu of further
disciplinary action: the effective date
would be the date of the license
surrender.
• Revocations based on termination
from a Federal health care program
other than Medicare (for example,
Medicaid): the effective date would be
the date of the termination.
• Revocations based on termination
of a provider agreement under 42 CFR
part 489: the effective date would be, as
applicable to the type of provider
involved, the later of the following: (1)
the date of the provider agreement
termination; or (2) as applicable, the
date that CMS establishes under 42 CFR
489.55. (Section 489.55 permits
payments beyond the provider
agreement termination date in certain
instances and for a certain period.)
• Revocations based on proposed
§ 424.535(a)(23) would be as follows:
++ If the standard or condition
violation involved the suspension,
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revocation, or termination (or surrender
in lieu of further disciplinary action) of
the provider’s or supplier’s Federal or
State license, certification,
accreditation, or MDPP recognition, the
revocation effective date would be the
date of the license, certification,
accreditation, or MDPP recognition
suspension, revocation, termination, or
surrender.
++ If the standard or condition
violation involved a non-operational
practice location (for example, an
IDTF’s failure to maintain a physical
facility on an appropriate site per
§ 410.33(g)(3)), the revocation effective
date would be the date the nonoperational status began.
++ If the standard violation involved
a felony conviction of an individual or
entity described in § 424.67(b)(6)(i), the
revocation effective date would be the
date of the felony conviction.
(For all other standard violations, the
effective date in paragraph (g)(1) would
apply if the effective date in new
paragraph (g)(3) (discussed later in this
section of the proposed rule) does not.)
As with our existing four bases for a
retroactive revocation, these new
grounds would help ensure that
providers and suppliers do not receive
payment for services rendered while
non-compliant with enrollment
requirements. For example, a provider’s
State license surrender would mean that
the provider is not appropriately
licensed (and can thus be revoked under
§ 424.535(a)(1)) and, accordingly,
should not be paid by Medicare for
furnished services while unlicensed.
Concerning terminations under another
Federal health care program, some such
programs are occasionally delayed in
reporting their actions to CMS, during
which period CMS continues making
payments to the affected provider or
supplier until CMS receives notice of
the termination. Any Federal program
termination is of concern to us, which
is why we promulgated a revocation
reason based on this action. We believe
that any such termination that leads to
a Medicare revocation should
consequently be retroactive to the date
of the program termination since the
latter stemmed from conduct that, in our
view, was serious enough to warrant the
subsequent revocation. Likewise, there
could be a brief administrative time
lapse between when a provider
agreement is terminated and a Medicare
revocation is effectuated, meaning that a
provider without a required provider
agreement might still receive payments
beyond the provider agreement
termination date or the date that CMS
establishes under § 489.55. The
aforementioned retroactive effective
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dates involving § 424.535(a)(23),
meanwhile, generally mirror those
currently in § 424.535(g) (for example,
felony conviction).
Third, new § 424.535(g)(3) would
state that if the action that triggered the
revocation occurred before the
provider’s or supplier’s enrollment
effective date, the revocation effective
date would be the enrollment effective
date that CMS assigned to the provider
or supplier. To illustrate, suppose an
adverse legal action occurred on
February 1 and the provider was
enrolled effective April 1. Although
CMS was unaware of the action at the
time of enrollment, it revoked the
provider on April 15 upon learning of
it. The revocation effective date would
be April 1 rather than February 1. The
aim of § 424.535(g)(3) is merely to
reiterate that we could not apply a
revocation effective date that is earlier
than the date the provider or supplier is
enrolled. It is a technical, though, we
believe, obvious clarification.
(D) Timeframes for Reversing a
Revocation Under § 424.535(e)
Section 424.535(e) states that if a
revocation was due to adverse activity
(sanction, exclusion, felony) by one of
the parties listed in § 424.535(e) (for
example, owner, managing employee,
authorized or delegated official,
supervising physician), the revocation
can be reversed if the provider or
supplier terminates and submits proof
that it has terminated its business
relationship with that party within 30
days of the revocation notification. We
have been concerned about this 30-day
period. We do not believe a provider or
supplier should be afforded so much
time to terminate this business
relationship; each day the revoked
provider or supplier remains affiliated
with the party in question, the more
Medicare dollars that could be paid
until the 30-day timeframe expires. It is
the provider’s or supplier’s constant
responsibility to ensure that its owning
and managing personnel present no
program integrity risks to the Medicare
program. To give the provider or
supplier 30 days to terminate a
relationship that should have been
promptly ended upon the commission
of the adverse action (for example, when
the owner became excluded) would be
inconsistent with our obligation to
protect the Trust Funds; it could also
convey a false impression that
maintaining affiliations with
problematic parties is acceptable so long
as the relationship ceases within a
month of the revocation notice. To this
end, we propose to revise § 424.535(e) to
reduce the 30-day period therein to 15
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days. We are not proposing, for
instance, a 5-day period because we
recognize that it might be
administratively and financially
difficult to immediately terminate the
business relationship in question,
especially an owner’s interest in the
provider or supplier. Still, the reduction
from 30 days to 15 days evidences our
concern about making Medicare
payments to providers and suppliers
that have relationships with parties
presenting program integrity risks.
We emphasize that this change would
have no impact on a revoked provider’s
or supplier’s ability to appeal a
revocation under 42 CFR part 498. It
would only affect the provider’s or
supplier’s utilization of § 424.535(e) to
reverse the revocation. We are soliciting
comments on whether 15 days is an
appropriate timeframe.
ii. Stay of Enrollment
CMS may deactivate a provider’s or
supplier’s Medicare billing privileges
for any of the reasons specified in
§ 424.540(a). A deactivation differs from
a revocation in that the former: (1)
merely involves the stoppage, rather
than the termination, of the provider’s
or supplier’s billing privileges; and (2)
does not entail any reenrollment bar
under § 424.535(c). The latter is a
particularly important distinction, for a
deactivated provider or supplier can
reactivate its billing privileges by
following the procedures in
§ 424.540(b). It need not wait (as a
revoked provider or supplier must) for
the expiration of the 1 to 10-year bar
period referenced in § 424.535(c) before
attempting to restore its ability to bill
Medicare. Indeed, we sometimes impose
a deactivation instead of a revocation
when we believe a more modest
sanction is warranted.
Nevertheless, a deactivation can still
impose a potential burden on a provider
or supplier. This is especially true
concerning § 424.540(e), which
prohibits a provider or supplier from
receiving payment for services or items
furnished while deactivated. While
deactivation is a less severe action than
a revocation, it may be too punitive in
certain cases. We believe that a middle
ground between a deactivation and nonaction on our part is warranted. In our
view, we need as much flexibility as
possible to take appropriate, fair, and
reasonable measures that are
commensurate with the degree of the
provider’s or supplier’s action, inaction,
or non-compliance.
For these reasons, we propose in new
§ 424.541 a new enrollment status
labeled a ‘‘stay of enrollment.’’ This
would be a preliminary, interim status—
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prior to any subsequent deactivation or
revocation—that would represent, in a
sense, a ‘‘pause’’ in enrollment, during
which the provider or supplier would
still remain enrolled in Medicare; in this
vein, CMS would neither formally nor
informally treat the stay as a sanction or
adverse action for purposes of Medicare
enrollment. We would also notify the
affected provider or supplier in writing
of the stay.
There would be two prerequisites for
a stay’s implementation. First, the
provider or supplier must be noncompliant with at least one enrollment
requirement in Title 42. Mere suspicion
of or information alleging nonadherence is insufficient. Actual noncompliance is required. Second, CMS
ascertains that the provider or supplier
can remedy the non-compliance via the
submission of, as applicable to the
situation, a Form CMS–855, Form CMS–
20134, or Form CMS–588 change of
information or revalidation application
(hereafter collectively referenced ‘‘Form
CMS–855 change request’’ or ‘‘change of
information application’’). This change
request could involve, for instance,
reporting a new street number (to
illustrate, a provider’s address changed
from 10 Smith Street to 15 Smith Street)
that the provider previously failed to
disclose to CMS. We believe that using
the aforementioned, comparatively
bright-line Form CMS–855 submission
standard would furnish clarity as to the
types of non-compliance that can be
remedied under our proposal and the
specific vehicle for said remedial action.
When a ‘‘stay period’’ is imposed, the
provider or supplier would not receive
payment for services or items furnished
during this period. These services and
items would not be payable because the
provider or supplier was non-compliant
with enrollment requirements and thus
not entitled to payment, even after the
stay concludes. To permit payment for
these services and items would be
contrary to our obligation to safeguard
the Trust Funds.
Although we acknowledge that this
denial of payment is similar to what
occurs with a deactivation under
§ 424.540, there are critical differences
between the two actions. First, § 424.541
would make clear that a stay period
lasts no more than 60 days. A
deactivation, on the other hand, has no
finite timeframe, meaning that services
and items might not be payable for a
long period of time if the provider or
supplier does not submit the required
reactivation application. Second, MACs
can generally process Form CMS–855
change requests more rapidly than a
reactivation application. A provider or
supplier subject to a stay could therefore
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begin receiving payments sooner than
would a deactivated provider or
supplier. Third, while a reactivation
application typically involves the
provider’s or supplier’s completion of
the entire Form CMS–855, a change of
information application may only
involve the submission of a limited
amount of data (such as the information
that is changing and basic identifying
data). Completion of a change of
information application is, in sum,
considerably less burdensome for
providers and suppliers than
completion of a reactivation application.
Indeed, the issue of burden is the core
consideration behind our proposal. As
previously indicated, we do not wish to
have to proceed to a deactivation (much
less a revocation) in all cases of noncompliance. This is especially true if
CMS believes in a particular case that
the non-adherence can be fairly quickly
corrected via the provider’s or supplier’s
submission of updated enrollment data.
Although we again recognize that
payments for services and items
furnished during the stay would not be
covered, we emphasize that this would
also be the case if CMS instead imposed
a deactivation or revocation, with the
important distinction that the period of
non-payment would often be
significantly shorter with a stay than
with a deactivation and certainly a
revocation. In all, we believe that our
stay provision would ultimately reduce
the burden on providers who would
otherwise be deactivated or revoked for
non-compliance.
Notwithstanding this, we believe the
affected provider or supplier should
have an opportunity to raise a concern
about a stay by submitting a rebuttal.
The rebuttal process would generally
mirror that for deactivations and
payment suspensions (outlined in 42
CFR 424.546 and 405.374, respectively),
the two actions most akin to a stay. We
recognize that given the comparatively
and rather short time period that a stay
would typically entail, many stays
would have long expired by the time a
provider or supplier files a rebuttal and
CMS makes its determination thereon.
In addition, if the provider or supplier
can quickly return to compliance, they
may likely pursue this course rather
than submit a rebuttal (although the
provider or supplier may still do so).
Yet merely because some providers and
suppliers might forego submitting a
rebuttal does not mean the process
should be unavailable to them.
Consistent with all of the foregoing,
we propose a number of provisions in
§ 424.541. In paragraph (a)(1), we
propose that CMS may stay an enrolled
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provider’s or supplier’s enrollment if
the provider or supplier:
• Is non-compliant with at least one
enrollment requirement in Title 42; and
• Can remedy the non-compliance via
the submission of, as applicable to the
situation, a Form CMS–855, Form CMS–
20134, or Form CMS–588 change of
information or revalidation application.
We emphasize that our authority to
impose a stay would be discretionary.
CMS would not be required to stay the
provider’s or supplier’s enrollment. We
could, for instance, elect to proceed
directly to a deactivation or revocation
(if grounds exist for either) without
applying a stay as a prerequisite thereto.
Our decision as to which action is most
appropriate would depend upon the
facts and circumstances of the case at
issue.
In paragraphs (a)(2)(i) and (ii),
respectively, we would state that during
the period of any stay imposed under
§ 424.541:
• The provider or supplier remains
enrolled in Medicare; and
• Claims submitted by the provider or
supplier with dates of service within the
stay period will be denied.
In paragraph (a)(3), we propose that a
stay of enrollment would last no longer
than 60 days from the postmark date of
the notification letter. We believe a 60day period would give the provider or
supplier adequate time to submit the
required Form CMS–855 change of
information application.
In paragraph (a)(4), we propose that
CMS must notify the affected provider
or supplier in writing of the stay’s
imposition.
In paragraph (b), we would outline
our proposed rebuttal process, which, as
stated, would largely align with that for
deactivations and payment suspensions.
In paragraph (b)(1), we propose that if
a provider or supplier receives written
notice from CMS or its contractor that
the provider or supplier is subject to a
stay under § 424.541, the provider or
supplier has 15 calendar days from the
date of the written notice to submit a
rebuttal to the stay as described in
§ 424.541.
In paragraph (b)(2), we propose that
CMS may, at its discretion, extend the
15-day time-period referenced in
paragraph (b)(1).
In paragraphs (b)(3)(i) through (iv), we
propose that the rebuttal must:
• Be in writing.
• Specify the facts or issues about
which the provider or supplier disagrees
with the stay’s imposition and/or the
effective date, and the reasons for
disagreement.
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• Submit all documentation the
provider or supplier wants CMS to
consider in its review of the stay.
• Be submitted in the form of a letter
that is signed and dated by the
individual supplier (if enrolled as an
individual physician or non-physician
practitioner), the authorized official or
delegated official (as those terms are
defined in § 424.502), or a legal
representative (as defined in § 498.10). If
the legal representative is an attorney,
the attorney must include a statement
that he or she has the authority to
represent the provider or supplier; this
statement is sufficient to constitute
notice of such authority. If the legal
representative is not an attorney, the
provider or supplier must file with CMS
written notice of the appointment of a
representative; this notice of
appointment must be signed and dated
by, as applicable, the individual
supplier, the authorized official or
delegated official, or a legal
representative.
In paragraph (b)(4), we propose that
the provider’s or supplier’s failure to
submit a rebuttal that is both timely
under paragraph (b)(1) of this section
and fully compliant with all of the
requirements of paragraph (b)(3) of
§ 424.541 constitutes a waiver of all
rebuttal rights under this section.
In paragraph (b)(5), we propose that
upon receipt of a timely and compliant
stay rebuttal, CMS reviews the rebuttal
to determine whether the imposition of
the stay and/or the effective date thereof
are correct.
In paragraph (b)(6), we propose that a
determination made under paragraph (b)
is not an initial determination under
§ 498.3(b), and therefore, not appealable.
In paragraph (b)(7), we propose that
nothing in paragraph (b) requires CMS
to delay the imposition of a stay
pending the completion of the review
described in paragraph (b)(5).
We propose in paragraph (b)(8) to
clarify the interaction between a stay
and a subsequent deactivation or
revocation.
In paragraph (b)(8)(i), we propose that
nothing in paragraph (b) would require
CMS to delay the imposition of a
deactivation or revocation pending the
completion of the review described in
paragraph (b)(5) of this section. We
believe we must retain the discretion to
apply a subsequent deactivation or
revocation should circumstances
warrant.
In paragraph (b)(8)(ii)(A), we propose
that if CMS deactivates the provider or
supplier during the stay, any rebuttal to
the stay the provider or supplier
submits that meets the requirements of
§ 424.541 would be combined and
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considered with the provider’s or
supplier’s rebuttal to the deactivation
under § 424.546 if CMS has not yet
made a determination on the stay
rebuttal. (This is meant to facilitate
efficiency and simplicity in the review
process of both rebuttals.) In paragraph
(b)(8)(ii)(B), however, we propose that
in all cases other than that described in
paragraph (b)(8)(ii)(A), a stay rebuttal
that was submitted in compliance with
§ 424.541 would be considered
separately and independently of any
review of any other rebuttal or, for
revocations, appeal.
Finally, existing § 424.555(b) states
that payment may not be made for
Medicare services and items furnished
to a Medicare beneficiary by a
deactivated, denied, or revoked provider
or supplier. The paragraph further states
that the beneficiary has no financial
liability for such services and items
provided by these providers and
suppliers. To clarify the issues of
payment and beneficiary liability for
purposes of § 424.541, we propose to
add providers and suppliers currently
under a stay of enrollment to the
categories of providers and suppliers
falling within the scope of § 424.555(b).
iii. Reporting Changes in Practice
Location
Consistent with §§ 424.57(c)(2),
410.33(g)(2), and 424.516(d)(1)(iii),
respectively, the following provider and
supplier types must report a change in
practice location within 30 days of the
change: (1) DMEPOS suppliers; (2)
IDTFs; and (3) physicians, nonphysician
practitioners, and physician and
nonphysician practitioner organizations.
All other provider and supplier types
are required per § 424.516(e)(2) to report
practice location changes within 90
days of the change. As explained below,
we propose two sets of regulatory
revisions regarding practice location
changes. First, we propose to revise
§ 424.516(e)(1) to require therein such
location changes involving providers
and suppliers other than the categories
previously described to be reported
within 30 days of the change. Second,
we would clarify in §§ 410.33(g)(2),
424.516(d)(1)(iii), and 424.516(e)(1) that
a change of practice location includes
adding a new location or deleting an
existing one.
We have recently discovered
instances where certain provider and
supplier types not addressed in
§§ 424.57(c)(2), 410.33(g)(2), or
424.516(d)(1)(iii), have moved their
practice location without notifying
CMS. This is problematic for two
reasons. One is that Medicare payments
are often based on the provider’s or
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supplier’s specific geographic location.
If we are not timely informed of the
change in location, CMS could be
making incorrect payments to the
provider or supplier for an extended
period (for instance, 90 days); this
would be inconsistent with CMS’s
obligation to protect the Trust Funds.
The other reason is that we would be
unable to promptly determine whether
the new site is compliant with Medicare
provider enrollment requirements (for
example, via a site visit) because we
would not yet know of the change. The
provider or supplier might be furnishing
services from an invalid location, hence
resulting in improper payments. CMS
needs to ensure the accuracy of its
payments, and being more rapidly
advised of critical data like a practice
location change would help facilitate
this. It would also facilitate consistency
with the aforementioned 30-day
requirement in §§ 424.57(c)(2),
410.33(g)(2), and 424.516(d)(1)(iii).
For purposes of reporting practice
location changes, we have traditionally
included additions and deletions of
locations within the scope of such
changes. There is as much payment
safeguard risk with belatedly reported
additions and deletions as with changes.
Paying a provider or supplier for
services it furnishes at an unreported
newly-established location could
involve improper payments because,
again, CMS does not even know
whether the site meets all provider
enrollment requirements; likewise, CMS
could be paying a provider or supplier
for services related to a location that
was deleted and no longer exists. To
make certain we are more promptly
notified of practice location additions
and deletions, we propose to revise
§§ 410.33(g)(2), 424.516(d)(1)(iii), and
424.516(e)(1) to reiterate that these two
transactions must be reported within 30
days of the addition or deletion. (A
similar revision to § 424.57(c)(2) is
unnecessary because all changes to
enrollment data (including practice
location additions, deletion, and
changes) must already be reported
within 30 days.)
iv. Definitions
We are also proposing several new
and clarified definitions to help explain
the meaning of certain provider
enrollment concepts.
(A) ‘‘Pattern or Practice’’
Several of our existing Medicare
enrollment revocation reasons are based
upon the provider or supplier engaging
in a pattern or practice of conduct.
These reasons include all of the
following:
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• Section 424.535(a)(8)(ii): The
provider or supplier has a pattern or
practice of submitting claims that fail to
meet Medicare requirements.
• Section 424.535(a)(14): The
physician or eligible professional has a
pattern or practice of prescribing Part B
or D drugs that is abusive, represents a
threat to the health and safety of
Medicare beneficiaries, or fails to meet
Medicare requirements.
• Section 424.535(a)(21): The
physician or eligible professional has a
pattern or practice of ordering,
certifying, referring, or prescribing
Medicare Part A or B services, items, or
drugs that is abusive, represents a threat
to the health and safety of Medicare
beneficiaries, or otherwise fails to meet
Medicare requirements.
In determining whether such a pattern
or practice exists and if a revocation
under any of these authorities is
warranted, CMS considers the factors
specified in § 424.535(a)(8)(ii), (14), and
(21), respectively.
We have received questions from
interested parties over the years as to
what constitutes a pattern or practice
under these provisions. We have always
made these determinations on a case-bycase basis, using the above-referenced
factors. We do not propose to change
this general procedure, for it gives us
the flexibility we need to address each
situation on its own facts and
circumstances. Every case is different,
and our factors are designed to account
for this. Nonetheless, and to furnish
elucidation to the provider community,
we believe that certain minimum
regulatory parameters are appropriate.
This would be based on our past
experience in applying
§ 424.535(a)(8)(ii), (14), and (21), our
review of the factors therein, and the
factual circumstances we have
encountered in these cases.
To this end, we propose to establish
a definition of ‘‘pattern or practice’’ in
§ 424.502. It would mean:
• For purposes of § 424.535(a)(8)(ii),
at least three submitted non-compliant
claims.
• For purposes of § 424.535(a)(14), at
least three prescriptions of Part B or Part
D drugs that are abusive, represent a
threat to the health and safety of
Medicare beneficiaries, or otherwise fail
to meet Medicare requirements.
• For purposes of § 424.535(a)(21), at
least three orders, certifications,
referrals, or prescriptions of Medicare
Part A or B services, items, or drugs that
are abusive, represent a threat to the
health and safety of Medicare
beneficiaries, or otherwise fail to meet
Medicare requirements.
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We recognize that our minimum
threshold of three might appear small
upon first impression. Yet interested
parties should not assume that three
non-compliant claims, orders, etc.
would always trigger a revocation. To
the contrary, it would often take more
than three (and, on occasion,
considerably more) to warrant
revocation action. In only the rarest of
circumstances would we revoke based
on three claims, referrals, etc., and these
would typically involve egregious noncompliance by the provider or supplier;
we specifically chose three as our
threshold to account for these isolated
instances. We assure the provider
community that, in every case, we
would continue to diligently consider
the factors outlined in
§ 424.535(a)(8)(ii), (14), and (21) and
would treat the provider or supplier
fairly given the facts presented. Our
proposed definition in no way negates
the validity or importance of these
factors; its sole purpose is to furnish
greater clarity to the provider
community.
To accommodate our definition, we
also propose to make several technical
changes to § 424.535(a)(8)(ii), (14), and
(21).
The introductory paragraph of
§ 424.535(a)(8)(ii) reads: ‘‘CMS
determines that the provider or supplier
has a pattern or practice of submitting
claims that fail to meet Medicare
requirements. In making this
determination, CMS considers, as
appropriate or applicable, the
following:’’. We are concerned that this
language could be construed as meaning
that so long as the ‘‘pattern or practice’’
definition in § 424.502 is met—that is, at
least three non-compliant claims,
orders, etc., were involved—a
§ 424.535(a)(8)(ii) revocation must
automatically follow. As previously
discussed, this is untrue. Even if the
definition’s threshold is met, we would
then consider the entirely separate
question of whether a revocation is
warranted. In other words, the first step
in our analysis would be to ascertain
whether the activity involved qualifies
as a ‘‘pattern or practice.’’ If (and only
if) it does, the second step would be to
determine, using the specified factors,
whether the provider or supplier should
be revoked. To clarify this approach, we
propose to change § 424.535(a)(8)(ii)’s
opening paragraph to state: ‘‘CMS
determines that the provider or supplier
has a pattern or practice of submitting
claims that fail to meet Medicare
requirements and that a revocation on
this basis is warranted. In determining
whether a revocation is warranted, CMS
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considers, as appropriate or applicable,
the following:’’.
Language similar to that in existing
§ 424.535(a)(8)(ii) is present in
§ 424.535(a)(14)(i) and (ii). For the
reasons outlined in the previous
paragraph, we propose to revise the
opening of § 424.535(a)(14)(i) to state:
‘‘The pattern or practice is abusive or
represents a threat to the health and
safety of Medicare beneficiaries, or both,
and CMS determines that a revocation
on this basis is warranted. In
determining whether a revocation is
warranted, CMS considers the following
factors:’’. The revised opening of
§ 424.535(a)(14)(ii) would read: ‘‘The
pattern or practice of prescribing fails to
meet Medicare requirements and CMS
determines that a revocation on this
basis is warranted. In determining
whether a revocation is warranted, CMS
considers the following factors:’’.
With respect to § 424.535(a)(21), the
closing language of the first sentence
and the entirety of the second sentence
reads: ‘‘. . . or otherwise fails to meet
Medicare requirements. In making its
determination as to whether such a
pattern or practice exists, CMS
considers the following factors:’’. We
propose to change this to state: ‘‘. . . or
otherwise fails to meet Medicare
requirements, and CMS determines that
a revocation on this basis is warranted.
In determining whether a revocation is
warranted, CMS considers the following
factors:’’.
(B) Indirect Ownership
We propose to define ‘‘indirect
ownership interest’’ in § 424.502. Some
interested parties have expressed
uncertainty about what indirect
ownership is. An understanding of
indirect ownership is important for
providers and suppliers because they
are required to report on their
enrollment application all of their 5
percent or greater indirect owners.
Section 420.201 defines an ‘‘indirect
ownership interest’’ as ‘‘any ownership
interest in an entity that has an
ownership interest in the disclosing
entity. The term includes an ownership
interest in any entity that has an
indirect ownership interest in the
disclosing entity.’’ We believe this
definition (albeit with certain
modifications for purposes of clarity
and to conform to the terminology of
part 424, subpart P) would provide the
desired elucidation. Accordingly, our
proposed definition of ‘‘indirect
ownership interest’’ would state:
• Any ownership interest in an entity
that has an ownership interest in the
enrolling or enrolled provider or
supplier. (For example, Provider A is
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owned by Entity B. Entity B is owned
by Entity C. Entity C would have an
indirect ownership interest in (and be
an indirect owner of) Provider A.)
• Any ownership interest in an
indirect owner of the enrolling or
enrolled provider or supplier. (Using the
preceding example, if Entity D had an
ownership interest in Entity C, Entity D
would have an indirect ownership
interest in Provider A.)
We would designate this portion of
our definition as paragraphs (1)(i) and
(ii). To further clarify the concept of
indirect ownership, we propose in
paragraph (2) to mirror an example
contained in § 420.202(a). Paragraph (2)
would state: ‘‘The amount of indirect
ownership interest is determined by
multiplying the percentages of
ownership in each entity. For example,
if A owns 10 percent of the stock in a
corporation that owns 80 percent of the
provider or supplier, A’s interest
equates to an 8 percent indirect
ownership interest in the provider or
supplier and must be reported on the
enrollment application. Conversely, if B
owns 80 percent of the stock of a
corporation that owns 5 percent of the
stock of the provider or supplier, B’s
interest equates to a 4 percent indirect
ownership entity in the provider or
supplier and need not be reported.’’
(C) PTs and OTs in Private Practice and
Speech-Language Pathologists
Physical therapists in private practice
(PTPPs), occupational therapists in
private practice (OTPPs), and speechlanguage pathologists (SLPs) are
permitted under the Act to receive
payment for furnished Medicare
services. However, they do not fall
within the regulatory definition of
‘‘supplier’’ under § 400.202. The reason
is that while the services they provide
are payable under Medicare (thus
allowing these individuals to enroll in
the program), PTPPs, OTPPs, and SLPs
are not formally recognized in either the
Act or the CFR as types of ‘‘suppliers.’’
Nevertheless, we have applied the
provisions of subpart P of part 424 to
PTPPs, OTPPs, and SLPs via current
guidance. We have also afforded PTPPs,
OTPPs, and SLPs the same appeal rights
(for example, appeals of enrollment
denials and revocations) as all other
enrolling or enrolled individuals and
entities. To codify these practices in the
CFR, we propose several regulatory
provisions.
First, we propose to define ‘‘supplier’’
in § 424.502 as follows: ‘‘Supplier
means, for purposes of this subpart, all
of the following: (1) the individuals and
entities that qualify as suppliers under
§ 400.202; (2) physical therapists in
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private practice; (3) occupational
therapists in private practice; and (4)
speech-language pathologists.’’ Second,
we would include within new
§ 405.800(d) the same definition of
‘‘supplier’’ we are proposing in
§ 424.502. This is because subpart H of
part 405 addresses various types of
provider enrollment appeals under
Medicare Part B. Third, 42 CFR part
498, too, contains various provisions
concerning provider enrollment
appeals. Section 498.2 defines
‘‘supplier’’ for purposes of part 498 by
outlining several categories of suppliers.
One such category, codified in
paragraph (6) of this definition, reads,
‘‘Physical therapist in independent
practice.’’ We propose to revise
paragraph (6) to state: ‘‘For purposes of
this part, physical therapist in private
practice, occupational therapist in
private practice, or speech-language
pathologist.’’
(D) Authorized Officials
Under § 424.510(d)(3), an authorized
official or delegated official must sign
the Medicare enrollment application
(for example, Form CMS–855A) on
behalf of the provider or supplier if the
latter is a corporation, partnership,
group, limited liability company, or
other organization. The terms
authorized official and delegated official
are defined in § 424.502. The former is
‘‘an appointed official (for example,
chief executive officer, chief financial
officer, general partner, chairman of the
board, or direct owner) to whom the
organization has granted the legal
authority to enroll it in the Medicare
program, to make changes or updates to
the organization’s status in the Medicare
program, and to commit the
organization to fully abide by the
statutes, regulations, and program
instructions of the Medicare program.’’
A delegated official is defined as an
individual ‘‘who is delegated by the
‘Authorized Official’ the authority to
report changes and updates to the
enrollment record. The delegated
official must be an individual with
ownership or control interest in, or be
a W–2 managing employee of, the
provider or supplier.’’
With respect to the authorized official
definition, interested parties have
questioned CMS on whether the term
‘‘organization’’ as used therein means:
(1) the entity listed in Section 2 of the
Form CMS–855 as identified by its legal
business name (LBN) and tax
identification number (TIN); or (2) the
provider or supplier type that is
enrolling. To illustrate, suppose Entity
A (with its unique LBN and TIN)
submits three separate Form CMS–855A
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initial enrollment applications to enroll
an HHA, a hospice, and a skilled
nursing facility (SNF), all of which have
Entity A’s LBN and TIN. In this type of
situation, the question is whether
‘‘organization’’ refers to Entity A or
instead to three separate ones—that is,
the HHA, hospice, and the SNF.
We propose to add a sentence to the
conclusion of the ‘‘authorized official’’
definition clarifying that the term
‘‘organization’’ therein—and exclusively
for purposes of applying the
‘‘authorized official’’ definition—means
the enrolling entity as identified by its
LBN and TIN and not the provider or
supplier type(s) that the entity is
enrolling as. Using our previous
illustration, this is because the HHA,
hospice, and the SNF are not legal
entities (such as corporations) separate
and distinct from Entity A but are, in
effect, part of Entity A itself; Entity A,
in other words, is enrolling as an HHA,
hospice, and SNF. In practical terms,
this means an authorized official serves
in that role on behalf of the enrolling
entity (Entity A). Per our example,
therefore, the individual could sign
CMS provider enrollment applications
concerning the HHA, hospice, and the
SNF. We welcome comments on our
proposed clarification.
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2. Medicaid and CHIP Enrollment
a. Background
The Medicaid program (title XIX of
the Act) is a joint Federal and State
health care program that (as of
December 2022) covers more than 85
million low-income individuals. States
have considerable flexibility when
administering their Medicaid programs
within a broad Federal framework, and
programs vary from State to State. The
Children’s Health Insurance Program
(CHIP) (title XXI of the Act) is a joint
Federal and State health care program
that (as of December 2022) provides
health care coverage to over 7 million
children in families with incomes too
high to qualify for Medicaid, but too low
to afford private coverage.
In operating Medicaid and CHIP, and
as required by sections 1902(a)(78) and
2107(e)(1)(D) of the Act, respectively,
each State requires providers to enroll if
the providers wish to furnish, order,
prescribe, refer, or certify eligibility for
Medicaid or CHIP items or services in
that State.253 States may also establish
their own provider enrollment
requirements which must be met in
253 Section 1902(kk)(7) also requires physicians
and other eligible professionals who order or refer
Medicaid services and items to be enrolled in
Medicaid. This requirement is made applicable to
CHIP via section 2107(e)(1)(G) of the Act.
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addition to the applicable Federal
provider enrollment requirements.
Similar to Medicare provider
enrollment, the purpose of the Medicaid
and CHIP provider enrollment processes
is to ensure that providers: (1) meet all
Medicaid or CHIP requirements (and
any other State-specific or Federal
requirements); (2) are qualified to
furnish, order, prescribe, refer, or certify
Medicaid and CHIP services, items, and
drugs; and (3) are eligible to receive
payment, where applicable.
Different States may have different
provider enrollment processes in
operating their Medicaid and CHIP
programs. However, all States must
comply with Federal Medicaid and
CHIP provider enrollment requirements,
including those in part 455, subparts B
and E.254 For example, under subpart B,
providers must disclose information
regarding, among other things,
ownership and control of the provider
entity, certain business transactions,
and criminal convictions related to
Federal health care programs. Under
subpart E, States must implement
various Medicaid provider screening
requirements. (In addition, State
enrollment requirements must be
consistent with section 1902(a)(23) of
the Act and implementing regulations at
§ 431.51, under which States may set
reasonable standards relating to the
qualifications of providers; however,
States may not restrict the right of
beneficiaries to obtain services from any
person or entity that is both qualified
and willing to furnish such services.)
Another such provision in part 455 to
which states must adhere involves
denial or termination of enrollment.
Under § 455.416, the State must deny or
terminate a provider’s Medicaid or CHIP
enrollment for reasons specified therein,
which include the following:
• Any person with a 5 percent or
greater direct or indirect ownership
interest in the provider fails to: (1)
submit timely and accurate information;
and (2) cooperate with any screening
methods required under part 455,
subpart E.
• Any person with a 5 percent or
greater direct or indirect ownership
interest in the provider has been
convicted of a criminal offense related
to that person’s involvement with
Medicare, Medicaid, or CHIP in the last
10 years.
• The provider, or a person with an
ownership or control interest in or who
is an agent or managing employee of the
provider, fails to submit timely or
accurate information as required.
254 All of subpart E, and 42 CFR 455.107 in
Subpart B, are applicable to CHIP under § 457.990.
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• The provider, or any person with a
5 percent or greater direct or indirect
ownership interest in the provider, fails
to submit sets of fingerprints in a form
and manner to be determined by the
State Medicaid agency within 30 days of
a CMS or a State Medicaid agency
request.
• The provider fails to permit access
to provider locations for any site visits
under § 455.432.
Of particular importance, as will be
discussed in more detail in this section
III.K. of this proposed rule is that, under
section 1902(a)(39) of the Act and
§ 455.416(c), the State must deny or
terminate the provider’s enrollment if
the provider is terminated under the
Medicare program, or the Medicaid
program or CHIP of any other State.
These termination reasons require
States to take action against providers
that have, for instance, demonstrated an
unwillingness or inability to meet
certain Medicaid or CHIP requirements,
or engaged in improper conduct. The
possibility of being terminated also
encourages providers to abide by
Medicaid and CHIP enrollment rules,
thus protecting Medicaid and CHIP
against improper provider activity.
Recognizing, however, that special
circumstances may exist concerning a
particular provider (and given the
importance of leaving the States with as
much discretion in their enrollment
processes as possible), several of the
otherwise mandatory termination
reasons in § 455.416 permit the State to
forgo termination if the State: (1)
determines that such an action would
not be in the Medicaid program’s best
interests; and (2) documents this
decision in writing. Furthermore, States
may develop additional State-specific
reasons for terminating a Medicaid or
CHIP provider, so long as such reasons
(and the enforcement thereof) are not
inconsistent with the requirements of
§§ 455.416 and 431.51.
b. The 21st Century Cures Act’s
Medicaid and CHIP Provider Enrollment
Requirements
The 21st Century Cures Act (Pub. L.
114–255; hereafter referred to as the
Cures Act) was signed into law on
December 13, 2016. The Cures Act
addresses a variety of nationwide health
care issues. Among the topics outlined
in section 5005 of the Cures Act is
Medicaid and CHIP provider enrollment
and, in particular, Medicaid and CHIP
provider terminations. For purposes of
our proposals in this section III.K., the
most pertinent provisions in section
5005 of the Cures Act are as follows:
• Section 5005(a)(1) of the Cures Act
added a new paragraph (8) to section
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1902(kk) of the Act requiring the State
to report the termination of a provider
under Medicaid or CHIP to the Secretary
within 30 days after the effective date of
the termination. Section 5005(a)(1) of
the Cures Act also outlines information
that must be included in the termination
notification that the State sends to CMS.
However, paragraph (8)(A) limits this
reporting requirement to terminations
for reasons specified in § 455.101 as in
effect on November 1, 2015, which are
limited to terminations ‘‘for cause’’
(including, but not limited to,
terminations for reasons relating to
fraud, integrity, or quality). Paragraph
(8)(B) provides that, for purposes of the
reporting requirement, the effective date
of a termination is the later of: (1) the
effective date specified in the notice of
termination; or (2) the date on which
applicable appeal rights have been
exhausted or the timeline for appeal has
expired.
• Section 5005(a)(3) of the Cures Act
added a new paragraph (ll) to section
1902 of the Act stating that within 30
days of receiving notification of a
Medicaid or CHIP provider termination,
the Secretary shall review such
termination and, if the Secretary
determines appropriate, include such
termination in any database or similar
system developed under section
6401(b)(2) of the Affordable Care Act.
• Section 5005(a)(4)(A) of the Cures
Act added a new paragraph (D) to
section 1903(i)(2) of the Act providing
that, except for emergency items or
services (but not including items or
services furnished in a hospital
emergency department), no Federal
financial participation (FFP) funds may
be paid for items and services furnished
by a provider terminated under
Medicaid or CHIP (as described in
section 1902(kk)(8)) beginning 60 days
after the date the termination is
included in the termination database.
We have issued extensive subregulatory guidance to assist States in
implementing Medicaid and CHIP
screening and enrollment provisions
outlined in 42 CFR part 455. This
guidance is compiled in a document
titled ‘‘Medicaid Provider Enrollment
Compendium’’ (MPEC) (https://
www.medicaid.gov/sites/default/files/
2021-05/mpec-3222021.pdf), originally
issued in May 2016 and subsequently
updated several times. After the
enactment of the Cures Act, CMS again
updated the MPEC to clarify the
operational details concerning several of
the statutory provisions amended by
section 5005.
Under CMS’ existing process (under
the statute and MPEC guidance), when
a State reports a ‘‘for cause’’
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termination, CMS determines whether:
(1) the State submitted the required
termination data in accordance with
section 1902(kk)(8) of the Act; and (2)
the termination is, indeed, ‘‘for cause.’’
If CMS concludes that the reported
termination is ‘‘for cause’’ and is thus
appropriate to be included in the
database referenced in section 1902(ll)
of the Act, the information is uploaded
into a CMS-managed database. This
database contains information on
Medicaid and CHIP terminations and
Medicare revocations, the latter of
which is updated at least monthly. The
database enables a State to review
Medicaid and CHIP terminations in
other States, as well as Medicare
revocations, and, under § 455.416(c), to
deny enrollment or take its own
termination action against a provider if
the latter is also enrolled in the State.
Moreover, the database gives CMS
access to information on Medicaid and
CHIP provider terminations nationwide,
which permits us to take a Medicare
revocation action against the provider
under § 424.535(a)(12)(i), if appropriate,
based on the Medicaid or CHIP
termination.
c. Proposed Provisions
i. Termination Lengths—Background
There are two termination databaserelated matters that have generated
uncertainty during our implementation
of the § 455.416(c) termination
requirement. They involve: (1) the
length of time for which a termination
remains active in the termination
database; and (2) the interaction of
different termination periods imposed
by the States and/or the Medicare
program.
Under § 424.535(c), if a Medicare
provider or supplier is revoked from
Medicare, they are barred from
participating in the Medicare program
from the effective date of the revocation
until the end of the reenrollment bar,
which, under existing § 424.535(c), is
generally for a period of 1 to 10 years.
This 1- to 10-year period typically
constitutes: (1) the time period for
which the provider or supplier is
revoked from Medicare; and (2) the
amount of time that the Medicare
revocation will remain in the
termination database.
Many States have similar
reenrollment bars for terminated
Medicaid and CHIP providers.
(Hereafter, and for purposes of
consistency, the terms ‘‘termination
period’’ and ‘‘reenrollment bar’’ as used
in this section III.K. refer to a Medicaid
or CHIP reenrollment bar, unless
otherwise noted.) Yet these termination
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periods often differ among the States.
For instance, State A may terminate a
provider for 3 years for a particular
transgression while State B might do so
for 10 years for the same conduct. We
recognize the traditional deference
given to States regarding the
establishment of reenrollment bars.
However, the interplay between varying
termination period lengths (especially
as they relate to the termination
database and the previously-mentioned
termination requirement in § 455.416(c))
has caused confusion among the States,
provider communities, and other
interested parties. Accordingly, we
propose to specify in regulation the
length of time for which for cause
provider terminations will remain in the
database and, by extension, the period
for which other States must deny or
terminate the provider under to
§ 455.416(c).
ii. Revision to § 455.416(c)
As previously indicated, under
§ 455.416(c) the State Medicaid agency
must deny or terminate the enrollment
of any provider that is terminated on or
after January 1, 2011, under title XVIII
of the Act, or under the Medicaid
program or CHIP of any other State. We
propose to add the following clause to
the end of § 455.416(c): ‘‘and is
currently included in the termination
database under § 455.417.’’ This
revision would clarify that the denial
and termination requirement under
§ 455.416(c) is predicated on the
provider’s inclusion in the termination
database.
iii. Length of Inclusion in Database
(§ 455.417)
For the reasons outlined above, we
propose several provisions in new
§ 455.417 as follows:
• In paragraph (a)(1), we propose that
a provider would remain in the
termination database referenced in
section 1902(ll) of the Act for a period
that is the lesser of:
++ The length of the termination
period imposed by the initially
terminating State Medicaid program or
CHIP, or the reenrollment bar imposed
by the Medicare program; or
++ 10 years (for those Medicaid or
CHIP terminations that are greater than
10 years).
• Under proposed paragraph (a)(2) all
other State Medicaid programs or CHIPs
in which the provider is enrolled or
seeking to enroll would be required to
terminate or deny the provider’s
enrollment from their respective
programs (under § 455.416(c)) for at
least the same length of time as the
termination database period).
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• In paragraphs (b)(1)(i) and (ii),
respectively, we propose that nothing in
paragraph (a) would prohibit:
++ The initially terminating State
from imposing a termination period of
greater than 10 years consistent with
that State’s laws, or
++ Another State from terminating
the provider, based on the original
State’s termination, for a period: (A) of
greater than 10 years; or (B) that is
otherwise longer than that imposed by
the initially terminating State.
In paragraph (b)(2), however, we
would make clear that the period
established under paragraph (b)(1)(ii)
must be no shorter than the period in
which the provider is to be included in
the termination database under
paragraph (a).
To illustrate how paragraphs (a)
through (b) would work in practice,
consider the following examples:
++ Example 1: State A, the initially
terminating State, terminates a provider
for a period of 5 years. Under paragraph
(a)(1), the provider would remain in the
termination database for 5 years. Under
paragraph (b), when State B terminates
the provider based on the State A
termination (under § 455.416(c)), it may
impose any termination period so long
as (under proposed paragraph (b)(2)) it
is no shorter than the 5-year period in
which the provider remains in the
termination database. (This is because
all States must adhere, at a minimum,
to the termination database period.)
However, whatever period State B
imposes would have no effect on the
length of time the provider is to remain
in the termination database, which is 5
years under the original State’s (State
A’s) termination period. If, therefore,
State B imposes an 8-year termination
period, the provider would still only
remain in the termination database for
5 years, but State B could (under its
State law) prohibit the provider from
enrolling in its State B Medicaid
program or CHIP for another 3 years
beyond that period.
++ Example 2: State A, the initially
terminating State, terminates a provider
for 15 years. Under paragraph (a)(1), the
provider would remain in the
termination database for only 10 years.
Under paragraph (b), however, State A
may enforce its original 15-year
termination period imposed on the
provider notwithstanding that the
provider would only remain in the
database for 10 years. When State B
terminates the provider based on the
State A termination (under
§ 455.416(c)), it may impose any
termination period permitted under its
State law so long as it is at least the
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length of the 10-year termination
database period in this Example 2.
As indicated in Examples 1 and 2,
there is a critical distinction between a
State-imposed termination period (or a
Medicare reenrollment bar) and the
length of time in which a provider
remains in the termination database.
The former generally involves the
period for which the provider is
prohibited from reenrolling in the
initially terminating State program or
Medicare (in the case of a revocation);
the latter involves the minimum period
in which other States must also
terminate the provider under
§ 455.416(c). (Hereafter, the former will
be referred to as the ‘‘termination
period’’ or ‘‘reenrollment bar’’ and the
latter the ‘‘termination database
period.’’)
Aside from the aforementioned need
for clarity, there are several other
important reasons for proposed
§ 455.417(a) and (b).
First, despite our aforementioned
concerns about inconsistencies in Stateimposed termination periods, we are
committed to ensuring that States have
as much discretion as possible in
administering their respective Medicaid
programs. We believe proposed
§ 455.417(a) and (b), taken together,
would clarify the duration of the
requirement to terminate under
§ 455.416(c) while preserving each
State’s ability to impose whatever
termination period it deems appropriate
(subject to proposed paragraph (b)(2),
which designates the termination
database period as a minimum).
Second, establishment of a maximum
10-year termination database period
would address situations where a State
imposes an extremely lengthy, or even
a lifetime, termination period that is far
longer than: (1) that imposed by other
States for the same conduct; or (2) the
maximum Medicare 10-year
reenrollment bar under § 424.535(c), but
other States wish to permit a provider
to reenroll before the initially
terminating State’s reenrollment bar has
expired. Moreover, a finite termination
database period is needed to address
instances where the initially terminating
State establishes an indefinite
termination period; if the termination
remained in the database until that State
permitted the provider to reenroll, this
would essentially cause the provider to
be barred from the Medicaid program in
all States indefinitely, regardless of the
underlying cause of the termination and
the circumstances associated therewith.
This could be very problematic for the
provider and perhaps lead to access to
care issues in some States. Indeed,
providers may experience undue burden
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in these cases because even if they can
prove that the underlying cause for the
termination has been resolved, they
might remain unable to enroll in other
States while an indefinite termination
remains in the termination database. We
believe that a maximum 10-year period
in the database (if the State imposes a
termination period of 10 years or longer)
would give the broadest possible
deference to the initially terminating
State while still providing a consistent
and finite period during which other
States are required to terminate (and
continue the termination) or deny the
provider’s enrollment under
§ 455.416(c).
In paragraph (c)(1), we propose that if
the initially terminating State agency or
the Medicare program reinstates the
provider prior to the end of the
termination period originally imposed
by the initially terminating State
program or Medicare, CMS would
remove the provider from the
termination database after the
reinstatement has been reported to CMS.
This proposal is intended to clarify the
impact of a reinstatement, including
those occurring prior to the expiration
of the original termination period. Such
instances of early reinstatement might
include: (1) resolution of the underlying
basis for the original termination; or (2)
access to care concerns of the originally
terminating State agency. However, we
also propose in § 455.417(c)(2) that if
the provider is removed from the
database due to reinstatement by the
originally terminating State agency,
nothing prohibits CMS from
immediately re-including the provider
in the database if a separate basis for
doing so exists under 42 CFR part 455
or 424. This is to emphasize that CMS
is not required to afford the provider
any sort of ‘‘waiting period’’ between
the expiration of the original
termination period and the
commencement of a new one should
grounds exist for the imposition of the
latter; the new termination database
period can become effective
immediately upon the expiration of the
prior one.
Consider the following example of
proposed § 455.417(c)(2)’s potential
applicability. State A initially
terminates a provider for 2 years. Under
proposed § 455.417(a), the provider
would be included in the termination
database for 2 years. Under proposed
§ 455.417(b), all other States must
terminate the provider from their
Medicaid programs for at least that same
time period. Yet Medicare is not
required to (and elects not to) revoke the
provider’s Medicare enrollment
notwithstanding the State A
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termination. Now assume that State A
reinstates the provider after 1 year. Two
days before the reinstatement takes
effect, though, the provider is revoked
from Medicare with a 3-year enrollment
bar for a reason unrelated to the grounds
behind the State A termination. Since
§ 455.416(c) requires State A (and all
other States) to terminate the provider
based on the Medicare revocation, CMS
may place the provider in the
termination database for a 3-year period
effective immediately upon the
expiration of the original termination
database period. This is to ensure that
the initial 1-year period runs its full
course before the beginning of the 3-year
termination database. If we commenced
the 3-year period 2 days before the 1year period expired, the 1-year period
would, in effect, have lasted 2 days less
than 1 year; likewise, the 3-year period
would essentially be 3 years minus 2
days. This is due to the 2-day overlap
between the two timeframes.
Aside from clarifying that Medicaid
termination periods can run
consecutively without any break
between them, we believe that proposed
§ 455.417(c) would help ensure a
seamless transition between the two
periods and, in the process, prevent
problematic Medicaid providers from
using any gap in periods to bill
Medicaid.
We indicated earlier that, per the
statute and MPEC guidance, States must
report ‘‘for cause’’ terminations to CMS
for purposes of the termination
database. We propose in new
§ 455.417(d) that, for purposes of
§ 455.417 only, terminations under
§ 455.416(c) (which, as previously
discussed, are based on another State’s
termination of the provider) are not
themselves considered ‘‘for cause’’
terminations, and therefore, need not be
separately reported to CMS for inclusion
in the termination database. Using
Examples 1 and 2 as previously
discussed, this would mean that State B
would not have to report the
terminations in those examples to CMS
for termination database purposes,
although State B would still be required
to: (i) terminate the provider under
§ 455.416(c), based on the State A
termination; and (ii) apply a termination
period no shorter than the termination
database period established under
§ 455.417(a). The goal of proposed
§ 455.417(d) is to eliminate
repetitiveness in reporting the same data
to CMS so as to ease the burden on
States. In our view, and under the
foregoing example, there is no reason for
State B (and, for that matter, other
States) to expend resources in reporting
a termination that was already reported
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by the originally terminating State.
Furthermore, this would avoid the
potential for additional confusion
regarding the termination database
period, in that it would ensure that such
period is based only on the initial
State’s termination and not on
subsequent derivative terminations.
L. Expand Diabetes Screening and
Diabetes Definitions
For CY 2024, we propose to: (1)
expand coverage of diabetes screening
tests to include the Hemoglobin A1C
test (HbA1c) test; (2) expand and
simplify the frequency limitations for
diabetes screening; and (3) simplify the
regulatory definition of ‘‘diabetes’’ for
diabetes screening (§ 410.18(a)), Medical
Nutrition Therapy (MNT) (§ 410.130)
and Diabetes Outpatient SelfManagement Training Services (DSMT)
(§ 410.140).
Medicare coverage for diabetes
screening tests under Part B are
described in statute (sections
1861(s)(2)(Y), 1861(ww)(2)(K), 1861(yy),
and 1862(a)(1)(M) of the Act) and in
regulation at 42 CFR 410.18. The statute
and regulations allow for diabetes
screening tests:
• The Fasting Plasma Glucose (FPG)
test (section 1861(yy)(1)(A) of the Act
and § 410.18(c)(1));
• The Post Glucose Challenge Test,
also called the Glucose Tolerance Test
(GTT) (§ 410.18(c)(2)); and
• Such other tests, and modifications
to tests, as the Secretary determines
appropriate, in consultation with
appropriate organizations (section
1861(yy)(1)(B) of the Act) and that may
be determined through a national
coverage determination
(§ 410.18(c)(3)).255
We propose to exercise our authority
in section 1861(yy)(1) of the Act to add
the HbA1c test to the types of diabetes
screening tests covered under
§ 410.18(c), in consultation with
recommendations by appropriate
organizations.
Section 1861(yy)(3) of the Act limits
the frequency of diabetes screening tests
to not more often than twice within the
12-month period following the date of
the most recent diabetes screening test
of that individual. Our regulations allow
two screening tests per calendar year if
the patient was previously diagnosed
with pre-diabetes and one screening test
per year for patients who were
previously tested who were not
diagnosed with pre-diabetes, or who
255 The Secretary, as of the date of this proposed
rule, has not approved additional diabetes
screening tests by through a national coverage
determination.
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were never tested before (§ 410.18(d)).
We propose to exercise our authority in
section 1861(yy)(1)(3) of the Act to
simplify our frequency limitations for
diabetes screening by aligning to the
statutory limitation of not more often
than twice within the 12-month period
following the date of the most recent
diabetes screening test of that
individual.
We also propose to simplify the
regulatory definitions of ‘‘diabetes’’ for
the purpose of diabetes screening at
§ 410.18(a) to remove the codified
clinical test requirements from the
definition of ‘‘diabetes.’’ We also
propose to remove the definition of
‘‘pre-diabetes’’ at § 410.18(a). The
diabetes and prediabetes definitions at
§ 410.18(a) supported existing
regulatory frequency limitations in
§ 410.18(d), which describe separate
frequency limitations between
individuals previously diagnosed, and
those terms would no longer be needed
under our proposed updates. We
recognize that it is unnecessary to
codify clinically specific test criteria
into the regulatory definition of
diabetes, which reduces flexibility for
the agency and health care system to
adapt to evolving clinical standards
without potentially producing
programmatic benefit. The proposed
revised definition of diabetes for
screening purposes would be shortened
to describe diabetes as diabetes mellitus,
a condition of abnormal glucose
metabolism.
Medicare coverage for MNT under
Part B is described in statute (primarily
sections 1861(s)(2)(V), 1861(vv), and
1861(ww)(2)(I) of the Act, in regulations
at 42 CFR part 410, subpart G, and in
National Coverage Determination (NCD)
(Section 180.1 of the Medicare National
Coverage Determinations Manual (NCD
Manual)). Section 410.130 currently
describes a number of definitions for
purposes of the MNT benefit, including
‘‘diabetes.’’ The regulatory definition of
diabetes for MNT purposes at § 410.130
is identical to the existing regulatory
definition of diabetes for screening
purposes at § 410.18(a). We propose to
simplify the regulatory definitions of
‘‘diabetes’’ for the purpose of MNT at
§ 410.130 to remove the codified clinical
test requirements. The proposed revised
definition of diabetes for MNT purposes
would be shortened to simply describe
diabetes as diabetes mellitus, a
condition of abnormal glucose
metabolism. NCD 180.1 refers to the
regulatory definition of diabetes at
§ 410.130, so no modifications would be
required to the NCD.
Medicare coverage for DSMT under
Part B is described in statute (sections
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1861(s)(2)(S), 1861(qq), 1861(ww)(2)(F)
of the Act) and in regulation at part 410
subpart H. Section 410.140 describes a
number of definitions for the purposes
of the DSMT benefit, including
‘‘diabetes’’. The regulatory definition of
diabetes for DSMT purposes at
§ 410.140 is identical to the existing
regulatory definition of diabetes for
MNT purposes at § 410.130 and the
existing regulatory definition of diabetes
for screening purposes at § 410.18(a).
We propose to exercise our authority to
simplify the regulatory definitions of
‘‘diabetes’’ for the purpose of DSMT at
§ 410.140 to remove the codified clinical
test requirements. The proposed revised
definition of diabetes for DSMT
purposes would be shortened to simply
define diabetes as diabetes mellitus, a
condition of abnormal glucose
metabolism.
1. Background
Diabetes is a chronic disease that
affects how the body turns food into
energy and includes three main types:
Type 1, Type 2 and gestational diabetes.
The Centers for Disease Control and
Prevention (CDC) reports that
approximately 37.3 million Americans
are living with diabetes and an
additional 96 million Americans are
living with prediabetes.256 CDC reports
that 326,000 persons age 65 years and
older are newly diagnosed with diabetes
each year. CDC also estimates that
among persons age 65 years and older,
21 percent have been diagnosed with
diabetes while 5 percent have
undiagnosed diabetes.257 Diabetes is the
leading cause of kidney failure and new
cases of blindness among adults, and
the sixth leading cause of death among
adults age 65 years and older in the
U.S.258 Screening is performed on
persons who may not exhibit symptoms
to identify persons with either
prediabetes or diabetes, who can then be
referred for appropriate prevention or
treatment, with the intention of
improving health outcomes.
In October 2015, the United States
Preventive Services Task Force
(USPSTF) issued a revised final
recommendation statement, with a
grade of B, for screening for abnormal
blood glucose as part of cardiovascular
tkelley on DSK125TN23PROD with PROPOSALS2
256 CDC
website on diabetes at https://
www.cdc.gov/diabetes/basics/.
257 Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2020. Accessed
March 9, 2023. https://www.cdc.gov/diabetes/pdfs/
data/statistics/national-diabetes-statisticsreport.pdf.
258 Heron M. Deaths: Leading causes for 2019.
National Vital Statistics Reports; vol 70 no 9.
Hyattsville, MD: National Center for Health
Statistics. 2021. DOI: https://dx.doi.org/10.15620/
cdc:107021.
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risk assessment in adults aged 40 to 70
years who are overweight or obese and
again identified the FPG, GTT and
HbA1c tests as appropriate for diabetes
screening.259 In August 2021, the
USPSTF issued a revised final
recommendation statement, with a
grade of B, that expanded recommended
screening for prediabetes and type 2
diabetes in adults aged 35 to 70 years
who have overweight or obesity, and
that clinicians should offer or refer
patients with prediabetes to effective
preventive interventions, which are
discussed in their report. The USPSTF
again recommended the FPG, GTT and
HbA1c tests as appropriate for diabetes
screening and noted, ‘‘Because HbA1c
measurements do not require fasting,
they are more convenient than using a
fasting plasma glucose level (FPG) or an
oral glucose tolerance test (GTT).’’ 260
The grade of B is indicated when the
USPSTF has high certainty that the net
benefit is moderate or moderate
certainty that the net benefit is moderate
to substantial.
We recognize that both the USPSTF
and specialty societies have identified
the HbA1c test as clinically appropriate
for diabetes screening. In addition, the
HbA1c test has certain unique
advantages and disadvantages compared
to the FPG and GTT tests that should be
considered by the practitioner and
patient when choosing a diabetes
screening test. The American Diabetes
Association (ADA) Standards of Care in
Diabetes—2023 reads, ‘‘Generally, FPG,
2-h PG during 75-g OGTT (aka GTT),
and A1C (aka HbA1c) are equally
appropriate for diagnostic screening
. . . The same tests may be used to
screen for and diagnose diabetes and to
detect individuals with prediabetes . . .
A1C (aka HbA1c) has several advantages
compared with FPG and OGTT (aka
GTT), including greater convenience
(fasting not required), greater
preanalytical stability, and fewer day-today perturbations during stress, changes
in nutrition, or illness. However, these
advantages may be offset by the lower
sensitivity of A1C (aka HbA1c) at the
designated cut point, greater cost,
limited availability of A1C (aka HbA1c)
testing in certain regions of the
developing world, and the imperfect
correlation between A1C (aka HbA1c)
and average glucose in certain
individuals . . . Despite these
259 USPSTF website: https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/screening-for-abnormal-bloodglucose-and-type-2-diabetes-october-2015.
260 USPSTF website: https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/screening-for-prediabetes-andtype-2-diabetes.
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limitations with A1C (aka HbA1c), in
2009, the International Expert
Committee added A1C (aka HbA1c) to
the diagnostic criteria with the goal of
increased screening.’’ 261 The American
Association of Clinical Endocrinology
(AACE) also recommends screening for
diabetes and prediabetes with similar
tests, including HbA1c.262
The regulatory texts for diabetes
screening, MNT, and DSMT include a
clinically specific test-based definition
for ‘‘diabetes’’ that has since been
overtaken by evolving clinical
standards. Since 2020, the ADA has
revised and expanded its criteria for the
diagnosis of diabetes to also include the
HbA1c test and a random plasma
glucose test for a patient appearing to
have hyperglycemia or hyperglycemic
crisis.263
2. Statutory Authority
Section 613 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) added section 1861(yy) to
the Act and mandated coverage of
diabetes screening tests in the Medicare
Part B program. Section 1861(yy)(1) of
the Act describes diabetes screening
tests as testing furnished to an
individual at risk for diabetes for the
purpose of early detection of diabetes,
including the FPG test and such other
tests, and modifications to tests, as the
Secretary determines appropriate, in
consultation with appropriate
organizations. Section 1861(yy)(2) of the
Act describes ‘‘individual at risk for
diabetes’’ as an individual who has any
of a number of listed risk factors,
including obesity, defined as a body
mass index greater than or equal to 30
kg/m2 as an independent qualifying
factor and overweight, defined as a body
mass index greater than 25 kg/m2, but
less than 30, kg/m2 (when present with
a second qualifying factor including a
family history of diabetes, a history of
gestational diabetes and an age of 65
years or older. Section 1861(yy)(3) of the
Act mandates that the Secretary shall
establish standards, in consultation with
appropriate organizations, regarding the
frequency of diabetes screening tests,
except that such frequency may not be
261 Diabetes Care 2023;46(Suppl. 1):S19–S40:
https://doi.org/10.2337/dc23-S002.
262 Lawrence Blonde, Guillermo E. Umpierrez, S.
Sethu Reddy, et al. American Association of
Clinical Endocrinology Clinical Practice Guideline:
Developing a Diabetes Mellitus Comprehensive
Care Plan—2022 Update. Endocrine Practice, 2023;
28: 923–1049, https://doi.org/10.1016/
j.eprac.2022.08.002.
263 Diabetes Care 2020;43(Supplement_1):S14–
S31, https://diabetesjournals.org/care/article/43/
Supplement_1/S14/30640/2-Classification-andDiagnosis-of-Diabetes.
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tkelley on DSK125TN23PROD with PROPOSALS2
more often than twice within the 12month period following the date of the
most recent diabetes screening test of
that individual. Section 1861(yy) of the
Act does not include a definition of
diabetes.
Section 105 of the Medicare,
Medicaid, and SCHIP Benefits
Improvement and Protection Act of
2000 (Pub. L. 106–554) added section
1861(vv) to the Act and mandated
coverage of MNT under Part B. Section
1861(s)(2)(V) of the Act limits coverage
of MNT to patients with diabetes or a
renal disease. Section 1861(vv)(1) of the
Act describes MNT, in pertinent part, as
nutritional diagnostic, therapy, and
counseling services for the purpose of
disease management. Sections
1861(s)(2)(V) and (vv) of the Act do not
include a codified definition of diabetes.
Section 4105(a) of the Balanced
Budget Act of 1997 (Pub. L. 105–33)
added section 1861(qq) to the Act and
mandated coverage of DSMT. Section
1861(qq) of the Act describes DSMT, in
part, as educational and training
services furnished to an individual with
diabetes by a certified provider in an
outpatient setting by an individual or
entity, but only if the physician who is
managing the individual’s diabetic
condition certifies that such services are
needed under a comprehensive plan of
care related to the individual’s diabetic
condition to ensure therapy compliance
or to provide the individual with
necessary skills and knowledge to
participate in the management of the
individual’s condition. Section 1861(qq)
of the Act does not establish a definition
of diabetes.
3. Regulatory Authority and National
Coverage Determinations
Our implementing regulations for
diabetes screening tests are codified at
§ 410.18. The regulatory definition of
diabetes and prediabetes for the
purposes of diabetes screening were
created, in part, to distinguish separate
frequency limitations for each. Section
410.18(d) allows two diabetes screening
tests per calendar year for individuals
diagnosed with pre-diabetes and one
diabetes screening test per calendar year
for individuals previously tested who
were not diagnosed with pre-diabetes,
or who were never tested before. Section
410.18(e) limit diabetes screening to
‘‘individual at risk for diabetes’’ with a
list of qualifying eligibility factors,
including obesity, defined as a body
mass index greater than or equal to 30
kg/m2 as an independent qualifying
factor (§ 410.18(e)(3)) and overweight,
defined as a body mass index greater
than 25 kg/m2, but less than 30, kg/m2
(when present with a second qualifying
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factor including a family history of
diabetes, a history of gestational
diabetes and an age of 65 years or older)
(§ 410.18(e)(5)).
Our implementing regulations for
MNT are codified at part 410 subpart G.
Section 410.130 described a number of
definitions for purposes of the MNT
benefit, including ‘‘diabetes.’’ MNT is
also described as a covered service at
section 180.1 of the NCD Manual. NCD
180.1 does not include a codified
definition of diabetes but does refer to
‘‘diabetes, as defined at § 410.130.’’ Our
implementing regulations for DSMT are
codified at part 410 subpart H. Section
410.140 describes a number of
definitions for the purposes of the
DSMT benefit, including ‘‘diabetes.’’
NCD 190.20, Blood Glucose Testing,
describes the indications and
limitations of blood glucose testing
generally but refers to § 410.18 and the
Claims Processing Manual for specific
policies on diabetes screening. NCD
190.21, Glycated Hemoglobin/Glycated
Protein, authorizes coverage of the
HbA1c test for the management of
diabetes but does not address screening
for diabetes.
In the CY 2004 PFS final rule (68 FR
63195), we finalized proposals to adopt
regulatory definitions of diabetes for the
purposes of MNT and DSMT. We
codified in regulatory text at §§ 410.130
and 410.140 that diabetes is defined as
‘‘diabetes mellitus, a condition of
abnormal glucose metabolism diagnosed
using the following criteria: A fasting
blood sugar greater than or equal to 126
mg/dL on two different occasions; a 2
hour post-glucose challenge greater than
or equal to 200 mg/dL on 2 different
occasions; or a random glucose test over
200 mg/dL for a person with symptoms
of uncontrolled diabetes.’’ The
definition of diabetes was based, in part
on a clinical recommendation submitted
by the American Association of Clinical
Endocrinologists. In the CY 2005 PFS
final rule (69 FR 66235), we finalized
proposals to adopt implementing
regulations for diabetes screening,
which was recently added as a Medicare
covered benefit in the Section 613 of the
MMA. We adopted a new regulatory
definition of prediabetes as condition of
abnormal glucose metabolism diagnosed
using the following criteria: a fasting
glucose level of 100–125 mg/dL, or a 2hour post-glucose challenge of 140–199
mg/dL, as well as including the
conditions of impaired fasting glucose
and impaired glucose tolerance. We also
adopted the regulatory definition of
diabetes finalized in the CY 2004 PFS
for MNT and DSMT. Neither the statutes
nor the regulatory text for diabetes
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52529
screening, MNT and DSMT distinguish
between different types of diabetes.
4. Proposed Revisions
We propose to exercise our authority
in section 1861(yy)(1)(B) of the Act to
add the HbA1c test to the types of
diabetes screening tests covered under
§ 410.18(c), consistent with a recently
revised recommendation by the
USPSTF. As described earlier in our
proposal, the USPSTF recommended
the HbA1C test for diabetes screening in
their October 2015 and August 2021
revised final recommendation
statements. We have engaged in
meetings with appropriate organizations
while developing our proposal to
expand diabetes screening coverage,
including the ADA, the Association of
Diabetes Care & Education Specialists
(ADCES), the National Clinical Care
Commission (NCCC) and the Diabetes
Advocacy Alliance (DAA). In addition,
we consulted the published clinical
recommendations from the USPSTF
(described earlier), the ADA 264 and the
AACE 265 in developing our proposal.
We look forward to further consultation
with organizations through the public
notice and comment rulemaking process
and invite public comment on our
proposal.
We propose to exercise our authority
in section 1861(yy)(1)(3) of the Act to
expand and simplify our frequency
limitations for diabetes screening by
aligning to the statutory limitation of
not more often than twice within the 12month period following the date of the
most recent diabetes screening test of
that individual. We also propose to
remove the regulatory definition of prediabetes for the purposes of diabetes
screening at § 410.18(a), which
functionally served, in part, to
distinguish the separate frequency
limitations of diabetes screening at two
diabetes screening tests per calendar
year for individuals diagnosed with prediabetes and one diabetes screening test
per calendar year for individuals
previously tested who were not
diagnosed with pre-diabetes, or who
were never tested before (§ 410.18(d)).
Our proposal to remove the regulatory
definition of pre-diabetes is intended to
simplify and expand diabetes screening
while reducing unnecessary regulatory
complexity. We recognize that prediabetes and diabetes exist on a
continuum and both are screened and
identified through common diabetes
screening tests. Our proposal to remove
264 https://diabetesjournals.org/care/article/45/
Supplement_1/S17/138925/2-Classification-andDiagnosis-of-Diabetes.
265 https://www.endocrinepractice.org/article/
S1530-891X(22)00576-6/fulltext.
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the regulatory definition of pre-diabetes
does not reflect a change in our position
on pre-diabetes screening and treatment
as a Medicare benefit. In making this
proposal we recognize that the FPG,
GTT and HbA1c tests include different
levels of burden for the patient and also
measure different aspects of diabetes
pathology. The August 2021 USPSTF
revised final recommendation statement
states ‘‘HbA1c is a measure of long-term
blood glucose concentration and is not
affected by acute changes in glucose
levels caused by stress or illness.
Because HbA1c measurements do not
require fasting, they are more
convenient than using a fasting plasma
glucose level or an oral glucose
tolerance test. Both fasting plasma
glucose and HbA1c levels are simpler to
measure than performing an oral
glucose tolerance test. The oral glucose
tolerance test is done in the morning in
a fasting state; blood glucose
concentration is measured 2 hours after
ingestion of a 75-g oral glucose load.
The diagnosis of prediabetes or type 2
diabetes should be confirmed with
repeat testing before starting
interventions.’’ 266 We have engaged in
meetings with appropriate organizations
while developing our proposal to
expand diabetes screening coverage,
including the ADA, the ADCES, the
NCCC, and the DAA. We also consulted
with the written recommendations of a
number of specialty societies and the
USPSTF in developing our proposal. We
acknowledge that the USPSTF, ADA
and AACE recommend diabetes
screening frequency screening of once
every 3 years.267 268 269 We propose
expanding the frequency limitations for
diabetes screening to twice in a 12month period under the theory that
additional flexibility in screening
frequency will remove barriers and
empower clinicians to apply screening
test by multiple types of tests or with
increased frequency where the
circumstances of the patient
demonstrate a medical necessity. We
look forward to further consultation
with organizations through the public
notice and comment rulemaking process
and invite public comment on our
proposal.
266 USPSTF website: https://www.uspreventive
servicestaskforce.org/uspstf/recommendation/
screening-for-prediabetes-and-type-2-diabetes.
267 https://diabetesjournals.org/care/article/43/
Supplement_1/S14/30640/2-Classification-andDiagnosis-of-Diabetes.
268 https://www.endocrinepractice.org/article/
S1530-891X(22)00576-6/fulltext.
269 https://www.uspreventiveservicestask
force.org/uspstf/recommendation/screening-forprediabetes-and-type-2-diabetes#bootstrap-panel-10.
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We propose to simplify the regulatory
definitions of ‘‘diabetes’’ for the purpose
of diabetes screening at § 410.18(a),
MNT at § 410.130 and DSMT at
§ 410.140. In all three instances, we
propose to remove the codified clinical
test requirements from the definition of
‘‘diabetes’’ and keep a shorted version of
the existing definition that would define
diabetes as diabetes mellitus, a
condition of abnormal glucose
metabolism. We now recognize that
regulatorily codifying clinically specific
test criteria into the regulatory
definition of diabetes for screening,
MNT and DSMT benefit reduces
flexibility for the agency and health care
system to adapt to evolving clinical
standards without potentially producing
programmatic benefit. We believe that
our proposal will empower practitioners
to apply clinically accurate and
appropriate criteria and that we can
ensure certain safeguards through
medical coding and claims processing
instructions. By analogy, we consider
that end stage renal disease (ESRD) is
not described with specific clinical test
criteria in section 226A and 1881 of the
Act, nor in regulations at § 406.13. We
generally believe that scientific
advancements in understanding and
measuring disease pathology outpace
the lengthy and formal notice and
comment rulemaking process. In the
instance of diabetes screening, MNT and
DSMT, the regulatory codification of
clinical test criteria into disease
definitions may not be necessary nor
ideal. We note that even without
clinical test criteria codified in the
regulatory definitions of diabetes and
pre-diabetes, a Medicare claim that
includes a diagnosis of diabetes or prediabetes would still need to include
appropriate coding, substantiation in
the medical record and compliance with
claims processing instructions from
CMS and Medicare Administrative
Contractors (MACs).
In the alternative, we considered not
removing the clinical test criteria for the
regulatory definitions of diabetes or
removing the regulatory definition of
pre-diabetes. We considered adding the
HbA1c test criteria result of 6.5% or
greater into the regulatory definition of
diabetes for screening, MNT and DSMT
and the HbA1c test criteria result of 5.7
percent to 6.4 percent to the regulatory
definition of pre-diabetes for screening.
The alternative would be consistent
with our proposal to expand coverage of
diabetes screening by adding the HbA1c
test, and would also be consistent with
clinical recommendations by the
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USPSTF 270 and the ADA.271 However,
we did not propose this alternative
because, while currently clinically
appropriate, we believed it would
further, unnecessarily complicate the
regulatory definition of diabetes and
pre-diabetes. As noted earlier, we now
recognize that regulatorily codifying
clinically specific test criteria into the
regulatory definition of ‘‘diabetes’’ and
‘‘pre-diabetes’’ for screening, and
‘‘diabetes’’ for the MNT and DSMT
benefits reduces flexibility for the
agency and health care system to adapt
to evolving clinical standards without
potentially producing programmatic
benefit. We invite public comment on
our proposal and alternative considered.
We believe that our proposal to
expand and simplify coverage for
diabetes screening aligns with the
administration’s strategic pillar to
advance health equity by addressing the
health disparities that underlie our
health system. The August 2021
updated USPSTF final recommendation
statement reads, ‘‘The prevalence of
diabetes is higher among American
Indian/Alaska Native (14.7 percent),
Asian (9.2 percent), Hispanic/Latino
(12.5 percent), and non-Hispanic Black
(11.7 percent) persons than among nonHispanic White (7.5 percent) persons.
Disparities in diabetes prevalence are
the result of a variety of factors. A large
body of evidence demonstrates strong
associations between prevalence of
diabetes and social factors such as
socioeconomic status, food
environment, and physical
environment. The higher prevalence of
diabetes in Asian persons may be
related to differences in body
composition. A difference in body fat
composition in Asian persons results in
underestimation of risk based on BMI
thresholds used to define overweight in
the US.’’ 272 The HbA1c test does not
require fasting or drinking an
unappetizing glucose solution.
Expanding coverage for diabetes
screening to include the HbA1c test will
reduce screening burdens for a disease
that disproportionally impacts minority
and disadvantaged populations. In
addition, earlier identification of
diabetes and prediabetes among
minorities and disadvantaged persons
may lead to improved diabetes control
270 https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/screening-for-prediabetes-andtype-2-diabetes#bootstrap-panel--6.
271 https://diabetesjournals.org/care/article/43/
Supplement_1/S14/30640/2-Classification-andDiagnosis-of-Diabetes.
272 USPSTF website: https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/screening-for-prediabetes-andtype-2-diabetes.
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and reduce its complications, which
currently occur disproportionately in
those groups.
tkelley on DSK125TN23PROD with PROPOSALS2
5. Summary
In summary, we propose to exercise
our authority in sections 1861(yy) of the
Act to: (1) expand coverage of diabetes
screening tests to include the HbA1c
test; (2) expand and simplify the
frequency limitations for diabetes
screening; and (3) simplify the
regulatory definition of ‘‘diabetes’’ for
diabetes screening, MNT and DSMT. We
believe our proposals will expand
access to quality care and improve
health outcomes for patients through
prevention, early detection, and more
effective treatment. We recognize that
expanded access and appropriate
utilization of diabetes screening is
critical to mitigating and avoiding
downstream health complications that
significantly impact beneficiary
wellbeing, as well as being costly and
burdensome to the healthcare system.
The National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK)
website states, ‘‘diabetes can cause
serious health problems, such as heart
disease, stroke, and eye and foot
problems. Prediabetes also can cause
health problems. The good news is that
type 2 diabetes can be delayed or even
prevented. The longer you have
diabetes, the more likely you are to
develop health problems, so delaying
diabetes by even a few years will benefit
your health.’’ 273 The U.S. Department of
Health and Human Services Office of
the Assistant Secretary for Planning and
Evaluation recently published a Report
to Congress on the Affordability of
Insulin that included a number of
generalized findings on downstream
impacts of serious diabetes related
complications on health care use.274
Their findings include:
• In 2019, there were 8.7 million
hospitalizations related to diabetes
overall. About 71 percent were a result
of the patient going to the emergency
department. Ten percent of the 8.7
million hospitalizations had a principal
diagnosis of diabetes.
• About 83 percent of
hospitalizations occurred among
patients living in communities in the
bottom 50 percent of U.S. income,
measured using median household
273 National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), part of the National
Institutes of Health, website: https://
www.niddk.nih.gov/health-information/diabetes/
overview/preventing-type-2-diabetes.
274 Office of the Assistant Secretary for Planning
and Evaluation, U.S. Department of Health &
Human Services. Report on the Affordability of
Insulin. December 16, 2022. https://aspe.hhs.gov/
reports/insulin-affordability-rtc.
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income of the patient’s zip code,
underscoring the need for affordable
access to treatment for diabetes.
• We also examined potentially
avoidable hospitalization costs for
Medicare and Medicaid beneficiaries
with diabetes, specifically examining
the costs for patients with amputations
and ketoacidosis. For Medicare in 2020,
total costs were $3.8 billion for
amputations, $5.6 billion for
ketoacidosis, and another $1.0 billion
for patients with both. Medicare paid
more than 90 percent of overall costs,
covering $3.5 billion for amputations,
$5.2 billion for ketoacidosis, and $936
million for hospitalizations involving
both.
M. Requirement for Electronic
Prescribing for Controlled Substances
for a Covered Part D Drug Under a
Prescription Drug Plan or an MA–PD
Plan
1. Previous Regulatory Action
In the CY 2021, CY 2022, and CY
2023 PFS final rules, we finalized
policies for the CMS EPCS Program
requirements specified in section 2003
of the SUPPORT Act (Pub. L. 115–271,
October 24, 2018). We refer readers to
85 FR 84802 through 84807, 86 FR
65361 through 65370, and 87 FR 70008
through 70014 for the details of the
statutory requirements and those
finalized policies. Specifically, in the
CY 2022 PFS final rule, we extended the
date of compliance actions to no earlier
than January 1, 2023 and, for prescribers
writing Part D controlled substances
prescriptions for beneficiaries in longterm care (LTC) facilities, January 1,
2025 (86 FR 65364 and 65365). We also
finalized a proposal requiring
prescribers to electronically prescribe at
least 70 percent of their Schedule II, III,
IV, and V controlled substances that are
Part D drugs, except in cases where an
exception or waiver applies (86 FR
65366); finalized multiple proposals
related to the classes of exceptions
specified by section 2003 of the
SUPPORT Act (86 FR 65366 through
65369); and finalized our proposal to
limit compliance actions with respect to
compliance through December 31, 2023
to a non-compliance notice (86 FR
65370).
In the CY 2023 PFS final rule (87 FR
70012 through 70013), we extended the
existing non-compliance action of
sending notices to non-compliant
prescribers, which we had finalized for
the CY 2023 CMS EPCS Program
implementation year (January 1, 2023
through December 31, 2023), to the CY
2024 Program implementation year
(January 1, 2024 through December 31,
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52531
2024). We also finalized a change to the
data sources used to identify the
geographic location of prescribers for
purposes of the recognized emergency
exception at § 423.160(a)(5)(iii) (87 FR
70011 through 70012) and finalized our
proposal to use the Prescription Drug
Event (PDE) data from the current
evaluated year instead of the preceding
year when CMS determines whether a
prescriber qualifies for an exception
based on issuing 100 or fewer Part D
controlled substance prescriptions per
calendar year (87 FR 70009 through
70011).
2. CMS EPCS Program Terminology
In the CY 2021, CY 2022, and CY
2023 PFS final rules (85 FR 84802
through 84807, 86 FR 65361 through
65370, and 87 FR 70008 through 70013),
we used various terminology to describe
aspects of the requirements for EPCS. In
order to provide consistency and clarity
throughout the CMS EPCS Program and
future rules, we will use the following
terms going forward.
• CMS EPCS Program. We will refer
to the program requirements for EPCS at
§ 423.160(a)(5) as the ‘‘CMS EPCS
Program.’’ We believe this provides an
appropriate distinction from the
prescriber’s act of electronically
submitting individual prescriptions for
controlled substances, which is also
referred to as EPCS.
• Non-compliance action or action
for non-compliance. We will use ‘‘noncompliance action’’ or ‘‘action for noncompliance’’ to refer to a consequence
for not meeting the CMS EPCS Program
compliance threshold, as described at
§ 423.160(a)(5), after exceptions have
been applied.
• Measurement year. When we refer
to ‘‘measurement year,’’ we mean the
time period (beginning on January 1 and
ending on December 31 of each calendar
year) during which data is collected to
calculate outcomes for the CMS EPCS
Program. In prior rules, we have used
the term ‘‘current year’’ or ‘‘evaluated
year,’’ but moving forward we will use
the term ‘‘measurement year.’’
• Compliance threshold. For the CMS
EPCS Program, ‘‘compliance threshold’’
is the requirement at § 423.160(a)(5) that
prescribers must conduct prescribing for
at least 70 percent of their Schedule II,
III, IV, and V controlled substances that
are Part D drugs electronically, after
exceptions, each measurement year.
• Compliance analysis period. The
‘‘compliance analysis period’’ is the
time period after the measurement year
where data is analyzed to determine
whether prescribers have met the
compliance threshold for the CMS EPCS
Program.
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• Notification period. The
‘‘notification period’’ is the time period
during which we notify a prescriber of
the prescriber’s initial compliance status
and any associated review or waiver
process that may be available prior to
CMS determining the prescriber’s final
compliance status.
• Measurement cycle. The
‘‘measurement cycle’’ is generally a
period of 24 months, consisting of a
measurement year, the compliance
analysis period, and the notification
period.
3. Standard for CMS EPCS Program
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a. Updates to the NCPDP Standards
In the CY 2021 PFS final rule (85 FR
84804), we finalized a requirement for
Part D prescribers to use the NCPDP
SCRIPT standard version 2017071
standard for electronic prescribing of
Schedule II, III, IV, and V controlled
substances covered under Medicare Part
D. In the CY 2021 PFS proposed rule,
we had stated our belief that because
prescribers were already required to use
this standard when e-prescribing for
covered Part D drugs for Part D eligible
individuals, prescribers should use this
same standard when e-prescribing
controlled substances (85 FR 50261).
On December 27, 2022, as part of the
Medicare Program; Contract Year 2024
Policy and Technical Changes to the
Medicare Advantage Program, Medicare
Prescription Drug Benefit Program,
Medicare Cost Plan Program, Medicare
Parts A, B, C, and D Overpayment
Provisions of the Affordable Care Act
and Programs of All-Inclusive Care for
the Elderly; Health Information
Technology Standards and
Implementation Specifications proposed
rule (herein referred to as the ‘‘CY 2024
Medicare Advantage and Part D Policy
and Technical Changes proposed rule’’)
(87 FR 79550), we proposed to update
provisions related to e-prescribing
standards at § 423.160(b), including,
after a transition period, requiring the
NCPDP SCRIPT standard version
2022011 proposed for adoption at 45
CFR 170.205(b), and retiring the current
NCPDP SCRIPT standard version
2017071, as the e-prescribing standard
for covered Part D drugs for Part D
eligible individuals. The CY 2024
Medicare Advantage and Part D Policy
and Technical Changes final rule
appeared in the April 12, 2023 Federal
Register (88 FR 22120). In the final rule,
we did not address comments received
on the provisions of the proposed rule
related to e-prescribing standards as
these provisions were not finalized in
the final rule. Rather, we will address
provisions of the proposed rule that we
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did not finalize at a later time, such as
in possible future rulemaking, as
appropriate.
As stated in the CY 2021 PFS
proposed rule (85 FR 50261), our intent
with the CMS EPCS Program is for
prescribers to use the same version of
the NCPDP SCRIPT standard for their
electronic prescribing of Schedule II–V
controlled substances that are Part D
drugs as for other electronic prescribing
for Part D eligible individuals. Although
we finalized the NCPDP SCRIPT
standard version 2017071 as the
standard in the CY 2021 PFS final rule,
we want to clarify that, based on the
existing regulatory text at
§ 423.160(a)(5), the CMS EPCS Program
will automatically adopt the electronic
prescribing standards at § 423.160(b) as
they are updated. This is based on the
requirement at § 423.160(a)(5) that
prescribers conduct prescribing for at
least 70 percent of their Schedule II, III,
IV, and V controlled substances that are
Part D drugs electronically using the
applicable standards in paragraph (b) of
§ 423.160. Therefore, any proposals
from the CY 2024 Medicare Advantage
and Part D Policy and Technical
Changes proposed rule to standards at
§ 423.160(b) that are finalized will apply
to electronic prescribing for the CMS
EPCS program as well.
b. Standards for Same Legal Entity
In the CY 2022 PFS final rule (86 FR
65366), we finalized an exception at
§ 423.160(a)(5)(i) for prescriptions
issued where the prescriber and
dispensing pharmacy are the same
entity (hereafter called the same entity
exception). We stated our belief that a
requirement to use the NCPDP SCRIPT
standard version 2017071 within a
closed system could increase costs and
the rate of performance errors, such as
data corruption and patient matching
errors, which we understand often
happens when a unified database is
split into a transaction system that
relays information to and from the same
entity.
As we have implemented the same
entity exception, our experience has
been that the Prescription Drug Event
(PDE) data, which we use for CMS EPCS
Program compliance calculations, does
not have a field that consistently and
accurately identifies prescribers and
dispensing pharmacies that are part of
the same entity, making it impossible to
exclude these prescriptions from the
compliance calculations using PDE data.
Additionally, we realized that we can
include prescriptions where the
prescriber and dispensing pharmacy are
the same entity without triggering the
concerns that led us to us to finalize the
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same entity exception, if we remove the
requirement to use the NCPDP SCRIPT
standard listed in § 423.160(b), as
described below.
Medicare Part D has an existing
electronic prescribing regulation that
permits the use of either HL7 messages
or the NCPDP SCRIPT Standard to
transmit prescriptions or prescriptionrelated information internally when the
sender and the beneficiary are part of
the same legal entity while still
maintaining the requirement for eprescribing. The Medicare Program; EPrescribing and Prescription Drug
Program final rule (70 FR 67581), which
appeared in the November 7, 2005
Federal Register, codified at
§ 423.160(a)(3)(ii), that either HL7
messages or the NCPDP SCRIPT
Standard could be used when all parties
to a transaction are, for example,
employed by and part of the same legal
entity. We subsequently finalized a
proposal to move the provision to
§ 423.160(a)(3)(iii) in the CY 2008 PFS
final rule (72 FR 66405).
We propose to integrate this
regulation into the CMS EPCS Program,
as it provides alignment across
electronic prescribing policies for
prescriptions prescribed and dispensed
within the same legal entity without
forcing these entities to adopt the
NCPDP SCRIPT standard for such
transmittals. With this proposal,
prescribers in the same legal entities as
the dispensing pharmacy would have
multiple methods to conduct internal
electronic transmittals for Schedule II,
III, IV, and V controlled substances that
are Part D drugs, as permitted in
§ 423.160(a)(3)(iii). Therefore, we
believe that these prescribers’
prescriptions can be included in the
CMS EPCS Program compliance
calculation so long as prescribers’
electronic prescriptions are transmitted
consistent with the exemption in
§ 423.160(a)(3)(iii).
With this proposal, we would no
longer need to separately identify and
apply different methodologies based on
whether the prescriber and dispensing
pharmacy are the same entity. We
would identify electronic prescriptions
for Schedule II–V controlled substances
that are Part D drugs using the
Prescription Origin Code data element
in the PDE record, where a value of
three indicates electronic transmission.
Additionally, this proposal would
expand the available standards for
prescribers that are within the same
legal entities as the dispensing
pharmacy under the CMS EPCS
Program, as defined by the Medicare
Program; E-Prescribing and Prescription
Drug Program final rule (70 FR 67581),
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by cross-referencing the standards at
§ 423.160(a)(3)(iii), which broadens the
requirements of the e-prescribing
standard that can be used to meet CMS
EPCS Program requirements. We believe
that by aligning with the regulation at
§ 423.160(a)(3)(iii), we are advancing eprescribing standardization and
addressing potential concerns about
burdening prescribers within the same
legal entity, including workflow and
data errors.
Therefore, to address our data
limitations and also to provide
flexibility where prescriptions are
transmitted within the same legal entity,
we are proposing to remove the same
entity exception at § 423.160(a)(5)(i)
from the CMS EPCS Program
requirements and to redesignate
paragraphs (a)(5)(ii) through (iv) as
paragraphs (a)(5)(i) through (iii),
respectively. We also propose to add
‘‘subject to the exemption in paragraph
(a)(3)(iii) of this section’’ to
§ 423.160(a)(5). Under this proposed
change, prescriptions that are prescribed
and dispensed within the same legal
entity would be included in CMS EPCS
Program compliance calculations as part
of the 70 percent compliance threshold
at § 423.160(a)(5), and prescribers will
not be exempt from the requirement to
prescribe electronically at least 70
percent of their Schedule II–V
controlled substances that are Part D
drugs—but such prescriptions would
only have to meet the applicable
standards in § 423.160(b) subject to the
exemption in § 423.160(a)(3)(iii).
We seek comment on the proposals to
remove the same entity exception and
expand the available standards for same
legal entities within the CMS EPCS
Program.
4. Definition of Prescriptions for
Compliance Calculation
In the CY 2022 PFS final rule, we
finalized the compliance threshold
requirement for the CMS EPCS Program
such that prescribers are required to
prescribe at least 70 percent of their
Schedule II, III, IV, and V controlled
substances that are Part D drugs
electronically, except in cases where an
exception or waiver applies (86 FR
65366). Additionally, we indicated that
the compliance threshold for each
prescriber would be calculated by
examining PDE data at the end of the
measurement year and dividing the
number of Part D controlled substances
that were e-prescribed by the total
number of Part D controlled substance
prescriptions (excluding from both the
numerator and denominator any
prescriptions issued while a prescriber
falls within an exception or is subject to
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a waiver) (86 FR 65365). Previously, we
did not define how prescriptions with
multiple fills would affect the
compliance threshold calculation. We
are now proposing to specify how the
compliance threshold is affected by
multiple fills within the same year.
For purposes of CMS EPCS Program,
we will count unique prescriptions in
the measurement year using the
prescription number assigned by the
pharmacy and included in the Part D
claims data. All prescriptions,
regardless of how they are transmitted,
may include a number of refills so that
the pharmacy may provide additional
fills of the prescribed medication
without the need for a new prescription
from, or visit to, a prescriber. Refills are
not separately transmitted prescriptions;
they are documented as part of the
original prescription transmittal, which
includes any refills issued against the
original prescription (by the pharmacy).
However, renewals of prescriptions
(such as those for maintenance
medications) require prescribers to
generate a new prescription along with
a new set of refills. Because of this
distinction, we will count renewals as
an additional prescription in the CMS
EPCS Program compliance threshold
calculation, and we will not count
refills as an additional prescription in
the CMS EPCS Program compliance
threshold calculation unless the refill is
the first occurrence of the unique
prescription in the measurement year.
We believe, if we were to include
every fill in the compliance threshold
calculation, an increased burden could
be placed on small prescribers, as they
would potentially no longer qualify for
the small prescriber exception at
§ 423.160(a)(5)(ii) (which we propose to
be redesignated to § 423.160(a)(5)(i), as
described in section III.M.3.b. of this
rule). If we were to count every single
fill, preliminary analysis of 2021 Part D
data shows that approximately 23,000
prescribers would no longer qualify for
the small prescriber exception and that
approximately 6,900 additional
prescribers would be considered noncompliant. For this reason, we would
count only the unique prescriptions in
the measurement year for the purposes
of CMS EPCS Program compliance
threshold calculations.
5. Updates to CMS EPCS Program
Exceptions for Cases of Recognized
Emergencies and Extraordinary
Circumstances
a. Background
In the CY 2022 PFS final rule (86 FR
65367 through 65368), we finalized two
exceptions related to exceptional
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circumstances that may prevent
prescribers from being able to conduct
EPCS. The first exception, codified at
§ 423.160(a)(5)(iii), is for prescribers
who are prescribing during a recognized
emergency, such as a natural disaster, a
pandemic, or a similar situation where
there is an environmental hazard.
Prescribers in a geographic area of an
emergency or disaster declared by a
Federal, State, or local government
entity are excluded from the CMS EPCS
Program requirements. In the CY 2023
PFS final rule (87 FR 70012), we
modified the exception to use the
prescriber’s PECOS address or, in
situations where a prescriber does not
have a PECOS address, the prescriber’s
address in the National Plan and
Provider Enumeration System (NPPES)
data, to determine whether the
exception at § 423.160(a)(5)(iii) is
applicable.
The second exception, codified at
§ 423.160(a)(5)(iv), is for prescribers
who request and receive from CMS a
waiver, which we grant to prescribers
who are facing extraordinary
circumstances that prevent them from
electronically prescribing a controlled
substance to a Part D beneficiary, but
who are not in an emergency or disaster
area. We defined ‘‘extraordinary
circumstance’’ for purposes of this
exception to mean a situation, other
than an emergency or disaster, outside
of the control of a prescriber that
prevents the prescriber from
electronically prescribing a controlled
substance to a Part D beneficiary (86 FR
65367).
In this rule, we are proposing to
further modify the recognized
emergency exception and extraordinary
circumstances waiver (which we
propose to be codified at
§ 423.160(a)(5)(ii) and (iii), respectively,
as described in section III.M.3.b. of this
rule). We are proposing to modify the
rules for when these exceptions apply
by enabling prescribers to apply for
waivers in times of an emergency and
disaster and by limiting the emergencies
or disasters that would trigger the
recognized emergency exception.
Additionally, we are proposing to
modify the duration of both exceptions
and proposing timing requirements for
submitting a waiver application.
b. Updating the Circumstances
Applicable for the Recognized
Emergency and Extraordinary
Circumstances Waiver Exceptions
Our current exception for recognized
emergencies applies to all prescribers
with an address in PECOS, or
alternatively in NPPES, in the
geographic area of an emergency or
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disaster declared by a Federal, State, or
local government entity. As we have
implemented this exception, we realize
there may be unintended consequences
to our existing policy. First, while we
can identify emergencies recognized by
the Federal Emergency Management
Agency (FEMA) or pandemics
recognized by the Department of Health
and Human Services (HHS), we may not
be able to identify every local or state
emergency. Because we excluded
emergencies and disasters from our
extraordinary circumstances waiver
policy, some prescribers may not be able
to receive an exception for an
emergency or disaster we did not
identify. Second, we realize that not
every emergency may impact the ability
of prescribers to conduct EPCS, and
thus it may not be appropriate to
automatically apply the exclusion to all
prescribers in the affected geographic
area of some emergencies. Third, we
realized that some of our policies do not
align with other emergency policies of
CMS programs for quality reporting and
performance. Therefore, in order to
address these concerns, we looked to
the Quality Payment Program Meritbased Incentive Payment System (MIPS)
automatic policy for extreme and
uncontrollable circumstances and to the
extraordinary circumstances exceptions
(ECE) for many of our quality reporting
and value-based purchasing programs
for hospitals and other types of facilities
to see other examples of when we apply
automatic exceptions versus when we
ask clinicians or facilities to apply for a
waiver.
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38410) and CY 2018 OPPS/
ASC final rule (82 FR 52584), we
worked to align common processes for
our ECE policies across many of our
quality programs including the Hospital
IQR Program, Hospital OQR Program,
IPFQR Program, ASCQR Program, and
PCHQR Program, as well as the Hospital
VBP Program, HAC Reduction Program,
and the Hospital Readmissions
Reduction Program. Using the Hospital
IQR Program as an example, generally,
CMS may grant an exception with
respect to quality data reporting
requirements in the event of
extraordinary circumstances beyond the
control of the hospital (42 CFR
412.140(c)(2)). A hospital may submit
such a request in the form and manner
described on QualityNet.org. CMS may
also grant an exception to one or more
hospitals that have not requested an
exception if: CMS determines that a
systemic problem with CMS data
collection systems directly affected the
ability of the hospital to submit data; or
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if CMS determines that an extraordinary
circumstance, such as an act of nature
(for example, hurricane), has affected an
entire region or locale (see
§ 412.140(c)(2)(ii) and 76 FR 51651). We
stated that if we make the determination
to grant an ECE to hospitals in a region
or locale, we would communicate this
decision through routine
communication channels (76 FR 51652).
Separately, in the context of clinicians
participating in MIPS, CMS established
another ECE policy. In the Medicare
Program; CY 2018 Updates to the
Quality Payment Program; and Quality
Payment Program: Extreme and
Uncontrollable Circumstance Policy for
the Transition Year (CY 2018 Quality
Payment Program final rule), we
adopted in an interim final rule with
comment period an automatic extreme
and uncontrollable circumstances
policy for one performance period due
to several hurricanes (82 FR 53895
through 53900). In discussing the
triggering events for this policy (82 FR
53897), we stated that we have
discretion not to require MIPS eligible
clinicians to submit an application for
reweighting the performance categories
in cases where an extreme and
uncontrollable circumstance, such as an
act of nature (for example, hurricane),
affects an entire region or locale. We
noted that we anticipate the types of
events that could trigger this policy
would be events designated by the
Federal Emergency Management Agency
(FEMA) as major disasters or a public
health emergency declared by the
Secretary, although we will review each
situation on a case-by-case basis. We
also noted our intention to align the
automatic extreme and uncontrollable
circumstance policy with the ECE
policies for other Medicare programs
such that events that trigger ECE
policies would also trigger the
automatic extreme and uncontrollable
circumstance policy (82 FR 53897). In
the CY 2019 PFS final rule (83 FR
59875), we finalized a similar policy for
all future years, which we codified at
§ 414.1380(c)(2)(i)(A)(8) and (C)(3).
We believe that it would be beneficial
to interested parties for the CMS EPCS
Program to have a similar policy as it
relates to applying for an exception
versus having an automatic exception
for all prescribers in an affected region.
This would streamline communications
across CMS programs, as well as ensure
that CMS can, where appropriate,
except all prescribers for an appropriate
circumstance beyond their control,
including disasters or emergencies. In
order to facilitate this transition, for the
waiver exception at § 423.160(a)(5)(iv)
(which we propose to codify at
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§ 423.160(a)(5)(iii), as described in
section III.M.3.b. of this rule), we are
proposing to modify the definition of
‘‘extraordinary circumstance’’ to mean a
situation outside of the control of a
prescriber that prevents the prescriber
from electronically prescribing a
Schedule II–V controlled substance that
is a Part D drug. This updated definition
would drop the restriction ‘‘other than
an emergency or disaster,’’ that we
previously included when discussing
this exception. This modification would
allow prescribers the ability to request
a waiver regardless of whether we
trigger the recognized emergency
exception.
Additionally, we are proposing to
modify the recognized emergency
exception at § 423.160(a)(5)(iii) (which
we propose to codify at
§ 423.160(a)(5)(ii), as described in
section III.M.3.b. of this rule) so that
CMS will identify which events trigger
the recognized emergency exception.
We believe the ability to identify
triggering events will allow us to ensure
that the emergency affects widespread
EPCS functionality. In applying this
determination of which emergencies or
disasters would trigger this exception,
we would review each emergency
situation on a case-by-case basis but
would generally look to events
designated as a FEMA major disaster or
a public health emergency declared by
the Secretary. We also intend to align
the determination of the emergency
exception with the MIPS automatic
extreme and uncontrollable
circumstances policy, such that events
that would trigger this policy, in most
instances, would also qualify under the
CMS EPCS Program exception for
recognized emergencies. We expect any
deviation from MIPS automatic extreme
and uncontrollable circumstances
policies would be rare and only in
circumstances which may cause
disruption for MIPS performance but
should not affect a prescriber’s ability to
electronically prescribe Schedule II–V
controlled substances that are Part D
drugs, or vice versa.
We would inform prescribers of
which emergencies or disasters qualify
for the exception, as determined by
CMS, using normal communication
channels such as listservs and the CMS
EPCS Program website.
We invite public comment on the
proposals related to circumstances
applicable for the recognized emergency
and extraordinary circumstances waiver
exceptions.
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c. Duration of Recognized Emergency
Exceptions
In the CY 2022 PFS final rule (86 FR
65367), we clarified that the recognized
emergency exception would be
applicable only if the dispensing date of
the medication occurs during the time
period that the declared disaster is
occurring. In an effort to continue
aligning the CMS EPCS Program with
the Quality Payment Program, we
propose that, as a default, prescribers
impacted by the CMS EPCS Program
recognized emergency exception at
§ 423.160(a)(5)(iii) (which we propose to
codify at § 423.160(a)(5)(ii), as described
in section III.M.3.b. of this rule) would
be excepted for the entire measurement
year, and not just for the duration of the
emergency. We believe this would
protect prescribers who may not be able
to monitor their compliance status over
multiple periods of time.
We seek comment on the proposed
duration for exceptions due to
recognized emergencies.
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d. Duration and Timing of Extraordinary
Circumstances Waiver Exception
In the CY 2022 PFS final rule (86 FR
65367 through 65368), we finalized an
attestation process for prescribers to
request a waiver.275 In this rule, we are
not proposing any modifications on the
information needed to request a waiver,
but we are proposing the timeframe that
would be covered by a waiver that is
authorized under the CMS EPCS
Program and the timing of waiver
requests.
Section 1860D–4(e)(7)(B)(iii) of the
Act, as added by section 2003 of the
SUPPORT Act, refers to a waiver or a
renewal thereof for a period of time, not
to exceed one year, as determined by the
Secretary. We propose that approved
waivers for the CMS EPCS Program
would apply to the entire measurement
year. Prescribers who receive a waiver
and continue to experience exceptional
circumstances that extend beyond
December 31 of a measurement year
would be required to complete a new
waiver application for the subsequent
measurement year.
In the CY 2022 PFS proposed rule (86
FR 39332), we signaled that we would
include more information about the
waiver process in subsequent
rulemaking. One issue that was not
clearly defined is the timing of when a
prescriber can request a waiver. In the
275 The waiver application is currently going
through the Paperwork Reduction Act approval
process under the document identifier CMS–10834,
and the proposed collection comment request
appeared in the March 10, 2023 Federal Register
(88 FR 15037).
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CY 2022 PFS final rule (86 FR 65370),
we finalized that we would notify
prescribers that they are violating the
EPCS requirement with information
about how they can come into
compliance, the benefits of EPCS, an
information solicitation as to why they
are not conducting EPCS, and a link to
the CMS portal to request a waiver. We
are now proposing that a prescriber has
a period of 60 days from the date of the
notice of non-compliance to request a
waiver. Approved waivers would apply
to prescriptions written by a prescriber
for the entire measurement year, and the
waiver would expire on December 31 of
the applicable measurement year.
We seek comment on the proposed
waiver duration and the proposal for the
timing and process of applying for
waiver in cases of extraordinary
circumstances.
6. Actions for Non-Compliance
In the CY 2022 PFS final rule (86 FR
65370), we limited compliance actions
with respect to compliance from January
1, 2023 through December 31, 2023, to
a non-compliance notice sent to
prescribers who are violating the CMS
EPCS Program requirement. In the CY
2023 PFS final rule (87 FR 70013), we
extended the existing compliance action
of sending notices to non-compliant
prescribers from the CY 2023 CMS EPCS
Program implementation year (January
1, 2023 through December 31, 2023) to
the CY 2024 EPCS Program
implementation year (January 1, 2024
through December 31, 2024). The
content of the notices will remain
unchanged and continue to consist of a
notice to prescribers that they are
violating the CMS EPCS Program
requirements, information about how
they can come into compliance, the
benefits of EPCS, and a link to the CMS
EPCS Program dashboard where the
prescriber may request a waiver and
provide information as to why they are
not conducting EPCS.
We propose to continue the practice
of issuing a prescriber notice of noncompliance as a non-compliance action
for subsequent measurement years. As
stated in the CY 2023 PFS final rule (87
FR 70013), we believe prescriber use of
EPCS encourages the use of
interoperable technology, produces a
verifiable and traceable history,
prevents fraud and abuse, and reduces
burden. We believe that continuing to
send non-compliance notices would
support increased EPCS adherence and
encourage increased EPCS adoption
rates, which could be more effective
than imposing more restrictive noncompliance actions or penalties that
may increase burden on prescribers.
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In the CY 2023 PFS proposed rule (87
FR 46240 through 46241), we solicited
ideas of possible non-compliance
actions with the goal of identifying one
that would be operationally feasible (for
example, can be accomplished without
requiring modifications to the data
available through the PDE file) and
support the nation’s ongoing fight
against drug abuse and diversion
without adding administrative burden
to prescribers or hindering beneficiary
access to needed medications. We did
not receive a large number of comments.
However, we did receive one comment
noting that non-compliance alone is not
a definitive indicator of fraud, waste, or
abuse. We agree with the commenter
that non-compliance alone is not a
definitive indicator of fraud, waste, or
abuse; however, we maintain that one
risk to public safety is potential fraud,
waste, and abuse and intend that a
prescriber’s non-compliance under the
CMS EPCS program may be considered
in our processes for assessing potential
fraud, waste, and abuse.
We may use this information in our
processes for assessing potential fraud,
waste, and abuse, which, in some
instances, could result in a referral to
law enforcement or revocation of billing
privileges, in the event that evidence of
fraud, waste, or abuse is present. At this
time, we believe the risk of fraud, waste,
or abuse can be mitigated without the
need for further penalties for CMS EPCS
program non-compliance. Literature
suggests a correlation between use of
EPCS and reduction in fraud, waste, and
abuse related to opioid
prescriptions.276 277 Prescriber use of
EPCS is directly related to improving
prescription security, decreasing
prescription forgery, and reducing the
overall chance of fraud and alteration
associated with paper prescribing.2 Also
notable are studies demonstrating
reductions in opioid overdoses when
EPCS use is increased and general
findings that e-prescribing can improve
coordination of care, reduce fraud and
abuse, and contribute to public health
safety.
Although we are not proposing
further non-compliance actions beyond
the extension of sending notices at this
time, we will continue to evaluate
compliance and prescriber performance
276 Achar, Suraj, et al. ‘‘Adoption and Increased
Use of Electronic Prescribing of Controlled
Substances.’’ Journal of Medical Regulation,
Federation of State Medical Boards, 27 Aug. 2021,
https://doi.org/10.30770/2572-1852-107.2.8.
277 Abuok, Rahi, and David Powell. ‘‘Can
Electronic Prescribing Mandates Reduce OpioidRelated Overdoses?’’ Science Direct, JOURNAL of
ECONOMICS & HUMAN BIOLOGY, Elsevier B.V.,
14 Apr. 2021, https://doi.org/10.1016/
j.ehb.2021.101000.
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under the CMS EPCS Program and will
consider whether to propose changes in
future years. We seek public comment
on our proposal to continue the action
of sending notice to prescribers who are
identified as non-compliant.
N. Proposed Changes to the Regulations
Associated With the Ambulance Fee
Schedule and the Medicare Ground
Ambulance Data Collection System
(GADCS)
1. Background on Ambulance Services
Section 1861(s)(7) of the Act
establishes an ambulance service as a
Medicare Part B service where the use
of other methods of transportation is
contraindicated by the individual’s
condition, but only to the extent
provided in regulations. Since April 1,
2002, payment for ambulance services
has been made under the ambulance fee
schedule (AFS), which the Secretary
established, as required by section
1834(l) of the Act, in 42 CFR part 414
subpart H. Payment for an ambulance
service is made at the lesser of the
actual billed amount or the AFS
amount, which consists of a base rate for
the level of service, a separate payment
for mileage to the nearest appropriate
facility, a geographic adjustment factor
(GAF), and other applicable adjustment
factors as set forth at section 1834(l) of
the Act and § 414.610 of the regulations.
In accordance with section 1834(l)(3) of
the Act and § 414.610(f), the AFS rates
are adjusted annually based on an
inflation factor. The AFS also
incorporates two permanent add-on
payments in § 414.610(c)(5)(i) and three
temporary add-on payments to the base
rate and/or mileage rate, which are
discussed in the next section of this
proposed rule.
Our regulations relating to coverage of
and payment for ambulance services are
set forth at 42 CFR part 410, subpart B,
and 42 CFR part 414, subpart H.
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2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of
the Act
Section 146(a) of the Medicare
Improvements for Patients and
Providers Act of 2008 (Pub. L. 110–275,
enacted July 15, 2009) (MIPPA),
amended section 1834(l)(13) of the Act
to specify that, effective for ground
ambulance services furnished on or after
July 1, 2008, and before January 1, 2010,
the ambulance fee schedule amounts for
ground ambulance services shall be
increased as follows:
• For covered ground ambulance
transports that originate in a rural area
or in a rural census tract of a
metropolitan statistical area, the fee
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schedule amounts shall be increased by
3 percent.
• For covered ground ambulance
transports that do not originate in a
rural area or in a rural census tract of
a metropolitan statistical area, the fee
schedule amounts shall be increased by
2 percent.
The payment add-ons under section
1834(l)(13) of the Act have been
extended several times. Most recently,
division FF, section 4103 of the CAA,
2023 (Pub. L. 117–328, December 29,
2022) amended section 1834(l)(13) of
the Act to extend the payment add-ons
through December 31, 2024. Thus, these
payment add-ons apply to covered
ground ambulance transports furnished
before January 1, 2025. We are
proposing to revise § 414.610(c)(1)(ii) to
conform the regulations to this statutory
requirement. (For a discussion of past
legislation extending section 1834(l)(13)
of the Act, please see the CY 2014 PFS
final rule with comment period (78 FR
74438 through 74439), the CY 2015 PFS
final rule with comment period (79 FR
67743), the CY 2016 PFS final rule with
comment period (80 FR 71071 through
71072) and the CY 2019 PFS final rule
with comment period (83 FR 59681
through 59682)).
This statutory requirement is selfimplementing. A plain reading of the
statute requires only a ministerial
application of the mandated rate
increase, and does not require any
substantive exercise of discretion on the
part of the Secretary.
b. Amendment to Section 1834(l)(12) of
the Act
Section 414(c) of the Medicare
Prescription Drug, Improvement and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173, December 8, 2003) added
section 1834(l)(12) to the Act, which
specified that, in the case of ground
ambulance services furnished on or after
July 1, 2004, and before January 1, 2010,
for which transportation originates in a
qualified rural area (as described in the
statute), the Secretary shall provide for
a percent increase in the base rate of the
fee schedule for such transports. The
statute requires this percent increase to
be based on the Secretary’s estimate of
the average cost per trip for such
services (not taking into account
mileage) in the lowest quartile of all
rural county populations as compared to
the average cost per trip for such
services (not taking into account
mileage) in the highest quartile of rural
county populations. Using the
methodology specified in the July 1,
2004 interim final rule (69 FR 40288),
we determined that this percent
increase was equal to 22.6 percent. As
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required by the MMA, this payment
increase was applied to ground
ambulance transports that originated in
a ‘‘qualified rural area,’’ that is, to
transports that originated in a rural area
comprising the lowest 25th percentile of
all rural populations arrayed by
population density. For this purpose,
rural areas included Goldsmith areas (a
type of rural census tract). This rural
bonus is sometimes referred to as the
‘‘Super Rural Bonus’’ and the qualified
rural areas (also known as ‘‘super rural’’
areas) are identified during the claims
process via the use of a data field
included in the CMS-supplied ZIP code
file.
The Super Rural Bonus under section
1834(l)(12) of the Act has been extended
several times. Most recently, division
FF, section 4103 of the CAA, 2023
amended section 1834(l)(12)(A) of the
Act to extend this rural bonus through
December 31, 2024. Therefore, we are
continuing to apply the 22.6 percent
rural bonus described in this section (in
the same manner as in previous years)
to ground ambulance services with
dates of service before January 1, 2025
where transportation originates in a
qualified rural area. Accordingly, we are
proposing to revise § 414.610(c)(5)(ii) to
conform the regulations to this statutory
requirement. (For a discussion of past
legislation extending section 1834(l)(12)
of the Act, please see the CY 2014 PFS
final rule with comment period (78 FR
74439 through 74440), CY 2015 PFS
final rule with comment period (79 FR
67743 through 67744), the CY 2016 PFS
final rule with comment period (80 FR
71072) and the CY 2019 PFS final rule
with comment period (83 FR 59682)).
This statutory provision is selfimplementing. It requires an extension
of this rural bonus (which was
previously established by the Secretary)
through December 31, 2024, and does
not require any substantive exercise of
discretion on the part of the Secretary.
3. Medicare Ground Ambulance Data
Collection System
a. Background
Section 50203(b) of the BBA of 2018
added paragraph (17) to section 1834(l)
of the Act, which requires ground
ambulance providers of services and
suppliers (ground ambulance
organizations) to submit cost and other
information. Specifically, section
1834(l)(17)(A) of the Act requires the
Secretary to develop a data collection
system (which may include use of a cost
survey) to collect cost, revenue,
utilization, and other information
determined appropriate by the Secretary
for providers and suppliers of ground
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ambulance services. Section
1834(l)(17)(B)(i) of the Act required the
Secretary to specify the data collection
system by December 31, 2019, and to
identify the ground ambulance
providers and suppliers that would be
required to submit information under
the data collection system. Section
1834(l)(17)(D) of the Act required that
beginning January 1, 2022, the Secretary
apply a 10 percent payment reduction to
payments made under section 1834(l) of
the Act for the applicable period to a
ground ambulance provider or supplier
that is required to submit information
under the data collection system and
does not sufficiently submit such
information. The term ‘‘applicable
period’’ is defined under section
1834(l)(17)(D)(ii) of the Act to mean, for
a ground ambulance provider or
supplier, a year specified by the
Secretary not more than 2 years after the
end of the period for which the
Secretary has made a determination that
the ground ambulance provider or
supplier has failed to sufficiently submit
information under the data collection
system. Division P, section 311 of the
CAA, 2022 (Pub. L. 117–103) amended
section 1834(l)(17)(F)(i) of the Act to
delay the deadline for MedPAC to
submit its report to Congress on the
ground ambulance data collection
system study until the second June 15th
following the date the Secretary
transmits data for the first representative
sample of ground ambulance
organizations. Section 1834(l)(17)(I) of
the Act states that the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.) does not apply to the collection of
information required under section
1834(l)(17) of the Act.
In the CY 2020 PFS final rule (84 FR
62864 through 62897), we implemented
section 1834(l)(17) of the Act and
codified regulations governing data
reporting by ground ambulance
organizations at §§ 414.601, 414.605,
414.610(c)(9), and 414.626. We also
finalized a data collection system that
collects detailed information on ground
ambulance provider and supplier
characteristics including service areas,
service volume, costs, and revenue
through a data collection instrument,
commonly referred to as the Medicare
Ground Ambulance Data Collection
Instrument, via a web-based system. We
refer the reader to our CY 2020 PFS final
rule (84 FR 62864 through 62897) for
more specifics on the establishment of
the Medicare Ground Ambulance Data
Collection System.
In the CY 2022 PFS final rule (86 FR
65306 through 65317), we finalized a
number of updates to the Medicare
Ground Ambulance Data Collection
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System, including: (1) a new data
collection period beginning between
January 1, 2023, and December 31, 2023,
and a new data reporting period
beginning between January 1, 2024, and
December 31, 2024, for selected ground
ambulance organizations in Year 3; (2)
aligning the timelines for the
application of penalties for not reporting
data with our new timelines for data
collection and reporting and a notice
that the data collected will be publicly
available beginning in 2024; and (3)
revisions to the Medicare Ground
Ambulance Data Collection Instrument
that include better accounting for labor
hours across different categories of
personnel and better distinguishing
between accrual and cost basis
accounting methodologies. We refer the
reader to our CY 2022 PFS final rule (86
FR 65306 through 65317) for more
specifics on the revisions to the
Medicare Ground Ambulance Data
Collection System.
In the CY 2023 PFS final rule (87 FR
70014) we finalized a series of changes
to the Medicare Ground Ambulance
Data Collection System. First, we
finalized our proposal to update our
regulations at § 414.626(d)(1) and (e)(2)
to provide the necessary flexibility to
specify how ground ambulance
organizations should submit hardship
exemption requests and informal review
requests, including to our web-based
portal once that portal is operational.
Second, we finalized our proposed
changes and clarifications to the
Medicare Ground Ambulance Data
Collection Instrument to reduce burden
on respondents, improve data quality, or
both. We refer the reader to our CY 2023
PFS final rule (87 FR 70014) for more
specifics on the revisions to the
Medicare Ground Ambulance Data
Collection System.
b. Proposed Revisions to the Medicare
Ground Ambulance Data Collection
Instrument
As described in the CY 2022 PFS final
rule (86 FR 65307) and the CY 2023 PFS
Final Rule (87 FR 70014), we made
several changes to the instrument
instructions and questions to improve
clarity and reduce burden for
respondents. A printable version of the
current instrument instructions and
questions is available in English and
Spanish on the CMS website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AmbulanceFeeSchedule/GroundAmbulance-Services-Data-CollectionSystem.
We continue to receive ad hoc
questions and feedback related to the
Medicare Ground Ambulance Data
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Collection System and the Medicare
Ground Ambulance Data Collection
Instrument via four primary channels.
First, we receive email and other written
communication from ground ambulance
organizations via the CMS Ambulance
Data Collection email inbox
(AmbulanceDataCollection@
cms.hhs.gov) and through other
channels (for example, inquiries sent by
organizations to Medicare
Administrative Contractors (MACs) and
then forwarded to CMS). These emails
and other communications often
include questions seeking clarification
of instrument questions and their
applicability to specific ground
ambulance organization scenarios and
context. We continue to update a
Medicare Ground Ambulance Data
Collection System Frequently Asked
Questions (FAQ) document with
answers and the GADCS User Guide to
commonly asked questions. These
documents are available on the CMS
website at https://www.cms.gov/
medicare/medicare-fee-for-servicepayment/ambulancefeeschedule/
ground-ambulance-services-datacollection-system. Through review of
questions and feedback, we identified
some instances where a clarification to
the instrument language itself will likely
be more useful and less burdensome to
respondents than having to respond
with reference to the FAQ document,
the GADCS User Guide, or to other
resources. Second, we answer questions
live from interested parties during
webinars, dedicated question and
answer sessions, and other educational
sessions. As with the emailed questions
described above, live question and
answer exchanges sometimes identify
opportunities for clarifying instrument
language. Third, we have begun
analyzing initial data responses
submitted via the GADCS portal by
selected organizations in Year 1 and
Year 2. Findings from this initial
analysis, including inconsistent
response patterns, unusual
combinations of responses across
questions, and investigation of outlier
results were helpful to identify some
additional opportunities for
clarification. Fourth, we continue to
identify opportunities to clarify
instructions and correct a small number
of typos through the final development
and launch of the web-based GADCS.
Based on information that we
received via the four sources described
above, we are proposing the following
further changes and clarifications to the
Medicare Ground Ambulance Data
Collection Instrument. The changes and
clarifications aim to reduce burden on
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respondents, improve data quality, or
both.
1. Addressing Partial-Year Responses
Ground ambulance organizations
selected to participate in the GADCS
that are in operation for only part of
their continuous, 12-month data
collection period are, following the
GADCS instructions, still required to
collect and report data. However, there
is not a field for these organizations to
report that they were in operation, and
therefore collecting data, for less than a
full 12-month period via the GADCS. In
these cases, we would not know that the
costs, revenue, and utilization reported
by these partial-year organizations are
comparatively smaller than those
reported by similar organizations in
operation for an entire 12-month period.
As a result, some statistics from
analyses of GADCS data, for example
total annual expenditures per ground
ambulance organization, would be
biased downward.
To address this limitation, we are
proposing to add a response option to
Section 2 (Organizational
Characteristics), Question 1 which asks
whether the selected national provider
identifier (NPI) linked to the
organization was used to bill Medicare
for ground ambulance services during
its data collection period. The current
response options are ‘‘Yes (1)’’ and ‘‘No
(0)’’. We propose to split the existing
‘‘Yes (1)’’ response into two separate
responses, one reading ‘‘Yes, throughout
the organization’s continuous, 12-month
data collection period (1)’’ and ‘‘Yes, but
for only part of the organization’s
continuous, 12-month data collection
period (2).’’ The ‘‘No (0)’’ response
would not change. Respondents from
organizations that billed for ground
ambulance services during part of, but
not all of, its continuous, 12-month data
collection period, would select ‘‘Yes,
but for only part of the organization’s
continuous, 12-month data collection
period (2)’’. Those that did so would be
prompted to enter the date they started
and/or stopped operations during the
continuous, 12-month data collection
period in a pop-up box, followed by an
instruction to proceed through the
remainder of the GADCS reporting
process.
Organizations selecting ‘‘Yes,
throughout the organization’s
continuous, 12-month data collection
period (1)’’ would proceed through the
rest of the GADCS reporting process as
do respondents answering ‘‘Yes (1)’’ to
this question currently. Organizations
selecting ‘‘No (0)’’ would, as is currently
the case, be prompted with several
follow-up questions which result in
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either outreach to the GADCS helpdesk
for assistance if the listed NPI does not
match their organization, or if they
answer that none of the scenarios in the
follow-up questions apply, or the
completion of the organization’s data
reporting requirement.
This approach allows CMS to
understand when reported costs,
revenue, and utilization are measured
over a period of time less than a full 12
months and, if necessary, to adjust
partial-year responses so that they are
more comparable to most responses that
will cover a continuous full 12-month
data collection period. Furthermore, we
believe this approach will reduce
confusion and burden for organizations
in operation for only part of their 12month data collection periods.
We invite comments on this proposal
to address partial-year responses.
2. Programming Logic for Hospitals and
Other Medicare Providers of Services
Section 2 of the GADCS printable
instrument includes a programming
note after Question 9 reading: ‘‘For the
remainder of the data collection
instrument, instructions and items
related to fire, police, or other public
safety department-based ground
ambulance organizations are shown to
organizations that answer Section 2,
Question 7 = ‘‘a’’ or ‘‘b’’ OR Question 8
= Yes (1) OR answer Question 9 = Yes
(1) to one or both of a and b.’’ The intent
of this programming note is to ensure
questions in Section 7 (Labor Costs)
present instructions and response fields
appropriate to organizations with staff
having both ground ambulance and fire,
police, or other public safety
responsibilities. In other words, a forprofit, ground ambulance-only
organization should not be asked
whether they have ground ambulance
staff with fire, police, or other public
safety responsibilities, while a fire
department-based ground ambulance
organization should.
Section 2, Question 8 asks whether
organizations reporting to be fire
department-based (response ‘‘a’’ in
Section 2, Question 7), police or other
public safety department-based
(response ‘‘b’’ in Section 2, Question 7),
or hospital or other Medicare provider
of services-based (response ‘‘d’’ in
Section 2, Question 7) share operational
costs between ground ambulance and
the respective other reported function.
A programming note for Section 2,
Question 8 states that the question
should be asked of organizations
responding a, b, or d to Section 2,
Question 7. As a result, hospitals and
other Medicare provider of servicesbased organizations responding ‘‘d’’ in
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Section 2, Question 7 are presented with
Section 2, Question 8, and many may
respond ‘‘Yes’’ to Section 2, Question 8.
As discussed above, answering ‘‘Yes’’ to
Section 2, Question 8 triggers the
appearance of table columns in Section
7, Question 1 related to fire, police, and
other public safety staff (‘‘Section 2,
Question 7 = ‘‘a’’ or ‘‘b’’ OR Question 8
= Yes (1) OR answer Question 9 = Yes
(1) to one or both of a and b.)
As a result of these programming
notes, many hospital-based
organizations answering ‘‘d’’ to Section
2, Question 7 and ‘‘Yes’’ to Section 2,
Question 8, and any options other than
‘‘a’’ or ‘‘b’’ in Section 2, Question 9 will
see columns for fire, police, and other
public safety staff in Section 7, Question
1, which was not intended. We believe
that no ground ambulance organizations
with this response pattern will have fire,
police, or other public safety staff to
report via the GADCS. Furthermore, we
are concerned that this will result in
confusion for hospital-based
organizations.
We are proposing to change the
programming note after Section 2,
Question 9 to read as follows: ‘‘. . .
instructions and items related to fire,
police, or other public safety
department-based ground ambulance
organizations are shown to
organizations that: (A) answer Section 2,
Question 7 = ‘‘a’’ or ‘‘b’’ AND answering
Question 8 = Yes (1); OR, (B) answer
Question 9 = Yes (1) to one or both of
‘‘a’’ or ‘‘b’’.’’ This change to the
programming logic will result in
provider-based ground ambulance
organizations seeing only two columns
in Section 7, Question 1, one for paid
and the other, if applicable, for
volunteer staff, and not columns
specific to staff with fire, police, or
other public safety responsibilities.
We invite comments on this proposal
to change the programming note after
Section 2, Question 9 in the GADCS
printable instrument.
3. Typos and Technical Corrections
We are proposing to make four
corrections to the GADCS printable
instrument.
• Section 2, Question 1a.ii is missing
the word ‘‘period’’ after ‘‘data
collection’’ in the text. Therefore, we are
proposing the question to read as: ‘‘The
NPI was in operation during the data
collection period but was not used
during the data collection to bill
Medicare for ground ambulance
services.’’
• Section 2, Question 3 in the
printable instrument questions ‘‘What is
the name of your organization? For the
remainder of the instrument, the term
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‘‘organization’’ refers to the NPI for
which we are requesting data. (enter
name)’’ while the web-based GADCS
asks ‘‘Is [ORGANIZATION NAME] the
name of your organization? For the
remainder of the instrument, the term
‘organization’ refers to the NPI for
which we are requesting data. Yes (1)/
No (0).’’ The web-based GADCS asks the
question in this way because
organization name is pre-populated in
the system and not entered directly. We
are proposing to change the language in
the printable instrument to match the
text in the web-based GADCS for
consistency.
• Section 9.1 (Ground Ambulance
Vehicle Costs), Question 5 current
wording states ‘‘Do not report ground
ambulance acquisition costs related to
an annual depreciation expense for the
same ambulance’’ which does not make
sense. We are proposing Question 5 to
read as: ‘‘Do not report an acquisition
cost and an annual depreciation
expense for the same ground
ambulance.’’
• Section 9.2 (Other Vehicle Costs
(Non Ambulance)), Question 5 current
wording includes the same error as
noted above for Section 9.1, Question 5,
and also mistakenly refers to ground
ambulances rather than non-ambulance
vehicles: ‘‘Do not report non-ambulance
vehicle acquisition costs related to an
annual depreciation expense for the
same ground ambulance.’’ We are
proposing to change the question to read
as: ‘‘Do not report an acquisition cost
and an annual depreciation expense for
the same ground non-ambulance
vehicle.’’
We invite comments on these
proposals related to GADCS typos and
technical corrections.
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O. Hospice: Changes to the Hospice
Conditions of Participation
1. Background and Statutory Authority
We have broad statutory authority for
most provider and supplier types to
establish health and safety regulations,
which includes the authority to
establish health and safety requirements
that advance health equity for
underserved communities. Certain
status explicitly gives CMS the authority
to enact regulations that the Secretary
finds necessary in the interest of the
health and safety of individuals who are
furnished services in an institution,
while others give CMS the authority to
prescribe regulations as may be
necessary to carry out the
administration of the program. Section
122 of the Tax Equity and Fiscal
Responsibility Act of 1982 (Pub. L. 97–
248) (TEFRA), added section 1861(dd)
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to the Act to provide coverage for
hospice care to terminally ill Medicare
beneficiaries who elect to receive care
from a Medicare-participating hospice.
Under the authority of section
1861(dd)(2)(G) of the Act, the Secretary
has established the Conditions of
Participation (CoPs) that a hospice must
meet to participate in Medicare and/or
Medicaid, and these conditions are set
forth at 42 CFR part 418. The CoPs
apply to the hospice as an entity, as well
as to the services furnished to each
individual under hospice care. Under
section 1861(dd), the Secretary is
responsible for ensuring that the CoPs
and their enforcement, are adequate to
protect the health and safety of the
individuals under hospice care. To
implement this requirement, State
survey agencies conduct surveys of
hospices to assess their compliance with
the CoPs.
The Consolidated Appropriations Act
of 2023 (Pub. L. 117–328) (CAA 2023),
was signed into law on December 29,
2022. Division FF, section 4121 of the
CAA 2023 establishes a new Medicare
benefit category for marriage and family
therapist (MFT) services and mental
health counselor (MHC) services
furnished by and directly billed by
MFTs and MHCs, respectively. Section
4121(b)(2) of CAA 2023 specifically
adds these services to covered hospice
care services under section
1861(dd)(2)(B)(i)(III) of the Act. In order
to implement division FF, section 4121
of the CAA 2023, we are proposing to
modify the requirements for the hospice
CoPs at § 418.56 ‘‘Interdisciplinary
group, care planning and coordination
of service’’ and § 418.114 ‘‘Personnel
qualifications.’’ This statutorily-required
modification allows MHCs or MFTs to
serve as members of the
interdisciplinary group (IDG).
Specifically, the CAA 2023 revised
section 1861(dd) of the Act to state that
the hospice interdisciplinary group is
required to include at least one social
worker, MFT, or MHC. In addition, we
are proposing to modify the hospice
personnel qualification at § 418.114(c)
to also include qualifications for an
MFT and an MHC.
2. Provisions of the Proposed
Regulations
a. Updates to the Hospice CoPs To
Permit Mental Health Counselors or
Marriage and Family Therapists To
Serve as Members of the Hospice
Interdisciplinary Group (§§ 418.56 and
418.114)
The CAA 2023 established the new
Medicare benefit category for MFT
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services and MHC services furnished by
and directly billed by MFTs and MHCs.
In accordance with the statute, we
propose to revise § 418.56(a)(1)(iii) to
specify that the IDG must include a
social worker (SW), an MFT, or an
MHC. In addition, we believe that with
the introduction of MHC and MFT into
the hospice CoPs, it is important to also
include these new disciplines into the
personnel qualifications at § 418.114.
Currently the requirement at § 418.114
establishes the requirements for several
disciplines that work in hospices
including but not limited to social
worker, nurse and the therapist. In this
rule, we are proposing to add both MHC
and MFT to the provider requirements
under 42 CFR subpart B, Medical and
Other Health Services at §§ 410.54 and
410.53. Therefore, to avoid duplication
and confusion between the CoP and the
Medical and Other Health Services
requirements, we are proposing to add
both MHC and MFT to the requirements
as new standards at § 418.114(c)(3) and
(4) and reference the new requirements
at §§ 410.54 and 410.53, respectively.
We note that the CAA 2023
specifically modified the statute to
require the hospice interdisciplinary
team to include at least one SW, MFT
or MHC. However, we emphasize that
each hospice patient and family are
different in their needs and goals.
Therefore, it is important for the hospice
to assess and determine, along with the
input from the patient and family,
which care and services best align with
the preferences and needs of the patient.
Furthermore, while we believe the
role of the SW in hospice is unique and
paramount to quality hospice care and
services as the patient and their family
approach the end of life, we also
understand that some patients may
benefit from the care and services of an
MFT or MHC. However, the role and
training of the SW, MFT and MHC vary
greatly. As part of the SW role they offer
unique support and services to the
patient and family such as explaining
what hospice care is and the role of the
hospice team, assisting the patient and
family in navigating the healthcare
system, assisting patients and their
family in understanding care options as
they relate to patient goals and life
circumstances, and identifying and
working with the patient and their
family to connect the patient to other
services that may improve the patients
quality of life. For example, a SW can
make a referral for Meals on Wheels or
link the patient to the Veteran’s
Administration (VA) and other benefits.
The hospice SW can also guide the
patient and family in applying for
financial assistance or resources, such
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as Medicaid, temporary assistance
programs for energy or utilities, or
county assistance programs. In addition,
hospice SW are educated to assist
patients in completing a living will and
other advance directives, as well as
educating patients about health care
choices and assisting the patient and
family in understanding the differences
between wills and powers of attorney.
They assist patients and family in
deciding what environment is best for
the patient to receive care and
coordinate the many requirements for
transferring the patient to the most
appropriate care setting. For example,
the SW will assist the patient as they
transition from a hospital, assisted
living facility or nursing home back to
their home, or vice versa.
SW, MFTs and MHCs have some
similar roles and responsibilities as they
relate to counseling. All three of these
providers can assist the patient and
family with issues related to family
dynamics, assessing situations,
strengths, and the patient’s support
network. They can also assist patients
and families with navigating the
changes and challenges at the end of life
including grief counseling and coping
strategies to ease day to day emotions.
The SW, MFT, or MHC can also provide
age-appropriate education and
emotional support for children and
grandchildren. Some examples of this
include providing activities that allow
them to express their feelings
appropriately, leading support groups,
and providing individual, couples, and
family counseling. The addition of the
MFT and MHC may also be particularly
beneficial for individuals living in rural
areas who were previously not able to
access these types of services.
We acknowledge that there are clear
similarities and differences between
SWs, MFTs and MHCs, ranging from
offered services to experience to scope
of practice. While the services SWs,
MFTs, and MHCs provide are not
interchangeable, each offers unique
supports that may be valuable to the
patient and family based on the
situation. Therefore, the individual
hospice patient’s needs, preferences,
and goals, should guide the
determination of which member of the
team (SW, MFT or MHC) serves as the
member of the IDG for that patient. For
example, if the patient’s assessed needs
relate to VA benefits, the SW may be the
most appropriate provider to meet those
needs. However, if the patient’s assessed
needs are related to unresolved issues
with their spouse, it may be appropriate
to have MHC or MFT provide services
to the patient. We believe the ability for
hospice patients to receive additional
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mental health services and supports as
part of their hospice care may empower
patients and their families in decision
making, thus improving the overall
health and safety of the patient.
b. Personnel Qualifications (§ 418.114)
As noted above, Division FF, section
4121 of the CAA 2023 requires CMS to
permit an MHC or MFT to serve as
members of the IDG. As discussed
previously, we are proposing to modify
the language at § 418.56 regarding the
composition of the IDG to include
MHCs and MFTs.
P. Request for Information:
Histopathology, Cytology, and Clinical
Cytogenetics Regulations Under the
Clinical Laboratory Improvement
Amendments (CLIA) of 1988
1. Background
The Clinical Laboratory Improvement
Advisory Committee (CLIAC), CMS,
interested parties, and State Agency
(SA) surveyors have identified areas in
the CLIA requirements that may need
updating.
trained under the supervision of a
qualified technical supervisor can
perform these staining techniques. An
independent facility (for example, a
processing center, that performs slide
staining) is not required to hold a CLIA
certificate. IHC stains are complex stains
designed to identify specific antigens
and targets within the cells. These
targets can include ribonucleic acid
(RNA) and deoxyribonucleic acid (DNA)
specific reactivity. The U.S. Food and
Drug Administration (FDA) has
categorized instruments that perform
automated IHC staining as high
complexity. Therefore, individuals that
perform IHC staining in a CLIA certified
laboratory (for example,
histotechnicians, histotechnologists,
and pathology assistants) must meet the
personnel requirements for facilities
carrying out high complexity testing.
The facility must also hold a CLIA
certificate in the subspecialty of testing
performed.
(1) Slide Preparation and Staining
Facilities only collecting or preparing
specimens (or both) or only serving as
a mailing service but not performing
testing are not considered
laboratories.278 Slide staining and tissue
processing have not been subject to the
CLIA regulations. However, we received
inquiries from interested parties stating
that slide staining and tissue processing
are an essential part of the testing
process for histopathology. Absent these
steps, the tissue cannot be prepared,
mounted onto a slide, or accurately
evaluated by a pathologist to make an
assessment for diagnosis.
Slide staining in histopathology
includes routine Hematoxylin and Eosin
(H&E) staining, special stains, and
immunohistochemical (IHC) stains.
Routine slide staining in histopathology
provides simple cellular identification
and requires minimal steps with
solutions, dyes, and clearing reagents
(for example, Hematoxylin & Eosin
stains, Giemsa stain). An individual
(2) Gross Tissue Examination Review
Testing in histopathology includes
both gross tissue examination
(macroscopic) and the microscopic
evaluation of the stained slide(s) with
evaluation and diagnostic
interpretations, and the reporting of
diagnostic findings by qualified
personnel. Gross examination means the
manipulation, orientation, and selection
of the desired representative pieces of
excised tissue from the total specimen
received. This includes the physical
examination and description, color,
weight, measurements, and other
characteristics of the tissue. Selected
portions of the tissue are placed into a
tissue cassette, subjected to a fixative,
processed and infiltrated with paraffin
wax, placed onto a slide(s), and stained
before being reviewed and evaluated by
a technical supervisor.
The CLIA State Operations Manual
(SOM), Appendix C (‘‘Interpretive
Guidelines’’) 279 for 42 CFR
493.1489(b)(7) state that gross
examinations may be performed by
individuals qualified under § 493.1489
as delegated by the technical supervisor.
The technical supervisor is not required
to provide on-site supervision, but is
responsible for the review, accuracy,
and confirmation of the macroscopic
gross examination in the patient report.
The documentation of the review of the
results of the macroscopic gross
examination by the technical supervisor
must be included in the signed
microscopic examination report, as
278 See definition of ‘‘laboratory’’, https://
www.ecfr.gov/current/title-42/chapter-IV/
subchapter-G/part-493#493.2.
279 CLIA Interpretive Guidelines: https://
www.cms.gov/regulations-and-guidance/legislation/
clia/interpretive_guidelines_for_laboratories.
a. Histopathology
The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Pub. L.
100–578, October 31, 1988) regulations
related to histopathology have not been
updated since 1992. The current
Histopathology requirements may not
represent new innovations and
technology performed in laboratories.
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required at § 493.1273(d). The CLIA
regulations do not cover the acceptable
timeframe in which the review of the
gross tissue examination must be
completed. The discussion surrounding
the review of the gross tissue
examination includes CLIA’s oversight
at this phase of the histopathology
testing process. CLIA supports an
acceptable timeframe to permit a
pathologist to review the tissue
specimen prepared during the gross
examination by a qualified technical
supervisor. This review can be
delegated by the technical supervisor to
a qualified individual. Gross
examination is a critical part of the
tissue analysis process to ensure
subsequent pathology tests are accurate
and reliable. The review of the gross
tissue is important to protect the
patient’s specimen identification during
the testing process.
b. Cytology
(1) CLIA Statute and Regulations
CLIA revised section 353 of the Public
Health Service Act (42 U.S.C 263a) to
authorize the regulation of all clinical
laboratories. Section 353(4)(B)(vi) of the
Public Health Service Act requires that
all cytological screening be done on the
premises of a laboratory that is certified
under this section.
The CLIA regulations for cytology
state that cytology slide preparations
must be evaluated on the premises of a
laboratory certified to conduct testing in
the subspecialty of cytology at
§ 493.1274(a).
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(2) Clinical Laboratory Improvement
Amendments (CLIA) Guidance for
Temporary Testing Sites Under the
Multiple Site Exception,280 CMS Policy
Memo (QSO–22–13–CLIA)
The intent of the CLIA program is to
ensure that test results provided to
individuals and their healthcare
providers are accurate, timely, and
reliable. During the COVID–19 public
health emergency (PHE), we issued
memo QSO–22–13–CLIA that informed
interested parties that we exercised
enforcement discretion to allow
pathologists the ability to examine
histopathology and cytology slides/
images remotely, under the following
conditions:
• The primary laboratory’s CLIA
certificate must include the specialty of
pathology with the subspecialties of
280 QSO–22–13–CLIA:
https://www.cms.gov/
medicareprovider-enrollment-andcertificationsurveycertificationgeninfopolicy-andmemos-states-and/clinical-laboratory-improvementamendments-clia-guidance-temporary-testing-sitesunder-multiple-site.
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histopathology and cytology, as
appropriate.
• The remote location complies with
other applicable Federal laws, including
the Health Insurance Portability and
Accountability Act of 1996 (HIPAA).
• The primary laboratory’s written
procedure manuals for tests, assays, and
examinations are available to the
pathologists at the remote location.
• Retention time for histopathology
slides (10 years), specimen blocks (2
years), preserved tissue remnants (until
a diagnosis was made), and cytology
slides (5 years) were maintained.
• The use of equipment, supplies and
reagents, and similar items needed at
the remote location are not allowed to
be permanently stored on site.
Under the memorandum, QSO–22–
13–CLIA, the remote location could
allow pathologists the opportunity to
examine histopathology and cytology
slides for specified intervals of time to
include a PHE, medical condition, or a
situation where a pathologist has to
examine slides away from the primary
location.
Pathologists that currently hold a
CLIA certificate are exempt from this
enforcement discretion. The pathology
community has expressed their desire to
make this enforcement discretion a
permanent provision after the end of the
PHE for COVID–19.
c. Clinical Cytogenetics
We require any testing facility that
meets the CLIA regulatory definition of
a ‘‘laboratory’’ (per § 493.2,
Definitions 281) to have a CLIA
certificate. A laboratory may choose to
outsource a test or a portion of their test
procedure because it lacks the
equipment, personnel with the expertise
in the subject, or is considered more
cost-efficient. The CLIA regulations at
§ 493.1242(c) require the laboratory to
only refer a test (for example, reflex,
confirmatory, or distributive testing) to
another laboratory that is CLIA certified
or a laboratory meeting equivalent
requirements as determined by CMS.
Therefore, each laboratory or testing
facility that performs clinical testing
must have its own CLIA certificate and
comply with the regulations for the
complexity of the testing it performs.
Clinical cytogenetics testing is
generally categorized as a CLIA high
complexity test. A cytogenetics test may
be conducted at one facility, or involve
a testing workflow model in which one
facility performs the analytical bench
testing activities (for example, sample
281 See definition of ‘‘laboratory’’, https://
www.ecfr.gov/current/title-42/chapter-IV/
subchapter-G/part-493#493.2.
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processing, extraction, chemical
reaction, slide preparation, imaging) and
another facility conducts the non-bench
testing activities (for example, review of
images, analysis, interpretation or
reporting of the results). When any part
of a test is performed by more than one
facility, this testing model is considered
distributive testing. CLIA defines
distributive testing under § 493.2,
Definitions, as ‘‘laboratory testing
performed on the same specimen, or an
aliquot of it, that requires sharing it
between two or more laboratories to
obtain all data required to complete an
interpretation or calculation necessary
to provide a final reportable result for
the originally ordered test. When such
testing occurs at multiple locations with
different CLIA certificates, it is
considered distributive testing.’’
Therefore, any facility performing
clinical cytogenetics testing activities
must be CLIA certified and meet high
complexity testing requirements.
During the PHE for COVID–19, we
exercised enforcement discretion
regarding clinical cytogenetics
distributive testing models. Under the
enforcement discretion, we allowed
clinical cytogenetics personnel the
opportunity to examine clinical
cytogenetics digital images (that is, nonbench testing activities) at a remote
testing location without obtaining a
separate CLIA certificate for the remote
site under certain conditions. Some
interested parties have requested we
make this enforcement discretion
permanent. Changes to the current CLIA
regulations would be necessary to allow
the examination of clinical cytogenetics
images at a different, remote location
from the primary CLIA-certified site
without a separate CLIA certificate.
Please note that a remote location not
associated with or covered by a primary
CLIA-certified laboratory would be
required to obtain its own CLIA
certificate. The primary site laboratory
director would be responsible for the
overall operation and administration of
the laboratory including the
employment of personnel who are
competent to perform test procedures,
record and report test results promptly,
accurately, and proficiently; for assuring
compliance with applicable regulations
in their primary laboratory; and for the
supervision of the personnel reviewing
digital laboratory data, digital results,
and digital images remotely.
2. Solicitation of Public Comments
We are soliciting public input and
comment on the following areas of
CLIA: Histopathology; Cytology; and
Clinical cytogenetics. The topics listed
in this RFI are areas that CMS, CDC,
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interested parties, and SA surveyors
have identified that may potentially be
used by CMS for future rulemaking.
a. Histopathology
We are seeking public comments on
the following:
• Whether, and how, CLIA should
provide oversight of histopathology
preparation and processing of tissue
samples for slide staining, specifically
related to guidance for routine
histopathology slide staining and
complex IHC staining.
• What criteria (for example, training
programs, on-the-job training,
experience, or academic degree) would
interested parties recommend for
personnel performing high complexity
automated IHC staining?
• How does the categorization of
automated staining systems impact
personnel who are currently performing
this task but do not meet the
qualifications for performing high
complexity testing?
• What is an acceptable timeframe
between the review of the macroscopic
gross tissue examination, and the review
and confirmation of these tissue
findings by a pathologist prior to the
microscopic review of slides to protect
the integrity of the macroscopic tissue?
• What education and experience or
training requirements should be
required for individuals to qualify as a
general supervisor (GS) for
histopathology? If qualified, what is an
acceptable timeframe for the GS to
review and evaluate gross examinations
under the specialty of histopathology?
• What education and professional
experience, or training requirements
should be required for individuals
performing gross tissue examination
that have an associate degree from a
histotechnician program or a PA who
has training from an accredited program
and is certified as a PA?
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b. Histopathology and Cytology Testing
at Remote Locations
We are seeking public comments on
the following:
• How should ‘‘remote testing
location’’ be defined?
• How should the CLIA regulations
be revised to allow pathologists to
examine histopathology and cytology
slides/images at a remote testing
location?
• What conditions (including,
location(s)) should apply for a
pathologist to examine histopathology
or cytology slides/images remotely
without obtaining a separate CLIA
certification?
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• Under what conditions should a
primary location cease permitting
testing at the remote location?
• How should the remote location be
included on the final patient report?
• How should CMS, SAs, or
Accreditation Organizations perform
onsite surveys at remote locations?
c. Clinical Cytogenetics
We are seeking public comments on
the following:
• Under what circumstances should
CLIA allow remote locations or testing
facilities to examine clinical
cytogenetics images without obtaining a
separate CLIA certification?
• Under what circumstances would
the examination of clinical cytogenetics
images be unacceptable for the remote
location scenario?
• What clinical cytogenetics testing
processes should the primary laboratory
have in place to ensure the remote site
complies with the CLIA requirements?
• What ‘‘conditions’’ or ‘‘criteria’’
would be necessary for the remote
location to ensure quality testing for the
examination of clinical cytogenetics
images?
Q. Changes to the Basic Health Program
Regulations
Section 1331 of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148, enacted March 23, 2010), as
amended by the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152, enacted March 30,
2010) (collectively referred to as the
Affordable Care Act or ACA), provides
States with the option to operate a Basic
Health Program (BHP). In the States that
elect to operate a BHP, the State’s BHP
makes affordable health benefits
coverage available for lawfully present
individuals under age 65 with
household incomes between 133 and
200 percent of the Federal poverty level
(or in the case of a lawfully present noncitizen, ineligible for Medicaid or the
Children’s Health Insurance Program
(CHIP) due to immigration status, whose
household income is between zero and
200 percent of the FPL) who are not
eligible for Medicaid, CHIP, or other
minimum essential coverage. As of the
date of this proposed rule, only New
York and Minnesota have implemented
a BHP.
Federal funding for BHP is based on
95 percent of the value of the premium
tax credits (PTC) and cost sharing
reduction (CSR) subsidies that BHP
enrollees would have received had they
instead enrolled in Qualified Health
Plans (QHPs) through the Exchange in
accordance with section 1331(d)(3)(A)(i)
of the ACA. These funds are paid to
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trusts established by the States and
dedicated to the BHP, and the States
then administer the payments to BHP
standard health plans within the BHP.
Under section 1331(d)(2) of the ACA,
Federal funding for the BHP can only be
used to reduce the premiums and costsharing of, or to provide additional
benefits for, eligible individuals
enrolled in standard health plans within
the State.
1. Allowing States To Suspend a BHP
Current regulations require States to
operate a BHP under a certified
Blueprint approved by CMS, and to
operate the BHP as long as their
approved certified Blueprint is in place.
Under 42 CFR 600.140, a State may
terminate its BHP, which requires that
the BHP trust fund balance must be
refunded to the Federal government. A
State has inquired about whether it
could ‘‘suspend’’ its program for a
portion of time, so that it could shift
BHP enrollees to other coverage with
comparable benefits and cost sharing,
while maintaining its BHP trust fund,
which it could use if the State were to
resume the BHP.
We see the value in allowing a State
currently operating a BHP to experiment
with other ways of providing coverage
that may increase the number of people
covered while not increasing Federal
costs. We propose to give a State the
option of temporarily ‘‘suspending’’ its
BHP program, while retaining accrued
funds in the BHP trust fund for a limited
period of time. Should the State decide
to resume operating its BHP, the
suspension would allow the State to
leverage accrued funds and avoid the
processes of terminating the program
and refunding trust funds, and then
later having to submit a new BHP
application for approval. For that
reason, under the authority of section
1331(c)(4) of the ACA, which requires
coordination with other State health
programs, we are proposing to amend
§ 600.140 to add an option at paragraph
(b) for a State to suspend its BHP.
We propose at § 600.140(b)(1) that
States wishing to suspend their BHP
must submit an application to HHS.
Under proposed § 600.140(b)(1), States
could also seek approval to extend a
BHP suspension previously approved by
HHS. In § 600.140(b)(1)(vi), we propose
that the application must be submitted
at least 9 months in advance of the
proposed effective date of the
suspension or extension. In § 600.140(c),
we propose that the State cannot
implement the suspension or extension
without prior approval by the Secretary.
However, for States seeking to suspend
a BHP in the first plan year that begins
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following publication of a final rule
adopting this proposal, States must
submit an application within 30 days of
the publication of such a final rule. HHS
will approve or deny such application
as expeditiously as possible. We
propose in § 600.140(b)(2) that a
suspension application would need to
be approved prior to the effective date
of suspension, except in the case of a
State seeking to suspend a BHP in the
first plan year that begins following
publication of a final rule adopting this
proposal.
The proposed substantive
requirements for the suspension
application are described in
§ 600.140(b)(1)(i) through (v). During the
period of suspension, BHP enrollees
should receive comparable coverage that
is as comprehensive and affordable as,
or more comprehensive and affordable
than, BHP coverage during the period of
suspension. Therefore, in
§ 600.140(b)(1)(i) through (iii), we
propose to require that the suspension
and extension application demonstrates
that the benefits that will be provided to
individuals that meet the BHP eligibility
criteria are at least equivalent to the
benefits offered in the State’s BHP. We
propose that the cost sharing and
premiums that will be charged to such
individuals under the new coverage
option do not exceed the amounts
charged under the BHP to reduce the
risk that these individuals are harmed
by the transition to other coverage.
We propose at § 600.140(b)(1)(i) to
require that benefits provided under the
new coverage option must be at least
equal to the BHP benefits in the certified
Blueprint in effect on the effective day
of suspension. This is the same standard
that is used in the Medicaid regulations
at § 440.330 to determine if a State’s
alternative benefit package is equivalent
to the benchmark benefit package.
Additionally, it is similar to the
standard that is used by CHIP at
§ 457.420 to determine if a State’s CHIP
benefit package is equivalent to the
benchmark benefit package, although
the CHIP standard allows for some
variation if the State is adding
additional benefits as required by Title
XXI. We note that it would be
acceptable to provide additional
benefits under the new coverage option,
such that individuals receive more or
greater benefits under the new coverage
option. We considered whether there
should be a look back period, such that
benefits under the new coverage option
would be compared to the BHP benefits
provided under the certified Blueprint
in effect for a period of time prior to the
effective date of the suspension and
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seek comments on this alternative
approach.
In order to determine that the cost
sharing required of individuals under
the new coverage option does not
exceed the BHP cost sharing levels, we
propose at § 600.140(b)(1)(ii) to require
that the actuarial value of the new
coverage option must meet or exceed
the actuarial value of the BHP standard
health plans in effect immediately prior
to the suspension period. This may
result in cost sharing for individual
benefits differing between the BHP and
the new coverage program, provided the
actuarial value of the new coverage
options meets or exceeds the actuarial
value of the BHP standard health plans.
If there are multiple health plans being
offered under the new coverage option
and/or multiple standard health plans
in effect in the State, we propose that
the median actuarial value of the health
plans offered under the new coverage
option must meet or exceed the median
actuarial value of the BHP standard
health plans. We considered whether to
require that cost sharing under the new
coverage option instead meet the cost
sharing requirements under current
regulations at § 600.520(c) and seek
comment on whether this alternative
approach should be adopted in the final
rule.
Similarly, we propose at
§ 600.140(b)(1)(iii) to require that the
premiums charged to individuals under
the new coverage option must be
comparable to BHP standard health plan
premiums in effect immediately prior to
the suspension period, beyond
reasonable increases due to inflation as
measured by the Consumer Price Index
(CPI). We considered alternative
methods for measuring equivalency in
premiums. First, we considered whether
to require that premiums under the new
coverage option instead meet the
premium requirements under
§ 600.505(a). Second, we considered
whether premiums charged to
individuals under the new coverage
option should instead not exceed the
premiums in effect on December 31,
2020, as these premiums levels do not
account for any additional premium tax
credit subsidies offered under the
American Rescue Plan Act or the
Inflation Reduction Act. Third, we
considered whether premium and cost
sharing levels, considered together,
under the new coverage option would
be considered sufficient, if those levels
meet the requirements under a section
1115 demonstration or section 1332
waiver. We also seek comment on
whether these alternative approaches
should be adopted in the final rule.
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We also considered alternatives to the
timing of the comparison of benefits and
cost sharing in BHP to the new coverage
option. Specifically, we considered
whether benefits and cost sharing under
the new coverage option should be
compared to the benefits and cost
sharing under the BHP on the date the
suspension application is submitted to
HHS, or some other date. We also seek
comment on the potential adoption of
these alternatives in the final rule.
Finally, we believe that the
suspension period should not result in
individuals losing coverage, solely due
to a change in eligibility criteria for the
program. Therefore, we are proposing in
§ 600.140(b)(1)(iv) that a state must
demonstrate in its application that the
eligibility criteria for coverage during
the suspension is not more restrictive
than the criteria described in § 600.305.
We believe that the suspension period
should be long enough to allow the
State to evaluate the alternative
coverage provided to BHP eligible
individuals, but should not be
indefinite. Therefore, we are proposing
in § 600.140(b)(1)(v) that a State could
request a suspension of up to 5 years in
an initial suspension application, after
which a State could request an
extension of up to 5 additional years.
Additional extension periods would not
be allowed. When the suspension
period, including any extension period,
ends, we propose that the State would
need to transition the BHP eligible
population back to the BHP, or
terminate the BHP. We propose at
§ 600.140(b)(7) that at least 9 months
before the end of the suspension period,
a State must submit a transition plan to
HHS that explains how the State will
reinstate its BHP, or terminate the
program under § 600.140(a) of the
current regulations. The state must also
notify the public of this change. Under
proposed § 600.140(b)(7), a State also
could elect to end a BHP suspension
before the end of the initial or extended
suspension period by following the
same process.
We chose 5 years for the initial
approval period because this aligns with
the duration of initial waivers and
demonstration projects approved under
section 1332 of the ACA and section
1115 of the Act. We believe these are the
most likely authorities under which
States could seek to provide alternative
coverage to BHP enrollees. Similarly, we
chose 5 years for the extension period
because it aligns with the duration of
typical extensions or amendment
periods under section 1332 waiver and
section 1115 demonstration projects. We
considered a shorter extension period of
2 or 3 years, and allowing multiple
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extension periods given both section
1332 waiver and 1115 demonstrations
can be extended. We seek comment on
these alternatives.
Under proposed § 600.140(b)(1)(vii),
States requesting an extension of a
previously-approved BHP suspension
also would need to provide an
evaluation of the alternative coverage in
its application. In the case of alternative
coverage provided through a section
1115 demonstration project or section
1332 waiver, the evaluation and
application required for such
demonstration projects and waivers
would satisfy this requirement.
If individuals and/or standard health
plans will experience a change in the
terms of the coverage, including
receiving additional benefits or being
charged different cost sharing amounts,
in § 600.140(b)(3), we propose to require
that the state provide notice to them at
least 90 days prior to the effective date
of the suspension. The notices would
need to include information regarding
the State’s assessment of their eligibility
for all other insurance affordability
programs in the State, and meet the
accessibility and readability standards
at 45 CFR 155.230(b).
In order to calculate a State’s BHP
payments, the State provides CMS an
estimate of the number of BHP enrollees
it projects will enroll in the upcoming
BHP program quarter each quarter of
program operations. We use those
estimates to calculate the prospective
payment, which is deposited in the
State’s BHP trust fund. Once the State
provides us with actual enrollment data
for those periods, the actual enrollment
data is used to calculate the final BHP
payment amount and make any
necessary reconciliation adjustments to
the prior quarters’ prospective payment
amounts due to differences between
projected and actual enrollment.
We believe that having an accurate
accounting of the balance of the State’s
trust fund is critical for any State
suspending its BHP. Therefore, we
propose to require in § 600.140(b)(4)
that States that suspend their BHP must
submit the data necessary to complete
the BHP payment reconciliation process
within 12 months of the effective date
of the suspension. We believe that 12
months is a reasonable amount of time
for a State to submit the actual
enrollment data for the periods it was
operating a BHP.
One reason it is important for a State
to complete the BHP payment
reconciliation process is to establish a
baseline balance for calculating interest.
Currently, States’ BHP trust funds can
accrue interest, and this interest is
retained in the BHP trust fund.
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However, we believe that interest
accrued on the BHP trust fund during
any suspension must be remitted to
HHS. Since the State is not operating a
BHP during the suspension period,
suspension should not generate
additional funds for the State. We
propose in § 600.140(b)(6) that while the
State is not providing BHP coverage,
any accrued interest on the trust fund
must be remitted to HHS on an annual
basis in the form and manner set out by
HHS.
States currently submit the balance of
their trust fund and any interest accrued
through the BHP annual report
described in § 600.170. We proposed
revisions to §§ 600.140(b) and
600.170(a) to require States that suspend
their BHP continue to submit an annual
report in order to document the interest
earned and to provide assurance that the
coverage provided to BHP-eligible
individuals meets the standards
discussed above. We propose in
§ 600.140(b)(5) to require States that
suspend their BHP continue to submit
an annual report during the suspension
period. We proposed amendments to
§ 600.170(a), which describes the
requirements for the annual reports, to
describe the standards that will apply to
States that have suspended their BHP.
Specifically, we propose to redesignate
the introductory language in paragraph
(a) as paragraph (a)(1), to redesignate
paragraphs (a)(1) through (a)(4) as
paragraphs (a)(1)(i) through (a)(1)(iv),
and to add a new paragraph
§ 600.170(a)(2) to require that States that
have suspended their BHP under
§ 600.140(b) must submit an annual
report that includes (1) the balance of
the BHP trust fund and any interest
accrued on that balance; (2) an
assurance that the coverage provided to
individuals who would be eligible for a
BHP under § 600.305 continues to meet
the standards described in
§ 600.140(b)(1)(i) through (iii); and (3)
any additional information specified by
the Secretary at least 120 days prior to
the date that the annual report is due.
If a State does not meet the proposed
requirements (that is, completing the
financial reconciliation process,
remitting interest on the trust fund, and
submitting the required information in
its annual report), we propose in
§ 600.140(d) that the Secretary can
withdraw approval of the suspension.
Specifically, we propose that the
Secretary can withdraw approval of the
suspension if the State ends
implementation of the alternative
coverage program for any reason, or if
the State fails to continue to meet the
coverage and cost sharing requirements
of the alternative coverage program. If
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the State seeks an amendment to the
alternative coverage program, the State
must inform CMS of this proposed
change so that CMS may evaluate if the
coverage is sufficient. In addition, we
propose at paragraph (d) that we could
also withdraw approval if we have
significant evidence of harm, financial
malfeasance, fraud, waste, or abuse
consistent with § 600.142. In
§ 600.140(d)(1) through (4), we propose
a process for withdrawing approval,
which mirrors the process for
withdrawing certification of a BHP
Blueprint in § 600.142. Specifically, we
propose that the Secretary will
withdraw approval only after providing
the State with notice of the findings
upon which the Secretary is basing the
withdrawal, a reasonable period for the
State to address the finding, and an
opportunity for a hearing before issuing
a final finding. We propose that the
Secretary shall make every reasonable
effort to resolve proposed findings
without withdrawing approval of the
suspension plan and in the event of a
decision to withdraw approval, will
accept a request from the State for
reconsideration. The effective date of an
HHS determination withdrawing
approval of the suspension plan would
not be earlier than 120 days following
issuance of a final finding. Within 30
days following a final finding under
paragraph (d)(1) of this paragraph, the
State shall submit a transition plan to
HHS.
During the transition period from the
BHP to other coverage the state may not
use funds from the BHP trust fund
toward the unwinding of the BHP
program and transition to the new
coverage program. Under section
1331(d)(2) of the ACA and current
regulations at § 600.705(c), Federal
funding for BHP can only be used to
reduce the premiums and cost-sharing,
or to provide additional benefits, for
BHP-eligible individuals enrolled in
standard health plans within the State.
Therefore, Federal funding is not
available for administrative expenses
associated with transitioning BHP
enrollees to a new coverage program or
for costs associated with providing new
coverage after the transition has
occurred. States cannot use Federal BHP
funding to cover premiums and cost
sharing (or additional benefits) for
individuals that would otherwise be
eligible for BHP funding. We solicit
comment on these proposals.
We seek comment on the proposed
process for suspending a BHP.
Specifically, we seek comment on how
far in advance of suspension a state
must submit a suspension application to
CMS and how far in advance of
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suspension CMS must approve or deny
the suspension request. We also seek
comment on duration of time a state
may suspend their BHP, without
terminating the program.
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2. Submission and Review of BHP
Blueprints
As noted above, under current
§ 600.110, States must submit to the
Secretary and receive certification of a
BHP Blueprint describing their
operational design choices prior to
implementation. Under the current
§ 600.125(a) a State that seeks to make
significant changes to its BHP must
submit a revised Blueprint to the
Secretary for review and certification;
however, the current regulation does not
specify any timeframes for the
submission and review of revised
Blueprints. The current § 600.125(a) also
describes a limited number of changes
under which submission of a revised
Blueprint is required. Most notably, the
current regulation does not require the
submission of a revised Blueprint in
response to changes in Federal law or
regulations. Additionally, under current
§ 600.125(a) and (b), any changes made
in a revised Blueprint can be
implemented prospective from the date
of certification; no changes can be
implemented until HHS certifies the
revised Blueprint.
We believe that additional parameters
are necessary in order to ensure
effective and efficient operation of the
BHPs and HHS review of a revised
Blueprint, consistent with section
1331(a)(1) of the ACA. Therefore, we
propose changes to § 600.125 to
establish timeframes and procedures for
the submission and review of BHP
Blueprints, similar to the Medicaid and
CHIP State plan amendment (SPA)
submission and review processes. We
note that these proposed timeframes
only apply to the submission and
review of revised Blueprints; we are not
proposing changes to the timeframes for
the submission and review of an initial
Blueprint, set forth in current
regulations at § 600.120, in the event
additional States seek to establish BHPs.
Additionally, we believe States need
flexibility to receive approval of a
retroactive effective date for changes to
their BHP Blueprint, similar to
flexibilities allowed under regulations at
§§ 430.20(b) and 457.60 for the
submission of Medicaid and CHIP SPAs.
We note, however, that in the event that
a State implements a change to its BHP
Blueprint that is ultimately disapproved
by HHS, the State could be required to
implement a corrective action plan
under § 600.715.
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Specifically, under existing
regulations at § 600.125(a), States must
submit a revised Blueprint whenever
they seek to make significant change(s)
that alter program operations the BHP
benefit package, enrollment,
disenrollment and verification policies
described in its certified BHP Blueprint.
Under the proposed revisions to
§ 600.125(a), we would broaden the
circumstances requiring submission of a
revised Blueprint to include States’
significant changes that alter any core
program operations under § 600.145(f).
States also would be required to submit
a revised Blueprint to HHS whenever
necessary to reflect changes in Federal
law, regulations, policy interpretations,
or court decisions that affect provisions
in their certified Blueprint. States would
continue to be required to submit a
revised Blueprint to make changes to
the BHP benefit package or to
enrollment, disenrollment, and
verification policies described in the
certified Blueprint, as currently required
under § 600.125(a).
At § 600.125, we also propose to
redesignate paragraph (b) as paragraph
(d) and to add new paragraph (b) to
provide that the effective date of a
revised Blueprint may be as early as, but
not earlier than, the first day of the
quarter in which an approvable revision
is submitted to HHS. This policy
mirrors the standards for submission of
a Medicaid SPA at § 430.20(b). The
current regulations do not specify as to
when revision is considered received.
We believe that it is reasonable to
consider a revised Blueprint to be
received when HHS receives an
electronic copy of a cover letter signed
by the Governor or Governor’s designee
and a copy of the currently approved
Blueprint with proposed changes
indicated in track changes. In the event
a State is unable to submit a revised
Blueprint electronically, due to a
disaster or other event outside of the
State’s control, CMS may consider other
modes of submission on a case-by-case
basis. Under current regulations at
§ 600.125(b), redesignated at
§ 600.125(d) in this proposed rule, the
State is responsible for continuing to
operate under the terms of the existing
certified Blueprint until the State adopts
a revised Blueprint, the State terminates
or suspends the BHP, or the Secretary
withdraws certification for the BHP.
We are also proposing to redesignate
paragraph (c) as paragraph (g) and to
add a new paragraph (c) to create clear
timelines for HHS’s review, approval,
and disapproval of revised Blueprints
similar to the timelines currently
applicable to CHIP SPAs under
§ 457.150. Under proposed
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§ 600.125(c)(1), a revised Blueprint will
be deemed approved unless HHS,
within 90 days after receipt of the
revised Blueprint, sends the State
written notice of disapproval or written
notice of additional information HHS
needs in order to make a final
determination. If HHS requests
additional information, the 90-day
review period will be stopped and will
resume the day after HHS receives all of
the requested additional information
from the State. Under proposed
paragraph (c)(2), if 90 days from the date
a Blueprint revision is received does not
fall on a business day, the 90-day review
period will end on the next business
day. Under proposed paragraph (c)(3),
HHS may send written requests for
additional information as many times as
needed to obtain all information
necessary to certify the revised
Blueprint. This mirrors the process used
by CHIP, of having one 90-day review
period that can start and stop multiple
times with a request for additional
information and response. It differs from
Medicaid, which has a 90-day review
period that can be stopped once by a
request for additional information,
followed by a second 90-day review
period when the state responds. At
paragraph (c), we propose that HHS may
disapprove a Blueprint amendment if
the Secretary determines that the
Blueprint revision is not consistent with
section 1331 of the ACA or the
regulations set forth in this part at any
time during the review process,
including when the 90-day review clock
is stopped due to a request for
additional information.
Once a Blueprint is approved, current
paragraph (b) specifies that the State is
responsible for continuing to operate
under the terms of the existing certified
Blueprint until and unless a revised
Blueprint that seeks to make significant
change(s) is certified, except during a
public health emergency, as described
in paragraph (c). We propose to revise
paragraph (b), redesignated as paragraph
(d) in this proposed rulemaking, to
provide that the State must continue to
operate under the terms of an existing
certified Blueprint until the State adopts
a revised Blueprint, terminates the BHP
following the procedures described in
§ 600.140(a), suspends the BHP
following the procedures described in
§ 600.140(b), or the Secretary withdraws
certification of the BHP under § 600.142.
Finally, we propose to apply some of
the existing parameters for initial
Blueprint submissions to Blueprint
revisions. In paragraph (e), we propose
that a State may withdraw the proposed
revised Blueprint during HHS review if
the State has not yet implemented the
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proposed changes and provides written
notice to HHS. This proposal mirrors
current § 600.130 for initial BHP
Blueprints. In paragraph (f), we propose
that HHS will accept a State’s request
for reconsideration of a decision not to
certify a revised Blueprint and provide
an impartial review against standards
for certification if requested. This
proposal mirrors current § 600.135(c) for
initial BHP Blueprints.
Under current § 600.135, HHS must
act on all initial BHP Blueprint
certification and revision requests in a
timely matter. Because we are proposing
to specify timeframes for the submission
and review of revised BHP Blueprints
under § 600.125, we propose to revise
§ 600.135 to apply only to the
submission of initial BHP Blueprints.
Specifically, we propose to revise the
title to clearly state that this section is
applicable to only initial Blueprints and
to remove the reference to BHP
Blueprint revisions in paragraph (a).
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3. BHP Notices
Under current § 600.330, States must
provide written notice to beneficiaries
conveying final determination of
eligibility or ineligibility. The regulation
does not require States to provide those
notices in a manner that is accessible to
individuals with disabilities or limited
English proficiency (LEP). Although
HHS Office for Civil Rights regulations
at 45 CFR 92.101, which apply to
programs such as Medicaid, CHIP and
BHP, require States to take reasonable
steps to provide meaningful access for
individuals with LEP and to ensure
effective communication with
individuals with disabilities, we believe
it is important for these obligations to
also be described clearly in the BHP
regulations. Therefore, we are proposing
to add paragraph (f) to § 600.330 to
require that BHP eligibility notices be
written in plain language and be
provided in a manner which ensures
that eligible individuals with LEP are
provided with meaningful language
access and individuals with disabilities
are provided with effective
communication.
4. BHP Appeals
Under current § 600.335(b),
individuals must be given the
opportunity to appeal BHP eligibility
determinations through the appeals
rules of the State’s Medicaid program or
the Exchange, as indicated in the State’s
Blueprint. Current BHP and Exchange
regulations do not provide for appeals of
health services matters. We believe all
BHP enrollees should be afforded the
opportunity to appeal not only
eligibility determinations but also
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decisions about health services matters.
The Exchange rules do not include an
opportunity to appeal a health services
matter, as such appeals are typically
handled by State Departments of
Insurance, as opposed to by the
Exchange itself. Therefore, we propose
in paragraph (b) to remove the option
for States to conduct their BHP appeals
process according to Exchange rules. In
paragraph (b)(2), we propose to require
States to provide individuals an
opportunity to appeal a delay, denial,
reduction, suspension, or termination of
health services, in whole or in part,
including a determination about the
type or level of service, after individuals
exhaust appeals or grievances through
the BHP standard health plans.
Because current BHP regulations do
not include provisions related to the
appeal of health services matters, these
appeals are not currently included in
the list of core operations of a BHP in
§ 600.145. We believe that appeals of
health services matter, like appeals of
eligibility determinations, are a core
function of a BHP. Therefore, in
proposed § 600.145(f)(2), we include
appeals of health services matters as
specified in § 600.335 as a core
operation of a BHP.
R. Updates to the Definitions of Certified
Electronic Health Record Technology
1. Background
The American Recovery and
Reinvestment Act of 2009 (Pub. L. 111–
5, enacted February 17, 2009) (ARRA),
authorized incentive payments to
eligible professionals, eligible hospitals
and critical access hospitals (CAHs),
and Medicare Advantage (MA)
organizations to promote the adoption
and meaningful use of certified
electronic health record (EHR)
technology (CEHRT). In 2010, the Office
of the National Coordinator for Health
Information Technology (ONC)
launched the Health IT Certification
Program (ONC Health IT Certification
Program) to provide for the certification
of health information technology (IT),
including EHRs. Requirements for
certification are based on standards,
implementation specifications, and
certification criteria adopted by the
Secretary pursuant to section 3004 of
the Public Health Service Act. The ONC
Health IT Certification Program
supports the use of certified health IT
under the programs that we administer,
including, but not limited to, the
Medicare Promoting Interoperability
Program (previously known as the
Medicare and Medicaid EHR Incentive
Programs), the Shared Savings Program,
and the Quality Payment Program,
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which includes the MIPS Promoting
Interoperability performance category
and the Advanced Alternative Payment
Models (Advanced APMs). While these
programs continue to require the use of
CEHRT, the use of certified health IT
has expanded to other government and
non-government programs.
For CY 2019 and subsequent years,
the definitions of CEHRT for the
Promoting Interoperability Programs at
42 CFR 495.4, the Quality Payment
Program at 42 CFR 414.1305, and the
Shared Savings Program at 42 CFR
425.20 require the use of EHR
technology that meets the 2015 Edition
Base EHR definition at 45 CFR 170.102
and is certified to 2015 Edition health
IT certification criteria under the ONC
Health IT Certification Program. In
addition, the CEHRT definitions in our
regulations for these programs require
technology to be certified to certain
specific 2015 Edition health IT
certification criteria, as specified in each
of the definitions, including criteria
necessary to be a meaningful EHR user
under the Medicare Promoting
Interoperability Program, and criteria
necessary to report on applicable
objectives and measures specified under
the MIPS Promoting Interoperability
performance category under the Quality
Payment Program. Prior Editions of
health IT certification criteria were
associated with ‘‘stages’’ of the EHR
Incentive Programs (now the Medicare
Promoting Interoperability Program and
the MIPS Promoting Interoperability
performance category), which linked
new and updated functionality in
certified health IT to significant
revisions to the objectives and measures
in the programs.
In the CY 2021 PFS final rule (85 FR
84815 through 84825), we finalized that
the technology used by health care
providers to satisfy the definitions of
CEHRT at 42 CFR 495.4 and 42 CFR
414.1305 must be certified under the
ONC Health IT Certification Program, in
accordance with the updated 2015
Edition certification criteria (2015
Edition Cures Update), as finalized in
the ONC 21st Century Cures Act:
Interoperability, Information Blocking,
and the ONC Health IT Certification
Program (Cures Act) final rule (85 FR
25642). We further finalized aligning the
transition period during which health
care providers participating in the
Medicare Promoting Interoperability
Program, the MIPS Promoting
Interoperability performance category,
and the Advanced Alternative Payment
Models (Advanced APMs) may use
technology certified to either the
existing or updated 2015 Edition
certification criteria, with the December
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31, 2022 date established in the ONC
interim final rule, Information Blocking
and the ONC Health IT Certification
Program: Extension of Compliance Dates
and Timeframes in Response to the
COVID–19 Public Health Emergency (85
FR 70064), for health IT developers to
make updated certified health IT
available (85 FR 84815 through 84825).
After this date, health care providers
were required to use only certified
technology updated to the 2015 Edition
Cures Update for an EHR reporting
period or performance period in CY
2023.
In the ONC ‘‘Health Data, Technology,
and Interoperability: Certification
Program Updates, Algorithm
Transparency, and Information Sharing’’
proposed rule (88 FR 23746 through
23917) (hereafter referred to as ‘‘ONC
HTI–1 proposed rule’’), which appeared
in the Federal Register on April 18,
2023, ONC has proposed to discontinue
the year themed ‘‘editions,’’ which ONC
first adopted in 2012, to distinguish
between sets of health IT certification
criteria finalized in different rules (88
FR 23758). In the proposed rule, ONC
noted public comments stating that the
continued use and reference to the 2015
Edition inaccurately implies an age and
outdatedness to the certification criteria
ONC has adopted. Given these concerns,
ONC stated that it believes there should
be a single set of certification criteria,
which will be updated in an
incremental fashion in closer alignment
to standards development cycles and
regular health IT development timelines
(88 FR 23750).
ONC further stated its belief that
maintaining a single set of ‘‘ONC
Certification Criteria for Health IT’’
would create more stability for the ONC
Health IT Certification Program and for
Federal partners who reference the ONC
Health IT Certification Program, as well
as make it easier for developers of
certified health IT to maintain their
product certificates over time (88 FR
23759). ONC stated this proposal to
remove ‘‘editions’’ from the ONC Health
IT Certification Program would also
help users of certified health IT identify
which certification criteria are necessary
for their participation in programs, such
as the Medicare Promoting
Interoperability Program, the Shared
Savings Program, and the Quality
Payment Program’s MIPS Promoting
Interoperability performance category
and Advanced APMs (88 FR 23760). For
example, users would only need to
know that their Health IT Module is
certified to 45 CFR 170.315(b)(3),
electronic prescribing, for successful
participation in the MIPS Promoting
Interoperability performance category
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related to electronic prescribing, as
compared to the current state, where
they must also know if the Health IT
Module supports electronic prescribing
as part of the 2014 Edition Certification
Criteria or the 2015 Edition Certification
Criteria, or 2015 Edition Cures Update
Certification Criteria. To implement this
approach, ONC has proposed to rename
all criteria within the ONC Health IT
Certification Program simply as ‘‘ONC
Certification Criteria for Health IT,’’
proposing associated changes to the
regulations at 45 CFR part 170 (88 FR
23759).
Similar to ONC’s proposal to move
away from ‘‘editions’’ and toward
incremental changes to its certification
criteria, we also have focused on
implementing incremental changes to
individual measures under, but not
limited to, the Medicare Promoting
Interoperability Program, the Shared
Savings Program, and the Quality
Payment Program, which includes the
MIPS Promoting Interoperability
performance category and the Advanced
APMs in recent years. We expect to
continue to prioritize incremental
changes in future years to reduce
burden on participants in these
programs (including eligible hospitals
and CAHs and MIPS eligible clinicians),
and build on the established base of
available certified health IT capabilities.
We believe our approach is consistent
with the strategy discussed in the ONC
HTI–1 proposed rule, in which ONC
proposes to pursue a framework for the
ONC Health IT Certification Program
that focuses on incremental updates to
a single set of certification criteria.
2. Updates to the Definition of Certified
Electronic Health Record Technology in
the Medicare Promoting Interoperability
Program and the Quality Payment
Program
a. Background and Previously Finalized
Certification Requirements
In consideration of the updates made
to the 2015 Edition certification criteria
as described in the CY 2021 PFS final
rule (85 FR 84815 through 84828), we
finalized that health care providers
participating in the Medicare Promoting
Interoperability Program and eligible
clinicians participating in the Quality
Payment Program must use certified
health IT that satisfies the definitions of
CEHRT at 42 CFR 495.4 and 42 CFR
414.1305, respectively, and is certified
under the ONC Health IT Certification
Program, in accordance with the 2015
Edition Cures Update certification
criteria, as finalized in the ONC 21st
Century Cures Act final rule (85 FR
25642). We explained this included
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technology used to meet the 2015
Edition Base EHR definition at 45 CFR
170.102, technology certified to the
criteria necessary to be a meaningful
EHR user under the Medicare Promoting
Interoperability Program and the MIPS
Promoting Interoperability performance
category, and technology certified to the
criteria necessary to report on
applicable objectives and measures. In
this proposed rule, we are proposing
revisions to the CEHRT definitions in
the Medicare Promoting Interoperability
Program and the Quality Payment
Program (on which the Shared Savings
Program’s definition of CEHRT at
§ 425.20 also relies) to support the
proposed transition from the historical
state of year themed ‘‘editions’’ to the
‘‘edition-less state’’ in the ONC HTI–1
proposed rule.
We included Table IX.H.–04 in the
Hospital Inpatient Prospective Payment
System for Acute Care Hospitals and the
Long-Term Care Hospital Prospective
Payment System and Fiscal Year 2024
Rates proposed rule (88 FR 27170),
which includes some, but not all,
certification criteria for the Medicare
Promoting Interoperability Program’s
measures and eCQMs for eligible
hospitals and CAHs, and Table 48 in
section IV.A.4.f.(4)(e)(iv) of this
proposed rule, which includes some,
but not all, certification criteria for
measures under the MIPS Promoting
Interoperability performance category.
These tables are only applicable for the
measures under the Medicare Promoting
Interoperability Program and the MIPS
Promoting Interoperability performance
category, and do not include all of the
updated certification criteria included
in the CEHRT definition as discussed in
the CY 2021 PFS proposed rule (85 FR
50265 through 50270). For further
discussion on the complete list of
changes to the certification criteria
under the CEHRT definition, we refer
readers to the ONC 21st Century Cures
Act final rule (85 FR 25667), the CY
2021 PFS proposed rule (85 FR 50265),
and the CY 2021 PFS final rule (85 FR
84818 through 84825).
b. Proposed Revisions to Certified
Electronic Health Record Technology
Definitions in Regulatory Text
We are proposing to revise the
definitions of CEHRT in 42 CFR 495.4
and 42 CFR 414.1305 for the Medicare
Promoting Interoperability Program and
for the Quality Payment Program so
these definitions would be consistent
with the ‘‘edition-less’’ approach to
health IT certification as proposed in
the ONC HT–1 proposed rule, should
the ONC proposal be finalized. First,
with respect to references to the ‘‘2015
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Edition Base EHR definition’’ defined at
45 CFR 170.102, we are proposing to
add a reference to the revised name
‘‘Base EHR definition,’’ proposed in the
ONC HTI–1 proposed rule, to ensure, if
finalized, it is applicable for the CEHRT
definitions going forward (88 FR 23759).
Next, we are proposing to replace our
references to ‘‘2015 Edition health IT
certification criteria,’’ with ‘‘ONC health
IT certification criteria’’ and to add the
regulatory citation for ONC health IT
certification criteria in 45 CFR 170.315.
By removing the reference to the ‘‘2015
Edition,’’ and pointing to the regulations
at 45 CFR 170.315, we believe this
proposal, if finalized, will ensure the
CEHRT definitions do not need to be
updated to reflect modified terminology
unless ONC changes the location of
these certification criteria.
While these proposed revisions would
allow us to maintain more permanent
cross-references to ONC’s regulations
and terminology, we recognize that ONC
has historically updated, and will likely
in the future continue to update over
time, the underlying certification
criteria contained in 45 CFR 170.315.
Previously under the year-themed
‘‘editions’’ construct, we periodically
revised the language in our regulatory
CEHRT definitions to refer to a new
Edition in order to incorporate ONC’s
updates to health IT certification
criteria. Then, in the CY 2021 PFS final
rule (85 FR 84818 through 84825), to
incorporate ONC’s updates to
certification criteria in its 2015 Edition
Cures Update, which ONC finalized
under the ONC 21st Century Cures Act
final rule (85 FR 25642 through 25961),
we did not revise the language of the
CEHRT definitions for the Medicare
Promoting Interoperability Program and
the Quality Payment Program. Instead,
we finalized that technology used to
satisfy the CEHRT definitions must be
certified under the ONC Health IT
Certification Program, in accordance
with the 2015 Edition Cures Update
certification criteria as finalized in the
ONC 21st Century Cures Act final rule.
Consistent with ONC’s proposal to
move away from year-themed
‘‘editions,’’ and in order to further
simplify our regulatory approach, we
are proposing revisions to our
definitions of CEHRT to ensure we
would not necessarily be required to
update our regulatory text each time
ONC proposed or finalized any updates
to its definition of Base EHR or
certification criteria.
This proposal would establish that
any certification criteria adopted or
updated in 45 CFR 170.315 would be
applicable for the CEHRT definitions in
our programs’ regulations at 42 CFR
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495.4 and 42 CFR 414.1305, if ONC’s
applicable regulations are referenced
directly in our CEHRT definitions. If
finalized, this proposal would allow the
CEHRT definitions in our regulations to
automatically incorporate ONC’s
updates to relevant certification criteria
without pursuing additional
rulemaking.
It is important to note that this
proposal, if finalized, would not mean
that any update to a certification
criterion finalized by ONC would
necessarily be immediately required for
use in CEHRT for our Medicare
Promoting Interoperability Program,
Quality Payment Program, and Shared
Savings Program. We remind readers
that ONC sets timelines through their
rulemaking for when health IT
developers must ensure their health IT
products meet ONC’s new or updated
certification criteria to maintain
certification under the ONC Health IT
Certification Program, including time
for health IT developers to implement
these updates for their customers who
may participate in programs that require
use of CEHRT (88 FR 23761). We also
note that CMS will continue to
determine when new or revised versions
of measures that require the use of
certified health IT would be required for
participation under the Medicare
Promoting Interoperability Program and
the Quality Payment Program. In
determining requirements for any
potential new or revised measures, we
will consider factors such as
implementation time and provider
readiness to determine when we
propose requiring participants to
complete measures that require the use
of certified health IT.
We believe this approach would
provide us with more flexibility to
finalize updates and is more consistent
with the incremental approach to
revising measures and technology
requirements described above.
Moreover, this additional flexibility
would allow eligible hospitals, CAHs,
and MIPS eligible clinicians to adopt,
implement, and use ONC’s updated
certification criteria for health IT,
including EHRs, as it becomes available
from their chosen vendor, without the
need to wait for us to first amend the
regulations at 42 CFR 495.4 and 42 CFR
414.1305 through separate rulemaking.
In summary, we are proposing to
revise the definitions of CEHRT for the
Medicare Promoting Interoperability
Program at 42 CFR 495.4, and for the
Quality Payment Program at 42 CFR
414.1305. Specifically, we are proposing
to add a reference to the revised name
of ‘‘Base EHR definition,’’ proposed in
the ONC HTI–1 proposed rule, to
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ensure, if finalized, it is applicable for
the CEHRT definitions going forward
(88 FR 23759). We are also proposing to
replace our references to the ‘‘2015
Edition health IT certification criteria’’
with ‘‘ONC health IT certification
criteria’’ and add the regulatory citation
for ONC health IT certification criteria
in 45 CFR 170.315. We also propose to
specify that technology meeting the
CEHRT definitions must meet ONC’s
certification criteria in 45 CFR 170.315
‘‘as adopted and updated by ONC.’’ We
believe that these revisions to the
CEHRT definitions, if finalized, would
ensure that updates to the definition at
45 CFR 170.102 and updates to
applicable health IT certification criteria
in 45 CFR 170.315 would be
incorporated into the CEHRT
definitions, without additional
regulatory action by CMS.
Finally, we note that while this
proposal is consistent with the approach
in ONC’s HTI–1 proposed rule (88 FR
23746 through 23917), we do not
believe that ONC must finalize its
proposed revisions for us to be able to
finalize the changes proposed in this
section for our regulatory definitions of
CEHRT.
We are inviting public comment on
these proposals.
S. A Social Determinants of Health Risk
Assessment in the Annual Wellness
Visit
Medicare coverage for the Annual
Wellness Visit (AWV) under Part B is
primarily described in statute at section
1861(hhh) of the Act, and in regulation
at 42 CFR 410.15. We propose to
exercise our authority in section
1861(hhh)(2)(I) of the Act to add other
elements to the AWV by adding a new
Social Determinants of Health (SDOH)
Risk Assessment as an optional,
additional element with an additional
payment. The proposed new SDOH Risk
Assessment would enhance patientcentered care and support effective
administration of an AWV. There are no
deductible requirements or Part B
coinsurance for the AWV. See
§§ 410.160(b)(12) and 410.152(l)(13).
Our proposal builds upon our separate
proposal described earlier to establish a
stand-alone G code (GXXX5) for SDOH
Risk Assessment furnished in
conjunction with an Evaluation and
Management (E/M) visit (see section
II.E. of this proposed rule).
1. Background
The AWV includes the establishment
(or update) of the patient’s medical and
family history, application of a health
risk assessment and the establishment
(or update) of a personalized prevention
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plan. The AWV also includes an
optional Advance Care Planning (ACP)
service. The AWV is covered for eligible
beneficiaries who are no longer within
12 months of the effective date of their
first Medicare Part B coverage period
and who have not received either an
Initial Preventive Physical Examination
(IPPE) or AWV within the past 12
months. The goals of AWV are health
promotion, disease prevention and
detection and include education,
counseling, a health risk assessment,
referrals for prevention services, and a
review of opioid use. Additional
information about the AWV is available
on the CMS website at https://
www.cms.gov/Outreach-and-Education/
Medicare-Learning-Network-MLN/
MLNProducts/preventive-services/
medicare-wellness-visits.html.
It is estimated 282 that around 50
percent of an individual’s health is
directly related to SDOH, which is
defined by Healthy People 2030 283 as,
‘‘The conditions in the environment
where people are born, live, work, play,
worship, and age that affect a wide
range of health, functioning, and
quality-of-life outcomes and risks.’’
Healthy People 2030 also defines 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.
These parameters include factors like
housing, food and nutrition access, and
transportation needs. Given the large
impact on health these factors have, the
health care system broadly has been
working to take these factors into
account when providing care and
rendering services.
Several Federal agencies, including
the CDC, AHRQ, ACL, ACF, SAMHSA,
HRSA, and ASPE are developing
policies and implementation
frameworks to better address the impact
SDOH has on patients, in support of
HHS’s Strategic Approach to Addressing
Social Determinants of Health to
Advance Health Equity.284 At CMS,
addressing SDOH is an essential piece
of the CMS Framework for Health
Equity,285 and it is tied in heavily with
the CMS Strategic Pillar to advance
equity. SDOH was also a foundational
concept with the CMS Innovation
Center Accountable Health
282 https://aspe.hhs.gov/sites/default/files/
documents/e2b650cd64cf84aae8ff0fae7474af82/
SDOH-Evidence-Review.pdf.
283 https://health.gov/healthypeople.
284 https://aspe.hhs.gov/sites/default/files/
documents/aabf48cbd391be21e5186eeae728ccd7/
SDOH-Action-Plan-At-a-Glance.pdf.
285 https://www.cms.gov/files/document/cmsframework-health-equity-2022.pdf.
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Communities (AHC) Model that ended
in 2022. Given the importance of and
focus surrounding SDOH and enhancing
equity, CMS is exploring ways to
recognize and quantify practitioner
work currently being done in this area,
and to provide support to enable
practitioners to assess and intervene
when SDOH is relevant to the
assessment, prevention and treatment
plan of a Medicare patient.
CMS tested the AHC Model between
2017 and 2022. One element of the
model test was the development and
application of the AHC Health-Related
Social Needs (HRSN) Screening Tool,
which helps providers to identify
patients’ SDOH related needs, including
housing instability, food insecurity,
family and community support and
mental health. Additional information
on the AHC model is available on the
CMS website at (https://
innovation.cms.gov/innovation-models/
ahcm).
We have heard from many health care
professionals and beneficiary groups
that there are barriers to completing the
AWV, including, but not limited to,
language and communication,
differences in cultural perspectives and
expectations regarding engagement with
the healthcare system. We increasingly
understand the importance that SDOH
be considered in an assessment of
patient histories, patient risk, and in
informing medical decision making,
prevention, diagnosis, care and
treatment.
In February 2018, Health Affairs
published an article titled, ‘‘Practices
Caring for the Underserved Are Less
Likely to Adopt Medicare’s Annual
Wellness Visit,’’ which described
findings from a statistical study of
Medicare primary care providers and
AWV’s from 2011 to 2015. The article
points out, ‘‘One of our most striking
results was that while underserved
patients were less likely to receive an
annual wellness visit regardless of
where they sought care, practices in
rural areas and those caring for
underserved and sicker populations
were less likely to provide such visits to
any of their patients—which suggests
these practices may face resource
constraints or have priorities that
compete with adoption of the visit.’’ 286
In August 2022, the Journal of the
American Geriatrics Society published
an article titled, ‘‘Medicare’s annual
wellness visit: 10 years of opportunities
286 Ganguli I, Souza J, McWilliams JM, Mehrotra
A. Practices Caring For The Underserved Are Less
Likely To Adopt Medicare’s Annual Wellness Visit.
Health Aff (Millwood). 2018 Feb;37(2):283–291.
doi: 10.1377/hlthaff.2017.1130. PMID: 29401035;
PMCID: PMC6080307.
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gained and lost.’’ The article expresses
the concern, ‘‘currently AWVs are a ‘one
size fits all’,’’ approach. This uniform
approach does not sufficiently take into
consideration the medical,
psychological, functional, racial,
cultural and socio-economic diversity of
older adults. Updated AWVs should be
tailored to meet the needs and priorities
of older adults receiving them.’’ It goes
on to recommend, ‘‘Medicare AWVs
should include screening and
counseling for social determinants of
health as a means of mitigating the
growing disparities in health and
longevity for underserved older
adults.’’ 287
2. Statutory and Regulatory Authority
Section 4103 of The Patient Protection
and Affordable Care Act (ACA) (Pub. L.
111–148) expanded Medicare coverage
by adding the AWV benefit at section
1861(hhh) of the Act, effective for
services furnished on or after January 1,
2011. We subsequently implemented
the AWV in CMS regulations at
§ 410.15. The AWV is a wellness visit
that focuses on identification of certain
risk factors, personalized health advice,
and referral for additional preventive
services and lifestyle interventions
(which may or may not be covered by
Medicare). The elements included in the
AWV differ from comprehensive
physical examination protocols with
which some providers may be familiar
since it is a visit that is specifically
designed to provide personalized
prevention plan services as defined in
the Act. The AWV includes a health risk
assessment (HRA) and the AWV takes
into account the results of the HRA. The
AWV is covered for eligible
beneficiaries who are no longer within
12 months of the effective date of their
first Medicare Part B coverage period
and who have not received either an
IPPE or AWV within the past 12
months. Section 1861(hhh)(2) of the Act
describes a number of elements
included in the AWV and section
1861(hhh)(2)(I) of the Act authorizes the
addition of any other element
determined appropriate by the
Secretary.
We note that § 410.15(a) requires that
the first AWV include the following:
• Review (and administration if
needed) of a health risk assessment (as
defined in § 410.15).
• Establishment of an individual’s
medical and family history.
287 Coll PP, Batsis JA, Friedman SM, Flaherty E.
Medicare’s annual wellness visit: 10 years of
opportunities gained and lost. J Am Geriatr Soc.
2022 Oct;70(10):2786–2792. doi: 10.1111/jgs.18007.
Epub 2022 Aug 17. PMID: 35978538.
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• Establishment of a list of current
providers and suppliers that are
regularly involved in providing medical
care to the individual.
• Measurement of an individual’s
height, weight, body-mass index (or
waist circumference, if appropriate),
blood pressure, and other routine
measurements as deemed appropriate,
based on the beneficiary’s medical and
family history.
• Detection of any cognitive
impairment that the individual may
have, as that term is defined in § 410.15.
• Review of the individual’s potential
(risk factors) for depression, including
current or past experiences with
depression or other mood disorders,
based on the use of an appropriate
screening instrument for persons
without a current diagnosis of
depression, which the health
professional may select from various
available standardized screening tests
designed for this purpose and
recognized by national medical
professional organizations.
• Review of the individual’s
functional ability and level of safety,
based on direct observation or the use
of appropriate screening questions or a
screening questionnaire, which the
health professional as defined in
§ 410.15 may select from various
available screening questions or
standardized questionnaires designed
for this purpose and recognized by
national professional medical
organizations.
• Establishment of the following:
++ A written screening schedule for
the individual such as a checklist for the
next 5 to 10 years, as appropriate, based
on recommendations of the United
States Preventive Services Task Force
(USPSTF) and the Advisory Committee
on Immunization Practices, and the
individual’s health risk assessment (as
that term is defined in § 410.15), health
status, screening history, and ageappropriate preventive services covered
by Medicare.
++ A list of risk factors and conditions
for which primary, secondary or tertiary
interventions are recommended or are
underway for the individual, including
any mental health conditions or any
such risk factors or conditions that have
been identified through an IPPE (as
described under § 410.16), and a list of
treatment options and their associated
risks and benefits.
++ Furnishing of personalized health
advice to the individual and a referral,
as appropriate, to health education or
preventive counseling services or
programs aimed at reducing identified
risk factors and improving selfmanagement, or community-based
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lifestyle interventions to reduce health
risks and promote self-management and
wellness, including weight loss,
physical activity, smoking cessation, fall
prevention, and nutrition.
++ At the discretion of the
beneficiary, furnish advance care
planning services to include discussion
about future care decisions that may
need to be made, how the beneficiary
can let others know about care
preferences, and explanation of advance
directives which may involve the
completion of standard forms.
++ Furnishing of a review of any
current opioid prescriptions as that term
is defined in this section.
++ Screening for potential substance
use disorders including a review of the
individual’s potential risk factors for
substance use disorder and referral for
treatment as appropriate.
++ Any other element determined
appropriate through the national
coverage determination process.
We note that § 410.15(a) requires that
a subsequent AWVs include the
following:
• Review (and administration, if
needed) of an updated health risk
assessment (as defined in § 410.15).
• An update of the individual’s
medical and family history.
• An update of the list of current
providers and suppliers that are
regularly involved in providing medical
care to the individual as that list was
developed for the first AWV providing
personalized prevention plan services or
the previous subsequent AWV
providing personalized prevention plan
services.
• Measurement of an individual’s
weight (or waist circumference), blood
pressure and other routine
measurements as deemed appropriate,
based on the individual’s medical and
family history.
• Detection of any cognitive
impairment that the individual may
have, as that term is defined in § 410.15.
• An update to the following:
++ The written screening schedule for
the individual as that schedule is
defined in paragraph (a) of § 410.15 for
the first AWV providing personalized
prevention plan services.
++ The list of risk factors and
conditions for which primary,
secondary or tertiary interventions are
recommended or are underway for the
individual as that list was developed at
the first AWV providing personalized
prevention plan services or the previous
subsequent AWV providing
personalized prevention plan services.
++ Furnishing of personalized health
advice to the individual and a referral,
as appropriate, to health education or
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preventive counseling services or
programs as that advice and related
services are defined in paragraph (a) of
§ 410.15.
++ At the discretion of the
beneficiary, furnish advance care
planning services to include discussion
about future care decisions that may
need to be made, how the beneficiary
can let others know about care
preferences, and explanation of advance
directives which may involve the
completion of standard forms.
++ Furnishing of a review of any
current opioid prescriptions as that term
is defined in this section.
++ Screening for potential substance
use disorders including a review of the
individual’s potential risk factors for
substance use disorder and referral for
treatment as appropriate.
++ Any other element determined
appropriate through the national
coverage determination process.
In the CY 2016 PFS final rule (80 FR
70885), we finalized a proposal to
include ACP as an optional element (at
beneficiary discretion) within the AWV.
We stated in the final rule we are adding
ACP as a voluntary, separately payable
element of the AWV. We are instructing
that when ACP is furnished as an
optional element of AWV as part of the
same visit with the same date of service,
CPT codes 99497 and 99498 should be
reported and will be payable in full in
addition to payment that is made for the
AWV under HCPCS code G0438 or
G0439, when the parameters for billing
those CPT codes are separately met,
including requirements for the duration
of the ACP services. Under these
circumstances, ACP should be reported
with modifier -33 and there will be no
Part B coinsurance or deductible,
consistent with the AWV (80 FR 70958).
We also added this policy to the
regulatory text at § 410.15(a).
3. Proposal
We propose to exercise our authority
in section 1861(hhh)(2)(I) of the Act to
add elements to the AWV by adding a
new SDOH Risk Assessment as an
optional, additional element of the
AWV with an additional payment. We
recognize that, for some patients,
identification and consideration of
SDOH is critical to furnishing a fully
informed health assessment and
personalized prevention plan in the
AWV. We have heard from interested
parties that the current elements of the
AWV may not directly or adequately
identify those SDOH challenges. We
propose that the SDOH Risk Assessment
be separately payable with no
beneficiary cost sharing when furnished
as part of the same visit with the same
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date of service as the AWV. We propose
that the SDOH Risk Assessment service
include the administration of a
standardized, evidence-based SDOH
risk assessment tool, furnished in a
manner that all communication with the
patient be appropriate for the patient’s
educational, developmental, and health
literacy level, and be culturally and
linguistically appropriate. We believe
that services that are culturally and
linguistically appropriate are critical to
providing effective, equitable,
understandable, and respectful quality
care that are responsive to diverse
cultural health beliefs and practices,
preferred languages, health literacy, and
other communication needs of each
patient. We recognize that patients with
SDOH risks and challenges may often
also experience communication barriers
of various kinds when interacting with
the health care system. We believe that
the SDOH Risk Assessment would only
be effective in informing the greater
AWV (including the health assessment
and personalized prevention plan) when
furnished in a manner that is intelligible
and appropriate to the individualized
characteristics and circumstances of the
patient. Additional information on
culturally and linguistically appropriate
services in healthcare can be found at
(https://thinkculturalhealth.hhs.gov/
clas). We believe the SDOH Risk
Assessment Tool would be most
effective and actionable when furnished
in a setting with staff-assisted supports
in place to ensure follow-up for healthrelated social needs associated to the
visit. We also encourage partnerships
with community-based organizations
such as Area Agencies on Aging to help
address identified social needs. We
propose that the SDOH Risk Assessment
be furnished as part of the same visit
and on the same date of service as the
AWV, so as to inform the care the
patient is receiving during the visit,
including taking a medical and social
history, applying health assessments
and prevention services education and
planning. We believe our proposal will
directly reduce barriers, expand access,
promote health equity and improve care
for populations that have historically
been underserved by recognizing the
importance that SDOH be considered
and assessed, where appropriate, in
support of the existing AWV. In
addition, we hope that our proposal will
help spread general awareness among
health professionals about the
importance of providing cultural and
linguistically appropriate services,
which in turn will encourage clinicians
to adopt language services and
technologies to achieve high quality
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communication between the
practitioner and patient. Our goal is the
development of a personalized
prevention plan that takes SDOH into
account and is truly tailored to the
individual patient. We invite public
comment on our proposal, including
whether a SDOH Risk Assessment
would ultimately inform and result in
the development of steps to address and
integrate SDOH in the patient’s AWV
health assessment and personalized
prevention plan.
We recognize that SDOH risk
assessments are an emerging and
evolving tool in healthcare and so we do
not restrict our proposal to a specific list
of approved assessments. In selecting an
evidence-based tool, we encourage
clinicians to explore the many widely
adopted and validated tools available,
including the CMS Accountable Health
Communities 288 tool, the Protocol for
Responding to & Assessing Patients’
Assets, Risks & Experiences (PRAPARE)
tool,289 and instruments identified for
Medicare Advantage Special Needs
Population Health Risk Assessment.290
We also encourage clinicians, where
feasible, to select screening instruments
that maximize opportunities to collect
and analyze standardized, quantifiable,
and actionable data. For instance,
clinicians are encouraged to utilize
screening instruments where questions
and responses are computable and
mapped to health IT vocabulary
standards (that is, have available
LOINC® coding terminology), to ensure
that data captured through assessments
is interoperable and can be shared,
analyzed and evaluated across the care
continuum.
Our proposal builds upon our
separate proposal described earlier to
establish a stand-alone G code (GXXX5)
for SDOH Risk Assessment furnished in
conjunction with an E/M visit. See
section II.E. for additional information
on coding, pricing, and additional
conditions of payment for the proposed
new SDOH Risk Assessment service.
Upon finalization of the CY 2024 PFS,
CMS will issue public guidance in the
Medicare Learning Network, the
Medicare & You Handbook, and more
formal, in-depth policy and payment
instructions in the Medicare Benefit
Policy Manual and the Medicare Claims
Processing Manual on the CMS website.
Over the past several years, we have
worked to develop payment
mechanisms under the PFS to improve
288 https://innovation.cms.gov/files/worksheets/
ahcm-screeningtool.pdf.
289 https://www.nachc.org/research-and-data/
prapare/.
290 CMS–10825.
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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 by
recommending the assessment of SDOH
through position or discussion
papers,291 292 293 organizational strategic
plans,294 and provider training
modules,295 among others. As described
earlier in our proposed rule, we have
discussed how the practice of medicine
currently includes assessment of healthrelated 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
performed by physicians and other
health professionals in support of
patient-centered care to better
understand and help address relevant
problems that are impacting medically
necessary care. Practitioners are
expending resources to obtain
information from the patient about
health-related social needs, and to
formulate diagnosis and treatment plans
that take these needs into account as
part of a person-centered care plan for
the treatment of medical problems. This
work currently is reported and paid for,
in part, under the PFS under E/M visit
codes, and we believe as such, is
undervalued and not optimized to allow
the health professional and patient to
benefit from the full value of a
dedicated SDOH assessment and have
that assessment immediately inform the
health assessment and prevention
planning services in the AWV.
We propose that Medicare would pay
100 percent of the fee schedule amount
for the SDOH Risk Assessment service
(beneficiary cost sharing would not be
applicable) when this risk assessment is
furnished to a Medicare beneficiary as
an optional element within an AWV (as
part of the same visit with the same date
of service as the AWV). Our proposal is
291 https://www.aafp.org/about/policies/all/
social-determinants-health-family-medicineposition-paper.html.
292 https://doi.org/10.7326/M17–2441.
293 https://nam.edu/social-determinants-ofhealth-201-for-health-care-plan-do-study-act/.
294 https://www.ama-assn.org/system/files/2021–
05/ama-equity-strategic-plan.pdf.
295 https://edhub.ama-assn.org/steps-forward/
module/2702762.
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analogous to our current approach to the
ACP service, which is an optional
service for which beneficiary cost
sharing is not applicable when
furnished as part of the same visit and
on the same date of service as the AWV.
Beneficiary cost sharing is not
applicable to the AWV and, because the
SDOH Risk Assessment would be an
optional element within the AWV, there
would not be any beneficiary cost
sharing for the SDOH Risk Assessment
either. See §§ 410.160(b)(12) and
410.152(l)(13). We note that beneficiary
cost sharing would apply to the SDOH
Risk Assessment if furnished in
conjunction with another service
(outside of the AWV) that is subject to
beneficiary cost sharing. We are
proposing that the SDOH Risk
Assessment would be optional for both
the health professional and the
beneficiary to empower clinicians and
patients to employ this assessment only
when appropriate and desired.
We propose to add regulatory text at
§ 410.15 that will include the new
SDOH Risk Assessment service as an
optional element within the AWV, at
the discretion of the health professional
and beneficiary. Furthermore, we
propose to add regulatory text that the
SDOH Risk Assessment be standardized,
evidence-based, and furnished in a
manner that all communication with the
patient be appropriate for the
beneficiary’s educational,
developmental, and health literacy
level, and be culturally and
linguistically appropriate. We invite
public comment on our proposal.
We have also received feedback from
interested parties that the AWV may be
more effectively furnished if elements
were allowed to be completed over
multiple visits and days, or prior to the
AWV visit. We invite public comment
on this issue for consideration in future
rulemaking.
4. Summary
In conclusion, we are proposing to
add a new Social Determinants of
Health (SDOH) Risk Assessment as an
optional element within the AWV. We
are also proposing the SDOH Risk
Assessment be paid at 100 percent of
the fee schedule amount of the risk
assessment. We are proposing that the
new SDOH Risk Assessment be
separately payable with no beneficiary
cost sharing when furnished as part of
the same visit with the same date of
service as the AWV. We believe our
proposal will directly reduce barriers,
expand access, promote health equity
and improve care for populations that
have historically been underserved by
recognizing the importance that SDOH
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be considered and assessed, where
appropriate, as an additional, optional
element in the AWV service.
IV. Updates to the Quality Payment
Program
A. CY 2024 Modifications to the Quality
Payment Program
1. Executive Summary
a. Overview
This section of the proposed rule sets
forth changes to the Quality Payment
Program starting January 1, 2024, except
as otherwise noted for specific
provisions. We continue to move the
Quality Payment Program forward,
including focusing more on our
measurement efforts and refining how
clinicians would be able to participate
in a more meaningful way, to achieve
continuous improvement in the quality
of health care services provided to
Medicare beneficiaries and other
patients through the Quality Payment
Program’s Merit-based Incentive
Payment System (MIPS) and Advanced
Alternative Payment Models (APMs) for
the CY 2024 performance period/2026
MIPS payment year.
Authorized by the Medicare Access
and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114–10, April 16,
2015), the Quality Payment Program is
a payment incentive program, by which
the Medicare program rewards
clinicians who provide high-value,
high-quality services in a cost-efficient
manner. The Quality Payment Program
includes two participation tracks for
clinicians providing services under the
Medicare program: MIPS and Advanced
APMs. The statutory requirements for
the Quality Payment Program are set
forth in section 1848(q) and (r) of the
Act for MIPS and section 1833(z) of the
Act for Advanced APMs.
For the MIPS participation track,
MIPS eligible clinicians (defined in 42
CFR at 414.1305) are subject to a MIPS
payment adjustment (positive, negative,
or neutral) based on their performance
in four performance categories: cost,
quality, improvement activities, and
Promoting Interoperability. We assess
each MIPS eligible clinician’s total
performance according to our
established performance standards with
respect to the applicable measures and
activities specified in each of these four
performance categories during a
performance period to compute a final
composite performance score (a ‘‘final
score’’ as defined at § 414.1305). In
calculating the final score, we must
apply different weights for the four
performance categories, subject to
certain exceptions, as set forth in
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section 1848(q)(5) of the Act and at
§ 414.1380. Unless we assign a different
scoring weight pursuant to these
exceptions, for CY 2024 performance
period/2026 MIPS payment year, the
scoring weights are as follows: 30
percent for the quality performance
category; 30 percent for the cost
performance category; 15 percent for the
improvement activities performance
category; and 25 percent for the
Promoting Interoperability performance
category.
Once calculated, each MIPS eligible
clinician’s final score is compared to the
performance threshold we have
established in prior rulemaking for that
performance period to calculate the
MIPS payment adjustment factor as
specified in section 1848(q)(6) of the
Act, such that the MIPS eligible
clinician will receive in the applicable
MIPS payment year: (1) a positive
adjustment, if their final score exceeds
the performance threshold; (2) a neutral
adjustment, if their final score meets the
performance threshold; or (3) a negative
adjustment, if their final score is below
the performance threshold. The actual
amount paid to the MIPS eligible
clinician in MIPS payment year, once
the MIPS payment adjustment factor is
applied, is subject to further
calculations such as application of the
scaling factor and budget neutrality
requirements, as further specified in
section 1848(q)(6) of the Act.
Section 1848(q) of the Act sets forth
other requirements applicable to MIPS,
including opportunities for feedback
and targeted review and public
reporting of MIPS eligible clinicians’
performance. Section 1848(r) of the Act
sets forth more specific requirements for
development of measures for the cost
performance category under MIPS.
If an eligible clinician participates in
an Advanced APM and achieves
Qualifying APM Participant (QP) or
Partial QP status, they are excluded
from the MIPS reporting requirements
and payment adjustment (though
eligible clinicians who are Partial QPs
may elect to be subject to the MIPS
reporting requirements and payment
adjustment). Eligible clinicians who are
QPs for the 2023 performance year
receive a 3.5 percent APM Incentive
Payment in the 2025 payment year, and,
beginning with the 2024 performance
year (payment year 2026), a higher PFS
payment rate (calculated using the
differentially higher ‘‘qualifying APM
conversion factor’’) than non-QPs. QPs
will continue to be excluded from MIPS
reporting and payment adjustments for
the applicable year.
As we move into the seventh year of
the Quality Payment Program, we are
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proposing the updates set forth in this
section of this proposed rule,
encouraging continued improvement in
clinicians’ performance with each
performance year and drive improved
quality of health care through payment
policy.
In developing and putting forth these
proposals, we intend to continue our
efforts to align the Quality Payment
Program with broader CMS initiatives,
such as the establishment of the
Universal Foundation (https://
www.nejm.org/doi/full/10.1056/
NEJMp2215539) and the CMS National
Quality Strategy (https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/
QualityInitiativesGenInfo/LegacyQuality-Strategy). These initiatives
unify strategic efforts across our
programs, including the Quality
Payment Program, to adopt measures
most critical to providing high quality
care and accelerate strategic
improvements for quality programs and
measures.
The vision for the CMS National
Quality Strategy is to shape a resilient,
high-value American health care system
to achieve high-quality, safe, equitable,
and accessible care for all. This strategy
aims to promote the highest quality
outcomes and safest care for all
individuals. It also focuses on a personcentered approach as individuals
journey across the continuum of care,
care settings, and across payer types.
The goals of this strategy incorporate
lessons learned from the COVID–19
public health emergency (PHE) to
inform both short and long-term
direction for our health care system.
The Universal Foundation moves
toward a building-block approach to
advance the overall vision of the
National Quality Strategy and increase
alignment across CMS quality programs
by capturing measures that are
meaningful, broadly applicable, and
capable of being digitally reported and
stratified, in order to identify and track
disparities over time. The Universal
Foundation seeks to improve health
outcomes, reduce provider burden,
improve standardization of
measurement, and promote
interoperability by prioritizing measures
to transition to interoperable digital
data.
The implementation of MIPS Value
Pathways (MVPs) aligns with many of
the objectives and goals the CMS
National Quality Strategy and the
Universal Foundation strive to achieve.
For example, in an effort to align
implementation of the measures in the
Universal Foundation across MIPS and
APMs, we are proposing updates to
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consolidate the Promoting Wellness and
Managing Chronic Conditions MVPs to
align with the adult Universal
Foundation measure set. We are also
exploring the expansion of the APM
Performance Pathway (APP) reported by
clinicians in the Shared Savings
Program and Advanced APMs to
include the primary care universal
measure set in the future. In our
continued strategy to incentivize
improved equity as well as advancing
value, in Performance Year 2023 the
Shared Savings Program will implement
an upside-only adjustment to reward
ACOs that provide excellent care for
underserved populations (87 FR 69838
through 69857). In our goal to accelerate
interoperability, we propose to require
Shared Savings Program ACO clinicians
to report the measures and objectives
required by the MIPS Promoting
Interoperability performance category.
We are also proposing to modify our
CEHRT use criterion for Advanced
APMs to promote flexibility in adopting
CEHRT that is clinically relevant to
participants, emphasizing the
importance of interoperability and
health information technology.
Moreover, we propose to expand our
portfolio of available MVPs for the CY
2024 performance period and remain
committed to our goal of ensuring more
meaningful participation in the Quality
Payment Program through MVPs.
b. Summary of Major Provisions
(1) Transforming the Quality Payment
Program
The CMS National Quality Strategy
addresses the urgent need for
transformative action to advance
towards a more equitable, safe, and
outcomes-based health care system for
all individuals. This vision is supported
by the alignment of policies and quality
measures in MIPS and APMs within the
Quality Payment Program. Priorities for
the Quality Payment Program include:
achieving more equitable outcomes;
utilizing clinically relevant measures for
specialty performance that inform
clinicians and beneficiaries; enhancing
quality, patient safety, and efficiency
through use of certified EHR technology
(CEHRT); reducing burden and
simplifying quality performance
reporting; articulating meaningful
outcomes, promoting alignment where
possible, and moving to all digital
reporting.
The Quality Payment Program allows
eligible clinicians to engage in patientcentered care via two tracks: the MeritBased Incentive Program (MIPS) and
APMs. We believe the Quality Payment
Program should continuously support
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the measurement and improvement of
specialty and primary care. To this end,
we are implementing MVPs to allow
clinicians to report on measures that are
directly relevant to their clinical
practice. MVPs provide more clinically
relevant performance measurement,
engage more specialists in performance
measurement, and reduce barriers to
APM participation. CMS has recently
laid out multiple steps intended to
fulfill the potential of APMs. The CMS
Innovation Center strategy refresh
acknowledges that whole person care
requires the depth and scope of services
that includes both primary and specialty
care and aims to provide ACOs with
tools to better engage specialists, test
ways to better link primary and
specialty care upstream in the patient
journey, and further movement into
value-based care.296
(2) Major MIPS Provisions
We are requesting comment on how
the Quality Payment Program can
facilitate continuous improvement of
Medicare beneficiaries’ healthcare and
best build on existing CMS Innovation
Center model policies and Medicare
programs, such as the Medicare Shared
Savings Program. We are seeking
feedback on how we might modify our
policies, requirements, and performance
standards to encourage clinicians to
continuously improve the quality of
care, particularly for clinicians with
little room for improvement in MIPS.
(a) MIPS Value Pathways Development
and Maintenance
In an effort to promote high-quality,
safe, and equitable care and to
implement the vision outlined in the
CMS National Quality Strategy, we are
proposing five new MVPs around the
topics of: Women’s Health; Infectious
Disease, Including Hepatitis C and HIV;
Mental Health and Substance Use
Disorder; Quality Care for Ear, Nose,
and Throat (ENT); and Rehabilitative
Support for Musculoskeletal Care. In
addition, we are proposing MVP
maintenance updates to our MVP
inventory that are in alignment with the
MVP development criteria, and in
consideration of the feedback from
interested parties we have received
through the maintenance process.
(b) Subgroup Reporting
We are proposing to codify previously
finalized subgroup policies in the
preamble to regulation text.
Additionally, we are proposing updates
296 CMMI Strategy Refresh. October 20, 2021.
https://innovation.cms.gov/strategic-directionwhitepaper.
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to previously finalized subgroup
policies to help guide clinicians and
groups to meaningfully participate in
MVPs through subgroup reporting.
Specifically, we are proposing to update
the subgroup policy for reweighting of
MVP performance categories, update the
facility-based scoring as well as the
complex patient bonus for subgroups
under final score calculation, and add
subgroups to the targeted review
regulation text.
(c) MIPS Performance Category
Measures and Activities
(i) Quality Performance Category
We are proposing six modifications to
the quality performance category. First,
we propose to expand the definition of
the collection type to include Medicare
Clinical Quality Measures for
Accountable Care Organizations
Participating in the Medicare Shared
Savings Program (Medicare CQMs).
Second, we propose to establish the
quality performance category data
submission criteria for eCQMs that
requires the utilization of CEHRT.
Third, we propose to establish the data
submission criteria for Medicare CQMs.
Fourth, we propose to require the
administration of the Consumer
Assessment of Healthcare Providers and
Systems (CAHPS) for MIPS Survey in
the Spanish translation. Fifth, we
propose to maintain the data
completeness criteria threshold to at
least 75 percent for the CY 2026
performance period/2028 MIPS
payment year, and increase the data
completeness criteria threshold to at
least 80 percent for the CY 2027
performance period/2029 MIPS
payment year. Sixth, we propose to
establish the data completeness criteria
for Medicare CQMs. Finally, we propose
to establish a measure set inventory of
200 MIPS quality measures.
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(ii) Cost Performance Category
We are proposing to add five new
episode-based measures to the cost
performance category beginning with
the CY 2024 performance period/2026
MIPS payment year. These five
proposed measures are Depression,
Emergency Medicine, Heart Failure,
Low Back Pain, and Psychoses and
Related conditions; several of these have
relevance to the CMS Behavioral Health
Strategy (https://www.cms.gov/cmsbehavioral-health-strategy). We are
proposing to use a 20-episode case
minimum for each of these new
measures, and are requesting comments
on our clarification of the indented
interpretation of the language on the
case minimums codified at
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§ 414.1350(c). We are also proposing to
remove the Simple Pneumonia with
Hospitalization episode-based measure
beginning with the CY 2024
performance period/2026 MIPS
payment year. Finally, we are proposing
to update the operational list of care
episode and patient condition groups
and codes to add all five new measures
and remove the Simple Pneumonia with
Hospitalization episode-based measure
from the operational list of care episode
and patient condition groups and codes.
(iii) Improvement Activities
Performance Category
We are proposing to add five new,
modify one existing, and remove three
existing improvement activities from the
Inventory. The new and modified
activities help fill gaps we have
identified in the Inventory as well as
seek to ensure that activities reflect
current clinical practice across the
category. Four of the new activities
being proposed relate to CMS Health
Equity, Increase All Forms of
Accessibility to Health Care Services
and Coverage. We are also
recommending the removal of three
activities, both to align with current
clinical guidelines and practice as well
as to eliminate duplication, so that the
Inventory offers flexibility and choice
without potentially causing burden with
too many activities to choose from.
(iv) Promoting Interoperability
Performance Category
We are proposing five policy
modifications for the Promoting
Interoperability performance category.
Specifically, we propose to: (1) lengthen
the performance period for this category
from 90 days to 180 days; (2) modify
one of the exclusions for the Query of
Prescription Drug Monitoring Program
(PDMP) measure; (3) provide a technical
update to the e-Prescribing measure’s
description to ensure it clearly reflects
our previously finalized policy; (4)
modify the Safety Assurance Factors for
Electronic Health Record Resilience
(SAFER) Guide measure to require MIPS
eligible clinicians to affirmatively attest
to completion of the self-assessment of
their implementation of safety practices;
and (5) continue to reweight this
performance category at zero percent for
clinical social workers for the CY 2024
performance period/2026 MIPS
payment year. In section III.R.2.b. of this
proposed rule, we are proposing to
revise our regulatory definition of
CEHRT for the Promoting
Interoperability performance category to
be more flexible in reflecting any
changes the Office of the National
Coordinator for Health Information
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Technology (ONC) may make to its Base
EHR definition, certification criteria,
and other standards for health
information technology.
(d) MIPS Final Scoring Methodology
(i) Performance Category Scores
We are proposing updates to our
scoring flexibilities policy. We are
proposing to update the criteria by
which we assess the scoring impacts of
coding changes and apply our scoring
flexibilities. We are also proposing that
eCQM measure specifications would be
required to include the ability to be
truncated to a 9-month performance
period.
(ii) Cost Improvement Scoring
We are proposing two modifications
to the cost improvement scoring method
that was established in the CY 2018
Quality Payment Program final rule.
First, we are proposing to change
improvement scoring from a measurelevel to a category-level method and to
remove the statistical significance
requirement. Second, we are proposing
that the maximum cost improvement
score is zero percentage points for the
2020 through 2024 MIPS payment years,
and one percentage point beginning
with the CY 2023 performance period/
2025 MIPS payment year.
(e) MIPS Payment Adjustments
We are proposing to revise our policy
for identifying the ‘‘prior period’’ by
which we will establish the
performance threshold beginning with
the CY 2024 performance period/2026
MIPS payment year. Specifically, we are
proposing to define the ‘‘prior period’’
by which we establish the performance
threshold as three performance periods,
instead of a single prior performance
period, and codify this policy at
§ 414.1405(g)(2). To determine the
performance threshold for the CY 2024
performance period/2026 MIPS
payment year, we are proposing to use
the CY 2017/2019 MIPS payment year
through CY 2019 performance period/
2021 MIPS payment year as the prior
period. Based on the mean final score
from that prior period, we are proposing
to establish the performance threshold
as 82 points for the CY 2024
performance period/2026 MIPS
payment year.
(f) MIPS Targeted Review
We are proposing to add virtual
groups and subgroups as being eligible
to submit a request for targeted review.
We are proposing to codify this addition
at § 414.1385(a).
We are proposing to amend at
§ 414.1385(a)(2) with respect to the
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timeline for MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM entities to request a targeted
review of our calculation of their MIPS
payment adjustment factor(s).
Specifically, we are proposing to permit
submission of a request for targeted
review beginning on the day we make
available the MIPS final score and
ending 30 days after publication of the
MIPS payment adjustment factors for
the MIPS payment year. This proposal
would modify the current time period to
submit a request for targeted review,
which is 60 days beginning on the day
that CMS makes available the MIPS
payment adjustment factors for the
MIPS payment year.
We also are proposing to amend
§ 414.1385(a)(5). Specifically, we are
proposing to require that, if CMS
requests additional information under
the targeted review process, then that
additional information must be
provided to and received by CMS
within 15 days of receipt of such
request. This proposal would modify
the current timeline to respond to CMS’
request set forth at § 414.1385(a)(5),
which is within 30 days of receipt of
such request.
(g) Third Party Intermediaries
In this proposed rule, in addition to
codifying previously finalized policies
and proposing to make technical
updates for clarity, we propose to: (1)
Add requirements for third party
intermediaries to obtain documentation
of their authority to submit on behalf of
a MIPS eligible clinician; (2) Specify the
use of a simplified self-nomination
process for existing QCDRs and
qualified registries; (3) Add
requirements for QCDRs and qualified
registries to provide measure numbers
and identifiers for performance
categories; (4) Add a requirement for
QCDRs and qualified registries to attest
that the information contained in the
qualified posting about them is correct;
(5) Modify requirements for QCDRs and
qualified registries to support MVP
reporting to increase flexibility for
measures supported; (6) Specify
requirements for a transition plan for
QCDRs and qualified registries
withdrawing from the program; (7)
Specify requirements for data validation
audits; (8) Add additional criteria for
rejecting QCDR measures; (9) Add a
requirement for QCDR measure
specifications to be displayed
throughout the performance period and
data submission period; (10) Eliminate
the Health IT vendor category; (11) Add
failure to maintain updated contact
information as criteria for remedial
action; (12) Revise corrective action
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plan requirements; (13) Specify the
process for publicly posting remedial
action; and (14) Specify the criteria for
audits.
(h) Public Reporting on Compare Tools
In an effort to expand the information
available to patients and caregivers
when choosing a doctor or clinician, we
are proposing to modify the existing
policy for public reporting on
individual clinician and group profile
pages, including proposals to revise:
• The telehealth indicator, such that,
we would use the most recent CMS
coding policies at the time the
information is updated to identify the
telehealth services provided on
clinician profile pages instead of only
using specific Place of Service (POS)
and claims modifier codes.
• Utilization data, such that we have
additional procedure code grouping
flexibility; can address procedure
volume limitations and provide a more
complete scope of a clinician’s
experience by adding Medicare
Advantage (MA) data to procedure
counts; and align the data in the
Provider Data Catalog (PDC) with the
procedural groupings shown on profile
pages.
Additionally, we solicit feedback from
interested parties through a request for
information on ways to publicly report
data submitted on measures under the
MIPS cost performance category on the
Compare tool.
(3) Major APM Provisions
(a) APM Performance Pathway
In section IV.A.4.e. of this proposed
rule, we are proposing to include the
Medicare Clinical Quality Measure
(Medicare CQM) for Accountable Care
Organizations Participating in the
Medicare Shared Savings Program
collection type in the APM Performance
Pathway (APP) measure set.
(b) Overview of the APM Incentive
In section IV.A.4.m. of this proposed
rule, we are proposing to end the use of
APM Entity-level QP determinations
and instead make all QP determinations
at the individual eligible clinician level.
We are also proposing to modify the
‘‘sixth criterion’’ under the definition of
‘‘attribution-eligible beneficiary,’’ which
is listed at § 414.1305.297 Specifically,
297 Currently, there are six criteria required for a
beneficiary to be an ‘‘attribution-eligible
beneficiary’’ during the QP Performance Period,
which can be found at § 414.1305. The sixth
criterion provides that an ‘‘attribution-eligible
beneficiary’’ must have ‘‘a minimum of one claim
for evaluation and management services furnished
by an eligible clinician who is in the APM Entity
for any period during the QP Performance Period
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we are proposing to include any
beneficiary who has received a covered
professional service furnished by the
NPI for the purpose of making QP
determinations. We are also proposing
to amend § 414.1430 to reflect the
statutory QP and Partial QP threshold
percentages for both the payment
amount and patient count methods
under the Medicare Option and the AllPayer Option with respect to payment
year 2025 (performance year 2023) in
accordance with amendments made by
the CAA, 2023. Relatedly, we are
proposing to amend § 414.1450 to reflect
the statutory APM Incentive Payment
amount for the 2025 payment year
(performance year 2023) of 3.5 percent
of the eligible clinician’s estimated
aggregate payments for covered
professional services in accordance with
amendments made by the CAA, 2023. In
section IV.A.4.j. of this proposed rule,
we are proposing to amend § 414.1385
to adjust the Targeted Review period to
address operational challenges that have
arisen ahead of the required transition
beginning for payment year 2026
(performance year 2024) from the APM
Incentive Payment to the higher PFS
payment rate for QPs (calculated using
the differentially higher ‘‘qualifying
APM conversion factor).
(c) Advanced APMs
In section IV.A.4.n. of this proposed
rule, we are proposing to modify the
CEHRT use criterion for Advanced
APMs to provide greater flexibility for
APMs to tailor CEHRT use requirements
to the APM and its participants. We are
proposing to amend the CEHRT use
criterion for Advanced APMs at
§ 414.1415(a)(1)(i) effective beginning
for CY 2024 to no longer apply the 75
percent CEHRT use minimum, and to
instead specify that the APM must
require all APM participants to use
CEHRT as defined in a proposed revised
definition of CEHRT under § 414.1305.
We are also proposing to amend the
Other-Payer Advanced APM CEHRT use
criterion at § 414.1420(b) to conform to
the proposed changes at
§ 414.1415(a)(1)(i).
or, for an Advanced APM that does not base
attribution on evaluation and management services
and for which attributed beneficiaries are not a
subset of the attribution-eligible beneficiary
population based on the requirement to have at
least one claim for evaluation and management
services furnished by an eligible clinician who is
in the APM Entity for any period during the QP
Performance Period, the attribution basis
determined by CMS based upon the methodology
the Advanced APM uses for attribution, which may
include a combination of evaluation and
management and/or other services.’’
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2. Definitions
At § 414.1305, we are proposing to
revise the definitions of the following
terms:
• Attribution-eligible beneficiary;
• Certified Electronic Health Record
Technology (CEHRT); and
• Collection type.
• Qualified posting
These terms and definitions are
discussed in detail in the relevant
sections of this proposed rule.
3. Transforming the Quality Payment
Program
a. Advancing CMS National Quality
Strategy Goals
(1) Increasing Alignment Across ValueBased Programs
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The CMS National Quality Strategy 298
addresses the urgent need for
transformative action to advance
towards a more equitable, safe, and
outcomes-based health care system for
all individuals. One of the CMS
National Quality Strategy goals is to
improve quality and health outcomes
across the health care journey through
implementation of a ‘‘Universal
Foundation’’ of impactful measures
across all CMS quality and value-based
programs.299 Adoption of the Universal
Foundation 300 301 will focus clinician
attention on specific quality measures,
reduce burden, help identify disparities
in care, prioritize development of
interoperable, digital quality measures,
allow for cross-comparisons across
programs, and help identify
measurement gaps.
We identified adult and pediatric
measures for the Universal Foundation
to be used across CMS programs and
populations, including the Quality
Payment Program, to the extent they are
applicable. The Quality Payment
Program measure inventory already
includes quality measures in the adult
core set from the Universal Foundation.
298 The National Quality Strategy: A PersonCentered Approach to Improving Quality . . .,
https://www.cms.gov/blog/cms-national-qualitystrategy-person-centered-approach-improvingquality.
299 CMS National Quality Strategy. https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/Value-Based-Programs/
CMS-Quality-Strategy.
300 Aligning Quality Measures across CMS.
https://www.cms.gov/aligning-quality-measuresacross-cms-universal-foundation https://
www.cms.gov/aligning-quality-measures-acrosscms-universal-foundation.
301 CMS National Quality Strategy. https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/Value-Based-Programs/
CMS-Quality-Strategy. CMS National Quality
Strategy. https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/ValueBased-Programs/CMS-Quality-Strategy.
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In addition, we propose in this
proposed rule to consolidate the
previously finalized Promoting
Wellness and Optimizing Chronic
Disease Management MVPs into a single
consolidated primary care MVP that
aligns with the adult Universal Core set
of quality measures. We refer readers to
section IV.A.4.b. and Appendix 3: MVP
Inventory, Table B.11 of this proposed
rule for our proposed updates to the
Promoting Wellness and Chronic
Disease Management MVPs. We will
continue to identify additional
measures, which may be included in
future MVPs, to capture aspects of
specialist quality in the Universal
Foundation.302 We also refer readers to
section III.G.2.c. of this proposed rule
for discussions on expanding the APM
Performance Pathway (APP) reported by
clinicians in the Shared Savings
Program and Advanced APMs to
include Medicare Clinical Quality
Measure (Medicare CQM) collection
types and further alignment with the
Universal Foundation.
(2) Advancing Health Equity
We also articulated a detailed strategy
to advance health equity and
accountability in order to design,
implement, and operationalize policies
to support health for all people served
by our programs, eliminate avoidable
differences in health outcomes
experienced by people who are
disadvantaged or underserved, and
provide the care and support that our
beneficiaries need to thrive.303
Specifically, the CMS Office of Minority
Health released the CMS Framework for
Health Equity,304 which updates the
CMS Equity Plan with an enhanced and
more comprehensive 10-year approach
to further embed health equity across
CMS programs including Medicare,
Medicaid, Children’s Health Insurance
Program, and the Health Insurance
Marketplaces. The CMS Office of
Minority Health also released Paving the
Way to Equity: A Progress Report 305 in
2021, which describes the CMS Equity
302 Aligning
Quality Measures across CMS—The
Universal Foundation. Jacobs, Schreiber,
Seshamani, Tsai, Fowler, and Fleisher. https://
www.nejm.org/doi/full/10.1056/NEJMp2215539.
303 CMS National Quality Strategy. https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/Value-Based-Programs/
CMS-Quality-Strategy.
304 CMS Equity Plan for Improving Quality in
Medicare. https://www.cms.gov/About-CMS/
Agency-Information/OMH/OMH_Dwnld-CMS_
EquityPlanforMedicare_090615.pdf.
305 CMS, Paving the Way to Equity: A Progress
Report (2015–2021) https://www.cms.gov/sites/
default/files/2021-01/Paving%20the%20Way
%20to%20Equity%20CMS%20OMH%20Progress
%20Report.pdf.
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Plan for Medicare and progress from
2015 to 2021.
In accordance with our health equity
strategy, both MVPs and APMs share a
goal of incenting improved equity as
well as advancing value (87 FR 70035).
For example, beginning in Performance
Year 2023 the Shared Savings Program
will implement an upside-only Health
Equity Adjustment (HEA) to an ACO’s
MIPS Quality performance category
score to reward ACOs that provide
excellent care for underserved
populations (87 FR 69838 through
69857).
(3) Accelerating Interoperability
The CMS National Quality Strategy
also calls for supporting the transition to
a digital and data driven health care
system. The CMS National Quality
Strategy proposed to achieve this
through the development of
requirements for sharing, receipt, and
use of digital data, including digital
quality measures.306 We believe that, as
clinicians strive to make improvements
in patient care, clinicians should
demonstrate increasingly more
advanced and innovative uses of health
information technology. In section
III.G.2.h. of this proposed rule, we
propose to require Shared Savings
Program ACO clinicians to report the
measures in the MIPS Promoting
Interoperability performance category.
Additionally, in section III.G.2.h.(2) of
this proposed rule, we propose to
modify our requirements for use of
CEHRT for Advanced APMs to promote
flexibility in adopting CEHRT that is
clinically relevant to participants,
emphasizing the importance of
interoperability and health information
technology. We believe these proposals,
in addition to ongoing efforts to build
CMS infrastructure and develop
technical solutions, are an important
step towards evolving our health
information technology ecosystem.
b. Quality Payment Program Vision and
Goals
(1) Emphasizing the Importance of
Value-Based Care
The Quality Payment Program was
designed and implemented to improve
health outcomes, promote smarter
spending, minimize burden of
participation, and provide fairness and
transparency in operations (81 FR
77010). The Quality Payment Program
allows for eligible clinicians to engage
in value-based, patient-centered care via
306 CMS National Quality Strategy. https://
www.cms.gov/medicare/quality-initiatives-patientassessment-instruments/value-based-programs/
cms-quality-strategy.
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two tracks: the Merit-Based Incentive
Program (MIPS) and Advanced
Alternative Payment Models (APMs).
MIPS encourages collection and
submission of data for evidence-based,
specialty-specific quality measures,
completion of practice-based
improvement activities, consideration of
cost measures, and use of certified
electronic health record (EHR)
technology (CEHRT) to support
interoperability (81 FR 77010). APMs
are models operating under section
1115A of the Act, the Shared Savings
Program under section 1899 of the Act
(that is, Accountable Care
Organizations), or a demonstration
under section 1866C or required by
Federal law. In the Advanced APM
track of the Quality Payment Program,
APM entities and eligible clinicians take
responsibility for improving the quality
of care, care coordination and health
outcomes for a group of beneficiaries
through participation in Advanced
APMs.307 Advanced APMs can ensure
that beneficiaries get the right care at the
right time by reducing fragmentation
between clinicians, which can reduce
unnecessary duplication of services and
preventable medical errors.308
Advanced APMs also support our goal
that all Traditional Medicare
beneficiaries be in a care relationship
with clinicians accountable for quality
and total cost of care by 2030, as
outlined by the CMS Innovation Center
strategy refresh.309
CMS recently established, and is
implementing, various strategies that are
intended to fulfill the potential of
Advanced APMs. The CMS Innovation
Center strategy refresh acknowledges
that whole person care requires the
depth and scope of services that
includes both primary and specialty
care, and aims to provide Accountable
Care Organizations (ACOs) with tools to
better engage specialists, test ways to
better link primary and specialty care
upstream in the patient journey, and
further movement into value-based
307 Medicare Value-Based Care Strategy:
Alignment, Growth and Equity. The Medicare
Value-Based Care Strategy: Alignment, Growth,
And Equity. Health Affairs, Jacobs, Fowler,
Fleisher, and Seshamani. https://
www.healthaffairs.org/content/forefront/medicarevalue-based-care-strategy-alignment-growth-andequity.
308 CMS Announces Increase in 2023 in
Accountable Care Organizations and Beneficiaries
Benefiting from Coordinated Care in Accountable
Care Relationship. https://www.cms.gov/newsroom/
press-releases/cms-announces-increase-2023organizations-and-beneficiaries-benefitingcoordinated-care-accountable.
309 Innovation Center Strategy Refresh. https://
innovation.cms.gov/strategic-direction-whitepaper.
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care.310 Our ongoing alignment of the
Shared Savings Program and the Quality
Payment Program supports new as well
as long term participation in ACOs for
clinicians choosing to participate in
accountable care relationships. In the
CY 2021 PFS final rule, we finalized the
Alternative Payment Model (APM)
Performance Pathway (APP) under
MIPS, in part, to reduce reporting
burden, and create new scoring
opportunities for MIPS eligible
clinicians participating in MIPS APMs
(85 FR 84720).
(2) MVP Reporting in the Quality
Payment Program
We believe the Quality Payment
Program should continuously support
the measurement and improvement of
specialty and primary care practice. To
this end, we are implementing MVPs in
MIPS to allow for clinicians to report on
measures that are directly relevant to
their clinical practice. Rather than
selecting individual measures and
activities from a large inventory to
report under each of the siloed MIPS
performance categories under
traditional MIPS, eligible clinicians who
select an MVP (for example, the
Coordinating Stroke Care to Promote
Prevention and Cultivate Positive
Outcomes MVP) can select from a
smaller, cohesive set of measures and
activities focused on the clinician’s
performance in rendering care for their
specialty or clinical condition.
We also developed MVPs with the
intention to support clinicians in their
journey of continuous performance
improvement and to reduce barriers to
APM participation as clinicians and
practices prepare to take on, and
successfully manage financial risk (84
FR 62946 through 62949).
c. Promoting Continuous Improvement
in MIPS
For the MIPS program, we developed
policies and methodologies to assess
clinicians’ performance, and to support
performance improvement across four
performance categories (quality, cost,
improvement activities, and Promoting
Interoperability) in accordance with
section 1848(q)(1)(A)(i) and (ii) of the
Act. We believe we should evaluate our
policies, requirements, and standards
for MIPS periodically to determine if we
need to raise the bar in order to foster
the availability of opportunities for
continuous performance improvement.
We are considering how we can
implement policies to support
310 CMMI Strategy Refresh. October 20, 2021.
https://innovation.cms.gov/strategic-directionwhitepaper.
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continuous improvement for clinicians
who consistently perform well in MIPS.
One challenge we face is that, after a
clinician has achieved high performance
scores on the same measures and
activities year over year, there may be
little or no room for the clinician to
improve their performance. Another
challenge is that some MIPS eligible
clinicians choose measures and
activities on which that they are already
performing well, rather than measures
and activities where they would be
required to implement changes in their
workflow, clinical care, or practices in
order to achieve a positive payment
adjustment. This selection practice, to
repeatedly choose the same measures
and activities on which the clinician is
confident they will perform well, can
mean that the clinician has less
incentive to transform the way that care
is delivered and continuously improve
quality of the care they provide. For
these reasons, we are considering
modifying our policies to encourage
clinicians who have consistently been
high performers in MIPS to
continuously improve various areas of
their clinical practice, including
implementing more rigorous standards
under MIPS and supporting
participation in an APM.
We are interested in feedback on
approaches to modifying our policies,
requirements, and standards under
MIPS, while remaining cognizant of the
burden any changes may place on MIPS
eligible clinicians. Section 1848(q)(1)(A)
and (5)(A) of the Act requires the
Secretary to develop a methodology for
assessing the total performance of each
MIPS eligible clinician according to
performance standards for applicable
measures and activities in each
performance category applicable to the
MIPS eligible clinician for a
performance period. We are particularly
interested in how we can balance the
impact of any policy changes on MIPS
eligible clinicians who have become
accustomed to our current program
requirements with the benefit of
potential modifications that foster
clinicians’ continuous improvement.
For example, we could increase
reporting requirements in traditional
MIPS and MVPs, or we could require
that specific measures be reported,
instead of allowing choice of measures,
once MVPs are mandatory to encourage
improvement for clinicians with
continuously perform well under MIPS.
d. Request for Feedback
We are seeking comment on how we
can modify our policies under the
Quality Payment Program to foster
clinicians’ continuous performance
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improvement and positively impact care
outcomes for Medicare beneficiaries.
Such modifications for MIPS may
include requiring more rigorous
performance standards, emphasizing
year-to-year improvement in the
performance categories, or requiring that
MIPS eligible clinicians report on
different measures or activities once
they have demonstrated consistently
high performance on certain measures
and activities.
In accordance with implementing
regulations of the Paperwork Reduction
Act of 1995 (PRA), specifically 5 CFR
1320.3(h)(4), this general solicitation
request for information is exempt from
the PRA.
We request public comment on
specifically the following questions:
• What potential policies in the MIPS
program would provide opportunities
for clinicians to continuously improve
care?
• Should we consider, in future
rulemaking, changes in policies to
assess performance to ensure ongoing
opportunities for continuous
performance improvement?
• Should we consider, for example,
increasing the reporting requirements or
requiring that specific measures are
reported once MVPs are mandatory?
• Should we consider creating
additional incentives to join APMs in
order to foster continuous improvement,
and if so, what should these incentives
be?
• What changes to policies should
CMS consider to assess continuous
performance improvement and
clinicians interested in transitioning
from MIPS to APMs?
• We acknowledge the potential
increase in burden associated with
increasing measure reporting or
performance standards. How should we
balance consideration of reporting
burden with creating continuous
opportunities for performance
improvement?
• While we are aware of potential
benefits of establishing more rigorous
policies, requirements, and performance
standards, such as developing an
approach for some clinicians to
demonstrate improvement, we are also
mindful that this will result in an
increasing challenge for some clinicians
to meet the performance threshold. Are
there ways to mitigate any unintended
consequences of implementing such
policies, requirements, and performance
standards?
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4. MVP Development, Maintenance, and
Scoring
a. Development of New MIPS Value
Pathways (MVPs)
In the in the CY 2023 PFS final rule
(87 FR 70035 and 70037), we finalized
modifications to our MVP development
process to include feedback from the
general public before the notice and
comment rulemaking process. We will
evaluate a submitted candidate MVP
through the MVP development process,
and if we determine it is ‘‘ready’’ for
feedback, we would post a draft version
of the submitted candidate MVP on the
Quality Payment Program (QPP) website
(https://qpp.cms.gov) and solicit
feedback for a 30-day period. The
general public would have the
opportunity to submit feedback on the
candidate MVP for CMS’s consideration
through an email inbox. We stated that
we would review the feedback received,
and determine if any changes should be
made to the candidate MVP prior to
potentially including the MVP in a
notice of proposed rulemaking. If we
determine changes should be made to
the candidate MVP, we would not notify
the interested parties who originally
submitted the candidate MVP for CMS
consideration in advance of the
rulemaking process. We refer readers to
the MVP Candidate Feedback Process
web page, available on the Quality
Payment Program website, to review the
public feedback we received for each
candidate MVP (https://qpp.cms.gov/
mips/candidate-feedback).
Through our development processes
for new MVPs (see 85 FR 84849 through
84856, 87 FR 70035 through 70037), we
aim to gradually develop new MVPs
that are relevant and meaningful for all
clinicians who participate in MIPs. In
this proposed rule, we are proposing the
inclusion of five new MVPs:
• Focusing on Women’s Health;
• Prevention and Treatment of
Infectious Disease Including Hepatitis C
and HIV;
• Quality Care in Mental Health and
Substance Use Disorder;
• Quality Care for Ear, Nose, and
Throat (ENT); and
• Rehabilitative Support for
Musculoskeletal Care
We continue to develop MVPs based
on needs and priorities, as described in
the MVP Needs and Priorities document
at https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
1803/MIPS%20Value
%20Pathways%20(MVPs)
%20Development%20Resources.zip.
We refer readers to Appendix 3: MVP
Inventory, in this proposed rule for
discussion of each proposed new MVP.
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b. MVP Maintenance on Previously
Finalized MVPs
In the CY 2023 PFS final rule (87 FR
70037), we finalized a modification to
the annual maintenance process for
MVPs that were previously adopted
through notice and comment
rulemaking (86 FR 65410). Interested
parties and the general public may
submit their recommendations for
potential revisions to established MVPs
on a rolling basis throughout the year.
We would then review the submitted
recommendations and determine
whether any are potentially feasible and
appropriate. We stated that if we
identify any submitted
recommendations that are potentially
feasible and appropriate, we would host
a public facing webinar, open to
interested parties and the general public
through which they may offer their
feedback on the potential revisions we
have identified. We would publish
details related to the timing and
registration process for the webinar
through our Quality Payment Program
Listserv. We held our first MVP
maintenance webinar in February 2023
(https://youtu.be/4cuZGUr88SA), to
discuss any feedback we received from
interested parties regarding previously
finalized MVPs.
In the CY 2022 PFS final rule (86 FR
65998 through 66031), we finalized
seven MVPs that are available for
reporting beginning with the CY 2023
performance period/2025 MIPS
payment year:
• Advancing Rheumatology Patient
Care;
• Coordinating Stroke Care to
Promote Prevention and Cultivate
Positive Outcomes;
• Advancing Care for Heart Disease;
• Optimizing Chronic Disease
Management;
• Adopting Best Practices and
Promoting Patient Safety within
Emergency Medicine;
• Improving Care for Lower Extremity
Joint Repair; and
• Patient Safety and Support of
Positive Experiences with Anesthesia.
In addition, in the CY 2023 PFS final
rule (87 FR 70037), we finalized five
additional MVPs that are available for
reporting beginning with the CY 2023
performance period/2025 MIPS
payment year:
• Advancing Cancer Care;
• Optimal Care for Kidney Health;
• Optimal Care for Neurological
Conditions;
• Supportive Care for CognitiveBased Neurological Conditions; and
• Promoting Wellness.
In this proposed rule, we are
proposing modifications to these twelve
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MVPs to propose the addition and
removal of measures and improvement
activities based on the MVP
development criteria (85 FR 84849
through 84854), feedback received
through the MVP maintenance process,
and based off the proposed removals of
certain improvement activities from the
improvement activities inventory and
the proposed addition of other relevant
existing quality measures for MVP
participants to select from. In addition,
through the MVP maintenance process,
we are proposing to consolidate the
previously finalized Promoting
Wellness and Optimizing Chronic
Disease Management MVPs into a single
consolidated primary care MVP titled
Value in Primary Care MVP, that aligns
with the Adult Universal Core Set, as
described in the journal article,
‘‘Aligning Quality Measures across
CMS—The Universal Foundation’’
(https://www.nejm.org/doi/full/10.1056/
NEJMp2215539). (https://www.nejm.org/
doi/full/10.1056/NEJMp2215539). We
refer readers to Appendix 3: MVP
Inventory of this final rule for the
proposed modifications to the
established MVPs.
c. Scoring MVP Performance
In the CY 2022 PFS final rule, we
finalized policies for MVP scoring that
take effect beginning with the CY 2023
performance period/2025 MIPS
payment year. We refer readers to 86 FR
65419 through 65427 for the details of
those finalized policies. We previously
finalized at § 414.1365(d)(2) that, unless
otherwise indicated in § 414.1365(d),
the performance standards described at
§ 414.1380(a)(1)(i) through (iv) apply to
the measures and activities included in
the MVP (86 FR 65419 through 65421).
We noted that in general, we intend to
adopt scoring policies from traditional
MIPS for MVP participants unless there
is a compelling reason to adopt a
different policy to further the goals of
the MVP framework (86 FR 65419).
We refer readers to section
IV.A.4.g.(1)(c)(i) of this proposed rule
for proposed policies on MIPS scoring
flexibilities in the quality performance
category scoring; section
IV.A.4.g.(1)(d)(i) in this proposed rule
for the proposed change to scoring
improvement in the cost performance
category; section IV.A.4.f.(3)(b) and
Appendix 2: Improvement Activities, of
this proposal rule for the proposed
improvement activity ‘‘IA_MVP,
Practice-wide quality improvement in
the MIPS Value Pathway Program
(MVP)’’ in the improvement activities
performance category; section
IV.A.4.f.(4) in this proposed rule for the
proposed policies for the Promoting
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Interoperability performance category,
including modifications of the SAFER
Guide Measure’s requirements and the
Query of Prescription Drug Monitoring
Program (PDMP) measure’s exclusion, a
technical update to the e-Prescribing
measure, an increase in the length of the
performance period from 90 continuous
days to 180 continuous day, and
continuation of our reweighting policy
of the performance category for clinical
social workers.
In addition, we refer readers to
section IV.A.4.d. of this proposed rule
for proposed policies regarding
subgroups, including reweighting
proposals, addition of subgroups to our
Targeted Review policies, and a
clarification regarding the scoring of
facility-based clinicians at the subgroup
level.
We refer readers to section IV.A.4.j. of
this proposed rule for proposed policies
regarding Targeted Review process,
including the addition of virtual groups
to our Targeted Review policies.
d. Subgroup Reporting
(1) Background
In the CY 2022 PFS final rule, we
finalized the option for clinicians to
participate as subgroups for reporting
MIPS value pathways (MVPs) beginning
in the CY 2023 performance period/
2025 MIPS payment year (86 FR 65392
through 65394). We refer readers to Title
42 of the Code of Federal Regulations
(CFR) at §§ 414.1318 and 414.1365, the
CY 2022 PFS final rule (86 FR 65398
through 65405), and the CY 2023 PFS
final rule (87 FR 70038 through 70045)
for additional details on previously
finalized subgroup policies.
In this section, we are proposing to:
(1) update the subgroup policy for
reweighting of MVP performance
categories at § 414.1365(e)(2); (2) update
the facility-based scoring and complex
patient bonus for subgroups under final
score calculation at § 414.1365(e)(3) and
(4); (3) update the targeted review policy
for subgroups at § 414.1385; and (4)
codify in our regulations the subgroup
policies finalized in previous years’
rules.
(2) Subgroup Reweighting
In the CY 2022 PFS final rule (86 FR
65425 through 65426), we finalized at
§ 414.1365(e)(2)(ii) that for an MVP
Participant that is a subgroup, any
reweighting applied to its affiliated
group will also be applied to the
subgroup. Additionally, we finalized
that if reweighting is not applied to an
affiliated group, then the subgroup may
receive reweighting under the
circumstances described at
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§§ 414.1365(e)(2)(ii)(A) and (B). In
establishing this policy, we noted our
concern about extreme and
uncontrollable circumstances (EUC) that
would impact only the subgroup (fire or
natural disaster at a specific practice
location) and does not affect the entire
affiliated group. We also finalized that
if a subgroup submits data for a
performance category which was
reweighted, the subgroup data
submission will void the reweighting
applied to the performance category.
Upon further consideration of the
previously finalized policy, we
identified technical constraints that
affect our ability to implement the
policy. Specifically, we are concerned
that the time necessary to adjudicate
reconsideration requests for both a
subgroup and its affiliated group may
deprive the subgroup of knowledge of
its reweighting status during a
significant portion of the relevant
performance period and undermine its
ability to plan data submission needs
accordingly.
There may be instances when a
subgroup and its affiliated group have
separate reasons to submit reweighting
applications. Those separate
applications may request the
reweighting of different performance
categories. Under § 414.1380(c)(2),
clinicians, groups, and APM Entities
submit reweighting applications
annually on a rolling basis throughout
the performance period, or a date
specified by CMS. However, the
requirement in § 414.1365(e)(2)(ii) that
any reweighting applied to a subgroup’s
affiliated group is also applied to the
subgroup means that when a subgroup
and its affiliated group both submit
reweighting applications, the subgroup
will not know its reweighting status
until CMS makes a determination
regarding the group’s reweighting
application. Depending on when the
group submitted its reweighting request,
this may not happen until after the close
of the performance period for which the
reweighting application was made.
We believe the uncertainty created for
a subgroup by not knowing its
reweighting status until later in the
performance period would disrupt its
ability to best plan for the measures and
activities on which it will be scored. We
recognize that there may be instances
when only the subgroup is affected by
an extreme and uncontrollable
circumstance (natural disaster, fire,
hurricane, etc.) and would want to
request its own reweighting,
independent of the affiliated group.
However, we believe that the need for
a subgroup to know of its data
submission requirements outweighs the
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benefit of being able to request its own
reweighting independent of the
affiliated group.
Separately, there are certain special
status designations (non-patient facing,
small practice, etc.) that automatically
qualify a group for reweighting of the
Promoting Interoperability performance
category. A subgroup can learn about its
affiliated group’s special status
designation as described in the second
paragraph under the definition of MIPS
determination period at § 414.1305.
Given that subgroup eligibility and
special status determinations are made
at the group level, we believe that
applying an affiliated group’s
reweighting to a subgroup, and
removing the ability of a subgroup to
submit a separate reweighting
application, would enable subgroups to
receive their reweighting status and
identify their data submission
obligations in a timely manner. We are
therefore proposing to revise
§ 414.1365(e)(2)(ii) to limit the
reweighting applied to a subgroup to
that which is also applied to its
affiliated group beginning with the CY
2024 performance period/2026 MIPS
payment year.
In order to operationalize the
previously established policy, we intend
to implement a manual process for
reviewing subgroup reweighting
applications for the CY 2023
performance period/2025 MIPS
payment year. We considered also using
the manual process for reviewing
subgroup reweighting applications in
future performance periods. However,
we are concerned that manually
reconciling the reweighting requests
would delay the approval of the
reweighting requests received from a
subgroup. Additionally, we are
concerned that it may create confusion
for a subgroup to determine whether a
performance category has been
reweighted and its potential impact on
subgroup data submission, specifically
in instances when both the subgroup
and its affiliated group submit a
reweighting application for one or more
of the MVP performance categories. For
the above reasons, we would use the
manual process only for the CY 2023
performance period/2025 MIPS
payment year.
We acknowledge that there may be
instances when an extreme and
uncontrollable circumstance impacts
only a subgroup and not the entire
affiliated group (for example, fire or
natural disaster at the subgroup’s
practice location). Because subgroup
reporting is not mandatory at this time,
we believe that in these instances, when
a registered subgroup is unable to
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participate in MVP reporting as a
subgroup, the eligible clinicians in the
registered subgroup would participate
in MIPS via another available reporting
option. These clinicians could either
participate as individuals or as a group,
if its affiliated group chooses to
participate in traditional MIPS, or in
MVP reporting. Additionally, we
established the policy in
§ 414.1318(b)(1) to not assign a score for
a registered subgroup that did not
submit data for the applicable
performance period (87 FR 70045). In
the scenario that the registered subgroup
did not submit data, we would assign
the highest of the available final scores
associated with the clinician’s TIN/NPI
for the eligible clinicians in the
subgroup (86 FR 65536 and 65537). We
refer readers to the CY 2023 PFS
proposed rule (87 FR 46272 through
46275) for examples that illustrate how
the final score is applied for a clinician
who is part of a group TIN where only
some of the clinicians under that TIN
choose to participate in MIPS through
subgroups. We will continue to monitor
subgroup participation trends and will
revisit this policy in the future, as
needed.
For the above reasons, we are
proposing to revise § 414.1365(e)(2)(ii)
to state that an MVP Participant that is
a subgroup will receive the same
reweighting that is applied to its
affiliated group, but that for the CY 2023
performance period/2025 MIPS
payment year, if reweighting is not
applied to the affiliated group, the
subgroup may receive reweighting in
the circumstances independent of the
affiliated group as described in
§ 414.1365(e)(2)(ii)(A) and (B).
We request comments on this
proposal.
(3) Subgroup Scoring Policies
(a) Facility-Based Score for Subgroups
We established policies for facilitybased measurement and scoring for
MIPS eligible individual clinicians and
groups at § 414.1380(e). Under these
standards, we calculate a MIPS eligible
clinician’s final facility-based score
using the clinician’s performance in
another value-based purchasing
program (83 FR 59866 through 59867).
In the CY 2022 PFS final rule (86 FR
65425), we finalized at § 414.1365(e)(3)
that if an MVP Participant that is not an
APM Entity is eligible for facility-based
scoring, a facility-based score will also
be calculated in accordance with
§ 414.1380(e). We recognize that we
inadvertently overlooked excluding
MVP Participants that are subgroups
from facility-based scoring. We note that
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it was not our intent to calculate a
facility-based score at the subgroup
level.
In the course of implementing MVPs,
we have offered clinicians and groups
the opportunity to elect to report via
MVPs and via traditional MIPS. If a
facility-based MIPS eligible clinician
participates in MVP reporting as an
individual or as part of a group, we will
calculate a final score for the MIPS
eligible clinician based on the MVP
reporting. We would not use the facilitybased scores to calculate the clinician’s
final scores under the MVP because we
currently do not have an MVP
specifically focused on facility-based
measurement. We believe eligible
clinicians would choose to participate
in MVP reporting with the intent to
report on measures applicable to the
scope of care provided and therefore, it
would be appropriate for facility-based
clinicians participating in MVP
reporting to receive a score based on the
data submitted for the measures and
activities in an MVP. We would also
calculate a score for traditional MIPS for
this clinician or group and assign the
higher of the scores. If a facility-based
clinician chooses to participate in MVP
for a MIPS performance period, a
facility-based score would be calculated
as part of traditional MIPS and not as
part of MVP reporting. Subgroup
reporting is limited to MVPs, and
subgroup reporting is not available for
clinicians reporting on measures in
traditional MIPS. Therefore, we are
proposing to modify the text at
§ 414.1365(e)(3) to state that if an MVP
Participant, that is not an APM Entity or
a subgroup, is eligible for facility-based
scoring a facility-based score will also
be calculated in accordance with
§ 414.1380(e).
We are requesting comments on this
proposal.
(b) Complex Patient Bonus for
Subgroups
In the CY 2018 Quality Payment
Program final rule (82 FR 53776), we
finalized at § 414.1380(c)(3)(i) that we
will add a complex patient bonus to the
final score of certain MIPS eligible
clinicians that submit data on at least
one performance category during the
applicable performance period. We
finalized that this complex patient
bonus would be calculated on the basis
of the average Hierarchical Condition
Category (HCC) risk score and the dual
eligible ratio for beneficiaries seen by
clinicians and groups. In the CY 2022
PFS final rule (86 FR 65425), we
finalized at § 414.1365(e)(4) that a
complex patient bonus will be added to
the final score for an MVP Participant in
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accordance with § 414.1380(c)(3). We
also revised § 414.1380(c)(3) to permit
subgroups to receive the complex
patient bonus as, in the case of
subgroups, we intended to apply the
bonus based on the patient population
of the subgroup.
Since then, however, we have
identified issues with using claims data
associated with the clinicians in a
subgroup that prevents us from
calculating the complex patient bonus at
the subgroup level. Specifically, we are
unable to identify the beneficiaries seen
by the clinicians in a subgroup, and
therefore we cannot calculate the
average HCC score and dual eligible
ratio scores. At the time the relevant
claims data is retrieved, the composition
of the subgroup may not be known,
making it impossible to calculate the
required data elements for the complex
patient bonus (for example, clinicians,
beneficiaries that received care, etc.) at
the subgroup level. Additionally, the
group may have subgroups that do not
collectively represent the entire group,
restricting our ability to gather the
beneficiary data necessary to calculate
the complex patient bonus score at the
subgroup level.
We recognize that we would need to
retroactively modify the previously
established policy at § 414.1365(e)(4) for
the CY 2023 performance period/2025
MIPS payment year to address the fact
that we cannot calculate the complex
patient bonus at the subgroup level.
Section 1871(e)(1)(A)(ii) of the Act
provides for retroactive application of a
substantive change to an existing policy
when the Secretary determines that
failure to apply the policy change
retroactively would be contrary to the
public interest. We believe that the
failure to apply the proposed change
retroactively would be contrary to the
public interest because the current rule
provides for the calculation of the
complex patient bonus score at the
subgroup level when it would be
impossible for CMS to do so. For the
reason stated previously in this section,
we are proposing to add
§ 414.1365(e)(4)(i) to provide that for
subgroups, beginning with the CY 2023
performance period/2025 MIPS
payment year, the affiliated group’s
complex patient bonus will be added to
the final score. Additionally, we are
proposing conforming changes in
§ 414.1380(c)(3)(v) by removing the term
‘‘subgroups’’ so that beginning with the
CY 2022 performance period/2024 MIPS
payment year, the complex patient
bonus is limited to MIPS eligible
clinicians, groups, APM Entities, and
virtual groups with a risk indicator at or
above the risk indicator calculated
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median. Similarly, we are proposing
conforming changes in
§ 414.1380(c)(3)(vi) by removing the
term ‘‘subgroups’’ so that beginning
with the CY 2022 performance period/
2024 MIPS payment year, for MIPS
eligible clinicians and groups, the
complex patient bonus components are
calculated as described under
§ 414.1365(c)(3)(vi).
We are requesting comments on this
proposal.
(4) Targeted Review for Subgroups
We previously established at
§ 414.1385(a) that a MIPS eligible
clinician or group may request a
targeted review of the calculation of the
MIPS payment adjustment factor under
section 1848(q)(6)(A) of the Act and, as
applicable, the calculation of the
additional MIPS payment adjustment
factor under section 1848(q)(6)(C) of the
Act (collectively referred to as the MIPS
payment adjustment factors) applicable
to such MIPS eligible clinician or group
for a year (81 FR 77353 through 77358
and 77546). We also finalized the
process to submit a targeted review
application, codified at § 414.1385(a)
(81 FR 77353 through 77358 and 77546).
Similar to the previously established
targeted review process for individual
clinicians and groups, MIPS eligible
clinicians who participate in MVP
reporting and are scored as a subgroup
may request a targeted review beginning
with the CY 2023 performance period/
2025 MIPS payment year. We recognize
that we did not propose changes in the
existing language for targeted review at
§ 414.1385(a) to reflect the availability
of the targeted review process for
subgroups. We are proposing to modify
§ 414.1385(a) to state that a MIPS
eligible clinician, group, or subgroup
may request a targeted review of the
calculation of the MIPS payment
adjustment factors applicable to such
MIPS eligible clinician, group, or
subgroup for a year. We are also
proposing to modify § 414.1385(a)(1) to
state that a MIPS eligible clinician,
group or subgroup (including their
designated support staff), or a third
party intermediary as defined at
§ 414.1305, may submit a request for a
targeted review. Additionally, we are
proposing to make conforming changes
at § 414.1385(a)(3), (5), and (6) to
remove the term ‘‘MIPS eligible
clinician or group’’ and add in its place
the term ‘‘MIPS eligible clinician, group,
or subgroup.’’ With these proposals, a
subgroup that would like to request a
review of the calculation for the MIPS
payment adjustment factor for MVP data
submission in the CY 2023 performance
period/2025 MIPS payment year may
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also submit a targeted review
application. We note that we are
proposing additional changes to the
targeted review process set forth in
§ 414.1385(a) as further described in
section IV.A.4.j. of this proposed rule.
We are requesting comments on the
above proposals.
(5) Codification of Previously Finalized
Subgroup Policies From Preamble
We have identified that some
subgroup policies were finalized in
prior rulemaking but were not codified
in the CFR. Additionally, we neglected
to propose to include subgroups in our
previously established definition of
‘‘attestation’’ in § 414.1305. We have
reviewed the existing language and
identified policies that should be
codified. We now propose to correct
these errors.
It is necessary for each of the
proposed changes to the policies
described below to be effective
beginning with the CY 2023
performance period/2025 MIPS
payment year in order for MIPS Value
Pathways to operate effectively. Section
1871(e)(1)(A)(ii) of the Act provides for
retroactive application of a substantive
change to an existing policy when the
Secretary determines that failure to
apply the policy change retroactively
would be contrary to the public interest.
Here, we believe that the failure to
apply the proposed changes
retroactively would be contrary to the
public interest because the
discrepancies remedied by the below
proposals may cause undue confusion
for clinicians participating as subgroups
and may also create unintended errors
in program implementation.
(a) Definitions
(i) Attestation
At § 414.1305, we currently define
attestation to mean a secure mechanism,
specified by CMS, with respect to a
particular performance period, whereby
a MIPS eligible clinician or group may
submit the required data for the
Promoting Interoperability or the
improvement activities performance
categories of MIPS in a manner
specified by CMS. Beginning in the CY
2023 performance period/2025 MIPS
payment year, clinicians participating as
subgroups would submit data for the
Promoting Interoperability and
improvement activities performance
categories in an MVP as described at
§ 414.1365(c). As described previously
in this section, we are proposing to
adopt this change retroactively pursuant
to section 1871(e)(1)(A)(ii). We believe
that the failure to apply the proposed
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change retroactively would be contrary
to the public interest because it would
create ambiguity in the requirement for
a subgroup to submit data through an
attestation for the Promoting
Interoperability and improvement
activities performance categories as
described in § 414.1365(c). Therefore,
we are proposing to add the term
‘‘subgroup’’ and revise the definition of
attestation in § 414.1305 to state that
attestation means a secure mechanism,
specified by CMS, with respect to a
particular performance period, whereby
a MIPS eligible clinician, group, or
subgroup may submit the required data
for the Promoting Interoperability or the
improvement activities performance
categories of MIPS in a manner
specified by CMS.
We are requesting comments on this
proposal.
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(ii) Submitter Type
At § 414.1305, we defined a submitter
type to mean the MIPS eligible
clinician, group, Virtual Group, APM
Entity, or third party intermediary
acting on behalf of a MIPS eligible
clinician, group, Virtual Group, or APM
Entity, as applicable, that submits data
on measures and activities under MIPS.
In accordance with the subgroup
reporting requirements at § 414.1318(c),
we inadvertently overlooked adding
subgroups in the definition of submitter
type at § 414.1305. As described
previously in this section, we are
proposing to adopt this change
retroactively pursuant to section
1871(e)(1)(A)(ii). We believe that the
failure to apply the proposed change
retroactively would be contrary to the
public interest because it would create
ambiguity in the requirement for a
subgroup to submit data as described at
§ 414.1318(c). Therefore, we are
proposing to add the term ‘‘subgroup’’
and revise the definition of submitter
type at § 414.1305 to state that a
submitter type means the MIPS eligible
clinician, group, Virtual Group,
subgroup, APM Entity, or third party
intermediary acting on behalf of a MIPS
eligible clinician, group, Virtual Group,
subgroup, or APM Entity, as applicable,
that submits data on measures and
activities under MIPS.
We are requesting comments on this
proposal.
(b) Data Submission Criteria for the
Improvement Activities Performance
Category
We refer readers to § 414.1360 for data
submission criteria for the improvement
activities performance category. In the
CY 2022 PFS final rule (86 FR 65462),
we finalized revisions to the data
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submission criteria at § 414.1360(a)(2) to
allow subgroups to perform and attest to
their improvement activities separately
and to apply the 50 percent threshold
within their subgroup. We inadvertently
overlooked codifying subgroups in the
regulation text at § 414.1360(a). The
existing regulation text at § 414.1360(a)
refers to data submission criteria in the
improvement activities performance
category for only MIPS eligible
clinicians and groups. As described
above, we are proposing to adopt this
change retroactively pursuant to section
1871(e)(1)(A)(ii). We believe that the
failure to apply the proposed change
retroactively would be contrary to the
public interest because it would create
ambiguity in the data submission
requirements established in
§ 414.1360(a)(2) regarding the reporting
of improvement activities by subgroups.
Therefore, we are proposing to revise
§ 414.1360(a) to state that for purposes
of the transition year of MIPS and future
years, MIPS eligible clinicians, groups,
or subgroups must submit data on MIPS
improvement activities in one of the
following manners described at
§ 414.1360(a)(1) through (a)(1)(i).
We are requesting comments on this
proposal.
e. APM Performance Pathway
(1) Overview
In the CY 2021 PFS final rule (85 FR
84859 through 84866), we finalized the
APM Performance Pathway (APP) at
§ 414.1367 beginning in performance
year 2021, which was designed to
provide a predictable and consistent
MIPS reporting option to reduce
reporting burden and encourage
continued APM participation. We also
established that ACOs will be required
to report quality data for purposes of the
Shared Savings Program via the APP (85
FR 84722).
Under policies finalized under the CY
2023 PFS (87 FR 69858), to meet the
quality performance standard under the
Shared Savings Program through the
2024 performance year, we stated that
ACOs must report the ten CMS Web
Interface measures or the three eCQMs/
MIPS CQMS and the CAHPS for MIPS
survey. Beginning in the 2025
performance year and subsequent
performance years, ACOs must report
the three eCQMS/MIPS CQMs and the
CAHPS for MIPS survey (87 FR 69858
through 69859).
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(2) Proposal for the Medicare Clinical
Quality Measure for Accountable Care
Organizations Participating in the
Medicare Shared Savings Program
As discussed in section III.F.2.b.(2) of
this proposed rule, we are proposing to
establish the Medicare Clinical Quality
Measure for Accountable Care
Organizations Participating in the
Medicare Shared Savings Program
(Medicare CQM) collection type in the
APP measure set. The Medicare CQM
collection type would be available to
only ACOs participating in the Shared
Savings Program. ACOs in the Shared
Savings Program would have the option
to report the Medicare CQM under the
APP on only their attributed Medicare
fee-for-service beneficiaries who meet
the definition of a ‘‘beneficiary eligible
for Medicare CQM(s)’’ as proposed in
section III.F.2.b.(2) of this proposed
rule, instead of their all payer/all patient
population, beginning with the 2024
performance year. The Medicare CQM
would also serve as another collection
type in addition to the existing eCQM/
MIPS CQM option, which is an all
payer/all patient collection type under
the APP.
In the CY 2023 PFS final rule, we
stated that we will monitor the impact
of policies such as the sunsetting of the
CMS Web Interface in the 2024
performance year and the requirement
to report all payer/all patient eCQMs/
MIPS CQMs beginning in the 2025
performance year (87 FR 69833). We
also stated that we may revisit these and
related issues in future rulemaking
based on lessons learned as we gain
more experience with ACOs reporting
eCQMs/MIPS CQMs (87 FR 69833). As
discussed in section III.F.2.b.(2) of this
proposed rule, we are committed to
supporting ACOs in the transition to all
payer/all patient eCQMs/MIPS CQMs
and in the transition to digital quality
measurement reporting. We encourage
readers to review additional background
on our proposal to include the Medicare
CQM collection type in the APP
measure set discussed at section
III.F.2.b.(2) of this proposed rule.
f. MIPS Performance Category Measures
and Activities
(1) Quality Performance Category
(a) Background
Section 1848(q)(1)(A)(i) and (ii) of the
Act requires the Secretary to develop a
methodology for assessing the total
performance of each MIPS eligible
clinician according to certain specified
performance standards and, using such
methodology, to provide for a final score
for each MIPS eligible clinician. Section
1848(q)(2)(A)(i) of the Act provides that
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the Secretary must use the quality
performance category in determining
each MIPS eligible clinician’s final
score, and section 1848(q)(2)(B)(i) of the
Act describes the measures that must be
specified under the quality performance
category.
We refer readers to §§ 414.1330
through 414.1340 and the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77097 through 77162 and
82 FR 53626 through 53641,
respectively), and the CY 2019, CY
2020, CY 2021, CY 2022, and CY 2023
PFS final rules (83 FR 59754 through
59765, 84 FR 63949 through 62959, 85
FR 84866 through 84877, 86 FR 65431
through 65445, and 87 FR respectively)
for a description of previously
established policies and statutory basis
for policies regarding the quality
performance category.
In this proposed rule, we are
proposing to:
• Amend the definition of the term
‘‘collection type’’ to include the
Medicare Clinical Quality Measures for
Accountable Care Organizations
Participating in the Medicare Shared
Savings Program (Medicare CQMs).
• Amend (through technical
modifications) the data submission
criteria for MIPS quality measures and
establish the data submission criteria for
Medicare CQMs.
• Require administration of the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) for
MIPS Survey in the Spanish translation.
• Maintain the data completeness
criteria threshold of at least 75 percent
for the CY 2026 performance period/
2028 MIPS payment year, and increase
the data completeness criteria threshold
to at least 80 percent for the CY 2027
performance period/2029 MIPS
payment year.
• Establish data completeness criteria
for Medicare CQMs.
• Modify the MIPS quality measure
set as described in Appendix 1 of this
proposed rule, including the addition of
new measures, updates to specialty sets,
removal of existing measures, and
substantive changes to existing
measures.
(b) Definition of Collection Type
With the proposed establishment of a
new collection type, the Medicare
Clinical Quality Measures for
Accountable Care Organizations (ACOs)
Participating in the Medicare Shared
Savings Program (Medicare CQMs)
specific to the APM Performance
Pathway (APP) as described in section
III.G.2. of this proposed rule, we are
proposing to amend the definition of the
term ‘‘collection type’’ to include
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Medicare CQMs in order account for the
new collection type available only to
Medicare Shared Savings Program ACOs
meeting the reporting requirements of
the APP. Specifically, starting with the
CY 2024 performance period, we are
proposing to amend the definition of the
term ‘‘collection type’’ in § 414.1305 to
mean a set of quality measures with
comparable specifications and data
completeness criteria, as applicable,
including, but not limited to: Electronic
clinical quality measures (eCQMs);
MIPS clinical quality measures (MIPS
CQMs); Qualified Clinical Data Registry
(QCDR) measures; Medicare Part B
claims measures; CMS Web Interface
measures (except as provided in
paragraph (1) of this definition, for the
CY 2017 through CY 2022 performance
periods/2019 through 2024 MIPS
payment years); the CAHPS for MIPS
survey measure; administrative claims
measures; and Medicare Clinical
Quality Measures for Accountable Care
Organizations Participating in the
Medicare Shared Savings Program
(Medicare CQMs). The Medicare CQMs
collection type would serve as a
transition collection type under the APP
and be available as determined by CMS.
We seek public comment on the
proposal to amend the definition of the
term collection type to include the
Medicare CQMs as an available
collection type in MIPS.
(c) Quality Data Submission Criteria
(i) Data Submission Criteria for Quality
Measures
In this proposed rule, we are
proposing technical amendments to data
submission criteria for MIPS quality
measures and proposing to establish
data submission criteria for Medicare
CQMs. The participants in MIPS have
expanded from MIPS eligible clinicians
and groups to virtual groups starting
with the CY 2018 performance period
(82 FR 53593 through 53617), APM
Entities starting with the CY 2021
performance period (85 FR 84860), and
subgroups starting with the CY 2023
performance period (86 FR 65392
through 65394). In order to account for
the expansion of participants in MIPS
and the applicability of data submission
criteria for MIPS quality measures, we
are proposing technical amendments.
We are proposing technical
amendments to recognize that a virtual
group, subgroup, and APM Entity are
able to meet the data submission
requirements pertaining to the quality
performance category at
§ 414.1325(a)(1), (c), and (d). Also, we
are proposing technical amendments to
recognize that a virtual group and an
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APM Entity are able to meet the data
submission requirements established at
§ 414.1335(a)(1)(i) and (ii) for the data
submission criteria pertaining to
Medicare Part B claims measures, MIPS
CQMs, eCQMs, and QCDR measures.
Additionally, in § 414.1335(a)(1)(ii), we
are proposing to modify references of
MIPS eligible clinicians and groups, to
refer to such clinicians and groups in
the singular to ensure that § 414.1335
uniformly references the various types
of MIPS participants in the singular. We
are making a grammatical correction to
§ 414.1335(a)(1)(i) to ensure subject-verb
agreement. We note that the technical
amendments in § 414.1335(a)(1)(i) and
(ii) are not applicable to subgroups
because MIPS subgroup participation is
part of the MVP framework, which has
separate data submission criteria
specified in § 414.1365.
We are proposing technical
amendments to the data submission
criteria for the CAHPS for MIPS Survey
measure, which would identify the
CAHPS for MIPS Survey as a measure
in § 414.1335(a)(3). The current rule
does not reference the CAHPS for MIPS
Survey as a measure, which is
erroneous. Also, we are proposing a
revision to § 414.1335(a)(3) to recognize
that a virtual group, subgroup, and APM
Entity are able to administer the CAHPS
for MIPS Survey in § 414.1335(a)(3)(i).
Additionally, we are proposing
amendments to the data submission
criteria for quality performance category
at § 414.1325(a)(1)(i) and (ii) in order to
clarify that the data submission of MIPS
quality measures specific to eCQMs
must be submitted utilizing certified
electronic health record technology
(CEHRT). Section 1848(q)(5)(B)(ii) of the
Act provides that under the
methodology for assessing the total
performance of each MIPS eligible
clinician, the Secretary shall: (1)
Encourage MIPS eligible clinicians to
report on applicable measures under the
quality performance category through
the use of CEHRT and QCDRs; and (2)
For a performance period for a year, for
which a MIPS eligible clinician reports
applicable measures under the quality
performance category through the use of
CEHRT, treat the MIPS eligible clinician
as satisfying the CQMs reporting
requirement under section
1848(o)(2)(A)(iii) of the Act for such
year. To encourage the use of CEHRT for
quality improvement and reporting on
measures under the quality performance
category, we established a scoring
incentive for MIPS eligible clinicians
who use their CEHRT systems to
capture and report quality information,
specifically the end-to-end electronic
reporting bonus points (81 FR 77294
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through 77297). We sunset the end-toend electronic reporting bonus points
starting with the CY 2022 performance
period (CY 2021 performance period/
2023 MIPS payment year was the last
performance period in which the endto-end electronic reporting bonus points
were available (85 FR 84907 through
84908)).
With the framework for transforming
MIPS through MVPs, we noted in the
CY 2021 PFS final rule that we will find
ways to incorporate digital measures
without needing to incentivize end-toend electronic reporting with bonus
points (85 FR 84907 through 84908). In
the CY 2018 Quality Payment Program
final rule (82 FR 53636), we encouraged
interested parties to consider
electronically specifying their quality
measures as eCQMs, to encourage MIPS
eligible clinicians, groups, and virtual
groups to move towards the utilization
of electronic reporting. As noted in the
CY 2019 PFS final rule (83 FR 59851),
bonus points were created as transition
policies which were not meant to
continue through the duration of the
program. Since the inception of MIPS,
our intention has been to encourage the
utilization of CEHRT, which
encompasses the requirement of CEHRT
pertaining to eCQM data submission.
With the sunset of the end-to-end
electronic reporting bonus points, there
is ambiguity regarding the requirement
of utilizing CEHRT for the data
submission of eCQMs. While the
sunsetting of the end-to-end electronic
reporting bonus points was merely to
eliminate such bonus points, our
intention was to continue the
requirement of utilizing CEHRT for
eCQM data submission. However, with
the sunset of the end-to-end electronic
reporting bonus points, there is an
inadvertent absence in policy that
would continue the requirement of
utilizing CEHRT for eCQM data
submission. As a result of such
inadvertent absence of policy
establishing the overarching CEHRT
requirements for eCQM data submission
for purposes of the quality performance
category (aside from the CEHRT
requirements under the end-to-end
electronic reporting bonus point
criteria), we are rectifying the issue by
establishing the requirement to utilize
CEHRT for the data submission of
eCQMs. We are proposing to establish
the quality performance category data
submission criteria for eCQMs that
requires the utilization of CEHRT in
§ 414.1335(a)(1). Specifically, in
§ 414.1335(a)(1)(i)(A) and (ii)(A), we are
proposing that the data submission
criteria for eCQMs requires the
utilization of CEHRT, as defined in
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§ 414.1305. Furthermore, we are
proposing to amend the definition of
CEHRT in § 414.1305(2)(ii) by
broadening the applicability of the
health IT certification criteria identified
in 42 CFR 170.315 that are necessary to
report objectives and measures specified
under MIPS (would no longer be limited
to the Promoting Interoperability
performance category). As a result of
this proposal, the health IT certification
criteria identified in § 414.1305(2)(ii)
would be applicable, where necessary,
for any MIPS performance category,
including the criteria that support
eCQMs identified in § 414.1305(2)(ii)(B).
We note that the proposal pertaining
to the data submission criteria for
eCQMs requiring the utilization of
CEHRT would not require third party
intermediaries that report eCQMs on
behalf of a MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity to obtain certification. Currently,
third party intermediaries may facilitate
reporting on behalf of a MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity for an eCQM
while not having been certified to the
certification criteria at 45 CFR
170.315(c)(1) through (3). However, if a
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity is
relying on a third party intermediary for
elements of the required certification
capabilities for the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity to meet the
CEHRT definition applicable for their
participation, then the third party
intermediary would need to provide the
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity with a
certified Health IT Module for the
needed capability or capabilities.
We note that the definition of CEHRT
in § 414.1305 references several
certification criteria in the ONC Health
IT Certification Program for clinical
quality measurement, including:
‘‘Clinical quality measures (CQMs)—
record and export’’ (45 CFR
170.315(c)(1)), as part of the 2015 Base
EHR definition in 45 CFR 170.102;
‘‘Clinical quality measures (CQMs)—
import and calculate’’ (45 CFR
170.315(c)(2)); ‘‘Clinical quality
measures (CQMs)—report’’ (45 CFR
170.315(c)(3)); and, optionally, ‘‘Clinical
quality measures (CQMs)—filter’’ (45
CFR 170.315(c)(4)). Under this proposal,
at a minimum, a MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity would need to utilize technology
certified to the criteria at 45 CFR
170.315(c)(1) through (3) to report on
eCQMs. We reiterate that certified
Health IT Modules meeting these
criteria are not required to be provided
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by the same health IT developer; a MIPS
eligible clinician, group, virtual group,
subgroup, or APM Entity may use
Health IT Modules to meet the
certification requirements provided by
more than one developer. For example,
a MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity could
use certified health IT meeting the
criteria in 45 CFR 170.315(c)(1) and
(c)(2) provided as part of their EHR
system while a third party intermediary
that supports reporting on behalf of a
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity could
supply a Health IT Module that meets
the criterion in 45 CFR 170.315(c)(3) to
generate a measure report and thus,
enable a MIPS eligible clinician, group,
virtual group, subgroup, or APM Entity
to meet the requirement to use CEHRT
for eCQMs.
Lastly, we are proposing to establish
data submission criteria for the
Medicare CQM collection type (as
proposed under the APP in section
III.G.2. of this proposed rule) in
§ 414.1335(a)(4). Specifically, in
§ 414.1335(a)(4)(i), we are proposing
that the data submission criteria
pertaining to Medicare CQMs would be
met by, a MIPS eligible clinician, group,
and APM Entity reporting on the
Medicare CQMs (reporting quality data
on beneficiaries eligible for Medicare
CQMs as defined at § 425.20) within the
APP measure set and administering the
CAHPS for MIPS Survey as required
under the APP.
We seek public comment on the
proposals regarding the technical
amendments that pertain to the data
submission criteria for MIPS quality
measures and the establishment of data
submission criteria for Medicare CQMs.
(ii) Data Submission Criteria for the
CAHPS for MIPS Survey Measure
The CAHPS for MIPS Survey
measures patients’ experience of care
within a group, virtual group, subgroup,
and APM Entity, including Shared
Savings Program ACOs. The survey
measures ten dimensions of patient
experience of care, known as summary
survey measures, for which patients
may be the best, if not only source of
information. The CAHPS for MIPS
Survey is optional for all groups, virtual
groups, subgroups, and APM Entities of
2 or more eligible clinicians reporting
via traditional MIPS or MIPS Value
Pathways (MVPs), and is required for
Shared Savings Program ACOs reporting
via the APM Performance Pathway
(APP).
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(A) Require the Administration of the
CAHPS for MIPS Survey in the Spanish
Translation
We have created official translations
of the CAHPS for MIPS Survey in 7
languages, including Spanish,
Cantonese, Korean, Mandarin,
Portuguese, Russian, and Vietnamese, in
addition to the required administration
of English survey. However, use of these
translations is generally voluntary, with
the exception of the requirement to
administer the Spanish translation of
the CAHPS for MIPS Survey for patients
residing in Puerto Rico. Groups, virtual
groups, subgroups, and APM Entities
that elect CAHPS for MIPS Survey must
contract with a CMS-approved survey
vendor to administer the CAHPS for
MIPS Survey, and must request survey
translations for the vendor to administer
the CAHPS for MIPS Survey in an
optional language. Generally, the
CAHPS for MIPS Survey translations are
an additional cost to the groups, virtual
group, subgroup, and APM Entities.
Our analysis of historic CAHPS data
indicates that the use of survey
translations has not been widespread
and there is unmet need for access to
surveys in the 7 available translations.
The analysis of survey translation use
by groups and Shared Savings Program
ACOs fielding the CY 2021 performance
period CAHPS for MIPS Survey
indicates that 406 out of 559
organizations have about one percent to
9 percent respondents reporting they
speak a language other than English at
home, and 141 out of 559 organizations
have 10 percent or more respondents
reporting they speak a language other
than English at home. Among these 141
organizations with 10 percent or more
respondents reporting they speak a
language other than English at home,
114 organizations have all of their
survey responses in English. These data
highlight a potential gap in the need for
and access to a CAHPS for MIPS Survey
translation within at least 20 percent
(114 out of 559 organizations) of the
groups and Shared Savings Program
ACOs administering the 2021 CAHPS
for MIPS Survey. For the CAHPS for
MIPS Survey, the most common nonEnglish language spoken at home by
patients is Spanish. We analyzed data
from the U.S. Census Bureau,
specifically from the 2021 American
Community Survey, and found that
Spanish is spoken by 61 percent of
those who speak a language other than
English at home.311 Among those age 65
311 U.S. Census Bureau, 2021 American
Community Survey, S1603: Characteristics of
People by Language Spoken at Home, 2021
American Community Survey 5-Year Estimate
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and older who speak a language other
than English at home, 49 percent speak
Spanish. Requiring groups, virtual
groups, subgroups, and APM Entities to
administer the CAHPS for MIPS Survey
in English and Spanish would therefore
address much of the unmet need. The
requirement would indirectly require
vendors to offer the administration of
the Spanish translation of the CAHPS
for MIPS Survey, and would increase
costs to groups, virtual groups,
subgroups, and APM Entities.
We propose to require the
administration of the CAHPS for MIPS
Survey in the Spanish translation; more
specifically, we propose to require
groups, virtual groups, subgroups, and
APM Entities to contract with a CMSapproved survey vendor that, in
addition to administering the survey in
English, would administer the Spanish
translation to Spanish-preferring
patients using the procedures detailed
in the CAHPS for MIPS Quality
Assurance Guidelines. Also, we are
recommending that groups, virtual
groups, subgroups, and APM Entities
administer the survey in the other
available translations (Cantonese,
Korean, Mandarin, Portuguese, Russian,
and Vietnamese) based on the language
preferences of their patients. The
proposal and recommendation would
make the survey more accessible to
survey respondents who can only
respond in Spanish or another available
translation, and provide an opportunity
to better understand their experiences of
care and any disparities in care.
Furthermore, the requirement of the
administration of the Spanish
translation and the recommendation of
utilizing the other translations of the
CAHPS for MIPS Survey align with
CMS’s effort to provide culturally and
linguistically appropriate services
(CLAS), which are intended to advance
health equity, improve quality, and help
eliminate health care disparities.312
Other CMS-administered CAHPS
Surveys, such as the Medicare
Advantage and Prescription Drug Plan
CAHPS, require the administration of
Spanish translation survey. For the
fiscal year (FY) 2024 Medicare Hospital
Inpatient Prospective Payment System
(IPPS) and Long Term Care Hospital
(LTCH) Prospective Payment System
(PPS) proposed rule, the PPS-Exempt
Cancer Hospital Quality Reporting
Subject Tables. Available at https://
data.census.gov/
table?q=S1603&tid=ACSST5Y2021.S1603.
312 Centers for Medicare & Medicaid Services.
Achieving Health Equity. Available at https://
www.cms.gov/Outreach-and-Education/MLN/WBT/
MLN1857916-OMH-AHE/OMHAHE/ahe/lesson01/
09/.
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(PCHQR) Program is proposing to
require hospitals to collect information
about the language that the patient
speaks while in the hospital (whether
English, Spanish, or another language),
and that the official Spanish translation
of the Hospital CAHPS Survey be
administered to all patients who prefer
Spanish (88 FR 27114).
We seek public comment on the
proposal to require the administration of
CAHPS for MIPS Survey in the Spanish
translation. In addition, we are
interested in comments from
organizations that administer the
CAHPS for MIPS Survey on whether
they consider contracting with vendors
to administer the survey in one or more
of the available survey translations
based on the language preferences of
patients. If so, we are also interested in
learning about the factors that more or
less likely affect the administration of
survey translations where there is need
for one or more of the available
translations. These comments may
inform future rulemaking.
(d) Data Completeness Criteria
(i) Data Completeness Criteria for
Quality Measures, Excluding the
Medicare CQMs
As described in the CY 2017 Quality
Payment Program proposed rule (81 FR
28188 and 28189), to ensure that data
submitted on quality measures are
complete enough to accurately assess
each MIPS eligible clinician’s quality
performance, we established a data
completeness requirement. Section
1848(q)(5)(H) of the Act provides that
analysis of the quality performance
category may include quality measure
data from other payers, specifically, data
submitted by MIPS eligible clinicians
with respect to items and services
furnished to individuals who are not
individuals entitled to benefits under
Part A or enrolled under Part B of
Medicare. In the CY 2017 and CY 2018
Quality Payment Program final rules
and the CY 2020 PFS final rule, we also
noted that we would increase the data
completeness criteria threshold over
time (81 FR 77121, 82 FR 53632, and 84
FR 62951). For the CY 2017
performance period/2019 MIPS
payment year (first year of the
implementation of MIPS), CMS
established the data completeness
criteria threshold to reflect a threshold
of at least 50 percent (81 FR 77125). We
increased the data completeness criteria
threshold from at least 50 percent to at
least 60 percent for the CY 2018
performance period/2020 MIPS
payment year (81 FR 77125 and 82 FR
53633) and maintained a threshold of at
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least 60 percent for the CY 2019
performance period/2021 MIPS
payment year (82 FR 53633 and 53634).
For the CY 2020 performance period/
2022 MIPS payment year, we increased
the data completeness criteria threshold
from at least 60 percent to at least 70
percent (84 FR 62952). We maintained
data completeness criteria threshold of
at least 70 percent for the CY 2021, CY
2022, and CY 2023 performance
periods/2023, 2024, and 2025 MIPS
payment years (86 FR 65435 through
65438). For the CY 2024 and CY 2025
performance periods/2026 and 2027
MIPS payment years, we increased the
data completeness criteria threshold
from at least 70 percent to at least 75
percent (87 FR 70049 through 70052).
We continue to believe that it is
important to incrementally increase the
data completeness criteria threshold as
MIPS eligible clinicians, groups, virtual
groups, subgroups, and APM Entities
gain experience with MIPS.
The incorporation of higher data
completeness criteria thresholds in
future years ensures a more accurate
assessment of a MIPS eligible clinician’s
performance on quality measures and
prevents selection bias to the extent
possible (81 FR 77120, 82 FR 53632, 83
FR 59758, 86 FR 65436, and 87 FR
70049). We have encouraged all MIPS
eligible clinicians to perform the quality
actions associated with the quality
measures on their patients (82 FR
53632, 86 FR 65436, and 87 FR 70049).
The data submitted for each measure is
expected to be representative of the
individual MIPS eligible clinician,
group, or virtual group’s overall
performance for that measure. A data
completeness criteria threshold of less
than 100 percent is intended to reduce
burden and accommodate operational
issues that may arise during data
collection during the initial years of the
program (82 FR 53632, 86 FR 65436,
and 87 FR 70049).
We previously noted concerns raised
by interested parties regarding the
unintended consequences of
accelerating the data completeness
thresholds too quickly, which may
jeopardize a MIPS eligible clinicians’
ability to participate and perform well
under MIPS (81 FR 77121, 82 FR 53632,
84 FR 62951, and 87 FR 70049). We
want to ensure that an appropriate, yet
achievable, data completeness criteria
threshold is applied to all eligible
clinicians participating in MIPS. Based
on our analysis of data completeness
rates from data submission for the CY
2017 performance period,313 it is
313 As
described in the CY 2020 PFS final rule (84
FR 62951), the average data completeness rates
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feasible for eligible clinicians and
groups to achieve a higher data
completeness criteria threshold without
jeopardizing their ability to successfully
participate and perform in MIPS.
As MIPS eligible clinicians, groups,
and virtual groups have gained
experience participating in MIPS,
particularly meeting the data
completeness criteria threshold over the
last 7 years (from CY 2017 performance
period to CY 2023 performance period),
such experience has prepared MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entity to
meet incremental increases in the data
completeness criteria threshold. We
have maintained a data completeness
criteria threshold of at least 70 percent
for four years from the CY 2020
performance period to the CY 2023
performance period and as a result,
individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities had 4 years of a
maintained data completeness criteria
threshold of at least 70 percent before
transitioning to an increased data
completeness criteria threshold of at
least 75 percent for a 2-year timeframe
(CY 2024 and CY 2025 performance
periods) with more than 12 months to
prepare for an increased data
completeness criteria threshold of at
least 75 percent before such threshold
becomes effective for the CY 2024 and
CY 2025 performance periods/2026 and
2027 MIPS payment years.
As we assessed the timeframe for
increasing the data completeness
criteria threshold, we determined that
maintaining the data completeness
criteria threshold of at least 75 percent
for a total of 3 years would provide
sufficient time for MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities to
transition to another increase in the data
completeness criteria threshold. For the
CY 2026 performance period/2028 MIPS
payment year, we are proposing to
maintain the data completeness criteria
threshold of at least 75 percent. This
would provide MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities with sufficient time to
prepare for an incrementally increase in
the data completeness criteria threshold
starting with the CY 2027 performance
period/2029 MIPS payment year.
Therefore, MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities could continue
transitioning to an incrementally
increased data completeness criteria
were as follows: for individual eligible clinicians,
it was 76.14; for groups, it was 85.27; and for small
practices, it was 74.76.
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threshold of at least 75 percent to at
least 80 percent. In establishing data
completeness criteria thresholds in
advance of an applicable performance
period, it is advantageous to delineate
the expectations for MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities, so they
can adequately prepare for a transition
to higher data completeness criteria
threshold, particularly the increase in
data completeness criteria threshold to
at least 80 percent. Thus, we are
proposing to increase the data
completeness criteria threshold from 75
percent to 80 percent for the CY 2027
performance period/2029 MIPS
payment year.
The use of electronic health records
(EHRs) and eCQMs can reduce burden
associated with meeting higher data
completeness standards as the
collection of eCQM data within the EHR
can allow eligible clinicians to report on
100 percent of the eligible population
with data in the EHR for a measure. We
continue to encourage individual MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entities,
including small and rural practices, to
explore EHR adoption and the reporting
of eCQMs to reduce burden and
technical challenges to ensure data
accuracy as we seek to increase the data
completeness criteria threshold.
Individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities that continue to utilize
other means of data collection for MIPS
CQMs, including the collection of MIPS
CQM data reported by registries and/or
QCDRs, would need have the logic code
of their EHRs to be updated to account
for the increased data completeness
criteria threshold. Increasing the data
completeness criteria threshold would
not pose a substantial burden to MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entities,
unless they are manually extracting and
reporting quality data. However,
increasing the data completeness
criteria threshold provides for the more
accurate assessment of performance.
For the aforementioned reasons, it is
important to incrementally increase the
data completeness criteria threshold. In
this proposed rule, we are proposing to
maintain the data completeness
threshold for an additional year before
incrementally increasing the data
completeness criteria threshold.
Specifically, in § 414.1340(a), we are
proposing the following data
completeness criteria thresholds
pertaining to QCDR measures, MIPS
CQMs, and eCQMs:
• At paragraph (a)(4), for the CY 2026
performance period/2028 MIPS
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payment year, a MIPS eligible clinician,
group, virtual group, subgroup, and
APM Entity submitting quality measures
data on QCDR measures, MIPS CQMs,
or eCQMs must submit data on at least
75 percent of the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity’s patients that
meet the measure’s denominator
criteria, regardless of payer.
• At paragraph (a)(5), for the CY 2027
performance period/2029 MIPS
payment year, a MIPS eligible clinician,
group, virtual group, subgroup, and
APM Entity submitting quality measures
data on QCDR measures, MIPS CQMs,
or eCQMs must submit data on at least
80 percent of the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity’s patients that
meet the measure’s denominator
criteria, regardless of payer.
Similarly, in § 414.1340(b),
respectively, we are proposing the
following data completeness criteria
thresholds pertaining to Medicare Part B
claims measures:
• At paragraph (b)(4), for the CY 2026
performance period/2028 MIPS
payment year, a MIPS eligible clinician,
group, virtual group, subgroup, and
APM Entity submitting quality measures
data on Medicare Part B claims
measures must submit data on at least
75 percent of the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity’s patients seen
during the corresponding performance
period to which the measure applies.
• At paragraph (b)(5), for the CY 2027
performance period/2029 MIPS
payment year, a MIPS eligible clinician,
group, virtual group, subgroup, and
APM Entity submitting quality measures
data on Medicare Part B claims
measures must submit data on at least
80 percent of the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity’s patients seen
during the corresponding performance
period to which the measure applies.
Also, for the data completeness
criteria pertaining to the quality
performance category, we are proposing
technical amendments to recognize that
a virtual group, subgroup, and APM
Entity must meet the data completeness
criteria requirements established at
§ 414.1340(a), (b), and formerly
paragraph (d), new paragraph (e) due to
the proposal to establish the data
completeness criteria for the new
collection type, Medicare CQM, in
§ 414.1340(d) as discussed in the
following section, IV.A.4.f.(1)(d)(ii), of
this proposed rule.
We seek public comment on these
proposals.
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(ii) Data Completeness Criteria for the
Medicare CQMs
As we propose to establish a new
collection type, the Medicare CQMs
specific to the APM Performance
Pathway (APP) as described in section
III.G.2. of this proposed rule, we are also
proposing to establish the data
completeness criteria thresholds for the
Medicare CQMs. Specifically, in
§ 414.1340(d), respectively, we are
proposing the following data
completeness criteria thresholds
pertaining to Medicare CQMs:
• At paragraph (d)(1), for the CY
2024, CY 2025, and CY 2026
performance periods/2026, 2027, and
2028 MIPS payment years, an APM
Entity, specifically a Shared Savings
Program ACO that meets the reporting
requirements under the APP, submitting
quality measure data on Medicare CQMs
must submit data on at least 75 percent
of the APM Entity’s applicable
beneficiaries eligible for the Medicare
CQM, as proposed to be defined at
§ 425.20, who meet the measure’s
denominator criteria.
• At paragraph (d)(2), for the CY 2027
performance period/2029 MIPS
payment year, an APM Entity,
specifically a Shared Savings Program
ACO that meets the reporting
requirements under the APP, submitting
quality measure data on Medicare CQMs
must submit data on at least 80 percent
of the APM Entity’s applicable
beneficiaries eligible for the Medicare
CQM, as proposed to be defined at
§ 425.20, who meet the measure’s
denominator criteria.
We are proposing to establish the
aforementioned data completeness
criteria thresholds for the Medicare
CQMs collection type 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 CQMs 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.
(e) Selection of MIPS Quality Measures
Section 1848(q)(2)(D)(i) of the Act
requires the Secretary, through notice
and comment rulemaking, to establish
an annual final list of quality measures
from which MIPS eligible clinicians
may choose for the purpose of
assessment under MIPS. Section
1848(q)(2)(D)(i)(II) of the Act requires
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that the Secretary annually update the
list by removing measures from the list,
as appropriate; adding to the list, as
appropriate, new measures; and
determining whether measures that
have undergone substantive changes
should be included on the updated list.
Previously finalized MIPS quality
measures can be found in the CY 2023
PFS final rule (87 FR 70250 through
70633), CY 2022 PFS final rule (86 FR
65687 through 65968); CY 2021 PFS
final rule (85 FR 85045 through 85377);
CY 2020 PFS final rule (84 FR 63205
through 63513); CY 2019 PFS final rule
(83 FR 60097 through 60285); CY 2018
Quality Payment Program final rule (82
FR 53966 through 54174); and CY 2017
Quality Payment Program final rule (81
FR 77558 through 77816). We are
proposing changes to the MIPS quality
measure set, as described in Appendix
1 of this proposed rule, include the
following: the addition of new
measures; updates to specialty sets;
removal of existing measures, and
substantive changes to existing
measures. For the CY 2024 performance
period, we are proposing a measure set
of 200 MIPS quality measures in the
inventory.
The new MIPS quality measures that
we are proposing to include in MIPS for
the CY 2024 performance period and
future years can be found in Table
Group A of Appendix 1 of this proposed
rule. For the CY 2024 performance
period, we are proposed 14 new MIPS
quality measures, which includes one
composite measure; and 7 high priority
measures, of which 4 are also patientreported outcome measures.
In addition to the establishment of
new individual MIPS quality measures,
we develop and maintain specialty
measure sets to assist MIPS eligible
clinicians with selecting quality
measures that are most relevant to their
scope of practice. We are proposing
modifications to existing specialty sets
and new specialty sets as described in
Table Group B of Appendix 1 of this
proposed rule. Specialty sets may
include: new measures, previously
finalized measures with modifications,
previously finalized measures with no
modifications, the removal of certain
previously finalized quality measures,
or the addition of existing MIPS quality
measures. Specialty and subspecialty
sets are not inclusive of every specialty
or subspecialty.
On January 3, 2023, we announced
that we would be accepting
recommendations for potential new
specialty measure sets or revisions to
existing specialty measure sets for year
8 of MIPS under the Quality Payment
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Program.314 These recommendations
were based on the MIPS quality
measures finalized in the CY 2022 PFS
final rule and the 2022 Measures Under
Consideration List; the
recommendations include the addition
or removal of current MIPS quality
measures from existing specialty sets, or
the creation of new specialty sets. All
specialty set recommendations
submitted for consideration were
assessed and vetted, and as a result, the
recommendations that we agree with
were proposed in this proposed rule.
In addition to establishing new
individual MIPS quality measures and
modifying existing specialty sets and
new specialty sets as described in
Tables Group A and Group B of
Appendix 1 of this proposed rule, we
refer readers to Table Group C of
Appendix 1 of this proposed rule for a
list of quality measures and rationales
for measure removal. We have
previously specified certain criteria that
will be used when we are considering
the removal of a measure (81 FR 77136
and 77137; 83 FR 59763 through 59765;
84 FR 62957 through 62959). For the CY
2024 performance period, we are
proposing to remove 12 MIPS quality
measures and partially remove 3 MIPS
quality measures that are proposed for
removal from traditional MIPS and
proposed for retention for use in MVPs.
We refer readers to Table Group DD of
Appendix 1 of this proposed rule for
further information regarding the
proposals to retain such measures for
retention for use in relevant MVPs. Of
the 12 MIPS quality measures proposed
for removal, the following pertains to
such measures: 2 MIPS quality measures
are duplicative to a proposed new MIPS
quality measure; 3 quality measures are
duplicative of current measures; 5 MIPS
quality measures that are under the
topped-out lifecycle; one measure is
extremely topped out; and one MIPS
quality measure is constructed in a
manner that makes it difficult to
attribute the quality action to the
clinician, which creates burden. We
have continuously communicated to
interested parties our desire to reduce
the number of process measures within
the MIPS quality measure set (see, for
example, 83 FR 59763 through 59765).
The proposal to remove the quality
measures described in Table Group C of
the this proposed rule would lead to a
314 Message to the Quality Payment Program
listserv on January 3, 2023, entitled: ‘‘The Centers
for Medicare & Medicaid Services (CMS) is
Soliciting Stakeholder Recommendations for
Potential Consideration of New Specialty Measure
Sets and/or Revisions to the Existing Specialty
Measure Sets for the 2024 Performance Year of the
Merit-based Incentive Payment System (MIPS).’’
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more parsimonious inventory of
meaningful, robust measures in the
program, and that our approach to
removing measures should occur
through an iterative process that
includes an annual review of the quality
measures to determine whether they
meet our removal criteria.
Also, we are proposing substantive
changes to several MIPS quality
measures, which can be found in Table
Group D of Appendix 1 of this proposed
rule. We have previously established
criteria that would apply when we are
considering making substantive changes
to a quality measure (81 FR 77137, and
86 FR 65441 through 65442). We are
proposing substantive changes to 59
MIPS quality measures, which includes
3 MIPS quality measures proposed to be
retained for utilization under MVPs (we
refer readers to Table Group DD of
Appendix 1 of this proposed rule for
such measures that are proposed for
retention for use in relevant MVPs). On
an annual basis, we review the
established MIPS quality measure
inventory to consider updates to the
measures. Possible updates to measures
may be minor or substantive.
Lastly, we are proposing substantive
changes to the CMS Web Interface
measures that are available as a
collection type and submission type for
the Medicare Shared Savings Program
ACOs meeting reporting requirements
under the APP. The substantive changes
to the CMS Web Interface measures can
be found in Table Group E of Appendix
1 of this proposed rule.
We seek public comment on the
proposals to modify the quality
performance category measure set, a
measure set of 200 MIPS quality
measures in the inventory for the CY
2024 performance period, which
includes the following:
• Implementation of 14 new MIPS
quality measures: one composite
measure; and 7 high priority measures,
of which 4 are also patient-reported
outcome measures;
• Removal of 12 MIPS quality
measures: 2 quality MIPS measure are
duplicative to a proposed new quality
measure; 3 MIPS quality measures are
duplicative to current quality measures;
5 MIPS quality measures are under the
topped-out lifecycle; one MIPS quality
measure is extremely topped out; and
one MIPS quality measure is
constructed in a manner that makes it
difficult to attribute the quality action to
the clinician, which creates burden;
• Partial removal of 3 MIPS quality
measures: 3 MIPS quality measures
removed from traditional MIPS and
retained for use in MVPs; and
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• Substantive changes to 59 MIPS
quality measures.
(2) Cost Performance Category
Section 1848(q)(2)(A) of the Act
includes resource use as a performance
category under the MIPS. We refer to
this performance category as the cost
performance category. As required by
sections 1848(q)(2) and (5) of the Act,
the four performance categories of the
MIPS are used in determining the MIPS
final score for each MIPS eligible
clinician. In general, MIPS eligible
clinicians will be evaluated under all
four of the MIPS performance
categories, including the cost
performance category.
In this proposed rule, we are
proposing to add five new episodebased measures to the cost performance
category beginning with the CY 2024
performance period/2026 MIPS
payment year. These five measures are:
Depression, Emergency Medicine, Heart
Failure, Low Back Pain, and Psychoses
and Related Conditions. We are
proposing that MIPS eligible clinicians
must meet or exceed a minimum of 20
cases for each of these measures to be
assessed on such measure, and we are
seeking comments on our interpretation
of the language on the case minima
codified at § 414.1350(c). We are also
proposing to remove the Simple
Pneumonia with Hospitalization
episode-based measure from the cost
performance category beginning with
the CY 2024 performance period/2026
MIPS payment year. Finally, we are
proposing to add the five new episodebased measures and remove the Simple
Pneumonia with Hospitalization
episode-based measure from the
operational list of care episode and
patient condition groups and codes.
For a description of the statutory basis
for and existing policies pertaining to
the cost performance category, we refer
readers to § 414.1350 and the CY 2017
Quality Payment Program final rule (81
FR 77162 through 77177), CY 2018
Quality Payment Program final rule (82
FR 53641 through 53648), CY 2019 PFS
final rule (83 FR 59765 through 59776),
CY 2020 PFS final rule (84 FR 62959
through 62979), CY 2021 PFS final rule
(85 FR 84877 through 84881), CY 2022
PFS final rule (86 FR 65445 through
65461), and CY 2023 PFS final rule (87
FR 70055 through 70057).
(a) Addition of Episode-Based Measures
(i) Background
Under § 414.1350(a), we specify cost
measures for a performance period to
assess the performance of MIPS eligible
clinicians on the cost performance
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category. There are currently 25 cost
measures in the cost performance
category for the CY 2023 performance
period/2025 MIPS payment year,
comprising of 23 episode-based
measures covering a range of conditions
and procedures and two populationbased measures. We worked with the
measure development contractor to
identify the proposed five new episodebased measures for development
through empirical analyses and public
comment. These proposed measures
cover clinical topics and MIPS eligible
clinicians currently with limited or no
applicable cost measures. As such, these
proposed measures would help fill gaps
in the cost performance category’s
measure set. In addition, these proposed
measures would support the transition
from traditional MIPS to MIPS Value
Pathways (MVPs) by allowing for new
MVPs to be created and enhancing
existing MVPs. Further, the addition of
these proposed measures would address
interested parties’ feedback about the
need for more clinically refined
episode-based measures in the cost
performance category. This proposal
would also increase the cost coverage of
care episode and patient conditions
groups, moving closer towards the
statutory goal of covering 50 percent of
expenditures under Medicare Parts A
and B, as specified under section
1848(r)(2)(i)(I) of the Act.
At a high level, episode-based
measures represent the cost to Medicare
and beneficiaries for the items and
services furnished during an episode.
They aim to compare MIPS eligible
clinicians on the basis of the cost of care
that is clinically related to their
treatment and management of a patient
and provided during the episode’s
timeframe. Specifically, for such
measures, we define and measure the
cost of care for the episode based on the
allowed amounts on Medicare claims,
which include both Medicare trust fund
payments and any applicable
beneficiary deductible and coinsurance
amounts. The cost of care for these
measures includes amounts paid under
Medicare Parts A and B, and, on a caseby-case basis, Medicare Part D that have
been standardized to remove price
variation from non-clinical factors. The
Parts A and B payment standardization
methodology and the Part D payment
standardization methodology are
available at https://resdac.org/articles/
cms-price-payment-standardizationoverview. Information about how the
Part D standardization methodology
incorporates rebates into standardized
amounts is available at https://
www.cms.gov/files/document/2023-
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part-d-rebate-methodology.pdf. We refer
the readers to section IV.A.4.f.(2)(a)(iii)
of this proposed rule for more
information on the five episode-based
measures we are proposing.
In this proposed rule, we provide
detail about the new measures that we
are proposing to include in the cost
performance category beginning with
the CY 2024 performance period/2026
MIPS payment year. In section
IV.A.4.f.(2)(a)(ii) of this proposed rule,
we summarize the timeline for
development of these proposed
measures, including engagement
activities undertaken by the measure
development contractor. In section
IV.A.4.f.(2)(a)(iii) of this proposed rule,
we summarize the proposed new
measures that would be included in the
cost performance category beginning
with the CY 2024 performance period/
2026 MIPS payment year. For the
proposed Emergency Medicine episodebased measure, we provide detail about
the measure’s construction, which
evaluates a MIPS eligible clinician’s or
clinician group’s risk-adjusted cost of
care to Medicare for patients who
receive treatment in the Emergency
Department (ED) setting. In section
IV.A.4.f.(2)(b) of this proposed rule, we
discuss our proposal that MIPS eligible
clinicians must meet or exceed a
minimum of 20 cases for each of these
proposed measures to be assessed on
such measure and request comments on
our interpretation of case minima
regulatory language.
(ii) Overview of Measure Development
Process for New Episode-Based
Measures
In this section, we describe the
development process for the five
proposed episode-based measures.
Development of episode-based
measures for the cost performance
category must comply with the
statutorily required processes set forth
in section 1848(r) of the Act. We note
that the measure developer uses a
‘‘wave’’ approach to indicate cycles of
measure development where clinical
expert panels convene to select episode
groups to develop into cost measures
and to provide input on the measures’
specifications. All five of the proposed
measures have been developed with
extensive engagement from interested
parties, including clinicians, persons
with lived experience, and the general
public. The term ‘‘persons with lived
experience,’’ as used in this section
IV.A.4.f.(2) of this proposed rule, refers
to persons and family of persons who
have experienced these conditions or
diseases. Our approach to engagement is
outlined in the CY 2018 Quality
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Payment Program final rule (82 FR
53644 through 53645), the CY 2019 PFS
final rule (83 FR 59767 through 59769),
and the CY 2022 PFS proposed rule (86
FR 39396 through 39397). These
processes have been refined over time to
incorporate feedback from interested
parties, such as to extend the
development timeline from 12 months
in Wave 2 to 18 months in Waves 3 and
4, and to integrate bidirectional
conversations between persons with
lived experience and clinical experts.
Four of these measures began
development in 2020 in Wave 4 of
development, and one of these measures
has been in development and
refinement since 2018 (as part of Wave
2 of measure development).
Specifically, the Depression, Emergency
Medicine, Heart Failure, and Low Back
Pain episode-based measures were
developed in the Wave 4 cycle of
measure development through an 18month process. As a first step, the
measure development contractor held a
public comment period from December
2020 through February 2021 to gather
feedback on which clinical areas to
prioritize for development. During the
public comment period, the measure
developer received 36 comments on the
candidate episode groups for
development in Wave 4. This feedback,
in conjunction with empirical testing by
the measure development contractor,
was used to inform the decision to
develop these specific clinical areas—
depression, emergency medicine, heart
failure, and low back pain—into
episode-based measures. The summary
of the public comments is available in
this document https://www.cms.gov/
files/document/wave-4-publiccomment-summary.pdf.
Following our decision to develop
measures for depression, emergency
medicine, heart failure, and low back
pain, the measure development
contractor convened four clinician
expert panels, comprised of a total of 73
members, affiliated with 63
organizations and specialty societies.
Each panel also incorporated the
perspective of persons with lived
experience following a new approach
where their input is collected via
structured focus groups, interviews or
surveys, and then summarized and
presented to the clinical expert panels.
Then, the measure development
contractor held a national field testing
period from January 14, 2022 to March
25, 2022. During this field testing
period, MIPS eligible clinicians and
clinician groups meeting a minimum
threshold of episodes for each measure
could review field test reports and an
episode-level file with detailed
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information to understand the types of
services that comprise a large or small
share of their episode costs.
Supplemental materials, such as testing
information on measures, a Frequently
Asked Questions document, and mock
field test reports were posted publicly
for interested parties’ review. The
measure development contractor
gathered all feedback via a survey and
a summary of this feedback from the
field testing period is available at
https://www.cms.gov/files/document/
2022-field-testing-feedback-summaryreport.pdf.
The measure development contractor
also has a standing technical expert
panel (TEP), composed of 20 members
from different clinical areas, academia,
health care and hospital administration,
and persons with lived experience,
which provides overarching input on
cross-measure topics, such as testing
approaches and methodology. For
example, the TEP discussed challenges
in developing chronic condition
episode-based measures and ways that
the framework can address those
challenges, provided feedback on the
attribution rules (that is, the algorithms
and the types of codes used in each
algorithm) that would demonstrate a
relationship between a clinician group
and a patient with a chronic
condition(s), and discussed service
assignment, risk adjustment, and
exclusions. This input helped inform
the specifications for the chronic
condition episode-based measure
framework, which serves as the
framework for three of the chronic
condition episode-based measures (that
is, Depression, Heart Failure, and Low
Back Pain episode-based measures)
developed in Wave 4 and being
proposed in this proposed rule.
Separately from the other four
proposed measures, the Psychoses and
Related Conditions measure originally
had begun development in 2018 as part
of Wave 2, alongside 10 other episodebased measures. However, this measure
has not yet been implemented in the
cost performance category. During the
2018 through 2019 measure
development cycle, a convened clinical
expert workgroup met four times to
provide detailed input on the measure
and the measure was field tested as part
of the field testing period in 2018. The
summaries of the workgroup webinars
as well as the comments received on the
original version of the measure during
field testing are available on the QPP
Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
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We included the Psychoses and
Related Conditions measure in the
‘‘2018 Measures Under Consideration
List’’ (https://www.cms.gov/files/
document/2018rmuclistclearancerpt.pdf) and the Measure
Application Partnership (MAP)
reviewed the measure during the 2018–
2019 review cycle. In December 2018,
the MAP Clinician Workgroup provided
the Psychoses and Related Conditions
episode-based measure a preliminary
recommendation of ‘‘Conditional
support for rulemaking,’’ on the
condition of endorsement by a
consensus-based entity (CBE). In
January 2019, the MAP Coordinating
Committee overturned the MAP
Clinician Workgroup’s recommendation
and voted to replace it with a
recommendation of ‘‘Do not support for
rulemaking.’’ The MAP Coordinating
Committee’s concerns with the
Psychoses and Related Conditions
measure related to: (1) the measure’s
attribution model and its potential to
hold clinicians responsible for costs
outside of their influence; (2) geographic
variation in community resource
availability; (3) effects of physical
comorbidities on measure score; and (4)
the potential to exacerbate access issues
in mental health care. For more detail
please refer to the final report at https://
www.qualityforum.org/Publications/
2019/03/MAP_Clinicians_2019_
Considerations_for_Implementing_
Measures_Final_Report.aspx.
In the CY 2020 PFS proposed rule (84
FR 40760), we responded to the MAP
Coordinating Committee’s concerns, as
we believed that these concerns had
already been addressed through the
development and testing processes, and
solicited comments as part of the
request for information (RFI) on the
potential use of the original draft
version of the Psychoses and Related
Conditions episode-based measure in
the cost performance category in a
future MIPS performance period.
The measure development contractor
considered the MAP Coordinating
Committee’s comments and responses to
the RFI that we received when refining
the Psychoses and Related Conditions
measure in 2021–2022. In October 2021,
the measure developer reconvened the
Psychoses and Related Conditions
Clinical Expert Workgroup to consider
measure refinements to address
concerns, noting that the measure
concept continued to be important as it
would encourage value in mental health
care. The details of these refinements
are outlined in section IV.A.4.f.(2)(a)(iii)
of this proposed rule. Then, the measure
development contractor field tested the
Psychoses and Related Conditions
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measure alongside the other four
proposed new episode-based measures
discussed previously in this section of
the proposed rule. The feedback
received during field testing was further
discussed by the Psychoses and Related
Conditions Clinical Expert Workgroup
in April 2022.
More information about the measure
development and interested parties
engagement process for the five
proposed episode-based measures for
inclusion in the cost performance
category is available in materials on the
QPP Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures. Summaries of
the public comment period and
clinician expert workgroup meetings
organized by the measure development
contractor are also available on the QPP
Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
Similar to previous years, the measure
development contractor has continued
to engage clinicians and interested
parties through the standing TEP, public
comment periods, measure-specific
Clinical Expert Workgroups, Person and
Family Engagement opportunities, and
national field testing, as well as conduct
extensive education and outreach
activities. For more information on the
methods through which the measure
development contractor gathered expert
input during measure development and
other interested parties engagement
activities, please refer to the ‘‘2023
Summary of Cost Measures’’ document
that is available at https://www.cms.gov/
files/document/2023-mips-summarycost-measures.pdf.
After these extensive measure
development and refinement activities,
we included the five proposed episodebased measures on our 2022 Measures
Under Consideration (MUC) List
(available for download at https://
mmshub.cms.gov/sites/default/files/
2022-MUC-Lst.xlsx) to be considered for
potential use in MIPS. The MAP
reviewed the measures during the 2022–
2023 review cycle. This process
involved reviews by the MAP Health
Equity and MAP Rural Health Advisory
Groups, as well as two public comment
periods. In December 2022, the MAP
Clinician Workgroup discussed the
measures, taking into consideration the
input from the MAP Health Equity and
MAP Rural Health Advisory Groups and
the public comments. The MAP
Clinician Workgroup reached consensus
to conditionally support all five
episode-based measures for rulemaking,
pending the endorsement of the
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measures by a CBE. The MAP Clinician
Workgroup’s concerns related to the
inclusion of Medicare Part D covered
items and services in certain measures,
potential unintended consequences of
assessing costs related to mental health
care, appropriateness of the attribution
methodology, and request for additional
detail on testing into adjusting for social
determinants of health (for example,
geographic location and socioeconomic
status) and evidence of care stinting. In
January 2023, the MAP Coordinating
Committee upheld the MAP Clinician
Workgroup’s preliminary
recommendation. More information
about these recommendations is
available in the 2022–2023 MAP Final
Recommendations document at https://
www.qualityforum.org/WorkArea/
linkit.aspx?LinkIdentifier=id&itemID=
98102.
We believe that the concerns raised
regarding these proposed measures have
been addressed during measure
development and the MAP meetings.
Additionally, some interested parties
recognized the importance of these
measures, specifically highlighting the
importance of episode-based measures
assessing mental health care. We agree
with these interested parties. On these
bases, we are proposing all five of these
episode-based measures for inclusion in
the cost performance category beginning
with the CY 2024 performance period/
2026 MIPS payment year.
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(iii) New Episode-Based Measures
Beginning With the CY 2024
Performance Period/2026 MIPS
Payment Year
In this section of this proposed rule,
we discuss the five new episode-based
The three chronic condition episodebased measures assess outpatient
treatment and ongoing management of
the following chronic conditions:
depression, heart failure, and low back
pain. The measure construction for
these three proposed measures follows
the approach described in the CY 2022
PFS final rule (86 FR 65445 through
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measures, which we propose to add to
the cost performance category beginning
with the CY 2024 performance period/
2026 MIPS payment year.
In conjunction with our measure
development contractor, we developed
these measures with consideration of
the common standards that are
described in the CY 2022 PFS final rule
(86 FR 65455 through 65459) to ensure
consistency across episode-based
measures being developed. Specifically,
the CY 2022 PFS final rule requires that
any episode-based measure for the cost
performance category include the
following: (1) episode definition based
on trigger codes that determine the
patient cohort; (2) attribution; (3) service
assignment; (4) exclusions; and (5) risk
adjustment. The five new episode-based
measures we are proposing meet all
requirements described in CY 2022 PFS
final rule, including these features. We
provide more information on the
specific requirements for each of the
proposed episode-based measures later
in this section of the proposed rule.
Generally, for all episode-based
measures, we exclude episodes where
costs cannot be fairly compared to the
costs for the whole cohort in the
episode-based measure. These
exclusions, like other features of each
episode-based measure, are developed
with extensive clinician and interested
parties’ engagement. We have specified
exclusions for all five proposed episodebased measures, and discuss certain
exclusions for the Psychoses and
Related Conditions and the Emergency
Medicine measure in further detail in
this section of this proposed rule.
Generally, we also apply a risk
adjustment model to all episode-based
measures in the cost performance
category. The model includes standard
risk adjustors that are applied to all
episode-based measures (for example,
CMS Hierarchical Condition Category
[HCC] variables, comorbidities, age
brackets, disability status, ESRD status),
and measure-specific risk adjustors (for
example, patient transfers from another
setting for the Emergency Medicine
measure). We assess the risk adjustment
model at the level of each stratification
to ensure that only like patients are
compared to each other. The risk
adjustment model we use in
development of the cost performance
category’s episode-based measures is
described in greater detail in CY 2019
PFS final rule (83 FR 59767 through
59773). As mentioned previously in this
section, all five proposed episode-based
measures have been risk adjusted in
accordance with this model.
More information on the episodebased measure development
requirements, which were outlined so
that external interested parties could
develop measures in the future, are
available in the Blueprint for the CMS
Measures Management System (https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/MMS/MMS-Blueprint) and
the Meaningful Measures Framework
(https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/QualityInitiativesGenInfo/
MMF/General-info-Sub-Page).
The episode-based measures that we
are proposing for CY 2024 performance
period/2026 MIPS payment year and
future performance periods are listed in
the Table 43.
65461), which also includes detailed
discussion of the attribution
methodology and examples of how
episodes are attributed.
The attribution methodology that
identifies a clinician-patient care
relationship is slightly different at the
clinician group and individual MIPS
eligible clinician levels, to reflect that
care provided at the clinician group and
individual MIPS eligible clinician
levels, respectively. At a high level,
these proposed chronic condition
episode-based measures attribute
episodes to the clinician group that
renders services that constitute a trigger
event, which is identified by the
occurrence of two claims billed in close
proximity by the same clinician group.
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Both claims must have a diagnosis code
indicating the same chronic condition
related to the specific episode-based
measure. For example, for the Heart
Failure measure, both claims of the
trigger event must have a diagnosis
indicating heart failure. The services
that trigger an event for these chronic
condition episode-based measures are
identified first by Evaluation and
Management (E/M) codes for outpatient
services, and then by a second claim
with either another E/M code for
outpatient services or a conditionrelated Current Procedural Terminology
(CPT)/Healthcare Common Procedure
Coding System (HCPCS) code (CPT/
HCPCS) related to the treatment or
management of the chronic condition.
The trigger event opens a year-long
attribution window from the date of the
initial E/M outpatient service, during
which the same clinician group could
reasonably be considered responsible
for managing the patient’s chronic
condition. If we see evidence that the
relationship is ongoing, represented by
another E/M or condition-related
procedure code that we refer to as the
reaffirming claim, then this window can
be extended.
For individual MIPS Eligible
clinicians, we would attribute episodes
to each individual MIPS eligible
clinician within an attributed clinician
group that renders at least 30 percent of
trigger or reaffirming codes on Part B
Physician/Supplier claim lines during
the episode, such as office visits or
diagnostic services. We also apply
conditions to ensure the MIPS eligible
clinicians to whom the episode is
attributed are reasonably responsible for
the management of the patient’s chronic
condition. Specifically, the MIPS
eligible clinician must have provided
condition-related care to this patient
prior to or on the episode start date.
Additionally, we use the providerlevel prescription billing patterns to
ensure that we are capturing the MIPS
eligible clinicians directly involved in
providing ongoing chronic care
management, rather than clinicians who
might have only refilled a patient’s
prescription once, as a courtesy to the
patient. Specifically, for some measures
(that is, Diabetes, Asthma/COPD
episode-based measure that were
finalized for use in the MIPS cost
performance category for the CY 2022
PFS final rule (86 FR 64996), and Heart
Failure episode-based measure that is
being proposed in this rule.
The Psychoses and Related
Conditions measure is an acute
inpatient medical condition episodebased measure, which focuses on
patients hospitalized for schizophrenia,
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delusional disorders, brief psychotic
disorder, schizoaffective disorder,
manic episode with psychotic
symptoms, bipolar disorder with
psychotic symptoms, major depressive
disorder with psychotic symptoms, or
unspecific psychosis. This acute
inpatient medical condition was
developed in accordance with the
previously established framework for
episode-based measures, which we
described in detail in the CY 2019 PFS
final rule (83 FR 59769 through 59771).
We selected the Psychoses and Related
Conditions measure for development
because empirical analyses have
identified psychoses-related
hospitalizations are one of the most
common inpatient stays, so it has a
strong potential to be impactful on
Medicare spending. This measure
would also contribute to filling the
current identified gap in the cost
performance category’s measurement of
mental health care, as currently there
are no episode-based or other cost
measures assessing this clinical area.
As noted in the previous section of
this proposed rule, the Psychoses and
Related Conditions measure has been
refined since the RFI in CY 2020 PFS
proposed rule (84 FR 40760 through
40761) considering expert and other
interested parties’ input and to further
address the MAP Coordinating
Committee’s previously expressed
concerns in the 2018–2019 measure
development cycle about the ability of
inpatient clinicians to affect postdischarge care. In response to this input
and these concerns, we implemented
three refinements of this measure. First,
we reduced the length of the episode
window reduced from 90 to 45 days.
This shortened episode window helps
to ensure that MIPS eligible clinicians
can reasonably be held accountable for
post-discharge care, while still
capturing readmissions and ED visits
shortly after the trigger event, which
persons with lived experience had
noted as being important outcomes to
identify and measure because these
outcomes could be avoided with better
discharge planning and follow-up care.
Second, we refined this measure’s
specifications to account for specific
scenarios where MIPS eligible clinicians
have limited ability to influence a
patient’s care. Specifically, this measure
now excludes episodes with involuntary
holds at admission and episodes which
are transfers to State hospitals. Third,
we refined this measure’s specifications
to risk adjust for facility type to account
for differences in payment policies
between Inpatient Prospective Payment
System (IPPS) and Inpatient Psychiatric
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Facility (IPF) hospitals. While we
continue to believe that the original
measure had accounted for concerns
about the ability of inpatient clinicians
to influence costs after discharge as
described in the CY 2020 PFS proposed
rule (84 FR 40760 through 40761), we
also believe that these changes further
refine the measure to meaningfully
assess costs related to the role of
clinicians caring for patients during
mental health hospitalizations.
The Emergency Medicine measure
assesses the cost of care clinically
related to the treatment of a patient
during an ED visit. The intent of this
measure is to comprehensively assess
all types of care in an ED, so the
construction of the measure reflects the
goal of capturing this broad scope of
care. As such, this measure is
characterized as a ‘‘care setting’’ episode
type.
A CPT/HCPCS code indicating that a
clinician has furnished care in the ED
setting triggers the Emergency Medicine
measure. The clinician billing the
trigger code is attributed the episode. A
clinician group is attributed by
aggregating all episodes attributed to
clinicians that bill to the clinician
group. The trigger code also opens a 14day episode window, during which the
attributed clinician is responsible for
costs.
The Emergency Medicine measure
stratifies episodes based on the type of
care the patient received during their ED
visit and by disposition status. First,
episodes are divided into 28 mutually
exclusive groups called ED visit types
that characterize the focus of care a
patient received during their visit.
These represent more granular,
exhaustive patient populations defined
by clinical criteria including the threedigit diagnosis codes available on a
patient’s ED visit claims, as well as a
Medicare Severity Diagnosis Related
Group (MS–DRG) of a subsequent
inpatient stay if present. Given the goal
of the Emergency Medicine measure to
capture the broader universe of care
provided in the emergency setting,
dividing this measure’s episodes into
ED visit types is a technique to ensure
clinical comparability. Examples of a
few of the most frequent ED visit types
associated with this Emergency
Medicine measure are respiratory,
gastrointestinal or liver, and kidney and
urinary conditions. The 28 ED visit
types are further stratified by whether
(1) the ED visit resulted in subsequent
observation care or inpatient admission
or (2) the patient was discharged
without subsequent observation care or
inpatient admission. For example, ED
visits for a stroke which end in
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discharge are only compared with other
ED visits for a stroke that also end in
discharge.
The Emergency Medicine measure
includes all Medicare Parts A and B
services during the 14-day episode
window, except for certain services
determined to not be clinically relevant
to the ED visit type. This reflects the
intent of the measure and the broad
clinician role in the ED setting. The ED
visit type associated with the specific
episode determines whether a service is
clinically unrelated and therefore
excluded from the episode. For
example, if a patient visits the ED for
ear, nose and throat (ENT) and eye
disorders, any subsequent services for
psychoses or behavioral and
developmental disorders are excluded.
However, if a patient visits the ED to
receive care for an altered mental state,
these subsequent services for psychoses
or behavioral and developmental
disorders are not excluded.
The Emergency Medicine measure
risk adjusts costs just like all other
episode-based measures. This measure
uses the standard risk adjustment model
described previously in this section.
Also, as discussed, we assessed the risk
adjustment model at the level of each
stratification. This means that for the
Emergency Medicine measure, the risk
adjustment is applied to each
combination of ED visit type and
disposition status. For example, the risk
adjustment model would assess
separately a kidney and urinary episode
that resulted in an inpatient stay, a
kidney and urinary episode that
resulted in a discharge, a fracture
episode that resulted in an inpatient
stay, and a fracture episode that resulted
in a discharge.
Similar to other episode-based
measures in use in the cost performance
category and the episode-based
measures proposed in this rule, we
exclude episodes in cases where costs
cannot be fairly compared to the costs
for the whole cohort in the Emergency
Medicine measure. For example,
episodes are excluded for patients
transferred to another ED facility from
the triggering ED facility.
The proposed specifications for all
five proposed episode-based measures
are available at https://www.cms.gov/
Medicare/Quality-Payment-Program/
Quality-Payment-Program/GiveFeedback. The specifications documents
for each proposed measure consist of a
methods document that describes the
steps for constructing the measure and
a measure codes list file that contains
the medical codes used in that
methodology. First, the methods
document provides detailed
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methodology describing each step to
construct the measure, including:
identifying patients receiving care,
defining an episode-based measure,
attributing episodes to MIPS eligible
clinicians and clinician groups,
assigning costs, defining exclusions, risk
adjusting, and calculating measure
score. Second, the measure codes list
file contains the codes used in the
measure specifications, including the
episode triggers, attribution,
stratification, assigned items and
services, exclusions, and risk adjustors.
More information about the five
proposed episode-based measures is
available in the measure justification
forms, which provide a comprehensive
characterization of the measures, their
justification, and testing results of these
measures’ specifications. These
documents are available through the
QPP Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
We are seeking public comment on
our proposal to add the five episodebased measures, which are listed in
Table 43.
(b) Reliability and Case Minimum
In this section of the proposed rule,
we discuss the proposed case minima to
use for the five proposed episode-based
measures and provide clarification on
the interpretation of our regulation at
§ 414.1350(c) regarding the case minima
for episode-based measures.
Specifically, we propose a 20-episode
case minimum for each of the five
proposed measures based on our
analysis of the reliability of each
measure. We also provide clarification
regarding application of our regulatory
language under § 414.1350(c)(4) through
(6). Currently, § 414.1350(c)(4) through
(6) establishes the case minima for each
type of episode-based measure (that is,
procedural, acute inpatient medical
condition, and chronic condition,
respectively) beginning with a certain
CY performance period/MIPS payment
year specified therein. In this proposed
rule, we are clarifying that the case
minima established in § 414.1350(c)(4)
through (6) applies to both the episodebased measure(s) we specified as
beginning in the indicated performance
period when the applicable regulatory
provision was codified and for all
episode-based measures of the same
type that we specify to begin in
subsequent performance periods, unless
we specify otherwise for individual
measure(s) in future rulemaking. We
also note that, consistent with our past
and current practice, we will continue
testing the mean reliability of any
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potential episode-based measures that
we propose to adopt in future
rulemaking before applying the case
minimum established in these
regulations, as described later in this
section.
Reliability is a metric that evaluates
the extent that variation in a measure
comes from clinician performance
(‘‘signal’’) rather than random variation
(‘‘noise’’). Higher reliability suggests
that a measure is effectively capturing
meaningful differences between
clinicians’ performance. However, we
continue to caution against using
reliability as the sole metric to evaluate
a measure because of the tradeoffs
between accuracy and reliability, and
the role of service assignment in
reducing noise. These and other
considerations are detailed in the CY
2022 PFS final rule (86 FR 65453
through 65455). We also note that
increasing case minima necessarily
reduces the number of clinicians who
meet the case minimum for a given
measure. Because these are clinically
refined measures, we aim to have as
many clinicians as possible to be able to
have their costs evaluated by them.
Therefore, we consider that a mean
reliability of 0.4 represents moderate
reliability because it accounts for these
considerations and is a sufficient
threshold to ensure that the measure is
performing as intended when assessed
in conjunction with other testing.
We previously established at
§ 414.1350(c)(5) a case minimum of 20
episodes for acute inpatient medical
condition episode-based measures in
the CY 2019 PFS final rule (83 FR 59773
through 59774). We also established at
§ 414.1350(c)(6) a case minimum of 20
episodes for chronic condition episodebased measures in the CY 2022 final
rule (86 FR 65453 through 65455). We
have not adopted any care setting
episode-based measures in the cost
performance category, and therefore we
have not established any case
minimums for this type of episodebased measures. In this proposed rule,
we considered a case minimum of 20 for
each of the five proposed episode-based
measures and then examined the
reliability of the measures against this
case minima.
We examined the reliability of the five
proposed episode-based measures, and
Table 44 presents the percentage of tax
identification numbers (TINs) and TIN/
National Provider Identifiers (NPIs) that
meet the 0.4 reliability threshold and
the mean reliability for TINs and TIN/
NPIs at our proposed case minimum of
20 for each of the episode-based
measures. At a 20-episode case
minimum, the mean reliability for the
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proposed Depression, Heart Failure,
Low Back Pain, and Psychoses and
Related Conditions measures exceeds
0.4 for both groups and individual
clinicians, and the majority of groups
and individual clinicians meet the 0.4
reliability threshold. Similarly, at a 20episode case minimum, the mean
reliability for the proposed Emergency
Medicine measure exceeds 0.4 for both
groups and individual clinicians, and
all groups and individual clinicians
meet the 0.4 reliability threshold.
We believe that calculating these five
proposed episode-based measures with
these case minimums will accurately
and reliably assess the performance of
clinicians and clinician group practices.
Therefore, we are proposing to adopt a
case minimum of 20 episodes for each
of the five proposed new episode-based
measures. Given that we have not
previously established any case
minimums for the care setting episodebased measures, we also propose to
codify the 20-episode case minimum for
care setting episode-based measures
under § 414.1350(c)(7).
Additionally, as we were reviewing
our existing regulatory language under
§ 414.1350(c), we recognized the need to
clarify the intended interpretation of the
language because we acknowledge that
the current framing is open to
reasonable interpretation. Specifically,
we clarify that the regulatory language
at § 414.1350(c)(4) through (6)
establishes the case minima for episodebased measures of each episode type
(that is, procedural, acute inpatient
medical condition, and chronic
condition, respectively) such that the
case minimum specified therein applies
to all episode-based measures of that
episode type, regardless of when the
measure is adopted for inclusion in the
cost performance category, unless
otherwise specified for individual
measure(s). For example, under
§ 414.1350(c)(6), the chronic condition
episode-based measures that were
specified beginning with the CY 2022
performance period/2024 MIPS
payment year when this regulatory
provision was codified (that is, the
Diabetes and the Asthma/COPD
measure) and any chronic condition
episode-based measure specified after
the CY 2022 performance period/2024
MIPS payment year will have a case
minimum of 20 episodes, unless we
specify otherwise for an individual
measure.
We are proposing to update the
regulatory language under
§ 414.1350(c)(4) through (6) to more
clearly reflect this clarification. In
addition, we are proposing that this
interpretation will also apply to
§ 414.1350(c)(7) for care setting episodebased measures, which we are
proposing under this section of this
proposed rule.
We believe that it is appropriate to
use case minimum based on the
measure type for current and future
measures in MIPS, as each measure
episode type uses a consistent
framework across measures so the case
minimum should be also consistent,
where possible. Additionally, consistent
case minimum simplifies the level of
information a MIPS eligible clinician or
clinician group must monitor for the
episode-based measures as the number
of measures used in the cost
performance category continues to grow.
We note that for any future measure
under consideration to be implemented
in the cost performance category, case
minima would still be evaluated against
reliability testing, and could be different
from the standard case minima
established for the respective measure
type under § 414.1350(c), as needed.
We are inviting comment on our
proposals in this section IV.A.4.f.(2)(b),
including our proposal to adopt these
five episode-based measures in the cost
performance category proposals and our
interpretation of the existing regulatory
language on the case minima for
episode-based measures.
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(c) Removal of Simple Pneumonia With
Hospitalization Measure From the MIPS
Cost Performance Category Beginning
With the CY 2024 Performance Period/
2026 MIPS Payment Year
In this section of the proposed rule,
we are proposing to remove the Simple
Pneumonia with Hospitalization
episode-based measure from the cost
performance category beginning with
the CY 2024 performance period/2026
MIPS payment year.
The Simple Pneumonia with
Hospitalization episode-based measure
was implemented for use in the MIPS
cost performance category starting with
CY 2019 performance period/2021 MIPS
payment year (83 FR 59767 through
59773). Due to the impact of the
COVID–19 pandemic, in accordance
with § 414.1380(c)(2)(i)(A)(2), we
assigned a weight of zero percent to the
cost performance category for the CY
2020 performance period/2022 MIPS
payment year and CY 2021 performance
period/2023 MIPS payment year, and
redistributed the prescribed weight to
another performance category or
categories, as established at
§ 414.1380(c)(2)(ii)(D). Therefore, no
clinician or clinician group was scored
on any episode-based measures,
including the Simple Pneumonia with
Hospitalization episode-based measure,
for those 2 years.
For the CY 2022 performance period/
2024 MIPS payment year, we
announced via email communication
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(subject: 2021 Quality Payment Program
Experience Report and Infographic Now
Available; Policy Update: Excluded
MIPS Cost Measure for 2022
Performance Period) on June 12, 2023,
that in accordance with
§ 414.1380(b)(2)(v)(A), we would
suppress the Simple Pneumonia with
Hospitalization episode-based measure,
so that eligible clinicians and clinician
groups would not be scored on this
measure for that performance period.
This is a direct result of the
International Classification of Diseases,
Tenth Revision (ICD–10) coding updates
related to COVID–19 that impacted the
underlying population originally
intended to be captured by this
measure. Specifically, on January 1,
2021, an ICD–10 diagnosis code for
pneumonia due to COVID–19 (J12.82)
came into effect. Our guidance in the FY
2021 ICD–10–CM Official Guidelines for
Coding and Reporting stated that this
should be coded as secondary to
COVID–19 (U07.1) (https://
www.cms.gov/files/document/2021coding-guidelines-updated12162020.pdf). However, these two
diagnosis codes (J12.82 and U07.1) map
to different Medicare Severity Diagnosis
Related Groups (MS–DRGs). J12.82
maps to the trigger codes for the Simple
Pneumonia with Hospitalization
measure (MS–DRGs 193–195, Simple
Pneumonia and Pleurisy with MCC,
with CC, and without CC/MCC,
respectively), while U07.1 maps to
Respiratory Infections and
Inflammations (MS–DRGs 177–179,
Respiratory Infections and
Inflammations with MCC, with CC, and
without CC/MCC, respectively), which
are not used in this measure’s trigger
codes. That is, while this cost measure
should include pneumonia due to
COVID–19, it is unable to because it
does not use MS–DRGs 177–179 in its
trigger logic. For more information on
the codes used to trigger Simple
Pneumonia with Hospitalization
measure episodes and the measure
construction steps in general, please
refer to the codes list file document
available for download from the QPP
Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
Once sufficient data became available
from claims submitted in CY 2022 for
our review and analysis, we conducted
empirical testing. This empirical testing
demonstrated that these coding changes
have resulted in a marked decrease in
the number of Simple Pneumonia with
Hospitalizations episodes. Specifically,
we have seen a significant decrease in
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the number of episodes, by almost half,
as a direct result of this coding change.
The measure does not use MS–DRGs
177–179 in its trigger logic and,
therefore, the measure is unable to
capture many pneumonia episodes, per
the original measure intent. Empirical
testing further showed that this
significant decrease has resulted in
many clinicians no longer meeting the
20-episode case minimum for
attribution of the measure On these
bases, we have excluded the Simple
Pneumonia with Hospitalization
measure from scoring for the CY 2022
performance period under
§ 414.1380(b)(2)(v)(A) because (1) these
coding changes present a significant
change external to care; and (2) these
changes impacted calculation of the cost
measures such that it would lead to
misleading or inaccurate results, as
demonstrated by the empirical analysis
described in this section.
Given that these underlying coding
issues affect the measure’s ability to
capture the intended population and
that their uneven impact on MIPS
eligible clinicians is expected to
continue, we are proposing to remove
the Simple Pneumonia with
Hospitalization measure from the cost
performance category beginning with
CY 2024 performance period/2026 MIPS
payment year. We do not believe that it
is appropriate to continue to use the
measure as currently specified without
any changes to address the coding
changes that formed our basis to
suppress this measure in the CY 2022
performance period/2024 MIPS
payment year. In other words, because
we have already determined that the
Simple Pneumonia with Hospitalization
measure warranted exclusion under
§ 414.1380(b)(2)(v)(A) because the
coding changes lead to misleading or
inaccurate results in calculating the
measure’s score, it would be
inappropriate to retain this measure for
the CY 2024 performance period/2026
MIPS payment year as currently
specified. This will continue to be true
while the triggering methodology is
specified in a way that is incongruous
with billing practices. While we are
exploring substantive changes to the
measure’s triggering methodology in
response to the coding changes, the
scope of these changes and the potential
impacts of these changes on other
elements of the measure require careful
consideration and feedback from the
Simple Pneumonia with Hospitalization
Clinician Expert Workgroup and other
interested parties prior to
implementation. Because of these
circumstances, we propose to remove
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the Simple Pneumonia with
Hospitalization measure as it is
currently specified from use in MIPS
beginning with the CY 2024
performance period/2026 MIPS
payment year.
We note that we have been
comprehensively re-evaluating the
Simple Pneumonia with Hospitalization
measure, given the significant coding
changes impacting calculation of this
measure. The purpose of comprehensive
re-evaluation is to ensure that measures
continue to meet criteria for importance,
scientific acceptability, and usability in
line with the CMS Measures
Management System Blueprint (https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/MMS/MMS-Blueprint). In
this process, we holistically review the
measure, seek public comment, and
consider whether any changes need to
be made to measure specifications after
a measure has been in use for 3 years.
A new version of the measure—
Respiratory Infection Hospitalization—
may be considered for implementation
in MIPS in future years, after
undergoing the pre-rulemaking and the
notice-and-comment rulemaking
processes. For more information on the
re-evaluation efforts of the Simple
Pneumonia with Hospitalization
episode-based measure or other
measures, please refer to the documents
under the ‘‘Wave 1 cost measure
comprehensive reevaluation (2022–
2023)’’ section of the QPP Cost Measure
Information page at https://
www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
We are inviting comments on this
proposal.
(d) Proposed Revisions to the
Operational List of Care Episode and
Patient Condition Groups and Codes
We are proposing revisions to the
operational list of care episode and
patient condition groups and codes to
reflect the proposal of any new episodebased measures. Section IV.A.4.f.(2)(d)
of this proposed rule provides context
on the statutory requirements for care
episode and patient condition groups
and proposes changes to the operational
list.
Section 1848(r) of the Act specifies a
series of steps and activities for the
Secretary to undertake to involve
physicians, practitioners, and other
interested parties in enhancing the
infrastructure for cost measurement,
including for purposes of MIPS and
APMs. Section 1848(r)(2) of the Act
requires the development of care
episode and patient condition groups,
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and classification codes for such groups,
and provides for care episode and
patient condition groups to account for
a target of an estimated one-half of
expenditures under Medicare Parts A
and B (with this target increasing over
time as appropriate). Sections
1848(r)(2)(E) through (G) of the Act
require the Secretary to post on the CMS
website a draft list of care episode and
patient condition groups and codes for
solicitation of input from interested
parties, and subsequently, post an
operational list of such groups and
codes. Section 1848(r)(2)(H) of the Act
requires that not later than November 1
of each year (beginning with 2018), the
Secretary shall, through rulemaking,
revise the operational list of care
episode and patient condition codes as
the Secretary determines may be
appropriate, and that these revisions
may be based on experience, new
information developed under section
1848(n)(9)(A) of the Act, and input from
physician specialty societies and other
interested parties.
For more information about past
revisions to the operational list that we
made as we developed and proposed
episode-based measures, we refer
readers to CY 2020 PFS final rule (84 FR
62968 through 62969) and CY 2022 PFS
final rule (86 FR 65445 through 65461).
The current operational list and prior
operational lists is available at the QPP
Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
Additionally, as required by section
1848(r)(2)(I) of the Act, information on
resource use (or cost) measures
currently in use in MIPS, cost measures
under development and the time-frame
for such development, potential future
cost measure topics, a description of
engagement with interested parties, and
the percent of expenditures under
Medicare Parts A and B that are covered
by cost measures must be provided on
the website of CMS not later than
December 31 of each year.
In accordance with section
1848(r)(2)(H) of the Act, we are
proposing to revise the operational list
beginning with the CY 2024
performance period/2026 MIPS
payment year to include five new care
episode and patient condition groups,
based on input from clinician specialty
societies and other interested parties, as
discussed in section IV.A.4.f.(2)(a)(ii) of
this proposed rule. We propose
including Emergency Medicine and
Psychoses and Related Conditions as
care episode groups and Heart Failure,
Low Back Pain, and Depression as
patient condition groups. These care
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episode and patient condition groups
serve as the basis for the five new
episode-based measures that we are
proposing in section IV.A.4.f.(2)(a)(iii)
of this proposed rule for the cost
performance category. The codes that
define these five care episode and
patient condition groups align with the
trigger codes of the proposed episodebased measures in section
IV.A.4.f.(2)(a)(iii) of this proposed rule.
As described in section
IV.A.4.f.(2)(a)(ii), these specifications
are developed with extensive input from
interested parties.
Additionally, we propose to revise the
operational list to remove the Simple
Pneumonia with Hospitalization care
episode group. As discussed in section
IV.A.4.f.(2)(c)of this proposed rule, we
are proposing to remove this episodebased measure from the cost
performance category, so the codes that
define this care episode group would no
longer need to remain in the operational
list.
Our proposed revisions to the
operational list are available on our QPP
Cost Measure Information page at
https://www.cms.gov/Medicare/QualityPayment-Program/Quality-PaymentProgram/Cost-Measures.
We are inviting comments on this
proposal.
(3) Improvement Activities Performance
Category
(a) Background
For previous discussions on the
general background of the improvement
activities performance category, we refer
readers to the CY 2017 Quality Payment
Program final rule (81 FR 77177 and
77178), the CY 2018 Quality Payment
Program final rule (82 FR 53648 through
53661), the CY 2019 PFS final rule (83
FR 59776 and 59777), the CY 2020 PFS
final rule (84 FR 62980 through 62990),
CY 2021 PFS final rule (85 FR 84881
through 84886), the CY 2022 PFS final
rule (86 FR 65462 through 65466), and
the CY 2023 PFS final rule (87 FR 70057
through 70061). We also refer readers to
42 CFR 414.1305 for the definitions of
improvement activities and attestation,
§ 414.1320 for standards establishing the
performance period, § 414.1325 for the
data submission requirements,
§ 414.1355 for standards related to the
improvement activity performance
category generally, § 414.1360 for data
submission criteria for the improvement
activity performance category, and
§ 414.1380(b)(3) for improvement
activities performance category scoring.
We are not proposing any changes to
the traditional MIPS improvement
activities policies for the CY 2024
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performance period/2026 MIPS
payment year. We are proposing
policies for group reporting in MIPS
Value Pathways (MVPs). In addition, we
are proposing changes to the
improvement activities Inventory for the
CY 2024 performance period/2026 MIPS
payment year and future years as
follows: adding five new improvement
activities; modifying one existing
improvement activity; and removing
three previously adopted improvement
activities.
(b) Improvement Activities Inventory
(i) Annual Call for Activities
Background
In the CY 2017 Quality Payment
Program final rule (81 FR 77190), for the
transition year of MIPS, we
implemented the initial improvement
activities Inventory consisting of
approximately 95 activities (81 FR
77817 through 77831). We took several
steps to ensure the Inventory was
inclusive of activities in line with
statutory and program requirements. We
discussed that we had conducted
numerous interviews with highly
performing organizations of all sizes and
had conducted an environmental scan
to identify existing models, activities, or
measures that met all or part of the
improvement activities performance
category, including patient-centered
medical homes, the Transforming
Clinical Practice Initiative (TCPI),
CAHPS surveys, and AHRQ’s Patient
Safety Organizations. In addition, we
reviewed the CY 2016 PFS final rule
with comment period (80 FR 71259) and
the comments received in response to
the MIPS and APMs RFI in relation to
the improvement activities performance
category, which sought input on what
activities could be classified as clinical
practice improvement activities
according to the definition under
section 1848(q)(2)(C)(v)(III) of the Act.
For the CY 2018 performance period/
2020 MIPS payment year, we provided
an informal process for submitting new
improvement activities or modifications
for potential inclusion in the
comprehensive improvement activities
Inventory for the Quality Payment
Program CY 2018 performance period/
2020 MIPS payment year and future
years through subregulatory
guidance.315 In the CY 2018 Quality
Payment Program final rule (82 FR
53656 through 53659), for the CY 2019
performance period/2021 MIPS
315 CMS, Annual Call for Measures and Activities:
Fact Sheet, https://www.cms.gov/Medicare/QualityIniCtiatives-Patient-Assessment-Instruments/MMS/
Downloads/Annual-Call-for-Measures-andActivities-for-MIPS_Overview-Factsheet.pdf.
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payment year and for future years, we
finalized a formal Annual Call for
Activities process for the addition of
possible new activities and for possible
modifications to current activities in the
improvement activities Inventory. This
process included the requirement to
submit a nomination form similar to the
one we utilized for the CY 2018
performance period/2020 MIPS
payment year (82 FR 53656 through
53659). In order to submit a request for
a new activity or a modification to an
existing improvement activity, the
interested party must submit a
nomination form (OMB control # 0938–
1314) available at www.qpp.cms.gov
during the Annual Call for Activities.
(ii) Changes to the Improvement
Activities Inventory
In the CY 2018 Quality Payment
Program final rule (82 FR 53660), we
finalized that we would establish
improvement activities through noticeand-comment rulemaking. We refer
readers to Table H in the Appendix to
the CY 2017 Quality Payment Program
final rule (81 FR 77177 through 77199),
Tables F and G in the Appendix to the
CY 2018 Quality Payment Program final
rule (82 FR 54175 through 54229),
Tables A and B in the Appendix 2 to the
CY 2019 PFS final rule (83 FR 60286
through 60303), Tables A, B, and C in
the Appendix 2 to the CY 2020 PFS
final rule (84 FR 63514 through 63538),
Tables A, B, and C in the Appendix 2
to the CY 2021 PFS final rule (85 FR
85370 through 85377), Tables A, B, and
C in the Appendix 2 to the CY 2022 PFS
final rule (86 FR 65969 through 65997),
and Tables A, B, and C in the Appendix
2 to the CY 2023 PFS final rule (70633
through 70650) for our previously
finalized improvement activities
Inventories. We also refer readers to the
Quality Payment Program website under
Explore Measures and Activities at
https://qpp.cms.gov/mips/exploremeasures?tab=improvement
Activities&py=2022#measures for a
complete list of the current
improvement activities. In the CY 2017
Quality Payment Program final rule (81
FR 77539), we codified the definition of
improvement activities at § 414.1305 to
mean an activity that relevant MIPS
eligible clinicians, organizations, and
other relevant interested parties identify
as improving clinical practice or care
delivery and that the Secretary
determines, when effectively executed,
is likely to result in improved outcomes.
We are proposing to add five new
improvement activities, modify an
existing improvement activity, and
remove three previously adopted
improvement activities for the CY 2024
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performance period/2026 MIPS
payment year and future years. The
proposed new and modified activities
will help fill gaps we have identified in
the Inventory, while the removal of
three activities will help ensure that the
Inventory reflects current clinical
practice. We note that the proposed
removal of one activity, IA_BMH_6,
titled ‘‘Implementation of co-location
PCP and MH services,’’ in the
Behavioral and Mental Health
subcategory is being proposed in order
to ensure that the improvement
activities Inventory best reflects current
clinical practice, and in no way reflects
a de-emphasis of the ongoing priority
CMS is placing on behavioral and
mental health in general, and on
substance use disorder in particular. We
also note that two of the five proposed
new activities are in the Behavioral and
Mental Health subcategory. We refer
readers to Appendix 2 of this proposed
rule for more details.
Four of the recommended new
improvement activities are in the
Population Management and the
Behavioral and Mental Health
subcategories. One proposed new
activity, IA_PM_XX, titled ‘‘Improving
Practice Capacity for Human
Immunodeficiency Virus (HIV)
Prevention Services’’ would allow MIPS
eligible clinicians to receive credit for
establishing policies and procedures to
improve practice capacity to increase
HIV prevention screening and linkage to
appropriate prevention resources
through taking action with the goals of
increasing capacity to expand HIV
prevention screening, improving HIV
prevention education and awareness,
and reducing disparities in pre-exposure
prophylaxis (PrEP) uptake. Another
activity, IA_PM_XX, titled ‘‘Decision
Support Improves Adherence to
Cervical Cancer Screening and
Management Guidelines’’ would allow
MIPS eligible clinicians to receive credit
for incorporating cervical cancer clinical
decision support (CDS) within the
electronic health record (EHR) system.
This activity leverages the convenience
and efficiency of more sophisticated
decision support tooling to assist
clinicians in applying complex datadriven guidelines to provide optimal
care and better engagement with their
patient population, including
historically underserved populations.
This activity proposal was submitted by
the CDC.
Two of the five proposed new
activities are in the Behavioral and
Mental Health (BMH) subcategory,
reflecting this important Federal
priority. IA_BMH_XX, titled
‘‘Behavioral/Mental Health and
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Substance Use Screening & Referral for
Pregnant and Postpartum Women’’
would allow MIPS eligible clinicians to
receive credit for screening for perinatal
mood and anxiety disorders (PMADs)
and substance use disorder (SUD) in
pregnant and postpartum women, as
well as screening and referring to
treatment and/or referring to
appropriate social services in patient
care plans. The second new activity
being proposed in the BMH subcategory,
IA_BMH_XX, titled ‘‘Behavioral/Mental
Health and Substance Use Screening &
Referral for Older Adults’’ would allow
MIPS eligible clinicians to receive credit
for the completion of age-appropriate
screening for mental health and
substance use in older adults, as well as
screening and referring to treatment
and/or referring to appropriate social
services in patient care plans.
Of the five proposed new
improvement activities, four activities
directly align with CMS’ Priority 5 for
advancing health equity, Increase All
Forms of Accessibility to Health Care
Services and Coverage. Therefore, the
activities aim to create a fair and just
opportunity for all people to attain their
optimal health regardless of race,
ethnicity, disability, sexual orientation,
gender identity, socioeconomic status,
geography, preferred language, and/or
other factors that affect access to care
and health outcomes. These four
proposed new improvement activities
are the following: IA_PM_XX, titled
‘‘Improving Practice Capacity for
Human Immunodeficiency Virus (HIV)
Prevention Services’’; IA_PM_XX, titled
‘‘Decision Support Improves Adherence
to Cervical Cancer Screening and
Management Guidelines’’; IA_BMH_XX,
titled ‘‘Behavioral/Mental Health and
Substance Use Screening & Referral for
Pregnant and Postpartum Women’’; IA_
BMH_XX, titled ‘‘Behavioral/Mental
Health and Substance Use Screening &
Referral for Older Adults.’’ The fifth
new proposed improvement activity is
focused on MVP: IA_MVP, titled
‘‘Practice-wide quality improvement in
the MIPS Value Pathways Program
(MVP).’’
With the advent of MVPs, MIPS
eligible clinicians can report measures
that are more relevant to their
specialized practice, including through
subgroup reporting. The proposed IA_
MVP activity would require a clinician
to complete a formal model for quality
improvement action that is linked to a
minimum of three of the measures
within the specific MVP. We believe
this activity would expand and
formalize quality improvement (QI)
activities across practices, ultimately
leading to improvements in quality of
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care and fostering a culture of
participation among staff. In addition,
this activity would incentivize
voluntary MVP adoption. It is important
to note that, a clinician who reports an
MVP can attest to the MVP
improvement activity. However, a
clinician in traditional MIPS is
ineligible report the MVP improvement
activity. Also, registration for an MVP is
not sufficient for reporting the MVP
improvement activity. Reporting the
chosen MVP and attesting to having
completed the necessary elements of the
MVP improvement activity are both
required. We refer readers to section
IV.A.3.b(2). of this proposed rule for
more information on MVPs.
We are proposing to modify one
existing activity’s description, titled
‘‘Use decision support and standardized
treatment protocols to manage workflow
in the team to meet patient needs,’’ and
its validation criteria to explicitly
promote the use of clinical decision
support (CDS), particularly open-source,
freely available, interoperable CDS.
Additionally, we are proposing to
remove three previously finalized
improvement activities to ensure that
the improvement activities Inventory
best reflects current clinical practice.
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(iii) Improvement Activity Reporting
Policies
Regarding group reporting, we are not
revising group reporting policies for
MVPs at this time. In the CY 2020 PFS
final rule (84 FR 62981 through 62988)
and codified at § 414.1360(a)(2), we
finalized the policy that, beginning with
the 2020 performance year, each
improvement activity for which groups
and virtual groups submit a yes
response in accordance with paragraph
(a)(1) of § 414.1360 must be performed
by at least 50 percent of the NPIs billing
under the group’s TIN or virtual group’s
TINs or that are part of the subgroup, as
applicable. Additionally, the NPIs must
perform the same activity during any
continuous 90-day period within the
same performance year. We would like
to clarify the relationship between a
subgroup’s successful completion of an
improvement activity and its impact on
the affiliated group. If a subgroup
consists of 50 percent or more of the
clinicians in the affiliated group, and
the subgroup attests to completing an
activity, then the group would receive
credit for this improvement activity as
this meets our standard for a group’s
completion of an improvement activity
specified at § 414.1360.
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(4) Promoting Interoperability
Performance Category
(a) Background
Section 1848(q)(2)(A) of the Act
includes the meaningful use of certified
electronic health record (EHR)
technology (CEHRT) as a performance
category under MIPS. We refer to this
performance category as the Promoting
Interoperability performance category
(and in past rulemaking, we referred to
it as the advancing care information
performance category).
For our previously established
policies regarding the Promoting
Interoperability performance category,
we refer readers to our regulation at
§ 414.1375 and the CY 2017 Quality
Payment Program final rule (81 FR
77199 through 77245), CY 2018 Quality
Payment Program final rule (82 FR
53663 through 53688), CY 2019 PFS
final rule (83 FR 59785 through 59820),
CY 2020 PFS final rule (84 FR 62991
through 63006), CY 2021 PFS final rule
(85 FR 84886 through 84895), CY 2022
PFS final rule (86 FR 65466 through
65490), and the CY 2023 PFS final rule
(87 FR 70060 through 70087).
(b) Promoting Interoperability
Performance Category Performance
Period
In the CY 2021 PFS final rule (85 FR
84886), we established that for the CY
2024 MIPS payment year and each
subsequent MIPS payment year, the
performance period for the Promoting
Interoperability performance category is
a minimum of any continuous 90-day
period within the calendar year that
occurs 2 years prior to the applicable
MIPS payment year, up to and including
the full calendar year. We codified the
policy at § 414.1320(g)(1) of our
regulations, and subsequently redesignated that section as
§ 414.1320(h)(1) in the CY 2022 PFS
final rule (86 FR 65671).
We are proposing that for the CY 2026
MIPS payment year, the performance
period for the Promoting
Interoperability performance category is
a minimum of any continuous 180-day
period within CY 2024, up to and
including the full CY 2024 (January 1,
2024, through December 31, 2024). This
proposal would minimally increase the
information collection burden on data
submitters.
We believe that having additional
data available from a longer
performance period is beneficial to
further improve the Promoting
Interoperability performance category,
and an integral step towards promoting
health information exchange. Reporting
on additional data during a longer
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performance period would provide
MIPS eligible clinicians the opportunity
to continuously monitor their
performance, identify gaps in their
reporting, and identify areas that may
require their investigation and
corrective action. We believe that
requiring MIPS eligible clinicians to
report additional data during a longer
performance period will encourage
MIPS eligible clinicians to produce
more comprehensive and reliable data
demonstrating that they are meaningful
users of CEHRT.
Our long-term goal for the Promoting
Interoperability performance category is
to ensure the meaningful use of CEHRT
and information exchange throughout
the year, for all data, all clinicians, and
all patients. Currently, when MIPS
eligible clinicians select a 90-day
performance period, this data is often
not representative of their overall use of
CEHRT throughout the entire calendar
year. Instead, it reflects their best
performing 90-days during the calendar
year. In order for MIPS eligible
clinicians to have a more accurate
understanding of their overall
performance, we want to move towards
reporting on a full years’ performance,
which can be achieved by incrementally
increasing the number of days in the
performance period.
We continue to focus on patient
safety, and the Promoting
Interoperability performance category
continues to focus on the safety and safe
use of patient data by demonstrating the
meaningful use of CEHRT. If a MIPS
eligible clinician were to only focus on
their best 90-day performance period,
they may not focus on improving their
overall performance in meaningfully
using CEHRT throughout the year, and
ultimately, observe, correct, and
mitigate any potential patient safety
concerns that may arise due to gaps in
interoperability throughout the calendar
year. If a MIPS eligible clinician does
not meaningfully use CEHRT
throughout the entire CY, there is a
possibility for gaps in the transfer of key
patient data necessary for supporting a
diagnosis, continued treatment, or
overall care planning.
Therefore, we are proposing to modify
§ 414.1320(h) for the Promoting
Interoperability performance category
performance period to remove the
reference to subsequent years after the
CY 2024 MIPS payment year, and
instead specify that the policy applies
only through the CY 2025 MIPS
payment year. We further propose to
add a new paragraph at § 414.1320(i)(1)
to reflect our proposed performance
period of a minimum of a continuous
180-day period within the calendar year
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that occurs 2 years prior to the
applicable MIPS payment year, up to
and including the full calendar year for
the Promoting Interoperability
performance category, beginning with
the CY 2026 MIPS payment year.
We are inviting public comment on
our proposal to require a continuous
180-day performance period for the
Promoting Interoperability performance
category beginning with the CY 2024
performance period/2026 MIPS
payment year, and the proposed
changes to the regulation text at
§ 414.1320.
(c) Certified Electronic Health Record
Technology Requirements
Section 1848(q)(2)(B)(iv) of the Act
requires that, for the Promoting
Interoperability performance category,
the MIPS eligible clinician must meet
the requirements established for the
specified performance period under
section 1848(o)(2) of the Act for
determining whether the MIPS eligible
clinician is a meaningful electronic
health record (EHR) user. Section
1848(o)(2)(A) of the Act requires that, to
be treated as a meaningful EHR user for
an EHR reporting period for a payment
year, a MIPS eligible clinician must be
using certified EHR technology
(CEHRT). Section 1848(o)(4) of the Act
defines CEHRT as a qualified electronic
health record (as defined in section
3000(13) of the Public Health Service
Act, or PHSA) that is certified by the
Office of the National Coordinator for
Health Information Technology (ONC)
pursuant to section 3001(c)(5) of the
PHSA in accordance with the
certification standards that ONC
adopted under section 3004 of the
PHSA.
Accordingly, the MIPS Promoting
Interoperability performance category
regulation at § 414.1375(b)(1) requires a
MIPS eligible clinician to use CEHRT as
defined at § 414.1305 for the
performance period. Since the CY 2019
performance period, in general, this has
consisted of EHR technology (which
could include multiple technologies)
certified under ONC’s Health IT
Certification Program that meets the
2015 Edition Base EHR definition (as
defined at 45 CFR 170.102), and has
been certified to certain other 2015
Edition health IT certification criteria as
specified in the definition of CEHRT at
§ 414.1305.
As discussed in section III.R. of this
proposed rule, in the Health Data,
Technology, and Interoperability:
Certification Program Updates,
Algorithm Transparency, and
Information Sharing proposed rule (88
FR 23758), which appeared in the April
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18,2023 Federal Register, ONC has
proposed to discontinue the yearthemed ‘‘editions,’’ which ONC first
adopted in 2012, to distinguish between
sets of health IT certification criteria
finalized in different rules. ONC is
proposing to instead maintain a single
set of ‘‘ONC Certification Criteria for
Health IT,’’ which would be updated in
an incremental fashion in closer
alignment to standards development
cycles and regular health information
technology (IT) development timelines
(88 FR 23750). As further discussed in
section III.R. of this proposed rule, we
are proposing to modify the definition
of CEHRT for purposes of the Quality
Payment Program at § 414.1305 to no
longer refer to year-specific editions,
and to incorporate any changes made by
ONC to its definition of Base EHR and
its certification criteria for health IT.
(d) Promoting Interoperability
Performance Category Measures for
MIPS Eligible Clinicians
i. Changes to the Query of Prescription
Drug Monitoring Program Measure
Under the Electronic Prescribing
Objective
We previously adopted the Query of
Prescription Drug Monitoring Program
(PDMP) measure under the Electronic
Prescribing (e-Prescribing) objective for
the Promoting Interoperability
performance category. For background
on this measure, we refer readers to the
CY 2019 PFS final rule (83 FR 59800
through 59803) and the CY 2020 PFS
final rule (84 FR 62992 through 62994).
In the CY 2021 PFS final rule (85 FR
84887 through 84888) and the CY 2022
PFS final rule (86 FR 65466 through
65467), we finalized that the Query of
PDMP measure will remain optional
and eligible for 10 bonus points for the
CY 2021 and CY 2022 performance
periods.
In the CY 2023 PFS final rule, we
finalized our proposal to require the
Query of PDMP measure beginning with
the CY 2023 performance period, and
that the measure will be worth 10 points
(87 FR 70061 through 70067). In
addition, along with other key
specifications described in the CY 2023
PFS final rule, we removed the phrase
‘‘except where prohibited in accordance
with applicable law’’ from the measure
description, and established two
exclusions beginning with the CY 2023
performance period: (1) Any MIPS
eligible clinician who is unable to
electronically prescribe Schedule II
opioids and Schedule III and IV drugs
in accordance with applicable law
during the performance period; and (2)
Any MIPS eligible clinician who writes
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fewer than 100 permissible
prescriptions during the performance
period (87 FR 70061 through 70067).
Finally, in the CY 2023 PFS final rule,
we finalized a third exclusion for the
Query of PDMP measure, but this
exclusion was only available for the CY
2023 performance period/2025 MIPS
payment year. (87 FR 70067)
The second exclusion is the same
exclusion that we adopted for ePrescribing measure in the CY 2018 PFS
final rule (82 FR 53679). It has come to
our attention that the second exclusion
is problematic because it does not
address situations where the MIPS
eligible clinician does not electronically
prescribe Schedule II opioids or
Schedule III and IV drugs, in accordance
with applicable law during the
performance period, but does write
more than 100 permissible prescriptions
during the performance period.
Therefore, we are proposing to modify
the second exclusion criterion to state
that any MIPS eligible clinician who
does not electronically prescribe any
Schedule II opioids or Schedule III or IV
drugs during the performance period
can claim the second exclusion.
We are inviting public comments on
this proposal.
ii. Proposed Technical Update to the
Electronic Prescribing Measure
The ONC 21st Century Cures Act final
rule (85 FR 25660 through 25661)
retired the ‘‘drug-formulary and
preferred drug list checks’’ certification
criterion at 45 CFR 170.315(a)(10),
which was associated with measures
under the Electronic Prescribing
Objective for the Medicare Promoting
Interoperability Program and the MIPS
Promoting Interoperability performance
category (80 FR 62882 and 83 FR
59817). ONC retired this criterion after
January 1, 2022, as provided in 45 CFR
170.550(m)(1) (85 FR 26661).
In the CY 2021 PFS final rule, we
finalized that the ‘‘drug-formulary and
preferred drug list checks’’ criterion will
no longer be associated with measures
under the Electronic Prescribing
Objective and will no longer be required
to meet the CEHRT definition for the
Medicare Promoting Interoperability
Program and the MIPS Promoting
Interoperability performance category,
beginning with CY 2021 EHR reporting
and performance periods (85 FR 84815
through 84825).
In the CY 2023 PFS final rule, we
inadvertently omitted a revision to
TABLE 92: Objectives and Measures for
the Medicare Promoting Interoperability
Performance Category for the CY 2023
performance period to reflect this
change (87 FR 70075). In an effort to
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more clearly capture the previously
established policy finalized in the CY
2021 PFS final rule with respect to the
e-Prescribing measure, we are proposing
to revise the measure description as
shown in Table 45 to read ‘‘At least one
permissible prescription written by the
MIPS eligible clinician is transmitted
electronically using CEHRT’’ and the
numerator will be updated to read to
indicate ‘‘Number of prescriptions in
the denominator generated and
transmitted electronically using
CEHRT’’ to reflect the removal of the
health IT certification criterion ‘‘drugformulary and preferred drug list
checks.’’
We are inviting public comments on
this proposal.
iii. Changes to the Safety Assurance
Factors for EHR Resilience Guides
(SAFER Guides) Measure
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A. Background
In the CY 2022 PFS final rule (86 FR
65475 through 65477), we adopted the
Safety Assurance Factors for EHR
Resilience Guides (SAFER Guides)
measure under the Protect Patient
Health Information Objective in the
Promoting Interoperability performance
category beginning with the CY 2022
performance period. ONC developed
several SAFER Guides, including the
High Priority Practices SAFER Guide, to
help organizations at all levels conduct
self-assessments which optimize the
safety and use of EHRs. Under the
SAFER Guides measure, MIPS eligible
clinicians are currently required to
attest to whether they have conducted
an annual self-assessment using the
High Priority Practices SAFER Guide
(available at https://www.healthit.gov/
topic/safety/safer-guides), at any point
during the calendar year in which the
performance period occurs, with one
‘‘yes/no’’ attestation statement.
Beginning with the CY 2022
performance period, we required MIPS
eligible clinicians to complete this
attestation for this measure, though
MIPS eligible clinicians are not scored
based on their answer to the attestation
or whether they fully complete the selfassessment. An attestation of ‘‘yes’’ or
‘‘no’’ is currently acceptable, and a
MIPS eligible clinician can attest ‘‘no’’
without penalty. For additional
information, please refer to our
discussion of the SAFER Guides
measure in the CY 2022 PFS final rule
(86 FR 65475 through 65477).
B. Proposed Change to the SAFER
Guides Measure
The SAFER Guides measure is
intended to encourage MIPS eligible
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clinicians to use the High Priority
Practices SAFER Guide, annually, to
assess their progress and status on
important facets of patient safety,
including CEHRT implementation,
safety and effectiveness, identifying
vulnerabilities, and developing a
‘‘culture of safety’’ within their
organization. For instance, the High
Priority Practices SAFER Guide asks
users to review and ensure that entries
of allergies, problem lists, and
diagnostic test results utilize
standardized coding elements in their
CEHRT (such as uniformly and
consistently coding results as ‘‘normal’’
or ‘‘high’’). By ensuring their CEHRT
consistently documents and codes
health information, MIPS eligible
clinicians confirm their CEHRT
supports clear communication of a
patient’s health status, mitigating the
risk of oversight, gaps, or potential
safety risks introduced by the CEHRT,
in the interoperable exchange of health
information. By implementing the High
Priority Practices SAFER Guide’s
recommended practices, MIPS eligible
clinicians may be better positioned to
operate CEHRT responsibly in care
delivery, and to make improvements to
the safe use of CEHRT as necessary over
time.
Given our interest in promoting the
safety and the safe use of CEHRT, we are
proposing to amend the SAFER Guides
measure to require MIPS eligible
clinicians to conduct this selfassessment annually, and attest a ‘‘yes’’
response, accounting for completion of
the self-assessment for the High Priority
Practices SAFER Guide. The selfassessment should be completed
between clinicians and staff members
together, allowing MIPS eligible
clinicians to see a snapshot of the status
of the CEHRT used by their organization
in terms of safety, and to identify areas
needing improvement. Therefore, we are
proposing to modify the SAFER Guides
measure beginning with the CY 2024
performance period/2026 MIPS
payment year such that only a ‘‘yes’’
response on the attestation will
constitute completion of this measure,
and a ‘‘no’’ response will result in a
score of zero for the whole Promoting
Interoperability performance category,
indicating that the MIPS eligible
clinician failed the requirements of the
Promoting Interoperability performance
category and is not a meaningful user of
CEHRT. To reflect this proposal, we are
proposing to modify our reporting
requirements at § 414.1375 (b)(2)(ii)(C)
to include ‘‘For the 2024 MIPS payment
year through the 2025 MIPS payment
year’’, and to add § 414.1375
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(b)(2)(ii)(D), to say ‘‘Beginning with the
2026 MIPS payment year, submit an
affirmative attestation regarding the
MIPS eligible clinician’s completion of
the annual self-assessment under the
SAFER Guides measure during the year
in which the performance period
occurs.’’
We believe this proposed
modification is feasible for MIPS
eligible clinicians to implement, as they
have had time to grow familiar with the
use of the SAFER Guides under this
measure by attesting either ‘‘yes’’ or
‘‘no’’ to conducting the self-assessment.
We also note the availability of
resources to assist MIPS eligible
clinicians with completing the selfassessment as required by the SAFER
Guides measure. One example of such
resources is the SAFER Guides authors’
paper titled ‘‘Guidelines for US
Hospitals and Clinicians on Assessment
of Electronic Health Record Safety
Using SAFER Guides,’’ available
without charge to download or use at
https://jamanetwork.com/journals/
jama/fullarticle/2788984.
Therefore, we are proposing to modify
our requirements for the SAFER Guides
measure beginning with the CY 2024
performance period and subsequent
years, to require MIPS eligible clinicians
to conduct, and therefore attest ‘‘yes,’’
an annual self-assessment of their
CEHRT using the High Priority Practices
SAFER Guide (available at https://
www.healthit.gov/topic/safety/saferguides), at any point during the calendar
year in which the performance period
occurs. Under this proposal, although
the SAFER Guides measure would
continue to be required with no
associated points, an attestation of ‘‘no’’
would result in the MIPS eligible
clinician not meeting the measure’s
requirements and therefore not a
meaningful user of CEHRT, warranting
a score of zero for the Promoting
Interoperability performance category.
If our proposal to modify the SAFER
Guides measure is finalized, we are also
proposing to modify our reporting
requirements at § 414.1375(b)(2)(ii)(C),
and to add § 414.1375(b)(2)(ii)(D).
Specifically, at § 414.1375(b)(2)(ii)(C),
we propose to end our current
requirements for the SAFER Guides
measure with the 2025 MIPS payment
year. Then, at § 414.1375(b)(2)(ii)(D), we
propose to require, beginning with the
2026 MIPS payment year, that a MIPS
eligible clinician submit an affirmative
attestation regarding the MIPS eligible
clinician’s completion of the annual
self-assessment under the SAFER
Guides measure during the year in
which the performance period occurs.
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As a reminder, under the SAFER
Guides measure, we do not currently
require, and do not propose to require,
MIPS eligible clinicians to attest to
whether they have implemented any
best practices ‘‘fully in all areas’’ as
described in the High Priority SAFER
Guide, nor will a MIPS eligible clinician
be scored on how many of the practices
they have fully implemented (86 FR
65475). We refer readers to Table 45 in
this proposed rule for a description of
the measure, and to the CY 2022 PFS
final rule for additional background
information (86 FR 65475 through
65477). Upon review of our current
regulation governing reporting of the
current SAFER Guides measure at
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§ 414.1375(b)(2)(ii)(C), we identified
areas where our regulation is unclear
regarding the requirements for reporting
the SAFER Guides measure. We are
therefore also proposing to amend the
regulatory text at § 414.1375(b)(2)(ii)(C)
to specify clearly that a MIPS eligible
clinician must submit an attestation,
with either an affirmative or negative
response, with respect to whether the
MIPS eligible clinician completed the
annual self-assessment under the
SAFER Guides measure during the year
in which the performance period
occurs. As previously discussed, if our
proposal to modify the SAFER Guides
measure is finalized, this proposed
regulatory provision would only be
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applicable for the 2024 MIPS payment
year through the 2025 MIPS payment
year.
We are inviting public comments on
these proposals.
(e) Requirements for the Promoting
Interoperability Performance Category
for the CY 2024 Performance Period
i. Objectives and Measures for the CY
2024 Performance Period
For ease of reference, Table 45 lists
the objectives and measures for the
Promoting Interoperability performance
category for the CY 2024 performance
period/2026 MIPS payment year as
revised to reflect the policies proposed
in this proposed rule.
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ii. Scoring Methodology for the CY 2024
Performance Period
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Interoperability performance category
for the CY 2024 performance period.
Many required measures have
exclusions associated with them as
shown on Table 45. If a MIPS eligible
clinician believes that an exclusion for
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a particular measure applies to them,
they may claim it when they submit
their data. The maximum points
available in Table 46 do not include the
points that will be redistributed in the
event that a MIPS eligible clinician
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claims an exclusion. For ease of
reference, Table 47 shows how points
will be redistributed among the
objectives and measures for the CY 2024
performance period in the event a MIPS
eligible clinician claims an exclusion.
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iii. Exclusion Redistribution
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methodology for the Promoting
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Criteria
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For ease of reference, Table 48 lists
the objectives and measures for the
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Promoting Interoperability performance
category for the CY 2024 performance
period and the associated 2015 Edition
health IT certification criteria.
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(f) Clinical Social Workers
In the CY 2022 PFS final rule (86 FR
65387 through 65389), we added
clinical social workers to the definition
of a MIPS eligible clinician under
§ 414.1305, beginning with the CY 2022
performance period/2024 MIPS
payment year. Prior to the CY 2022
performance period, this clinician type
was not eligible to participate in the
Medicare Promoting Interoperability
Program to earn incentive payments for
meaningful use of CEHRT or receive
reduced Medicare payments for failing
to meaningfully use CEHRT. Clinical
social workers were also not eligible for
Medicaid EHR incentive payments.
In the CY 2022 PFS final rule (86 FR
65489), we stated that clinical social
workers therefore may lack experience
with the adoption or use of CEHRT, and
that we believed there may not be
sufficient Promoting Interoperability
performance category measures that are
applicable and available to them. In the
CY 2022 PFS final rule (86 FR 65489)
and the CY 2023 PFS final rule (87 FR
70087), we established that we will
apply to clinical social workers the
same reweighting policy for the
Promoting Interoperability performance
category that we adopted previously for
NPs, PAs, CNSs, CRNAs, and other
types of MIPS eligible clinicians who
are non-physician practitioners for the
CY 2022 performance period/2024 MIPS
payment year and the CY 2023
performance period/2025 MIPS
payment year. Specifically, because we
believed there may not be sufficient
Promoting Interoperability performance
category measures available and
applicable to clinical social workers,
pursuant to section 1848(q)(5)(F) of the
Act, we assigned a weight of zero to the
Promoting Interoperability performance
category for clinical social workers.
However, if a clinical social worker
submits any data for any of the
measures specified for the Promoting
Interoperability performance category,
then this category will not be
reweighted to zero and we will score the
clinical social worker on this category as
part of their final composite
performance score in accordance with
§ 414.1380(c)(1). This reweighting
policy for clinical social workers is
codified at § 414.1380(c)(2)(i)(A)(4)(iii).
Because CY 2022 was the first year
that clinical social workers were
included in our definition of MIPS
eligible clinicians, we do not yet have
any performance period data that we
could use to evaluate whether the
Promoting Interoperability performance
category measures are applicable to this
type of MIPS eligible clinician. In the
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CY 2023 PFS final rule (87 FR 70087),
when we reweighted the Promoting
Interoperability performance category
for clinical social workers for the CY
2023 performance period/2025 MIPS
payment year, we noted we would
evaluate whether this reweighting
policy should be continued for future
years when we have performance period
data available. Given that we do not
have data from the CY 2022
performance period available to analyze
at the time of this proposed rule, we are
proposing to continue the existing
policy of reweighting the Promoting
Interoperability performance category
for clinical social workers for the CY
2024 performance period/2026 MIPS
payment year, and making the
corresponding revisions to the
regulatory text at
§ 414.1380(c)(2)(i)(A)(4)(iii).
We are inviting public comments on
this proposal.
(5) APM Improvement Activities
Performance Category Score
(a) Background
Section 1848(q)(5)(C) of the Act
establishes specific scoring rules for the
improvement activities performance
category. Section 1848(q)(5)(C)(ii) of the
Act provides that a MIPS eligible
clinician who is in an Alternative
Payment Model (APM), as defined in
section 1833(z)(3)(C) of the Act, with
respect to a performance period shall
earn a minimum score of one half of the
highest potential score for the
improvement activities performance
category. In accordance with section
1848(q)(5)(C)(ii) of the Act, we codified
at § 414.1380(b)(3)(i) that individual
MIPS eligible clinicians or groups who
participate in an APM (as defined in
section 1833(z)(3)(C) of the Act) for a
performance period will earn at least 50
percent for the improvement activities
performance category (81 FR 30132).
With respect to MIPS eligible clinicians
who participate in a MIPS APM for a
performance period, we stated that they
may receive an improvement activity
score higher than 50 percent (81 FR
30132). Because we had identified all
MIPS APMs as having met the
improvement activity threshold score
requirement, we noted that all MIPS
APM participants will receive a score of
100 percent for the improvement
activities performance category (85 FR
84865, 85031).
(b) Proposal
It has come to our attention that in the
preamble of the CY 2021 PFS final rule
(85 FR 84865) the terminology
‘‘automatic’’ was used in reference to
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the baseline score provided by section
1848(q)(5)(C)(ii) of the Act (85 FR
84865). This has led to an interpretation
by some MIPS eligible clinicians that
the baseline score represents ‘‘credit’’
that is ‘‘automatically applied’’ in all
circumstances.316 This is not how we
intended this provision to function, and
we wish to ensure that our rules do not
automatically grant such ‘‘credit’’.317
We are concerned that absent revisions
the application of our current regulation
may produce unintended or unexpected
scoring outcomes for MIPS eligible
clinicians and groups.
In order to prevent such scoring
scenarios, we are proposing to amend
§ 414.1380 by revising paragraph
(b)(3)(i) to require that, in order to
initiate the baseline score for the
improvement activities performance
category, a MIPS eligible clinician or
group with APM participation must
have submitted data for two
performance categories or attest to
having completed an improvement
activity. We are also proposing to
amend § 414.1380 by adding paragraph
(c)(2)(iv) to provide that we will not
apply a baseline score if we have also
approved a request for performance
category reweighting or hardship
exception affecting the improvement
activities performance category,
including MIPS EUC Exception
applications under
§ 414.1380(c)(2)(i)(A)(6) or (C)(2), and
automatic EUC events per
§ 414.1380(c)(2)(i)(A)(8) or (C)(3).
We believe that these proposals are
necessary in part because
§ 414.1380(c)(2)(i)(A)(6) requires us to
score any data submitted by a MIPS
eligible clinician with an approved
application-based hardship exception or
who was identified as a clinician in a
CMS-designated region affected by an
automatic EUC event under
§§ 414.1380(c)(2)(i)(A)(6), (A)(8), (C)(2),
and (C)(3), regardless of whether that
submission was for the purpose of MIPS
final scoring. Based upon our current
policies, a submission of data for the
quality or Promoting Interoperability
performance categories would initiate or
prompt the calculation of a baseline
316 For example, in the ‘‘2022 Data Submission
FAQs,’’ available at https://qpp.cms.gov/resources/
resource-library, we stated that MIPS eligible
clinicians participating in APMs are eligible to
receive ‘‘automatic credit’’ in the improvement
activities performance category.
317 Similarly, in the CY 2021 PFS final rule, we
finalized a proposal to modify § 414.1380(b)(3)(ii) to
make clear that the baseline score provided by
section 1848(q)(5)(C)(i) of the Act for the
improvement activities performance category is not
automatically granted for clinicians participating in
patient-centered medical homes and comparable
specialty practices (83 FR 59868).
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score for the improvement activities
performance category, making the
improvement activities category eligible
for scoring. We believe that result is
contrary to the purpose of hardship
exceptions, such as the MIPS EUC
Exception application provided by
§ 414.1380(c)(2)(i)(A)(6), which are
designed to reweight the improvement
activities performance category to zero
percent.
We also believe this proposal would
further our vision that ‘‘the bedrock of
the Quality Payment Program is highquality, patient-centered care followed
by useful feedback, in a continuous
cycle of improvement’’ (81 FR 77010).
Generally speaking, through MIPS, we
collect feedback based upon data and
measures submitted for the quality,
Promoting Interoperability,
improvement activities, and cost
performance categories. We need
composite scores from at least two of
those four performance categories in
order for us to calculate a clinician’s
final score. There is no data submission
requirement for the cost performance
category—we use the Medicare claims
data submitted by that clinician to
calculate their cost-measure
performance. Similarly, a MIPS eligible
clinician is not required to submit
detailed data for the improvement
activities performance category; instead,
a MIPS eligible clinician simply attests
to having completed an activity or
activities to report the performance
category. We therefore believe that it is
most appropriate for a MIPS eligible
clinician to submit measurable data on
the quality and Promoting
Interoperability performance categories
for the purpose of final scoring in order
to be credited with the baseline score for
the improvement activities performance
category.318
We believe these proposals are timely
in light of the proposal at section
III.F.h.2. to require that Medicare
Shared Savings Program (SSP)
Accountable Care Organization (ACO)
clinicians report the Promoting
Interoperability performance category at
the TIN level, as opposed to the APM
Entity (that is, the, ACO) or individual
level. If our existing policies are not
amended, an SSP ACO clinician’s
submission of data to the Promoting
Interoperability category will prompt
318 There is no data submission requirement for
the quality and cost performance categories for a
MIPS eligible clinician assessed under the facilitybased measurement scoring methodology described
in § 414.1380(e). Therefore, we would require that
such clinicians report data on the Promoting
Interoperability performance category (or attest to
having completed an improvement activity) in
order to prompt the baseline score for the
improvement activities performance category.
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the baseline score in the improvement
activities performance category in every
circumstance regardless of whether the
clinician’s group requested or otherwise
qualified for reweighting of the
performance categories. This proposal
would allow us to conform to the
general scoring expectation that, in the
event the participant’s request to
reweight three or four performance
categories to zero percent due to a
hardship, per §§ 414.1380(c)(2)(i)(A)(6),
(A)(8), (C)(2), and (C)(3), the participant
would receive a final score equal to the
performance threshold, resulting in a
neutral payment adjustment, even if
data are incidentally submitted for other
performance categories.
In summary, we propose to amend
§ 414.1380 by revising paragraph
(b)(3)(i) and adding paragraph (c)(2)(iv)
to limit the application of baseline
scores provided under section
1848(q)(5)(C)(ii) of the Act for the
purpose of MIPS final scoring. We seek
comment on these proposals.
g. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
Sections 1848(q)(1)(A)(i) and (ii) and
(5)(A) of the Act provide, in relevant
part, that the Secretary shall develop a
methodology for assessing the total
performance of each MIPS eligible
clinician according to certain specified
performance standards with respect to
applicable measures and activities
specified for the four performance
categories for a performance period and
use such methodology to provide for a
composite performance score for each
such clinician for each performance
period.
For the CY 2024 performance period/
2026 MIPS payment year, we intend to
continue to build on the scoring
methodology we have finalized for prior
years. This scoring methodology allows
for accountability and alignment across
the performance categories and
minimizes burden on MIPS eligible
clinicians. In this proposed rule we are
proposing to update our scoring policies
consistent with this framework.
Specifically, we propose to—
• Provide a technical update to
§ 414.1380(a)(1)(i) and (b)(1)(v)(A),
• Amend our criteria for assessing
ICD–10 coding impacts under our
scoring flexibilities policy; and
• Update our policies regarding
Improvement scoring for the cost
performance category.
We are not proposing changes to
scoring policies for the Promoting
Interoperability or improvement
activities performance categories.
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(b) Technical Updates
In the CY 2022 PFS final rule, we
finalized proposals to remove measure
bonus points for reporting additional
high priority measures and using end to
end electronic reporting beginning in
the CY 2022 performance period/2024
MIPS payment year (86 FR 65504
through 65507). We updated
corresponding regulation at
§ 414.1380(b)(1)(v)(B)(1)(iii) regarding
the end to end measure bonus points,
but not § 414.1380(a)(1)(i) regarding
performance standards or
§ 414.1380(b)(1)(v)(A) regarding the high
priority bonus points. Accordingly, we
propose to revise § 414.1380(a)(1)(i) to
provide that, measure bonus points for
submitting high priority measures and
using end-to-end reporting are available
for performance periods and payment
years prior to the CY 2023 performance
period/2025 MIPS payment year. We
also propose to revise
§ 414.1380(b)(1)(v)(A) to state that,
beginning with the CY 2022
performance period/2024 MIPS
payment year, MIPS eligible clinicians
will no longer receive these measure
bonus points for submitting high
priority measures.’’
We refer readers to our regulation at
§ 414.1380 for our current policies on
scoring. We request comments on these
technical update proposals.
(c) Scoring the Quality Performance
Category for the Following Collection
Types: Medicare Part B Claims
Measures, eCQMs, MIPS CQMs, QCDR
Measures, the CAHPS for MIPS Survey
Measure and Administrative Claims
Measures
We refer readers to § 414.1380(b)(1)
for our current policies regarding
quality measure benchmarks,
calculating total measure achievement
and measure bonus points, calculating
the quality performance category score,
including achievement and
improvement points, and the small
practice bonus (81 FR 77276 through
77308, 82 FR 53716 through 53748, 83
FR 59841 through 59855, 84 FR 63011
through 63018, 85 FR 84898 through
84913, 86 FR65490 through 65509, and
87 FR 70088 through 70091). In the CY
2023 PFS final rule, we finalized
policies to score administrative claims
measures in the quality performance
category using benchmarks calculate
from data submitted during the
associated performance period and
clarified the topped-out measure
lifecycle (87 FR 70088 through 70091).
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(i) Scoring Flexibility for Changes That
Impact Quality Measures During the
Performance Period
We refer readers to CY 2018, CY 2019,
Quality Payment Program final rules
and the CY 2021, and CY 2022 PFS final
rules (82 FR 53714 through 53716, 83
FR 59845 through 59847, 85 FR 84898
through 84901, and 86 FR 65491 and
65492 respectively) and
§ 414.1380(b)(1)(vii)(A) for our
previously establish scoring flexibilities
policy.
In the CY 2018 Quality Payment
Program final rule (82 FR 53714 through
53716), we finalized that, beginning
with the CY 2018 performance period,
we will assess performance on measures
considered significantly impacted by
ICD–10 coding changes during the
performance period based only on the
first 9 months of the 12-month
performance period. We stated that our
determination as to whether a measure
is significantly impacted by ICD–10
coding changes would include these
factors: A more than 10 percent change
in codes in the measure numerator,
denominator, exclusions, and
exceptions; clinical guideline changes
or new products or procedures reflected
in ICD–10 code changes; and feedback
on a measure received from measure
developers and stewards (82 FR 53714).
We stated that 9 months of data is
sufficient to assess performance when
12 months of data is not available. We
finalized that we would publish a list of
measures requiring 9 months of data on
the CMS website by October 1st of the
performance period if technically
feasible, but no later than the beginning
of the data submission period (for
example, January 2, 2021 for the CY
2020 performance period) (82 FR
53716).
In the CY 2019 Quality Payment
Program final rule (83 FR 59845 through
59847), we finalized policies beginning
with the CY 2019 performance period/
2021 MIPS payment year to reduce the
total available measure achievement
points in the quality performance
category by 10 points for MIPS eligible
clinicians for each measure submitted
that is significantly impacted by clinical
guideline changes or other changes
when we believe adherence to the
guidelines in the existing measures
could result in patient harm or
otherwise no longer be comparable to a
historic benchmark. We wanted the
flexibility to respond to instances in
which the clinical evidence and
guidelines change and approved
measures no longer reflect the most upto- date clinical evidence and could
even result in a practice that is harmful
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to patients. We finalized expanding the
list of reasons that a quality measure
may be impacted during the
performance period in addition to
revising when we will allow scoring of
the measure with a performance period
truncation (to 9 months of data) or the
complete suppression of the measure if
9 months of data are not available.
In the CY 2021 PFS final rule (85 FR
84898 through 84901), we finalized a
consolidation of the CY 2018 and CY
2019 scoring flexibilities policies that
allowed, beginning with the CY 2021
performance period/2023 MIPS
payment year, truncation of the
performance period or suppression of a
quality measure respectively if CMS
determines that revised clinical
guidelines, measure specifications or
codes impact clinician’s ability to
submit information on the measure or
may lead to potentially misleading
results. Based on the timing of the
changes to clinical guidelines, measure
specifications or codes, we will assess
the measure on 9 months of data, and
if 9 consecutive months of data are not
available, we will suppress the measure
by reducing the total available measure
achievement points from the quality
performance category by 10 points for
each measure submitted that is
impacted.
In the CY 2022 PFS final rule (86 FR
65491), we finalized a policy to expand
the situations in which the scoring
flexibilities policies would be applied.
This update revised
§ 414.1380(b)(1)(vii)(A) to change
‘‘significant changes’’ to ‘‘significant
changes or errors’’ and to include the
omission of codes or inclusion of
inactive or inaccurate codes. Previous
versions of the policy only included
changes to codes (such as ICD–10, CPT,
or HCPCS codes), clinical guidelines, or
measure specification as impacts
outside the control of the clinician and
its agents and that CMS determines may
result in patient harm or misleading
results and trigger application of this
policy.
In this year’s rule, we are proposing
two modifications to the criteria by
which we assess the impacts of ICD–10
coding changes. Firstly, we are
proposing to eliminate the 10 percent
ICD–10 coding change factor established
in the CY 2018 Quality Payment
Program rule (82 FR 53714). The quality
and cost performance categories rely on
measures that use detailed
specifications that include ICD–10 code
sets. We annually issue new ICD–10
coding updates, which are effective
from October 1 through September 30.
As part of this update, codes are added
and removed from the ICD–10 code sets.
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When we adopted this standard in the
CY 2018 Quality Payment Program final
rule (82 FR 53714), we were concerned
that ICD–10 coding changes in the final
quarter of the performance period may
render a measure no longer comparable
to its historical benchmark. However,
we have found that a 10 percent change
to ICD–10 codes does not necessarily
reflect a meaningful impact to
clinicians’ ability to report and be fairly
scored on a quality measure. In the CY
2018 Quality Payment Program
proposed rule, we discussed an
approach where we would consider any
change in ICD–10 coding to impact
performance on a measure and thus
only rely on the first 9 months of the 12month performance period for such
measures; however, we stated that such
an approach was too broad (overly
inclusive of changes) and would
truncate measurement for too many
measures where performance may not
be significantly affected (82 FR 30098).
We maintain this perspective but have
concluded that a 10 percent change in
codes is similarly over inclusive as it
leads to the suppression of measures
that can still be scored using all 12
months of the performance period. In
place of the 10 percent threshold we
propose to assess the overall impact on
a measure resulting from changes to
ICD–10 codes. Rather than consider a
flat 10 percent change as a factor for
when ICD–10 coding changes affect a
measure, we would instead assess how
the coding changes affect the measure
numerator, denominator, exclusions,
and exceptions in ways that could lead
to misleading or harmful results. We
would assess whether resultant changes
to the numerator, denominator,
exceptions, exclusions, or other measure
elements change the scope or intent of
the measure.
Changes in measure scope or intent
would be considered significant changes
that affect the applicability of the
historical benchmark. ICD–10 codes
include information related to clinical
diagnoses and eligible patient
population. For example, ICD–10 codes
in the denominator correspond to the
total eligible patient population
considered for a measure. If as a result
of a clinical guideline change a code is
changed from an exclusion to a code to
be considered in the total patient
population indicated in the
denominator for a measure, this would
meaningfully change the scope of the
measure and could lead to misleading
results in measurement. Additionally,
instances in which coding changes
change the designation of whether
performance was met or not (numerator)
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could similarly lead to misleading
results. These changes would be
considered significant and therefore
trigger our scoring flexibilities policy.
Second, we are proposing to assess
the impacts of coding changes and our
associated course of action
(suppression, truncation, or standard
12-month reporting) by measure
collection type. Our scoring policy
states that we calculate benchmarks by
collection type (§ 414.1380(b)(1)(ii). As
benchmarks are assessed by collection
type, we must consider by collection
type whether the changes or errors will
result in patient harm or misleading
results.
Each collection type has different
technical limitations. For example,
measure specifications for the MIPS
CQMs and Medicare Part B claims
collection types can be updated in the
performance period immediately
following the publication each October
of changes to ICD–10 codes. If an ICD–
10 coding change occurs in October of
2024, CMS can immediately update the
specifications for the measure’s MIPS
CQMs and Medicare Part B claims
collection types and the ICD–10 changes
would not result in any misleading
results for the measure for those
collection types.
This differs from eCQM measure
specifications, which are posted in the
May the year before the measure
specifications take effect and are valid
for the 12-month reporting period. For
the CY 2024 performance period/2026
MIPS payment year, eCQM measures
specifications will be posted in May of
2023 and are valid for the applicable 12month performance period in CY 2024.
In the example given above, the
measure’s eCQM collection type would
not be updated again until May 2025 for
the CY 2026 performance period/2028
MIPS payment year, and clinicians
would be left reporting pursuant to
outdated specifications for the final
quarter of the CY 2024 performance
period. This could result in misleading
results for the measure’s eCQM
collection type. As a result, it would be
appropriate for CMS to assess the
impact of changes to measures and
implement the appropriate scoring
flexibility by collection type.
Lastly, we are proposing that measure
specifications for eCQMs include the
capability to be truncated to a 9-month
performance period. Current measure
specifications for eCQMs provide
exclusively for a 12-month reporting
period. If a measure is significantly
impacted by ICD–10 coding changes, it
therefore cannot be reported for a
truncated performance period of 9month. In order to implement the
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scoring flexibilities policy as intended
and protect our ability to score measures
where 9 consecutive months of data is
available, we propose to begin requiring
measure specifications to include logic
for a 9-month performance period in
addition to the currently existing 12month performance period.
These updates will help us to better
provide scoring flexibilities to clinicians
by being sensitive to the particular
impacts to and capabilities of the
particular quality measures collection
types. We seek comment on our
proposal to update the criteria by which
be apply scoring flexibilities in response
to ICD–10 coding changes.
(d) Cost Performance Category Score
(i) Improvement Scoring Methodology
(A) Background
Section 1848(q)(5)(D)(i) requires that,
if sufficient data are available to
measure a MIPS eligible clinician’s
improvement in the quality and cost
performance categories, then our
methodology for computing the final
score must take into account such
improvement. In the CY 2018 Quality
Payment Program final rule (82 FR
53748 through 53752), we established
policies related to measuring
improvement in the cost performance
category at the measure level, an
improvement scoring methodology for
the cost performance category, and a
formula for calculating the cost
performance category percent score to
include achievement and improvement.
These policies were to apply beginning
with the CY 2018 performance period/
2020 MIPS payment year. We codified
these policies at 42 CFR
414.1380(b)(2)(iii) and (iv) (82 FR 53748
through 53752, 53957).
Subsequent to the publication of the
CY 2018 Quality Payment Program final
rule, the Bipartisan Budget Act of 2018
(BBA 18) (Pub. L. 115–123, February 9,
2018) was enacted. Section
51003(a)(1)(B) of the BBA 18 added a
new clause at section 1848(q)(5)(D)(iii)
of the Act which provided that the cost
performance category score shall not
take in to account the improvement of
the MIPS eligible clinician for each of
the second, third, fourth, and fifth years
for which the MIPS applies to payments
(the CY 2018 performance period/2020
MIPS payment year through the CY
2021 performance period/2023 MIPS
payment year).
To implement these statutory
changes, in the CY 2019 PFS final rule
(83 FR 35956, 36080 through 36082), we
established that the maximum cost
improvement score for the CY 2018
performance period/2020 MIPS
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payment year through the CY 2021
performance period/2023 MIPS
payment year is zero percentage points,
which we codified at § 414.1380(a)(1)(ii)
and (b)(2)(iv)(E). In the CY 2023 PFS
final rule (87 FR 70091 through 70093,
70228), we stated that we would begin
to implement cost improvement scoring
in the CY 2022 performance period/
2024 MIPS payment year and
established that the maximum cost
improvement score available would be 1
percentage point. We codified this
policy at § 414.1380(b)(2)(iv)(E). In
addition, under our authority at
§ 414.1380(c)(2)(i)(A)(8), we reweighted
the cost performance category’s score to
zero percent of the final score for the CY
2019 performance period/2022 MIPS
payment year through the CY 2021
performance period/2023 MIPS
payment year due to the COVID–19
Public Health Emergency (PHE) (85 FR
19277 through 19278; See ‘‘Extension to
Data Submission Deadline’’ on Quality
Payment Program website at https://
qpp.cms.gov/). On these bases, to date,
we have not applied a cost improvement
score to MIPS eligible clinicians’ final
scores in accordance with the policies
we established in the CY 2018 Quality
Payment Program final rule and our
regulations at § 414.1380(b)(2)(iii) and
(iv). (https://qpp.cms.gov/).
(B) Description of Previously Finalized
Cost Improvement Scoring Methodology
As discussed previously in this
section, we established several policies
related to our calculation and
application of cost improvement scores
to MIPS eligible clinicians’ final scores
in the CY 2018 Quality Payment
Program final rule (82 FR 53748 through
53752). First, we established that we
would determine the cost improvement
score at the individual measure level,
instead of the performance category
level, for the cost performance category
(82 FR 53749 through 53750). Second,
we established our methodology for
calculating the cost improvement score,
generally by comparing the number of
cost measures with significant
improvement in performance and the
number of cost measures with
significant declines in performance for a
MIPS eligible clinician or group
between two consecutive performance
periods (82 FR 53750 through 53752).
Specifically, we established that we
would quantify the cost improvement
score by subtracting the number of cost
measures with a significant decline from
the number of cost measures with a
significant improvement, and then
dividing the result by the number of
cost measures for which the MIPS
eligible clinician or group was scored
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for two consecutive performance
periods, and then multiply the resulting
fraction by the maximum improvement
score (82 FR 53750 through 53752). We
further established that we would
determine whether there was significant
improvement or decline in performance
between the two performance periods
by applying a common standard
statistical test to measure significance,
the t-test, as used in the Shared Savings
Program (82 FR 53750 through 53752).
Finally, we established that the cost
improvement score cannot be lower
than zero percentage points (82 FR
53750 through 53752).
We codified our cost improvement
scoring policies at § 414.1380(b)(2)(iv).
These policies governing our cost
improvement scoring methodology have
not been modified since the CY 2018
Quality Payment Program final rule.
(C) Mathematical Feasibility Issue for
Cost Improvement Scoring Methodology
In reviewing our cost improvement
scoring methodology, we discovered
that calculating cost improvement
scoring based on comparing only cost
measures with a statistically significant
change, determined by using a t-test, is
not congruent with the underlying data.
A t-test compares how significant the
differences are between group means,
which are aggregate values, and cannot
compare how significant the differences
are between single values. However, our
current cost improvement methodology
set forth at § 414.1380(b)(2)(iv) requires
comparing a MIPS eligible clinician’s
scores for an individual cost measure,
which are single value points rather
than group means. Further, the current
methodology purports to compare those
single value points between two
consecutive performance periods to
determine if there has been a
statistically significant change
(improvement or decline) in
performance. Therefore, a t-test cannot
be applied to the single cost measure
score data points for consecutive time
periods to determine if a statistically
significant change has occurred,
rendering our cost improvement scoring
methodology mathematically infeasible.
When we initially developed the cost
improvement scoring methodology for
the cost performance category, there
were only two population-based cost
measures (total per capita cost and
Medicare Spending per Beneficiary
measures), and no episode-based
measures. As of the CY 2023
performance period/2025 MIPS
payment year, there are 23 episodebased cost measures in addition to the
two population-based measures. We
expect to add additional episode-based
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measures to the cost performance
category in future years as MIPS
matures.
We believe that the aggregated nature
of the two population-based measures
influenced our determination regarding
the feasibility of establishing statistical
significance, using a t-test, when we
developed and established the cost
improvement scoring methodology.
However, although these populationbased measures are aggregated
measures, they are calculated as
individual single values in time, and not
aggregate values which the t-test
requires, for a specific clinician for each
of the two consecutive performance
periods. Further, considering a method
using statistical significance might have
been an oversight because of the lack of
episode-based measures when the cost
improvement scoring method was
developed.
Because we have not implemented
cost improvement scoring since we
finalized this methodology in the CY
2018 Quality Payment Program final
rule as discussed in section (4)(a)(iv) of
this proposed rule, we failed to identify
that the currently established cost
improvement scoring method is not
mathematically feasible. We identified
the mathematical infeasibility of the
current cost improvement methodology
in the process of implementing cost
improvement scoring for the CY 2023
performance period/2025 MIPS
payment year.
(D) Operational Feasibility Issues for
Cost Improvement Scoring Methodology
In addition, in the process of
implementing cost improvement scoring
for the CY 2023 performance period/
2025 MIPS payment year, we identified
three issues with our current policy at
§ 414.1380(b)(2)(iv)(A) because we
determine each MIPS eligible clinician’s
cost improvement score at the
individual cost measure level, and not
the category level, for the cost
performance category. To address these
three issues, further specified herein, we
propose to revise this policy so that we
will determine the cost improvement
score at the category level, instead of the
cost measure level, for the cost
performance category.
• Measure level improvement scoring
implementation issue: The growing
number of cost measures brings into
question if using the current
methodology for cost improvement
scoring introduces complexities to its
implementation, which in turn brings
into question operational feasibility.
When the methodology was established,
in the CY 2018 Quality Payment
Program final rule (82 FR 53748 through
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53752), there were only two cost
measures. As of the CY 2023
performance period/2025 MIPS
payment year, there are 25 cost
measures; we expect to add additional
measures to the cost performance
category as MIPS matures. Maintaining
measure level improvement scoring, for
a performance category that will
continue to see growth in the number of
measures, would be resource intensive,
complex to implement, and error prone.
Specifically, every measure would need
its own workflow and testing, which
would increase the amount of work to
ensure year-over-year comparisons are
accurate and increase risk of calculation
or data errors. Further, maintaining
measure level cost improvement scoring
would introduce the same operational
complexities we see in benchmarking
measures, particularly when a measure
encounters significant change from one
year to the next—a reality that might
present in future MIPS performance
years. These challenges support our
proposal to changing improvement
scoring from measure level to category
level for the cost performance category.
• Performance category improvement
scoring consistency: As set forth at
§ 414.1380(b)(1)(vi)(C), we calculate
each MIPS eligible clinician’s
improvement score for the quality
performance category in MIPS at the
performance category level. Upon
further evaluation, we found that using
two different methods of improvement
scoring for the quality and cost
performance categories would increase
the implementation cost and operational
complexity described above—as well as
confuse MIPS eligible clinicians and
call into question why we use two
different methodologies. As such, we
concluded that using category level
assessment for cost improvement
scoring would establish consistency
across MIPS and allow effective
communication with MIPS eligible
clinicians, while reducing
implementation cost and operational
complexity.
• Fairness of improvement scoring:
The episode-based measures for the cost
performance category are specific to
certain clinical conditions and/or care
settings. Some MIPS eligible clinicians
might not have the sufficient volume
threshold for any or all of the episodebased measures for two consecutive
performance periods, making year over
year improvement scoring at the
measure level less viable. Measure level
improvement scoring might negatively
impact these clinicians’ overall cost
performance category scoring because of
the inclusion of episode-based measures
outside of their scope of practice.
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(E) Proposed Modifications for Cost
Improvement Scoring Methodology
Beginning With the CY 2023
Performance Period/2025 MIPS
Payment Year
In light of both the mathematical and
operational feasibility issues with our
current cost improvement scoring
methodology, we are proposing two
modifications beginning with the CY
2023 performance period/2025 MIPS
payment year.
First, we propose to determine each
MIPS eligible clinician’s cost
improvement score at the category level,
instead of the current measure level,
beginning with the CY 2023
performance period/2025 MIPS
payment year. We propose this
modification based on the operational
feasibility considerations previously
discussed. We also propose that, if this
proposal is finalized,
§ 414.1380(b)(2)(iv)(A) and (C) would be
amended to reflect that the cost
improvement score will be determined
at the category level for the cost
performance category. In addition, we
propose that, if this proposal is
finalized, § 414.1380(b)(2)(iv)(B) would
be amended to reflect that we would
determine whether sufficient data are
available to measure improvement to
calculate the cost improvement score
based on whether a MIPS eligible
clinician or group participates in MIPS
using the same identifier in 2
consecutive performance periods and is
scored on the cost performance category
for 2 consecutive performance periods.
Second, we propose to modify the
cost improvement scoring methodology
to remove the requirement that we
compare measures with a ‘‘statistically
significant change (improvement or
decline) in performance’’ as determined
based on application of a t-test
beginning with the CY 2023
performance period/2025 MIPS
payment year. As previously discussed
in section IV.A.4.g.(1)(d)(i)(C) of this
proposed rule, determining cost
improvement scoring based on
statistical significance, using a t-test, is
not congruent with our underlying data
and is mathematically infeasible.
As such, we are proposing to remove
the statistical significance requirement
and update the calculation on how we
quantify cost improvement scoring
accordingly. Specifically, at
§ 414.1380(b)(2)(iv)(C), we are proposing
to determine the cost improvement
score at the category level by subtracting
the cost performance category score
from the previous performance period
(for example, CY 2022 performance
period/2024 MIPS payment year) from
the cost performance category score
from the current performance period
(for example, CY 2023 performance
period/2025 MIPS payment year), and
then by dividing the difference by the
cost performance category score from
the previous performance period (for
example, CY 2022 performance period/
2024 MIPS payment year), and by
dividing by 100.
In our current and established policy
set forth at § 414.1380(b)(2)(iii), the
overall cost performance category score
for the current year with the
improvement assessment is based on the
following calculation: Cost Performance
Category Score = Current Year
Performance Score + Improvement
Score. We do not propose any changes
to this established policy.
The following is an example to
illustrate how the cost improvement
score will be calculated if our two
proposals to modify our cost
improvement scoring policies are
adopted. An individual clinician, using
the same identifier (TIN A/NPI 1) for
two consecutive performance periods,
has a cost performance category score of
52.00 percent from the previous year,
and 63.71 percent in the current year.
Using our proposed change, at
§ 414.1380(b)(2)(iv)(C), to determine the
cost improvement score at the categorylevel, without using statistical
significance, the first step is to quantify
the change between current
performance period score and the
previous performance period score. This
is 63.71 percent¥52.00 percent, which
equals 11.71 percent. Then, the cost
improvement score is determined as
follows: ((change between current and
previous year performance scores/
previous year performance score))/100.
This is ((11.71 percent/52 percent)/100).
Therefore, the cost improvement score
for the current year is 0.23 percentage
points.
Based on our current and established
policy, set forth at § 414.1380(b)(2)(iii),
the overall cost performance category
score for current performance period is
current year performance score +
improvement score. This is 63.71
percent + 0.23 percentage point, which
equals 63.94 percent.
Lastly, to determine how many points
the cost performance category
contributes to the final score as set forth
in § 414.1380(c)(1), the current year cost
performance category score (63.94
percent) is multiplied by the weight of
the cost performance category (30
percent of the final score) and by 100 to
determine the points to the final score.
The individual clinician would have
63.94 percent × 30 percent × 100 = 19.18
points cost performance category
contribution to the final score.
We are proposing that these two
modifications to our cost improvement
scoring policy would be effective
Further in the CY 2018 Quality Payment
Program final rule (82 FR 53750) we
received comments in favor of category
level assessment for cost improvement
scoring because of concerns with the
inclusion of episode-based measures
and their potential growth for the cost
performance category. Specifically, the
concerns highlighted that determining
improvement scoring at the measure
level might be unfair; it would be
difficult for all MIPS eligible clinicians
to demonstrate improvement across all
measures. A category level assessment
provides an equitable cost improvement
scoring for MIPS eligible clinicians with
different scopes of practice because it
would only reflect measures that are
applicable to them.
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beginning with the CY 2023
performance period/2025 MIPS
payment year. As discussed previously
in section IV.A.4.g.(1)(d)(i)(A) of this
proposed rule, section 1848(q)(5)(D)(i)
of the Act requires that we account for
a MIPS eligible clinician’s improvement
in the cost performance category if we
have sufficient data available to measure
improvement. Because we have not
implemented cost improvement scoring
to date, we did not have sufficient data
available to measure year-over-year
improvement scoring for the cost
performance category until the CY 2023
performance period/2025 MIPS
payment year. However, we do have
such sufficient data available beginning
with the CY 2023 performance period/
2025 MIPS payment year. Further,
section 1848(q)(5)(D)(iii) of the Act,
requiring that we delay our
implementation of cost improvement
scoring through the CY 2021
performance period/2023 MIPS
payment year, no longer applies.
Therefore, we are proposing to
implement cost improvement scoring,
with these two proposed modifications,
beginning with the CY 2023
performance period/2025 MIPS
payment year.
On this basis, we are proposing to
amend § 414.1380(b)(2)(iv)(E) to state
that the maximum cost improvement
score for the 2020, 2021, 2022, 2023,
and 2024 MIPS payment years is zero
percentage points and that the
maximum cost improvement score
beginning with the CY 2025 MIPS
payment year is 1 percentage point. In
addition, we are proposing to amend
§ 414.1380(a)(1)(ii) to state that
improvement scoring is available in the
cost performance category starting with
the 2025 MIPS payment year, instead of
the 2024 MIPS payment year. The
remainder of the language currently at
§ 414.1380(a)(1)(ii) will remain the
same.
We are soliciting public comment on
these proposals.
f. MIPS Payment Adjustments
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(1) Background
Section 1848(q)(6)(A) of the Act
requires that we specify a MIPS
payment adjustment factor for each
MIPS eligible clinician for a year. This
MIPS payment adjustment factor is a
percentage determined by comparing
the MIPS eligible clinician’s final score
for the given year to the performance
threshold we established for that same
year in accordance with section
1848(q)(6)(D) of the Act. The MIPS
payment adjustment factors specified
for a year must result in differential
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payments such that MIPS eligible
clinicians with final scores above the
performance threshold receive a
positive MIPS payment adjustment
factor, those with final scores at the
performance threshold receive a neutral
MIPS payment adjustment factor, and
those with final scores below the
performance threshold receive a
negative MIPS payment adjustment
factor.
For previously established policies
regarding our determination and
application of MIPS payment
adjustment factors to each MIPS eligible
clinician, we refer readers to the CY
2017 Quality Payment Program final
rule (81 FR 77329 through 77343), CY
2018 Quality Payment Program final
rule (82 FR 53785 through 53799), CY
2019 PFS final rule (83 FR 59878
through 59894), CY 2020 PFS final rule
(84 FR 63031 through 63045), CY 2021
PFS final rule (85 FR 84917 through
84926), CY 2022 PFS final rule (86 FR
65527 through 65537), and CY 2023 PFS
final rule (87 FR 70096 through 70102).
In the CY 2023 PFS final rule (87 FR
70096 through 70102), we established
the performance threshold for the CY
2023 performance period/2025 MIPS
payment year by calculating the mean of
the final scores for all MIPS eligible
clinicians using CY 2017 performance
period/2019 MIPS payment year data. In
addition, we included information
about our timing for providing MIPS
performance feedback to MIPS eligible
clinicians for the CY performance
period in accordance with section
1848(q)(12) of the Act.
(2) Establishing the Performance
Threshold
(a) Statutory Background and Authority
As discussed above, in order to
determine a MIPS payment adjustment
factor for each MIPS eligible clinician
for a year, we must compare the MIPS
eligible clinician’s final score for the
given year to the performance threshold
we established for that same year in
accordance with Section 1848(q)(6)(D)
of the Act. Section 1848(q)(6)(D)(i) of
the Act requires that we compute the
performance threshold such that it is the
mean or median (as selected by the
Secretary) of the final scores for all
MIPS eligible clinicians with respect to
a ‘‘prior period’’ specified by the
Secretary. Section 1848(q)(6)(D)(i) of the
Act also provides that the Secretary may
reassess the selection of the mean or
median every 3 years.
Sections 1848(q)(6)(D)(ii) through (iv)
of the Act provided special rules,
applicable only for certain initial years
of MIPS, for our computation and
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application of the performance
threshold for our determination of MIPS
payment adjustment factors.
Specifically, for the CY 2017
performance period/2019 MIPS
payment year through CY 2022
performance period/2024 MIPS
payment year, section 1848(q)(6)(D)(ii)
of the Act required that we establish an
additional performance threshold for
determining additional positive MIPS
payment adjustment factors applicable
to MIPS eligible clinicians with
exceptional performance. Then, for the
CY 2017 performance period/2019 MIPS
payment year through CY 2021
performance period/2023 MIPS
payment year, section 1848(q)(6)(D)(iii)
required that we establish a
performance threshold based on a
period prior to such performance
periods and take into account available
data with respect to performance on
measures and activities that we may use
under the four MIPS performance
categories and other factors determined
appropriate by the Secretary.
Specifically, section 1848(q)(6)(D)(iii) of
the Act addressed how we would
establish a performance threshold for
MIPS in its initial years prior to having
final score data available from prior
periods of MIPS. Finally, for the CY
2019 performance period/CY 2021 MIPS
payment year through CY 2021
performance period/2023 MIPS
payment year, section 1848(q)(6)(D)(iv)
of the Act required that we methodically
increase the performance threshold each
year to ‘‘ensure a gradual and
incremental transition’’ to the
performance threshold we estimated
would be applicable in the CY 2022
performance period/2024 MIPS
payment year. Although sections
1848(q)(6)(D)(ii) through (iv) of the Act
are no longer applicable for establishing
the performance threshold for the CY
2024 performance period/2026 MIPS
payment year, these previously
applicable statutory requirements
explain our prior computations of the
performance threshold that impact our
policy considerations for establishing
the performance threshold for MIPS
going forward.
In the CY 2022 PFS final rule (86 FR
65527 through 65532), we selected the
mean as the methodology for
determining the performance threshold
for the CY 2022 through 2024
performance periods/2024 through 2026
MIPS payment years. We also
established in our regulation at 42 CFR
414.1405(g) that, for the CY 2022
performance period/2024 MIPS
payment year through the CY 2024
performance period/2026 MIPS
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payment year, the performance
threshold would be the mean of the
final scores for all MIPS eligible
clinicians from a prior period. For CY
2022 through CY 2023 performance
periods/2024 through 2025 MIPS
payment years, we selected a single
performance period when selecting a
prior period to compute the mean of the
final scores and establish the
performance threshold. However, as
discussed under paragraph (b) of this
section, we propose to modify and
refine our policy for selecting a ‘‘prior
period’’ to establish the performance
threshold under paragraph (b) of this
section.
For further information on our current
performance threshold policies, we refer
readers to the CY 2017 Quality Payment
Program final rule (81 FR 77333 through
77338), CY 2018 Quality Payment
Program final rule (82 FR 53787 through
53792), CY 2019 PFS final rule (83 FR
59879 through 59883), CY 2020 PFS
final rule (84 FR 63031 through 63037),
CY 2021 PFS final rule (85 FR 84919
through 84923), CY 2022 PFS final rule
(86 FR 65527 through 65532), and CY
2023 PFS final rule (87 FR 70096
through 70100).
We codified the performance
thresholds for each of the first 7 years
of MIPS at § 414.1405(b)(4) through (9).
These performance thresholds are
shown in Table 50.
(b) Proposal To Modify Our Policy for
Establishing the Performance Threshold
Beginning With the CY 2024
Performance Period/2026 MIPS
Payment Year
In previous years, we selected a single
performance period when selecting a
prior period. In this proposed rule, we
are reassessing our previous
interpretation of ‘‘prior period’’ as
described at section 1848(q)(6)(D)(i) of
the Act.
Section 1848(q)(6)(D)(i) states that the
performance threshold for a year shall
be the mean or median (as selected by
the Secretary) of the composite
performance scores for all MIPS eligible
professionals with respect to a ‘‘prior
period’’ specified by the Secretary. The
use of ‘‘prior period’’ in section
1848(q)(6)(D)(i) of the Act differs from
other provisions in the statute which
specifically refer to ‘‘a year’’ or
‘‘performance period.’’ For example,
section 1848(q)(6)(A) of the Act
specifies application of a MIPS
adjustment factor for ‘‘a year.’’
Meanwhile, section 1848(q)(4) of the
Act specifically defines the term
‘‘performance period’’ for MIPS,
requiring that the Secretary shall
establish ‘‘a performance period (or
periods) for a year (beginning with
2019)’’ and such ‘‘performance period
(or periods)’’ shall begin and end prior
to the beginning of such ‘‘year and be
as close as possible to such year.’’ These
statutory provisions governing MIPS
clearly distinguish the terms
‘‘performance period’’ and ‘‘year’’ from
‘‘prior period’’ used in section
1848(q)(6)(D)(i) of the Act. If the ‘‘prior
period’’ we use to determine the mean
or median of all MIPS eligible
clinicians’ final scores to establish the
performance threshold under section
1848(q)(6)(D)(i) of the Act was intended
to be limited to a single year or
performance period, we believe the
statute would have been more specific
on that point rather than using the
unique term, ‘‘prior period.’’
Because section 1848(q)(6)(D)(i) of the
Act does not specifically refer to ‘‘a
performance period’’ or ‘‘year’’ to
establish the performance threshold, we
believe that the term ‘‘prior period’’ can
refer to a time span other than a single
year or performance period as long as
that ‘‘prior period’’ is specified by the
Secretary. More specifically, given our
interpretation that ‘‘prior period’’ does
not require CMS to select a single
performance year as the period, we
propose to add § 414.1405(g)(2) to
specify that, beginning with CY 2024
performance period/2026 MIPS
payment year, a ‘‘prior period’’ for
purposes of establishing a performance
threshold as identified in § 414.1405(b)
is a time span of 3 performance periods.
Subsequently, we also propose to
redesignate language at § 414.1405(g)
which states that, for each of the 2024,
2025, and 2026 MIPS payment years,
the performance threshold is the mean
of the final scores for all MIPS eligible
clinicians from a prior period as
specified under paragraph (b) of this
section, as § 414.1405(g)(1).
Recognizing the flexibility of the term,
‘‘prior period,’’ we reviewed the data we
have available from prior MIPS
performance periods, and believe it
would be appropriate to specify a ‘‘prior
period’’ as three performance periods.
Using three performance periods as the
prior period would prevent the
performance threshold from being
dependent on a single potentially
anomalous performance period, or on
two performance periods, whose mean
or median final score may be an outlier
compared to other performance periods.
The mean or median of final scores over
36 months is less likely to be impacted
by unusual fluctuations in performance
specific to a shorter time frame, is more
likely to reflect clinician performance,
and therefore, more appropriate to set
the performance threshold. Using the
mean or median of final scores of three
performance periods would allow us to
include more scores in the computation
of the mean or median, and therefore,
mitigate the impact of outliers. Further,
using three performance periods would
also smooth out year-to-year
fluctuations in the performance
threshold, developing greater
consistency and stability in MIPS, and
providing more predictability for MIPS
eligible clinicians who may wish to set
MIPS performance goals. Additionally,
as more data become available, we will
consider whether a longer time span
than three performance periods may be
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While we chose to use the mean in
our methodology for determining the
performance threshold for the CY 2022
through 2024 performance periods/2024
through 2026 MIPS payment years, we
have not specified which prior period’s
mean final score we would use for the
CY 2024 performance period/2026 MIPS
payment year’s performance threshold.
From our review of the data available to
us, we identified the mean final scores
for each of the CY 2017 through 2021
performance periods/2019 through 2023
MIPS payment years individually, as
well as the mean of the final scores for
CY 2017 through CY 2019 performance
periods/2019 through 2021 MIPS
payment years combined, as shown in
Table 51. Based on our proposed
definition of ‘‘prior period,’’ we
included means of final scores for MIPS
eligible clinicians spanning over three
performance periods within Table 51 in
addition to a single year performance
period. These six values represent the
mean final scores for all MIPS eligible
clinicians from prior periods that are
available for consideration for the CY
2024 performance period/2026 MIPS
payment year performance threshold.
We are not considering the means of
the final scores for certain prior periods
because of issues with the underlying
data. First, for the CY 2020 through
2021 performance periods/2022 through
2023 MIPS payment years for the
purpose of establishing the performance
threshold because we extensively
applied our extreme and uncontrollable
circumstances policies described under
§ 414.1380(c)(2)(i) to MIPS eligible
clinicians nationwide due to the
COVID–19 PHE, which we believe
resulted in skewing the final scores from
those years such that they are not an
appropriate indicator for future
clinician performance. We announced
on April 6, 2020, the application of
extreme and uncontrollable
circumstances policies described under
§ 414.1380(c)(2)(i) to MIPS eligible
clinicians nationwide due to the
COVID–19 PHE for the CY 2019
performance period/2021 MIPS
payment year (85 FR 19277 through
19278). However, given the timing of
the COVID–19 PHE and this
announcement, the data was likely
minimally impacted because many
MIPS eligible clinicians had already
submitted the data. Second, the final
scores for the CY 2022 performance
period/2024 MIPS payment year were
not finalized in time for this proposed
rule and, therefore, the mean final score
for the CY 2022 performance period/
2024 MIPS payment year is not
included for consideration as a potential
performance threshold value for the CY
2024 performance period/2026 MIPS
payment year.
As shown in Table 51, the mean final
scores available for consideration for the
CY 2024 performance period/2026 MIPS
payment year performance threshold
cover a range of values from 74.65
points to 89.47 points (rounded to 75
points and 89 points, respectively). We
propose to use the CY 2017 through CY
2019 performance periods/2019 through
2021 MIPS payment years (mean of 82
points, rounded down from 82.06
points) as the prior period for the
purpose of establishing the performance
threshold for the CY 2024 performance
period/2026 MIPS payment year for
several reasons.
First, as stated above in section
IV.A.4.h.(2)(b) of this proposed rule, we
believe using the mean or median of
final scores across three performance
periods would smooth out year-to-year
fluctuations in the performance
threshold, developing greater
consistency and stability in MIPS, and
providing more predictability for MIPS
eligible clinicians who may wish to set
MIPS performance goals. This would
also allow us to include more scores in
the computation of the mean or median,
and therefore mitigate the impact of
unusual fluctuations in performance
specific to a 24-month or a 12-month
timeframe. For example, since we
applied extreme and uncontrollable
circumstances policies described under
§ 414.1380(c)(2)(i) (85 FR 19277 through
19278) for the CY 2019 performance
period/2021 MIPS payment year, we
believe using the additional 24 months
of data from the CY 2017 and 2018
performance periods/2019 and 2020
MIPS payment years will allow us to
mitigate any potential impact of outliers
in computing the mean to establish the
performance threshold.
Second, we also believe continuing a
gradual and incremental increase in the
performance threshold by establishing
the performance threshold for the CY
2024 performance period/2026 MIPS
payment year at 82 will provide stability
to MIPS eligible clinicians. This
proposed performance threshold value
would be an increase of nearly 7 points
from the CY 2023 performance period/
2025 MIPS payment year performance
threshold of 75 points. This increase
would be smaller than the 12-to-15point increases in previous years, apart
from the CY 2023 performance period/
2025 MIPS payment year, during which
the performance threshold remained the
same as the previous year. We note that
appropriate to mitigate outliers and
better reflect clinician performance
trends.
In the CY 2022 PFS final rule (86 FR
65531 through 65532), we stated that,
under our interpretation of section
1848(q)(6)(D)(i) of the Act at that time,
choosing the mean or median from a
‘‘prior period’’ does not allow us to
balance scores from multiple years.
However, on further reflection, the
presence of distinctions in the statute
between ‘‘prior period’’ and
‘‘performance period’’ and ‘‘year’’ has
prompted us to reevaluate the
appropriateness of limiting our
establishment of the performance
threshold based on a single prior
performance period.
We request comments on our proposal
to use three performance periods as the
‘‘prior period’’ we use to establish a
performance threshold and codify the
policy at § 414.1405(g)(2).
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(c) Performance Threshold for the CY
2024 Performance Period/2026 MIPS
Payment Year
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the incremental and gradual increase is
no longer required by section
1848(q)(6)(D)(iv) of the Act. However,
we still believe that in the long term, the
program is served by incremental and
gradual changes, such as an increase in
the performance threshold to best reflect
MIPS eligible clinicians’ recent
performance by using data from later
years. We also believe an incremental
and gradual change in the performance
threshold for the CY 2024 performance
period/2026 MIPS payment year is
appropriate as the PHE for COVID–19
concludes.
Finally, we also believe the
performance threshold of 82 strikes an
appropriate balance of using more
robust data and yet accounting for
clinician practices that are still
recovering from the impacts of the
COVID–19 PHE. If we were to use more
recent data from CY 2018 performance
period/2020 MIPS payment year or CY
2019 performance period/2021 MIPS
payment year means, the increase
would be more substantial than the
incremental increase to 82.
The CY 2023 performance period/
2025 MIPS payment year is the only
year for which we did not increase the
performance threshold from the prior
year due to reasons noted in the CY
2023 PFS final rule (87 FR 70096
through 70100). First, we acknowledged
that we removed transition policies,
such as quality bonus points which had
been established for scoring the quality
performance category for the CY 2018
through 2020 performance periods/2020
through 2022 MIPS payment years (86
FR 65491 through 65507). Second, we
stated that, for the CY 2019 through
2021 performance periods/2021 through
2023 MIPS payment years, we applied
certain extreme and uncontrollable
circumstances policies described under
§ 414.1380(c)(2)(i) to MIPS eligible
clinicians nationwide due to the
COVID–19 PHE, which resulted in the
reweighting of some performance
categories if data were not submitted for
a MIPS eligible clinician. Given the
elimination of those transition policies,
as well as the possibility the
performance categories will not be
reweighted for as many MIPS eligible
clinicians for the CY 2023 performance
period/2025 MIPS payment year, we
expected the mean final score for CY
2023 performance period/2025 MIPS
payment year to be lower than the mean
final scores from the CY 2018 through
2020 performance periods/2020 through
2022 MIPS payment years. On these
bases, we established the performance
threshold at 75 for the CY 2023
performance period/2025 MIPS
payment year, without any change from
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the prior year (87 FR 70096 through
70100).
However, for the CY 2024
performance period/2026 MIPS
payment year, we no longer need to
account for those reasons stated in CY
2023 PFS final rule (87 FR 70096
through 70100) and explained above,
and therefore, believe it is appropriate
to increase the performance threshold.
For example, the COVID–19 PHE
expired on May 11, 2023, emphasizing
the less unpredictable impact of the
COVID–19 PHE on health systems’
expenditures and resources.319 In
addition, we no longer believe we need
to consider MIPS transition policies
because they are no longer in effect and
clinicians have now had several years of
experience in reporting within MIPS,
which has been in effect for seven years.
Finally, we believe that, as clinicians
gain more experience within the MIPS
program and as more recent data are
available, we should incorporate more
recent data in determining the
performance threshold. We believe our
proposal to use the mean of the final
scores for the CY 2017 through 2019
performance periods/2019 through 2021
MIPS payment years as the prior period
for the purpose of determining the
performance threshold for the CY 2024
performance period/2026 MIPS
payment year achieves an appropriate
balance.
Under this proposal, and pursuant to
the methodology we established
previously at § 414.1405(g), the
performance threshold for the CY 2024
performance period/2026 MIPS
payment year would be the mean of the
final scores for all MIPS eligible
clinicians for the CY 2017 through 2019
performance periods/2019 through 2021
MIPS payment years, which is 82 points
(rounded from 82.06 points). We are
proposing corresponding changes to
§ 414.1405(b)(9) to reflect this proposal.
Alternatively, as an effort to use more
recent data, we considered using the
single 2019 performance period/2021
MIPS payment year, with a mean of 86
(rounded from 85.63) to establish the
performance threshold for the CY 2024
performance period/2027 MIPS
payment year. However, in efforts to use
more robust data from a longer period
of time, we are proposing using the CY
2017 through 2019 performance period/
2019 through 2021 MIPS payment year
as the prior period, with its mean of 82
points, to set the performance threshold
for the CY 2024 performance period/
319 https://aspr.hhs.gov/legal/PHE/Pages/covid1911Jan23.aspx; https://www.nytimes.com/2023/01/
30/us/politics/biden-covid-public-healthemergency.html.
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2026 MIPS payment year. We also
believe the performance threshold of 82
instead of 86 would be more appropriate
for clinician practices that are still
recovering from the impacts of the
COVID–19 PHE.
In the Regulatory Impact Analysis
(RIA) in section VII.E.23.d.(4) of this
proposed rule, we estimate that
approximately 46 percent of MIPS
eligible clinicians would receive a
negative payment adjustment for the CY
2024 performance period/2026 MIPS
payment year if the policies proposed in
this proposed rule are finalized and the
performance threshold is equal to 82
points. We refer readers to the
alternatives considered in the RIA in
section VII.F.4 of this proposed rule
where we present the impact of using
data from alternative years to determine
the performance threshold for the CY
2024 performance period/2026 MIPS
payment year.
We are requesting comments on this
proposal, as well as whether we should
use means of final scores from
alternative years to set the performance
threshold for the CY 2024 performance
period/2026 MIPS payment year, which
we considered and discussed in the RIA
in section VII.F.4 of this proposed rule.
(3) Example of Adjustment Factors
Figure 1 provides an illustrative
example of how various final scores will
be converted to a MIPS payment
adjustment factor using the statutory
formula and based on our proposed
policies for the CY 2024 performance
period/2026 MIPS payment year. In
Figure 1, the performance threshold is
set at 82 points, as we have proposed in
section IV.A.4.h.(2)(c) of the proposed
rule.
For purposes of determining the
maximum and minimum range of
potential MIPS payment adjustment
factors, section 1848(q)(6)(B) of the Act
defines the applicable percentage as 9
percent for the CY 2024 performance
period/2026 MIPS payment year. The
MIPS payment adjustment factor is
determined on a linear sliding scale
from zero to 100, with zero being the
lowest possible score which receives the
negative applicable percentage and
resulting in the lowest payment
adjustment, and 100 being the highest
possible score which receives the
highest positive applicable percentage
and resulting in the highest payment
adjustment.
However, there are two modifications
to this linear sliding scale. First, as
specified in section 1848(q)(6)(A)(iv)(II)
of the Act, there is an exception for a
final score between zero and one-fourth
of the performance threshold (zero and
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20.5 points based on the performance
threshold of 82 points for the CY 2024
performance period/2026 MIPS
payment year). All MIPS eligible
clinicians with a final score in this
range will receive a negative MIPS
payment adjustment factor equal to 9
percent (the applicable percentage).
Second, the linear sliding scale for the
positive MIPS payment adjustment
factor is adjusted by the scaling factor,
which cannot be higher than 3.0, as
required by section 1848(q)(6)(F)(i) of
the Act.
If the scaling factor is greater than
zero and less than or equal to 1.0, then
the MIPS payment adjustment factor for
a final score of 100 will be less than or
equal to 9 percent (the applicable
percentage). If the scaling factor is above
1.0 but is less than or equal to 3.0, then
the MIPS payment adjustment factor for
a final score of 100 will be greater than
9 percent. Only those MIPS eligible
clinicians with a final score equal to 82
points (the proposed performance
threshold for the CY 2024 performance
period/2026 MIPS payment year) would
receive a neutral MIPS payment
adjustment.
Beginning with the CY 2023
performance period/2025 MIPS
payment year, the additional MIPS
payment adjustment for exceptional
performance described in section
1848(q)(6)(C) of the Act is no longer
available. For this reason, Figure 1 does
not illustrate an additional adjustment
factor for MIPS eligible clinicians with
final scores at or above the additional
performance threshold described in
section 1848(q)(6)(D)(ii) of the Act.
Table 52 illustrates the changes in
payment adjustment based on the final
policies from the CY 2023 PFS final rule
(87 FR 70096 through 70103) for the CY
2023 performance period/2025 MIPS
payment year and the proposed policies
for the CY 2024 performance period/
2026 MIPS payment year, as well as the
applicable percent required by section
1848(q)(6)(B) of the Act.
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g. Review and Correction of MIPS Final
Score
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(1) Feedback and Information To
Improve Performance
K. Targeted Review
Under section 1848(q)(12)(A)(i) of the
Act, we are required to provide MIPS
eligible clinicians with timely (such as
quarterly) confidential feedback on their
performance under the quality and cost
performance categories beginning July 1,
2017, and we have discretion to provide
such feedback regarding the
improvement activities and Promoting
Interoperability performance categories.
In the CY 2018 Quality Payment
Program final rule (82 FR 53799 through
53801), we finalized that on an annual
basis, beginning July 1, 2018,
performance feedback will be provided
to MIPS eligible clinicians and groups
for the quality and cost performance
categories, and if technically feasible,
for the improvement activities and
advancing care information (now called
the Promoting Interoperability)
performance categories.
We made performance feedback
available for the CY 2019 performance
period/2021 MIPS payment year on
August 5, 2020; for the CY 2020
performance period/2022 MIPS
payment year on August 2 and
September 27, 2021; and for the CY
2021 performance period/2023 MIPS
payment year on August 22, 2022.
Although we aim to provide feedback
for the CY 2022 performance period/
2024 MIPS payment year on or around
July 1, 2023, it is possible the release
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date could be later depending on
circumstances. We direct readers to
qpp.cms.gov for more information.
a. Background
Section 1848(q)(13)(A) of the Act
requires that the Secretary establish a
process under which a MIPS eligible
clinician may seek an informal review
of the calculation of the MIPS
adjustment factor (or factors) applicable
to the MIPS eligible clinician. In the CY
2017 Quality Payment Program final
rule (81 FR 77353 through 77358), we
finalized a targeted review process and
related requirements under MIPS
wherein a MIPS eligible clinician or
group may request a review of the
calculation of the MIPS payment
adjustment factor and, as applicable, the
calculation of the additional MIPS
payment adjustment factor applicable to
such MIPS eligible clinician or group for
a year. Currently, MIPS eligible
clinicians, groups, and Alternative
Payment Model (APM) entities may
request and receive targeted review of
our calculation of their MIPS payment
adjustment factor(s) under our
established process and related
requirements. In the CY 2017 Quality
Payment Program final rule (81 FR
77546), we codified the MIPS targeted
review process and related requirements
at § 414.1385(a).
In the CY 2020 PFS final rule (84 FR
63045 through 63049), we revised the
MIPS targeted review process and
related requirements to address persons
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eligible to request targeted review,
timeline for submission of targeted
review requests, denial of targeted
review requests, our requests for
additional information, notification of
targeted review decisions, and scoring
recalculations. We codified these
revisions to the targeted review process
and related requirements at
§ 414.1385(a) (84 FR 63197 through
63198).
Currently, as specified at
§ 414.1385(a)(2), we provide that all
requests for targeted review must be
submitted within a 60-day period,
beginning on the day that we make
available the MIPS payment adjustment
factors for the MIPS payment year
applicable to each MIPS eligible
clinician. In addition, § 414.1385(a)(2)
provides that we may extend the
targeted review request submission
period. However, this current
submission period for MIPS targeted
review presents significant challenges to
CMS as we seek to implement
application of a differentially higher
PFS conversion factor for eligible
clinicians who are Qualifying APM
Participants (QPs) for a year beginning
with the CY 2024 QP Performance
period/2026 payment year, as required
by section 1848(d)(1)(A) of the Act.
Specifically, to ensure application of
the alternative conversion factor for
eligible clinicians who are QPs, we must
submit the final list of QPs to our
Medicare Administrative Contractors no
later than October 1st of the preceding
year. However, under our current
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targeted review timeline for MIPS, this
information would not be available until
the first week of December. This is
because the targeted review request
submission period begins upon
notification of the MIPS payment
adjustment factors, which takes place
sometime in August, and ends 60 days
later, sometime in November. While
QPs are excluded from MIPS reporting
and any MIPS payment adjustment, we
have received and addressed several
requests for targeted review based on a
clinician disputing whether they should
be designated as a QP or a MIPS eligible
clinician for purposes of payment under
the Quality Payment Program. Based on
our experience, we have found that
more often than not a MIPS eligible
clinician was initially identified as a QP
but did not in fact participate in an
Advanced APM and, conversely, a MIPS
eligible clinician who believes they had
achieved QP status was not identified as
such. The targeted review process
allows for clinicians to bring these
issues to our attention. Accordingly, the
targeted review process is essential to
compiling an accurate list of QPs, which
is necessary for purposes of determining
who receives the application of the
higher PFS conversion factor (also
known as ‘‘qualifying APM conversion
factor’’) of 0.75 percent (versus non-QPs,
who receive 0.25 percent).
Section 1848(q)(13)(A) of the Act does
not specify a timeframe for targeted
review, broadly requiring that we
‘‘establish a process’’ for informal
review of our calculation of the MIPS
adjustment factor. Section
1848(q)(13)(A) of the Act only requires
that the targeted review process permit
a MIPS eligible clinician to seek
‘‘informal review of the calculation of
the MIPS adjustment factor (or factors)’’
applicable to the MIPS eligible clinician
for a MIPS payment year. We believe
this broad authority for establishing this
targeted review process, and lack of
specificity as to any timeframe required
for such process, permits CMS to
determine a reasonable time period for
submission of a request for targeted
review so long as a MIPS eligible
clinician can submit a request after we
have informed them of our calculation
of their MIPS adjustment factor(s).
Therefore, we are proposing to permit
submission of a request for targeted
review beginning on the day we make
available the MIPS final score and
ending 30 days after publication of the
MIPS payment adjustment factors for
the MIPS payment year. This proposal
will allow for a total of approximately
60 days for the targeted review
submission period (approximately 30
days before publication of the MIPS
payment adjustments factors and 30
days thereafter). We believe this
proposal will provide us with the
necessary time to adjudicate the targeted
reviews and finalize the QP status list
by October 1st. If finalized, we are
proposing to codify this proposed
modification to this policy at
§ 414.1385(a)(2).
In Figure 2, we illustrate our proposed
change to the timeline of the targeted
review. The text above the timeline
reflects the current process for targeted
review while the text below the timeline
reflects the proposed process in Figure
2.
To further shorten the timeline of the
targeted review process for the reasons
discussed above, we also are proposing
to amend § 414.1385(a)(5). Specifically,
we are proposing to require that, if CMS
requests additional information under
the targeted review process, that that
additional information must be
provided to and received by CMS
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within 15 days of receipt of such
request. This proposal would modify
the current timeline to respond to CMS’
request set forth at § 414.1385(a)(5),
which is within 30 days of receipt.
In the CY 2017 Quality Payment
Program final rule (81 FR 77353 through
77358), we implemented a virtual
groups participation option under MIPS.
Since virtual groups are eligible to
submit data to the MIPS program, we
are proposing to add virtual groups as
being eligible to submit a request for
targeted review. Finally, as discussed in
section IV.A.4.d (4) of this proposed
rule, we are also proposing to add
subgroups as being eligible to submit a
request for targeted review. We are
proposing to codify these additions at
§ 414.1385(a).
We invite public comment on these
proposals.
k. Third Party Intermediaries General
Requirements
(1) Codification of Previously Finalized
Policy From Preamble
A third party intermediary is an entity
that CMS has approved under
§ 414.1400 to submit data on behalf of
a MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity for one
or more of the quality, improvement
activities, and Promoting
Interoperability performance categories
(§ 414.1305). Many of the policies that
apply to third party intermediaries were
finalized through prior rulemaking but
not codified in the CFR. Among other
things, this has made it challenging for
third party intermediaries to track
certain program requirements and has
caused confusion for MIPS participants
and third party intermediaries.
We have reviewed the previously
finalized language and identified
policies that we believe should be
codified for these reasons. We describe
these proposals and provide background
throughout this section.
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(2) General Requirements
(a) Background
We refer readers to §§ 414.1305 and
414.1400, the CY 2017 Quality Payment
Program final rule (81 FR 77362 through
77390), the CY 2018 Quality Payment
Program final rule (82 FR 53806 through
53819), the CY 2019 PFS final rule (83
FR 59894 through 59910), the CY 2020
PFS final rule (84 FR 63049 through
63080), the May 8th COVID–19 IFC (85
FR 27594 and 27595), the CY 2021 PFS
final rule (85 FR 84926 through 84947),
the CY 2022 PFS final rule (86 FR 65538
through 65550), and the CY 2023 PFS
final rule (87 70102 FR through 70109)
for our previously established policies
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regarding third party intermediaries.
Where we are proposing to codify
existing final policy, we incorporate the
rationale described in these prior rules
by reference.
In this proposed rule, in addition to
codifying previously finalized policies
and making technical updates for
clarity, we propose to: (1) Add
requirements for third party
intermediaries to obtain documentation;
(2) Specify the use of a simplified selfnomination process for existing
qualified clinical data registries
(QCDRs) and qualified registries; (3)
Add requirements for QCDRs and
qualified registries to provide measure
numbers and identifiers for performance
categories; (4) Add a requirement for
QCDRs and qualified registries to attest
that information on the qualified
posting is correct; (5) Modify
requirements for QCDRs and qualified
registries to support MVP reporting; (6)
Specify requirements for a transition
plan for QCDRs and qualified registries;
(7) Specify requirements for data
validation audits; (8) Add additional
criteria for rejecting QCDR measures; (9)
Add a requirement for QCDR measure
specifications to be displayed
throughout the performance period and
data submission period; (10) Eliminate
the Health IT vendor category; (11) Add
failure to maintain updated contact
information as criteria for remedial
action; (12) Revise corrective action
plan requirements; (13) Specify the
process for publicly posting remedial
action; and (14) Specify the criteria for
audits.
(b) Requirement To Obtain
Documentation
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 and 77385), we
established requirements that QCDRs
and qualified registries obtain signed
documentation from clinicians and
groups regarding their authority to
handle and submit data on the clinician
and group’s behalf. We established that
QCDRs and qualified registries must
enter into appropriate Business
Associate Agreements with MIPS
eligible clinicians. QCDRs and qualified
registries must obtain signed
documentation that each holder of a
national provider identifier (NPI) has
authorized the third party intermediary
to submit ‘‘quality measure results,
improvement activities measure and
activity results, advancing care
information objective results and
numerator and denominator data or
patient-specific data on Medicare and
non-Medicare beneficiaries to CMS for
the purpose of MIPS participation.’’ The
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documentation should be annually
obtained at the time the clinician or
group enters into an agreement with the
QCDR or qualified registry for the
submission of MIPS data to the QCDR
or qualified registry. A group, subgroup,
Virtual Group, or APM Entity may have
their authorized representative give
permission to the third party
intermediary to submit their data.
Additionally, in the CY 2018 Quality
Payment Program final rule (82 FR
53812), we clarified that Business
Associate Agreements must comply
with the HIPAA Privacy and Security
Rules. Records of the authorization must
be maintained for 6 years after the
performance period ends (81 FR 77370).
We propose to codify these
requirements at § 414.1400(b)(3)(xii) and
(xiii).
We invite comments on this proposal.
(c) Requirement To Report in Form and
Manner Specified
(i) Criteria for Data Submission
At § 414.1400(a)(2)(C), we require that
all data submitted by a third party
intermediary must be submitted in the
form and manner specified by CMS. We
are specifying that these requirements
include the obligation for a third party
intermediary to: (1) report the number of
eligible instances (reporting
denominator); (2) report the number of
instances a quality service is performed
(performance numerator); (3) report the
number of performance exclusions,
meaning the quality action was not
performed for a valid reason as defined
by the measure specification; (4) comply
with a CMS-specified secure method for
data submission, such as submitting the
QCDR’s data in an XML file; (5) be able
to calculate and submit measure-level
reporting rates or the data elements
needed to calculate the reporting and
performance rates by taxpayer
identification number (TIN)/NPI and/or
TIN; (6) be able to calculate and submit
a performance rate (that is the
percentage of a defined population who
receive a particular process of care or
achieves a particular outcome based on
a calculation of the measures’ numerator
and denominator specifications) for
each measure on which the TIN/NPI or
TIN reports; (7) provide the performance
period start date the QCDR will cover;
(8) provide the performance period end
date the QCDR will cover; (9) report the
number of reported instances,
performance not met, meaning the
quality actions was not performed for no
valid reason as defined by the measure
specification; and (10) submit quality,
advancing care information, or
improvement activities data and results
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to us in the applicable MIPS
performance categories for which the
QCDR is providing data (81 FR 77367
through 77369 and 77384 through
77385). These criteria for data
submission are technical requirements
of functioning QCDRs and qualified
registries.
(ii) Reporting on All Patients, Including
Non-Medicare Patients
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 through 77385), we
established that QCDRs and qualified
registries are required to submit data on
all patients, not just Medicare patients.
In section IV.A.4.f.(1)(b) of this rule, we
propose a revision to the definition of
the term collection type to allow Shared
Saving Program ACOs meeting the
reporting requirements under the APP
to report on a subset of patients that is
partially defined by having the payer of
Medicare. We propose to codify our
previously established requirement that
data submitted by third party
intermediaries must include data on all
of the MIPS eligible clinician’s patients
regardless of payer, with the addition of
the phrase ‘‘unless otherwise specified
by the collection type’’ at
§ 414.1400(a)(3)(ii)(A). We invite
comments on this proposal.
(3) Requirements for QCDRs and
Qualified Registries
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As described at § 414.1305, a QCDR is
an entity that demonstrates clinical
expertise in medicine and quality
measurement development experience
and collects medical or clinical data on
behalf of a MIPS eligible clinician for
the purpose of patient and disease
tracking to foster improvement in the
quality of care provided to patients.
Section 1848(q)(5)(B)(ii) of the Act
provides that the Secretary shall
encourage MIPS eligible professionals to
report on applicable measures through
the use of certified EHR technology
(CEHRT) and qualified clinical data
registries.
We refer readers to § 414.1400(b)(4),
the CY 2017 Quality Payment Program
final rule (81 FR 77374 and 77375), the
CY 2018 Quality Payment Program final
rule (82 FR 53813 and 53814), the CY
2019 PFS final rule (83 FR 59900
through 59906), the CY 2020 PFS final
rule (84 FR 63058 through 63074), the
May 8th COVID–19 IFC (85 FR 27594
and 27595), the CY 2021 PFS final rule
(85 FR 84937 through 84944), the CY
2022 PFS final rule (86 FR 65540
through 65550) and the CY 2023 PFS
final rule (87 FR 70103 through 70106)
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(b) Self-Nomination and Program
Requirements
(i) Subgroup Reporting
(a) Background
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for previously finalized standards and
criteria for QCDRs and QCDR measure
requirements.
As described at § 414.1305, a
qualified registry is a medical registry,
a maintenance of certification program
operated by a specialty body of the
American Board of Medical Specialties
or other data intermediary that, with
respect to a particular performance
period, has self-nominated and
successfully completed a vetting process
(as specified by CMS) to demonstrate its
compliance with the MIPS qualification
requirements specified by CMS for that
performance period. The registry must
have the requisite legal authority to
submit MIPS data (as specified by CMS)
on behalf of a MIPS eligible clinician or
group to CMS.
We refer readers to § 414.1400(b), the
CY 2017 Quality Payment Program final
rule (81 FR 77382 and 77386), the CY
2018 Quality Payment Program final
rule (82 FR 53815 and 53818), the CY
2019 PFS final rule (83 FR 59906), the
CY 2020 PFS final rule (84 FR 63074
through 63077), the CY 2021 PFS final
rule (85 FR 84944 through 84947), and
the CY 2022 PFS final rule (86 FR 65539
through 65548) for previously finalized
standards and criteria for qualified
registries.
In the CY 2022 Quality Payment
Program final rule (86 FR 65544), we
established the requirement that third
party intermediaries must support
subgroup reporting beginning with the
CY 2023 performance period/2025 MIPS
payment year. This requirement that
third party intermediaries support
subgroup reporting was finalized
because it would allow for clinicians to
meaningfully report MIPS Value
Pathways (MVPs) given that subgroups
will be implemented concurrently with
MVPs. We propose to add new language
to codify this policy. We propose to
revise § 414.1400(b)(1)(iii) that
beginning with the CY 2023
performance period/2025 MIPS
payment year, QCDRs and qualified
registries must support subgroup
reporting.
We invite comments on this proposal.
(ii) Simplified Self-Nomination Process
for Existing QCDRs and Qualified
Registries in MIPS, That Are in Good
Standing
In the CY 2018 Quality Payment
Program final rule (82 FR 53811 through
53812 and 53817 through 53818), we
established that beginning with the CY
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2019 performance period/2021 MIPS
payment year, QCDRs and qualified
registries in good standing (that is,
QCDRs and qualified registries that are
not on probation or disqualified) (81 FR
77386 through 77389) that ‘‘wish to selfnominate using the simplified process
can attest, in whole or in part, that their
previously approved form is still
accurate and applicable’’ (see also
§ 414.1400(b)(2)). When this is the case,
third party intermediaries may use the
simplified process. The goal of the
simplified self-nomination form is to
reduce the self-nomination burden for
third party intermediaries in good
standing by allowing them to selfnominate with a mostly pre-populated
self-nomination form. The policy allows
third party intermediaries to attest that
sections of their application have no
changes even if there are minimal
changes or substantive changes in other
parts of their application. An example of
a minimal change is adding or removing
MIPS quality measures. An example of
a substantive change is new QCDR
measures for consideration. For sections
of an application that do require
changes, the requirements are the same
as those for the normal self-nomination
process (82 FR 53808).
In the course of implementing this
policy, we have learned that the text of
§ 414.1400(b)(2) has confused some
third party intermediaries such that they
have attested that their previously
approved self-nomination form is still
accurate and have not submitted selfnomination forms because they thought
they did not need to do so if they had
no changes. We are proposing to revise
§ 414.1400(b)(2) to reflect that QCDRs
and qualified registries are still required
to submit their self-nomination form
even if they utilize the simplified selfnomination process. Even if a third
party intermediary has no change to
make to its form from the previous year,
there may be new sections to fill out and
they need to respond to attestations
within the course of the application. We
propose to revise the last sentence of
§ 414.1400(b)(2) from ‘‘For the CY 2019
performance period/2021 MIPS
payment year and future years, existing
QCDRs and qualified registries that are
in good standing may attest that certain
aspects of their previous year’s
approved self-nomination have not
changed and will be used for the
applicable performance period’’ to state,
‘‘For the CY 2019 performance period/
2021 MIPS payment year and future
years, an existing QCDR or qualified
registry that is in good standing may use
the simplified self-nomination process
during the self-nomination period, from
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July 1 and September 1 of the CY
preceding the applicable performance
period.’’ This proposal would ensure
that third party intermediaries that have
previously participated in MIPS and are
in good standing can use the process to
reduce the burden of self-nomination.
We invite comments on this proposal.
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(iii) Measure Numbers and Identifiers
and Titles for the Improvement Activity
Performance Category, the Promoting
Interoperability Performance Category,
and MVPs
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 through 77385), we
established that QCDRs and qualified
registries must provide the measure
numbers for the MIPS quality measures
on which the QCDR and qualified
registry is reporting. We propose to
codify this previously finalized
provision at § 414.1400(b)(3)(ix). For
completion and consistency, we also
need to receive identifiers for
improvement activities, Promoting
Interoperability, and titles for MVPs.
This information is used to track which
quality measures, improvement
activities, Promoting Interoperability
performance category measures and
MVPs QCDRs and qualified registries
support in a performance period. This
information is available on the qualified
postings that are published on the QPP
Resource Library. We propose that
§ 414.1400(b)(3)(ix) would additionally
require QCDRs and qualified registries
to submit to CMS the identifiers for the
improvement activity performance
category, the Promoting Interoperability
performance category measures, and
titles for MVPs.
We invite comments on this proposal.
(iv) Quality Measures
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 through 77385), we
established that one criterion for data
submission for QCDRs and qualified
registries is that they must be able to
submit results to CMS for at least six
individual quality measures with at
least one outcome measure during selfnomination. If an outcome measure is
not available, a QCDR or qualified
registry must be able to submit to CMS
results for at least one other high
priority measure. We propose to codify
this previously finalized provision at
§ 414.1400(b)(3)(x).
We invite comments on this proposal.
(v) Qualified Posting Attestation
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 through 77385), we
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established that QCDRs and qualified
registries must sign a document that
verifies their ‘‘name, contact
information, cost for MIPS eligible
clinicians or groups to use the qualified
registry, services provided, and the
specialty-specific measure sets the
qualified registry intends to report.’’ As
technology has progressed, we no longer
need third party intermediaries to sign
a document and instead require an
attestation. We became aware that this
requirement is not consistent with our
established policy in describing the
manner in which the QCDR or qualified
registry documents this information. In
order to align with current processes,
we propose to add § 414.1400(b)(3)(xiv),
which would require that QCDRs and
qualified registries attest that the
information listed on the qualified
posting is accurate. The qualified
posting contains information to help
clinicians, groups, subgroups, virtual
groups, APM Entities determine the
services, cost, reporting options,
measures/activities, etc. that a CMSapproved intermediary supports. We
publish it every performance period and
update it, as needed. While we have
used the term qualified posting since
the inception of the Quality Payment
Program, we have not previously
defined this term, and therefore, we
propose to define qualified posting as
the document made available by CMS
that lists QCDRs or qualified registries
available for use by MIPS eligible
clinicians, groups, subgroups, virtual
groups, and APM Entities at § 414.1305.
We invite comments on these
proposals.
(vi) Data Access Capabilities
In the CY 2017 Quality Payment
Program final rule (81 FR 77367 through
77369 and 77384 through 77385), we
established that QCDRs and qualified
registries must comply with any request
by CMS to review data submitted by a
third party intermediary for purposes of
MIPS. We propose to codify this
previously finalized provision at
§ 414.1400(b)(3)(xv).
We invite comments on this proposal.
(vii) Attestation of Data Access
Capabilities
As was previously described, the CY
2017 Quality Payment Program rule
finalized the requirement for third party
intermediaries to comply with any
request by CMS to review data
submitted by a third party intermediary
for purposes of MIPS reporting
requirements (81 FR 77367 through
77369 and 77384 through 77385).
However, it did not require third party
intermediaries to attest to their
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capabilities. Attestation during the selfnomination period emphasizes the
importance of this capability for third
party intermediaries even if the
capability is not ultimately utilized
later. We propose to add
§ 414.1400(b)(3)(xvi)(A) to require that a
QCDR or a qualified registry attest that
it has required each MIPS eligible
clinician on whose behalf it reports to
provide the QCDR or qualified registry
with all documentation necessary to
verify the accuracy of the data on
quality measures that the eligible
clinician submitted to the QCDR or
qualified registry. We also propose to
add § 414.1400(b)(3)(xvi)(B) to require
that a QCDR or a qualified registry must
attest that it has required each MIPS
eligible clinician to permit the QCDR or
qualified registry to provide the
information described in
§ 414.1400(b)(3)(xvi)(A) to CMS upon
request to ensure that data can be
accessed by the third party intermediary
for auditing purposes as we have heard
from some third party intermediaries
that they do not have access to the data
and depend on clinicians do the audit.
We invite comments on this proposal.
(viii) Third Party Intermediary Support
of MVPs
In the CY 2022 PFS final rule (86 FR
65543), we finalized a new requirement
at § 414.1400(b)(1)(ii) that, beginning
with the CY 2023 performance period/
2025 MIPS payment year, QCDRs and
qualified registries must support MVPs
that are applicable to the MVP
participants on whose behalf they
submit MIPS data. QCDRs and qualified
registries may also support the APP.
This proposal was finalized because
MVPs are beginning to be implemented
in the CY 2023 performance period/
2025 MIPS payment year, and third
party intermediaries have the necessary
experience reporting data to support
MVP reporting.
To further clarify this finalized policy,
we responded to a comment in the CY
2022 PFS final rule (86 FR 65543) by
explaining that third party
intermediaries who support MVPs are
required to ‘‘support all measures and
activities available in the MVP across
the quality, improvement activities, and
Promoting Interoperability performance
categories. The exceptions to this
requirement are the cost measures and
population health measures . . . [and]
QCDR measures, which are only
reportable through a QCDR. In instances
where QCDR measures are included in
an MVP, a qualified registry or health IT
vendor will be expected to support all
other quality measures included within
the MVP.’’ Some interested parties have
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expressed concern regarding this
requirement as many MVPs include
measures that may be reported by
clinicians across multiple specialties,
some of whom might be outside their
intended customer base. We are
concerned that continuing this strict
requirement for MVP support could
undermine adoption during the time in
which MVP submission is an option
under MIPS. Given that many third
party intermediaries may not support
measures for clinicians in all specialty
areas that might report a MVP, we are
proposing to add a sentence at the end
of § 414.1400(b)(1)(ii) that a QCDR or a
qualified registry is required to support
MVPs pertinent to the specialties they
support. The proposed addition states
that a QCDRs or a qualified registry
must support all measures and
improvement activities available in the
MVP with two exceptions. The first
proposed exception to this requirement
at § 414.1400(b)(1)(ii)(A) is that if an
MVP includes several specialties, then a
QCDR or a qualified registry is only
expected to support the measures that
are pertinent to the specialty of their
clinicians. For example, if an orthopedic
care MVP includes both surgery and
physical therapy measures, and the
third party intermediary caters
specifically to physical therapists, they
are not required to support the surgical
measures. The second proposed
exception at § 414.1400(b)(1)(ii)(B) is
that QCDR measures are only required
to be reported by the QCDR measure
owner. In instances where a QCDR does
not own the QCDR measures in the
MVP, the QCDR may only support the
QCDR measures if they have the
appropriate permissions.
We invite comments on these
proposals.
(ix) Readiness To Accept Data
In the CY 2019 PFS final rule (83 FR
59761), we established that a QCDR or
a qualified registry must be up and
running by January 1st of the
performance period so that they can
accept and retain clinician data starting
on January 1st. We propose to codify at
§ 414.1400(b)(3)(xvii) the requirement
that a QCDR or a qualified registry must
be able to accept and retain data by
January 1 of the applicable performance
period.
We invite comments on this proposal.
(x) Duration of Services Provided
In the CY 2020 PFS final rule (84 FR
63053), we finalized a new requirement
at § 414.1400(a)(2)(i)(E) that the
organization must provide services
throughout the entire performance
period and applicable data submission
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period. In section IV.A.4.k.(3)(b)(xi) of
this rule, we discuss the requirements
for a transition plan for cases in which
organizations are not able to provide
services throughout the entire year.
While we recognize and allow for cases
in which organizations may find
themselves unable to provide services
throughout the course of an entire year,
we would require that they indicate
their intent to do so as part of program
requirements. We propose to modify
this requirement to state the
organization must certify it intends to
provide services throughout the entire
performance period and applicable data
submission period. We propose to make
this change at § 414.1400(a)(2)(i)(C) as a
result of our proposal to divide
requirements for self-nomination from
programmatic requirements as
discussed in section IV.A.4.k.(7) of this
rule.
We invite comments on these
proposals.
(xi) Transition Plan Requirements
In the CY 2020 PFS final rule (84 FR
63052 through 63053), we finalized a
new requirement at
§ 414.1400(a)(2)(i)(F) that prior to
discontinuing services to any MIPS
eligible clinician, group, virtual group,
subgroup, or APM Entity during a
performance period, the third party
intermediary must support the
transition of such MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity to an alternate
third party intermediary, submitter type,
or, for any measure on which data has
been collected, collection type
according to a CMS approved a
transition plan. As part of an overall
effort to divide self-nomination
requirements from program
requirements as discussed in section
IV.A.4.k.(7) of this rule, at § 414.1400,
we propose to redesignate and revise
paragraph (a)(2)(i)(F) to paragraph
(a)(3)(iv) that, prior to discontinuing
services to any MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity during a performance period, the
third party intermediary must support
the transition of such MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity to an alternate
third party intermediary, submitter type,
or, for any measure on which data has
been collected, collection type
according to a CMS approved transition
plan by a date specified by CMS. The
transition plan must address the
following issues, unless different or
additional information is specified by
CMS. We propose to specify the
contents required in the transition plan
in paragraphs (a)(3)(iv)(A) through (E).
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Therefore, we propose to add
§ 414.1400(a)(3)(iv)(A) to require that
the transition plan state the issues that
contributed to the withdrawal midperformance period or discontinuation
of services mid-performance period. We
also propose to add
§ 414.1400(a)(3)(iv)(B), which would
require that the transition plan state the
number of clinicians, groups, virtual
groups, subgroups or APM entities
inclusive of MIPS eligible, opt-in and
voluntary participants that would need
to find another way to report and as
applicable, and identify any QCDRs that
were granted licenses to QCDR
measures which would no longer be
available for reporting due to the
transition. We further propose to add
paragraph (a)(3)(iv)(C) to state the steps
the third party intermediary will take to
ensure that the clinicians, groups,
virtual groups, subgroups, or APM
Entities identified in
§ 414.1400(a)(3)(iv)(B)(1) are notified of
the transition in a timely manner and
successfully transitioned to an alternate
third party intermediary, submitter type,
or, for any measure or activity on which
data has been collected, collection type,
as applicable. At paragraph (a)(3)(iv)(D),
we propose to require that the transition
plan include a detailed timeline of
when the third party intermediary will
take the steps identified in paragraph
(a)(3)(iv)(C), including notification of
affected clinicians, groups, virtual
groups, subgroups, or APM Entities, the
start of the transition, and the
completion of the transition. Finally, we
propose to add at paragraph (a)(3)(iv)(E)
that the third party intermediary must
communicate to CMS that the transition
was completed by the date included in
the detailed timeline. The proposals
would enable CMS to have
documentation of the steps, actions,
tasks, and timeline for completion of the
transition of clients.
We invite comments on these
proposals.
(c) Submission Requirements
(i) Risk-Adjusted Measures
In the CY 2017 Quality Payment
Program final rule (81 FR 77384 through
77385), we established that qualified
registries ‘‘submitting MIPS quality
measures that are risk-adjusted . . .
must submit the risk-adjusted measure
results to CMS when submitting the
data for these measures.’’ We propose to
codify this previously finalized
provision at § 414.1400(b)(3)(xi).
We invite comments on this proposal.
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(ii) Data Validation Audit Requirements
Section 414.1400(b)(3)(v) outlines the
requirements for third party
intermediary’s annual data validation
audits. As specified at paragraph
(b)(3)(v)(E), the QCDR or qualified
registry must conduct each data
validation audit using a sampling
methodology that meets the following
requirements: (1) Uses a sample size of
at least 3 percent of the TIN/NPIs for
which the QCDR or qualified registry
will submit data to CMS, except that if
a 3 percent sample size would result in
fewer than 10 TIN/NPIs, the QCDR or
qualified registry must use a sample size
of at least 10 TIN/NPIs, and if a 3
percent sample size would result in
more than 50 TIN/NPIs, the QCDR or
qualified registry may use a sample size
of 50 TIN/NPIs. (2) Uses a sample that
includes at least 25 percent of the
patients of each TIN/NPI in the sample,
except that the sample for each TIN/NPI
must include a minimum of 5 patients
and does not need to include more than
50 patients. We finalized this policy (81
FR 77366 through 77367) to reflect the
number of reporting entities, which may
be individuals, as represented by TIN/
NPIs, but are often compositions of TIN/
NPIs as represented by groups,
subgroups, or APM entities. Since these
compositions represent a single unit of
measurement, we believe that they
should be considered as a single unit.
We have received questions about the
required sampling methodology from
interested parties who are confused by
the references to TIN/NPI in the context
of sample size and how they map to
individual MIPS eligible clinicians,
groups, virtual groups, subgroups or
APM Entities. To reduce confusion
among third party intermediaries
regarding the data validation audit
sample, we propose to revise
§ 414.1400(b)(3)(v)(E)(1) and (2) to
replace references to TIN/NPI with ‘‘a
combination of individual MIPS eligible
clinicians, groups, virtual groups,
subgroups and APM Entities.’’ The new
text would state: (1) Uses a sample size
of at least 3 percent of a combination of
individual clinicians, groups, virtual
groups, subgroups and APM Entities for
which the QCDR or qualified registry
will submit data to CMS, except that if
the sample size may be no fewer than
a combination of 10 individual
clinicians, groups, virtual groups,
subgroups and APM Entities, and no
more than a combination of 50
individual clinicians, groups, virtual
groups, subgroups and APM Entities,
the QCDR or qualified registry may use
a sample size of a combination of 50
individual clinicians, groups, virtual
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groups, subgroups and APM Entities;
and (2) Uses a sample that includes at
least 25 percent of the patients of each
individual clinician, group, virtual
group, subgroup or APM Entity in the
sample, except that the sample for each
individual clinician, group, virtual
group, subgroup or APM Entity must
include a minimum of 5 patients and
need not include more than 50 patients.
We invite comments on this proposal.
(4) Requirements Specific to QCDRs
(a) Background
As described at § 414.1305, a QCDR is
an entity that demonstrates clinical
expertise in medicine and quality
measurement development experience
and collects medical or clinical data on
behalf of a MIPS eligible clinician for
the purpose of patient and disease
tracking to foster improvement in the
quality of care provided to patients.
Section 1848(q)(5)(ii)(B) of the Act
provides that the Secretary shall
encourage MIPS eligible professionals to
report on applicable measures through
the use of CEHRT and qualified clinical
data registries.
We refer readers to § 414.1400(b)(4),
the CY 2017 Quality Payment Program
final rule (81 FR 77374 and 77375), the
CY 2018 Quality Payment Program final
rule (82 FR 53813 and 53814), the CY
2019 PFS final rule (83 FR 59900
through 59906), the CY 2020 PFS final
rule (84 FR 63058 through 63074), the
May 8th COVID–19 IFC (85 FR 27594
and 27595), the CY 2021 PFS final rule
(85 FR 84937 through 84944), the CY
2022 PFS final rule (86 FR 65540
through 65550) and the CY 2023 PFS
final rule (87 FR 70103 through 70106)
for previously finalized standards and
criteria for QCDRs and QCDR measure
requirements.
(b) QCDR Measure Self-Nomination
Requirements
(i) New QCDR Measures May Not Be
Submitted After Self-Nomination
In the CY 2017 Quality Payment
Program final rule (81 FR 77375 through
77377), we established that QCDRs
could submit measures that are not on
the annual list of MIPS quality measures
as part of the self-nomination process
for an entity to become a QCDR. In the
CY 2018 Quality Payment Program final
rule (82 FR 53808), we established a
process by which existing QCDRs that
are in good standing could attest that
certain aspects of their previous year’s
approved self-nomination have not
changed. We intended for the selfnomination document to be
comprehensive in terms of which QCDR
measures would be submitted for
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consideration. However, we have
received requests to add measures
following the completion of the QCDR
self-nomination process for the
performance year. Our review process
requires consideration of a complete
self-nomination with all measures, so
we propose to add that the measure was
submitted after self-nomination to our
list of reasons for rejecting a QCDR
measure at § 414.1400(b)(4)(iv)(O).
We invite comments on this proposal.
(ii) Limitations on Number of QCDR
Measures Submitted for SelfNomination
In the CY 2017 Quality Payment
Program final rule, we established at
§ 414.1400(b)(4)(i) that QCDRs must
submit certain specifications for QCDR
measures that would be considered for
approval by CMS (81 FR 77374 through
77378). These measures would then be
considered for approval or rejection
under the requirements of
§ 414.1400(b)(4)(iii) and (iv). CMS
reviews these measures carefully and
each additional measure takes
considerable time and effort to review.
We have had experiences in which a
single QCDR has submitted a large
number of QCDR measures for
consideration. While we are mindful
that there may be a number of valid
measure concepts, we are generally
trying to focus measurement within the
Quality Payment Program. In an effort to
optimize resource allocation and
encourage QCDRs to focus their
submitted measures on those that have
the highest value, we are proposing to
add at § 414.1400(b)(4)(iv)(P) that a
QCDR measure may be rejected if the
QCDR submits more than 30 quality
measures not in the annual list of MIPS
quality measures for CMS consideration.
We considered a lower limit given that
clinicians in traditional MIPS are only
required to report on 6 quality measures
and clinicians reporting via MVPs may
report even fewer. However, we
recognize that some QCDRs serve more
diverse clinical populations and could
conceivably wish to submit this many as
part of self-nominations. We note that
we would continue to evaluate
individual measures on their merits as
specified in our requirements at
§ 414.1400(b)(4)(iii) and (iv).
We invite comments on this proposal.
(iii) Requirements for Previous Data on
QCDR Measures
In the CY 2017 Quality Payment
Program final rule (81 FR 77368), we
established a requirement that for nonMIPS measures the QCDR must provide
us, if available, data from years prior to
the start of the performance period. We
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propose to codify this previously
finalized provision at
§ 414.1400(b)(4)(i)(C).
We invite comments on this proposal.
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(iv) Requirement for QCDR Measure
Specifications To Remain Published
Through the Performance Period and
Data Submission Period
In the CY 2017 Quality Payment
Program final rule (81 FR 77375 through
77376), we established at
§ 414.1400(b)(4)(i)(B) that no later than
15 calendar days following CMS posting
of all approved specifications for a
QCDR measure, the QDCR must
publicly post the CMS-approved
measure specifications for the QCDR
measure (including the CMS-assigned
QCDR measure ID) and provide CMS
with a link to where this information is
posted. While we established when this
posting was required, we did not
establish a standard for the duration of
this posting. We have become aware of
situations in which QCDR measure
owners have removed this
documentation during the course of the
performance period or before the
closure of the submission period. We
propose to revise § 414.1400(b)(4)(i)(B)
to add a provision that the approved
QCDR measure specifications must
remain published through the
performance period and data
submission period. Although it was not
previously specified, it was our
intention that this information be made
available for the entirety of the time that
the measure could be considered and
reported by clinicians or groups as part
of the Quality Payment Program.
Measure specifications must be
available throughout the duration of
measure use for interested parties to
understand the target population of the
measure, how the measure is built and
calculated, and to identify existing
measure gaps. Clinicians may elect to
begin collecting data at various times in
the year and even if data collection has
started, may need to consult
specifications throughout the
performance period to confirm that data
collection is in concordance with the
specifications. We believe this addition
will prevent QCDRs from removing
specifications following the initial
required posting and increase
transparency for participants. We also
propose to make a technical update to
the language removing the reference to
providing the NQF number due to
changes in the contractor that CMS uses
for measure endorsement.
We invite comments on this proposal.
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(5) Health IT Vendors
(a) Background
In the CY 2017 Quality Payment
Program final rule (81 FR 77377 through
77382), we established the category of
health IT vendor in the Quality Payment
Program, along with requirements for
data submission. In the CY 2019 PFS
final rule, we codified the definition of
a health IT vendor as an entity that
supports the health IT requirements on
behalf of a MIPS eligible clinician
(including obtaining data from a MIPS
eligible clinician’s CEHRT) (83 FR
59907). In the CY 2022 PFS final rule
(86 FR 65541), we finalized a
reorganization of the regulatory text
governing the third party intermediary
section to improve clarity and
readability. In that revised text, we
established general requirements at
§ 414.1400(a), additional requirements
for QCDRs and qualified registries at
§ 414.1400(b), and additional
requirements for health IT vendors at
§ 414.1400(c).
(b) Proposal To Remove Health IT
Vendor Category
In the CY 2021 PFS final rule, we
established additional program
safeguards regarding data validation
audit and targeted audit requirements
that would apply specifically to QCDRs
and qualified registries. We noted (85
FR 84928 and 84929) that while we did
not propose these additional
requirements for health IT vendors, we
had become aware of situations in
which health IT vendors have submitted
data that are inaccurate and unusable
and that could result in improper
payments or otherwise undercut the
integrity of the MIPS program. In our
review of comments in response to our
solicitation on the future application of
such requirements on health IT vendors,
we observed that several commenters
supported requirements for health IT
vendors to perform data validation to
align requirements with QCDRs and
qualified registries and improve data
integrity. We also observed that several
commenters opposed additional data
validation requirements for health IT
vendors due to the associated cost, and
that such a requirement would be
duplicative of requirements of health IT
vendors under the ONC regulatory
framework.
Since the publication of the CY 2021
PFS final rule, we continue to have
experiences with third party
intermediaries submitting data that is
inaccurate and unusable. We believe
this necessitates a reconsideration of the
lack of data validation requirements for
health IT vendors in contrast to those
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requirements for QCDRs and qualified
registries.
In the CY 2019 PFS final rule (83 FR
59747 through 59749), we established
the definition of collection type,
submitter type, and submission type.
These definitions are intended to more
precisely describe how data is collected
and submitted for the Quality Payment
Program. For the quality, Promoting
Interoperability, and improvement
activity performance categories, an
approved third party intermediary may
submit directly to the submissions
application programming interface
(API), or upload files via qpp.cms.gov.
Historically, third party intermediaries
are able to receive tokens by virtue of
successful self-nomination as a QCDR or
qualified registry or, for those
technologies that use CEHRT, through a
request to CMS.
In examining the different
requirements for QCDRs and qualified
registries and health IT vendors, we
note that the primary difference is the
requirement for self-nomination at
§ 414.1400(b)(2) and requirements
primarily related to data validation
audits at § 414.1400(b)(3). We
considered whether we should add a
self-nomination requirement for health
IT vendors or require data validation
audits for health IT vendors or both.
However, we believe that adding a selfnomination requirement or data
validation audit requirements would
essentially eliminate the difference
between a health IT vendor and a
qualified registry. We observe today that
many vendors serve in capacities as
qualified registries, QCDRs or health IT
vendors with similar technology. Rather
than establish identical or nearly
identical requirements for different
categories of vendors, we instead
propose to eliminate the health IT
vendor category beginning with the CY
2025 performance period and by
revising § 414.1400(a)(1)(iii). Absent a
self-nomination process for Health IT
vendors, we do not believe we can
establish a meaningful enforcement
mechanism to ensure that the vendors
are meeting the requirements as we have
laid out.
Removing Health IT vendors from the
definition of third party intermediary
will not preclude the vendors from
assisting MIPS eligible clinicians with
reporting under the program. Instead,
the vendors may still provide their
technology for clinicians to directly
report under MIPS. We believe that
eliminating the category of Health IT
vendor as a distinct type of third party
intermediary will create a clearer
distinction between those vendors that
are submitting data to us for the
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purposes of MIPS and must meet the
requirements of a qualified registry or
QCDR and those vendors that work with
clinicians through the sale and support
of health IT that permits the clinician or
group to submit the data.
We invite comments on this proposal.
(6) Remedial Action and Termination of
Third Party Intermediaries
(a) Background
We refer readers to § 414.1400(e), the
CY 2017 Quality Payment Program final
rule (81 FR 77386 through 77389), the
CY 2019 PFS final rule (83 FR 59908
through 59910), the CY 2020 PFS final
rule (84 FR 63077 through 63080), the
CY 2021 PFS final rule (85 FR 84947),
the CY 2022 PFS final rule (86 FR 65542
and 65550) and the CY 2023 PFS final
rule (87 FR 70106 through 70109) for
previously finalized policies for
remedial action and termination of third
party intermediaries.
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(b) Additional Basis for Remedial
Action
(i) Failure To Maintain Correct Contact
Information
In the CY 2017 Quality Payment
Program final rule, we established the
process for self-nomination for QCDRs
(81 FR 77364 through 77367) and
qualified registries (81 FR 77383
through 77384). We also established the
process for corrective action plans in the
CY 2017 Quality Payment Program final
rule (81 FR 77389). In our work with
QCDRs and qualified registries, we
experienced times when the QCDR or
qualified registry did not respond to
certain requests in a timely manner,
thereby delaying program operations. In
some cases, we had further
correspondence with the QCDR or
qualified registry and those
organizations suggested that the contact
information (generally an email address)
submitted as part of the self-nomination
was not correct, so the request was
never received. While we understand
that personnel can change over time in
an organization, such a change does not
relieve the QCDR or qualified registry of
its obligations under these rules.
Therefore, we propose an additional
provision at § 414.1400(e)(2)(iv) to allow
us to immediately or with advance
notice terminate a third party
intermediary that has not maintained
current contact information for
correspondence.
We invite comments on this proposal.
(ii) Consecutive Years on Remedial
Action
In the CY 2017 Quality Payment
Program final rule, we established a
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process for placing third party
intermediaries on probation for not
meeting requirements (81 FR 77387).
Specifically, if a third party
intermediary did not meet requirements
for qualification, they could be placed
on probation for the current
performance period and/or the
following performance period. We also
established that after two years on
probation, a third party intermediary
would be disqualified for the
subsequent performance year (81 FR
77387 through 77389). In the CY 2019
PFS final rule, policies relating to
probation and disqualification were
renamed and reorganized under
remedial action and termination of third
party intermediaries (83 FR 59908
through 59910). Additionally, we
finalized reasons for terminating third
party intermediaries including being
placed on remedial action, not
submitting a corrective action plan, and
not promptly correcting data errors (83
FR 59908 through 59910). At that time,
we did not propose any actions related
to third party intermediaries on
remedial action for multiple years, as
had been established under our initial
probation policy.
We continue to experience issues
with third party intermediaries that
require corrective action plans in
multiple years. We believe that third
party intermediaries that consistently
require corrective action plans, whether
for the same or unrelated issues, do not
further the goals of the Quality Payment
Program, which are to improve quality
of care while limiting administrative
burden. We believe allowing third party
intermediaries that have consistently
demonstrated failure to comply with
CMS requirements such that they
required corrective action plans
undermine clinicians’ and groups’
efforts to improve quality and could
result in increased administrative
burden for those clinicians and groups.
For this reason, we propose to add at
§ 414.1400(e)(2)(v) that CMS may
terminate third party intermediaries that
are on remedial action for 2 consecutive
years. This proposal will minimize risk
within the Quality Payment Program by
terminating third party intermediaries
that are consistently deemed as noncompliant.
We invite comments on this proposal.
(c) Revised Corrective Action Plan
Requirements
As described in § 414.1400(e)(1)(i),
among the remedial actions that CMS
may take against a non-compliant third
party intermediary is a corrective action
plan (CAP). Under paragraphs
(e)(1)(i)(A) through (D), unless different
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or additional information is specified by
CMS, the CAP must address the
following issues: (A) the issues that
contributed to the non-compliance; (B)
the impact to individual clinicians,
groups, virtual groups, subgroups, or
APM Entities, regardless of whether
they are participating in the program
because they are MIPS eligible,
voluntarily participating, or opting in to
participating in the MIPS program; (C)
the corrective actions to be
implemented by the third party
intermediary to ensure that the noncompliance has been resolved and will
not recur in the future; and (D) a
detailed timeline for achieving
compliance with the applicable
requirements. In the CY 2023 PFS final
rule, we finalized a policy at
§ 414.1400(e)(1)(i)(E) to require third
party intermediaries to provide a
communication plan for communicating
the impact to the parties identified
within the corrective action plan (87 FR
70107).
Based on our experience with
corrective action plans from third party
intermediaries through the years, we
have identified a gap in our ability to
determine if certain elements of the
corrective action plan have been
completed in the time and manner
specified within the action plan.
Therefore, we propose to add at
§ 414.1400(e)(1)(i)(F) an additional
requirement for a third party
intermediary under a corrective action
plan to communicate the final
resolution to CMS once the resolution is
complete, and to provide an update, if
any, to the monitoring plan provided
under § 414.1400(e)(1)(i)(C). We believe
this additional step will ensure that
third party intermediaries complete the
required actions within the corrective
action plan.
We invite comments on this proposal.
(d) Public Posting of Deficiencies
In the CY 2017 Quality Payment
Program final rule (81 FR 77386 through
77388), we established a remedial action
that, in the event that a QCDR or
qualified registry had data inaccuracies
that affected more than 3 percent but
less than 5 percent of the total number
of MIPS eligible clinicians, we would
have this information identified on the
CMS public posting. We modified this
requirement in the CY 2019 PFS final
rule (83 FR 59909) that the data error
rate would be publicly disclosed until
the data error rate falls below 3 percent.
We are proposing to modify this
requirement. While we previously
determined that a single, objective
measure (that is, a 3 percent error rate)
would support our goals of public
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notice, we believe that the precise
metric is not a meaningful indicator.
Specifically, some errors may be minor
in nature yet affect a large number of
clinicians for whom the QCDR or
qualified registry has reported data.
Other errors, however, may be
materially significant but may not affect
3 percent of the MIPS eligible clinicians
due to the unique nature of the data
point at issue.
We believe that there is significant
value in informing the public and
potential customers which QCDRs and
qualified registries are under remedial
action or are terminated. Therefore, we
propose to add a new provision at
§ 414.1400(e)(1)(ii)(B) that CMS may,
beginning with the CY 2025
performance period/2027 MIPS
payment year, publicly disclose on the
CMS website that CMS took remedial
action against or terminated the third
party intermediary. We note that this
public disclosure would be limited to
the presence of the corrective action
plan and would not include any
proprietary information from the QCDR
or qualified registry. We also propose to
modify § 414.1400(e)(1)(ii) by
redesignating it as § 414.1400(e)(1)(ii)(A)
and ending this policy after the CY 2025
performance period/2027 MIPS
payment year. We are proposing to
remove this policy because we believe
it would be superseded by the proposal
included in § 414.1400(e)(1)(ii)(B).
We invite comments on these
proposals.
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(e) Considering Past Performance in
Approving Third Party Intermediaries
In the CY 2017 Quality Payment
Program final rule, we established that
third party intermediaries would be
placed on probation status if they had
not met criteria for qualification
following self-nomination (81 FR 77386
through 77389). Under the terms of the
probation policy, a corrective action
plan could be required to address any
deficiencies or prevent them from
recurring. In addition, a third party
intermediary that was on probation
status for 2 years would be disqualified
for the subsequent performance period.
In the CY 2019 PFS final rule (83 FR
59909), we consolidated the corrective
actions that we would take in the event
of a deficiency or error on the part of a
third party intermediary. This included
the elimination of a policy of probation
for third party intermediaries and the
establishment of a policy of remedial
action for third party intermediaries. We
did not change the factors made to
determine a remedial action or
probation.
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We have continued to experience
issues related to data errors from third
party intermediaries and these errors
often extend over multiple years. We are
concerned that some third party
intermediaries fail to address
deficiencies with regularity, and are
required to perform remedial actions as
defined in corrective action plans over
the course of many years. This suggests
that these organizations are not able to
properly adhere to the criteria for
qualification for third party
intermediaries. While we have
established criteria for approval of third
party intermediary at
§ 414.1400(a)(2)(ii)(A) which state that
our determination to approve a third
party intermediary may take into
account whether the entity failed to
comply with the requirements for a
previous MIPS payment year, we wish
to clarify that the consideration of past
compliance can also include remedial
actions. While we already have the
ability to consider whether the entity
failed to comply with certain
requirements, we do not believe that the
existing requirements are explicit
enough for third party intermediaries to
understand that a history of remedial
actions, even if addressed such that the
third party intermediary was not
terminated could result in CMS not
approving future approval.
We invite comment on this proposal.
(f) Terms of Audits
In the CY 2017 Quality Payment
Program final rule (81 FR 77389 through
77390), we finalized that third party
intermediaries submitting MIPS data
must comply with auditing procedures
as a condition to participate in MIPS. In
this rule, we did not establish the
reasons we have for auditing a
particular third party intermediary. We
note that we perform both random and
targeted compliance audits based on a
number of reasons and we wish to
document those reasons for
transparency to the public. Therefore,
we propose at § 414.1400(f) that third
party intermediaries may be randomly
selected for compliance evaluation or
may be selected at the suggestion of
CMS if there is an area of concern
regarding the third party intermediary.
For example, areas of concern could
include but are not limited to: high data
errors, support call absences, delinquent
deliverables, remedial action status,
clinician concerns regarding the third
party intermediary, a continuing pattern
of Quality Payment Program Service
Center inquiries or support call
questions, and/or CMS concerns
regarding the third party intermediary.
We also propose to redesignate the
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existing section § 414.1400(f) (which
includes paragraphs (f)(1), (2), and (3))
as paragraph (a)(3)(v) with minor
changes in the text for clarity. We note
that this section refers to program
requirements, which we believe is a
more appropriate characterization of
these requirements.
We invite comments on these
proposals.
(7) Technical Changes
In the course of reviewing the
regulation for third party intermediaries,
we identified areas in which certain
language was used that is not as
consistent or clear as it could be. We
propose to make the following changes
to § 414.1400 to improve clarity as
denoted below:
• At paragraph (a)(2), to clarify that
an organization may only become a
third party intermediary for the
purposes of MIPS by meeting the
approval criteria by replacing the term
‘‘third party intermediary’’ with
‘‘organization’’.
• Redesignate paragraph (a)(3) to
delineate third party intermediary
approval criteria from requirements for
third party intermediaries as they
participate in the Quality Payment
Program. We propose the following
redesignations:
• § 414.1400(a)(3) redesignated as
§ 414.1400(a)(3)(i);
• § 414.1400(a)(2)(i)(C) redesignated
as § 414.1400(a)(3)(ii);
• § 414.1400(a)(2)(i)(D) redesignated
as § 414.1400(a)(3)(iii);
• § 414.1400(a)(2)(i)(F) redesignated
as § 414.1400(a)(3)(iv); and
• § 414.1400 (a)(2)(iii) redesignated as
§ 414.1400(a)(3)(vi).
These reorganized sections also
include minor changes to the text.
Please note that we discuss new
proposals related to these requirements
in section IV.A.4.k.(3) of this proposed
rule. There is also a conforming change
to reference this section at
§ 414.1400(e)(1).
• At § 414.1400(e)(3) to remove the
word ‘‘total’’ from the phrase ‘‘total
clinicians’’ as this word was included in
error.
• At § 414.1400(e)(4) to improve
clarity and remove a paragraph.
We invite comments on these
proposals.
l. Public Reporting on Compare Tool
Section 10331(a)(1) of the Affordable
Care Act provides for the development
of a Physician Compare internet website
(‘‘Physician Compare’’) with
information on physicians and other
eligible professionals enrolled in
Medicare who participate in the
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Physician Quality Reporting Initiative
(PQRI). Section 1848(q)(9) of the Act, as
added by section 101(c) of MACRA,
aligned Physician Compare with the
newly established Merit-Based Incentive
Payment System (MIPS) by requiring the
public reporting of MIPS performance
information for MIPS eligible
professionals through Physician
Compare.
For previous discussions of public
reporting of physician and clinician
performance and information, we refer
readers to the CY 2016 Physician Fee
Schedule (PFS) final rule (80 FR 71116
through 71123), the CY 2017 Quality
Payment Program final rule (81 FR
77390 through 77399), the CY 2018
Quality Payment Program final rule (82
FR 53819 through 53832), the CY 2019
PFS final rule (83 FR 59910 through
59915), the CY 2020 PFS final rule (84
FR 63080 through 63083), the CY 2022
PFS final rule (86 FR 65550 through
65554), the CY 2023 PFS final rule (87
FR 70109 through 70113) and the Care
Compare: Doctors and Clinicians
Initiative web page at https://
www.cms.gov/medicare/qualityinitiatives-patient-assessmentinstruments/care-compare-dacinitiative. We also note that as finalized
at § 414.1305 ‘‘Physician Compare’’ is
defined as the Physician Compare
internet website of CMS (or a successor
website). As discussed in prior
rulemaking, we note the current website
is the Compare Tools hosted by the U.S.
Department of Health and Human
Services (HHS), referred to as the
‘‘Compare tool’’ throughout prior
rulemaking and this proposed rule (86
FR 39466). (https://www.cms.gov/
medicare/quality-initiatives-patientassessment-instruments/care-comparedac-initiative.)We also note that as
finalized at § 414.1305 ‘‘Physician
Compare’’ is defined as the Physician
Compare internet website of CMS (or a
successor website). As discussed in
prior rulemaking, we note the current
website is the Compare Tools hosted by
the U.S. Department of Health and
Human Services (HHS), referred to as
the ‘‘Compare tool’’ throughout prior
rulemaking and this proposed rule (86
FR 39466).
(1) Telehealth Indicator
In the CY 2023 PFS final rule, we
finalized the addition of an indicator to
the profile pages of clinicians who
furnish telehealth services (87 FR 70109
through 70111) to established processes
and coding policies to identify such
clinicians (id.). Among the originally
proposed policies, we proposed using
Place of Service (POS) code 02
(indicating telehealth) on paid
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physician and ancillary service (that is,
carrier) claims or modifier 95 appended
on paid claims (87 FR 46330). During
the CY 2023 PFS proposed rule public
comment period, we received
unanimous support for adding a
telehealth indicator. One of the
commenters also brought to our
attention a POS coding update, and we
subsequently finalized a policy of using
both POS 02 and POS 10, as well as
modifier 95 to identify clinicians that
furnish telehealth services.
At the time of the CY 2023 PFS
proposed rule, we were not aware of an
update in process for POS Code 02
revising the description from
‘‘telehealth’’ to ‘‘telehealth provided
other than in patient’s home’’ for
locations in which telehealth services
were furnished. In connection with this
change to POS Code 02, Medicare also
adopted the then newly added POS
Code 10, ‘‘telehealth provided in
patient’s home.’’ Since many telehealth
visits occur in patients’ homes it was
appropriate and consistent with the
intent of our proposal to include POS 10
in addition to POS 02 and claims
modifier 95 to identify clinicians
providing telehealth services in our
final policy.
The POS Code 10 comment, described
earlier in this section, received in
response to our proposal in the CY 2023
PFS proposed rule, inferred the need to
stay current with all types of coding
changes that occur throughout the year,
outside of the annual PFS rulemaking
cycle. Under our current policy, we
would already be using the most current
CPT codes for each telehealth indicator
update; however, we would need to use
annual rulemaking to update the POS
and claims modifier codes used for
telehealth indicator public reporting
purposes. Depending on how frequently
codes are updated, there could be the
unintended consequence of using the
annual rulemaking cycle to adopt
updated codes that could otherwise be
avoided through establishing a coding
flexibility policy. If we are limited to the
codes specifically finalized via
rulemaking, the codes used to inform
the telehealth indicator may be
incomplete or outdated when we refresh
the telehealth indicator on clinician
profile pages throughout the year,
resulting in users of the Compare tool
receiving incorrect information.
Adding coding flexibility for other
codes, such as POS and claims
modifiers, would both help avoid future
regulatory burden and allow for more
real-time accuracy of the telehealth
information provided on Care Compare.
This is particularly important since
consumer testing and 1–800–
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MEDICARE inquiries have shown that
patients and caregivers are actively
looking for telehealth services, as well
as for health equity purposes since
telehealth is critical to those who live in
rural areas, lack transportation, or have
other limitations.
For these reasons, we are proposing to
update our policy for identifying
clinicians furnishing telehealth services,
such that we remain current with CMS
coding changes, without proposing and
finalizing such coding changes via
rulemaking. Specifically, instead of only
using POS code 02, 10, or modifier 95
to identify telehealth services furnished
for the telehealth indicator, we would
use the most recent codes at the time the
data are refreshed that identify a
clinician as furnishing services via
telehealth. This flexibility is consistent
with how we use the most current CPT
codes, some of which are time-limited,
to identify clinicians furnishing
telehealth services. We are proposing
that at the time of such a data refresh
we would publish the details of which
codes are used for the telehealth
indicator through education and
outreach, such as via a fact sheet,
listserv, and information posted on the
Care Compare: Doctors and Clinicians
Initiative page, available at https://
www.cms.gov/medicare/qualityinitiatives-patient-assessmentinstruments/care-compare-dacinitiative. We are seeking comment on
this proposal.
(2) Publicly Reporting Utilization Data
on Profile Pages
Section 104(a) of MACRA provides
that, beginning with 2015, the Secretary
shall make publicly available on an
annual basis, in an easily
understandable format, information
with respect to physicians and, as
appropriate, other eligible professionals,
on items and services furnished to
Medicare beneficiaries. The information
made available must be similar to the
physician and other supplier utilization
data we have historically made available
through the Medicare Provider
Utilization and Payment Data: Physician
and Other Supplier Public Use File
(‘‘PUF’’) and shall include information
on the number of services furnished by
the physician or other eligible
professional under Medicare, which
may include information on the most
frequently furnished services or
groupings of services. Section 104(e) of
the MACRA requires that we integrate
this data into the Compare tool. We
finalized a policy to report the most
recent available utilization data in
downloadable format beginning in late
2017 (80 FR 71130). This information
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continues to be available today in the
Medicare Provider Data Catalog (PDC)
available at https://data.cms.gov/
provider-data/topics/doctors-clinicians.
Separately, we have reported on the
Compare tool clinician training
information as well as a clinician’s
primary and secondary specialties.
In the CY 2023 PFS final rule, we
established a policy for publicly
reporting procedure information on
clinician profile pages to provide
patients more information in their
clinician searches in an understandable
format, beginning no earlier than CY
2023 (87 FR 70111 through 70113).
Until that time, we had gathered
utilization data for procedures from
physician/supplier Medicare Part B
non-institutional claims on certain
services and procedures and published
it in the Physician and Other Supplier
Data PUF. Although these data are
useful to the healthcare industry,
healthcare researchers, and other
interested parties, this information was
presented in a technical manner that
was not easily accessible or usable by
patients, who do not frequently visit
https://data.cms.gov or understand
medical procedure coding.
We also established that priority
procedures selected for utilization data
public reporting will meet one or more
of the following criteria:
• Have evidence of a positive
relationship between volume and
quality in the published peer reviewed
clinical research;
• Are affiliated with existing MIPS
measures indicating importance to CMS;
• Represent care that a patient might
shop for a clinician to provide; and/or
• Are an HHS priority.
We finalized that this data would be
based on a 12-month lookback period,
with data refreshes updated bi-monthly,
as technically feasible, and we would
not initially prioritize complex, rare
procedures. We noted that the
utilization data shown on profile pages
would only reflect Medicare Fee-forService (FFS) claims data and would not
include procedures performed for
patients who have other types of
insurance. To meaningfully categorize
procedures, we finalized the policy of
using the Restructured Berenson-Eggers
Type of Service (BETOS) Codes
Classification System to collapse
Healthcare Common Procedure Coding
System (HCPCS) data into procedural
categories, and when no Restructured
BETOS categories are available,
procedure code sources used in MIPS,
such as the procedure categories already
defined for MIPS cost or quality
measures. Restructured BETOS is a
taxonomy that allows for the grouping
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of procedure codes into clinically
meaningful categories and
subcategories. Additional Restructured
BETOS information is available at
https://data.cms.gov/provider-summaryby-type-of-service/provider-serviceclassifications/restructured-betosclassification-system. These category
sources, as finalized, allow us to
publicly report procedural utilization
data in a meaningful way to patients
and caregivers rather than showing
thousands of rows of individual HCPCS
data, as we do for the research
community in the PDC. For example,
applying categories enables us to list
that a clinician performs knee
arthroplasties. Using plain language, we
would simplify the procedure category
name to ‘‘knee replacements’’ for
understandability instead of listing each
of nine unique procedure codes
indicating the specifics of exactly which
bones and which implants were
involved.
Since the publication of the CY 2023
PFS final rule, we conducted additional
consumer testing and data analysis to
prepare and select certain procedurerelated utilization data for publication.
Consumer testing showed that publicly
reporting utilization data on patientfacing clinician profile pages and using
plain language, is helpful for patients
and caregivers to make informed
healthcare decisions, since it allows
them to find clinicians who have
performed specific types of procedures.
Consumer testing results showed that
patients and caregivers understand this
language, would not select a health care
provider based on this information
alone, and find the information helpful
but would like the procedure volume to
also reflect patients with other
insurance if possible. Our data analyses
have confirmed the availability of
Medicare Advantage (MA) data
increasing the representativeness of the
procedure (that is, utilization) data, as
discussed later in this section.
We are targeting to release procedure
data based on FFS claims on clinician
profile pages later this year, beginning
with 13 priority procedure categories
identified for public reporting. Details
on the utilization data publicly reported
on clinician profile pages will be
available on the Care Compare: Doctors
and Clinicians Initiative page, available
at https://www.cms.gov/medicare/
quality-initiatives-patient-assessmentinstruments/care-compare-dac-initiative
and on the PDC at https://data.cms.gov/
provider-data/dataset/eedd-4c6c.
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(a) Updating the Provider Data Catalog
(PDC) Utilization Data Policy
As discussed earlier in this section,
we historically have published a PDC
file that is a subset of the most
commonly performed procedures in the
PUF. With the upcoming release of the
initial procedural utilization data, we
will publish a second utilization file in
the PDC that will reflect the procedure
category information on clinician profile
pages. That is, consistent with what will
be publicly reported on profile pages,
the second PDC file will aggregate like
procedures and include an indication of
low volume counts, in accordance with
the CMS small cell size policy, in which
counts below 11 cannot be publicly
reported, to protect patient privacy.
It would be of greater use for the PDC
to only have one utilization
downloadable file that reflects the same
subset of data, in the same format, as
what will be publicly reported on
clinician profile pages. Doing so aligns
the criteria for selecting utilization data
in the PDC to reflect the same criteria
for selection on clinician profile pages
and will assist researchers in analyses of
utilization data on clinician profile
pages. Moreover, the researcher and
clinician communities, who are the
primary users of the PDC, would
appreciate having the single
downloadable dataset that reflects the
same procedure utilization data that
would appear on clinician profile pages.
It would also be more efficient to focus
resources on maintaining one file
reflective of clinician profile page
utilization data rather than both
produce that file and duplicate some of
the PUF information on the PDC. The
full CMS PUF of FFS data is still
available on https://data.cms.gov for
researchers and clinicians who are
interested in the full set of Medicare
procedure information at the individual
procedure code level. To direct
researchers to the PUF of Medicare FFS
information, we currently communicate
where to locate the original PUF and the
details of the updated PDC file through
education and outreach, such as via a
fact sheet, listserv, and information
posted on the Care Compare: Doctors
and Clinicians Initiative page, available
at https://www.cms.gov/medicare/
quality-initiatives-patient-assessmentinstruments/care-compare-dacinitiative.
Therefore, we propose revising the
policy to publicly report a subset of the
Medicare PUF on the PDC to instead
provide a single downloadable dataset
including the procedure utilization data
that would appear on clinician profile
pages. If this proposal is finalized, we
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would remove the PUF subset file from
the PDC and only keep the utilization
data file that reflects the information on
clinician profile pages in the PDC.
We seek comment on all aspects of
this proposal, including any concerns
about technical feasibility; our proposed
approach to aligning the criteria for
selecting utilization data in the PDC to
reflect the same criteria for selection on
clinician profile pages; ways in which
we inform researchers on the location of
the full CMS PUF for continued use;
and any other considerations. The
proposals discussed later in sections
IV.A.4.l.(2)(b) and (2)(c) would also be
reflected in the new downloadable
utilization data file in the PDC if the
other proposals are finalized as
proposed.
(b) Procedure Grouping Policy for
Publicly Reporting Utilization Data
As mentioned earlier in this section,
in the CY 2023 PFS final rule, we
finalized using Restructured BETOS and
procedure code sources used in MIPS
when no Restructured BETOS categories
are available, such as the procedure
categories already defined for MIPS
measures to meaningfully categorize
procedures for public reporting (87 FR
70111). However, since finalizing this
policy, we identified some commonly
sought procedures, such as
hysterectomy, that do not have a
procedure category specified in the
Restructured BETOS categorization
system or a relevant code set in any
MIPS quality or cost measures. We
anticipate this issue could occur for
additional procedures as we continue to
identify additional priority procedures
for public reporting.
We received a few comments on the
CY 2023 PFS proposed rule that stated
that some of the Restructured BETOS
categories may be too broad and
acknowledged that there is no other
existing standard, systematic way to
group procedures by HCPCS codes (87
FR 70111 and 70112). However, we did
not receive any suggestions for
alternative sources for the purpose of
grouping procedures during the CY
2023 PFS proposed rule public
comment period.
We now propose to define meaningful
categories using subject matter expert
(for example clinician) input in
instances where a procedure category is
unavailable under the Restructured
BETOS or MIPS measures, if a code
category exists but is not suitable for
public reporting, or in instances where
a procedure category does not exist, to
create new, clinically meaningful, and
well-understood procedure categories as
needed. Added flexibility in grouping
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HCPCS codes to create procedure
categories meaningful to patients and
caregivers would allow users of the
Compare tool to better assess a
clinician’s volume and scope of
experience with a particular procedure
and inform healthcare decision making.
To implement this, we are proposing
to modify the existing policy such that,
in addition to the two previously
finalized sources (Restructured BETOS
categorization system and code sources
used in MIPS), we may use alternate
sources to create clinically meaningful
and appropriate procedural categories,
particularly when no relevant grouping
exists. If we develop new procedure
categories for publicly reporting
utilization data on clinician profile
pages, we propose to engage subject
matter experts and interested parties
through periodic requests for feedback
using methods outside of rulemaking,
such as listserv emails, listening
sessions, and focus groups to solicit
feedback on bespoke procedure
categories planned for future releases of
utilization data, as appropriate and
technically feasible.
We are seeking comment on all
aspects of our proposal to modify
existing procedural categorization
policy to use alternate sources to create
clinically meaningful and appropriate
procedural categories and our proposed
approach to engaging with subject
matter experts in developing procedure
categories, as appropriate and
technically feasible.
(c) Incorporating Medicare Advantage
(MA) Data Into Public Reporting
Between the time of the CY 2023 PFS
proposed and final rules, our Medicare
FFS claims data analyses showed that
for the initial 13 priority procedures
identified, approximately 50 percent of
clinician-procedure combinations fall
into the low volume category, which
meant that, based on Medicare
physician and ancillary service (carrier)
claims in the past 12 months, we could
only publish an indicator that a
clinician has experience with the
procedure rather than specific counts.
Under the small cell size policy, we
prohibit the use of specific procedure or
patient counts in cases where the count
is below ten. The high number of
clinicians with a low volume indicator
is partly due to not including data for
patients with other coverage, such as
MA plans or other payers, for whom a
given clinician has also performed such
procedures. As such, we are currently
limited in our ability to contextualize
low volume clinician experience with
procedures in a way that is useful and
easily understandable for patients and
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caregivers who may be looking for a
clinician with experience performing a
specific procedure.
As we identify more priority
procedures for public reporting, more
procedures may be subject to the small
cell size policy using Medicare FFS data
alone, which would prevent us from
publicly reporting health care provider
experience with such procedures for
patients and caregivers to use in their
healthcare decisions. Based on public
comments and consumer testing,
including other payer data would help
prevent this issue. Specifically, we
received several comments on the CY
2023 PFS proposed rule from the
clinician community who had
expressed concern about the
understandability of the data and that
limiting procedure data counts to
Medicare FFS claims only does not
reflect the full scope of clinician
practice (87 FR 70112). Consumer
testing findings have also shown that
patients and caregivers would like
procedure information to reflect all
procedures performed, since it better
represents clinicians’ experience.
While we agreed with comments
received on the CY 2023 PFS proposed
rule, we were unable to finalize the
possibility of using other payer data as
appropriate and technically feasible at
that time. However, we have
subsequently determined through
analysis of MA encounter data
submitted to CMS that it would be
technically feasible to integrate MA
encounter data into procedure category
counts and that adding such data adds
to the representation of some clinicians’
scope of care. For example, adding MA
encounter data to the initial set of
publicly reported procedure categories
would reduce the low volume clinicianprocedure counts by approximately 12
percent. An additional 10,689 unique
clinicians would have information on
their profile pages, since they do not
have this information based on FFS data
alone. These unique clinicians account
for furnishing 9 percent (10,869/
114,243) of the combined FFS and MA
patient populations from July 1, 2021 to
June 30, 2022.
Therefore, we are proposing to
publicly report aggregated counts of
procedures performed by providers
based on MA encounter data in addition
to Medicare FFS utilization data, given
that we have determined it is
appropriate and technically feasible.
Section 104(a) and (b) of MACRA
provides for the public reporting of
items and services furnished to
Medicare beneficiaries under title XVIII
of the Act, including, at a minimum,
information on the most frequent
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services or groupings of services
furnished by physicians or other eligible
professionals under part B of title XVIII
of the Act. This provision authorizes the
publication of information on the items
and services furnished to ‘‘Medicare
beneficiaries under Medicare by
physicians and certain other
professionals.’’ Notably, the statute
authorizes the disclosure of information
on all items and services furnished to
Medicare beneficiaries under the
Medicare Act; that is, the statute does
not limit the disclosure to a particular
subset of Medicare services. Indeed,
section 104(c)(1) of MACRA provides
that the information made available
must include ‘‘at a minimum’’ certain
information on Part B services. This
does not limit the disclosure authorized
by section 104(a) of MACRA to
information on Part B items and
services; instead, it specifies the
minimum information that CMS must
disclose, leaving additional disclosures
under section 104(a) of MACRA to CMS’
discretion. MA plans cover Part A and
Part B benefits (excluding hospice
services, acquisition costs for kidneys
used for transplants, and, for a limited
period, certain services under new
National Coverage Determinations and
changes in legislation) for Medicare
beneficiaries that elect to enroll in an
MA plan; this coverage is also under
Title XVIII of the Act. Section 104(a) of
MACRA thus authorizes the disclosure
of certain information about items and
services provided as benefits under an
MA plan and furnished by a physician
or other eligible professional.
Separately, section 10331(b)(4) of the
Affordable Care Act provides for the
Secretary to, in developing and
implementing his plan to make
information as determined appropriate
by the Secretary available on Physician
Compare, include data that reflects the
care provided to all patients seen by
physicians, under both the Medicare
program and, to the extent practicable,
other payers, to the extent such
information would provide a more
accurate portrayal of physician
performance. Thus, the inclusion of MA
encounter data is consistent with the
relevant statutory provisions regarding
the disclosures on the Care Compare
website.
Per section 1853(a)(3)(B) of the Act,
CMS has required MA organizations to
submit the data necessary to
characterize the context and purposes of
each item and service provided to a
Medicare beneficiary enrolled in an MA
plan to use for risk adjusting payments
by CMS to MA plans. Per the MA
regulation at § 422.310(f)(1)(vii), CMS
may use this risk adjustment data,
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which includes MA encounter data, for
activities to support administration of
the Medicare program and for purposes
authorized by other applicable law. The
MA regulation at § 422.310(f)(2) allows
CMS to release encounter data for any
of the purposes specified in
§ 422.310(f)(1) in accordance with
applicable Federal laws and CMS data
sharing procedures, subject to
protections of beneficiary
confidentiality and commercially
sensitive data. Finally, § 422.310(f)(3)
imposes restrictions on when the data is
available for release. We propose to rely
on § 422.310(f), as well as section 104 of
the MACRA and section 10331 of the
Affordable Care Act, for using and
releasing the MA encounter data as part
of the Care Compare website. To
accomplish this, we are also proposing
to amend § 422.310(f)(3) to permit the
release of the MA encounter data on the
timeframe(s) used for disclosure and
release of the data on the Care Compare
website. This proposal would ensure
that there is no confusion about our
ability to use and release the MA
encounter data for the Care Compare
website and downloadable files and
permit release of MA when necessary
and appropriate to support activities or
authorized uses under paragraph
(f)(1)(vii) of this section.
Using and analyzing MA encounter
data as part of the aggregated
information disclosed through the Care
Compare website will more completely
fulfill the public reporting required by
section 104 of the MACRA and section
10331 of the ACA and using the MA
encounter data in implementing these
statutory provision supports
administration of the Medicare program.
In addition, it is also consistent with
administering the Medicare program
overall to provide appropriate and
helpful information to beneficiaries in
selecting a provider. Thus, the use and
disclosure of the MA encounter data
here are within the scope of
§ 422.310(f)(1)(vii).
The aggregated utilization data we
propose to include in the Compare tool
meets the additional requirements to
protect beneficiary and commercially
sensitive information at § 422.310(f)(2)
because only identifying information
about healthcare providers and types of
procedures performed within a specific
time period would be disclosed on the
website and available for release in the
PDC downloadable files. The disclosure
and release of these portions of the MA
encounter data are consistent with CMS
data sharing procedures, which are
applied to the Medicare FFS data
already displayed and available for
download on the Care Compare website.
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However, when releasing the MA
encounter data under § 422.310(f)(2), the
timing limitations at § 422.310(f)(3)
prohibit releasing encounter data before
the applicable payment year’s
reconciliation has been completed
except for in specified circumstances.
Neither of the exceptions applies here.
Because we propose to use information
from the MA encounter data, in
combination with FFS claims data, over
a 12-month rolling period, but risk
adjustment reconciliation occurs no
sooner than 13 months after the end of
the year that services were provided, the
timing of the proposed release of the
MA encounter data is not within the
scope of the timing requirements in
§ 422.310(f)(3).
MA organizations submit encounter
data continuously, but do not have the
same timeliness requirements for
submission that FFS providers have for
submitting claims. In the August 22,
2014 final rule entitled, ‘‘Medicare
Program; Hospital Inpatient Prospective
Payment Systems for Acute Care
Hospitals and the Long-Term Care
Hospital Prospective Payment System
and Fiscal Year 2015 Rates; Quality
Reporting Requirements for Specific
Providers; Reasonable Compensation
Equivalents for Physician Services in
Excluded Hospitals and Certain
Teaching Hospitals; Provider
Administrative Appeals and Judicial
Review; Enforcement Provisions for
Organ Transplant Centers; and
Electronic Health Record (EHR)
Incentive Program’’ (79 FR 49854), CMS
adopted § 422.310(f)(3) to address
concerns that the need to update or
correct MA encounter data prior to the
final submission deadline could mean
that the MA encounter data was not
sufficiently complete or fully reliable for
public release. However, since that time,
which was during the first few years of
submission of MA encounter data to
CMS, submissions of MA encounter
data have improved. In particular, the
provider identifying information and
procedure codes required for the
Compare tool are well reported. Because
the Compare tool is reporting aggregated
counts of procedures, and not at the
beneficiary level, releasing this data
before final reconciliation is appropriate
to support the administration of the
Medicare program. Furthermore,
including utilization and limited
provider-identifying data from MA
encounters prior to the data being
reconciled by the MA organization
would substantially improve the
Compare tool and, thereby, the
administration of the Medicare program
overall by providing patients and
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caregivers with more useful and easily
understandable information about
procedures performed by providers in
their search for a clinician. We therefore
propose to amend § 422.310(f)(3) to
include an additional exception at
(f)(3)(iv) that permits CMS to release
aggregated risk adjustment data before
the reconciliation for the applicable
payment year has been completed if
CMS determines that releasing
aggregated data is necessary and
appropriate for the purposes specified
in § 422.310(f)(1)(vii).
Based on our analyses, the inclusion
of data about utilization in the MA
program would reduce the low volume
procedure counts subject to the small
cell size policy, in which precise counts
less than ten procedures or patients
cannot be publicly reported. This would
allow us to more accurately report the
types of services that Medicare
clinicians provide. Based on the public
comments in our prior rulemakings
about the Care Compare website and
consumer feedback, aggregating
utilization data from the Medicare FFS
and MA program would also enhance
patient use of the information. Although
the initial release of publicly reported
utilization data on the Compare tool is
limited to clinicians’ Medicare FFS
claims, publicly reporting utilization
data that includes Medicare FFS and
MA would also be more consistent with
MIPS quality information submitted via
health IT vendors or registries that
include other payer data. Lastly, adding
MA data to the counts in the existing
Medicare FFS utilization data file will
mitigate interested party concerns by
ensuring the data is more reflective of
the physician’s/clinician’s scope of
practice.
We seek comment on all aspects this
proposal.
(3) Request for Information: Publicly
Reporting Cost Measures
Section 1848(q)(9)(A)(i) of the Act
requires us to publicly report MIPS
eligible clinicians’ final scores and
performance category scores and
authorizes, but does not require, us to
publicly report MIPS eligible clinicians’
performance with respect to each
measure or activity. In the CY 2017
Quality Payment Program final rule (81
FR 77390 through 77399), we finalized
our policies for publicly reporting MIPS
eligible clinicians’ and groups’ final
scores, performance category scores, and
measure-level scores in an easily
understandable format. Currently, we
publicly report certain MIPS
performance information that meet
public reporting standards on clinician,
group, and Accountable Care
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Organization (ACO) profile pages of the
Compare tool (available at https://
www.medicare.gov/care-compare/) so
Medicare patients and caregivers can
use it when making healthcare
decisions. In addition to publicly
reporting final scores and performance
category scores in the PDC, we
established a policy to publicly report
performance on measures, activities,
and attestations, from the MIPS quality,
cost, Promoting Interoperability
(previously called Advancing Care
Information), and improvement
activities performance categories that
meet established public reporting
standards (81 FR 77395). We codified
these public reporting standards in our
regulations at § 414.1395(b), requiring
that performance data be statistically
valid, reliable, accurate, and comparable
across collection types, to be included
in the PDC, available at https://
data.cms.gov/provider-data/topics/
doctors-clinicians. The data must also
resonate with patients and caregivers as
determined by user testing to be
included on the Compare tool profile
pages.
As of the time of this proposed rule,
data from the CY 2021 performance
period/2023 MIPS payment year
regarding MIPS eligible clinicians’
performance in the quality,
improvement activities, and Promoting
Interoperability performance categories
that meet public reporting standards are
publicly available on Compare tool
profile pages and in the PDC. However,
we have not publicly reported any cost
measure information from the cost
performance category since the
inception of MIPS for two primary
reasons.
First, in the CY 2019 PFS final rule
(83 FR 59910 through 59912), we
established a policy to delay publicly
reporting any new quality and cost
measures for the first two years they are
in MIPS to allow MIPS eligible
clinicians and groups to gain experience
with the new measures. We codified
this policy in our regulation at
§ 414.1395(c). After this period, we
would reevaluate the measures to
determine when and if they are suitable
for public reporting (83 FR 59910
through 59912). Second, we have not
had cost measures available for public
reporting because of the COVID–19
Public Health Emergency (PHE), during
which we reweighted the cost
performance category to zero percent for
MIPS eligible clinicians’ final scores in
the CY 2019 performance period/2021
MIPS payment year, as discussed at
https://qpp.cms.gov/resources/
covid19?py=2019, the CY 2020
performance period/2022 MIPS
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payment year, as discussed at https://
qpp.cms.gov/resources/
covid19?py=2020, and the CY 2021
performance period/2023 MIPS
payment year, as discussed at https://
qpp.cms.gov/resources/
covid19?py=2021. That is, for several
years, we provided cost measure scores
to clinicians for informational purposes
only and did not publicly report MIPS
eligible clinicians’ performance in the
cost measure category.
However, given the number of cost
measures we have adopted in MIPS for
at least two years and the PHE ending,
we are evaluating ways to publicly
report performance on cost measures on
clinician and group profile pages
beginning with data from the 2024
performance period/2026 MIPS
payment year being publicly reported in
2026. Public reporting of these data
would assist patients and caregivers in
making healthcare decisions. In section
IV.A.4.f.(2) of this proposed rule, we are
proposing, beginning with the CY 2024
performance period/2026 MIPS
payment year, adoption of five new
episode-based cost measures and
removal of one episode-based cost
measure. If our proposal is finalized,
there would be a total of 25 cost
measures—23 Episode-Based Cost
Measures (EBCMs), Medicare Spending
Per Beneficiary (MSPB), and Total Per
Capita Cost (TPCC)—available for public
reporting in CY 2026, provided they
meet public reporting standards as set
forth in our regulation at § 414.1395. In
the CY 2019 PFS final rule (83 FR 59910
through 59912), we finalized a policy to
delay publicly reporting any new
quality and cost measures for the first 2
years they are in MIPS at § 414.1395(c).
There are currently 25 cost measures
available for public reporting at the time
of this Request for Information, and the
5 cost measures proposed for inclusion
in section IV.A.4.f.(2) of this rule would
not be eligible for public reporting until
the CY 2026 performance period/2028
MIPS payment year. Additionally, by
publicly reporting cost measures, we
would further our goals of transparency,
encouraging MIPS eligible clinicians to
prioritize cost efficiency, and enabling
patients and caregivers to make
informed decisions about clinicians
who consider costs as part of their care.
Research suggests that patients and
caregivers are interested in comparative
cost information.320 An Agency for
320 Greene, J., & Sacks, R.M. (2018). Presenting
Cost and Efficiency Measures That Support
Consumers to Make High-Value Health Care
Choices. Health services research, 53 Suppl 1(Suppl
1), 2662–2681. https://doi.org/10.1111/14756773.12839.
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Healthcare Research and Quality
(AHRQ) environmental scan and
systematic review of all payer claims
databases (APCDs) in 2017 found there
is a need for standardized and
transparent cost measures reporting, as
well as user-friendly interfaces that help
patients and caregivers make informed
healthcare decisions.321 Several sources
highlight the importance of presenting
cost information in the context of
quality metrics to improve healthcare
consumers’ ability to interpret cost
data.322 323 Although there is limited
research in this area, there is evidence
that consumers can make high-value
choices using cost in combination with
other performance data.324
During a recent consumer testing
session with patients, the majority of
whom were Medicare beneficiaries and
included two retired clinicians, several
participants noted that they find cost
information valuable and would use it
in conjunction with other information
when making healthcare decisions. This
early finding suggests that this type of
information is valued by healthcare
consumers; additional consumer testing
with patients and caregivers and input
from clinical subject matter experts
would be beneficial for gathering
feedback from the population who use
the website and ensure that publicly
reported MIPS cost measures are
interpreted correctly and useful to
website users. Further consumer testing
with patients and caregivers would also
help determine which aspects of cost
performance information resonate most
with them, as well as how to best
display and plain language cost measure
information on clinician and group
profile pages.
We intend to propose in future
rulemaking to publicly report MIPS cost
measures beginning with data from the
CY 2024 performance period/2026 MIPS
payment year in CY 2026 on Compare
tool clinician and group profile pages
321 Agency for Healthcare Research and Quality,
All-Payer Claims Databases Measurement of Care:
Systematic Review and Environmental Scan of
Current Practices and Evidence (2017) https://
www.ahrq.gov/data/apcd/envscan/findings.html.
322 Greene, J., & Sacks, R.M. (2018). Presenting
Cost and Efficiency Measures That Support
Consumers to Make High-Value Health Care
Choices. Health services research, 53 (Suppl 1),
2662–2681. https://doi.org/10.1111/14756773.12839.
323 Commonwealth Fund, Hospital Price
Transparency: Making It Useful for Patients, (2019),
available at https://www.commonwealthfund.org/
blog/2019/hospital-price-transparency-making-ituseful-patients.
324 Greene, J., & Sacks, R.M. (2018). Presenting
Cost and Efficiency Measures That Support
Consumers to Make High-Value Health Care
Choices. Health services research, 53 (Suppl 1),
2662–2681. https://doi.org/10.1111/14756773.12839.
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and in the PDC in 2026. In this Request
for Information (RFI), we are seeking
comment on a number of aspects of how
to best establish publicly reporting cost
measures, as discussed below.
• Potential approaches to reporting
MIPS cost measures, including whether
it is more meaningful to only report
aggregated episodes or include
component-level cost information for
the EBCMs. Cost measure components
are specified in the measure
construction for each episode type
based on input from clinical expert
engagement activities during the
development process and can include
services related to either clinical
treatments or adverse events (for
example, clinically related diagnostic
care, the need to receive post-acute care
following the initial procedure or
hospitalization, and the need to visit an
emergency room or be readmitted for
additional inpatient care following the
initial procedure or hospitalization).
With this context, patients would have
additional information enabling them to
make informed healthcare decisions.
To provide actionable cost measure
data, we will test the consumer
perceptions of the components of cost
measures in addition to the overall cost
measure scores to determine whether
they resonate with users. We expect that
component costs will provide context
for patients and caregivers to
understand the extent to which costs are
driven by what may be perceived as
high-quality care (for example, postdischarge follow-up visits) or lowquality care (for example, procedure redo). For example, when comparing
clinicians, consumers could assess
frequency or severity (for example, as
measured by above average costs
associated with clinically related
complications).
• Benchmarking and possible
comparators as well as how to best
present this information to provide
frames of reference for the cost
performance information. Cost measures
present a unique challenge to public
reporting as their interpretation is not
intuitive to consumers. While higher
than expected costs may be driven by
adverse outcomes, overall cost is
comprised of care components that
consumers could perceive as higher
quality (for example, follow-up visits) as
well as lower quality (for example,
clinically related emergency department
visits and re-hospitalizations). As a
result, overall costs alone do not
provide sufficient context about the
drivers of those costs and may cause
consumers more confusion in making a
choice about where to seek care.
Publishing overall costs could also be
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misleading, as previous consumer
testing showed that some patients and
caregivers interpret higher costs as a
reflection of higher quality, when in fact
testing during cost measure
development has consistently
demonstrated that clinicians with
higher shares of costly adverse events,
such as hospital readmission, tend to
have worse scores.
One mechanism of contextualizing
cost measure performance is through
displaying cost measures alongside
clinically relevant quality measures,
resulting in a reflection of value.
However, there are two main reasons
the current structure of MIPS does not
consistently support this preferred
display. First, under the self-selection
policy for quality measures, MIPS
eligible clinicians may select measures
on which they expect to score best,
rather than those that are most clinically
relevant to their practice. This can result
in a clinician profile with quality
measures that are clinically unrelated to
the clinician’s core practice activities
and, therefore, the clinician’s cost
measures. Second, MIPS eligible
clinicians have a choice between
reporting their performance on quality
measures as individuals or as part of a
group. Group-reported quality measure
performance cannot be disaggregated to
the clinician level. Because we calculate
cost measures independently for all
eligible clinicians and groups using
Medicare claims, performance
information is available at both levels.
When reporting cost measure
performance at the clinician level
(because patients and caregivers using
the Compare tool prefer measure
performance at the most granular level
available), we could have cost measures
on a MIPS eligible clinician’s profile
page with no accompanying quality
measures. Given these realities inherent
to MIPS, there may not always be
relevant quality measure information
available to display alongside cost for a
value concept. MIPS Value Pathways
(MVPs) may mitigate some of these
issues, since clinicians would have a
smaller set of quality measures, some of
which could be more related to their
specialty, for selection, but clinician
versus group level performance
reporting discrepancies would persist.
Therefore, we have considered several
approaches to presenting cost measure
performance information without
assuming related quality measures
would be available for adjacent display,
including reporting the ratio of cost to
the national average cost and the dollar
cost per episode. These approaches may
result in challenges to interpreting
meaningful differences in costs. The
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Achievable Benchmark of Care (ABCTM)
methodology we currently use to star
rate performance on publicly reported
MIPS quality and Promoting
Interoperability measures would not be
appropriate for cost measures, because
this method is used for measures in
which a single direction of performance
(for example, higher) is universally
desirable, which, as discussed
previously, is not always the case with
cost performance. We have also
considered an approach to display the
MIPS eligible clinician’s or group’s
relative position in the distribution of
the cost measure performance compared
to the national average we calculate
from MIPS cost measures using three
levels. Doing so, we could determine
whether each clinician or group
performance on each scored cost
measure is ‘‘greater than,’’ ‘‘less than,’’
or ‘‘no different’’ compared to the
national average cost.
We are inviting comment on this
possible approach to publicly reporting
individual MIPS eligible clinician’s or
group’s performance on individual
EBCMs, MSPB, and TPCC compared to
the average performance of all MIPS
eligible clinicians nationally. We are
also seeking comment on considerations
for these comparators or benchmarks
discussed above, particularly whether
they would be useful to present or if
there are any alternatives we have not
yet considered.
To summarize the aspects discussed
above in which we request additional
information, we are seeking comment
on the following topics related to public
reporting of MIPS cost measures on the
Compare tool:
• How can we present MIPS cost
measures information in a way that
reflects meaningful outcomes to patients
and their caregivers and the value of
care, rather than cost alone?
• What are the considerations for
publicly reporting the total episodic
cost, component-level costs, or both? Do
the component costs provide adequate
context for patients and their caregivers
to make informed healthcare decision?
What other specific information about
MIPS cost measures, including the
context of quality measures and MVPs,
should we consider including on the
Compare tool?
• What are the considerations for
publicly reporting the national average
cost, ratio of cost to the national average
cost, and/or the dollar cost per episode
as possible benchmarks for comparison
discussed above in this section? What
other benchmarks or comparator
approaches should we consider?
• Are there any considerations for
evaluating cost measures for public
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reporting beginning with cost measure
data from CY 2024 performance period/
2026 MIPS payment year in the CY
2026?
• What other factors, such as those
related to health equity, should be taken
into consideration?
• We request comment on additional
information that we may not have
considered or discussed above about
publicly reporting MIPS cost measures,
as well as any unintended impacts and/
or positive outcomes that could result
from making this information publicly
available on the Compare tool.
n. Overview of QP Determinations and
the APM Incentive
(1) Overview
The Quality Payment Program
provides incentives for eligible
clinicians to engage in value-based,
patient-centered care under Medicare
Part B via MIPS and Advanced APMs.
The structure of the Quality Payment
Program enables us to advance
accountability and encourage
improvements in care. The Secretary
has also adopted the closely related goal
of having all people with Traditional
Medicare in an accountable care
relationship with their health care
provider by 2030, where their needs are
holistically assessed and their care is
coordinated within a broader total cost
of care system. Our vision for increased
participation among clinicians in
Advanced APMs is driven by a belief
that integrating individuals’ clinical
needs across a spectrum of providers
and settings will improve patient care
and population health.
As we continue to improve the
Quality Payment Program, we seek to
develop, propose, and implement
policies that encourage broad clinician
participation in Advanced APMs. For
example, in this section, we are
proposing to calculate QP
determinations at the individual level
for each unique NPI associated with an
eligible clinician participating in an
Advanced APM. As discussed further in
the proposal, we believe that this
change will provide a more accurate
measure of the actual engagement of
individual clinicians participating in
Advanced APMs. This accuracy is
important for administration of the
Quality Payment Program incentives
and also could help us better identify
and understand the motivating factors
and indicators of clinician readiness for
greater adoption of Advanced APMs.
In the CY 2017 Quality Payment
Program final rule (81 FR 77439 through
77445), we finalized our policy at
§ 414.1425(b) for Qualifying APM
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Participant (QP) determinations. For the
purposes of making QP determinations,
an eligible clinician must be present on
the Participation List of an APM Entity
in an Advanced APM on one of the
‘‘snapshot dates’’ (March 31, June 30, or
August 31) for the QP Performance
Period. An eligible clinician included
on a Participation List on any one of
such dates is included in the APM
Entity group even if that eligible
clinician is not included on that
Participation List at one of the prior- or
later-listed dates. We perform QP
determinations for the eligible clinicians
in an APM Entity group three times
during the QP Performance Period using
claims data for services furnished from
January 1 through each of the respective
QP snapshot dates. An eligible clinician
can be determined to be a QP only if the
eligible clinician appears on the
Participation List on a snapshot date
that we use to determine the APM
Entity group and to make QP
determinations at the APM Entity group
level based on participation in the
Advanced APM. For eligible clinicians
who appear on a Participation List for
more than one APM Entity, but do not
to achieve QP status based on any APM
Entity-level determinations, we make
QP determinations at the individual
level as described in § 414.1425(c)(4).
Likewise, for eligible clinicians on an
Affiliated Practitioner list for an
Advanced APM, we make QP
determinations at the individual level
three times during the QP Performance
Period using claims data for services
furnished from January 1 through each
of the respective QP determination
snapshot dates as described in
§ 414.1425(b)(2).
(2) Individual QP Determination
Under the current policy at
§ 414.1425(b), most eligible clinicians
participating in Advanced APMs receive
their QP determinations at the APM
Entity level. In the CY 2017 Quality
Payment Program proposed rule (81 FR
28319), we contemplated that ‘‘as with
any group assessment, there will be
some situations in which individual
Threshold Scores would differ from
group Threshold Scores if assessed
separately. This could lead to some
eligible clinicians becoming QPs when
they would not have met the QP
Threshold individually (a ‘free-rider’
scenario) or, conversely, some eligible
clinicians not becoming QPs within an
Advanced APM Entity when they might
have qualified individually (a dilution
scenario).’’ At that time, we believed
that the benefits of performing QP
determinations for the APM Entity as a
group outweighed these potential
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scenarios. However, as we previously
indicated in a Request for Information
in the CY 2023 PFS proposed rule (87
FR 46337 through 46339), we have come
to believe that the effects of these types
of scenarios, including effects that we
had not intended or foreseen in the 2017
rule, have come to outweigh the benefits
of performing QP determinations at the
APM Entity level.
First, it has been brought to our
attention that our policy to conduct
most QP determinations at the APM
Entity level may have inadvertently
discouraged some APM Entities from
including certain types of eligible
clinicians, particularly in multispecialty APM entities such as ACOs,
leading those clinicians to be excluded
from participation in Advanced APMs.
Because the APM Entity Threshold
Scores (using the payment amount and
patient count methods) that are used to
make APM Entity-level QP
determinations are based on an
aggregate calculation across all eligible
clinicians participating in the APM
Entity group, eligible clinicians in the
APM Entity group who furnish
proportionally fewer services that lead
to attribution of patients or payment
amounts to the APM Entity are likely to
lower the APM Entity’s Threshold
Score. Many Advanced APMs attribute
patients to APM Entity groups based in
part on the provision of primary care
services, but not all eligible clinicians
typically furnish primary care services.
For example, primary care physicians
may furnish proportionally more
evaluation and management (E/M)
(office visit) services, which, as we
explain more in the next section, are
frequently the basis for attribution of
patients and payment amounts to the
numerator of the APM Entity’s
Threshold Score, whereas specialist
physicians may furnish proportionally
more diagnostic tests and surgical
procedures, which are not usually part
of the attribution basis to the APM
Entity.
We have received reports from
Advanced APM participants and
specialty societies that some APM
Entities have taken steps to exclude
from their APM Entity groups (and
consequently from their Participation
Lists) eligible clinicians who furnish
proportionally fewer services that lead
to the attribution of patients or payment
amounts for purposes of calculating
Threshold Scores for APM Entity-level
QP determinations. For reasons stated
above, this action typically would lead
to the exclusion of certain specialists
from the APM Entity. There are
important reasons that it is not
beneficial for an APM Entity to exclude
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specialists and other eligible clinicians
who furnish relatively fewer services
that lead to attribution. In both the
Medicare Shared Savings Program and
in models tested by the Innovation
Center that the meet the criteria to be
Advanced APMs, CMS seeks to promote
patient-centered care that is integrated
across the continuum of care. The
inclusion of specialists in APM Entities
is essential for achieving this goal. For
example, a comprehensive network that
includes a range of specialists is central
to the success of an ACO in the
Medicare Shared Savings Program for its
intended purpose in patient-centered
care that coordinates items and services
for Medicare FFS beneficiaries, a key
aim of value-based care and practice
transformation.325 The methodology
used in beneficiary assignment for the
Shared Savings Program is deliberately
constructed such that assignment is
largely based on primary care, rather
than specialty care, which results in
specialists contributing proportionately
less in terms of payment amounts and
patient counts to the numerator of the
ACO’s Threshold Score calculation used
for APM Entity-level QP determinations.
Similarly, it was not our intent to create
a policy whereby eligible clinicians who
are seeing most or all of their Medicare
patients through an Advanced APM
may remain unable to achieve QP status
because the APM Entity with which
they participate in the Advanced APM
includes eligible clinicians who furnish
very few services through the Advanced
APM. It has always been one of the
goals of the APM track of the Quality
Payment Program for the availability of
QP status to incentivize eligible
clinicians to join Advanced APMs. But
under our current policy to make most
QP determinations at the APM Entity
level, there is the potential that eligible
clinicians who are fully engaged in an
Advanced APM may still be unable to
earn QP status. We carefully considered
our policy to make most QP
determinations at the APM Entity level,
and believed it was the best approach at
the time. However, we did not intend
for the policy to create potentially
conflicting incentives for APM Entities
between the goal for their eligible
clinicians to achieve QP status under
the Quality Payment Program, and their
full participation in an Advanced APM
with a group of eligible clinicians that
can deliver a full spectrum of care.
In the CY 2017 Quality Payment
Program proposed rule (81 FR 28319),
we stated that ‘‘the statute consistently
refers to an eligible clinician throughout
325 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/sharedsavingsprogram/about.
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section 1833(z) of the Act and clearly
identifies that the QP determinations are
to be made for an eligible clinician,’’
then noted that ‘‘in section 1833(z)(3)(B)
of the Act, the definition of an eligible
clinician includes a group of such
professionals.’’ While the statutory
scheme provides for the flexibility to
establish policies that apply for groups
of eligible clinicians, it does not require
that approach. When we proposed the
policy to calculate Threshold Scores at
the APM Entity level, we based this
policy in part on ‘‘a premise that
positive change occurs when entire
organizations commit to participating in
an Advanced APM and focusing on its
cost and quality goals as a whole.’’
While we continue to believe in this
premise, we also recognize that, if APM
Entities are removing or otherwise not
including eligible clinicians who may
technically contribute less to the APM
Entity-level Threshold Score, such
actions may impede other worthy goals
of the Advanced APM (such as
increased care coordination directly
among providers caring for a patient), in
which case that larger positive change
we were seeking to foster is not being
achieved.
Conversely, we are concerned that,
under our current policy to make most
QP determinations at the APM Entity
level, in situations where an APM Entity
does attain QP status, some eligible
clinicians who furnish relatively fewer
of their services through that APM
Entity may receive a disproportionate
financial benefit because their QP status
was achieved as a result of the care
furnished by other eligible clinicians in
the APM Entity while their APM
Incentive Payment is calculated based
on all of the covered professional
services that the individual eligible
clinician furnishes during the base year,
including services that were not
furnished through an Advanced APM.
Our policy to make most QP
determinations at the APM Entity level
allows these windfall financial rewards
because we calculate the Threshold
Scores using the aggregate of payment
amounts or patient counts for attributed
patients based on Medicare Part B
covered professional services furnished
by all the eligible clinicians in the APM
Entity, whether an individual eligible
clinician furnished a few or many such
services. Once an eligible clinician
receives QP status for a year, the APM
Incentive Payment is calculated based
on paid claims for the individual QP’s
covered professional services across all
their TINs in the base year. This can
allow an eligible clinician with minimal
Advanced APM participation to receive
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a disproportionately large APM
Incentive Payment, which we do not
believe aligns with the intent of the
Quality Payment Program.
As a result, we have reconsidered our
current policy to make most QP
determinations at the APM Entity level.
Instead, we propose to amend
§ 414.1425(b) so that, beginning with the
QP Performance Period for CY 2024, we
would make all QP determinations at
the individual level. We note that under
§§ 414.1425(b)(2) and 414.1425(c)(4) we
currently calculate Threshold Scores at
the individual level when the Advanced
APM includes eligible clinicians only
on an Affiliated Practitioner List, and
further, under § 414.1425(c)(4) we also
calculate QP determinations
individually when the eligible clinician
participates in multiple Advanced
APMs and does not achieve QP status at
the APM Entity level. The proposal
would not change our policy for these
determinations, but would change the
way we make QP determinations for all
other eligible clinicians. Under the
proposal, we would calculate Threshold
Scores for QP determinations at the
individual level for each unique NPI
associated with an eligible clinician
participating in an Advanced APM. We
would calculate a Threshold Score for
each NPI based on all covered
professional services furnished across
all Tax Identification Numbers (TINs) to
which the eligible clinician has
reassigned their billing rights. This
individual Threshold Score would
provide a more specific measurement of
each eligible clinician’s participation in
an Advanced APM. This proposed
methodology would ensure that those
eligible clinicians who individually
meet a QP threshold would receive QP
status and its commensurate financial
and other benefits. At the same time, it
would remove the incentive for APM
Entities to exclude certain types of
eligible clinicians from their
Participation Lists, because the success
or failure of the APM Entity’s eligible
clinicians to reach QP status no longer
would be collective. Because each
eligible clinician on the APM Entity’s
Participation List would be evaluated
individually at the NPI level, eligible
clinicians with lower proportions of
payments and payments through the
Advanced APM Entity would not affect
the QP status of other eligible clinicians
on the APM Entity’s Participation List.
(3) Payment Amount and Patient Count
Methods
In the CY 2017 Quality Payment
Program final rule (81 FR 77450 through
77457) we finalized the payment
amount method and patient count
method for calculation of Threshold
Scores used for QP determinations
under the Medicare option, and codified
these methods at § 414.1435(a) and (b),
respectively. The payment amount
method is based on payments for
Medicare Part B covered professional
services, including certain supplemental
service payments, while the patient
count method is based on numbers of
patients. Both methods use the ratio of
‘‘Attributed beneficiaries’’ to
‘‘Attribution-eligible beneficiaries, as
defined at § 415.1305.326
Attributed beneficiaries are those who
are attributed to the APM Entity under
the terms of the Advanced APM as
indicated on the most recent available
list of Attributed beneficiaries at the
time of a QP determination. Attributioneligible beneficiaries generally are those
who, during the QP Performance Period,
meet six criteria specified in the
definition of that term at § 414.1305 and
described in section IV.A.4.m.(3) of this
proposed rule.
When making QP determinations at
the APM Entity or individual eligible
clinician level, we begin by calculating
Threshold Scores using the payment
amount and patient count methods.
These Threshold Scores are percentages
based on the ratio of the payment
amounts or patient counts for Attributed
beneficiaries to the payment amounts or
patient counts for Attribution-eligible
beneficiaries during the QP performance
period. If the Threshold Score (using
either the payment amount or patient
count method) for the eligible clinician
or APM Entity, as applicable, meets or
exceeds the relevant QP threshold
described at § 414.1430(a), the relevant
eligible clinicians (either the individual
eligible clinician or all those on the
APM Entity’s Participation List) attain
QP status for such year.
The regulation at § 414.1435(b)(3)
provides that a beneficiary may be
counted only once in the numerator and
denominator for a single APM Entity
group, and at § 414.1435(b)(4), that a
beneficiary may be counted multiple
times in the numerator and denominator
for multiple different APM Entity
groups. In the CY 2021 PFS final rule
(85 FR 84951 through 84952), we
amended § 414.1435(c)(1)(i) to specify
that beneficiaries who have been
prospectively attributed to an APM
Entity for a QP Performance Period will
be excluded from the Attributioneligible beneficiary count for any other
APM Entity that is participating in an
APM where that beneficiary would be
ineligible to be added to the APM
Entity’s attributed beneficiary list. This
means that beneficiaries who have been
attributed to one APM Entity and are
thus barred under the terms of an
Advanced APM from attribution to
another APM Entity are removed from
the denominator of the payment amount
method and patient count method in QP
Threshold Score calculations for the
APM Entity to which they cannot be
attributed (in other words, we do not
penalize an APM Entity in the QP
Threshold Score calculation by
including a beneficiary in its
326 For technical information on the QP
calculation methodology, see the ‘‘QP Methodology
Fact Sheet’’ that we publish annually, which can be
found as part of the ‘‘2023 Learning Resources for
QP Status and APM Incentive Payment’’ materials
on the Quality Payment Program Resource Library
at https://qpp-cm-prod-content.s3.amazonaws.com/
uploads/1509/2023%20Learning%20Resources
%20for%20QP%20Status%20and%20APM
%20Incentive%20Payment.zip.
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denominator when the terms of an
Advanced APM do not permit such
beneficiary to be attributed to such APM
Entity).
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(a) Attributed Beneficiary
An Attributed beneficiary is a
beneficiary attributed to the APM Entity
under the terms of the Advanced APM
as indicated on the most recent
available list of attributed beneficiaries
at the time of a QP determination. There
may be beneficiaries on the most recent
available list who do not meet the
criteria to be Attribution-eligible
beneficiaries because the QP
performance period does not coincide
with the Advanced APM’s performance
period or attribution period, or for other
reasons. There may be cases where a
beneficiary’s status changes, for
example by enrolling in a Medicare
Advantage Plan. We exclude these
beneficiaries from our Threshold Score
calculations because they do not meet
criteria to be Attribution-eligible
beneficiaries. Although APMs may have
reconciliation processes in place to
address changes in beneficiary status at
various intervals, those processes do not
necessarily coincide with the timeframe
of QP determinations. Therefore, when
calculating Threshold Scores for QP
determinations, we exclude from the list
of Attributed beneficiaries any
beneficiaries who do not meet the
criteria to be Attribution-eligible
beneficiaries at that point in time.
(b) Attribution-Eligible Beneficiary
An Attribution-eligible beneficiary is
a beneficiary who:
• Is not enrolled in Medicare
Advantage or a Medicare cost plan;
• Does not have Medicare as a
secondary payer;
• Is enrolled in both Medicare Parts A
and B;
• Is at least 18 years of age;
• Is a United States resident; and
• Has a minimum of one claim for
E/M services furnished by an eligible
clinician who is in the APM Entity for
any period during the QP Performance
Period or, for an Advanced APM that
does not base attribution on E/M
services and for which attributed
beneficiaries are not a subset of the
attribution-eligible beneficiary
population based on the requirement to
have at least one claim for E/M services
furnished by an eligible clinician who is
in the APM Entity for any period during
the QP Performance Period, the
attribution basis determined by CMS
based upon the methodology the
Advanced APM uses for attribution,
which may include a combination of
E/M and/or other services.
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Our stated intent when we finalized
the definition of Attribution-eligible
beneficiary (81 FR 77451 through
77452) was to have a definition that
would, for the purposes of QP
determinations, allow us to be
consistent across Advanced APMs in
how we consider the population of
beneficiaries served by an APM Entity.
The criteria we used to define
Attribution-eligible beneficiary were
aligned with the attribution
methodologies and rules for our
contemporaneous Advanced APMs. The
first five criteria are conditions that are
required for a beneficiary to be
attributed to any Advanced APM. The
sixth criterion identifies beneficiaries
who have received certain services from
an eligible clinician who is associated
with an APM Entity for any period
during the QP Performance Period. For
Most Advanced APMs, we chose to refer
to E/M services because many
Advanced APMs use E/M services to
attribute beneficiaries to their
participant APM Entities. Over time we
have updated the list of services that are
considered to be E/M services for
purposes of identifying Attributioneligible beneficiaries and have
published this list as part of the ‘‘2023
Learning Resources for QP Status and
APM Incentive Payment’’ materials on
the Quality Payment Program Resource
Library at https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
1509/2023%20Learning%20Resources
%20for%20QP%20Status%20and
%20APM%20Incentive
%20Payment.zip.
We also included an exception in this
sixth criterion to allow an alternative
approach for Advanced APMs that do
not base attribution exclusively on E/M
services, and thus for which Attributed
beneficiaries are not a subset of the
Attribution-eligible beneficiary
population based on the requirement to
have at least one claim for E/M service.
To date we have implemented this
alternative approach for four Advanced
APMs:
• Bundled Payments for Care
Improvement Advanced Model.
• Comprehensive Care for Joint
Replacement Payment Model (CEHRT
Track).
• Comprehensive ESRD Care Model
(LDO arrangement and Non LDO Two
Sided Risk Arrangement).
• Maryland Total Cost of Care Model
(Care Redesign Program).
We have published links to the
methodologies we use to identify
Attribution-eligible beneficiaries for
these Advanced APMs in the ‘‘2023
Learning Resources for QP Status and
APM Incentive Payment’’ materials on
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the Quality Payment Program Resource
Library at https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
1509/2023%20Learning%20Resources
%20for%20QP%20Status%20and
%20APM%20Incentive
%20Payment.zip.
We adopted the general rule with
flexibility to apply alternative methods
for this criterion to ensure that, for the
Advanced APMs for which attribution is
based on services other than E/M
services, the Attributed beneficiary
population is truly a subset of such
Advanced APMs’ attribution-eligible
populations and, ultimately, so that our
way of identifying beneficiaries for
purposes of Threshold Score
calculations for QP determinations is
appropriate for such Advanced APMs.
That said, our thinking at the time that
we developed these approaches was
shaped by the form and nature of the
Advanced APMs that existed at that
time. A key lesson we have learned over
time as we have implemented the APM
track of the Quality Payment Program is
that, by affording sufficient flexibility
within the program, we can both foster
innovation in Advanced APMs and
simplify our execution of the program.
By having a more narrowly-defined
default approach to beneficiary
attribution (relying on E/M services), we
frequently needed to exercise the
flexibility to determine an appropriate
attribution methodology for an
Advanced APM that falls into the
exception, which meant that we
identified several individually-tailored
ways of performing the attribution
methodology for each specific
Advanced APM. As such, we have come
to believe that application of our current
regulations may result in increased
complexity over time if, as we
anticipate, Advanced APMs continue to
evolve and use novel approaches to
value-based care that may emphasize a
broad range of covered professional
services.
Further, as we noted in our discussion
of the proposal to calculate QP status at
the individual NPI level, primary care
practitioners generally furnish a higher
proportion of E/M services to
beneficiaries than do specialists, and as
for the Threshold Score calculations
described previously, the emphasis on
E/M services in our beneficiary
attribution policy may have
inadvertently encouraged APM Entities
to exclude specialists from their
Participation Lists. Under our current
policy, if one or more eligible clinicians
on the APM Entity’s Participation List
are furnishing covered professional
services to a beneficiary but none of
those services are among the E/M
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services we use for attribution, that
beneficiary would not be Attributioneligible, and therefore, would not be
included in our QP determination
calculation at all, even though they
actually are receiving covered
professional services from an eligible
clinician on the APM Entity’s
Participation List.
We are proposing to change the
definition of ‘‘Attribution-eligible
beneficiary’’ at § 414.1305 so that a
single definition using covered
professional services will be applied
regardless of the Advanced APMs in
which the eligible clinician participates.
We believe that this complements our
proposal to no longer conduct APM
Entity group-level QP determinations
and switch to making QP
determinations at the individual eligible
clinician level. We are also concerned
that retention of the current policy
under which E/M services are the
default basis for attribution and special
processes are required for Advanced
APMs that use a different attribution
basis could result in a complex set of
unique attribution approaches for
Advanced APMs.
In order to create a uniform basis for
beneficiary attribution across all
Advanced APMs, we are proposing to
modify the sixth criterion of the
definition of ‘‘attribution-eligible
beneficiary’’ at § 414.1305 to include
any beneficiary who has received a
covered professional service furnished
by the eligible clinician (NPI) for whom
we are making the QP determination. By
no longer specifying E/M services as the
default attribution basis in the sixth
criterion, we also eliminate the need for
flexibility to use a different attribution
basis that ties attribution-eligibility to a
specific Advanced APM’s attribution
methodology. This would simplify and
streamline the attribution methodology
by making attribution based on covered
professional services across all
Advanced APMs.
The proposal to base attribution
eligibility on the receipt of a covered
professional service also would address
the issue discussed earlier in this
section whereby, under our current
policy, beneficiary attribution for
purposes of QP determinations is
contingent upon the beneficiary
receiving an E/M services, and as a
result beneficiaries who are actually
being provided covered professional
services by eligible clinicians on an
APM Entity’s Participation List are not
Attribution-eligible if none of the
services provided are E/M services.
Under our proposal, because we would
consider all covered professional
services for attribution, and not solely
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E/M services, we would be able to
include as Attributed beneficiaries those
who are receiving only other (non-E/M)
covered professional services through
the Advanced APM. We believe this
proposal would result in a QP
calculation that, by including
beneficiaries receiving any covered
professional service, more accurately
reflects eligible clinicians’ actual
participation in Advanced APMs.
We note that the proposal would not
change the dates of service used for
purposes of QP determinations. As
such, QP determinations at any given
snapshot date (March 31, June 30, and
August 31, respectively) would be made
by including all covered professional
services furnished during the QP
Performance Period for January 1
through the applicable snapshot date.
We believe that this change would
more appropriately recognize the
Advanced APM participation of the
eligible clinicians for whom these
determinations are being made,
particularly when considered in
conjunction with the proposal to make
QP determinations at the individual
eligible clinician level. We further
believe that this proposal would
simplify and streamline QP
determinations, and address the
challenges to Advanced APM
participation reportedly faced by
specialists who are less likely than
primary care practitioners to provide
E/M services.
We seek comment on this proposal to
modify the sixth criterion in the
definition of ‘‘Attribution-eligible
beneficiary’’ at § 414.1305 to include a
beneficiary who has a minimum of one
claim for a covered professional service
furnished by an eligible clinician who is
on the Participation List for the APM
Entity at any determination date during
the QP Performance Period.
(4) QP Thresholds and Partial QP
Thresholds
Section 1833(z)(2) of the Act specifies
the thresholds for the level of
participation in Advanced APMs
required for an eligible clinician to
become a QP for a year. The Medicare
Option, based on Part B payments for
covered professional services or counts
of patients furnished covered
professional services under Part B, has
been applicable since payment year
2019 (performance year 2017). The AllPayer Combination Option, through
which QP status is calculated using the
Medicare Option as well as an eligible
clinician’s participation in Other Payer
Advanced APMs, has been applicable
since payment year 2021 (performance
year 2019). In the CY 2017 Quality
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Payment Program final rule (81 FR
77433 through 77439), we finalized our
policy for QP and Partial QP Thresholds
for the Medicare Option as codified at
§ 414.1430(a) and for the All-Payer
Combination Option at § 414.1430(b).
Section 4111(a)(2) of the Consolidated
Appropriations Act, 2023 (CAA, 2023)
(Pub. L. 117–328, December 29, 2022)
amended section 1833(z)(2) of the Act
by extending for payment years 2024
and 2025 (performance years 2022 and
2023) the applicable payment amount
and patient count thresholds for an
eligible clinician to achieve QP status.
Specifically, section 4111(a)(2) of the
CAA, 2023, amended section 1833(z)(2)
of the Act to continue the QP payment
amount thresholds that applied in
payment year 2024 (performance year
2022) to payment year 2025
(performance year 2023). Additionally,
section 4111(a)(2) of the CAA, 2023,
amended section 1833(z)(2) of the Act to
require that, for payment year 2025, the
Secretary use the same percentage
criteria for the QP patient count
threshold that applied in payment year
2022. As such, the Medicare Option QP
thresholds for payment year 2025 will
remain at 50 percent for the payment
amount method and 35 percent for the
patient count method. The CAA, 2023,
also amended section 1848(q)(1)(C)(iii)
of the Act to extend through payment
year 2025 the Partial QP thresholds that
were established since payment year
2021 under the Medicare Option.
Therefore, the Partial QP thresholds for
payment year 2025 (performance year
2023) will remain at 40 percent for the
payment amount method and 25 percent
for the patient count method.
Under the All-Payer Combination
Option, the QP thresholds for payment
year 2025 (performance year 2023) will
be 50 percent for the payment amount
method and 35 percent for the patient
count method. The Partial QP
thresholds for payment year 2025 will
be 40 percent for the payment amount
method and 25 percent for the patient
count method. In order to become a QP
through the All-Payer Combination
Option, eligible clinicians must first
meet certain minimum threshold
percentages under the Medicare Option.
For payment year 2025 (performance
year 2023), the minimum Medicare
Option threshold an eligible clinician
must meet for the All-Payer
Combination Option to become a QP is
25 percent for the payment amount
method or 20 percent under the patient
count method. For Partial QP status, the
minimum Medicare Option threshold an
eligible clinician must meet for the AllPayer Combination Option is 20 percent
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for the payment amount method or 10
percent under the patient count method.
To conform our regulation with the
amendments made by the CAA, 2023,
we propose to amend § 414.1430 by
revising paragraphs (a) and (b) to reflect
the statutory QP and Partial QP
threshold percentages for both the
payment amount and patient count
under the Medicare Option and the AllPayer Option with respect to payment
year 2025 (performance year 2023) in
accordance with the CAA, 2023
amendments.
The proposed revisions to
§ 414.1430(a) and (b) for the Medicare
Option and All-Payer Combination
Option QP and Partial QP thresholds are
as follows:
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• Paragraph (a)(1)(iv) to state that for
2025 the amount is 50 percent, and
paragraph (a)(1)(v) to state that for 2026
and later, the amount is 75 percent.
• Paragraph (a)(2)(iv) to state that for
2025 the amount is 40 percent, and
paragraph (a)(2)(v) to state that for 2026
and later, the amount is 50 percent.
• Paragraph (a)(3)(iv) to state that for
2025 the amount is 35 percent, and
paragraph (a)(3)(v) to state that for 2026
and later, the amount is 50 percent.
• Paragraph (a)(4)(iv) to state that for
2025 the amount is 25 percent, and
paragraph (a)(4)(v) to state that for 2026
and later, the amount is 35 percent.
• Paragraph (b)(1)(i)(A) to state that
for 2021 through 2025 the amount is 50
percent, and paragraph (b)(1)(i)(B) to
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state that for 2026 and later, the amount
is 75 percent.
• Paragraph (b)(2)(i)(A) to state that
for 2021 through 2025 the amount is 40
percent and paragraph (b)(2)(i)(B) to
state that for 2026 and later, the amount
is 50 percent.
• Paragraph (b)(3)(i)(A) to state that
for 2021 through 2025 the amount is 35
percent, and paragraph (b)(3)(i)(B) to
state that for 2026 and later, the amount
is 50 percent.
• Paragraph (b)(4)(i)(A) to state that
for 2021 through 2025 the amount is 25
percent, and paragraph (b)(4)(i)(B) to
state that for 2026 and later, the amount
is 35 percent.
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(5) APM Incentive Payment
Prior to amendments made by the
CAA, 2023, section 1833(z)(1) of the Act
provided for APM Incentive Payments
for eligible clinicians who are QPs with
respect to a year in each payment year
from 2019 through 2024. Specifically,
for each of the specified payment years,
in addition to the amount of payment
that would otherwise be made for
covered professional services furnished
by an eligible clinician who is a QP for
such year, there is an additional lump
sum APM Incentive Payment equal to 5
percent of the eligible clinician’s
estimated aggregate payment amounts
for such covered professional services
for the preceding year (which we
defined as the ‘‘base year’’). Covered
professional services is defined at
§ 414.1305, with reference to the
statutory definition at section 1848(k)(3)
of the Act, as services for which
payment is made under, or based on, the
PFS and which are furnished by an
eligible clinician (physician;
practitioner as defined in section
1842(b)(18)(C) of the Act; PT, OT, or
speech-language pathologist; or
qualified audiologist as defined under
section 1861(ll)(4)(B) of the Act).
In the CY 2017 Quality Payment
Program final rule (81 FR 77445), we
established a policy that, beginning with
the 2017 QP Performance Period, the QP
Performance Period would be the
calendar year that is 2 calendar years
before the payment year for the APM
Incentive Payment. Thus, we
established that the first QP
Performance Period would begin on
January 1, 2017, the first ‘‘base year’’
(established at 81 FR 77481 and 77482)
for which we would use claims for
professional services to calculate the 5
percent APM Incentive Payment amount
would be in 2018, and the first payment
year for the APM Incentive Payment
would be in 2019 as required by the
statute. Under our previously finalized
policies, the QP Performance Period,
base year, and payment year continue in
this fashion on a rolling basis through
payment year 2024, which was the final
year for which the statute authorized an
APM Incentive Payment. In the CY 2023
PFS final rule (87 FR 70114 through
70116), we explained that, beginning in
payment year 2025, which correlates
with performance year 2023, the statute
did not provide for any type of payment
incentive for eligible clinicians who
become QPs.
Section 4111(a) of the CAA, 2023
amended section 1833(z)(1) of the Act to
provide that eligible clinicians who are
QPs with respect to payment year 2025
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(performance year 2023) will receive an
APM Incentive Payment equal to 3.5
percent of their estimated aggregate
payment amounts for Medicare Part B
covered professional services in the
preceding year. In effect, this statutory
change extends the APM Incentive
Payment for one additional year, at a
new percentage of 3.5 percent rather
than 5 percent.
Accordingly, we propose to
incorporate the change made by the
CAA, 2023, by amending the regulation
text at § 414.1450 to add the payment
year 2025 APM Incentive Payment
amount of 3.5 percent of covered
professional services payments. We
propose to amend paragraph (b)(1) to
state that the amount of the APM
Incentive Payment for payment years
2019 through 2024 is equal to 5 percent
and, for payment year 2025, 3.5 percent,
of the estimated aggregate payments for
covered professional services furnished
during the calendar year immediately
preceding the payment year.
We also note that the CAA, 2023, did
not extend the APM Incentive Payment
beyond payment year 2025. Beginning
for the 2026 payment year, which
relates to the 2024 QP Performance
Period, section 1848(d)(1)(A) of the Act
specifies that there shall be two separate
PFS conversion factors, one for items
and services furnished by a QP, and the
other for other items and services (the
nonqualifying APM conversion factor).
Each conversion factor will be equal to
the conversion factor for the previous
year multiplied by the applicable
update specified in section 1848(d)(20)
of the Act. The update specified for the
conversion factor for QPs will be 0.75
percent, while the update for all others
will be 0.25 percent.
(6) Targeted Review of QP
Determinations
In the CY 2021 PFS final rule (85 FR
84952), we finalized a policy to provide
an opportunity for eligible clinicians to
bring to our attention potential clerical
errors we have may made that could
have resulted in the omission of an
eligible clinician from a Participation
List used for purposes of QP
determinations, and for us to review and
make corrections if warranted. We also
finalized that, after the conclusion of the
time period for targeted review, there
would be no further review of our QP
determination with respect to an eligible
clinician for the QP Performance Period.
We noted that, consistent with section
1833(z)(4) of the Act, and as provided
under § 414.1455(a) of our regulations,
there is no right to administrative or
judicial review under sections 1869 or
1878 of the Act, or otherwise, of the
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determination that an eligible clinician
is a QP or Partial QP under § 414.1425,
or of the determination of the amount of
the APM Incentive Payment under
§ 414.1450.
In the CY 2021 PFS final rule (85 FR
84953), we finalized our proposal to
align the timing and procedures for this
targeted review process with the MIPS
targeted review process as codified at
§ 414.1385. We noted this alignment
would reduce the likelihood of
confusion and burden on eligible
clinicians and APM Entities.
In light of the transition in incentives
for eligible clinicians who are QPs for a
year, as provided in statute, from an
APM Incentive Payment to the
differentially higher PFS conversion
factor beginning with the 2024 QP
performance period and 2026 payment
year, we are proposing at section
IV.A.4.j. of this proposed rule to adjust
the Targeted Review period in order to
meet operational timelines to ensure
that we can meet statutory requirements
for the application of the differential
conversion factors, and the resulting
differential PFS payment rates, to
eligible clinicians who are, and are not,
QPs for the year. As discussed in section
IV.A.4.j. of this proposed rule, we
believe that adjusting the Targeted
Review period will enable us to meet
our statutory obligation to apply the
differentially higher QP conversion
factor beginning on January 1 of each
payment year beginning with CY 2026.
We encourage readers to review section
IV.A.4.j. of this proposed rule.
n. Advanced APMs
(1) General Overview
In this section, we address policies
regarding several aspects of the
Advanced APM criterion for CEHRT use
at § 414.1415(a). We are proposing to
amend the definition of CEHRT at
§ 414.1305 that would apply to
Advanced APM participants, and
modify the Advanced APM CEHRT use
criterion at § 414.1415(a) to recognize
the CEHRT that is relevant to the
clinical practice of participants in the
Advanced APM.
We believe the Quality Payment
Program must be responsive to, and
supportive of, innovation in technology
and in provider organization. It is our
goal to encourage not only provider
ownership of this technology, but full
adoption and integration of the most
advanced health information technology
(health IT) into clinical practice. We
developed these proposals to modify the
CEHRT that is required for Advanced
APMs with this goal in mind, and we
will continue to monitor advancements
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and opportunities in the health IT space
to better prepare and align our program
and APMs with the most cutting-edge
technologies and innovative provider
arrangements, for the benefit of eligible
clinicians participating in APMs, and
the Medicare beneficiaries we serve.
(2) Background
(a) Advanced APM CEHRT Use
Criterion
Under section 1833(z)(3)(D)(i)(I) of the
Act, Advanced APMs are those APMs
that require participants to use CEHRT.
We codified this CEHRT use criterion
for Advanced APMs at § 414.1415(a)(1).
As such, the CEHRT use criterion under
§ 414.1415(a)(1) states that, to be an
Advanced APM, the APM must require
at least a certain percentage of eligible
clinicians in each APM Entity
participating in the APM, or, for APMs
in which hospitals are the APM Entities,
each hospital, to use CEHRT to
document and communicate clinical
care to their patients or health care
providers. In the CY 2017 Quality
Payment Program final rule, we
specified at § 414.1415(a)(1)(i) that an
Advanced APM is one that requires at
least 50 percent of eligible clinicians in
each APM Entity to use CEHRT to
document and communicate clinical
care to their patients or health providers
(81 FR 77410). In the CY 2019 PFS final
rule (83 FR 59918), we amended
§ 414.1415(a)(1) to increase the required
percentage from 50 percent to 75
percent.
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(b) Definition of CEHRT
Section 1848(o)(4) of the Act defines
CEHRT as a qualified electronic health
record (as defined in section 3000(13) of
the Public Health Service Act, or PHSA)
that is certified by the Office of the
National Coordinator for Health
Information Technology (ONC) pursuant
to section 3001(c)(5) of the PHSA in
accordance with the certification
standards that ONC adopted under
section 3004 of the PHSA.
In implementing the definition of
CEHRT at § 414.1305 for the MIPS track
of the Quality Payment Program, we
adopted the definition of CEHRT used
for the Medicare EHR Incentive Program
(also known as ‘‘Meaningful Use’’) at
§ 495.4 (81 FR 77211 through 77213). In
the CY 2017 Quality Payment Program
final rule, we explained that we
intended ‘‘to maintain continuity for
MIPS eligible clinicians and health IT
vendors who may already have CEHRT
or who have begun planning for a
transition to technology certified to the
2015 Edition based on the definition of
CEHRT finalized for the EHR Incentive
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Programs in the 2015 EHR Incentive
Programs final rule’’ and ‘‘to maintain
consistency with the EHR Incentive
Programs CEHRT definition at 42 CFR
495.4’’ (81 FR 77212).
For the Advanced APM track of the
Quality Payment Program, we in turn
adopted the definition of CEHRT for
MIPS under § 414.1305 (81 FR 77409
through 77410). We explained that
applying the same definition of CEHRT
for purposes of both the MIPS and
Advanced APM tracks of the Quality
Payment Program would reduce
administrative costs and confusion
among clinicians and maintain
consistency across programs, permitting
clinicians to use shared CEHRT systems
to participate in either MIPS or
Advanced APMs (81 FR 77409 through
77410).
Consequently, the MIPS and
Advanced APM tracks of the Quality
Payment Program share the same
definition of CEHRT at § 414.1305.
Since the CY 2019 performance period,
this has generally meant EHR
technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that meets the 2015 Edition Base EHR
definition (as defined at 45 CFR
170.102) and that has been certified to
certain other 2015 Edition health IT
certification criteria as specified in the
definition of CEHRT at § 414.1305. The
currently applicable definition of
CEHRT at § 414.1305 specifically
requires that the EHR technology has
been certified to the following 2015
Edition health IT certification criteria:
(1) family health history at 45 CFR
170.315(a)(12); (2) patient health
information capture at 45 CFR
170.315(e)(3); and (3) as necessary to
report on applicable objectives and
measures specified for the MIPS
Promoting Interoperability performance
category, including applicable measure
calculation certification criteria at 45
CFR 170.315(g)(1) or (2) and clinical
quality measure certification criteria
that support the calculation and
reporting of clinical quality measures at
45 CFR 170.315(c)(2) and (c)(3)(i) and
(ii) (and optionally (c)(4)) and can be
electronically accepted by CMS.
Because our definition of CEHRT at
§ 414.1305 ultimately derives from the
definition of CEHRT used for the
Meaningful Use Program, our Advanced
APMs have required their participants
to use CEHRT that is capable of meeting
all requirements of a qualified EHR. As
such, Advanced APMs generally require
participants to use CEHRT that meets
requirements for 2015 Edition Base EHR
(as defined at 45 CFR 170.102); all
requirements of Meaningful Use set
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52625
forth in section 1848(o)(2) of the Act;
and all requirements for reporting on
applicable objectives and measures
specified for the MIPS Promoting
Interoperability performance category.
When we adopted the same definition of
CEHRT at § 414.1305 for purposes of
MIPS and Advanced APMs in the CY
2017 Quality Payment Program final
rule, we acknowledged that such a
policy may include some requirements
not directly applicable to the APM
Entities’ practice. Specifically, we stated
at that time that ‘‘we understand this
proposed CEHRT definition may
include some EHR functionality used by
MIPS eligible clinicians which may be
less relevant for an APM participant and
likewise APM participants may use
additional functions that are not
required for MIPS participation’’ (81 FR
77409). At the time, we reasoned that
‘‘using the same CEHRT definition for
both MIPS and Advanced APMs would
allow eligible clinicians to continue to
use shared EHR systems and give
eligible clinicians flexibility of
participation as a MIPS eligible
clinician or an eligible clinician in an
Advanced APM without needing to
change or upgrade EHR systems’’ (81 FR
77409).
Although we acknowledged that this
CEHRT definition may impose more
rigorous requirements on APM
participants than necessary, we
nonetheless maintained that ‘‘we
generally want APMs to retain the
flexibility to require activities
performed using CEHRT that may vary
from those prescribed under the
advancing care information performance
category in MIPS’’ (81 FR 77412).327 We
also recognized that aligning the CEHRT
definition for Advanced APMs with
MIPS ‘‘would go beyond what the
statute requires’’ (81 FR 77412). When
we adopted the CEHRT definition for
MIPS and Advanced APMs, one
commenter suggested that our proposed
CEHRT criterion for Advanced APMs
was narrow, and that ‘‘a strong, broad
health IT infrastructure should be a key
element used to identify Advanced
APMs rather than the narrow proposed
CEHRT criteria’’ (81 FR 77410). We
327 Section 1848(q)(2)(A)(iv) and (B)(iv) of the Act
requires that the Secretary assess MIPS eligible
clinicians’ performance with respect to the
‘‘meaningful use of certified EHR technology’’ in
accordance with the requirements set forth at
section 1848(o)(2) of the Act as one of the four
performance categories for MIPS. In the CY 2017
Quality Payment Program final rule, we named this
required MIPS performance category the
‘‘advancing care information performance
category.’’ (81 FR 77010). We have since renamed
this MIPS performance category, requiring the
meaningful use of CEHRT, as the ‘‘Promoting
Interoperability performance category.’’ (85 FR
84820 through 84821).
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agreed that ‘‘Advanced APMs need a
strong health IT infrastructure as a
foundation for communicating and
delivering comprehensive and
coordinated care to their patients,’’ but
at that time we wanted to prioritize
continuity between the two tracks of the
Quality Payment Program to maximize
flexibility for eligible clinicians.
However, we indicated that we would
be prepared to update this definition as
needed in the future.
(3) Proposal To Update CEHRT
Definition and CEHRT Use Criterion for
Advanced APMs
After several years of experience with
the uniform definition of CEHRT for
purposes of MIPS and Advanced APMs,
and based on input we have received
from interested parties, we now believe
that the standard for CEHRT use for
Advanced APMs may have been
unnecessarily burdensome, imposing
unwarranted barriers to organization of
and participation in Advanced APMs,
and not clinically relevant for many
prospective and current participants in
Advanced APMs. As previously
discussed, our policy at
§ 414.1415(a)(1)(i) currently requires
that at least 75 percent of eligible
clinicians in each participating APM
entity group, and each hospital that are
APM Entities, to use CEHRT, as defined
in § 414.1305, to document and
communicate clinical care to their
patients or health care providers. By
referring in the Advanced APM CEHRT
use criterion to CEHRT, as defined in
§ 414.1305, Advanced APMs required
participants to adopt and implement
health IT that is capable of meeting all
requirements of a qualified EHR, which
means CEHRT that meets all
requirements for 2015 Edition Base EHR
(as defined at 45 CFR 170.102); all
requirements of Meaningful Use set
forth in section 1848(o)(2) of the Act;
and all requirements for reporting on
applicable objectives and measures
specified for the MIPS Promoting
Interoperability performance category.
We have heard from many interested
parties that our requirements for use of
CEHRT are falling short of some of our
intended goals. Specifically, we have
heard from many interested parties that
our current requirements for use of
CEHRT have led Advanced APMs to
apply an inflexible standard that does
not allow them to take into account
whether certain CEHRT modules are
relevant for, and applicable to, the
specific clinical practice areas of their
intended or actual participants. By
placing a broad set of requirements for
use of CEHRT, particularly regarding the
criteria the health IT must be certified
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as meeting to satisfy our definition of
CEHRT at § 414.1305, interested parties
report that we are needlessly burdening
some potential and actual APM
participants because they must adopt
health IT modules that are not always
clinically relevant across provider types
that would participate in an Advanced
APM. Specifically, interested parties
noted that our requirement that
Advanced APMs must require
participants to use health IT certified as
meeting criteria necessary to report on
objectives and measures of the MIPS
Promoting Interoperability performance
category, even when such health IT is
not clinically relevant for or applicable
to APM participants’ practice, is
needlessly burdensome and a barrier to
innovation and participation in APMs.
To support their position, interested
parties noted as an example, that
application of our current Advanced
APM CHERT use criterion and
associated CEHRT definition has
required specialists in the Kidney Care
Choices (KCC) Model or providers in the
ACO Realizing Equity, Access, and
Community Health (REACH) Model to
purchase certified Health IT Modules
beyond those required as part of the
2015 Edition Base EHR definition at 45
CFR 170.102 that are not immediately
necessary or applicable to their clinical
practice.
We have learned that Advanced
APMs have not had the flexibility to
require certified health IT that is
tailored to their specific participants’
practice areas. Likewise, we could
envision a scenario where, to achieve
Advanced APM status under our current
policy, an APM or APM Entity would
exclude from participation specialists or
other eligible clinician types, such as
pathologists, for whom compliance with
our current CEHRT requirements
beyond the Base EHR definition would
be burdensome and beyond the scope of
their typical practice, even though
participation of such eligible clinicians
would be relevant and beneficial to the
goals of the APM.
For Advanced APMs, we believe that
it is important both to apply a rigorous
standard for use of CEHRT and to allow
sufficient flexibility to Advanced APMs
to specify CEHRT modules that are
clinically relevant for their participants.
We believe that our current CEHRT use
requirements meet the former goal
(application of a rigorous standard), but
not the latter (allowing sufficient
flexibility).
Further, our current CEHRT use
criterion specifies that 75 percent of
participants in the APM must use
CEHRT as defined in § 414.1305, and
allows for 25 percent of participants to
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not have or use CEHRT. This policy
establishes a minimum percentage of
Advanced APM participants must use
CEHRT, but without consideration of
which eligible clinicians in each
participating APM Entity (or hospital)
must use CEHRT, or whether it is
clinically appropriate for any of those
eligible clinicians to not use CEHRT. As
such, this policy could allow eligible
clinicians who could and should be
using CEHRT to forego CEHRT use
solely because enough of their
colleagues are using CEHRT to meet the
requirement of the Advanced APM.
Additionally, we have heard from
interested parties that, for most
Advanced APM participants, CEHRT
use among eligible clinicians is close to
100 percent. Given this information and
the fact that the 70 percent CEHRT use
standard has been in effect for almost
five years, we believe it would be
appropriate to re-evaluate our approach
to the application of the CEHRT use
requirement to Advanced APMs and
their participants. We want to maintain
the rigor of our CEHRT use criterion for
Advanced APMs while providing
Advanced APMs flexibility to require
CEHRT use that is applicable for the
practice areas of their participants and
their eligible clinicians. Further, we
believe any exceptions to CEHRT use
that are permitted under the Advanced
APM should be based on clinical
appropriateness, rather than on
generalized application of percentages.
First, we are proposing to amend the
definition of CEHRT at § 414.1305 by
adding a new paragraph (3) to specify
that, for purposes of the Advanced APM
criterion under § 414.1415(a)(1),
beginning with CY 2024, CEHRT means
EHR technology certified under the
ONC Health IT Certification Program
that meets: (1) the 2015 Edition Base
EHR definition, or any subsequent Base
EHR definition (as defined in at 45 CFR
170.102); and (2) any such ONC health
IT certification criteria adopted or
updated in 45 CFR 170.315 that are
determined applicable for the APM, for
the year, considering factors such as
clinical practice areas involved,
promotion of interoperability, relevance
to reporting on applicable quality
measures, clinical care delivery
objectives of the APM, or any other
factor relevant to documenting and
communicating clinical care to patients
or their health care providers in the
APM.
We believe our proposal to update the
definition of CEHRT for Advanced
APMs at § 414.1305 would provide
flexibility to each APM to determine
what CEHRT functionalities are relevant
to the model and its participant APM
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Entities and eligible clinicians. We
believe that providing Advanced APMs
with the greater flexibility permitted by
the statute with respect to requiring
CEHRT use will foster innovation in
model design and diversity in APM
participation. Specifically, we believe
our proposed amendment to the CEHRT
definition at § 414.1305 will facilitate
innovation in APM design, and enable
a broad range of participants and their
eligible clinicians to meet Advanced
APM CEHRT use requirements by
adopting health IT that satisfies the
2015 Edition Base EHR definition at 45
CFR 170.102 and is certified as meeting
other ONC health IT certification
criteria adopted, or updated in 45 CFR
170.315, as is clinically relevant to their
practice, without unnecessarily
obtaining other health IT, such as the
health IT necessary to report on
applicable objectives and measures
specified for the MIPS Promoting
Interoperability performance category.
We note that participation in an
Advanced APM does not automatically
exclude eligible clinicians from MIPS.
Eligible clinicians in an Advanced APM
who do not achieve Qualifying APM
Participant (QP) status or Partial QP
status, or who are not otherwise exempt
from MIPS, are subject to MIPS
reporting requirements and the MIPS
payment adjustment. Our proposed
amendment to the CEHRT definition
under paragraph (3) at § 414.1305 for
Advanced APMs has limited effect upon
the requirement to participate in MIPS
if QP or Partial QP status is not
achieved. Accordingly, under our
proposal, eligible clinicians in
Advanced APMs would still need to be
prepared to report to MIPS, including
using CEHRT as necessary to report on
applicable objectives and measures
specified for the MIPS Promoting
Interoperability performance category,
in the event that they do not achieve QP
or Partial QP status.
In section IV.A.4.f.(4) of this proposed
rule, we are also proposing other
modifications to the CEHRT definition
at § 414.1305 to be more flexible in
reflecting any changes ONC may make
to its Base EHR definition, certification
criteria, and other standards for health
IT at 45 CFR part 170. Our proposed
amendment to the CEHRT definition
under paragraph (3) at § 414.1305 for
Advanced APMs is consistent with our
other proposed amendments as set forth
in section IV.A.4.f.(4) of this proposed
rule.
Second, we are proposing to amend
our current Advanced APM CEHRT use
criterion at § 414.1415(a)(1).
Specifically, we propose to amend the
regulation to end the current 75 percent
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CEHRT use requirement at
§ 414.1415(a)(1)(i) with the CY 2023 QP
performance period. Then we propose
to add a new paragraph at
§ 414.1415(a)(1)(iii) to specify that, to be
an Advanced APM, the APM must
require all eligible clinicians in each
participating APM Entity, or for APMs
in which hospitals are the participants,
each hospital, to use CEHRT that meets
our proposed new paragraph (3) of the
CEHRT definition at § 414.1305. In
essence, we are proposing to no longer
specify a minimum number of eligible
clinicians that an Advanced APM must
require to use CEHRT, and instead,
simply specify that the Advanced APM
must require all participating eligible
clinicians to use CEHRT that meets our
proposed modified, and more flexible,
definition. We are also proposing to
revise § 414.1415 by making nonsubstantive technical edits to
paragraphs (a)(1)(i) and (a)(1)(ii) to
improve clarity.
This proposal is consistent with
section 1833(z)(3)(D)(i)(I) of the Act,
which generally requires that Advanced
APMs require their participants to use
CEHRT as defined in section 1848(o)(4)
of the Act. We believe this proposed
amendment to the Advanced APM
CEHRT use criterion will further
enhance innovation in Advanced APM
development and diversity in
participation, allowing for novel APM
Entity compositions, because Advanced
APM participants will no longer have to
concern themselves with what
percentage of eligible clinicians meet
our current CEHRT requirements. We
further believe that, under our more
flexible proposed CEHRT definition and
Advanced APM CEHRT use criterion,
Advanced APMs could create their own
CEHRT use requirements, potentially
beyond what we currently require,
tailored to the various types of
clinicians and practice areas the
Advanced APM intends to include in its
model. We believe our proposal would
permit Advanced APMs to recruit and
retain participants that represent a
variety of practice types, and to require
different types of EHR technologies
certified under the ONC Health IT
Certification Program as meeting the
2015 Edition Base EHR definition, or
subsequent Base EHR definition, at 45
CFR 170.102 and additional ONC health
IT certification criteria adopted and
updated in 45 CFR 170.315 as
specifically applicable to different types
of clinical practice.
We seek comment on this proposal.
(4) All Payer Advanced APMs
In the CY 2017 Quality Payment
Program final rule (81 FR 77459), we
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52627
proposed policies, effective beginning
for performance year 2021, that would
allow eligible clinicians to earn QP
status through participation in a
combination of payment arrangements
designed and implemented by Other
Payers and Medicare Advanced APMs.
The statute includes a CEHRT use
criterion for Other Payer Advanced
APMs as it does for Medicare Advanced
APMs, and we finalized the same
CEHRT use criterion for Other Payer
Advanced APMs as for Medicare
Advanced APMs (81 FR 77463).
Likewise, in this rule, we are proposing
to amend the Other Payer Advanced
APM criteria at § 414.1420(b) to conform
to the changes we now propose for the
Medicare Advanced APMs, and to be
reflected in amendments to
§ 414.1415(a)(1)(i), to remove the 75
percent minimum CEHRT use
requirement for Advanced APMs and
replace it with a more flexible CEHRT
use requirement based on our proposed
revised definition of CEHRT for
purposes of Advanced APM
determinations. We are also proposing
to revise § 414.1420(b) by making
additional non-substantive technical
edits to improve clarity.
The changes we are proposing for
Medicare Advanced APMs are designed
to require use of technologically
sufficient EHRs, while affording
Advanced APMs the ability to tailor
additional CEHRT use requirements to
those features or capabilities that are
clinically relevant to the APM and its
participants. We believe that this same
flexibility should be afforded in the
context of Other Payer Advanced APMs.
The All Payer Combination Option
through which we consider the
participation of eligible clinicians in
Other Payer Advanced APMs offers an
additional pathway to achieve QP status
for eligible clinicians participating in
both Medicare Advanced APMs and
Other Payer Advanced APMs. Under the
All Payer Combination Option, we
consider the combined participation of
eligible clinicians in Medicare and
Other Payer Advanced APMs. Similar to
the statutory CEHRT use requirement
for Advanced APMs under section
1833(z)(3)(D)(i)(I) of the Act, section
1833(z)(2)(iii)(II)(bb) of the Act specifies
that Other Payer Advanced APMs are
those under which CEHRT is used.
Since the All Payer Combination Option
for QP determinations involves the same
eligible clinician participants as the
Medicare Option, and considers
participation in both Medicare
Advanced APMs and Other Payer
Advanced APMs, we believe we should
continue to apply the same CEHRT use
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responded to within the subsequent
final rule.
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.),
we are required to publish a 60-day
notice in the Federal Register and
solicit public comment before a
‘‘collection of information’’ requirement
is submitted to the Office of
Management and Budget (OMB) for
review and approval. For the purposes
of the PRA and this section of the
preamble, collection of information is
defined under 5 CFR 1320.3(c) of the
PRA’s implementing regulations.
To fairly evaluate whether an
information collection should be
approved by OMB, PRA section
3506(c)(2)(A) requires that we solicit
comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our burden
estimates.
• The quality, utility, and clarity of
the information to be collected.
• Our effort to minimize the
information collection burden on the
affected public, including the use of
automated collection techniques.
We are soliciting public comment (see
section VI. of this proposed rule) on
each of these issues for the following
sections of this document that contain
information collection requirements.
Comments, if received, will be
For our purposes, BLS’ May 2022
National Occupational Employment and
Wage Estimates does not provide an
occupation that we could use for
‘‘Physician’’ wage data. To estimate a
Physician’s costs, we are using an
average conglomerate wage of $274.44/
hr as demonstrated below in Table 55.
standard for both Medicare and Other
Payer Advanced APMs. Further, we
believe the same need exists for
flexibility in the CEHRT that is required
to be used in Other Payer Advanced
APMs. This would allow Other Payer
Advanced APMs to structure their
CEHRT use requirements to be clinically
relevant to the APM and participating
eligible clinicians, and avoid the need to
obtain clinically unnecessary
technology simply for purposes of
meeting what we now believe to be an
overly restrictive CEHRT use criterion.
We seek comment on this proposal.
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V. Collection of Information
Requirements
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A. Wage Estimates
Private Sector: To derive average
costs, we used data from the U.S.
Bureau of Labor Statistics’ (BLS) May
2022 National Occupational
Employment and Wage Estimates for all
salary estimates (https://www.bls.gov/
oes/2022/oes_nat.htm). In this regard,
Table 54 presents BLS’ mean hourly
wage, our estimated cost of fringe
benefits and other indirect costs
(calculated at 100 percent of salary), and
our adjusted hourly wage. There are
many sources of variance in the average
cost estimates, both because fringe
benefits and other indirect costs vary
significantly from employer to
employer, and because methods of
estimating these costs vary widely from
study to study. Therefore, we believe
that doubling the hourly wage to
estimate total cost is a reasonably
accurate estimation method.
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52628
Beneficiaries: We believe that the cost
for beneficiaries undertaking
administrative and other tasks on their
own time is a post-tax wage of $21.98/
hr.
The Valuing Time in U.S. Department
of Health and Human Services
Regulatory Impact Analyses: Conceptual
Framework and Best Practices 328
identifies the approach for valuing time
when individuals undertake activities
on their own time. To derive the costs
for beneficiaries, a measurement of the
usual weekly earnings of wage and
salary workers of $1,059 329 for 2022,
divided by 40 hours to calculate an
hourly pre-tax wage rate of $26.48/hr.
This rate is adjusted downwards by an
estimate of the effective tax rate for
median income households of about 17
percent or $4.50/hr ($26.48/hr x 0.17),
resulting in the post-tax hourly wage
rate of $21.98/hr ($26.48/hr—$4.50/hr).
Unlike our State and private sector wage
adjustments, we are not adjusting
beneficiary wages for fringe benefits and
other indirect costs since the
individuals’ activities, if any, would
occur outside the scope of their
employment.
328 https://aspe.hhs.gov/sites/default/files/
migrated_legacy_files//176806/VOT.pdf.
329 https://fred.stlouisfed.org/series/
LEU0252881500A.
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B. Proposed Information Collection
Requirements (ICRs)
1. ICRs Requiring Manufacturers of
Certain Single-Dose Container or SingleUse Package Drugs To Provide Refunds
With Respect to Discarded Amounts
(§ 414.940)
The following proposed changes will
be submitted to OMB for review under
control number 0938–1435 (CMS–
10835).
As discussed in section III.A. of this
proposed rule, as a part of implementing
section 1847A(h) of the Act, as added by
section 90004 of the Infrastructure Act,
the Secretary is authorized to recognize,
through notice and comment
rulemaking, drugs with unique
circumstances that justify an increase of
the applicable percentage greater than
10 percent. In section III.A.3.d of this
proposed rule, we are proposing
modifications to § 414.940 to establish
an application process for drug
manufacturers to request an increased
applicable percentage for an individual
drug product based on its unique
circumstances.
We are proposing that, to request we
consider increasing the applicable
percentage for 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) FDAapproved labeling; (3) justification for
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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.
As discussed in section VII.E.4. of this
proposed rule, our estimates show a
projected 28 billing and payment codes
meeting the definition of refundable
single-dose container or single-use
package drug with 10 percent or more
discarded units, which is the applicable
percentage specified in section
1847A(h)(3) of the Act. Therefore, we
anticipate a similar number of drugs
could owe a refund under section 90004
of the Infrastructure Act. Since 25 of
those billing codes have an estimated
annual refund obligation of over
$50,000, we expect that, initially (that
is, the first year the proposed
application process is available), the
manufacturers of those 25 drugs to
submit an application for consideration
of an increased applicable percentage
based on unique circumstances.
Once a manufacturer has applied for
a drug and a decision has been made
regarding whether an increased
applicable percentage is appropriate, the
manufacturer would not need to apply
again. Therefore, subsequent years we
would expect a smaller number of
applications. When evaluating the
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approval dates of these 25 drugs, we
find that there is a range of 0 to 4 drugs
per year approved that would be
expected to owe a refund of more than
$50,000 per year. From 2010 through
2020, the mean number of such
approvals is 1.45 per year. If rounded
up, we estimate that we would typically
receive 2 applications per subsequent to
the initial application year.
We estimate that the burden per
respondent/applicant of drafting and
submitting the unique circumstance
application to be 5 hours. As we
anticipate 25 applications in the initial
year that applications are available, we
estimate a total burden of 125 hours (25
applications × 5 hr) per at a cost of
$5,218 ($41.74/hr × 125 hr). For
subsequent years, we estimate a total
annual burden related to drafting and
submission of 10 hours (2 applications
× 5 hr per respondent/applicant) at an
annual cost of $418 (41.74/hr × 10 hr).
2. ICRs Regarding the Clinical
Laboratory Fee Schedule: Data
Reporting by Laboratories
As described in section III.D of this
proposed rule, under the Clinical
Laboratory Fee Schedule, ‘‘reporting
entities’’ must report to CMS during a
‘‘data reporting period’’ ‘‘applicable
information’’ collected during a ‘‘data
collection period’’ for their component
‘‘applicable laboratories,’’ and we
proposed to revise the regulations at
§ 414.504(a)(1) to account for a delay in
reporting until January 1, 2024 through
March 31, 2024. As stated in section
1834A(h)(2) of the Act, chapter 35 of
title 44 U.S.C., which includes such
provisions as the PRA does not apply to
information collected under section
1834A of the Act. Consequently, we are
not setting out any proposed burden
estimates under this section of the
proposed rule. Please refer to section
VII.E.7. of this proposed rule for a
discussion of the impacts associated
with the changes described in section
III.D. of this proposed rule.
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3. ICRs Regarding the Medicare Shared
Savings Program
Section 1899(e) of the Act provides
that chapter 35 of title 44 U.S.C., which
includes such provisions as the PRA,
shall not apply to the Shared Savings
Program. Accordingly, we are not
setting out proposed Shared Savings
Program burden estimates under this
section of the preamble. Please refer to
section VII.E.10. of this proposed rule
for a discussion of the impacts
associated with the changes to the
Shared Savings Program as described in
section III.G. of this proposed rule.
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4. ICRs Regarding the Updates to the
Medicare Diabetes Prevention Program
In section III.L. of this proposed rule,
we propose to extend specific Medicare
Diabetes Prevention Program (MDPP)
flexibilities allowed during the PHE for
COVID–19 1135 waiver event by 4
years. In addition, we are proposing to
update the MDPP payment structure to
pay for beneficiary attendance on a feefor-service basis while retaining the
diabetes risk reduction performance
payments. Finally, we are proposing to
remove the requirement for MDPP
interim preliminary recognition and
replace it with CDC preliminary
recognition as well as remove most
references to, and requirements of, the
Ongoing Maintenance Sessions given
that eligibility for these services will
end on December 31, 2023. We expect
the proposed policies will increase the
number of eligible organizations willing
to enroll as MDPP suppliers. We also
anticipate that the extended PHE
flexibilities will make MDPP more
marketable to both suppliers and
beneficiaries due to the continued
flexibility in how the MDPP set of
services are delivered live, either inperson or virtually (or a combination of
the two). We anticipate the proposed
payment structure changes will
motivate suppliers to retain participants
due to more frequent payments. Section
1115A(d)(3) of the Act exempts
Innovation Center model tests and
expansions, which include the MDPP
expanded model, from the provisions of
the PRA. Accordingly, this collection of
information section does not set out any
burden for the provisions.
5. Appropriate Use Criteria for
Advanced Diagnostic Imaging
As discussed in section III.J. of this
proposed rule, we are proposing to
pause efforts to implement the
Appropriate Use Criteria (AUC) for
Advanced Diagnostic Imaging Services
program for reevaluation and to rescind
the current AUC program regulations at
§ 414.94. The program was established
in the Protecting Access to Medicare Act
of 2014 (PAMA) and we have used
rulemaking over the ensuing years to
stand up the program in phases while
aiming for a clinically useful and least
provider-burdensome approach. At this
time, we have exhausted all reasonable
options for fully operationalizing the
AUC program consistent with the
statutory provisions as prescribed in
section 1834(q)(B) of the Act directing
CMS to require real-time claims-based
reporting to collect information on AUC
consultation and imaging patterns for
advanced diagnostic imaging services to
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ultimately inform outlier identification
and prior authorization. As a result, we
propose in section III.J. of this proposed
rule to pause implementation of the
AUC program for reevaluation, and
rescind the current AUC program
regulations from § 414.94.
The following collection of
information requests would be affected
by this rule’s proposal to rescind the
AUC program regulations from § 414.94:
CMS–10570 (OMB 0938–1288), CMS–
10624 (OMB 0938–1315), and CMS–
10654 (OMB 0938–1345). Given that the
AUC program regulations, which
include these information collection
requirements, would be rescinded, all
three collections would no longer be
needed.
CMS–10570 (OMB 0938–1288) relates
to the application and qualification
process for provider-led entities (PLEs).
If we finalize the proposal and rescind
the current regulations at § 414.94, then
we will discontinue this collection of
information. The following table scores
the impact of discontinuing the
requirements and burden that are
currently active and approved by OMB
under the aforementioned control
number, showing an expected 10 reapplications per year. We note however,
that because we received less than 10
applicants in each year 2017–2022,
there have been and will continue to be
fewer than 10 re-applicants each year. In
fact, the number of PLEs has overall
decreased as qualified PLEs exit the
program, choosing not to re-apply. In
2022 we expected all seven PLEs
approved in 2017 to reapply; however,
only two submitted re-applications and
were re-qualified. For 2023, we froze the
re-application process, continuing the
approval of the three PLEs that had
initially qualified in 2018. If we were
not proposing to pause the AUC
program and rescind the current
regulations at § 414.94, then we would
expect one re-application in 2024 and
no re-applications in 2025.
At the time of the last approval in
2021, we expected the burden for PLEs
re-applying for qualification to be half
the burden of the initial application
process. In the explanation below, we
continue to use the previously approved
number of responses, respondents and
time, while updating the labor cost to
reflect May 2022 BLS wages. As
previously estimated, the PLEs would
be able to make modifications to their
original application which should result
in a burden of 10 hours at $80.08/hr for
a business operations specialist
(occupation code 13–100) to compile,
prepare and submit the required
information, 2.5 hours at $123.06/hr for
a medical and health services manager
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(occupation code 11–911) to review and
approve the submission, and 2.5 hours
at $242.3/hr for a physician (occupation
code 29–1210) to review and approve
the submission materials. Annually, we
estimate 15 hours per submission at a
cost of $1,714.2 per organization. In
aggregate, we estimate 150 hours (15 hr
× 10 submissions) at $17,142 ($1,714 ×
10 submissions).
CMS–10624 (OMB 0938–1315) relates
to the application and qualification
process for Clinical Decision Support
Mechanisms (CDSMs). This collection
of information is no longer active. CMS–
10624 was first approved on March 6,
2017, and was associated with the CY
2017 Physician Fee Schedule final rule
(November 15, 2016; 81 FR 80170).
CMS–10624 last expired on March 31,
2020. In June 2020, CMS filed a request
to discontinue CMS–10624 (OMB 0938–
1315).
CMS–10654 (OMB 0938–1345) relates
to the consultation of AUC through a
qualified CDSM by an ordering
professional or clinical staff acting
under the direction of the ordering
professional. While this collection of
information is no longer active, the
impact of discontinuing the
requirements and burden is addressed
in this proposed rule RIA (see section
VII. Regulatory Impact Analysis of this
proposed rule).
other information determined
appropriate by the Secretary with
respect to providers of services and
suppliers of ground ambulance services
(ground ambulance organizations).
Section 1834(l)(17)(I) of the Act states
that the PRA does not apply to the
collection of information required under
section 1834(l)(17) of the Act.
Accordingly, we are not setting out any
proposed burden estimates under this
section of the rule.
problems, and rules for the storage,
handling, and administration of drugs
and biologicals.
As we are proposing to include MFTs
and MHCs as professionals who can
provide services in an RHC and FQHC,
there will be a burden associated with
the existing requirement at
§ 491.9(b)(3)(i). This requirement states
that policies include ‘‘A description of
the services they provide directly or
through agreement or arrangement.’’
Therefore, if an RHC or FQHC provides
services furnished by an MFT or MHC
they must update their policies to
include a description of the services
provided.
We note that the time and effort
required to conduct this activity will
vary depending on if a clinic or center
chooses to provide services furnished by
an MFT or MHC. We also believe that
some RHCs and FQHCs may already
provide services furnished by an MFT
or MHC. State Medicaid programs can
cover ambulatory care services
(including mental health and substance
use disorder services) under a number
of different mandatory Medicaid
benefits such as outpatient hospital
services, physician services, RHC and
FQHC services, as well as optional
benefits such as rehabilitative services,
and services of other licensed
practitioners.
The National Association of
Community Health Center’s 2017 policy
assessment suggests that 21 State
Medicaid programs cover services
provided by MFTs, and 25 State
Medicaid programs cover services
provided by licensed professional
counselors.330 Due to approximately
half of the State’s Medicaid programs
already covering services furnished by
an MFT or MHC and the assumption
that some centers and clinics will not
6. ICRs for Medicare Provider and
Supplier Enrollment
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None of this rule’s Medicare and
Medicaid provider enrollment
provisions propose any new, revised, or
removed information collection
requirements or burden. Regarding the
proposal to reduce the timeframe for
reporting practice location changes from
90 days to 30 days, this change would
not alter the requirement for disclosing
the change via the applicable Form
CMS–855 or Form CMS–20134. It would
only revise the timeframe in which the
change must be reported. Hence, there
would be no change in the ICR burden.
7. ICRs Regarding the Medicare Ground
Ambulance Data Collection System
(GADCS) (§ 414.626)
Section 1834(l)(17) of the Act requires
that the Secretary develop a ground
ambulance data collection system that
collects cost, revenue, utilization, and
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8. ICRs Related to the Changes in the
RHC/FQHC CfCs and Hospice CoPs
a. Permitting MFT and MHCs To
Furnish Services in RHC/FQHCs
The following proposed changes will
be submitted to OMB for review under
control number 0938–0344 (CMS–R–
38).
In section III.C. of this proposed rule,
we implement section 4121 of the CAA
by proposing conforming changes at
§ 491.8(a)(3) and (a)(6) that would add
MFT and MHCs to the list of staff who
may be the owner or an employee of the
clinic or center or may furnish services
under contract to the clinic or center as
well as included as staff available to
furnish patient care services at all times
the clinic or center operates. If an RHC
or FQHC provides services furnished by
an MFT or MHC they would be required
to update their patient care policy, as set
out in section § 491.9(b)(2) of the CfCs.
The existing requirement at
§ 491.9(b)(2), Patient care policies,
requires that policies are developed
with the advice of a group of
professional personnel that includes one
or more physicians and one or more
physician assistants or nurse
practitioners, with at least one member
who is not a member of the clinic or
center staff. The patient care policies
must describe the services the clinic or
center furnishes directly, through
agreement or arrangement, guidelines
for medical management of health
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provide these services, we believe only
50 percent of RHCs and 50 percent of
FQHCs will incur this burden. The total
RHCs and FQHCs who will have to meet
this 1-time burden is 2,643 clinics and
5,643 centers, or 8,286 combined.331 332
Each clinic or center is required by
the existing requirement at 491.9(b)(2)
to have at least two clinical
professionals (one physician/
administrator at $229.52/hr and one
advanced practice provider at $119.88/
hr) reviewing and updating the policies.
We estimate that it takes existing RHCs
and FQHCs 4 hours every 2 years for
clinical staff to review and make
changes to all patient care policies.
Based on this, we estimate that adding
MFT and MHC services (as necessary) to
the patient care policies would take
approximately 15 minutes (.25 hr) for
each clinical professional. In aggregate,
we estimate an annual burden of
2,071.50 hours (0.25 hr × 8,268 RHC and
FQHCs) at a cost of $361,891.05
[(1,035.75 hr × $229.52/hr) + (1,035.75
hr × $119.88/hr)].
b. ICRs Related to Permitting MFTs and
MHCs To Serve as Members of the
Interdisciplinary Group (IDG) in
Hospices (§ 418.56 and § 418.114)
In accordance with the implementing
regulations of the PRA at 5 CFR
1320.3(b)(2), we believe that both the
existing requirements and the proposed
revisions to the requirements at
§§ 418.56(a)(iii) and 418.114(c)(3) and
(4) are exempt from the PRA. We believe
permitting hospices the ability to select
one of these disciplines (SW, MFT or
MHC) to serve as a member of the IDG
and the addition of both MFT and MHC
to the personnel requirements with
reference to the new requirement at
§§ 410.53 and 410.54 respectively, is
reasonable and customary business
practice. We state such in the
information collection request that is
currently approved under OMB control
number: 0938–1067 ((CMS–10277).
Therefore, we are not proposing to seek
OMB’s approval for any information
collection or recordkeeping activities
that may be conducted in connection
with the proposed revisions to
§§ 418.56(a)(1)(iii) and 418.114(c)(3) and
(4), but we request public comment on
our determination that the time and
effort necessary to comply with these
evaluation requirements is usual and
customary and this time and effort
would be incurred by hospice staff even
absent this regulatory requirement.
9. RFI: Histopathology, Cytology, and
Clinical Cytogenetics Regulations Under
the Clinical Laboratory Improvement
Amendments (CLIA) of 1988
In section III.O. of this proposed rule,
we would implement subtitle C, section
4121 of the CAA 2023 by proposing
conforming changes at § 418.56(a)(1)(iii)
that would permit MFTs or MHCs, in
addition to social workers, to serve as
members of the IDG. The conforming
change would require hospices to
include at least one SW, MFT or MHC
to serve as a member of the IDG.
Hospices would have the flexibility to
determine which discipline(s) are
appropriate to serve on the IDG based
on the needs of the patients. We believe
that with the introduction of MHC and
MFT into the hospice CoPs, it is
important to include these new
disciplines into the personnel
qualifications at § 418.114.
In this rule we are also proposing to
add both MFT and MHC to the provider
requirements under 42 CFR subpart B
(Medical and Other Health Services) at
§§ 410.53 and 410.54. Therefore, to
avoid duplication and confusion
between the CoP and the provider
requirements under the Medical and
Other Health Services provision, we are
proposing to add both MFT and MHC to
the requirements at § 418.114(c)(3) and
(4) and referencing the new requirement
at §§ 410.53 and 410.54, respectively.
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Please note that this is an RFI only. In
accordance with the implementing
regulations of the Paperwork Reduction
Act of 1995 (PRA), specifically 5 CFR
1320.3(h)(4), this general solicitation is
exempt from the PRA. Facts or opinions
submitted in response to general
solicitations of comments from the
public, published in the Federal
Register or other publications,
regardless of the form or format thereof,
provided that no person is required to
supply specific information pertaining
to the commenter, other than that
necessary for self-identification, as a
condition of the agency’s full
consideration, are not generally
considered information collections and
therefore not subject to the PRA.
This RFI is issued solely for
information and planning purposes; it
does not constitute a Request for
Proposal, applications, proposal
abstracts, or quotations. This RFI does
not commit the U.S. Government to
contract for any supplies or services or
make a grant award. Further, we are not
seeking proposals through this RFI and
will not accept unsolicited proposals.
Responders are advised that the U.S.
Government will not pay for any
information or administrative costs
incurred in response to this RFI; all
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costs associated with responding to this
RFI will be solely at the interested
party’s expense. We note that not
responding to this RFI does not
preclude participation in any future
procurement, if conducted. It is the
responsibility of the potential
responders to monitor this RFI
announcement for additional
information pertaining to this request.
In addition, we note that we will not
respond to questions about the policy
issues raised in this RFI.
We will actively consider all input as
we develop future regulatory proposals
or future subregulatory policy guidance.
We may or may not choose to contact
individual responders. Such
communications would be for the sole
purpose of clarifying statements in the
responders’ written responses.
Contractor support personnel may be
used to review responses to this RFI.
Responses to this notice are not offers
and cannot be accepted by the U.S.
Government to form a binding contract
or issue a grant. Information obtained as
a result of this RFI may be used by the
Government for program planning on a
non-attribution basis. Respondents
should not include any information that
might be considered proprietary or
confidential. This RFI should not be
construed as a commitment or
authorization to incur cost for which
reimbursement would be required or
sought. All submissions become U.S.
Government property and will not be
returned.
10. Basic Health Program (BHP)
Provisions
a. Proposed Information Collection
Requirements (ICRs)
The following proposed changes will
be submitted to OMB for review under
OMB control number 0938–1218 (CMS–
10510).
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(1) ICRs Regarding the BHP Blueprint
(§ 600.125)
We propose at § 600.125(a)(1)–(3) that
Blueprint revisions must be submitted
to reflect: (1) changes in Federal laws,
regulations, policy interpretations or
court decisions that affect provisions in
the certified Blueprint; (2) significant
changes that alter core program
operations or the BHP benefit package;
or (3) changes to enrollment,
disenrollment, and verification policies
described in the certified Blueprint. We
note that only § 600.125(a)(1) is a new
requirement. The requirements under
§ 600.125(a)(2) and (3) are existing. We
propose at § 600.125(b) that a State may
submit revisions to its certified
Blueprint at any time within the same
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quarter of the proposed effective date of
revised Blueprint. We propose at
§ 600.125(c) that HHS must review the
revised Blueprint within 90 calendar
days or provide the State written notice
of disapproval or additional information
it needs to make a final determination.
We estimate that, on average, a State
operating a BHP will submit one revised
Blueprint in response to § 600.125(a)(1)
annually. Because only two States are
currently certified to operate a BHP, we
are providing the burden estimate for
two States. We estimate that the
proposal under § 600.125(a)(1) will
increase State burden. We estimate that
the proposals under § 600.125(b) and (c)
will have no impact on State burden.
We estimate that, on average, it will take
a State 4 additional hours at $80.08/hr
for a Business Operations Specialist and
2 additional hours at $118.14/hr for a
General Manager to meet the new
Blueprint requirements under
§ 600.125(a)(1). In aggregate, we
estimate an increased burden of 12
hours (2 States × 6 hr/State) at a cost of
$1,113 [2 States × ((4 hr × $80.08/hr) +
(2 hr × $118.14/hr))]. We note that this
cost will be incurred 100 percent by the
State, as Federal BHP funds cannot be
used for program administration.
(2) ICRs Regarding the Operation of a
BHP (§§ 600.145(a), 600.145(f)(2), and
600.330(f))
We propose at § 600.145(a) that a
State must implement its BHP in
accordance with: (1) the approved and
full certified State BHP Blueprint; or (2)
the approved suspension application
(see ICR section 3 below).
We propose at § 600.145(f)(2) that the
State operating a BHP must perform
eligibility and health services appeals as
specified in § 600.335.
The ongoing burden associated with
the requirements under § 600.145 is the
time and effort it would take each
participating State to perform the
recordkeeping and reporting portions of
the core operating functions of a BHP
including eligibility determinations and
appeals as well as enrollment and
disenrollment, health plan contracting,
oversight and financial integrity,
consumer assistance, and if necessary
program termination or suspension.
Because only two States are currently
certified to operate a BHP, we are
providing the burden estimate for two
States. We estimate that it would take a
business operations specialist 4
additional hours at $80.08/hr to meet
these new recordkeeping and reporting
requirements for health services
appeals. In aggregate, we estimate an
increased burden of 8 hours (2 States ×
4 hr/response) at a cost of $641 (2 States
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× 4 hr × $80.08/hr). We note that this
cost will be incurred 100 percent by the
State, as Federal BHP funds cannot be
used for program administration.
We propose at § 600.330(f), BHP
eligibility notices must be written in
plain language and be provided in a
manner which ensures individuals with
disabilities are provided with effective
communication and takes steps to
provide meaningful access to eligible
individuals with limited English
proficiency. These notices must be
developed and processed in a
coordinated fashion with other
insurance affordability programs which
have the same accessibility standards at
45 CFR 155.230(b). As such, we propose
no additional burden for the BHP for the
noticing requirement.
(3) ICRs Regarding Suspension of a BHP
(§§ 600.140(b) and 600.170(a)(2))
We propose at § 600.140(b)(1) if a
State decides to suspend its BHP or
requests a suspension extension, a State
must submit to the Secretary a
suspension application or suspension
extension application. We propose at
§ 600.140(b)(3) that a State must submit
written notices to all BHP enrollees and
participating standard health plan offers
at least 90 days prior to the effective
date of the suspension. We propose at
§ 600.140(b)(4) that the State must
submit to HHS within 12 months of the
suspension effective date the data
required by § 600.610 needed to
complete the financial reconciliation
process with HHS. We propose at
§ 600.140(b)(5) that the State must
submit the annual report required by
§ 600.170(a)(2). We propose at
§ 600.140(b)(6) that the State must
annually remit to HHS any interest that
has accrued on the balance of the BHP
trust fund during the suspension period.
We propose at § 600.140(b)(7) that the
State must submit a transition plan to
HHS that describes how the State will
reinstate its BHP or terminate the
program.
Two States are currently certified to
operate a BHP; therefore, we are
providing the burden estimate for two
States.
We estimate that, on average, it would
take a Business Operations Specialist 30
hours at $80.08/hr and a General
Manager 4 hours at $118.14/hr to submit
a suspension application to the
Secretary. In aggregate, we estimate a
one-time burden of 68 hours (2 States ×
34 hr/response) at a cost of $5,780 [2
States × ((30 hr × $80.08/hr) + (4 hr ×
$118.14/hr))]. We estimate that, on
average, it would take a Business
Operations Specialist 30 hours at
$80.08/hr and a General Manager 4
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hours at $118.14/hr to submit a
suspension extension application to the
Secretary. In aggregate, we estimate a
one-time burden of 68 hours (2 States ×
34 hr/response) at a cost of $5,780 [2
States × ((30 hr × $80.08/hr) + (4 hr ×
$118.14/hr))].
We estimate that, on average, it would
take a Business Operations Specialist 32
hours at $80.08/hr to prepare and
submit notification to all participating
standard health plans and enrollees. In
aggregate, we estimate a one-time
burden of 64 hours (2 States × 32 hr/
response) at a cost of $5,125 [2 States ×
(32 hr × $80.08/hr)].
We estimate that it would take a
Business Operations Specialist 25 hours
at $80.08/hr and a General Manager 4
hours at $118.14/hr to compile and
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submit data required for quarterly
financial reconciliation. In aggregate, we
estimate an annual burden of 232 hours
(2 States × 29 hr/response × 4 responses/
yr) at a cost of $19,796 [2 States × 4
responses/yr ((25 hr × $80.08/hr) + (4 hr
× $118.14/hr)).
We estimate that, on average, it would
take a Financial Specialist 8 hours at
$88.74/hr to remit annually the interest
accrued on the balance of the BHP trust
fund while in suspension. In aggregate,
we estimate an annual burden of 16
hours (2 States × 8 hr/response) at a cost
of $1,420 [2 States × (8 hr × $88.74/hr)].
We estimate that it would take a
Business Operations Specialist 20 hours
at $80.08/hr and a General Manager 4
hours at $118.14/hr to submit a
transition plan to reinstate its BHP or
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terminate the program. In aggregate, we
estimate a one-time burden of 48 hours
(2 States × 24 hr/response) at a cost of
$4,148 [2 States × ((20 hr × $80.08/hr)
+ (4 hr × $118.14/hr))].
We estimate that, on average, it will
take a Business Operations Specialist 40
hours at $80.08/hr and 4 hours at
$118.14/hr for a General Manager to
complete and submit the State’s annual
report, for a total annual burden of 88
hours at a cost of $7,352 [2 States × ((40
hr × $80.08/hr) + (4 hr × $118.14/hr))].
We note that these costs will be
incurred 100 percent by the State, as
Federal BHP funds cannot be used for
program administration.
b. Burden Summary
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11. The Quality Payment Program (QPP)
(42 CFR Part 414 and Section IV. of This
Proposed Rule)
The following QPP-specific ICRs
reflect changes to our currently
approved burden due to proposed
policy changes in this CY 2024
proposed rule as well as adjustments to
the policies that have been previously
finalized in the CY 2017 and CY 2018
Quality Payment Program final rules (81
FR 77008 and 82 FR 53568,
respectively), CY 2019, CY 2020, CY
2021, CY 2022, and CY 2023 PFS final
rules (83 FR 59452, 84 FR 62568, 85 FR
84472, 86 FR 64996, and 87 FR 70131,
respectively) due to revised
assumptions based on updated data
available at the time of the publication
of this proposed rule.
a. Background
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(1) ICRs Associated With Merit-Based
Incentive Payment System (MIPS) and
Advanced Alternative Payment Models
(APMs)
In the following sections, we discuss
a series of ICRs associated with the
Quality Payment Program, including for
MIPS and Advanced APMs. The
following sections describe the changes
in the estimated burden for the
information collections relevant to the
proposed revisions in the policies
associated with the CY 2024 PFS
proposed rule and the proposed
revisions to our currently approved
information requests for MIPS and
Advanced APM ICRs. The proposed
estimated burden will be submitted to
OMB under control number 0938–1314
(CMS–10621). The proposed estimated
burden for the CAHPS for MIPS Survey
discussed in sections V.B.11.c.(5),
V.B.11.e.(8), and V.B.11.e.(9) of this rule
will be submitted under OMB control
number 0938–1222 (CMS–10450). We
note that we have received approvals for
the collection of information associated
the virtual group election process under
OMB control number 0938–1343 (CMS–
10652).
(2) Summary of Proposed Changes for
the Quality Payment Program: MIPS
We have included the change in the
estimated burden for the CY 2024
performance period/2026 MIPS
payment year due to the proposed
policies and information collections in
this proposed rule. The proposed
policies in this proposed rule impact the
burden estimates for the CY 2024
performance period/2026 MIPS
payment year.
The following five MIPS ICRs show
changes in burden due to the proposed
policies in this proposed rule: (1)
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Quality performance category data
submission by Medicare Part B claims
collection type; (2) Quality performance
category data submission by qualified
clinical data registry (QCDR) and MIPS
CQM collection type; (3) Quality
performance category data submission
by eCQM collection type; (4) MIPS
Value Pathways (MVP) quality
performance category submission, and
(5) MVP registration. In aggregate, we
estimate the proposed policies will
result in a net decrease in burden of
4,002 hours and $459,553 for the CY
2024 performance period/2026 MIPS
payment year. The remaining changes to
our currently approved burden
estimates are proposed adjustments due
to the revised burden assumptions
based on the updated data available at
the time of publication of this proposed
rule. As discussed in section VII.E.23.a.
of this proposed rule, we are basing our
estimates on data from the CY 2021
performance period.
We are proposing to add two new
ICRs, ‘‘QCDR full self-nomination
process’’ and ‘‘qualified registry full
self-nomination process’’ in sections
V.B.11.c.(2) and V.B.11.c.(3) of this rule
to distinctly capture the burden for the
number of QCDRs and qualified
registries submitting applications for the
simplified and full self-nomination
process. We note that the proposed
addition of these ICRs is not due to the
proposed policy changes in section
IV.A.4.k. of this rule. It is a proposed
change in our approach in representing
the estimated burden for the third -party
intermediary self-nomination process
due to availability of updated data.
We are proposing to remove one ICR,
‘‘nomination of Promoting
Interoperability measures,’’ in section
V.B.11.h. of this rule. We note that the
proposed removal of the ICR is not due
to proposed policy changes in section
IV.A.4.f.(4) of this rule. It is due to a
consistent decline in the number of
submissions received for the ICR.
We are not proposing any changes or
adjustments to the following ICRs:
Registration for virtual groups; OAuth
credentialing and token request process;
Quality Payment Program identity
management application process;
subgroups registration; submitting
Promoting Interoperability data;
improvement activities submission;
nomination of MVPs; and opt-out of
performance data display on Compare
Tools for voluntary participants. See
section V.B.11. of this proposed rule for
a summary of the ICRs, the overall
burden estimates, and a summary of the
assumption and data changes affecting
each ICR.
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The accuracy of our estimates of the
total burden for data submission under
the quality, Promoting Interoperability,
and improvement activities performance
categories may be impacted by two
primary factors. First, we are unable to
predict with absolute certainty who will
be a Qualifying APM Participant (QP)
for the CY 2024 performance period/
2026 MIPS payment year. New eligible
clinician participants in Advanced
APMs who become QPs will be
excluded from MIPS reporting
requirements and payment adjustments,
and as such, are unlikely to report under
MIPS; while some current Advanced
APM participants may end participation
such that the APM Entity’s eligible
clinicians may not be QPs for a year
based on § 414.1425(c)(5), and thus be
required to report under MIPS. Second,
it is difficult to predict whether Partial
QPs, who can elect to report to MIPS,
will choose to participate in the CY
2024 performance period/2026 MIPS
payment year compared to the CY 2021
performance period/2023 MIPS
payment year. Therefore, the actual
number of Advanced APM participants
and how they elect to submit data may
be different than our estimates.
However, we believe our estimates are
the most appropriate given the available
data. Additionally, we will continue to
update our estimates annually as data
becomes available.
(3) Summary of Quality Payment
Program Changes: Advanced APMs
For these ICRs (identified above
under, ‘‘ICRs Associated with MIPS and
Advanced APMs’’), we did not
implement any changes to currently
approved burden estimates for the CY
2024 performance period/2026 MIPS
payment year. Therefore, we did not
propose any changes to the Partial QP
elections; Other Payer Advanced APM
identification: Payer Initiated and
Eligible Clinician Initiated Processes;
and submission of Data for QP
determinations under the All-Payer
Combination Option.
(4) Framework for Understanding the
Burden of MIPS Data Submission
Because of the wide range of
information collection requirements
under MIPS, Table 59 presents a
framework for understanding how the
organizations permitted or required to
submit data on behalf of clinicians vary
across the types of data, and whether
the clinician is a MIPS eligible clinician
or other eligible clinician voluntarily
submitting data, MIPS APM participant,
or an Advanced APM participant. In
Table 59, MIPS eligible clinicians and
other clinicians voluntarily submitting
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data to MIPS may submit data as
individuals, groups, or virtual groups
for the quality, Promoting
Interoperability, and improvement
activities performance categories. Note
that virtual groups are subject to the
same data submission requirements as
groups, and therefore, we will refer only
to groups for the remainder of this
section, unless otherwise noted.
Beginning with the CY 2023
performance period/2025 MIPS
payment year, clinicians could also
participate as subgroups for reporting
measures and activities in an MVP. We
note that the subgroup reporting option
is not available for clinicians
participating in traditional MIPS. We
finalized in the CY 2022 PFS final rule
that a subgroup reporting measures and
activities in an MVP will submit its
affiliated group’s data for the Promoting
Interoperability performance category
and in the scenario that a subgroup does
not submit its affiliated group’s data, the
subgroup will receive a zero score for
the Promoting Interoperability
performance category (86 FR 65413
through 65414).
Because MIPS eligible clinicians are
not required to submit any additional
information for assessment under the
cost performance category, the
administrative claims data used for the
cost performance category is not
represented in Table 59.
For MIPS eligible clinicians
participating in MIPS APMs, the
organizations submitting data on behalf
of MIPS eligible clinicians will vary
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between performance categories and, in
some instances, between MIPS APMs.
We previously finalized in the CY 2021
PFS final rule that the APM
Performance Pathway is available for
both Accountable Care Organization
(ACO) participants and non-ACO
participants to submit quality data (85
FR 84859 through 84866). Due to data
limitations and our inability to
determine who will use the APM
Performance Pathway versus the
traditional MIPS submission mechanism
for the CY 2024 performance period/
2026 MIPS payment year, we assume
ACO APM Entities will submit data
through the APM Performance Pathway,
using the CMS Web Interface option,
and non-ACO APM Entities will
participate through traditional MIPS,
thereby submitting as an individual or
group rather than as an entity. We also
want to note that as finalized in the CY
2022 PFS final rule (86 FR 65259
through 65263), the CMS Web Interface
collection type is available through the
CY 2024 performance period/2026 MIPS
payment year only for clinicians
participating in the Shared Savings
Program. Per section 1899(c) of the Act,
submissions received from eligible
clinicians in ACOs are not included in
burden estimates for this proposed rule
because quality data submissions to
fulfill requirements of the Shared
Savings Program are not subject to the
PRA.
For the Promoting Interoperability
performance category, group TINs may
submit data on behalf of eligible
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clinicians in MIPS APMs, or eligible
clinicians in MIPS APMs may submit
data individually. Additionally, we
finalized the introduction of a voluntary
reporting option for APM Entities to
report the Promoting Interoperability
performance category at the APM Entity
level beginning with the CY 2023
performance period/2025 MIPS
payment year (87 FR 70087 and 70088).
For the improvement activities
performance category, we will assume
no reporting burden for MIPS APM
participants. In the CY 2017 Quality
Payment Program final rule, we
established that, for MIPS APMs, we
compare the requirements of the
specific MIPS APM with the list of
activities in the improvement activities
inventory and score those activities in
the same manner that they are otherwise
scored for MIPS eligible clinicians (81
FR 77185). Although the policy allows
for the submission of additional
improvement activities if a MIPS APM
Entity receives less than the maximum
improvement activities performance
category score, to date all MIPS APM
Entities have qualified for the maximum
improvement activities score. Therefore,
we assume that no additional
submission will be needed.
Eligible clinicians who attain Partial
QP status may incur additional burden
if they elect to participate in MIPS,
which is discussed in more detail in the
CY 2018 Quality Payment Program final
rule (82 FR 53841 through 53844).
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The policies finalized in the CY 2017
and CY 2018 Quality Payment Program
final rules (81 FR 77008 and 82 FR
53568), the CY 2019, CY 2020, CY 2021,
CY 2022, and CY 2023 PFS final rules
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(83 FR 59452, 84 FR 62568, 85 FR
84472, 86 FR 64996, and 87 FR 70131),
and continued in this proposed rule
create some additional data collection
requirements not listed in Table 59.
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These additional data collections, some
of which are currently approved by
OMB under the control numbers 0938–
1314 (Quality Payment Program, CMS–
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10621) and 0938–1222 (CAHPS for
MIPS, CMS–10450), are as follows:
Additional ICRs related to MIPS thirdparty intermediaries (see section V.B.11.
c. of this proposed rule):
• Self-nomination of new and
returning QCDRs (81 FR 77507 through
77508, 82 FR 53906 through 53908, and
83 FR 59998 through 60000) (OMB
0938–1314).
• Self-nomination of new and
returning registries (81 FR 77507
through 77508, 82 FR 53906 through
53908, and 83 FR 59997 through 59998)
(OMB 0938–1314)
• Third party intermediary plan
audits
• Approval process for new and
returning CAHPS for MIPS survey
vendors (82 FR 53908) (OMB 0938–
1222).
• Open Authorization Credentialing
and Token Request Process (OMB 0938–
1314) (85 FR 84969 through 84970).
Additional ICRs related to the data
submission and the quality performance
category (see section V.B.11.e. of this
proposed rule):
• CAHPS for MIPS survey completion
by beneficiaries (81 FR 77509, 82 FR
53916 through 53917, and 83 FR 60008
through 60009) (OMB 0938–1222).
• Quality Payment Program Identity
Management Application Process (82 FR
53914 and 83 FR 60003 through 60004)
(OMB 0938–1314).
Additional ICRs related to the
Promoting Interoperability performance
category (see section V.B.11.g. of this
proposed rule):
• Reweighting Applications for
Promoting Interoperability and other
performance categories (82 FR 53918
and 83 FR 60011 through 60012) (OMB
0938–1314).
Additional ICRs related to call for
new MIPS measures and activities (see
sections V.B.11.j, V.B.11.f, V.B.11.k.,
and V.B.11.h. of this proposed rule):
• Nomination of improvement
activities (82 FR 53922 and 83 FR 60017
through 60018) (OMB 0938–1314).
• Call for MIPS quality measures (83
FR 60010 through 60011) (OMB 0938–
1314).
• Nomination of MVPs (85 FR 84990
through 84991) (OMB 0938–1314)
Additional ICRs related to MIPS (see
section V.B.11.o. of this proposed rule):
• Opt out of performance data display
on Compare Tools for voluntary
reporters under MIPS (82 FR 53924
through 53925 and 83 FR 60022) (OMB
0938–1314).
Additional ICRs related to APMs (see
sections V.B.11.m. and V.B.11.n. of this
proposed rule):
• Partial QP Election (81 FR 77512
through 77513, 82 FR 53922 through
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53923, and 83 FR 60018 through 60019)
(OMB 0938–1314).
• Other Payer Advanced APM
determinations: Payer Initiated Process
(82 FR 53923 through 53924 and 83 FR
60019 through 60020) (OMB 0938–
1314).
• Other Payer Advanced APM
determinations: Eligible Clinician
Initiated Process (82 FR 53924 and 83
FR 60020) (OMB 0938–1314).
• Submission of Data for All-Payer
QP Determinations (83 FR 60021) (OMB
0938–1314).
b. ICRs Regarding the Virtual Group
Election (§ 414.1315)
This rule does not propose any new
or revised collection of information
requirements or burden related to the
virtual group election. The virtual group
election requirements and burden are
currently approved by OMB under
control number 0938–1343 (CMS–
10652). Consequently, we are not
proposing any changes under that
control number.
c. ICRs Regarding Third Party
Intermediaries (§ 414.1400)
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621). As discussed above in section
V.B.11.a.(2) of this rule, we are
proposing to add two new ICRs, ‘‘QCDR
simplified self-nomination process’’ and
‘‘qualified registry self-nomination
process’’, to represent the estimated
burden for the third-party
intermediaries submitting applications
for the simplified self-nomination
process. We discuss the details of these
proposed changes in the below sections.
In section IV.A.4.k. of this rule, we are
proposing to: (1) add requirements for
third party intermediaries to obtain
documentation; (2) add requirements for
third party intermediaries to submit
data in the form and manner specified
by CMS; (3) specify the use of a
simplified self-nomination process for
existing QCDRs and qualified registries;
(4) add requirements for QCDRs and
qualified registries to provide measure
numbers and identifiers for performance
categories; (5) add a requirement for
QCDRs and qualified registries to attest
that information on the qualified
posting is correct; (6) modify
requirements for QCDRs and qualified
registries to support MVP reporting; (7)
specify requirements for a transition
plan for QCDRs and qualified registries;
(8) specify requirements for data
validation execution reports; (9)
eliminate the Health IT vendor category;
(10) add failure to maintain updated
contact information as criteria for
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remedial action; (11) revise corrective
action plan requirements; (12) specify
the process for publicly posting
remedial action; and (13) specify the
criteria for audits. Specifically, we note
that the proposed policy to eliminate
the health IT vendor category beginning
with the CY 2025 performance period/
2027 MIPS payment year, if finalized,
would not have any impact on the
estimated burden for third party selfnomination process in the CY 2024
performance period/2026 MIPS
payment year. If the proposed removal
of health IT vendor category is finalized
for the CY 2025 performance period/
2027 MIPS payment year, we recognize
that it could encourage some existing
health IT vendors to complete the
requirements under the qualified
registry self-nomination process.
However, we believe that many thirdparty intermediaries serve as both
health IT vendors and qualified
registries for the purposes of submitting
data for MIPS eligible clinicians.
Therefore, we assume that there would
not be an increase in the number of
qualified registries that would submit
applications for the qualified registry
self-nomination process during the CY
2024 performance period/2026 MIPS
payment year.
We assume that the proposed changes
to codify previously finalized preamble
language related to third party
intermediaries in the regulatory text
would result in modifying the
regulatory text to reflect previously
finalized policies for third party
intermediaries or provide additional
clarification of the previously finalized
policies. We do not expect to receive
additional information from QCDRs and
qualified registries during the selfnomination process due to the above
proposed policies and therefore, we are
not proposing any adjustments to the
currently approved burden estimates for
third party intermediaries. We refer
readers to section IV.A.4.k. of this rule
for details on proposed policies for third
party intermediaries. Additionally, we
refer readers to section VII.E.23.e.(2)(a)
of this proposed rule where we discuss
the details in our impact analysis for
these policies.
(1) Background
Under MIPS, the quality, Promoting
Interoperability, and improvement
activities performance category data
may be submitted via relevant thirdparty intermediaries, such as qualified
registries, QCDRs, and health IT
vendors. Data on the CAHPS for MIPS
survey, which counts as either one
quality performance category measure,
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(a) Self-Nomination Process and Other
Requirements
As described below in section
V.B.11.c.(2)(a) of this rule, we are
proposing to separate the burden for the
number of QCDR self-nomination
applications submitted for the
simplified and full self-nomination
process for the CY 2024 performance
period/2026 MIPS payment year. In the
CY 2023 PFS final rule (87 FR 70137
through 70139), we used the same
estimate for the number of respondents
that submitted applications for the
simplified and full self-nomination
process because we did not have
separate estimates at the time.
Additionally, we only used the burden
for the full QCDR self-nomination
process in our final burden summary
estimates. Due to the availability of
updated data and the distinct number of
estimated respondents for the simplified
and full self-nomination process, we are
proposing to add a new ICR to capture
the burden for the simplified QCDR selfnomination process. We note that the
proposed change in estimated burden is
not due to policy proposals in section
IV.A.4.k. of this rule. In order to
accurately represent the estimated
burden incurred by the QCDRs for the
simplified and full self-nomination
process, we discuss the burden under
separate ICRs. We are not proposing any
changes to our estimates for the number
of existing or borrowed QCDR measures
submitted for consideration by each
QCDR at the time of self-nomination
and the average time required to submit
information for each QCDR measure.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77507 through 77508, and
82 FR 53906 through 53908,
respectively), and the CY 2019, CY
2020, CY 2021, CY 2022, and CY 2023
PFS final rules (83 FR 59998 through
60000, 84 FR 63116 through 63121, 85
FR 84964 through 84969, 86 FR 65569
through 65573, and 87 FR 70138
through 70139, respectively) for our
previously finalized requirements and
estimated burden for self-nomination of
QCDRs and nomination of QCDR
measures.
In Table 61, the addition of this new
ICR for the CY 2024 performance
period/2026 MIPS payment year would
result in an increase of 365 hours at a
cost of $37,689 for the simplified QCDR
self-nomination process. We note that
the proposed increase in burden is due
to separating the estimated burden for
the simplified QCDR self-nomination
process.
or towards an improvement activity, can
be submitted via CMS-approved survey
vendors. Entities seeking approval to
submit data on behalf of clinicians as a
qualified registry, QCDR, or survey
vendor must complete a self-nomination
process annually.333 The processes for
self-nomination of entities seeking
approval as qualified registries and
QCDRs are similar with the exception
that QCDRs have the option to nominate
QCDR measures for approval for the
reporting of quality performance
category data. Therefore, differences
between QCDRs and qualified registry
self-nomination are associated with the
preparation of QCDR measures for
approval.
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(2) QCDR Self-Nomination Applications
Based on the number of applications
that we expect to receive during the CY
2023 self-nomination period for the CY
2024 performance period/2026 MIPS
payment year, we estimate that 45
QCDRs would submit applications using
the simplified self-nomination process.
We note that we are not making any
changes to the currently approved time
of 8.1 hours required for the simplified
QCDR self-nomination process (87 FR
70139).
Based on the above assumptions, we
provide an estimate of the total annual
burden associated with a QCDR selfnominating to be considered ‘‘qualified’’
to submit data on behalf of MIPS
eligible clinicians.
As shown in Table 60, we assume that
the staff involved in the simplified
QCDR self-nomination process will
continue to be computer systems
analysts or their equivalent who have an
average adjusted labor rate of $103.40/
hr. We estimate the burden per response
would be $837.54 (8.1hr × $103.40/hr).
In aggregate, for the CY 2024
performance period/2026 MIPS
payment year, we estimate that the
annual burden for the simplified QCDR
self-nomination process would be 365
hours (45 responses × 8.1 hr) at a cost
of $37,689 (45 applications × $837.54/
application).
333 As stated in the CY 2019 PFS final rule (83
FR 59998), health IT vendors are not included in
the burden estimates for MIPS.
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Based on the number of applications
that we expect to receive during the CY
2023 self-nomination period for the CY
2024 performance period/2026 MIPS
payment year, we estimate that 10
QCDRs would submit applications using
the full self-nomination process. This is
a decrease of 53 respondents from the
currently approved estimate of 63 for
the QCDR self-nomination process (87
FR 70139). We note that we are not
making any changes to the currently
approved time of 10.1 hours required for
the full QCDR self-nomination process
(87 FR 70139).
Based on the above assumptions, we
provide an estimate of the total annual
burden associated with a QCDR selfnominating to be considered ‘‘qualified’’
to submit data on behalf of MIPS
eligible clinicians.
In Table 62, we assume that the staff
involved in the full QCDR self-
nomination process will continue to be
computer systems analysts or their
equivalent who have an average
adjusted labor rate of $103.40/hr. We
estimate the burden per response would
be $1,044.34 (10.1hr × $103.40/hr). In
aggregate, for the CY 2024 performance
period/2026 MIPS payment year, we
estimate that the annual burden for the
full QCDR self-nomination process
would be 101 hours (10 responses × 10.1
hr) at a cost of $10,443 (10 applications
× $1,044.34/application).
In Table 63, we use the currently
approved burden as the baseline for
calculating the net change in burden for
the full QCDR self-nomination process.
We note that we discussed the estimated
burden for the full QCDR selfnomination process under ‘‘maximum
burden’’ in Table 105 in the CY 2023
PFS final rule (87 FR 70139). For the CY
2024 performance period/2026 MIPS
payment year, the change in the
representation of burden for this ICR
described above results in a decrease of
535 hours and $55,350 for the full self-
nomination process. We also note that
the decrease in burden accounts for the
change due to separating the estimated
burden based on the simplified and full
self-nomination process.
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(b) Full QCDR Self-Nomination Process
and Other Requirements
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(c) QCDR Measure Requirements
In the CY 2017 Quality Payment
Program final rule (81 FR 77375 through
77377), we established that QCDRs
could submit measures that are not on
the annual list of MIPS quality measures
as part of the self-nomination process
for an entity to become a QCDR.
In section IV. of this rule, we are
proposing to add that if the measure was
submitted for consideration after selfnomination to our list of reasons for
rejecting a QCDR measure at
§ 414.1400(b)(4)(iv)(O). We will not
revise or adjust our active requirements
or burden estimates because the
proposed policy only clarifies
requirements for rejecting a QCDR
measure and will not substantively
change the currently approved
estimated average weighted time
required for a QCDR to submit
information for a QCDR measure at the
time of self-nomination.
In section IV. of this rule, we are
proposing at § 414.1400(b)(4)(iv)(P) that
a QCDR measure may be rejected if the
QCDR submits more than 30 quality
measures not in the annual list of MIPS
quality measures for CMS consideration.
We will not revise or adjust our
currently approved burden estimates as
result of this change because limiting
the number of measures submitted
during the QCDR self-nomination
process would not substantively change
the currently approved estimated
average weighted time required for a
QCDR to submit information for a QCDR
measure at the time of self-nomination.
In section IV.A.4.k.(4)(b)(i) of this
rule, we are proposing to revise
§ 414.1400(b)(4)(i)(B) to add a provision
that the approved QCDR measure
specifications must remain published
through the performance period and
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data submission period. We will not
revise or adjust our currently approved
burden estimates as result of this change
because establishing a standard for the
duration of posting the approved QCDR
measure specifications would not
substantively change the currently
approved estimated average weighted
time required for a QCDR to submit
information for a QCDR measure at the
time of self-nomination.
(3) Qualified Registry Self-Nomination
Process and Other Requirements
We refer readers to § 414.1400(b)(2)
which states that qualified registries
interested in submitting MIPS data to us
on behalf of MIPS eligible clinicians,
groups, or virtual groups need to
complete a self-nomination process to
be considered for approval to do so.
As described below, in this rule we
are proposing to separate the burden for
the number of qualified registry selfnomination applications submitted for
the simplified and full self-nomination
process for the CY 2024 performance
period/2026 MIPS payment year. In the
CY 2023 PFS final rule (87 FR 70139
through 70140), we used the same
estimate for the number of respondents
that submitted applications for the
simplified and full self-nomination
process because we did not have
separate estimates at the time.
Additionally, we only used the burden
for the full qualified registry selfnomination process in our final burden
summary estimates. Due to the
availability of updated data and the
distinct number of estimated
respondents for the simplified and full
self-nomination process, we are
proposing to add a new ICR to capture
the burden for the qualified registry selfnomination process. We note that the
proposed change is not due to policy
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proposals in section IV.A.4.k. of this
rule. With the addition of a new ICR, we
believe that we would be able to
accurately represent the estimated
burden incurred by the qualified
registries for both the simplified and full
self-nomination process.
(a) Simplified Qualified Registry SelfNomination Process
Based on the number of applications
that we expect to receive during the CY
2023 self-nomination period for the CY
2024 performance period/2026 MIPS
payment year, we estimate that 89
qualified registries would submit
applications using the simplified selfnomination process. We note that we
are not making any changes to the
currently approved time of 0.5 hours
required for the simplified qualified
registry self-nomination process (87 FR
70140).
Based on the above assumptions, we
provide an estimate of the total annual
burden associated with a qualified
registry self-nominating to be
considered ‘‘qualified’’ to submit data
on behalf of MIPS eligible clinicians.
In Table 64, we assume that the staff
involved in the simplified qualified
registry self-nomination process will
continue to be computer systems
analysts or their equivalent, who have
an average adjusted labor rate of
$103.40/hr. We estimate the burden per
response would be $51.70 (0.5hr ×
$103.40/hr) for the simplified selfnomination process. In aggregate, for the
CY 2024 performance period/2026 MIPS
payment year, we estimate that the
annual burden for the simplified
qualified registry self-nomination
process would be 45 hours (89
responses × 0.5 hr) at a cost of $4,601
(89 applications × $51.70//application).
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$4,601 for the simplified qualified
registry self-nomination process. We
note the increase in burden is due to
separating the estimated burden for the
simplified and full qualified registry
self-nomination process.
(b) Full Qualified Registry SelfNomination Process
Based on the number of applications
we expect to receive during the CY 2023
self-nomination period for the CY 2024
performance period/2026 MIPS
payment year, we estimate 36 qualified
registries would submit applications
using the full self-nomination process.
This is a decrease of 96 from the
currently approved estimate of 132 for
the qualified registry self-nomination
process (87 FR 70140). We note we are
not making any changes to our currently
approved per response time estimate of
0.5 hours for the simplified qualified
registry self-nomination process and 2
hours for the full qualified registry selfnomination process (87 FR 70139
through 70140).
Based on the assumptions discussed
in this section, we provide an estimate
of the total annual burden associated
with a qualified registry self-nominating
to be considered ‘‘qualified’’ to submit
data on MIPS eligible clinicians.
In Table 66, we assume the staff
involved in the qualified registry self-
nomination process will continue to be
computer systems analysts or their
equivalent, who have an average labor
rate of $103.40/hr. We estimate the
burden per response would be $206.80
(2 × 103.40/hr) for the full selfnomination process. In aggregate, for the
CY 2024 performance period/2026 MIPS
payment year, we estimate that the
annual burden for the full qualified
registry self-nomination process would
be 72 hours (36 responses × 2 hr) at a
cost of $7,445 (36 applications ×
$206.80/application).
In Table 67, we use the currently
approved burden as the baseline for
calculating the net change in burden for
the simplified qualified registry self-
nomination process. We note that we
discussed the estimated burden for the
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In Table 65, the addition of this ICR
for the CY 2024 performance period/
2026 MIPS payment year would result
in a change of +45 hours at a cost of
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full qualified registry self-nomination
process under ‘‘maximum burden’’ in
Table 107 in the CY 2023 PFS final rule
(87 FR 70140). For the CY 2024
performance period/2026 MIPS
payment year, the change in the
representation of burden for this ICR
described above results in a decrease of
192 hours and a decrease of $19,853 for
the full qualified registry selfnomination process. We note the
decrease in burden accounts for the
changes due to separating the estimated
burden based on the simplified and full
qualified registry self-nomination
process.
(4) Third Party Intermediary Plan
Audits
qualified registry to submit a targeted
audit will range from $517 (5 hr ×
$103.40/hr) to $1,034 (10 hr × $103.40/
hr). In aggregate, we estimate an annual
burden ranging from 165 hours (33
responses × 5 hr/audit) and $17,061 (33
targeted audits × $517/audit) to 330
hours (33 responses × 10 hr/audit) and
$34,122 (33 targeted audits × $1,034/
audit) (see Table 69 for the cost per
audit).
submit participation plans for the CY
2024 performance period/2026 MIPS
payment year.
In Table 69, we estimate that the cost
for a QCDR or a qualified registry to
submit a participation plan is $310.20 (3
hours × $103.40/hr). In aggregate, we
estimate the total impact associated
with QCDRs and qualified registries to
submit participation plans would be 225
hours (75 participation plans × 3 hr/
plan) at a cost of $23,265 (75
participation plans × $310.20/plan) (see
Table 69 for the cost per audit).
The following proposed changes
associated with developing the plans
and audits by QCDRs and qualified
registries will be submitted to OMB for
review under control number 0938–
1314 (CMS–10621).
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(a) Targeted Audits
In the CY 2022 PFS final rule (86 FR
65547 through 65548), we finalized that
beginning with the CY 2021
performance period/CY 2023 MIPS
payment year, the QCDR or qualified
registry must conduct targeted audits in
accordance with requirements at
§ 414.1400(b)(3)(vi). Consistent with our
assumptions in the CY 2022 PFS and CY
2023 PFS final rules for the QCDRs (86
FR 65574 and 87 FR 70141 respectively)
and qualified registries (86 FR 65571
and 87 FR 70141 respectively) that
would submit the results of targeted
audits, we estimate the time required for
a QCDR or qualified registry to submit
a targeted audit ranges between 5 and 10
hours for the simplified and full selfnomination process, respectively. We
assume the staff involved in submitting
the targeted audits will continue to be
computer systems analysts or their
equivalent, who have an average labor
rate of $103.40/hr.
Based on the number of data
validation execution reports submitted
for the CY 2021 performance period/
2023 MIPS payment year, we estimate
that 33 third party intermediaries (13
QCDRs and 20 qualified registries) will
submit targeted audits for the CY 2024
performance period/2026 MIPS
payment year (See Table 68). We
estimate that the cost for a QCDR or a
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(b) Participation Plans
In the CY 2022 PFS final rule (86 FR
65546), we finalized requirements for
approved QCDRs and qualified
registries that did not submit
performance data and therefore will
need to submit a participation plan as
part of their self-nomination process.
We refer readers to § 414.1400(e) for
additional details on policies for
remedial action and termination of
third-party intermediaries.
Consistent with our assumptions in
the CY 2023 PFS final rule for the
QCDRs and qualified registries (87 FR
70141) that will submit participation
plans, we estimate that it will take 3
hours for a QCDR or qualified registry
to submit a participation plan during
the self-nomination process. We assume
the staff involved in submitting a
participation plan will continue to be
computer systems analysts or their
equivalent, who have an average labor
rate of $103.40/hr.
As shown in Table 68, we are not
changing our currently approved
estimate that 75 third party
intermediaries [five self-nomination
participation plans (two QCDRs and
three qualified registries) and 70 QCDR
measure participation plans] will
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(c) Corrective Action Plans (CAPs)
In the CY 2017 Quality Payment
Program final rule, we established the
process for corrective action plans
(CAPs) (81 FR 77386 through 77389). In
section IV.A.4.k.(6)(b), we are proposing
an additional provision at
§ 414.1400(e)(2)(iv) to allow us to
immediately or with advance notice
terminate a third party intermediary that
has not maintained current contact
information for correspondence.
Additionally, we propose to add at
§ 414.1400(e)(2)(v) that we may
terminate third party intermediaries that
are on remedial action for two
consecutive years. We are not proposing
any changes to our currently approved
estimated burden due to these proposals
because these changes provide
additional rationale for remedial action
policies and do not add any additional
requirements for third party
intermediaries.
Based on the increased number of
QCDR and qualified registries that
required remedial actions for the CY
2022 performance period/2024 MIPS
payment year, we anticipate the same
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In the CY 2020 PFS final rule (84 FR
63052 through 63053), we established a
policy at § 414.1400(a)(4)(vi) which
states a condition of approval for the
third party intermediary is to agree that
prior to discontinuing services to any
MIPS eligible clinician, group or virtual
group during a performance period, the
third party intermediary must support
the transition of such MIPS eligible
clinician, group, or virtual group to an
alternate third party intermediary,
submitter type, or, for any measure on
which data has been collected,
collection type according to a CMS
approved transition plan. In this rule,
we estimate we will receive five
transition plans for the CY 2024
performance period/2026 MIPS
payment year. This adjustment would
result in a decrease of five from the
currently approved estimate of 10 (87
FR 70142). We continue to estimate it
will take approximately 1 hour for a
computer system analyst or their
equivalent at a labor rate of $103.40/hr
to develop a transition plan on behalf of
each QCDR or qualified registry during
the self-nomination period. However,
we are unable to estimate the burden for
implementing the actions in the
transition plan because the level of
effort may vary for each QCDR or
qualified registry. In aggregate, we
estimate the impact associated with
qualified registries completing
transition plans is 5 hours (5 transition
plans × 1 hr/plan) at a cost of $517 (5
hr × $103.40/hr). We refer readers to
section VII.E.23.e.(2)(a) of this proposed
rule where we discuss our impact
analysis for the transition plans
submitted by QCDRs and qualified
registries.
In section IV.A.4.k.(6)(c) of this rule,
we are proposing at
§ 414.1400(e)(1)(i)(F) an additional
requirement for the QCDR or qualified
registry under a corrective action plan to
communicate the final resolution to
CMS once the resolution is complete
and to provide an update, if any, to the
monitoring plan provided under
§ 414.1400(e)(1)(i)(C). We believe the
proposed revision would ensure third
party intermediaries complete the
requirements within the communication
plan and would not add any additional
requirements for a third-party
intermediary to submit a CAP.
In section IV.A.4.k.(6)(d) of this rule,
we are proposing to add a new
provision at § 414.1400(e)(1)(ii)(B) that
we may publicly disclose on the CMS
website that CMS took remedial action
on the third party intermediary or
terminated it. We are also proposing to
modify § 414.1400(e)(1)(ii) by
redesignating it as § 414.1400(a)(2)(ii)(A)
and ending the policy after the CY 2025
MIPS reporting period/CY 2027 MIPS
payment year.
In section IV.A.4.k.(6)(e) of this rule,
we are proposing to modify
§ 414.1400(a)(2)(ii)(A) to state that our
consideration can include past
compliance including remedial actions.
We are proposing at § 414.1400(f) that
third party intermediaries may be
randomly selected for compliance
evaluation or may be selected at the
suggestion of CMS if there is an area of
concern regarding the third party
intermediary. We are also proposing to
redesignate the existing section
§ 414.1400(f) (which includes
paragraphs (f)(1), (2), and (3)) as
paragraph (a)(3)(vii) with no changes in
the text.
We do not expect to receive
additional information from QCDRs and
qualified registries during the selfnomination process due to the above
proposed policies and therefore, are not
proposing any adjustments to the
currently approved burden estimates for
third party intermediary plan audits.
Additionally, we refer readers to section
VII.E.23.e.(2)(a) of this proposed rule
where we discuss the details in our
impact analysis for these policies.
In Table 69, we assume that the staff
involved in the submission of the plan
audits during the third party
intermediary self-nomination process
will continue to be computer systems
analysts or their equivalent, who have
an average labor rate of $103.40/hr. For
the CY 2024 performance period/2026
MIPS payment year, in aggregate, the
proposed estimated annual burden for
the submission of third party
intermediary plan audits will range
from 446 hours to 611 hours at a cost
ranging from $46,116 (446 hr × $103.40/
hr) and $63,177 (611 hr × $103.40/hr)
(see Table 69).
(d) Transition Plans
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(e) Final Burden for Third Party
Intermediary Plan Audits
In aggregate, as shown in Table 68, we
assume that 130 third party
intermediaries will submit plan audits
(33 targeted audits, 75 participation
plans, 17 CAPs, and 5 transition plans).
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trend would continue for the CY 2024
performance period/2026 MIPS
payment year. Therefore, we estimate 17
third party intermediaries will submit
CAPs for the CY 2024 performance
period/2026 MIPS payment year. This is
an increase of seven respondents from
the currently approved estimate of ten
(87 FR 70142). We are not changing our
currently approved estimate of 3 hours
for a QCDR or qualified registry to
submit a CAP. We also assume the staff
involved in submitting the CAP will
continue to be computer systems
analysts or their equivalent, who have
an average labor rate of $103.40/hr. As
shown in Table 69, we estimate that the
cost for a QCDR or a qualified registry
to submit a CAP is $310.20 (3 hours ×
$103.40/hr). In aggregate, we estimate
the total impact associated with QCDRs
and qualified registries to CAPs will be
51 hours (17 CAPs × 3 hr/plan) at a cost
of $5,273 (17 CAPs × $310.20/plan).
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In Table 70, for the CY 2024
performance period/2026 MIPS
payment year, the change in the number
of respondents for third party
intermediary plan audits results in a
change of +21 hours at a cost of +$2,171
for the simplified self-nomination
process and +26 hours at a cost of
+$2,688 for the full self-nomination
process.
We note for the purposes of
calculating proposed estimated change
in burden in Tables 96 through 98 of
this rule, we use only estimated burden
for the plan audits submitted under the
full self-nomination process.
(5) Survey Vendor Requirements
The following proposed changes
associated with CAHPS survey vendors
to submit data for eligible clinicians will
be submitted to OMB for review under
control number 0938–1222 (CMS–
10450). We note that the associated
burden will be made available for public
review and comment under the standard
non-rule PRA process which includes
the publication of 60- and 30-day
Federal Register notices.
We refer readers to § 414.1400(d) for
the requirements for CMS-approved
survey vendors that may submit data on
the CAHPS for MIPS Survey.
In this rule, we are adjusting the
estimated number of vendors that will
apply to participate as CAHPS for MIPS
Survey vendors that were previously
approved in the CY 2018 Quality
Payment Program final rule (82 FR
53908). We estimate that we will receive
approximately 10 survey vendor
applications for the CY 2024
performance period/2026 MIPS
payment year. This adjustment will
result in a decrease of 5 survey vendor
applications from our currently
approved estimate of 15 vendors in the
CY 2018 QPP final rule (82 FR 53908).
As shown in Table 71, for the CY 2024
performance period/2026 MIPS
payment year, we continue to estimate
that the per response time is 10 hours.
This will result in an estimated annual
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cost of $10,340 (10 applications ×
$1,034/application)).
In Table 72, we illustrate the net
change in estimated burden for survey
vendor requirements using the currently
approved burden in the CY 2018 QPP
final rule (82 FR 53908). In aggregate,
using our currently approved per
response time estimate, the decrease in
the number of respondents participating
as CAHPS for MIPS Survey vendors
would result in a total annual
adjustment of -50 hours (-5 responses ×
10 hr/application) at a cost of -$5,170 (5 × (10 hr × $103.40/hr)) for the CY 2024
performance period/2026 MIPS
payment year.
d. ICRs Regarding Open Authorization
(OAuth) Credentialing and Token
Request Process
This rule is not proposing any new or
revised collection of information
requirements or burden related to the
OAuth credentialing and token request
process. The requirements and burden
for the OAuth credentialing and token
request process are currently approved
by OMB under control number 0938–
1314 (CMS–10621). Consequently, we
are not proposing any changes to the
OAuth credentialing and token burden
under that control number.
FR 63121 through 63124, 85 FR 84970
through 84974, 86 FR 65576 through
65588, and 87 FR 70145 through 70154,
respectively) for our previously
finalized estimated burden associated
with data submission for the quality
performance category.
Under our current policies, two
groups of clinicians must submit quality
data under MIPS: those who submit data
as MIPS eligible clinicians, and those
who submit data voluntarily but are not
subject to MIPS payment adjustments.
Clinicians are ineligible for MIPS
payment adjustments if they are newly
enrolled to Medicare; are QPs; are
partial QPs who elect to not participate
in MIPS; are not one of the clinician
types included in the definition for
MIPS eligible clinician; or do not exceed
the low-volume threshold as an
individual or as a group.
Advanced APM payment and patient
percentages from the APM Participant
List for the third snapshot date for the
2022 QP Performance period. From this
data, we calculated the QP
determinations as described in the
Qualifying APM Participant (QP)
definition at § 414.1305 for the CY 2024
performance period/2026 MIPS
payment year. Due to data limitations,
we could not identify specific clinicians
who have not yet enrolled in APMs, but
who may become QPs in the future for
the CY 2024 performance period/2026
MIPS payment year (and therefore will
no longer need to submit data to MIPS);
hence, our model may underestimate or
overestimate the number of
respondents.
In the CY 2019 PFS final rule, we
finalized limiting the Medicare Part B
claims collection type to small practices
beginning with the CY 2019
performance period/2021 MIPS
payment year and allowing clinicians in
small practices to report Medicare Part
B claims as a group or as individuals (83
(1) Background
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77502 through 77503 and
82 FR 53908 through 53912,
respectively), the CY 2019, CY 2020, CY
2021, CY 2022, and CY 2023 PFS final
rules (83 FR 60000 through 60003, 84
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(2) Changes and Adjustments to Quality
Performance Category Respondents
To determine which QPs should be
excluded from MIPS, we used the
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burden of 100 hours (10 survey vendor
applications × 10 hr/application) at a
e. ICRs Regarding Quality Data
Submission (§§ 414.1318, 414.1325,
414.1335, and 414.1365)
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FR 59752). We note in this proposed
rule, we are using the same CY 2021
performance period/2023 MIPS
payment year submissions data used in
the 2023 PFS Final Rule (87 FR 70145
through 70148).
We assume 100 percent of ACO APM
Entities will submit quality data to CMS
as required under their models. While
we do not believe there is additional
reporting for ACO APM entities,
consistent with assumptions used in the
CY 2021, CY 2022 and CY 2023 PFS
final rules (85 FR 84972, 86 FR 65567
and 87 FR 70145), we include all quality
data voluntarily submitted by MIPS
APM participants at the individual or
TIN-level in our respondent estimates.
As stated in section V.B.11.a.(4) of this
proposed rule, we assume non-ACO
APM Entities will participate through
traditional MIPS and submit as an
individual or group rather than as an
entity. To estimate who will be a MIPS
APM participant in the CY 2024
performance period/2026 MIPS
payment year, we used the Advanced
APM payment and patient percentages
from the APM Participant List for the
final snapshot date for the 2021 QP
performance period. We elected to use
this data source because the overlap
with the data submissions for the CY
2019 performance period/2021 MIPS
payment year enabled the exclusion of
Partial QPs that elected to not
participate in MIPS and required fewer
assumptions as to who is a QP or not.
Based on this information, if we
determine that a MIPS eligible clinician
will not be scored as a MIPS APM, then
their reporting assumption is based on
their reporting as a group or individual
for the CY 2021 performance period/
2023 MIPS payment year.
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Our burden estimates for the quality
performance category do not include the
burden for the quality data that APM
Entities submit to fulfill the
requirements of their APMs. The
associated burden is excluded from this
collection of information section but is
discussed in the regulatory impact
analysis section of this proposed rule
because sections 1899(e) and
1115A(d)(3) of the Act (42 U.S.C.
1395jjj(e) and 1315a(d)(3), respectively)
state that the Shared Savings Program
and the testing, evaluation, and
expansion of Innovation Center models
tested under section 1115A of the Act
(or section 3021 of the Affordable Care
Act) are not subject to the PRA.334
For the CY 2024 performance period/
2026 MIPS payment year, respondents
will have the option to submit quality
performance category data via Medicare
Part B claims, direct, and log in and
upload submission types. We estimate
the burden for collecting data via
collection type: Medicare Part B claims,
QCDR and MIPS CQMs, and eCQMs.
Additionally, we capture the burden for
clinicians who choose to submit via
these collection types for the quality
performance category of MVPs. We
believe that, while estimating burden by
submission type may be better aligned
with the way clinicians participate with
the Quality Payment Program, it is more
important to reduce confusion and
enable greater transparency by
maintaining consistency with previous
rulemaking.
Because MIPS eligible clinicians may
submit data for multiple collection
334 Our estimates do reflect the burden on MIPS
APM participants of submitting Promoting
Interoperability performance category data, which
is outside the requirements of their APMs.
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types for a single performance category,
the estimated numbers of individual
clinicians and groups to collect via the
various collection types are not
mutually exclusive and reflect the
occurrence of individual clinicians or
groups that collected data via multiple
collection types during the CY 2021
performance period/2023 MIPS
payment year. We captured the burden
of any eligible clinician that may have
historically collected via multiple
collection types, as we assume they will
continue to collect via multiple
collection types and that our MIPS
scoring methodology will take the
highest score where the same measure is
submitted via multiple collection types.
Table 73 uses methods similar to
those described above to estimate the
number of MIPS eligible clinicians that
will submit data as individual clinicians
via each collection type in the CY 2024
performance period/2026 MIPS
payment year. For the CY 2024
performance period/2026 MIPS
payment year, we estimate
approximately 14,402 clinicians will
submit data as individuals using the
Medicare Part B claims collection type;
approximately 11,197 clinicians will
submit data as individuals using MIPS
CQM and QCDR collection type; and
approximately 17,944 clinicians will
submit data as individuals using eCQMs
collection type. Based on performance
data from the CY 2021 performance
period/2023 MIPS payment year, these
are decreases of 334, 261, and 418
respondents from the currently
approved estimates of 14,736, 11,458,
and 18,362 for the Medicare Part B
claims, MIPS CQM and QCDR, and
eCQM collection types, respectively.
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CY 2024 performance periods/2026
MIPS payment year. We assume
clinicians who submitted quality data as
groups in the CY 2021 performance
period/2023 MIPS payment year will
continue to submit quality data either as
groups, or virtual groups for the same
collection types for the 2024
performance period/2026 MIPS
payment years. We used the same
methodology described in the CY 2022
PFS final rule (86 FR 65577) on our
assumptions related to the use of an
alternate collection type for groups that
submitted data via the CMS Web
Interface collection type for the CY 2021
performance period/2023 MIPS
payment year.
As shown in Table 74, for the CY
2024 performance period/2026 MIPS
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payment year we estimate 6,312 groups
and virtual groups will submit data for
the MIPS CQM and QCDR collection
type and 5,402 groups and virtual
groups will submit for eCQM collection
types. These are decreases of 146 and
125 respondents from the currently
approved estimates of 6,458, and 5,527
for the groups and virtual groups that
will submit data using MIPS CQM and
QCDR, and eCQM collection types,
respectively.
As the data does not exist for APM
performance pathway or MIPS quality
measures for non-ACO APM entities, we
assume non-ACO APM Entities will
participate through traditional MIPS
and base our estimates on submissions
received in the CY 2021 performance
period/2023 MIPS payment year.
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Consistent with the policy finalized in
the CY 2018 Quality Payment Program
final rule that for MIPS eligible
clinicians who collect measures via
Medicare Part B claims, MIPS CQM,
eCQM, or QCDR collection types and
submit more than the required number
of measures (82 FR 53735 through
54736), we will score the clinician on
the required measures with the highest
assigned measure achievement points
and thus, the same clinician may be
counted as a respondent for more than
one collection type. Therefore, our
columns in Table 73 are not mutually
exclusive.
Table 74 provides our estimated
counts of groups or virtual groups that
will submit quality data on behalf of
clinicians for each collection type in the
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The burden associated with the
submission of quality performance
category data has some limitations. We
believe it is difficult to quantify the
burden accurately because clinicians
and groups may have different processes
for integrating quality data submission
into their practices’ workflows.
Moreover, the time needed for a
clinician to review quality measures and
other information, select measures
applicable to their patients and the
services they furnish, and incorporate
the use of quality measures into the
practice workflows is expected to vary
along with the number of measures that
are potentially applicable to a given
clinician’s practice and by the collection
type. For example, clinicians submitting
data via the Medicare Part B claims
collection type need to integrate the
capture of quality data codes for each
encounter whereas clinicians submitting
via the eCQM collection types may have
quality measures automated as part of
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their Electronic Health Record (EHR)
implementation.
We believe the burden associated
with submitting quality measures data
will vary depending on the collection
type selected by the clinician, group, or
third-party. As such, we separately
estimated the burden for clinicians,
groups, and third parties to submit
quality measures data by the collection
type used. For the purposes of our
burden estimates for the Medicare Part
B claims, MIPS CQM and QCDR, and
eCQM collection types, we also assume
that, on average, each clinician or group
will submit 6 quality measures.
Additionally, as finalized in the CY
2022 PFS final rule (86 FR 65394
through 65397), group TINs could also
choose to participate as subgroups for
MVP reporting beginning with the CY
2023 performance period/2025 MIPS
payment year. We refer readers to the
CY 2022 PFS final rule for additional
details on MVP quality reporting
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requirements (86 FR 65411 through
65412).
In terms of the quality measures
available for clinicians and groups to
report for the CY 2024 performance
period/2026 MIPS payment year, we
propose a measure set of 200 quality
measures. The new MIPS quality
measures proposed for inclusion in
MIPS for the CY 2024 performance
period/2026 MIPS payment year and
future years are found in Table Group A
of Appendix 1; MIPS quality measures
with substantive changes can be found
in Table Group D of Appendix 1; and
MIPS quality measures proposed for
removal can be found in Table Group C
of Appendix 1. These measures are
stratified by collection type in Table 75,
as well as counts of new, removed, and
substantively changed measures. There
are no changes to the remaining
measures not included in Appendix 1.
We refer readers to Appendix 1: MIPS
Quality Measures of this proposed rule
for additional information.
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For the CY 2024 performance period/
2026 MIPS payment year, we are
proposing 200 measures, a net increase
of 2 quality measures across all
collection types compared to the
currently approved estimate of 198
measures. Specifically, as discussed in
section IV.A.4.f.(1)(e) of this rule, we are
proposing to add 14 new MIPS quality
measures, remove 12 MIPS quality
measures, partially remove 3 MIPS
quality measures that are proposed for
removal from traditional MIPS and
proposed for retention for use in MVPs,
and make substantive updates to 59
MIPS quality measures. We do not
anticipate our provision to remove these
measures will increase or decrease the
reporting burden on clinicians and
groups as respondents generally are still
required to submit quality data for 6
measures.
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(3) Quality Payment Program Identity
Management Application Process
This rule does not propose any new
or revised collection of information
requirements or burden related to the
identity management application
process. The identity management
application process requirements and
burden are currently approved by OMB
under control number 0938–1314
(CMS–10621). Consequently, we are not
proposing any changes for the identity
management application process under
that control number.
(4) Quality Data Submission by
Clinicians: Medicare Part B ClaimsBased Collection Type
The following proposed changes will
be submitted to OMB for review under
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control number 0938–1314 (CMS–
10621).
This rule does not propose any new
or revised collection of information
requirements or burden related to the
submission of Medicare Part B claims
data for the quality performance
category. Our updated estimate for MVP
participation due to policy changes to
the MVP inventory as discussed in
section IV.A.4.a. of this rule, impacts
the number of clinicians submitting
quality data for MIPS using the
Medicare Part B Claims-based collection
type. We refer readers to Table 79 of this
section for the change in associated
burden related to the submission of
Medicare Part B claims data for the MVP
quality performance category in the CY
2024 performance period/2026 MIPS
payment year.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77501 through 77504 and
82 FR 53912, respectively), the CY 2019,
CY 2020, CY 2021, CY 2022, and CY
2023 PFS final rules (83 FR 60004
through 60005, 84 FR 63124 through
63126, 85 FR 84975 through 84976, 86
FR 65582 through 65584, and 87 FR
70149 through 70151 respectively) for
our previously finalized requirements
and burden for quality data submission
via the Medicare Part B claims
collection type.
As noted in Table 73, we estimate that
14,402 individual clinicians will collect
and submit quality data via the
Medicare Part B claims collection type,
a decrease of 334 from the currently
approved estimate of 14,736 (87 FR
70150).
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In Table 76, consistent with our
currently approved per response time
figures and using the updated wage
rates in Table 54 of this proposed rule,
we continue to estimate the burden of
quality data submission using Medicare
Part B claims will range from 0.15 hours
(9 minutes) at a cost of $15.51 (0.15 hr
× $103.40) for a computer systems
analyst to 7.2 hours at a cost of $744.48
(7.2 hr × $103.40/hr). The burden also
accounts for the effort needed to become
familiar with MIPS quality measure
specifications.
Consistent with our currently
approved per response time estimates
and using the updated wage rates in
Table 54 of this proposed rule, we
believe that the start-up cost for a
clinician’s practice to review measure
specifications is 7 hours, consisting of 3
hours for a medical and health services
manager at $123.06/hr, 1 hour for a
physician at $274.44/hr, 1 hour for an
LPN at $53.72/hr, 1 hour for a computer
systems analyst at $103.40/hr, and 1
hour for a billing and posting clerk at
$43.08/hr.
In Table 76, considering both data
submission and start-up requirements
for our adjusted number of clinicians,
the estimated time (per clinician) ranges
from a minimum of 7.15 hours (0.15 hr
+ 7 hr) to a maximum of 14.2 hours (7.2
hr + 7 hr). In aggregate, the total annual
time for the CY 2024 performance
period/2026 MIPS payment year ranges
from 102,974 hours (7.15 hr × 14,402
clinicians) to 204,508 hours (14.2 hr ×
14,402 clinicians). The total annual cost
for the CY 2024 performance period/
2026 MIPS payment year ranges from a
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In Table 77, we used the currently
approved burden as the baseline to
calculate the net burden for the quality
data submissions from clinicians using
the Medicare Part B Claims-based
collection type. In aggregate, using our
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currently approved per response time
estimates, the decrease in number of
responses from 14,736 to 14,402 (¥334)
results in a total maximum adjustment
of ¥4,743 hours (¥334 responses × 14.2
hr/response) at a cost of ¥$530,492
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(¥334 response × $1,588.30/response).
For purposes of calculating total burden
associated with this proposed rule as
shown in Tables 99 through 101, only
the maximum burden is used.
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minimum of $12,376,071 to a maximum
of $22,874,697.
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types. This is a decrease of 407
clinicians from the currently approved
estimate of 17,916 clinicians provided
in the CY 2023 PFS final rule (87 FR
70152). Given the number of measures
required for clinicians and groups is the
same, we expect the burden to be the
same for each respondent collecting
data via MIPS CQM or QCDR, whether
the clinician is participating in MIPS as
an individual or group.
Under the MIPS CQM and QCDR
collection types, the individual
clinician or group may either submit the
quality measures data directly to us, log
in and upload a file, or utilize a third
party intermediary to submit the data to
us on the clinician’s or group’s behalf.
We estimate that the burden associated
with the QCDR collection type is similar
to the burden associated with the MIPS
CQM collection type; therefore, we
discuss the burden for both together
below. For MIPS CQM and QCDR
collection types, we estimate an
additional time for respondents
(individual clinicians and groups) to
become familiar with MIPS quality
measure specifications and, in some
cases, specialty measure sets and QCDR
measures. Therefore, we believe the
burden for an individual clinician or
group to review measure specifications
and submit quality data is a total of 9
hours at a cost of $1,039.54 per
response. This consists of 3 hours at
$103.40/hr for a computer systems
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analyst (or their equivalent) to submit
quality data along with 2 hours at
$123.06/hr for a medical and health
services manager, 1 hour at $103.40/hr
for a computer systems analyst, 1 hour
at $53.72/hr for a LPN, 1 hour at $43.08/
hr for a billing clerk, and 1 hour at
$274.44/hr for a physician to review
measure specifications. Additionally,
clinicians and groups who do not
submit data directly will need to
authorize or instruct the qualified
registry or QCDR to submit quality
measures’ results and numerator and
denominator data on quality measures
to us on their behalf. We estimate the
time and effort associated with
authorizing or instructing the quality
registry or QCDR to submit this data
will be approximately 5 minutes (0.083
hr) at $103.40/hr for a computer systems
analyst at a cost of $8.15 (0.083 hr ×
$103.40/hr). Overall, we estimate 9.083
hr/response (3 hr + 2 hr + 1 hr + 1 hr
+ 1 hr + 1 hr + 0.083 hr) at a cost of
$1,039.54/response [(3 hr × $103.40/hr)
+ (2 hr × $123.06/hr) + (1 hr × $274.44/
hr) + (1 hr × $103.40/hr) + (1 hr ×
$53.72/hr) + (1 hr × $43.08/hr) + (0.083
hr × $103.40/hr)].
In Table 78, for the CY 2024
performance period/2026 MIPS
payment year, in aggregate, we estimate
a burden of 159,034 hours [9.083 hr/
response × 17,509 responses] at a cost of
$18,201,306 (17,509 responses ×
$1,039.54/response).
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(5) Quality Data Submission by
Individuals and Groups Using MIPS
CQM and QCDR Collection Types
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621).
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77504 through 77505 and
82 FR 53912 through 53914,
respectively), the CY 2019, CY 2020, CY
2021, CY 2022, and CY 2023 PFS final
rules (83 FR 60005 through 60006, 84
FR 63127 through 63128, 85 FR 84977
through 84979, 86 FR 65584 through
65586, and 87 FR 70151 through 70153,
respectively) for our previously
finalized requirements and burden for
quality data submission via the MIPS
CQM and QCDR collection types. We
refer readers to Table 74 for the
estimated change in associated burden
for quality data submission using MIPS
CQM and QCDR collection types related
to MVP and subgroup reporting in the
CY 2024 performance period/2026 MIPS
payment year.
As noted in Tables 73 and 74, based
on data from the CY 2021 performance
period/2023 MIPS payment year, for the
CY 2024 performance period/2026 MIPS
payment year, we assume that 17,509
clinicians (11,197 individuals and 6,312
groups and virtual groups) will submit
quality data as individuals or groups
using MIPS CQM or QCDR collection
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MIPS payment year results in a decrease
of 3,697 hours (¥407 responses × 9.083
hr/response) at a cost of ¥$423,093
(¥407 responses × $1,039.54/response).
EP07AU23.097
(87 FR 70151 through 70153). In
aggregate, using the unchanged
currently approved time per response
estimate, the decrease of 407
respondents from 17,916 to 17,509 for
the CY 2024 performance period/2026
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In Table 79, we calculated the net
change in estimated burden for quality
performance category submissions using
the MIPS CQM and QCDR collection
type by using the currently approved
burden in the CY 2023 PFS final rule
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(6) Quality Data Submission by
Clinicians and Groups: eCQM
Collection Type
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The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621).
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77505 through 77506 and
82 FR 53914 through 53915), CY 2019
PFS final rule (83 FR 60006 through
60007), CY 2020 PFS final rule (84 FR
63128 through 63130), CY 2021 PFS
final rule (85 FR 84979 through 84980),
the CY 2022 PFS final rule (86 FR 65586
through 65588), and the CY 2023 PFS
final rule (87 FR 70153 through 70154)
for our previously finalized
requirements and burden for quality
data submission via the eCQM
collection types. For the change in
associated burden for quality data
submission related to the provisions
introducing MVP and subgroup
reporting beginning in the CY 2024
performance period/2026 MIPS
payment year, we refer readers to Table
84.
Based on updated data from the CY
2022 performance period/2024 MIPS
payment year data, we assume that
23,346 clinicians will submit quality
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data using the eCQM collection type for
the CY 2024 performance period/2026
MIPS payment year. This is a decrease
of 543 clinicians from the estimate of
23,889 clinicians provided in the CY
2023 PFS final rule (87 FR 70153). We
assume the burden to be the same for
each respondent using the eCQM
collection type, whether the clinician is
participating in MIPS as an individual
or group.
Under the eCQM collection type, the
individual clinician or group may either
submit the quality measures data
directly to us from their eCQM, log in
and upload a file, or utilize a third-party
intermediary to derive data from their
certified EHR technology (CEHRT) and
submit it to us on the clinician’s or
group’s behalf.
To prepare for the eCQM collection
type, the clinician or group must review
the quality measures on which we will
be accepting MIPS data extracted from
eCQMs, select the appropriate quality
measures, extract the necessary clinical
data from their CEHRT, and submit the
necessary data to a QCDR/qualified
registry or use a health IT vendor to
submit the data on behalf of the
clinician or group. We assume the
burden for collecting quality measures
data via eCQM is similar for clinicians
and groups who submit their data
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directly to us from their CEHRT and
clinicians and groups who use a health
IT vendor to submit the data on their
behalf. This includes extracting the
necessary clinical data from their
CEHRT and submitting the necessary
data to a QCDR/qualified registry.
We estimate that it will take no more
than 2 hours at $103.40/hr for a
computer systems analyst to submit the
actual data file. The burden will also
involve becoming familiar with MIPS
quality measure specifications. In this
regard, we estimate it will take 6 hours
for a clinician or group to review
measure specifications. Of that time, we
estimate 2 hours at $123.06/hr for a
medical and health services manager, 1
hour at $274.44/hr for a physician, 1
hour at $103.40/hr for a computer
systems analyst, 1 hour at $53.72/hr for
an LPN, and 1 hour at $43.08/hr for a
billing clerk. Overall, we estimate a cost
of $927.56/response [(2 hr × $103.40/hr)
+ (2 hr × $123.06/hr) + (1 hr × $274.44/
hr) + (1 hr × $103.40/hr) + (1 hr ×
$53.72/hr) + (1 hr × $43.08/hr)].
In Table 80, for the CY 2024
performance period/2026 MIPS
payment year, in aggregate, we estimate
a burden of 186,768 hours [8 hr × 23,346
responses] at a cost of $21,654,816
(23,346 responses × $927.56/response).
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In Table 81, we illustrate the net
change in burden for submissions in the
quality performance category using the
eCQM collection type from the currently
approved burden in the CY 2023 PFS
final rule (87 FR 70153 through 70154).
In aggregate, using our currently
approved time per response burden
estimate, the decrease of 543
respondents from 23,889 to 23,347 for
the CY 2024 performance period/2026
MIPS payment year results in a decrease
of 4,344 hours (¥543 responses × 8 hr/
response) at a cost of ¥$503,665 (¥543
responses × $927.56/response).
(7) ICRs Regarding Burden for MVP
Reporting
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621).
(a) Burden for MVP Reporting
Requirements
In the CY 2022 PFS final rule, we
finalized an option for clinicians
choosing to report MVPs to participate
through subgroups beginning with the
CY 2023 performance period/2025 MIPS
payment year (86 FR 65392 through
65394). We refer readers to the CY 2022
and CY 2023 PFS final rules for our
previously finalized burden
assumptions and requirements for
submission data for the MVP
performance category, and for the
estimated number of clinicians
participating as subgroups in the CY
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2023 performance period/2025 MIPS
payment year (86 FR 65590 through
65592 and 87 FR 70155).
In section IV.A.4.b. of this rule, we are
proposing to add five new MVPs to the
MVP Inventory. Additionally, we are
proposing to consolidate the previously
finalized Promoting Wellness and
Optimizing Chronic Disease
Management MVPs into a single
consolidated primary care MVP titled
Value in Primary Care MVP. Therefore,
MVP participants will have a total of
sixteen MVPs available for the CY 2024
performance period/2026 MIPS
payment year. Due to the availability of
new MVPs, we expect an increase in the
projected number of MVP participants.
For each newly proposed MVP, we
calculated the average quality measure
submission rate across the measures
available in each MVP for the CY 2021
performance period/2023 MIPS
payment year. The total of these average
quality measure submissions for each
MVP was equivalent to about 2 percent
of total quality measure submissions in
the CY 2021 performance period/2023
MIPS payment year. We assume there
would not be any changes to MVP
submissions due to the proposed
consolidation of the measures in the
Promoting Wellness and Optimizing
Chronic Disease Management MVPs into
a Value in Primary Care MVP, discussed
in section IV.A.4.b. of this rule. That is,
we assume clinicians who would have
submitted the Optimizing Chronic
Disease Management MVP or the
Promoting Wellness MVP would instead
submit the Value in Primary Care MVP.
Therefore, we estimate that 14 percent
of the clinicians will participate in MVP
reporting in the CY 2024 performance
period/2026 MIPS payment year. This is
an increase of 2 percentage points from
the currently approved estimate of 12
percent in the CY 2023 PFS final rule
(87 FR 70155). We refer readers to
Appendix 3: MVP Inventory of this
proposed rule for additional details on
the MVPs proposed for the CY 2024
performance period/2026 MIPS
payment year.
We assume the changes to the existing
MVPs and the addition of new MVPs
will not impact the currently approved
number of subgroups. We expect
clinician participation in subgroups will
be relatively low for the CY 2024
performance period/2026 MIPS
payment year due the voluntary
subgroup reporting option and the
additional burden involved for groups
to organize clinicians into subgroups.
Therefore, we did not make any
adjustments to our previously finalized
assumption in the CY 2023 PFS final
rule (87 FR 70155) of 20 subgroups that
will participate in MVP reporting.
In Table 83, we illustrate the net
change in burden for MVP registration
using the currently approved burden in
the CY 2023 PFS final rule (87 FR 70155
through 70156). In aggregate, for the CY
2024 performance period/2026 MIPS
payment year, the adjustment in the
number of respondents expected to
register for MVP reporting from 7,731 to
9,015 results in an increase of 1,284
responses. In aggregate, when combined
with the currently approved per
response time estimate, this will result
in an increase of 321 hours (2,254 hours
¥ 1,933 hours) at a cost of $33,192
($233,038 ¥ $199,846).
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(i) Burden for MVP Registration:
Individuals, Groups and APM Entities
We refer readers to the CY 2023 PFS
final rule (87 FR 70155 through 70156)
for our previously finalized burden
relevant to MVP registration for
clinicians participating as an individual
and/or group for MVP reporting.
As previously discussed, we estimate
that approximately 14 percent of the
clinicians that currently participate in
MIPS will submit data for the measures
and activities in an MVP. For the CY
2024 performance period/2026 MIPS
payment year, we assume that the total
number of individual clinicians, groups,
subgroups and APM Entities that will
complete the MVP registration process
is 9,015. In Table 82, we estimate that
it will take 2,254 hours (9,015 responses
× 0.25 hr/response) at a cost of $233,038
(9,015 registrations × $25.85/
registration) for individual clinicians,
groups and APM Entities to register for
MVPs in the CY 2024 performance
period/2026 MIPS payment year.
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(ii) Burden for Subgroup Registration
We are not proposing any changes to
our previously finalized subgroup
registration burden. We note that the
proposed subgroup policies in section
IV.A.4.d. of this rule do not impact the
currently approved burden for subgroup
registration. We discuss in detail below,
the proposed policies and our reasons
for not changing the currently approved
burden for subgroup registration. The
burden relevant to the subgroup
registration requirement is currently
approved by OMB under control
number 0938–1314 (CMS–10621).
Consequently, we are not proposing any
changes pertaining to subgroup
registration under that control number.
In section IV.A.4.d.(2) of this rule, we
are proposing to modify
§ 414.1365(e)(2)(ii) to read that, an MVP
Participant that is a subgroup will
receive the same reweighting that is
applied to its affiliated group, but that
for the CY 2023 MIPS performance
period/2025 MIPS payment year, if
reweighting is not applied to the
affiliated group, the subgroup may
receive reweighting in the
circumstances independent of the
affiliated group as described in
§ 414.1365(e)(2)(ii)(A) and (B). We
believe that the proposed modification
to the subgroup reweighting policy
would not impact the currently
approved burden for subgroup
registration because it would not change
any requirements related to subgroup
registration.
In section IV.A.4.d.(3) of this rule, we
are proposing to modify the text at
§ 414.1365(e)(3) to read that if an MVP
Participant, that is not an APM Entity or
a subgroup, is eligible for facility-based
scoring, a facility-based score will also
be calculated in accordance with
§ 414.1380(e). Additionally, we are
proposing to add § 414.1365(e)(4)(i) to
read that for subgroups, the affiliated
group’s complex patient bonus will be
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added to the final score. The proposed
revisions would not impact the
currently approved burden for subgroup
registration since these changes only
modify the regulatory text relevant to
subgroup scoring policies.
In section IV.A.4.d.(4) of this rule, we
are proposing to modify § 414.1385(a)(1)
to read that a MIPS eligible clinician,
subgroup, or group (including their
designated support staff), or a thirdparty intermediary as defined at
§ 414.1305, may submit a request for a
targeted review. The proposed change
would not impact the currently
approved burden for subgroup
registration since the addition of
subgroups to the targeted review
language only modifies the regulatory
text relevant to the targeted review
process and does not change the
subgroup registration requirements. We
finalized in the CY 2017 Quality
Payment Program final rule that a MIPS
eligible clinician or group may request
a targeted review of the calculation of
the MIPS payment adjustment factor
under section 1848(q)(6)(A) of the Act
and, as applicable, the calculation of the
additional MIPS payment adjustment
factor under section 1848(q)(6)(C) of the
Act (collectively referred to as the MIPS
payment adjustment factors) applicable
to such MIPS eligible clinician or group
for a year (81 FR 77546). We note that
information collection requirements,
such as targeted reviews, that are
imposed after an administrative action
are not subject to the PRA under 5 CFR
1320.4(a)(2). Therefore, we are not
making any adjustments to the currently
approved subgroup registration burden
because of the proposal to add
subgroups to the targeted review
regulation text.
(iii) Burden for MVP Quality
Performance Category Submission.
In the CY 2022 PFS final rule (86 FR
65411 through 65415), we previously
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finalized the reporting requirements for
the MVP quality performance category
at § 414.1365(c)(1)(i). As discussed in
section V.B.11.e. of this rule, we did not
propose new requirements to submit
data for the quality performance
category of MVPs. Therefore, we did not
propose any changes to our currently
approved per response time estimates
for submitting the MVP quality
performance category data.
As described in section V.B.11.e.(7)(a)
of this proposed rule, we estimate that
14 percent of the clinicians who
participated in MIPS for the CY 2021
performance period/2023 MIPS
payment year will submit data for the
quality performance category of MVP in
the CY 2024 performance period/2026
MIPS payment year. We also estimate
there will be 20 subgroup reporters in
the CY 2024 performance period/2026
MIPS payment year. In Table 84, we
estimate that 3,801 clinicians and 10
subgroups will submit data using
eCQMs collection type at $614.45/
response (see line q for eCQMs); 2,850
clinicians and 10 subgroups will submit
data using MIPS CQM and QCDR
collection type at $683.73/response (see
line q for CQM and QCDRs); and 2,344
clinicians and 0 subgroups will submit
data for the MVP quality performance
category using the Medicare Part B
claims collection type at $1,055.70/
response (see line q for claims). For the
CY 2024 performance period/2026 MIPS
payment year, using our currently
approved per response time estimates
for the clinicians and subgroups
submitting data for the MVP quality
performance category, we estimate a
burden of 20,198 hours [5.3 hr × 3,811
(3,801 +10) responses] at a cost of
$2,341,669 (3,811 responses × $614.45/
response) for the eCQM collection type,
17,074 hours [5.97 hr × 2,860 (2,443
+10)] at a cost of $1,955,468 (2,860
responses × $683.73/responses) for the
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MIPS CQM and QCDR collection type,
and 18,974 hours (9.44 hr × 2,344
clinician responses) at a cost of
$2,474,561 (2,344 responses ×
$1,055.70/response) for the Medicare
Part B claims collection type.
Table 85 illustrates the proposed
changes in estimated burden for
clinicians who will submit the MVP
quality performance category utilizing
the eCQM, MIPS CQM and QCDR, and
claims collection types in the CY 2024
performance period/2026 MIPS
payment year. We note we used the
currently approved burden in the CY
2023 PFS final rule (87 FR 70157
through 70159) as the baseline to
determine the net change in burden. In
aggregate, when combined with our
currently approved per response time
estimate, the increase in 1,284
respondents who will submit data for
the MVP quality performance category
will result in an increase of 2,878 hours
and $333,633 for the eCQM collection
type, an increase of 2,430 hours and
$278,273 for the CQM and QCDR
collection type, and an increase of 3,153
hours and $352,599 for the claims
collection type.
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(8) Beneficiary Responses to CAHPS for
MIPS Survey
The following proposed changes
associated with CAHPS survey vendors
to submit data for eligible clinicians will
be submitted to OMB for review under
control number 0938–1222 (CMS–
10450). We note that the associated
burden will be made available for public
review and comment under the standard
non-rule PRA process which includes
the publication of 60- and 30-day
Federal Register notices.
We refer readers to the CY 2021
Quality Payment Program final rule (85
FR 84982 through 84983) for our
previously finalized estimated burden
associated with beneficiary responses to
the CAHPS for MIPS Survey.
In section IV.A.4.f.(1)(c)(ii) of this
proposed rule, we are proposing to
require Spanish language administration
of the CAHPS for MIPS Survey.
Specifically, we are proposing to require
organizations to contract with a CMSapproved survey vendor that, in
addition to administering the survey in
English, will administer the Spanish
survey translation to Spanish-preferring
patients using the procedures detailed
in the CAHPS for MIPS Quality
Assurance Guidelines. For requirements
and burden, we estimate an average
administration time of 13.1 minutes (or
0.2183 hr) at a pace of 4.5 items per
minute for the English version of the
survey. For the Spanish version, we
estimate an average administration time
of 15.7 minutes (assuming 20 percent
more words in the Spanish translation).
However, since less than 1 percent of
surveys were administered in Spanish
for the CY 2022 performance period, we
are not updating our burden estimates to
include the time associated with the
Spanish version at this time.
In this rule, we are adjusting the
estimated number of beneficiaries that
will respond to the CAHPS for MIPS
survey from the previously approved
number of beneficiaries in the CY 2021
PFS final rule (85 FR 84982 through
84983). For the CY 2024 performance
period/2026 MIPS payment year, we are
estimating that 100 groups will elect to
report on the CAHPS for MIPS survey.
Based on the number of complete and
partially complete surveys for groups
participating in CAHPS for MIPS survey
administration for the CY 2022
performance period/2024 MIPS
payment year, we estimate that an
average of 255 beneficiaries will
respond per group for the CY 2024
performance period/2026 MIPS
payment year. Therefore, we estimate
that the CAHPS for MIPS survey will be
administered to approximately 25,500
beneficiaries for the CY 2024
performance period/2026 MIPS
payment year. This adjustment will
result in a decrease of 4,452 beneficiary
respondents from our currently
approved estimate of 29,952 beneficiary
respondents in the CY 2021 PFS final
rule (85 FR 84982). As shown in Table
86, for the CY 2024 performance period/
2026 MIPS payment year, we continue
to estimate that the per response time to
administer the survey is 0.2183 hours.
This will result in an estimated annual
burden of 5,567 hours at a cost of
$165,750.
In Table 87, we illustrate the net
change in estimated burden for
beneficiary response requirements using
the currently approved burden in the
CY 2021 PFS final rule (85 FR 84982
through 84983). In aggregate, using our
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the CAHPS for MIPS survey results in
a total annual adjustment of ¥972 hours
at a cost of ¥$28,938 for the CY 2024
performance period/2026 MIPS
payment year.
(9) Group Registration for CAHPS for
MIPS Survey
The following proposed changes will
be submitted to OMB for review under
control number 0938–1222 (CMS–
10450). We note that the associated
burden will be made available for public
review and comment under the standard
non-rule PRA process which includes
the publication of 60- and 30-day
Federal Register notices.
We refer readers to CY 2019 PFS final
rule (83 FR 60009 through 60010) for
the previously approved requirements
and burden for group registration for the
CAHPS for MIPS Survey.
In this rule, we are adjusting the
estimated number of groups registering
for the CAHPS for MIPS Survey that
were previously approved in the CY
2019 PFS final rule (83 FR 60009
through 60010) based on updated data
from the CY 2022 performance period/
2024 MIPS payment year. We estimate
that 266 groups will register for the
CAHPS for MIPS Survey for the CY
2024 performance period/2026 MIPS
payment year. This adjustment will
result in a decrease of 16 group
registrations from our currently
approved estimate of 282 groups in the
CY 2019 PFS final rule (83 FR 60010).
In Table 88, for the CY 2024
performance period/2026 MIPS
payment year, we continue to estimate
that the per response time is 0.75 hours.
This will result in an estimated annual
burden of 200 hours (266 groups × 0.75
hr/registration) at a cost of $20,628 (266
registrations × $77.55/registration) for a
computer systems analyst).
In Table 89, we illustrate the net
change in estimated burden for groups
registering for the CAHPS for MIPS
Survey using the currently approved
burden in the CY 2019 PFS final rule
(83 FR 60009 through 60010). In
aggregate, using our currently approved
per response time estimate, the decrease
in the number of respondents registering
for the CAHPS for MIPS Survey from
282 to 266 results in a total annual
adjustment of ¥12 hours (¥16
responses × 0.75 hr/nomination) at a
cost of ¥$1,241 for the CY 2024
performance period/2026 MIPS
payment year.
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currently approved per response time
estimate, the decrease in the number of
respondents submitting responses for
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for CMS consideration during the 2023
Annual Call for Quality Measures, we
are adjusting our burden estimates for
the CY 2024 performance period/2026
MIPS payment year.
In this rule, we estimate we will
receive 31 quality measure submissions
during the 2023 Annual Call for Quality
Measures, an increase of 2 from the
currently approved number of quality
measure submissions for consideration
(87 FR 70159 through 70160). We are
not proposing any changes to the 5.5
hour (2.4 hr for practice administrator +
3.1 hr for clinician) per response time
estimate for quality measure
submissions.
In Table 90, we estimate an annual
burden of 171 hours (31 measure
submissions × 5.5 hr/measure) at a cost
of $35,529 (31 measure submissions ×
$1,146.11/submission for the CY 2024
performance period/2026 MIPS
payment year.
In Table 91, we illustrate the net
change in estimated burden for the call
for quality measures using the currently
approved burden in the CY 2023 PFS
final rule (87 FR 70159 through 70160).
In aggregate, the estimated increase in
the number of quality measure
submissions will result in an adjustment
of +11 hours (+2 measure submissions
× 5.5 hr/measure submission) at a cost
of $2,292 (+2 measure submissions ×
$1,146.11/measure submission) for the
CY 2024 performance period/2026 MIPS
payment year.
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f. ICRs Regarding the Call for MIPS
Quality Measures
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621).
This rule does not propose any new
or revised collection of information
requirements or burden related to the
call for MIPS quality measures.
However, based on the actual number of
quality measure submissions received
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g. ICRs Regarding Promoting
Interoperability Data (§§ 414.1375 and
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(1) Background
For the CY 2024 performance period/
2026 MIPS payment year, MIPS eligible
clinicians, groups, subgroups, and APM
Entities can submit Promoting
Interoperability performance category
data through direct log in and upload,
or log in and attest submission types.
We note that the log in and attest
submission type is only available for the
Promoting Interoperability performance
category and is not available for the
quality performance category. With the
exception of submitters who elect to use
the log in and attest submission type for
the Promoting Interoperability
performance category, we anticipate that
MIPS eligible individual clinicians,
groups, subgroups, and APM Entities
will use the same data submission type
for both the quality and Promoting
Interoperability performance categories
and that the clinicians, practice
managers, and computer systems
analysts involved in supporting the
quality data submission will also
support the Promoting Interoperability
data submission process. The following
burden estimates show only incremental
hours required above and beyond the
time already accounted for in the
quality data submission process. We
note that this analysis assesses burden
by performance category and
submission type and emphasizes that
MIPS is a consolidated program. We
analyze data submitted by MIPS eligible
clinicians, groups, subgroups and APM
Entities, and assesses clinician
performance based on all the four MIPS
performance categories, as applicable.
(2) Reweighting Applications for
Promoting Interoperability and Other
Performance Categories
The following proposed changes will
be submitted to OMB for review under
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control number 0938–1314 (CMS–
10621).
We refer readers to the CY 2017
Quality Payment Program final rule (81
FR 77240 through 77243), CY 2018
Quality Payment Program final rule (82
FR 53918 through 53919), and the CY
2019, CY 2020, CY 2021, CY 2022, and
CY 2023 PFS final rules (83 FR 60011
through 60012, 84 FR 63134 through
63135, 85 FR 84984 through 84985, 86
FR 65596 through 65598, and 87 FR
70160 through 70162, respectively) for
our previously finalized requirements
for, and our analysis of the information
collection and reporting burden
associated with, reweighting
applications for Promoting
Interoperability and other performance
categories.
As established in the CY 2017 and CY
2018 Quality Payment Program final
rules, MIPS eligible clinicians may
submit an application requesting
reweighting to zero percent for the
Promoting Interoperability, quality, cost,
and/or improvement activities
performance categories under specific
circumstances as set forth in
§ 414.1380(c)(2), including, but not
limited to, extreme and uncontrollable
circumstances and significant hardship
or other type of exception (81 FR 77240
through 77243, 82 FR 53680 through
53686, and 82 FR 53783 through 53785).
Table 92 summarizes our analysis of the
estimated burden for MIPS eligible
clinicians to apply for reweighting of
the Promoting Interoperability
performance category to zero percent
due to a significant hardship or other
exception as provided in
§ 414.1380(c)(2)(i)(C).
Respondents (MIPS eligible
individual clinicians, groups, or APM
Entities) who apply for a reweighting of
the quality, cost, and/or improvement
activities performance categories have
the option of applying for reweighting of
the Promoting Interoperability
performance category on the same
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online form. We assume respondents
applying for a reweighting of the
Promoting Interoperability performance
category due to extreme and
uncontrollable circumstances (for
example, PHE for COVID–19, vendor
issues, etc.) will also request a
reweighting of at least one of the other
performance categories simultaneously
and not submit multiple reweighting
applications.
In section IV.A.4.f.(4)(f) of this rule,
we are proposing to continue the
existing policy of reweighting the
Promoting Interoperability performance
category for clinical social workers for
the CY 2024 performance period/2026
MIPS payment year and making the
corresponding revisions to the
regulatory text at
§ 414.1380(c)(2)(i)(A)(4)(iii). In our
analysis of the information collection
and reporting burden, we are not
adjusting our estimated number of
respondents submitting reweighting
applications due to this proposal
because these proposed changes only
modify the regulatory text and do not
change the existing reweighting policy
for these clinician types participating in
MIPS in the CY 2024 performance
period/2026 MIPS payment year. To
further clarify, these clinician types are
automatically reweighted for the
Promoting Interoperability performance
category and do not need to submit a
reweighting application, and therefore
do not impact our information
collection and reporting burden
analysis.
Based on the number of reweighting
applications received at the time of the
publication of this rule for the CY 2022
performance period/2024 MIPS
payment year, we are adjusting our
burden estimates relevant to this ICR. In
this proposed rule, we estimate that we
will receive a total of 29,227
applications to request reweighting for
any or all the four MIPS performance
categories for the CY 2024 performance
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period/2026 MIPS payment year. Out of
the 29,227, we estimate that 2,706
respondents will submit a request to
reweight the Promoting Interoperability
performance category to zero percent
due to a significant hardship or other
exception as provided in
§ 414.1380(c)(2)(i)(C). We estimate the
remaining 26,510 respondents will
submit a request to reweight one or
more of the quality, cost, Promoting
Interoperability, or improvement
activities performance categories due to
an extreme or uncontrollable
circumstance. Additionally, we estimate
11 APM Entities will submit an extreme
and uncontrollable circumstances
exception application for the CY 2024
performance period/2026 MIPS
payment year. This adjustment results
in an increase of 23,788 respondents
compared to our currently approved
estimate of 5,439 respondents (87 FR
70161). This increase is based on the
actual number of reweighting
applications submitted for the CY 2022
performance period/2024 MIPS
payment year. We note this estimate
reflects the significant increase in the
number of submitted applications due
to extending the deadline, as a result of
the ongoing PHE for COVID–19 at the
time, for submitting the reweighting
applications for the CY 2022
performance period/2024 MIPS
payment year to March 3rd, 2023.
Consistent with our assumptions in
the CY 2023 PFS final rule (87 FR 70160
through 70162), we continue to estimate
it will take 0.25 hours for a computer
system analyst to complete and submit
the reweighting application. In Table 92,
we estimate an annual burden of 7,307
hours (29,227 applications × 0.25 hr/
application) at a cost of $755,518
(29,227 applications × $25.85/
application).
In Table 93, we illustrate the
proposed net change in estimated
burden for submission of reweighting
applications for Promoting
Interoperability and other performance
categories using the currently approved
burden in the CY 2023 PFS final rule
(87 FR 70160 through 70162). The
proposed adjustment in the estimated
number of respondents, from 5,439 to
29,227 respondents, results in an
increase of 23,788 respondents. In
aggregate, using our currently approved
per response time estimate, as shown in
Table 93, the proposed increase in
23,788 respondents results in an
increase of 5,947 hours (+23,788
responses × 0.25 hr/response) and
$614,920 (+5,947 hr × $103.40/hr) for
the CY 2024 performance period/2026
MIPS payment year.
(3) Submitting Promoting
Interoperability Data
requirements or burden related to the
submission of Promoting
Interoperability performance category
data. We note the policy proposals in
section IV.A.4.f.(4) of this rule related to
the submission of Promoting
Interoperability data do not impact the
currently approved estimated burden for
We are not proposing any new or
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this ICR. We discuss in detail below the
proposed policies and our reasons for
not changing our currently approved
burden for submission of Promoting
Interoperability data. The submission of
Promoting Interoperability data
requirements and burden are currently
approved by OMB under control
number 0938–1314 (CMS–10621).
Consequently, we are not proposing any
submission of Promoting
Interoperability changes under that
control number.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77509 through 77511, and
82 FR 53919 through 53920,
respectively), and the CY 2019, CY
2020, CY 2021, CY 2022, and CY 2023
PFS final rules (83 FR 60013 through
60014, 84 FR 63135 through 63137, 85
FR 84985 through 84987, 86 FR 65598
through 65600, and 87 FR 70162
through 70164, respectively) for our
previously finalized requirements and
burden for submission of data for the
Promoting Interoperability performance
category.
In section IV.A.4.f.(4)(b)of this
proposed rule, we are proposing that for
the CY 2026 MIPS payment year, the
performance period for the Promoting
Interoperability performance category is
a minimum of any continuous 180-day
period within CY 2024, up to and
including the full CY 2024 (January 1,
2024, through December 31, 2024). We
are proposing to modify the Promoting
Interoperability performance category
performance period that we established
under § 414.1320(h)(1) to remove
subsequent years, include the 2025
MIPS payment year, and add
§ 414.1320(i)(1) to reflect our proposal.
We assume MIPS eligible clinicians and
groups that currently submit data for the
Promoting Interoperability performance
category would utilize the CEHRT for an
entire calendar year performance period
and therefore, the proposed increase in
the length of the performance period for
the Promoting Interoperability
performance category from 90 to 180
days would not create additional burden
for MIPS eligible clinicians and groups
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that would submit data for the
Promoting Interoperability performance
category. We note that this is consistent
with the discussion of burden for the
above policy in the FY 2022 IPPS final
rule (86 FR 45515).
In section IV.A.4.f.(4)(d)(i)of this rule,
we are proposing changes to the Query
of Prescription Drug Monitoring
Program Measure under the Electronic
Prescribing Objective. Specifically, we
are proposing to modify the second
exclusion criterion to state that any
MIPS eligible clinician who does not
electronically prescribe any Schedule II
opioids or Schedule III or IV drugs
during the performance period can
claim the second exclusion. The
proposed changes would not affect the
requirements for MIPS eligible
clinicians and groups that submit data
for the Promoting Interoperability
performance category since the revision
is meant to revise the previously
finalized second exclusion in the CY
2018 Quality Payment Program final
rule (82 FR 53679). Therefore, we are
not making any adjustments to our
currently approved estimated burden for
this ICR.
In section IV.A.4.f.(4)(d)(ii) of this
rule, we are proposing to revise the ePrescribing measure description in
Table 45 to read ‘‘At least one
permissible prescription written by the
MIPS eligible clinician is transmitted
electronically using CEHRT’’ and the
numerator will be updated to read to
indicate ‘‘Number of prescriptions in
the denominator generated and
transmitted electronically’’ to reflect the
removal of the health IT certification
criterion ‘‘drug-formulary and preferred
drug list checks.’’ These proposed
revisions would not affect the
requirements for MIPS eligible
clinicians and groups that submit data
for the Promoting Interoperability
performance category since these
changes provide technical updates to
the e-prescribing measure. Therefore,
we are not making any adjustments to
our currently approved estimated
burden for this ICR.
In section IV.A.4.f.(4)(d)(iii)of this
rule, we are proposing to modify our
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requirements for the SAFER Guides
measure beginning with the CY 2024
performance period/2026 MIPS
payment year and subsequent years, to
require MIPS eligible clinicians
conduct, and therefore attest ‘‘yes’’ an
annual self-assessment of the CEHRT
using the High Priority Practices SAFER
Guide (available at https://
www.healthit.gov/topic/safety/saferguides), at any point during the calendar
year in which the performance period
occurs. We note we have captured the
estimated burden for reporting this
measure in the CY 2022 PFS final rule
(86 FR 65599) and the proposed revision
would not affect the data collection and
submission requirements for MIPS
eligible clinicians and groups that
submit data for the Promoting
Interoperability performance category.
Therefore, we are not making any
adjustments to our currently approved
estimated burden for this ICR.
h. ICRs Regarding the Nomination of
Promoting Interoperability Measures
The following proposed changes
associated with the information
collection related to the nomination of
Promoting Interoperability measures
will be submitted to OMB for review to
remove the information collection
relevant to the nomination of Promoting
Interoperability measures under control
number 0938–1314 (CMS 10621). This
rule does create any new or revised
collection of information requirements
or burden related to the nomination of
Promoting Interoperability performance
category measures. Due to a consistent
decline in the number of submissions
received for the Promoting
Interoperability performance category
measures, we estimate to receive fewer
than 10 responses for this ICR.
Therefore, we are proposing to remove
the ICR for nomination of Promoting
Interoperability performance category
measures.
As shown in Table 94, we estimate an
annual burden of zero hours at a cost of
$0 for the CY 2024 performance period/
2026 MIPS payment year.
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In Table 95, we illustrate the
proposed net change in estimated
burden for nomination of Promoting
Interoperability measures using the
currently approved burden in the CY
2023 PFS final rule (87 FR 70163). The
proposed removal of the ICR for
nomination of Promoting
Interoperability measures results in a
decrease of 5 hours (-10 responses × 0.5
hr/response) and a decrease of $918 for
the CY 2024 performance period/2026
MIPS payment year.
i. ICRs Regarding Improvement
Activities Submission (§§ 414.1305,
414.1355, 414.1360, and 414.1365)
submission changes under that control
number.
In section IV.A.4.f.(3)(b)(ii) of this
proposed rule, we are proposing
changes to the improvement activities
inventory for the CY 2024 performance
period/2026 MIPS payment year and
future years as follows: adding five new
improvement activities; modifying one
existing improvement activity; and
removing four previously adopted
improvement activities. We do not
believe the changes will impact our
currently approved time for interested
parties to submit information because
MIPS eligible clinicians are still
required to submit the same number of
activities and the estimated per
response time for each activity is
uniform. Therefore, we are not
proposing to adjust our currently
approved burden for improvement
activities submission as a result of this
proposal.
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j. ICRs Regarding the Nomination of
Improvement Activities (§ 414.1360)
The proposed changes associated with
data submission will be submitted to
OMB for review under control number
0938–1314 (CMS 10621).
In this rule, based on the actual
number of respondents that submitted
improvement activity nominations, we
are proposing to adjust the estimated
number of improvement activity
nominations that were previously
approved in the CY 2022 PFS final rule
(86 FR 65603 through 65605). We
estimate that we will receive
approximately 15 improvement activity
nominations for the CY 2024
performance period/2026 MIPS
payment year. This adjustment will
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We are not proposing any new or
revised collection of information
requirements or burden related to the
submission of improvement activity
data. We note that the policy proposal
in section IV.A.4.f.(3) of this proposed
rule related to the improvement
activities submission does not impact
our currently estimated burden for this
ICR. We discuss in detail below the
proposed policy and reasons that it does
not change our currently approved
burden for improvement activities
submission. The improvement activity
submission requirements and burden
are currently approved by OMB under
control number 0938–1222 (CMS–
10450). Consequently, we are not
proposing any improvement activity
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result in a decrease of 16 improvement
activity nominations from our currently
approved estimate of 31 nominations in
the CY 2022 PFS final rule (86 FR
65605). In Table 96, for the CY 2024
performance period/2026 MIPS
payment year, we continue to estimate
that the per response time is 4.4 hours.
This will result in an estimated annual
burden of 66 hours (15 nominations ×
4.4 hr/nomination) at a cost of $11,755
(15 × [(2.8 hr × $123.06/hr for a medical
and health services manager) + (1.6 hr
× $274.44/hr for a physician)]).
In Table 97, we illustrate the
proposed net change in estimated
burden for nomination of improvement
activities using the currently approved
burden in the CY 2022 PFS final rule
(86 FR 65605). In aggregate, using our
currently approved per response time
estimate, the proposed decrease in the
number of respondents submitting
improvement activity nominations
results in a total annual adjustment of
-70 hours (-16 responses × 4.4 hr/
nomination) at a cost of -$12,539 (-16 x
[(2.8 hr × $123.06/hr) + (1.6 hr ×
$274.44/hr)]) for the CY 2024
performance period/2026 MIPS
payment year.
k. Nomination of MVPs
Medicare Parts A and B claims
submission process (OMB control
number 0938–1197; CMS–1500 and
CMS–1490S) is used to collect data on
cost measures from MIPS eligible
clinicians. MIPS eligible clinicians are
not required to provide any
documentation by CD or hardcopy.
Moreover, the policies in this rule do
not result in the need to add or revise
or delete any claims data fields.
Consequently, we are not making any
changes under that control number.
requirements or burden related to the
Partial QP Elections to participate in
MIPS as a MIPS eligible clinician. The
requirements and burden for Partial QP
Elections are currently approved by
OMB under control number 0938–1314
(CMS–10621). Consequently, we are not
proposing any changes to Partial QP
Elections under that control number.
This rule does not propose any new
or revised collection of information
requirements or burden related to the
nomination of MVPs. The requirements
and burden for nomination of MVPs are
currently approved by OMB under
control number 0938–1314 (CMS–
10621). Consequently, we are not
proposing any changes to the
nomination of MVPs under that control
number.
l. ICRs Regarding the Cost Performance
Category (§ 414.1350)
The cost performance category relies
on administrative claims data. The
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m. ICRs Regarding Partial QP Elections
(§§ 414.1310(b) and 414.1430)
This rule is not proposing any new or
revised collection of information
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n. ICRs Regarding Other Payer
Advanced APM Determinations: PayerInitiated Process (§ 414.1445) and
Eligible Clinician-Initiated Process
(§ 414.1445)
This rule is not proposing any new or
revised collection of information
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requirements related to Other Payer
Advanced APM determinations.
(1) Payer-Initiated Process (§ 414.1445)
This rule is not proposing any new or
revised collection of information
requirements related to the PayerInitiated Process. The requirements and
burden associated with this information
collection are currently approved by
OMB under control number 0938–1314
(CMS–10621). Consequently, we are not
proposing any changes to the PayerInitiated process under that control
number.
(2) Eligible Clinician-Initiated Process
(§ 414.1445)
This rule is not proposing any new or
revised collection of information
requirements or burden related to the
Eligible Clinician-Initiated Process. The
requirements and burden associated
with this information collection are
currently approved by OMB under
control number 0938–1314 (CMS–
10621). Consequently, we are not
proposing any changes to the Eligible
Clinician-Initiated Process under that
control number.
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(3) Submission of Data for QP
Determinations Under the All-Payer
Combination Option (§ 414.1440)
This rule is not proposing any new or
revised collection of information
requirements or burden related to the
Submission of Data for QP
Determinations under the All-Payer
Combination Option. The requirements
and burden for the All-Payer
Combination option are currently
approved by OMB under control
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number 0938–1314 (CMS–10621).
Consequently, we are not proposing any
changes under that control number.
o. ICRs Regarding Voluntary
Participants Election To Opt-Out of
Performance Data Display on Compare
Tools (§ 414.1395)
This rule is not proposing any new or
revised collection of information
requirements or burden related to the
election by voluntary participants to
opt-out of public reporting on Compare
Tools. The requirements and burden
associated with this information
collection are currently approved by
OMB under control number 0938–1314
(CMS–10621). Consequently, we are not
proposing any changes to the election of
voluntary participants to opt-out of
performance data display on Compare
Tools under that control number.
p. Summary of Annual Quality Payment
Program Burden Estimates
Table 99 summarizes this proposed
rule’s total burden estimates for the
Quality Payment Program for the CY
2024 performance period/2026 MIPS
payment year.
In the CY 2023 PFS final rule, the
total estimated burden for the CY 2024
performance period/2026 MIPS
payment year (see Table 99, row a) was
710,644 hours at a cost of $75,687,130
(87 FR 70169). Accounting for updated
wage rates and the subset of all Quality
Payment Program ICRs discussed in this
rule compared to the CY 2023 PFS final
rule, the total estimated annual burden
of continuing policies and information
set forth in the CY 2023 PFS final rule
into the CY 2024 performance period/
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2026 MIPS payment year is 626,007
hours at a cost of $70,778,884 (see Table
99, row b). These represent a decrease
of 84,637 hours and a decrease of
$4,908,246. To understand the burden
implications of the policies in this rule,
we provide an estimate of the total
burden associated with continuing the
policies and information collections set
forth in the CY 2023 PFS final rule into
the CY 2024 performance period/2026
MIPS payment year. This burden
estimate of 630,570 hours at a cost of
$71,317,983 (see Table 99, row c)
reflects the availability of more accurate
data to account for all potential
respondents and submissions across all
the performance categories and more
accurately reflects the exclusion of QPs
from all MIPS performance categories,
an increase of 4,563 hours and $539,099
(see Table 99, row d). This burden
estimate is higher than the burden
approved for information collection
related to the CY 2023 PFS final rule
due to updated data and assumptions.
Our total burden estimate for the CY
2024 performance period/2026 MIPS
payment year is 626,568 hours and
$70,858,430 (see Table 99, row e),
which represents an increase of 561
hours and $79,546 from the CY 2023
PFS final rule (see Table 99, row f). The
difference of ¥4,002 hours (561 hours
¥ 4,563 hours) and ¥$459,553 ($79,546
¥ $539,099) (see Table 99, row g)
between this estimate and the total
burden shown in Table 99 is the
decrease in burden associated with
impacts of the policies for the CY 2024
performance period/2026 MIPS
payment year.
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proposed rule. We have divided the
reasons for our change in burden into
those related to proposed policies in the
CY 2024 PFS rule and those related to
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adjustments in burden continued from
the CY 2023 PFS final rule policies that
reflect updated data and revised
methods.
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Table 100 provides the reasons for
changes in the estimated burden for
information collections in the Quality
Payment Program segment of this
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C. Summary of Annual Burden
Estimates for Changes
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D. Submission of PRA-Related
Comments
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We have submitted a copy of this
proposed rule to OMB for its review of
the rule’s information collection
requirements. The requirements are not
effective until they have been approved
by OMB.
To obtain copies of the supporting
statement and any related forms for the
proposed collections discussed in this
section, please visit the CMS website at
https://www.cms.gov/regulations-andguidance/legislation/
paperworkreductionactof1995/pralisting, or call the Reports Clearance
Office at 410–786–1326.
We invite public comments on these
potential information collection
requirements. If you wish to comment,
please submit your comments
electronically as specified in the DATES
and ADDRESSES section of this proposed
rule and identify the rule (CMS–1784–
P) the ICR’s CFR citation, and OMB
control number.
VI. Response to Comments
Because of the large number of public
comments, we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
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this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VII. Regulatory Impact Analysis
A. Statement of Need
In this proposed rule, we are
proposing payment and policy changes
under the Medicare PFS and required
statutory changes under the
Consolidated Appropriations Act, 2021
(CAA, 2021); sections 301, 302, 303,
304, and 305 under the Consolidated
Appropriations Act, 2022 (CAA, 2022);
sections 2003 and 2005 of the SUPPORT
for Patients and Communities Act of
2018, sections 4113, 4114, and 4121
under the Consolidated Appropriations
Act of 2023 (CAA, 2023), section 90004
of the Infrastructure Investment and
Jobs Act, section 6 of the Sustaining
Excellence in Medicaid Act of 2019, and
sections 11101, 11402, 11403, 11407
under the Inflation Reduction Act (IRA).
Our policies in this rule specifically
address: changes to the PFS; other
changes to Medicare Part B payment
policies to ensure that payment systems
are updated to reflect changes in
medical practice, the relative value of
services, and changes in the statute;
updates and refinements to Medicare
Shared Savings Program (Shared
Savings Program) requirements; updates
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to the Quality Payment Program;
updates to the Medicare coverage of
opioid use disorder services furnished
by opioid treatment programs; updates
to certain Medicare provider enrollment
policies; updates to 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); changes to the regulations
associated with the Ambulance Fee
Schedule and the Medicare Ground
Ambulance Data Collection System; and
changes to release Medicare Advantage
risk adjustment data early for use with
Care Compare websites. The policies
reflect CMS’ stewardship of the
Medicare program and overarching
policy objectives for ensuring equitable
beneficiary access to appropriate and
quality medical care.
1. Statutory Provisions
a. Extension of Certain Medicare
Telehealth Flexibilities, Under Section
1834(m) of the Act, as Amended by the
CAA, 2023
Section II.D.1.e. of this proposed rule
implements section 4113, of the CAA,
2023, which extended through CY 2024
several temporary flexibilities for
Medicare telehealth services adopted
during the PHE for COVID–19.
Specifically, section 4113 extended the
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temporary inapplicability of geographic
and location restrictions, extended the
temporary expansion of practitioner
types who can be paid for Medicare
telehealth services, delayed the inperson visit requirements for mental
health services furnished via telehealth,
and extended audio-only flexibilities for
certain telehealth services. This
provision is necessary to fulfill the
statutory requirement to implement this
extension through December 31, 2024.
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b. Drugs and Biological Products Paid
Under Medicare Part B
Section III.A.1. of this proposed rule
proposes regulations text changes to
implement provisions of the Inflation
Reduction Act of 2022 that affect
payment amounts or patient out-ofpocket costs for certain drugs and
biologicals payable under Part B. Two
provisions affect payment amounts for
biosimilar biological products. 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.
Section 11403 makes changes to the
payment limit for certain biosimilar
products with an ASP that is not more
than the ASP of the reference biological
for a period of 5 years. Two other
provisions make statutory changes to
patient 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 inflationadjusted payment amount, beginning on
April 1, 2023. Section 11407 makes
statutory changes to waive the
deductible for insulin that is furnished
through a covered item of durable
medical equipment (DME) and
establishes a $35 cap on cost sharing for
a month’s supply of insulin furnished
through a covered item of DME, both
beginning July 1, 2023.
Section III.A.3 of this proposed rule
proposes policies to implement section
90004 of the Infrastructure Investment
and Jobs Act (Pub. L. 117–9, November
15, 2021) (IIJA) which requires drug
manufacturers to provide a refund to
CMS for certain discarded amounts from
a refundable single-dose container or
single-use package drug. These
provisions are necessary to fulfill the
statutory requirement to implement this
policy effective January 1, 2023 and
reduce unnecessary Medicare spending
for discarded drug.
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c. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
Section III.B.2. of this proposed rule
implements sections 4113, 4121, and
4124 of the CAA, 2023. Section 4113 of
the CAA, 2023 amends section
1834(m)(8) of the Act to extend payment
for telehealth services furnished by
RHCs and FQHCs for the limited period
beginning on the first day after the end
of the PHE for COVID–19 and ending on
December 31, 2024. Section 4113 also
delays the in-person requirements under
Medicare for mental health visits
furnished by RHCs and FQHCs via
telecommunications technology until
January 1, 2025.
Section 4121 of the CAA, 2023
amends section 1861(aa)(1)(B) of the Act
by adding marriage and family
therapists (MFT) and mental health
counselors (MHC) as eligible
practitioners of RHCs and FQHCs
beginning January 1, 2024. Section 4121
allows MFTs and MHCs to bill directly
and be paid as an RHC and FQHC
practitioner under the RHC AIR an
FQHC PPS.
Section 4124 of the CAA, 2023
establishes an Intensive Outpatient
benefit in RHCs and FQHCs. Proposals
related to implementation of IOP for
RHCs and FQHCs are discussed in the
CY 2024 OPPS proposed rule.
d. Clinical Laboratory Fee Schedule
(CLFS)—Proposed Revisions Consistent
With Recent Statutory Changes
Section III.D.5. of this rule proposes
conforming regulations text changes for
CLFS data reporting requirements due
to the enactment of section 4114 of the
CAA, 2023. For clinical diagnostic
laboratory tests (CDLTs) that are not
advanced diagnostic laboratory tests
(ADLTs), the CAA, 2023 delays the next
data reporting period by one year.
Instead of taking place from January 1,
2023 through March 31, 2023, data
reporting will now take place from
January 1, 2024 through March 31, 2024,
based on the original data collection
period of January 1, 2019 through June
30, 2019. Data reporting for these tests
then resumes on a 3-year cycle (2027,
2030, etc.). Additionally, the CAA, 2023
amends the statutory provisions for the
phase-in of payment reductions
resulting from private payor rate
implementation to specify that the
applicable percent in 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. The
CAA, 2023 further amends the statutory
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phase-in provisions to provide that for
CYs 2024 through 2026, the payment
amount for a CDLT may not be reduced
by more than 15 percent as compared to
the payment amount for that test
established in the preceding year.
e. 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)
In this rule, we are proposing changes
to the electronic prescribing for
controlled substances (EPCS)
requirement specified in section 2003 of
the SUPPORT Act (referred to as the
CMS EPCS Program). The proposals
specify the basis for the evaluation of
compliance by describing how
prescriptions are calculated, remove the
same entity exception while
conditioning the electronic prescribing
requirement as subject to the exemption
in § 423.160(a)(3)(iii), identify noncompliance actions for subsequent
measurement years, and update other
CMS EPCS Program exceptions.
Previously finalized policies did not
include actions for non-compliance after
the 2024 measurement year, and we
need to identify actions for noncompliance in subsequent measurement
years.
f. Ambulance Fee Schedule and the
Medicare Ground Ambulance Data
Collection System
Section 4103 of the CAA amended
section 1834(l)(12)(A) and (l)(13) of the
Act to extend the payment add-ons set
forth in those subsections through
December 31, 2024. The ambulance
extender provisions are enacted through
legislation that is self-implementing. We
are proposing only to revise the dates in
§ 414.610(c)(1)(ii) and (c)(5)(ii) to
conform the regulations to these selfimplementing statutory requirements.
Section 1834(l)(17)(A) of the Act
requires the Secretary to develop a data
collection system (which may include
use of a cost survey) to collect cost,
revenue, utilization, and other
information determined appropriate by
the Secretary for providers and
suppliers of ground ambulance services.
In this proposed rule, we are proposing
revisions to the Medicare Ground
Ambulance Data Collection Instrument.
The changes and clarifications aim to
reduce burden on respondents, improve
data quality, or both.
g. Quality Payment Program
This proposed rule is also necessary
to make changes to the Quality Payment
Program to move the program forward to
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focus more on measurement efforts,
refine how clinicians will be able to
participate in a more meaningful way
through the Merit-based Incentive
Payment System (MIPS) Value Pathways
(MVPs), and highlight the value of
participating in Advanced Alternative
Payment Models (APMs). Authorized by
MACRA, the Quality Payment Program
is an incentive program that includes
two participation tracks, MIPS and
Advanced APMs. MIPS eligible
clinicians are subject to a MIPS payment
adjustment based on their performance
in four performance categories: cost,
quality, improvement activities, and
Promoting Interoperability. Currently,
reporting for traditional MIPS is seen as
siloed across the performance
categories. These policy proposals are
intended to promote better quality
reporting to improve patient health
outcomes by coordinating reporting for
MIPS across performance categories,
and make changes to scoring that will
provide a better picture of clinicians’
performance.
2. Discretionary Provisions
a. Drugs and Biological Products Paid
Under Medicare Part B
In section III.A. of this proposed rule,
as part of our continued
implementation, section 90004 of the
Infrastructure Investment and Jobs Act
(Pub. L. 117–9, November 15, 2021)
(IIJA) which amended section 1847A of
the Act to require manufacturers to
provide a refund to CMS for certain
discarded amounts from a refundable
single-dose container or single-use
package drug. We are proposing the date
of the initial report to manufacturers,
the date for subsequent reports, method
of calculation when there are multiple
manufacturers for a refundable drug,
increased applicable percentages for
drugs with unique circumstances, and a
future application process by which
manufacturers may apply for an
increased applicable percentage for a
drug.
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b. RHCs and FQHCs
In section III.B.2. of this proposed
rule, we are proposing to continue to
define ‘‘immediate availability’’ as
including real-time audio and visual
interactive telecommunications for the
direct supervision of services and
supplies furnished incident to a
physician’s service through December
31, 2024 for RHCs and FQHCs.
In section III.B.3. of this proposed
rule, we are proposing to change the
required level of supervision for
behavioral health services furnished
‘‘incident to’’ a physician or non-
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physician practitioner’s services at
RHCs and FQHCs to allow general
supervision, rather than direct
supervision, consistent with the policies
finalized under the PFS for CY 2023.
In section III.B.4. of this proposed
rule, we are proposing a policy to
include Remote Patient Monitoring
(RPM), Remote Therapeutic Monitoring
(RTM), Community Health Integration
(CHI), and Principal Illness Navigation
(PIN) services in the general care
management HCPCS code G0511 when
these services are provided by RHCs and
FQHCs. We are proposing to revise the
calculation for G0511 to include the
weighted average of these services using
the CY 2021 PFS non-facility utilization.
These provisions are necessary in that
we evaluate coding provisions in this
rule and their applicability to RHCs and
FQHCs.
Also, in section III.B.4. of this
proposed rule, we are proposing to
remove the direct supervision
requirement for obtaining consent for
CCM services and virtual
communication services furnished in
RHCs and FQHCs.
c. Pulmonary Rehabilitation (PR),
Cardiac Rehabilitation (CR) and
Intensive Cardiac Rehabilitation (ICR)
Expansion of Supervising Practitioners
In section III.E. of this proposed rule,
we are proposing revisions to §§ 410.47
(PR) and 410.49 (CR/ICR) 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). These provisions are
necessary to fulfill the statutory
requirement to implement these changes
made in section 51008 of the Bipartisan
Budget Act of 2018 (Pub. L. 115–123,
enacted February 9, 2018) (BBA of 2018)
effective January 1, 2024.
d. Modifications Related to Medicare
Coverage for Opioid Use Disorder (OUD)
Treatment Services Furnished by
Opioid Treatment Programs (OTPs)
As discussed in section III.F. of this
proposed rule, we are proposing to
allow periodic assessments to be
furnished via audio-only
communication when two-way audiovideo communications technology is not
available to the beneficiary through the
end of CY 2024, to the extent that it is
authorized by SAMHSA and DEA at the
time the service is furnished and all
other applicable requirements are met.
We believe this modification is needed
because extending these audio-only
flexibilities for an additional year may
minimize disruptions associated with
the conclusion of the PHE, and evidence
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has shown that Medicare beneficiaries
from historically underserved
populations are more likely to be offered
and use audio-only telemedicine
services than audio-video services.335
Therefore, minimizing disruptions to
care for audio-only periodic assessments
may further promote health equity and
minimize disparities in access to care.
e. Medicare Shared Savings Program
In section III. G. of this proposed rule,
we are proposing modifications to the
Shared Savings Program 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. The proposed changes to the
Shared Savings Program include the
following: modifications to the quality
performance standard and reporting
requirements under the APP that would
continue to move ACOs toward digital
measurement of quality and to align
with QPP; modifications to the stepwise beneficiary assignment
methodology to add a new third step
and related changes to how we identify
the assignable beneficiary population;
updates to the definition of primary care
services used for purposes of beneficiary
assignment to remain consistent with
billing and coding guidelines;
refinements to the financial
benchmarking methodology for ACOs in
agreement periods beginning on January
1, 2024, and in subsequent years to (1)
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,
(2) 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, (3) 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 (4) 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; refine newly established
335 https://pubmed.ncbi.nlm.nih.gov/33471458/.
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AIP policies; make updates to other
programmatic areas including the
program’s eligibility requirements; and
make timely technical changes to the
regulations for clarity and consistency.
f. Medicare Part B Payment for
Preventive Vaccine Administration
Services
Section III.H.3 of this proposed rule
discusses the implementation of
policies that impact the payment
amount for administration of preventive
vaccines paid under the Part B vaccine
benefit, specifically the proposed inhome additional payment for Part B
vaccine administration. Section III.H.4.
of this proposed rule codifies other
amendments to the regulation text for
Part B preventive vaccine
administration. These provisions are
necessary to provide stable payment for
preventive vaccine administration and
to allow predictability for providers and
suppliers to rely on for building and
sustaining robust vaccination programs.
tkelley on DSK125TN23PROD with PROPOSALS2
g. Appropriate Use Criteria (AUC) for
Advanced Diagnostic Imaging
In section III.J. of this proposed rule,
we are proposing to pause
implementation of the AUC program for
reevaluation and to rescind the current
AUC program regulations at § 414.94.
These provisions are necessary because
we have exhausted all reasonable
options for fully operationalizing the
AUC program consistent with the
statutory provisions as prescribed in
section 1834(q)(B) of the Act directing
CMS to require real-time claims-based
reporting to collect information on AUC
consultation and imaging patterns for
advanced diagnostic imaging services to
ultimately inform outlier identification
and prior authorization.
h. Medicare and Medicaid Provider
Enrollment
This proposed rule also proposes
several regulatory enhancements to our
Medicare and Medicaid provider
enrollment policies. These provisions
focus on, but are not limited to: (1)
expanding the bases for denying or
revoking a provider’s or supplier’s
Medicare enrollment; (2) revising the
effective dates of certain Medicare
revocations; and (3) revising certain
policies regarding Medicaid
terminations. These changes are
necessary to help ensure that payments
are made only to qualified providers
and suppliers and/or to increase the
efficiency of the Medicare and Medicaid
provider enrollment processes. We
believe that fulfilling these objectives
would assist in protecting the Trust
Funds and Medicare beneficiaries.
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i. Expand Diabetes Screening and
Diabetes Definitions
well as oversight of the BHP program,
beginning with program year 2024.
In section III.L. of this proposed rule,
we are proposing to (1) expand coverage
of diabetes screening tests to include the
Hemoglobin A1C test (HbA1c) test, (2)
expand and simplify the frequency
limitations for diabetes screening, and
(3) simplify the regulatory definition of
‘‘diabetes’’ for diabetes screening,
Medical Nutrition Therapy (MNT) and
Diabetes Outpatient Self-Management
Training Services (DSMT). Diabetes is a
chronic disease that affects how the
body turns food into energy and
includes three main types: Type 1, Type
2 and gestational diabetes. The Centers
for Disease Control and Prevention
(CDC) reports that approximately 37.3
million Americans are living with
diabetes and an additional 96 million
Americans are living with
prediabetes.336 CDC reports that 326,000
persons age 65 years and older are
newly diagnosed with diabetes each
year. CDC also estimates that among
persons age 65 years and older, 21
percent have been diagnosed with
diabetes while 5 percent have
undiagnosed diabetes.337 Diabetes is the
leading cause of kidney failure and new
cases of blindness among adults, and
the sixth leading cause of death among
adults age 65 years and older in the
US.338 Screening is performed on
persons who may not exhibit symptoms
to identify persons with either
prediabetes or diabetes, who can then be
referred for appropriate prevention or
treatment, with the intention of
improving health outcomes.
k. A Social Determinants of Health Risk
Assessment in the Annual Wellness
Visit
In section III.S. of this proposed rule,
we are proposing to exercise our
authority in section 1861(hhh)(2)(I) of
the Act to add elements to the Annual
Wellness Visit (AWV) by adding a new
Social Determinants of Health (SDOH)
Risk Assessment as an optional,
additional element with an additional
payment. We propose that the SDOH
Risk Assessment be separately payable
with no beneficiary cost sharing when
furnished as part of the same visit with
the same date of service as the AWV.
The AWV includes the establishment
(or update) of the patient’s medical and
family history, application of a health
risk assessment and the establishment
(or update) of a personalized prevention
plan. The AWV also provides an
optional Advance Care Planning (ACP)
service. The AWV is covered for eligible
beneficiaries who are no longer within
12 months of the effective date of their
first Medicare Part B coverage period
and who have not received either an
Initial Preventive Physical Examination
(IPPE) or AWV within the past 12
months. The goals of AWV are health
promotion, disease prevention and
detection and include education,
counseling, a health risk assessment,
referrals for prevention services, and a
review of opioid use. Additional
information about the AWV can be
found on the CMS website at (https://
www.cms.gov/Outreach-and-Education/
Medicare-Learning-Network-MLN/
MLNProducts/preventive-services/
medicare-wellness-visits.html).
j. Basic Health Program Provisions
Section 1331 of the ACA requires the
Secretary to establish a BHP, and
section 1331(c)(4) of the ACA
specifically provides that a State shall
coordinate the administration of, and
provision of benefits under the BHP
with other State programs. Additionally,
section 1331(f) of the ACA requires the
Secretary to review each State’s BHP on
an annual basis. These proposed
regulations build from previous BHP
regulations to provide for options for
BHP implementation and operations as
336 CDC Website on diabetes at https://
www.cdc.gov/diabetes/basics/.
337 Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2020. Accessed
March 9, 2023. https://www.cdc.gov/diabetes/pdfs/
data/statistics/national-diabetes-statisticsreport.pdf.
338 Heron M. Deaths: Leading causes for 2019.
National Vital Statistics Reports; vol 70 no 9.
Hyattsville, MD: National Center for Health
Statistics. 2021. DOI: https://dx.doi.org/10.15620/
cdc:107021.
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B. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), Executive Order 14094 entitled
‘‘Modernizing Regulatory Review’’
(April 6, 2023), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104–4),
and Executive Order 13132 on
Federalism (August 4, 1999).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
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(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). The Executive Order 14094
entitled ‘‘Modernizing Regulatory
Review’’ (hereinafter, the Modernizing
E.O.) amends section 3(f)(1) of Executive
Order 12866 (Regulatory Planning and
Review). The amended section 3(f) of
Executive Order 12866 defines a
‘‘significant regulatory action’’ as an
action that is likely to result in a rule:
(1) having an annual effect on the
economy of $200 million or more in any
1 year (adjusted every 3 years by the
Administrator of OIRA for changes in
gross domestic product), or adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
territorial, or tribal governments or
communities; (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raise legal or policy issues
for which centralized review would
meaningfully further the President’s
priorities or the principles set forth in
this Executive order, as specifically
authorized in a timely manner by the
Administrator of OIRA in each case.
A regulatory impact analysis (RIA)
must be prepared for major rules with
significant regulatory action/s and/or
with significant effects as per section
3(f)(1) ($200 million or more in any 1
year). Based on our estimates, OMB’s
Office of Information and Regulatory
Affairs has determined this rulemaking
is significant per section 3(f)(1)) as
measured by the $200 million or more
in any 1 year. Accordingly, we have
prepared an RIA that, to the best of our
ability, presents the costs and benefits of
the rulemaking. The RFA requires
agencies to analyze options for
regulatory relief of small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. Most hospitals,
practitioners, and most other providers
and suppliers are small entities, either
by nonprofit status or by having annual
revenues that qualify for small business
status under the Small Business
Administration standards. (For details,
see the SBA’s website at https://
www.sba.gov/document/support-tablesize-standards (refer to the 620000
series)). Individuals and States are not
included in the definition of a small
entity.
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The RFA requires that we analyze
regulatory options for small businesses
and other entities. We prepare a
regulatory flexibility analysis unless we
certify that a rule would not have a
significant economic impact on a
substantial number of small entities.
The analysis must include a justification
concerning the reason action is being
taken, the kinds and number of small
entities the rule affects, and an
explanation of any meaningful options
that achieve the objectives with less
significant adverse economic impact on
the small entities.
Approximately 95 percent of
practitioners, other providers, and
suppliers are considered to be small
entities, based upon the SBA standards.
There are over 1 million physicians,
other practitioners, and medical
suppliers that receive Medicare
payment under the PFS. Because many
of the affected entities are small entities,
the analysis and discussion provided in
this section, as well as elsewhere in this
proposed rule is intended to comply
with the RFA requirements regarding
significant impact on a substantial
number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare an RIA if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 603
of the RFA. For purposes of section
1102(b) of the Act, we define a small
rural hospital as a hospital that is
located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. Medicare does not pay rural
hospitals for their services under the
PFS; rather, the PFS pays for physicians’
services, which can be furnished by
physicians and NPPs in a variety of
settings, including rural hospitals. We
did not prepare an analysis for section
1102(b) of the Act because we
determined, and the Secretary certified,
that this proposed rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits on State, local, or
tribal governments or on the private
sector before issuing any rule whose
mandates require spending in any 1 year
of $100 million in 1995 dollars, updated
annually for inflation. In 2023, that
threshold is approximately $177
million. This rule will impose no
mandates on State, local, or tribal
governments or on the private sector.
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Executive Order 13132 establishes
certain requirements that an agency
must meet when it issues a proposed
rule (and subsequent final rule) that
imposes substantial direct requirement
costs on State and local governments,
preempts State law, or otherwise has
federalism implications. Since this rule
does not impose any costs on State or
local governments, the requirements of
Executive Order 13132 are not
applicable.
We prepared the following analysis,
which together with the information
provided in the rest of this rule, meets
all assessment requirements. The
analysis explains the rationale for and
purposes of this proposed rule; details
the costs and benefits of the rule;
analyzes alternatives; and presents the
measures we will use to minimize the
burden on small entities. As indicated
elsewhere in this proposed rule, we
discussed a variety of changes to our
regulations, payments, or payment
policies to ensure that our payment
systems reflect changes in medical
practice and the relative value of
services, and to implement provisions of
the statute. We provide information for
each of the policy changes in the
relevant sections of this proposed rule.
We are unaware of any relevant Federal
rules that duplicate, overlap, or conflict
with this proposed rule. The relevant
sections of this proposed rule contain a
description of significant alternatives
we considered, if applicable.
C. Changes in Relative Value Unit
(RVU) Impacts
1. Resource-Based Work, PE, and MP
RVUs
Section 1848(c)(2)(B)(ii)(II) of the Act
requires that increases or decreases in
RVUs may not cause the amount of
Medicare Part B expenditures for the
year to differ by more than $20 million
from what expenditures would have
been in the absence of these changes. If
this threshold is exceeded, we make
adjustments to preserve budget
neutrality.
Our estimates of changes in Medicare
expenditures for PFS services compared
payment rates for CY 2023 with
payment rates for CY 2024 using CY
2022 Medicare utilization. The payment
impacts described in this proposed rule
reflect averages by specialty based on
Medicare utilization. The payment
impact for an individual practitioner
could vary from the average and will
depend on the mix of services they
furnish. The average percentage change
in total revenues will be less than the
impact displayed here because
practitioners and other entities generally
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furnish services to both Medicare and
non-Medicare patients. In addition,
practitioners and other entities may
receive substantial Medicare revenues
for services under other Medicare
payment systems. For instance,
independent laboratories receive
approximately 83 percent of their
Medicare revenues from clinical
diagnostic laboratory tests that are paid
under the Clinical Laboratory Fee
Schedule (CLFS).
The PFS update adjustment factor for
CY 2024, as specified in section
1848(d)(19) of the Act, is 0.00 percent
before applying other adjustments. In
addition, the CAA, 2023 provided a onetime 2.50 percent increase in PFS
payment amounts for services furnished
on or after January 1, 2023, and a onetime 1.25 percent increase in PFS
payment amounts for services furnished
on or after January 1, 2024, and required
that the supplementary increases shall
not be taken into account in
determining PFS payment rates for
subsequent years.
To calculate the CY 2024 PFS
conversion factor (CF), we took the CY
2023 conversion factor without the oneyear 2.50 percent payment increase
provided by the CAA, 2023 for CY 2023
and multiplied it by the budget
neutrality adjustment required as
described in the preceding paragraphs
and the 1.25 percent PFS payment
increase provided by the CAA, 2023 for
CY 2024. We estimate the CY 2024 PFS
CF to be 32.7476 which reflects the
¥2.17 percent budget neutrality
adjustment under section
1848(c)(2)(B)(ii)(II) of the Act, the 0.00
percent update adjustment factor
specified under section 1848(d)(19) of
the Act, and the 1.25 percent payment
increase for services furnished in CY
2024, as provided in the CAA, 2023. We
estimate the CY 2024 anesthesia CF to
be 20.4370 which reflects the same
overall PFS adjustments with the
addition of anesthesia-specific PE and
MP adjustments.
Table 104 shows the payment impact
of the policies contained in this
proposed rule on PFS services. To the
extent that there are year-to-year
changes in the volume and mix of
services provided by practitioners, the
actual impact on total Medicare
revenues will be different from those
shown in Table 104 (CY 2023 PFS
Estimated Impact on Total Allowed
Charges by Specialty). The following is
an explanation of the information
represented in Table 104.
• Column A (Specialty): Identifies the
specialty for which data are shown.
• Column B (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2022 utilization and CY 2023 rates. That
is, allowed charges are the PFS amounts
for covered services and include
coinsurance and deductibles (which are
the financial responsibility of the
beneficiary). These amounts have been
summed across all services furnished by
physicians, practitioners, and suppliers
within a specialty to arrive at the total
allowed charges for the specialty.
• Column C (Impact of Work RVU
Changes): This column shows the
estimated CY 2024 impact on total
allowed charges of the changes in the
work RVUs, including the impact of
changes due to potentially misvalued
codes.
• Column D (Impact of PE RVU
Changes): This column shows the
estimated CY 2024 impact on total
allowed charges of the changes in the PE
RVUs.
• Column E (Impact of MP RVU
Changes): This column shows the
estimated CY 2024 impact on total
allowed charges of the changes in the
MP RVUs.
• Column F (Combined Impact): This
column shows the estimated CY 2024
combined impact on total allowed
charges of all the changes in the
previous columns. Column F may not
equal the sum of columns C, D, and E
due to rounding.
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update our data and offer interested
parties additional information that
addresses some of the concerns raised,
we have recently improved our current
suite of public use files (PUFs) by
including a new file that shows
estimated specialty payment impacts at
a more granular level, specifically by
showing ranges of impact for
practitioners within a specialty. This
file is available on the CMS website
under downloads for the CY 2024 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
For this rulemaking cycle, we are
providing an additional impact table
that includes a facility/non-facility
breakout of payment changes. The
following is an explanation of the
information represented in Table 105.
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• Column A (Specialty): Identifies the
specialty for which data are shown.
• Column B (Setting): Identifies the
facility or nonfacility setting for which
data are shown.
• Column C (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2022 utilization and CY 2023 rates. That
is, allowed charges are the PFS amounts
for covered services and include
coinsurance and deductibles (which are
the financial responsibility of the
beneficiary). These amounts have been
summed across all services furnished by
physicians, practitioners, and suppliers
within a specialty to arrive at the total
allowed charges for the specialty.
• Column D (Combined Impact): This
column shows the estimated CY 2024
combined impact on total allowed
charges.
BILLING CODE 4120–01–P
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In recent years, we have received
requests from interested parties for CMS
to provide more granular information
that separates the specialty-specific
impacts by site of service. These
interested parties have presented highlevel information to CMS suggesting
that Medicare payment policies are
directly responsible for the
consolidation of privately-owned
physician practices and freestanding
supplier facilities into larger health
systems. Their concerns highlight a
need to update the information under
the PFS to account for current trends in
the delivery of health care, especially
concerning independent versus facilitybased practices. We published an RFI in
the CY 2023 PFS proposed rule to gather
feedback on this issue and refer readers
to the discussion in last year’s final rule
(87 FR 69429 through 69438). As part of
our holistic review of how best to
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2. CY 2024 PFS Impact Discussion
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a. Changes in RVUs
The most widespread specialty
impacts of the RVU changes are
generally related to the changes to RVUs
for specific services resulting from the
misvalued code initiative, including
RVUs for new and revised codes. The
estimated impacts for some specialties,
including family practice,
endocrinology, nurse practitioner,
physician assistant, clinical social
worker, psychiatry, clinical
psychologist, and general practice,
reflect increases relative to other
physician specialties. These increases
can largely be attributed to proposed
implementation of the separate payment
for the O/O E/M visit inherent
complexity add-on code, the Year 3
update to clinical labor pricing, and/or
the proposed adjustment to certain
behavioral health services.
Approximately 90 percent of the budget
neutrality adjustment is attributable to
the O/O E/M visit inherent complexity
add-on code with all other proposed
valuation changes making up the other
10 percent. The services that make up
these specialties rely primarily on E/M
services, behavioral health care, or on
clinical labor for their practice expense
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costs. These increases are also due to
increases in value for particular services
after considering the recommendations
from the American Medical
Association’s (AMA) Relative Value
Scale Update Committee (RUC) and
CMS review, and increased payments
resulting from updates to supply and
equipment pricing.
The estimated impacts for several
specialties, including anesthesiology,
interventional radiology, radiology,
vascular and thoracic surgery, physical/
occupational therapy, and audiologists
reflect decreases in payments relative to
payment to other physician specialties,
largely resulting from the redistributive
effects of the implementation of separate
payment for the O/O E/M visit inherent
complexity add-on code, the Year 3
update to clinical labor pricing, and/or
the proposed adjustment to certain
behavioral health services. The services
that make up these specialties were
negatively affected by the redistributive
effects of increases in work RVUs for
other codes, and/or rely primarily on
supply/equipment items for their
practice expense costs and therefore
were affected negatively by the updated
Year 3 clinical labor pricing under
budget neutrality. These decreases are
also due to the revaluation of individual
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procedures based on reviews, including
consideration of AMA RUC review and
recommendations, as well as decreases
resulting from the continued phase-in
implementation of the previously
finalized updates to supply and
equipment pricing. The estimated
impacts also reflect decreases due to
continued implementation of previously
finalized code-level reductions that are
being phased in over several years. For
independent laboratories, it is important
to note that these entities receive
approximately 83 percent of their
Medicare revenues from services that
are paid under the CLFS.
We often receive comments regarding
the changes in RVUs displayed on the
specialty impact table (Table 104),
including comments received in
response to the valuations. We remind
interested parties that although the
estimated impacts are displayed at the
specialty level, typically the changes are
driven by the valuation of a relatively
small number of new and/or potentially
misvalued codes. The percentage
changes in Table 104 are based upon
aggregate estimated PFS allowed
charges summed across all services
furnished by physicians, practitioners,
and suppliers within a specialty to
arrive at the total allowed charges for
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the specialty, and compared to the same
summed total from the previous
calendar year. Therefore, they are
averages, and may not necessarily be
representative of what is happening to
the particular services furnished by a
single practitioner within any given
specialty.
As discussed above, we have
reviewed our suite of public use files
and have worked on new ways to offer
interested parties additional information
that addresses some of the concerns
raised about lack of granularity in our
impact tables. To illustrate how impacts
can vary within specialties, we created
a public use file that models the
expected percentage change in total
RVUs per practitioner. Using CY 2022
utilization data, Total RVUs change
between ¥1 percent and 1 percent for
more than 15 percent of practitioners,
representing approximately 26 percent
of the changes in Total RVUs for all
practitioners, with variation by
specialty. Specialties, such as
gastroenterology, exhibit little variation
in changes in total RVUs per
practitioner. Table 104 (CY 2024 PFS
Estimated Impact on Total Allowed
Charges by Specialty) indicates an
overall change of 0 percent for this
specialty, and the practitioner-level
distribution shows that 89 percent of
these practitioners will experience a
change in Total RVUs between ¥2
percent and 2 percent. The specific
service mix within a specialty may vary
by practitioner, so individual
practitioners may experience different
changes in total RVUs. For example,
Table 104 indicates a 1 percent increase
in RVUs for the internal medicine
specialty as a whole, however, 49
percent of internal medicine specialty
practitioners—representing over 41
percent of Total RVUs for the
specialty—will experience a 1 percent
or more decrease in Total RVUs.
Meanwhile, 40 percent of internal
medicine specialty practitioners will
experience 2 percent or more increases
in Total RVUs, and these practitioners
account for a similar 41 of Total RVUs
for this specialty. We also note the code
level RVU changes are available in the
Addendum B public use file that we
make available with each rule.
The specialty impacts displayed in
Table 104 reflect changes that take place
within the pool of total RVUs. The
specialty impacts table therefore
includes any changes in spending
which result from finalized policies
within BN (such as the updated
proposals associated with the
complexity add-on code G2211 in CY
2024 or the clinical labor pricing update
that began in CY 2022) but does not
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include any changes in spending which
result from finalized policies that are
not subject to BN adjustment, and
therefore, have a neutral impact across
all specialties. The 2.50 and 1.25
percent payment supplements for CY
2023 and CY 2024, respectively, are
statutory changes that take place outside
of BN, and therefore, are not captured in
the specialty impacts displayed in Table
104.
b. Impact
Column F of Table 104 displays the
estimated CY 2024 impact on total
allowed charges, by specialty, of all the
RVU changes. A table showing the
estimated impact of all of the changes
on total payments for selected high
volume procedures is available under
‘‘downloads’’ on the CY 2024 PFS
proposed rule website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/. We selected these
procedures for sake of illustration from
among the procedures most commonly
furnished by a broad spectrum of
specialties. The change in both facility
rates and the nonfacility rates are
shown. For an explanation of facility
and nonfacility PE, we refer readers to
Addendum A on the CMS website at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/.
3. Health Equity
Advancing health equity is the first
pillar of CMS’s 2022 Strategic
Framework.339 As part of our efforts to
gain insight into how the PFS policies
could affect health equity, we are
considering adding elements to our
impact analysis which would detail
how policies impact particular patient
populations. Patient populations that
have been disadvantaged or
underserved by the healthcare system
may include patients with the following
characteristics, among others: members
of racial and ethnic minorities; members
of federally recognized Tribes, people
with disabilities; members of the
lesbian, gay, bisexual, transgender, and
queer (LGBTQ+) community;
individuals with limited English
proficiency, members of rural
communities, and persons otherwise
adversely affected by persistent poverty
or inequality.
In the FY 2024 IPPS/LTCH PPS
proposed rule, (88 FR 27261 through
27266), we included a table that details
providers in terms of the beneficiaries
they serve, as well as differences in
339 Available at https://www.cms.gov/files/
document/2022-cms-strategic-framework.pdf.
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estimated average payments per case
and changes in estimated average
payments per case relative to other
providers. Because we do not have data
for all characteristics that may identify
disadvantaged or underserved patient
populations, we use several proxies to
capture these characteristics, including
elements from claims data and Medicare
enrollment data. The characteristics
included in the table in the IPPS/LTCH
PPS proposed rule, described in further
detail below, include race/ethnicity,
dual eligibility for Medicaid and
Medicare, Medicare low income subsidy
(LIS) enrollment, a joint indicator for
dual or LIS enrollment, presence of an
ICD–10–CM Z code indicating a ‘‘social
determinant of health’’ (SDOH),
presence of a behavioral health
diagnosis code, receiving end-stage
renal disease (ESRD) Medicare coverage,
qualifying for Medicare due to
disability, living in a rural area, and
living in an area with an area
deprivation index (ADI) greater than or
equal to 85.
a. Race and Ethnicity
The first health equity-relevant
grouping is race/ethnicity. To assign the
race/ethnicity variables, we utilized the
Medicare Bayesian Improved Surname
Geocoding (MBISG) data in conjunction
with the claims data. The method used
to develop the MBISG data involves
estimating a set of six racial and ethnic
probabilities (White, Black, Hispanic,
American Indian or Alaska Native,
Asian or Pacific Islander, and
multiracial) from the surname and
address of beneficiaries by using
previous self-reported data from a
national survey of Medicare
beneficiaries, post-stratified to CMS
enrollment files. The MBISG method is
used by the CMS Office of Minority
Health in its reports analyzing Medicare
Advantage plan performance on
Healthcare Effectiveness Data and
Information Set (HEDIS) measures, and
is being considered by CMS for use in
other CMS programs. In the 2024 IPPS/
LTCH proposed rule (88 FR 27261
through 27266), we estimated the
percentage of discharges for each
specified racial/ethnic category for each
hospital by taking, the sum of the
probabilities for that category for that
hospital and dividing by the hospital’s
total number of discharges.
b. Income
The two main proxies for income
available in the Medicare claims and
enrollment data are dual eligibility for
Medicare and Medicaid and Medicare
LIS status. Dual-enrollment status is a
powerful predictor of poor outcomes on
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some quality and resource use measures
even after accounting for additional
social and functional risk factors.340
Medicare LIS enrollment refers to a
beneficiary’s enrollment in the lowincome subsidy program for the Part D
prescription drug benefit. This program
covers all or part of the Part D premium
for qualifying Medicare beneficiaries
and gives them access to reduced
copays for Part D drugs. (We note that
beginning on January 1, 2024, eligibility
for the full low-income subsidy will be
expanded to include individuals
currently eligible for the partial lowincome subsidy.) Because Medicaid
eligibility rules and benefits vary by
State/territory, Medicare LIS enrollment
identifies beneficiaries who are likely to
have low income but may not be eligible
for Medicaid. Not all beneficiaries who
qualify for the duals or LIS programs
actually enroll. Due to differences in the
dual eligibility and LIS qualification
criteria and less than complete
participation in these programs,
sometimes beneficiaries were flagged as
dual but not LIS or vice versa. Hence
this analysis also used a ‘‘dual or LIS’’
flag as a third proxy for low income.
The dual and LIS flags were constructed
based on enrollment/eligibility status in
the CMS Chronic Conditions Data
Warehouse (CCW) during the month of
the hospital discharge.
c. Social Determinants of Health (SDOH)
Social determinants of health (SDOH)
are the conditions in the environments
where people are born, live, learn, work,
play, worship, and age that affect a wide
range of health, functioning, and
quality-of-life outcomes and risks.341
These circumstances or determinants
influence an individual’s health status
and can contribute to wide health
disparities and inequities. ICD–10–CM
contains Z-codes that describe a range of
issues related—but not limited—to
education and literacy, employment,
housing, ability to obtain adequate
amounts of food or safe drinking water,
and occupational exposure to toxic
agents, dust, or radiation. The presence
of ICD–10–CM Z-codes in the range
Z55–Z65 identifies beneficiaries with
these SDOH characteristics. The SDOH
flag used for this analysis was turned on
if one of these Z-codes was recorded on
the claim for the physician service itself
(that is, the beneficiary’s prior claims
were not examined for additional Z340 https://aspe.hhs.gov/sites/default/files/
migrated_legacy_files//195046/Social-Risk-inMedicare%E2%80%99s-VBP-2nd-ReportExecutive-Summary.pdf.
341 Available at: https://health.gov/
healthypeople/priority-areas/social-determinantshealth.
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codes). Analysis of Z-codes in Medicare
claims data from 2019 suggests that Zcodes are used inconsistently across
provider types and population groups,
and are generally underreported.342
Therefore, we believe Z-codes do not
reflect the actual rates of SDOH.
d. Behavioral Health
Beneficiaries with behavioral health
diagnoses often face co-occurring
physical illnesses, but often experience
difficulty accessing care.343 The
combination of physical and behavioral
health conditions can exacerbate both
conditions and result in poorer
outcomes than one condition alone.344
Additionally, the intersection of
behavioral health and health inequities
is a core aspect of CMS’ Behavioral
Health Strategy.345 We used the
presence of one or more ICD–10–CM
codes in the range of F01–F99 to
identify beneficiaries with a behavioral
health diagnosis.
e. Disability
Individuals under age 65 who are
determined eligible for Social Security
disability benefits may also be eligible
for Medicare coverage.346 Individuals
may qualify for Social Security
disability benefits on the basis of a
medically determinable physical or
mental impairment(s) that has lasted or
is expected to last for a continuous
period of at least 12 months or is
expected to result in death.347 Disabled
beneficiaries often have complex
healthcare needs and difficulty
accessing care. Compared to people
without disabilities, people with
disabilities generally have less access to
health care, have more depression and
anxiety, engage more often in risky
health behaviors such as smoking, and
342 Maksut JL, Hodge C, Van CD, Razmi, A, &
Khau MT. Utilization of Z Codes for Social
Determinants of Health among Medicare Fee-ForService Beneficiaries, 2019. Office of Minority
Health (OMH) Data Highlight No. 24. Centers for
Medicare and Medicaid Services (CMS), Baltimore,
MD, 2021. Available at https://www.cms.gov/files/
document/z-codes-data-highlight.pdf.
343 Viron M, Zioto K, Schweitzer J, Levine G.
Behavioral Health Homes: an opportunity to
address healthcare inequities in people with serious
mental illness. Asian J Psychiatr. 2014 Aug;10:10–
6. doi: 10.1016/j.ajp.2014.03.009.
344 Cully, J.A., Breland, J.Y., Robertson, S. et al.
Behavioral health coaching for rural veterans with
diabetes and depression: a patient randomized
effectiveness implementation trial. BMC Health
Serv Res 14, 191 (2014). https://doi.org/10.1186/
1472-6963-14-191.
345 https://www.cms.gov/cms-behavioral-healthstrategy.
346 Medicare eligibility on the basis of disability
is discussed in 42 CFR 406.12.
347 https://www.ssa.gov/disability/professionals/
bluebook/general-info.htm.
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are less physically active.348
Beneficiaries were classified as disabled
for the purposes of this analysis if their
original reason for qualifying for
Medicare was disability; this
information was obtained from
Medicare’s CCW enrollment data. We
note that this is likely an
underestimation of disability, because it
does not account for beneficiaries who
became disabled after becoming entitled
to Medicare.
f. End-Stage Renal Disease (ESRD)
Beneficiaries with ESRD have high
healthcare needs and high medical
spending, and often experience
comorbid conditions and poor mental
health. Beneficiaries with ESRD also
experience significant disparities, such
as a limited life expectancy.349
Beneficiaries were classified as ESRD
for the purposes of this analysis if they
were receiving Medicare ESRD coverage
during the month of the discharge; this
information was obtained from the CCW
enrollment data.
g. Geography
Beneficiaries in some geographic
areas—particularly rural areas or areas
with concentrated poverty—often have
difficulty accessing care. 350 351 For this
analysis, beneficiaries were classified on
two dimensions: from a rural area and
from an area with an area deprivation
index (ADI) greater than or equal to 85.
Rural status is defined for purposes of
this analysis using the primary RuralUrban Commuting Area (RUCA) codes
4–10 (including micropolitan, small
town, and rural areas) corresponding to
each beneficiary’s zip code. RUCA
codes are defined at the census tract
level based on measures of population
density, urbanization, and daily
commuting. The ADI is obtained from a
publicly available dataset designed to
capture socioeconomic disadvantage at
the neighborhood level.352 It utilizes
data on income, education,
348 https://www.cdc.gov/ncbddd/
humandevelopment/health-equity.html#ref.
349 Smart NA, Titus TT. Outcomes of early versus
late nephrology referral in chronic kidney disease:
a systematic review. Am J Med. 2011
Nov;124(11):1073–80.e2. doi: 10.1016/
j.amjmed.2011.04.026. PMID: 22017785.
350 National Healthcare Quality and Disparities
Report chartbook on rural health care. Rockville,
MD: Agency for Healthcare Research and Quality;
October 2017. AHRQ Pub. No. 17(18)–0001–2–EF
available at https://www.ahrq.gov/sites/default/
files/wysiwyg/research/findings/nhqrdr/chartbooks/
qdr-ruralhealthchartbook-update.pdf.
351 Muluk, S, Sabik, L, Chen, Q, Jacobs, B, Sun,
Z, Drake, C. Disparities in geographic access to
medical oncologists. Health Serv Res. 2022; 57(5):
1035–1044. doi:10.1111/1475–6773.13991.
352 https://
www.neighborhoodatlas.medicine.wisc.edu/.
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employment, housing quality, and 13
other factors from the American
Community Survey (ACS) and combines
them into a single raw score, which is
then used to rank neighborhoods
(defined at various levels), with higher
scores reflecting greater deprivation.
The version of the ADI used for this
analysis is at the Census Block Group
level and the ADI corresponds to the
Census Block Group’s percentile
nationally. Living in an area with an
ADI score of 85 or above, a validated
measure of neighborhood disadvantage,
is shown to be a predictor of 30-day
readmission rates, lower rates of cancer
survival, poor end of life care for
patients with heart failure, and longer
lengths of stay and fewer home
discharges post-knee surgery even after
accounting for individual social and
economic risk factors.353 354 355 356 357 The
MedPAR discharge data was linked to
the ADI data available in the CCW.
Beneficiaries with no recorded ADI
were treated as being from an urban area
and as having an ADI less than 85.
In examining how we might expand
our PFS impact analysis, we considered
what framework might accurately
provide insight into the relationship
between PFS policies and health equity.
Rather than examining changes in
estimated average payments, we believe
that illuminating the baseline is a
necessary first step toward advancing
our goal of measuring the impact of PFS
policies on health equity. Table 107
displays the share of utilization for each
of the health-equity relevant
characteristics listed above. First, we list
the share of enrollees with each
characteristic. Next, we list the share of
utilization by beneficiaries (that is,
enrollees with at least one claim for a
physician service in CY 2022) with each
characteristic by provider specialty. The
information contained in Table 107 is
provided solely to demonstrate
beneficiary utilization of services by
provider specialty impact across a
number of health equity dimensions and
does not form the basis or rationale for
the proposed policies.
In consideration of the differences
between IPPS/LTCH and the PFS
discussed below, we are seeking
comment from interested parties about
how we might structure a PFS impact
analysis that addresses these and other
considerations to examine how changes
in the PFS would impact beneficiaries
of particular groups. We are also seeking
comment about how such a framework
would allow us to consider developing
policies that enhance health equity
under our existing statutory authority.
We welcome suggestions about
alternative measures of health equity in
our impact analysis, in particular with
regard to the ADI as a proxy for
disparities related to geographic
variation. Finally, we seek feedback
about additional categories beyond
those described previously that should
be considered in our analysis, along
with potential data sources.
Nature of a service. In the table that
details providers in terms of the
beneficiaries they serve in the IPPS/
LTCH PPS proposed rule, the unit of
measurement we used was a hospital
discharge. A discharge includes all
resources involved in the hospital’s
caring for a beneficiary during the
hospital stay. There is no parallel
construct under the PFS. While the
resources involved in furnishing a given
discharge can and do vary under the
IPPS, a discharge consists of a
somewhat predictable set of resources
that occur across a number of cost
centers. On the other hand, a service
unit under the PFS can range from very
discrete services, such as a single pulse
oximetry measurement (CPT code
94760) with total RVUs of 0.07 to
complex services that include several
visits during a global period, such as a
liver transplant (CPT code 47135) with
total RVUs of 160.44. As an illustration,
based on the MS–DRGs reported in the
claims data, the standard deviation of
the mean IPPS relative weight is of
similar magnitude to the mean. In
contrast, based on the PFS services
reported in the claims data, the standard
deviation of the mean PFS RVU service
is vastly larger than the mean.
In addition, under the PFS, some
services furnished during a single
encounter are billed in multiple units.
These services could range from allergy
testing (CPT codes 95004 through
95078) to anesthesia services (CPT
codes 00100 through 01860). The
average total RVUs for services billed in
multiple units are not comparable to
services billed in a single unit per
encounter.
Number of practitioners serving a
beneficiary and associated spending.
Under the IPPS, most beneficiaries who
had one or more IPPS claims during
fiscal year 2022 were served by 1 or 2
providers, which accounts for most of
the spending under the IPPS. The share
of beneficiaries served by a given
number of providers is consistent with
the share of spending incurred for these
discharges. Less than 10 percent of
beneficiaries were served by 5 or more
providers. Under the PFS, during CY
353 7 U.S. Department of Health & Human
Services, ‘‘Executive Summary: Report to Congress:
Social Risk Factors and Performance in Medicare’s
Value-Based Purchasing Program,’’ Office of the
Assistant Secretary for Planning and Evaluation,
March 2020. Available at https://aspe.hhs.gov/sites/
default/files/migrated_legacy_files//195046/SocialRisk-inMedicare%E2%80%99s-VBP-2nd-ReportExecutive-Summary.pdf.
354 Kind AJ, et al., ‘‘Neighborhood socioeconomic
disadvantage and 30-day rehospitalization: a
retrospective cohort study.’’ Annals of Internal
Medicine. No. 161(11), pp 765–74, doi: 10.7326/
M13–2946 (December 2, 2014), available at https://
www.acpjournals.org/doi/epdf/10.7326/M13-2946.
355 Jencks SF, et al., ‘‘Safety-Net Hospitals,
Neighborhood Disadvantage, and Readmissions
Under Maryland’s All-Payer Program.’’ Annals of
Internal Medicine. No. 171, pp 91–98, doi:10.7326/
M16–2671 (July 16, 2019), available at https://
www.acpjournals.org/doi/epdf/10.7326/M16-2671.
356 Cheng E, et al., ‘‘Neighborhood and Individual
Socioeconomic Disadvantage and Survival Among
Patients With Nonmetastatic Common Cancers.’’
JAMA Network Open Oncology. No. 4(12), pp 1–17,
doi: 10.1001/jamanetworkopen.2021.39593
(December 17, 2021), available at https://
onlinelibrary.wiley.com/doi/epdf/10.1111/
jrh.12597.
357 Khlopas A, et al., ‘‘Neighborhood
Socioeconomic Disadvantages Associated With
Prolonged Lengths of Stay, Nonhome Discharges,
and 90-Day Readmissions After Total Knee
Arthroplasty.’’ The Journal of Arthroplasty. No.
37(6), pp S37–S43, doi: 10.1016/j.arth.2022.01.032
(June 2022), available at https://
www.sciencedirect.com/science/article/pii/
S0883540322000493.
358 The IPPS relative weights are not fully
comparable to PFS RVUs because IPPS payments
may include outliers. Even considering outliers,
however, the standard deviation on IPPS payments
is only slightly higher relative to the mean
($17,104+/¥$21,825).
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2022, most beneficiaries with one or
more PFS claims saw 5 or more
practitioners. In contrast to the pattern
under the IPPS, PFS spending for
beneficiaries who saw 10 or more
practitioners accounted for a
disproportionate share of total spending.
Under the IPPS, examining providers in
terms of beneficiary characteristics
reflects the care of most beneficiaries
with one or more discharges under the
IPPS. Under the PFS, the same
framework would be mostly describing
the forty percent of beneficiaries with
one or more PFS services who account
for close to 80 percent of total spending.
Utilization of services by beneficiary
characteristic. As shown in Table 107,
the specialty-level services utilized by
beneficiaries with particular
characteristics varies widely.
Beneficiaries with the characteristics in
Table 107 do not access services
consistent with the share of enrollees
with that characteristic. As a result,
comparing across deciles, for example,
of practitioners serving beneficiaries of
one race, would often be comparing
very different service mixes. How
discrete a service is, the setting it is
furnished in, and the associated inputs
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may result in services that have very
different baseline allowed charges.
A significant body of literature has
examined the reasons for differential
access to physician services by
beneficiary characteristic. Some of the
explanations of the differential
utilization of services include:
• Patient preferences and willingness
to undergo procedures, such as due to
decreased belief in treatment efficacy
and concerns about surgical
risks359 360 361 362
• Geographic location: specialists and
sub-specialists are sometimes clustered
359 Ibrahim SA, Siminoff LA, Burant CJ, et al.
Differences in expectations of outcome mediate
African American/white patient differences in
‘‘willingness’’ to consider joint replacement.
Arthritis Rheum. 2002;46:2429–2435.
360 Vina ER, Cloonan YK, Ibrahim SA, et al. Race,
sex, and total knee replacement consideration: role
of social support. Arthritis Care Res (Hoboken)
2013;65:1103–1111.
361 Allen KD, Golightly YM, Callahan LF, et al.
Race and sex differences in willingness to undergo
total joint replacement: the Johnston County
Osteoarthritis Project. Arthritis Care Res (Hoboken)
2014;66:1193–1202.
362 Hausmann LR, Mor M, Hanusa BH, et al. The
effect of patient race on total joint replacement
recommendations and utilization in the orthopedic
setting. J Gen Intern Med. 2010;25:982–988.
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in urban areas due to higher demand for
services 363
• Differences in referral patterns 364
from primary care physicians and
following hospitalizations
• Differences in providers who can
speak the language of beneficiaries with
Limited English Proficiency 365
The information contained in Table
107 is provided solely to demonstrate
beneficiary utilization by provider
specialty impact across a number of
health equity dimensions. This does not
form the basis or rationale for the
proposed policies in this proposed rule.
363 Cyr, M.E., Etchin, A.G., Guthrie, B.J. et al.
Access to specialty healthcare in urban versus rural
US populations: a systematic literature review.
BMC Health Serv Res 19, 974 (2019). https://
doi.org/10.1186/s12913-019-4815-5.
364 Landon BE, Onnela J, Meneades L, O’Malley
AJ, Keating NL. Assessment of Racial Disparities in
Primary Care Physician Specialty Referrals. JAMA
Netw Open. 2021;4(1):e2029238. doi:10.1001/
jamanetworkopen.2020.29238.
365 Berdahl TA, Kirby JB. Patient-Provider
Communication Disparities by Limited English
Proficiency (LEP): Trends from the US Medical
Expenditure Panel Survey, 2006–2015. J Gen Intern
Med. 2019 Aug;34(8):1434–1440. doi: 10.1007/
s11606–018–4757–3. Epub 2018 Dec 3. PMID:
30511285; PMCID: PMC6667581.
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BILLING CODE 4120–01–C
E. Other Provisions of the Regulation
D. Impact of Proposed Changes Related
to Telehealth Services
1. Impact of Proposals for Medicare
Parts A and B Payment for Dental
Services Inextricably Linked to Specific
Covered Medical Services
In section II.K.2. of this proposed rule,
we are: (1) proposing to allow payment
for dental examinations, diagnostic, and
treatment services prior to and during
certain treatments for cancer
(chemotherapy and CAR–T cell
therapy); (2) proposing to allow
payment for dental examinations,
diagnostic, and treatment services prior
to and during antiresorptive and/or
antiangiogenic drug therapy associated
with the treatment for cancer; and (3)
requesting comments on other types of
cardiovascular interventions (analogous
to cardiac valve replacements and
valvuloplasty procedures) where dental
services may be inextricably linked to,
and substantially related and integral to
the clinical success of, other
cardiovascular covered medical
services.
If we were to finalize the proposal
that Medicare Part A and Part B
payment can be made for oral or dental
examination, and necessary treatment,
performed prior to and during certain
cancer treatments or drug therapies
associated with managing cancer related
care, we do not anticipate any
significant increase in utilization or
payment impact for additional dental
services given the historically low
utilization of these therapies. Although,
we acknowledge that the observed
utilization of these services might have
been low because of the size of the
population of patients whose treatment
would include such dental services and
also because the dental services have
been viewed as subject to the payment
preclusion under section 1862(a)(12).
Based on an analysis of 2018–2022
incurred claims experience, we estimate
that there are potentially 155,000
additional beneficiaries who might
receive dental services for which
Medicare payment could be made,
relative to the current number of
beneficiaries that received dental
services. These are beneficiaries who
would receive any of the treatments
identified in our proposals for CY 2024
(that is, chemotherapy/CAR T/bonemodifying agent therapies used in the
treatment of cancer) who would likely
require dental services, and could
utilize dental services for which
services Medicare could pay in CY
2024, if these proposals are finalized.
The estimated average cost for these
additional dental services is about $525
per person. This assumption is based on
an analysis of 2019 incurred claims, but
We are proposing to implement the
provisions of the CAA, 2023 that
amended section 1834(m) of the Act) to
extend the application of certain
Medicare telehealth flexibilities through
December 31, 2024, including allowing
Medicare telehealth services to be
furnished to patients located anywhere
within the U.S.; continuing the
expanded scope of telehealth
practitioners to include occupational
therapists, physical therapists, speechlanguage pathologists, and audiologists;
extending payment for telehealth
services furnished by FQHCs and RHCs;
and delaying the requirement that there
be an in-person visit with the physician
or practitioner within 6 months before
an initial mental health telehealth
service.
In this proposed rule, we are
proposing a refined process for
considering requests received for
addition of services to the Medicare
Telehealth Services List, which would
include a decision on whether the
services should be proposed for
inclusion on the list on either a
permanent or provisional basis. Because
the underlying criteria for adding
services to the Medicare Telehealth
Services List are not changing, we do
not expect this proposal to have an
impact on the utilization of Medicare
Telehealth services beginning in CY
2024 but we will continue to monitor
utilization of these services. We are
proposing that, beginning in CY 2024,
claims billed with POS 10 (Telehealth
Provided in Patient’s Home) would be
paid at the non-facility PFS rate. Claims
billed with POS 02 (Telehealth Provided
Other than in Patient’s Home) will
continue to be paid at the PFS facility
rate. As we are currently paying for the
majority of services that will be billed
with POS 10 at the PFS non-facility rate
under the PHE-specific policy of paying
the place of service code had the service
been furnished in person, we believe
that these services furnished via
telehealth will largely be paid as they
are currently. Therefore, we believe the
impact of this proposal will roughly
neutral even if utilization remains at
current levels for these services. We
anticipate that these provisions will
result in continued utilization of
Medicare telehealth services during CY
2024 at levels comparable to observed
utilization of these services during the
PHE for COVID–19.
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we believe results using more recent
data would not be likely to change, due
to the limited claims involving these
services. Based on this same analysis,
the effective rate of coverage was less
than 0.2 percent. We do acknowledge
that the actual take-up rate of services
could be higher due to the proposed
additional examples of medical services
to which dental services are inextricably
linked, which may raise awareness that
payment is available. Therefore, we
prepared impact estimates under the
utilization assumptions of 0.2 percent
and between 1–3 percent. We then
applied these utilization ratios to
estimate projected payments for dental
exams and treatments in connection
with cancer therapies. We found that
the estimated yearly impact beginning
in CY 2024 to be roughly $162,000 per
year with a 0.2 percent utilization
assumption, and roughly $800,000 to 2
million per year for the utilization
assumptions of 1–3 percent. Therefore,
we do not anticipate a significant
payment impact for these provisions.
We note, however, that if we were to
finalize, as discussed in section II.K. of
this proposed rule, payment in other
clinical scenarios for dental services
inextricably linked to, and substantially
related and integral to the clinical
success of, certain covered medical
services, we may adjust this estimate for
the final rule.
We continue to believe that because
we are updating existing Medicare
payment policies by proposing
additional examples of clinical
scenarios where dental services are
inextricably linked to covered medical
services, as stated in the CY 2023 PFS
final rule, it is not appropriate to
incorporate these budget neutrality
adjustments into the conversion factor.
Additionally, while the impact of access
to these services to some individuals
enrolled in Medicare could be very
significant, we do not anticipate a
significant impact in the context of
overall spending and utilization under
the PFS nor do we anticipate significant
utilization and spending impact of these
policies finalized in section II.K.2. of
this proposed rule.
We acknowledge that the actual takeup rate of services could be higher than
the utilization assumptions included
within our current estimates. We
continue to be open to updating and
conducting further impact analysis once
we have additional data and input from
interested parties.
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2. Impact of Proposal To Implement
Separate Payment for the Office/
Outpatient (O/O) E/M Visit Inherent
Complexity Add-on Code (HCPCS
G2211)
In recent years, the AMA’s CPT
Editorial Committee has restructured
the E/M visit code sets largely to
acknowledge changes in medical
practice. The AMA RUC has reviewed
and provided us recommendations for
the revised E/M visit code sets in the
context of the generally recognized need
to better recognize resources involved in
furnishing different types of services
within the broader PFS. While we
adopted the RUC-recommended values
for the O/O E/M visit code family in the
CY 2021 final rule, recognizing that
those values generally reflect the
resources involved in furnishing those
services, we did not believe those
valuations appropriately reflected the
resource costs involved in furnishing
primary and other similarly longitudinal
medical care for a serious or complex
condition in office settings. To address
this concern, effective beginning in CY
2021, we finalized an add-on code to
separately pay for visit complexity
inherent to O/O E/M visits for primary
care and other medical care services that
are part of ongoing care related to a
patient’s single, serious, or complex
condition in the office setting (the O/O
E/M visit inherent complexity add-on).
After we finalized the CY 2021 payment
changes for O/O E/M visits, in the CAA
of 2021, Congress imposed a statutory
moratorium on Medicare payment for
the O/O E/M visit inherent complexity
add-on code until January 1, 2024.
We propose to implement payment
for the O/O E/M visit inherent
complexity add-on, HCPCS code G2211,
with significant refinements to target
improved payment for primary and
other similar longitudinal care for
serious or complex conditions.
Specifically, we are proposing that the
O/O E/M visit complexity add-on code
cannot be billed with visits reported
using Modifier 25 which is used to
indicate that the service is billed on the
same day as a minor procedure or
another E/M visit. (Previously, in the CY
2021 final rule, we stated we would not
expect such billing; but as there was no
explicit prohibition, these visits were
included in the budget neutrality
adjustment (85 FR 84572)). We also
propose to set PFS rates with a refined,
more specific utilization assumption
that better recognizes likely uptake of
the code, differential use among
specialties, and new and established
patient visits, among other changes.
These refined assumptions were
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developed, taking into consideration
perspectives and information provided
by interested parties. The resulting
estimate reflects that the O/O E/M visit
inherent complexity add-on code would
likely be reported with approximately
38 percent of all O/O E/M visits for CY
2024. As discussed previously and
shown below, we estimate the specific
portion of the total budget neutrality
adjustment attributable to the proposal
to make payment for the O/O E/M
inherent complexity add-on code to be
approximately 2.00 percent compared to
an attributable budget neutrality
adjustment of 3.20 percent as calculated
in CY 2021 rulemaking.
3. Advancing Access to Behavioral
Health
a. Impact of Proposed Payment for
Marriage and Family Therapist (MFT)
Services and Mental Health Counselor
(MHC) Services
As discussed in section II.J. of this
proposed rule, section 4121 of CAA,
2023 added section 1861(s)(2)(II) to
establish a new Medicare benefit
category for MFT services and MHC
services furnished and billed by MFTs
and MHCs, respectively. MFT and MHC
services are defined in section
1861(lll)(2) and 1861(lll)(4),
respectively, as services for the
diagnosis and treatment of mental
illnesses (other than services furnished
to an inpatient of a hospital). An MFT
or MHC is defined as an individual who
possesses a master’s or doctor’s degree,
is licensed or certified by the State in
which they furnish services, who has
performed at least 2 years of clinical
supervised experience, and meets other
requirements as the Secretary
determines appropriate. Section
1833(a)(1)(FF) of the statute requires
that MFT and MHC services be paid at
75 percent of the amount determined for
payment of a clinical psychologist. MFT
and MHC services are excluded from
consolidated billing requirements under
the skilled nursing facility prospective
payment system. Services furnished by
an MFT and MHC are covered when
furnished in a rural health clinic and
federally qualified health center. In
addition, the hospice interdisciplinary
team is required to include at least one
social worker, MFT or MHC.
Expenditures associated with payment
for services furnished by MFTs and
MHCs in CY 2024 will be incorporated
into budget neutrality for PFS
ratesetting in future years.
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4. Drugs and Biological Products Paid
Under Medicare Part B
Section 90004 of the Infrastructure
Investment and Jobs Act (Pub. L. 117–
9, November 15, 2021) amended section
1847A of the Act to require
manufacturers to provide a refund to
CMS for certain discarded amounts from
a refundable single-dose container or
single-use package drug. The refund
amount is either as noted in section
1847A(b)(1)(B) of the Act in the case of
a single source drug or biological or as
noted in section 1847A(b)(1)(C) of the
Act in the case of a biosimilar biological
product, multiplied by the amount of
discarded drug that exceeds an
applicable percentage, which is required
to be at least 10 percent, of total charges
(subject to certain exclusions) for the
drug in a given calendar quarter. In the
CY 2023 final rule, we finalized several
policies to implement the provision,
including: reporting requirements for
the JW and JZ modifiers; the date upon
which we will begin to edit claims for
appropriate use of the JW and JZ
modifiers, October 1, 2023; the
definition of ‘‘refundable single-dose
container or single-use package drug’’;
the manner in which refund amounts
will be calculated; the annual basis we
will send reports to manufacturers; the
dispute resolution process; and
enforcement provisions. In section III.A
of this proposed rule, we are proposing
the date of the initial report to
manufacturers, the date for subsequent
reports, method of calculation when
there are multiple manufacturers for a
refundable drug, increased applicable
percentages for drugs with unique
circumstances, and a future application
process by which manufacturers may
apply for an increased applicable
percentage for a drug.
For this proposed rule, we reanalyzed
JW modifier data from 2021 as if the
data represented dates of service on or
after the effective date of section 90004
of the Infrastructure Act (that is, January
1, 2023).368 That is, to assess if there
was a change in the status of the billing
and payment codes that were identified
in the proposed rule as met the
definition of refundable single-dose
container or single-use package drug
and have 10 percent or more discarded
units, except for five drugs with higher
applicable percentages finalized in the
CY 2023 final rule or as proposed under
this proposed rule.
Overall in the 2021 calendar year,
Medicare paid nearly $1.56 billion for
discarded amounts of drugs from a
368 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-discarded-drug-units.
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single-dose container or single-use
package paid under Part B. In that year,
there were 51 billing and payment codes
with 10 percent or more discarded units
based on JW modifier data. Of these, 11
did not meet the definition of
refundable single-dose container or
single-use package drug in section
1847A(h)(8) of the Act because they are
multiple source drug codes; 5 were
excluded from the definition of
refundable single-dose container or
single-use package drug (as specified in
section 1847A(h)(8)(B) of the Act)
because they are identified as
radiopharmaceuticals or imaging agents
in FDA-approved labeling; and 3 are
products referred to as skin substitutes,
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which were removed because we
anticipate making changes to coding
and payment policies regarding those
products in future rulemaking. After
these exclusions, there were 31 billing
and payment codes that met the
definition of refundable single-dose
container or single-use package drug
and have discarded units above the
relevant finalized applicable percentage.
Of these, three have discarded units that
would fall below increased applicable
percentages proposed in this proposed
rule.
We estimated refund amounts as
described in section 1847A(h)(3) of the
Act were calculated based on this data
by subtracting the percent units
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discarded by 10 percent (the applicable
percentage), except for drugs with
higher applicable percentages finalized
in the CY 2023 final rule or as proposed
under this proposed rule. Then, we
multiplied the appropriate percentage
by the CY 2021 total allowed amount to
estimate the annual refund for a given
billing and payment code. The quarterly
refund was estimated by dividing the
annual estimate by 4. Based on this
data, there would be approximately
$83.1 million in refunds due from
manufacturers for the calendar year of
2021 ($20.8 million each calendar
quarter). See Table 108.
BILLING CODE 4120–01–P
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There are several limitations to this
analysis that could substantially affect
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the total quarterly refund. Since new
drugs are continually being approved,
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this estimate does not consider newer
drugs that will meet the definition of
refundable single-dose container or
single-use package drug on or after the
effective date of January 1, 2023. Since
section 1847A(h)(8)(B)(iii) of the Act
excludes 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 from this
definition, we expect an impact on
refund amounts after the 18-month
exclusion has ended if the drug
otherwise meets the definition. We also
note that this estimate is based on CY
2021 data for discarded drug amounts,
which, for reasons discussed in the CY
2023 final rule (87 FR 69716), we
believe to be an underestimate due to
the frequent omission of the JW
modifier. Once we begin to edit claims
for both the JW and JZ modifiers,
reported discarded drug amounts will
likely increase. Other substantial
changes to this estimate may occur if a
billing and payment code no longer
meets this definition. For example, if a
generic version of one of these drugs is
marketed, the billing and payment code
will become a multiple source drug
code and will no longer meet the
definition of refundable single-dose
container or single-use package drug.
Subsequently, the manufacturers will
not be responsible for refunds under
this provision. There may be changes in
the percent discarded units for a given
refundable single-dose container or
single-use package drug if the
manufacturer introduces additional vial
sizes or modifies the vial size to reduce
the amount discarded. Lastly, since data
from the CMS website only includes
billing and payment codes on the ASP
drug pricing file 370 and implementation
of section 90004 of the Infrastructure
Act is not restricted to billing and
payment codes included on the file,
there may be other applicable data that
was not assessed as part of this estimate.
a. Impacts Related to the Issuance of the
Initial Report
In section III.A.3.b. of this proposed
rule, we propose to issue the initial
refund report to manufacturers, to
include all calendar quarters for 2023,
no later than December 31, 2024.
Accordingly, as discussed in section
III.A.3.c., 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.
370 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Part-B-Drugs/
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Delaying the receipt of the rebate, that
is in 2025 instead of 2024, only
represents a cost to the extent the SMI
trust fund receives less interest revenue.
Only a portion of SMI trust fund
revenue ends up invested in the bond
portfolio. Based on current SMI trust
fund operation patterns a delay in rebate
collection as described in the rule
would represent a cost less than $2
million dollars in any given year and
therefore would be negligible to SMI
trust fund operations.
b. Impacts Related to the Application for
Consideration
As described in section VII.B.1. of this
proposed rule, the information
collection requirements, we estimate the
annual burden per applicant to be 5
hours. If we anticipate no more than 25
applications per year, the total annual
drafting and submitting burden would
be 125 hours (25 applications per year
× 5 hours per applicant). We estimate an
annual cost of this burden to be
$4,937.50 ($39.50/hour × 125 hours).
5. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
In section III.B.2. of this proposed
rule, we are proposing to include
Remote Patient Monitoring (RPM) and
Remote Therapeutic Monitoring (RTM)
services, and the proposed Community
Health Integration (CHI) and Principal
Illness Navigation (PIN) services if
finalized, in the general care
management HCPCS code G0511 when
these services are provided by RHCs and
FQHCs. Due to the growing number of
services in the code, we are also
proposing to revise the calculation for
G0511 to include the weighted average
of these services based on utilization
under the PFS as this may provide a
more complete and accurate payment
amount.
In terms of estimated impacts to the
Medicare program, expanding use of
General Care Management HCPCS code
G0511 to include RPM, RTM, CHI, and
PIN may result in an increase in
spending. Prior updates to G0511 have
resulted in negligible increases.
6. RHC and FQHC CfC Changes:
Permitting MFTs and MHCs To Furnish
Services
Section 4121 of the CAA, 2023
amends section 1861(aa)(1)(B) of the Act
by adding MFTs and MHCs as eligible
practitioners of RHCs and FQHCs
beginning January 1, 2024. We are
proposing regulation text changes to
permit MFT and MHCs to provide
services furnished at RHCs and FQHCs.
These changes would include MFTs and
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MHCs as members of the staff who may
be the owner or an employee of the
clinic or center, or furnish services
under contract to the clinic or center.
Along with other permitted physicians
and nonphysician practitioners, MFT
and MHCs may be available to furnish
patient care services at all times the
clinic or center operates.
At § 491.9(b)(3) RHCs and FQHCs
must have patient care policies that
include: (1) a description of the services
the clinic or center furnishes directly or
through agreement or arrangement; (2)
guidelines for medical management of
health problems; and (3) rules for
storage, handling, and administration of
drugs and biologicals. Additionally,
§ 491.9(b)(4) states that the RHC and
FQHC patient policies must regularly be
reviewed at least once every 2 years by
a group of professional personnel that
includes one or more physicians, one or
more physician assistants (PAs) or nurse
practitioners (NPs), and at least one
person who is not a member of the
clinic or center staff. If an RHC or FQHC
provides services furnished by an MHC
or MFT they must update their patient
care policies with a description of the
services they will provide.
The most recently published
collection of information for RHCs and
FQHCs (OMB control number 0938–
0334), estimates that an annual review
of the patient care policies may take
approximately 2 hours. Therefore, we
assume, it would take each medical
professional (at least one physician and
at least one PA or NP) 1 hour to review
all policies and procedures, annually.
Based on the prior analysis, we estimate
it will take 15 minutes to add the
description of MFT and MHC services.
We also assume that only half of the
RHCs and half of the FQHCs would
have this burden applied to them, for a
total burden estimate of $361,891.05.
We note that there would be variations
in how many clinics or centers employ
or contract with an MFT and MHC
based on their ability to expand their
services. We also recognize that some
RHCs and FQHCs may already provide
these services as some States provide
reimbursement under the Medicaid
program; however, we do not know the
exact number of clinics or centers that
already have these practitioners on staff
and would not incur the burden.
While this proposed rule does have a
1-time burden, there is evidence to
suggest there are long-term financial
savings in integrating mental health in
medical care. Effectively integrating
mental and medical care can save
upwards of $52 billion annually due to
the existing Medicare mental health
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coverage gap.371 Though this total
encompasses all facility types,
expanding access to MFT and MHC
services in RHCs and FQHCs will have
individual and societal cost savings.
Older adults with mental health
conditions have poorer health
outcomes, higher hospitalization rates,
and emergency room visits.372 While
there is an increasing need for mental
health services, one barrier to effective
treatment is access to mental health
services.373 Ensuring access to mental
health care in rural communities is
challenging as there are fewer mental
health providers per capita in
nonmetropolitan counties.374 This
coincides with HRSA’s second quarter
of the fiscal year 2023 designated health
professional shortage area (HPSA)
quarterly summary, which breaks down
the number of HPSAs by primary
medical care, dental, and mental health
HPSAs based on four categories (rural,
non-rural, partial rural, and unknown);
and as population HPSAs, geographic
HPSAs, or Facility HPSAs. The report
does not provide accumulative HPSAs
by the four categories.375 Approximately
65 percent of federally designated
health professional shortage areas are
located in rural areas, and about 30
percent are located in non-rural
areas.376 The shortage of professionals
in rural areas is severe, and the shortage
of qualified professionals in
combination with geographic
limitations only exacerbates the mental
health crisis in older adults.377 While
there are disparities in the availability of
the behavioral workforce between rural
and nonrural areas, counselors are
integral to providing care in rural
areas.378
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7. Clinical Laboratory Fee Schedule
In section III.D of this proposed rule,
we discuss statutory revisions to the
371 https://onlinelibrary.wiley.com/doi/full/
10.1002/jcad.12409?casa_token=z412GCn3OuYAA
AAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxv
YtRUo4aj8AwB-tq2w_ZJV11gGpWW-oxilDK3awU
0xIc2XKMnKhtAQ#jcad12409-bib-0003.
372 https://onlinelibrary.wiley.com/doi/full/
10.1002/jcad.12409?casa_token=z412GCn3OuYAA
AAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxv
YtRUo4aj8AwB-tq2w_ZJV11gGpWW-ox
ilDK3awU0xIc2XKMnKhtAQ#jcad12409-bib-0005.
373 https://psycnet.apa.org/fulltext/2020-75725002.html.
374 https://psycnet.apa.org/record/2018-25164007.
375 https://data.hrsa.gov/topics/health-workforce/
shortage-areas.
376 https://data.hrsa.gov/Default/
GenerateHPSAQuarterlyReport.
377 https://psycnet.apa.org/fulltext/2020-75725002.html.
378 chrome-extension://efaidnbmnnnibpcajpc
glclefindmkaj/https://depts.washington.edu/
fammed/rhrc/wp-content/uploads/sites/4/2016/09/
RHRC_DB160_Larson.pdf.
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data reporting period and phase-in of
payment reductions under the CLFS. In
accordance with section 4114 of the
CAA, 2023, we are proposing certain
conforming changes to the data
reporting and payment requirements in
our regulations at 42 CFR part 414,
subpart G. Specifically, for CDLTs that
are not ADLTs, we are proposing to
update certain definitions and revise
§ 414.504(a)(1) to indicate that initially,
data reporting begins January 1, 2017,
and is required every 3 years beginning
January 2024. The CAA, 2023 delays the
next data reporting period under the
CLFS for CDLTs that are not ADLTs by
1 year, that is, it requires the next data
reporting period for these tests to take
place during the period of January 1,
2024 through March 31, 2024.
Subsequently, the next private payor
rate-based CLFS update for these tests
will be effective January 1, 2025, instead
of January 1, 2024. In addition, we are
proposing to make conforming changes
to our requirements for the phase-in of
payment reductions to reflect the CAA,
2023 amendments. Specifically, we are
proposing to revise § 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 recognize that private payor rates
for CDLTs paid on the CLFS and the
volumes paid at each rate for each test,
which are used to determine the
weighted medians of private payor rates
for the CLFS payment rates, have
changed since the first data collection
period (January 1, 2016 through June 30,
2016) and data reporting period (January
1, 2017 through March 31, 2017). In
addition, as discussed in section III.D. of
this proposed rule, in the CY 2019 PFS
final rule (83 FR 59671 through 59676),
we amended the definition of applicable
laboratory to include hospital outreach
laboratories that bill Medicare Part B
using the CMS–1450 14x Type of Bill.
As such, the CAA, 2023 amendments to
the data reporting period will delay
using updated private payor rate data to
set revised CLFS payment rates for
CDLTs that are not ADLTs.
Due to unforeseen changes in private
payor rates due to shifts in market-based
pricing for laboratory tests and the
unpredictable nature of test volumes
and their impact on calculating updated
CLFS payment rates based on the
weighted median of private payor rates,
it is uncertain whether the delay in data
reporting will result in a measurable
budgetary impact. In other words, to
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52705
assess the impact of delayed reporting
and subsequent implementation of
updated CLFS rates, we will need to
calculate weighted medians of private
payor rates based on new data and
compare the revised rates to the current
rates. As such, we believe that we will
only know the impact of the delay in
data reporting after collecting actual
updated applicable information from
applicable laboratories, and calculating
the updated CLFS rates.
Regarding the conforming changes to
our requirements for the phase-in of
payment reductions that we are
proposing in this rule, we note that 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. Based on data
reported in the 2017 data collection
period, we estimate 14.8 percent (191)
of tests on the CLFS may be subject to
the full 15 percent phase-in reduction in
CY 2024.
8. Pulmonary Rehabilitation (PR),
Cardiac Rehabilitation (CR) and
Intensive Cardiac Rehabilitation (ICR)
Expansion of Supervising Practitioners
As discussed in section III.E. of this
proposed rule, we are proposing
revisions to §§ 410.47 (PR) and 410.49
(CR/ICR) to codify the statutory changes
made in section 51008 of the Bipartisan
Budget Act of 2018 (Pub. L. 115–123,
enacted February 9, 2018) (BBA of 2018)
which permit other specific types of
practitioners to supervise these services
effective January 1, 2024. The
amendments 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). Accordingly, we are
proposing additions and revisions to the
PR and CR/ICR regulations to reflect
these statutory amendments.
To assess the potential impact from
expanding the types of practitioners that
may supervise PR/CR/ICR we searched
the literature for articles that evaluated
the utilization rates of PR, CR and ICR
to determine the historical utilization
trends of these services as well as
known barriers to utilization. Based on
historical utilization trends as well as
barriers to utilization discussed in the
literature, we do not expect the
proposed changes to make a significant
impact on the Medicare program.
Nishi et al. (2016) investigated the
number of Medicare beneficiaries with
COPD who received PR from January 1,
2003, to December 31, 2012. Their
results included both individuals who
had experienced hospitalizations for
COPD and those who were outpatients
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only. The number of unique patients
with COPD who initially participated in
PR during the study period was 2.6
percent in 2003 (before conditions of
coverage at § 410.47 were established)
and 2.88 percent in 2012 (after
conditions of coverage at § 410.47 were
established).379 In 2019, Spitzer, et al.
published an article based on Medicare
claims data from 2012, finding that 2.7
percent of eligible Medicare
beneficiaries received PR within 12
months of hospitalization with
COPD.380 Using claims data from feefor-service Medicare beneficiaries
hospitalized for COPD in 2014,
Lindenauer et al. (2020) reported that
only 3 percent initiated PR within 1
year of their hospital discharge.381
Taken together, this data informs us that
utilization of PR in the Medicare
population is very low.
Million Hearts® 2027, a national
initiative co-led by the Centers for
Disease Control and Prevention (CDC)
and CMS to prevent 1 million
preventable cardiovascular disease
(CVD) events in the next 5 years,382
includes a goal of increasing use of CR
and states that CR participation rates
remain low, ranging from 19 percent to
34 percent.383 Fleg and colleagues
(2020) report that less than 25 percent
‘‘of eligible patients participate in CR’’
with a smaller proportion completing 36
sessions as recommended.384 In their
2022 article, Varghese and colleagues
state that less than 30 percent of eligible
patients participate in CR in the United
379 Nishi SP, Zhang W, Kuo YF, Sharma G.
Pulmonary Rehabilitation Utilization in Older
Adults With Chronic Obstructive Pulmonary
Disease, 2003 to 2012. J Cardiopulm Rehabil Prev.
2016;36(5):375–382. doi: 10.1097/
HCR.0000000000000194.
380 Spitzer KA, Stefan MS, Priya A, et al.
Participation in pulmonary rehabilitation after
hospitalization for chronic obstructive pulmonary
disease among Medicare beneficiaries. Ann Am
Thorac Soc. 2019;16:99–106. DOI: 10.1513/
AnnalsATS.201805–332OC. PMID: 30417670;
PMCID: PMC6344454.
381 Lindenauer PK, Stefan MS, Pekow PS, et al.
Association Between Initiation of Pulmonary
Rehabilitation After Hospitalization for COPD and
1-Year Survival Among Medicare Beneficiaries.
JAMA. 2020;323(18):1813–1823. doi:10.1001/
jama.2020.4437.
382 https://millionhearts.hhs.gov/about-millionhearts/.
383 https://millionhearts.hhs.gov/about-millionhearts/optimizing-care/cardiac-rehabilitation.html.
384 Fleg JL, Keteyian SJ, Peterson PN, Benzo R,
Finkelstein J, Forman DE, Gaalema DE, Cooper LS,
Punturieri A, Joseph L, Shero S, Zieman S.
Increasing Use of Cardiac and Pulmonary
Rehabilitation in Traditional and Community
Settings: OPPORTUNITIES TO REDUCE HEALTH
CARE DISPARITIES. J Cardiopulm Rehabil. Prev.
2020 Nov;40 (6):350–355. doi: 10.1097/
HCR.0000000000000527. PMID: 33074849; PMCID:
PMC7644593.
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States.385 Husaini and colleagues (2022)
analyzed a sample of Medicare fee-forservice claims between 2012 and 2016
and reported that within 1 year of a
qualifying event, 16 percent of patients
completed one or more CR session and
0.1 percent of patients completed one or
more ICR sessions. They observed an
increase of combined CR and ICR
utilization from 14 percent (patients
with qualifying events in 2012) to 18
percent (patients with qualifying events
in 2015).386 Taken together, this data
informs us that utilization of CR and
ICR is low, although not as low as PR.
Underutilization of PR, CR and ICR
has been attributed to numerous factors
as described by Fleg et al. ‘‘including a
lack of referral or strong
recommendation from a physician and
inadequate follow-up or facilitation of
enrollment after referral. Financial
issues such as limited or absent health
insurance coverage and the inability to
afford copayments, even when insured,
also limit CR/PR participation as do
conflicting work and home
responsibilities and distance and
transportation difficulties. Social and
cultural factors, including the lack of
gender and racial diversity among CR/
PR staff, language and cultural barriers,
and lack of program availability and
access are additional challenges . . .
Many eligible patients are also
commonly perceived as too frail
. . .’’ 387 Husaini et al. (2022) reinforce
the impact of similar factors in CR
underuse. They cite ‘‘lower
reimbursements relative to cost and
variability in access’’, physician
‘‘skepticism over benefit and a primary
emphasis on cardiac medications and
procedures’’, and patient ‘‘reluctance or
inability to commit 3–6 hr/wk for 8–12
wk to CR, logistical (transportation,
work, etc) or financial impediments, a
preference for exercise/rehabilitation at
385 Varghese MS, Beatty AL, Song Y, et al.,
Cardiac Rehabilitation and the COVID–19
Pandemic: Persistent. Declines in Cardiac
Rehabilitation Participation and Access Among US
Medicare Beneficiaries. Circ Cardiovasc Qual
Outcomes. 2022;15:e009618. DOI: 10.1161/
CIRCOUTCOMES.122.009618.
386 Husaini M, Deych E, Racette SB, et al.
Intensive Cardiac Rehabilitation Is Markedly
Underutilized by Medicare Beneficiaries: RESULTS
FROM A 2012–2016 NATIONAL SAMPLE. J
Cardiopulm Rehabil Prev. 2022 May 1;42(3):156–
162. doi: 10.1097/HCR.0000000000000632. Epub
2021 Sep 9. PMID: 34508035.
387 Fleg JL, Keteyian SJ, Peterson PN, Benzo R,
Finkelstein J, Forman DE, Gaalema DE, Cooper LS,
Punturieri A, Joseph L, Shero S, Zieman S.
Increasing Use of Cardiac and Pulmonary
Rehabilitation in Traditional and Community
Settings: OPPORTUNITIES TO REDUCE HEALTH
CARE DISPARITIES. J Cardiopulm Rehabil. Prev.
2020 Nov;40 (6):350–355. doi: 10.1097/
HCR.0000000000000527. PMID: 33074849; PMCID:
PMC7644593.
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home, fear of failure, and physical
limitations.’’ 388
While the expansion of supervision
requirements to include nonphysician
practitioners could offer greater
flexibility for PR and CR programs to
operate, the barriers to utilization as
described by Fleg and colleagues (2020)
and Husiani and colleagues (2022) are
widespread and complex and low
participation in PR, CR and ICR has
remained steady for many years. We do
not believe the expansion of supervising
practitioners is likely to address these
barriers. Therefore, we do not anticipate
any significant increase in utilization of
PR, CR and ICR services and subsequent
impact to the Medicare program or
interested parties.
9. Modifications Related to Medicare
Coverage for Opioid Use Disorder (OUD)
Treatment Services Furnished by
Opioid Treatment Programs (OTPs)
As discussed in section III.F. of this
proposed rule, we are proposing
allowing periodic assessments to be
furnished via audio-only
communication when two-way audiovideo communications technology is not
available to the beneficiary through the
end of CY 2024, to the extent that it is
authorized by SAMHSA and DEA at the
time the service is furnished and all
other applicable requirements are met.
We believe the Part B cost impact of
this flexibility for the use of
telecommunications will be minimal
because we do not expect that these
flexibilities will increase the frequency
with which medically necessary
assessments are furnished.
10. Medicare Shared Savings Program
a. General Impacts
As of January 1, 2023, 10.9 million
Medicare beneficiaries receive care from
a health care provider in one of the 456
ACOs participating in the Shared
Savings Program, the largest value-based
care program in the country. The Shared
Savings Program proposed policies
advance Medicare’s overall value-based
care strategy of growth, alignment, and
equity, with many proposals
overlapping these categories. The
proposed policies in this proposed rule
are incremental refinements to the
broader changes finalized in the CY
2023 PFS final rule (87 FR 69777
through 69968). Those changes were
designed to reverse recent trends where
388 Husaini M, Deych E, Racette SB, et al.
Intensive Cardiac Rehabilitation Is Markedly
Underutilized by Medicare Beneficiaries: RESULTS
FROM A 2012–2016 NATIONAL SAMPLE. J
Cardiopulm Rehabil Prev. 2022 May 1;42(3):156–
162. doi: 10.1097/HCR.0000000000000632. Epub
2021 Sep 9. PMID: 34508035.
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program participation had plateaued,
higher spending populations were
increasingly underrepresented in the
program since the change to regionallyadjusted benchmarks, and access to
ACOs appeared inequitable as
evidenced by data indicating
underserved populations are less likely
to be assigned to a Shared Savings
Program ACO, and to encourage growth
of ACOs in underserved communities.
The changes to the Shared Savings
Program regulations finalized with the
CY 2023 PFS final rule were designed
to increase program participation for
new ACOs through the AIP option
intended to promote health equity, and
provide ACOs greater choice in the pace
of progression to performance-based
risk; sustain program participation by
reducing the effect of ACO performance
on benchmark updates and benchmark
rebasing; mitigate the bias in regional
expenditure calculations that benefits
ACOs electing prospective assignment;
strengthen incentives for ACOs serving
high risk and high dual populations;
improve the risk adjustment
methodology to better account for
medically complex, high cost
beneficiaries while continuing to guard
against coding initiatives; increase
opportunities for low revenue ACOs in
the BASIC track to share in savings by
allowing ACOs that do not meet the
minimum savings rate (MSR)
requirement to share in savings at a
lower rate; encourage ACOs to transition
more quickly to all-payer quality
measure reporting; update the ACO
beneficiary assignment methodology;
and reduce administrative burden on
ACOs. The proposed changes to Shared
Savings Program policies in this
proposed rule include modifications
designed to further these goals in
concert with implementation of certain
changes finalized in the CY 2023 PFS
final rule, which are applicable for
agreement periods beginning on January
1, 2024, and in subsequent years.
On average, updated benchmarks
would marginally increase as a result of
the proposal to modify the calculation
of the regional component of the
blended update factor used to update
the historical benchmark between
benchmark year (BY) 3 and the
performance year (PY) by capping an
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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).
This change is expected to increase the
regional update factor amount in certain
cases where an ACO may operate in a
regional service area with rapid change
in the average prospective HCC risk
score for the FFS assignable beneficiary
population. The current methodology
for calculating the regional update factor
risk adjusts county-level FFS
expenditures in an ACO’s regional
service area by Medicare enrollment
type by dividing average county-level
FFS expenditures for assignable
beneficiaries in the county by the
average prospective HCC risk score for
both the performance year and BY3. The
expenditure growth between BY3 and
the performance year calculated using
risk-adjusted regional expenditures
could therefore be reduced by large
increases in average prospective HCC
risk scores in the ACO’s regional service
area that would only be partly offset by
the increase in prospective HCC risk
score growth for the ACO’s assigned
beneficiary population due to the cap on
ACO assigned beneficiary prospective
HCC risk score growth when updating
the benchmark between BY3 and the
performance year. The proposed
adjustment, applicable for agreement
periods beginning on January 1, 2024,
and in subsequent years, would
effectively strengthen the regional
portion of the three-way blended update
factor and help to limit losses ACOs
may face when operating in regional
service areas with high risk score
growth and a beneficiary population
that becomes more medically complex
between BY3 and the performance year,
increasing incentives for ACOs to form
or continue participation in such areas.
By utilizing a market share adjusted cap
to account for ACO market share in the
ACO’s regional service area, the
proposed adjustment would still retain
a disincentive against coding intensity
for ACOs that may have a high market
share in their region and consequently
have greater influence on regional
service area risk score changes. For
example, this feature of the proposal
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would help dissuade such ACOs from
attempting to artificially increase their
benchmark by selectively serving lower
risk beneficiaries and increasing the
intensity of diagnoses submitted for
those beneficiaries.
Analyses described in the section
III.G.4.b.(2) of this proposed rule,
surrounding tables 33 and 34, provide
the basis for estimating the impact for
the proposal to cap regional service area
risk score growth. Analysis of average
prospective HCC risk score changes at
the Hospital Referral Region (HRR) level
over an extended 2007 to 2021 historical
period consistently indicated that risk
score changes would be highly unlikely
to exceed the proposed cap in the first
two years of an ACO’s agreement period
but would increase somewhat as the 5year agreement period progresses. The
analysis also notably showed that
average prospective HCC risk score
variation increased markedly in 2020
and 2021 with the COVID–19 PHE.389
The 11 percent of ACOs simulated to be
impacted by the proposed adjustment in
PY 2021 (a mix of ACOs with 2-year and
3-year gaps between their respective
BY3 and the simulated PY 2021) is
therefore anticipated to overstate
variation expected in agreement periods
that start on January 1, 2024 or later.
Based on the simulation in the
context of the longer-run HRR data, we
project that starting in 2024 the
proposed adjustment would impact less
than 1 percent of ACOs in PY1 of an
agreement period, between 5 to 7
percent of ACOs by PY3, and up to 10
to 15 percent of ACOs by PY5. The
adjustment for ACOs that are simulated
to be impacted is relatively small,
increasing updated benchmarks by
about 0.2 percent up to 0.4 percent on
average by PY5, but with the potential
for up to a net adjustment of about 1.5
percent in extreme scenarios. The
estimated cost from additional shared
savings payments resulting from these
adjustments totals $370 million over 10
years as shown in Table 109.
389 Public use data on Medicare Geographic
Variation—by Hospital Referral Region, used for
this analysis, is available at https://data.cms.gov/
summary-statistics-on-use-and-payments/medicaregeographic-comparisons/medicare-geographicvariation-by-hospital-referral-region.
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A material, albeit uncertain impact, is
also estimated for the proposals to (a)
use a rolling 3-year historical period
instead of contemporary performance to
calculate the 40th percentile of the
MIPS Quality performance category
scores starting in PY 2024 and (b) the
proposal to use the higher of the ACO’s
health equity adjusted quality
performance score or the 40th percentile
MIPS Quality performance category
score across all MIPS Quality
performance scores if measure
suppression is required. It is likely that
MIPS Quality performance will improve
at least marginally over time and
therefore the historical performance
could produce a target that effectively is
lower than the contemporary 40th
percentile stipulated at baseline. The
effective reduction in the threshold
when using the historical MIPS scores,
combined with the ‘higher of’ proposal
when suppression is necessary, are
assumed to effectively reduce the
quality target by 0 to 5 percentage points
(mode 1.5 percentage points), which
would produce an estimated $110
million in additional shared savings
payments over 10 years, as shown in the
Table 110.
The impact is also estimated to be
material for the proposal to mitigate the
impact of the negative regional
adjustment on the benchmark. In the CY
2023 PFS final rule, CMS finalized
changes applicable for agreement
periods beginning on January 1, 2024,
and in subsequent years, that would
reduce the cap on negative regional
adjustments from 5 percent to 1.5
percent and provide an offset factor to
gradually decrease the negative regional
adjustment amount as an ACO’s
proportion of dually eligible Medicare
and Medicaid beneficiaries increases or
its weighted average prospective HCC
risk score increases, or both. Removing
the regional adjustment entirely, when
the ACO’s regional adjustment amount
(expressed as a single per capita value)
is negative, would incrementally
increase benchmarks for higher
spending ACOs (increasing shared
savings payments) but would also
improve the incentive for higher
spending ACOs to join the Shared
Savings Program and drive down
unnecessary spending. For a high cost
estimate we conservatively assume no
new participation is generated in
response to this change and estimate the
higher benchmarks would generate
about $1.8 billion in additional shared
savings payments partly offset by about
$1.6 billion in reduced spending in
response to improved incentives. For a
mean estimate we additionally assume
10 percent growth in participation from
new high spending ACOs leading to
about $490 million net savings over 10
years.390 For a low cost estimate we
instead assume 20 percent growth in
participation from high spending ACOs
leading to about $1.2 billion in net
savings over 10 years. Table 111 shows
these estimates over the 2024–2033
window.
390 Elimination of overall negative regional
adjustments, under the proposed approach, would
likely generate participation growth from ACOs that
will face significant negative adjustments despite
the changes from the CY 2023 PFS final rule to
reduce the impact of the negative regional
adjustment, but also from other prospective high
spending ACOs that may have difficulty estimating
the relief they will ultimately receive from the
offsets applicable to agreement periods beginning
on January 1, 2024, and in subsequent years.
Eliminating overall negative regional adjustment
entirely would materially improve the business case
for participation from ACOs in the former category
and may at least optically improve the business
case for ACOs in the latter category without actually
incurring cost to the program by increasing their
benchmarks.
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The proposal to specify the use of the
CMS–HCC risk adjustment model(s)
applicable to the calendar year
corresponding to the performance year
to calculate a Medicare FFS
beneficiary’s prospective HCC risk score
for the performance year, and for each
benchmark year of the ACO’s agreement
period for agreement periods beginning
January 1, 2024, and in subsequent
years, is anticipated to remove a
potential bias that may otherwise reduce
benchmarks particularly for ACOs with
beneficiaries exhibiting higher average
renormalized risk scores at baseline. An
increase in average shared savings
payments to ACOs that would have
participated regardless of this proposed
modification is expected to ultimately
be more than offset by additional
savings from increased participation
from ACOs serving high risk
beneficiaries that would have otherwise
dropped out or avoided entering the
Shared Savings Program under the
current approach to calculating
prospective HCC risk scores. Net savings
are expected to be greater at the end of
the 10 year scoring window because
residual savings from added
participation would grow, whereas
benchmarks would not be as impacted
in the later part of the scoring window
because there is lower likelihood that
later agreement periods would have
been impacted by changes in the CMS
HCC risk adjustment methodology.
Table 112 shows these estimates over
the 2024–2033 window.
An overall net impact is difficult to
quantify for the proposed changes in
section III.G.3.a of this proposed rule, to
incorporate use of a new third step in
the step-wise beneficiary assignment
methodology and the proposed changes
to identification of the assignable
beneficiary population. These proposed
changes are not currently estimated to
have a net impact on program spending
in either direction. Impacts on
benchmark calculations for individual
ACOs would likely be mixed and of
relatively limited magnitude. The
proposed changes could allow some
ACOs to increase efficiency by utilizing
more non-physician clinicians in
delivering primary care without
jeopardizing assignment. On the other
hand, they could marginally increase
shared savings payments for efficiencies
that currently would accrue entirely to
the program as spillover effects on
beneficiaries unable to be assigned. The
overall impact is currently anticipated
to be roughly neutral. We will continue
to analyze data on the potential impact
of these proposed changes on existing
ACOs, and will monitor effects if the
proposals are finalized and
implemented in future agreement
periods.
The remaining proposed changes to
the Shared Savings Program regulations
are not estimated to have an impact on
program spending at the aggregate level.
These proposed changes include
modifying the definition of primary care
services for purposes of determining
beneficiary assignment, recalculating
the prior savings adjustment for changes
in the amount of savings earned by an
ACO in a benchmark year due to
compliance action taken to address
avoidance of at-risk beneficiaries or
changes in the amount of savings or
losses for a benchmark year as a result
of the issuance of a revised initial
determination of financial performance,
expanding quality reporting options to
include Medicare CQMs, requiring
reporting of MIPS PI performance
category for all eligible clinicians
participating in ACOs, and using
beneficiary counts instead of person
years in health equity adjustment
calculations, as well as proposals to
further refine AIP policies, revise
program eligibility requirements, and
make technical changes.
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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
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Section 1899(i)(3) of the Act
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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. When
considered together these changes to the
Shared Savings Program’s payment
methodology are expected to improve
the quality and efficiency of items and
services furnished under the Medicare
program by improving the ability for
ACOs to sustain effective participation
in regions with changing populations
and increasing the overall proportion of
Medicare beneficiaries assigned to
ACOs, 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.
In the CY 2023 PFS final rule we
estimated that the projected impact of
the payment methodology that
incorporates all finalized changes from
that final rule would result in $4.9
billion in greater program savings
compared to a hypothetical baseline
payment methodology that excludes the
policies that require section 1899(i)(3) of
the Act authority (see 87 FR 70195 and
70196). The marginal impact of the
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proposed changes discussed in this
proposed rule is estimated to be $330
million lower net spending over the ten
year window for all new proposals
combined, including the proposal to cap
an ACO’s regional service area risk score
growth and the proposals to add a new
third step to the beneficiary assignment
methodology and to revise the approach
to identify the assignable beneficiary
population. Therefore, we believe the
requirements of section 1899(i)(3)(B) of
the Act would not be violated by these
relatively minor changes to program
spending.
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.
11. Medicare Part B Payment for AtHome Preventive Vaccine
Administration Services
In section III.H.3.c of this proposed
rule, we propose to maintain the
additional payment when a COVID–19
vaccine is administered in a
beneficiary’s home under certain
circumstances, and to extend this
payment to the administration of a
pneumococcal, hepatitis B or influenza
vaccines.
We estimated the impact of the
proposal to maintain the additional
payment for in-home COVID–19 vaccine
administrations and to expand the
policy to the administration of all Part
B preventive vaccines. For this estimate,
we analyzed CY 2021–2022 utilization
of HCPCS code M0201 for the providers
and suppliers that billed it, along with
their utilization of the relevant
preventive vaccine administration
codes. During this period, the in-home
additional payment was billed about
200,000 times by roughly 1,500 different
providers and suppliers. For those
providers or suppliers who
administered COVID–19 vaccine in the
home in 2021–2022, HCPCS code
M0201 was billed about 2 percent of the
time they administered any COVID–19
vaccination. Total Medicare payments
for this service in 2021 and 2022 were
$4 million and $3 million, respectively.
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While we expect that in-home
administrations of COVID vaccines will
continue into CY 2024, we note that the
overall utilization of the COVID–19
vaccine was significantly lower in 2022
than in 2021, and future utilization is
unknown. Further, if we apply the
prevalence of the utilization of HCPCS
code M0201 for in-home administration
of the COVID–19 vaccine to the
utilization of the other three Part B
preventive vaccinations, it would result
in higher spending of roughly $1–2
million. Therefore, the overall estimated
impact of this proposal is increased
spending of less than $5 million in
2024. We note that our analysis
assumed that there would be no
additional providers or suppliers who
would decide to begin providing these
vaccines at home for CY2024, given that
COVID–19 PHE ended on May 11, 2023
12. Effects of Proposals Relating to the
Medicare Diabetes Prevention Program
Expanded Model
a. Effects on Beneficiaries
We propose to modify certain
Medicare Diabetes Prevention Program
(MDPP) expanded model policies to: (1)
Extend the flexibilities allowed during
the PHE for the COVID–191135 waiver
event by 4 years (or until December 31,
2027), (2) update the MDPP payment
structure to pay for beneficiary
attendance on a fee-for-service basis
while retaining the diabetes risk
reduction performance payments, (3)
remove the requirement for MDPP
interim preliminary recognition and
replace it with CDC preliminary
recognition, and (4) remove most
references to, and requirements of, the
Ongoing Maintenance Sessions given
that eligibility for these services will
end on December 31, 2023. We
anticipate that these proposed changes
will have a positive impact on
beneficiaries’ access to MDPP services
by increasing the number of MDPP
eligible organizations that enroll in
Medicare as MDPP suppliers and, more
importantly, increasing beneficiary
access to the Set of MDPP services by
allowing them continued access to
MDPP through a live in-person or
virtual classroom (or a combination of
both modalities). The proposed changes
would also remove barriers specific to
attending these classes solely in-person,
which may include a lack of MDPP
suppliers in certain communities and
challenges related to beneficiary
logistics concerning course attendance.
These proposed modifications address
MDPP supplier and beneficiary needs
based upon available monitoring and
evaluation data received to date,
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feedback from Medicare Advantage
plans and existing MDPP suppliers, and
feedback from beneficiary focus groups.
The proposed changes are also in
response to comments from interested
parties made through public comments
in response to prior rulemaking.
During the initial rulemaking for the
MDPP expanded model, we sought to
ensure that MDPP would be delivered
in-person, in a classroom-based setting,
and within an established period of
service to maintain consistency with the
original DPP model test. At the time,
priority was placed on establishing a
structured expanded model that, when
delivered within the confines of the
rule, would create the least risk of fraud,
waste, and abuse, increase the
likelihood of success, and maintain the
integrity of the data collected for
evaluation purposes.
However, circumstances such as the
PHE for COVID–19 led us to make
changes to the MDPP expanded model
through implementation of an
Emergency Policy for MDPP that allows
for temporary flexibilities while
prioritizing availability and continuity
of services for MDPP suppliers and
MDPP beneficiaries impacted by such
section 1135 waiver events. For
example, in the CY 2021 PFS, we
finalized the regulations in the March
31st COVID–19 IFC to amend the MDPP
expanded model to revise certain MDPP
policies during the COVID–19 PHE as
well as any future 1135 waiver events
where such 1135 waiver event may
cause a disruption to in-person MDPP
service delivery. These flexibilities
allowed beneficiaries to either continue
to have access to MDPP through
participation in virtual sessions, pause
an in-person MDPP class and resume
with the most recent attendance session
of record, or restart MDPP from the
beginning in accordance with the March
31st COVID–19 IFC (85 FR 19230).
When establishing these flexibilities,
we could not predict that the COVID–
19 PHE would continue for over 3 years.
Although beneficiary participation
decreased significantly during the initial
year of the COVID–19 PHE, MDPP
participation has slowly increased since
2021. As this additional modality of
delivery has helped improve supplier
access to beneficiaries, removing the
PHE flexibilities and suppliers’ ability
to deliver MDPP virtually after 3 years
would not only be disruptive to
suppliers, it may in-fact be detrimental
to the operations of the MDPP expanded
model.
During the COVID–19 PHE, we
permitted virtual delivery of the Set of
MDPP services by MDPP suppliers who
were recognized by the CDC with
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Diabetes Prevention Recognition
Program (DPRP) in-person delivery
mode, but did not permit suppliers who
were only recognized by the CDC with
either online or distance learning
delivery modes. Although we finalized
in the CY 2021 PFS that suppliers had
to be prepared to return to in-person
delivery when the PHE ended, the PHE
lasted for over 39 months. Therefore,
returning to a solely in-person, pre-PHE
delivery model may not be as simple for
some suppliers.
Post-PHE, many beneficiaries and
suppliers have reported the desire to
continue utilizing virtual delivery of
MDPP for a wide range of reasons.
Maintaining suppliers’ ability to offer
both synchronous virtual (distance
learning) and in-person MDPP may
increase beneficiary uptake of these
services. It is important to note that
permitting virtual delivery of MDPP
throughout the PHE has not resulted in
a spike in MDPP utilization. A reason
for a lack of beneficiary participation
may be tied to the fact that suppliers
still had to maintain the ability to
deliver in-person services (rent or own
physical space), while some suppliers
were unfortunately unable to pivot to
virtual delivery during the COVID–19
PHE for a variety of reasons.
Current data depict that the most
impactful MDPP results correspond to
attending MDPP sessions virtually or
through utilizing a hybrid approach
(attending classes both virtually and inperson). Interim MDPP evaluation data
illustrated that average participant
weight loss is 5.1 percent since the
expanded model launched on April 1,
2018, surpassing the expanded model’s
weight loss goal of 5 percent. In
addition, the interim evaluation data
show that, 53 percent of MDPP
participants attained the 5 percent
weight-loss goal, and 24.6 percent
attained the 9 percent weight-loss
goal.391 Aligning with the Diabetes
Prevention Program (DPP) model test 392
and studies on the National DPP,393 394
391 MDPP
2nd Annual Evaluation Report.
International. Evaluation of the Health
Care Innovation Awards: Community Resource
Planning, Prevention, and Monitoring: THIRD
ANNUAL REPORT. March 2017. https://
downloads.cms.gov/files/cmmi/hcia-crppmthirdannrptaddendum.pdf.
393 Knowler WC, Barrett-Connor E, Fowler SE, et
al. Reduction in the incidence of type 2 diabetes
with lifestyle intervention or metformin. N Engl J
Med. 2002;346(6):393–403. doi:10.1056/
NEJMoa012512.
394 Diabetes Prevention Program Research Group.
Long-term effects of lifestyle intervention or
metformin on diabetes development and
microvascular complications over 15-year followup: the Diabetes Prevention Program Outcomes
Study. Lancet Diabetes Endocrinol. 2015;3(11):866–
875. doi:10.1016/S2213-8587(15)00291-0.
392 RTI
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MDPP participants who attended more
sessions lost more weight. For example,
among beneficiaries who attended at
least 9 sessions, 64 percent met the 5
percent weight loss goal and 30 percent
met the 9 percent weight loss goal. For
MDPP participants impacted by the
COVID–19 PHE, evaluation data confirm
significantly increased weight loss
accompanied with a higher number of
sessions attended by participants
completing the expanded model in
2021, with these participants attending
primarily virtual sessions or a mixture
of virtual and in-person sessions.
To date, there have been no
preliminary indications that the
synchronous virtual delivery of MDPP
has limited supplier instruction or
beneficiary success, as defined by
achievement of the 5 percent weight
loss goal. However, it is too early to
determine the impact of synchronous
virtual delivery of MDPP on other
outcomes such as cost-savings or
incidence of diabetes. MDPP has been
fundamentally limited by low
beneficiary participation and
corresponding small sample sizes. We
believe that an increase in supplier
uptake, which may be accomplished
through our proposal to maintain more
options of MDPP delivery modalities,
will result in an increase in beneficiary
enrollment. This will be critical to
conducting robust programmatic
evaluations, including a potential future
certification of the synchronous virtual
delivery of MDPP.
To assist with our ability to improve
monitoring and evaluation of the
synchronous virtual delivery of MDPP,
we have proposed a new HCPCS G-code
specific to distance learning.
Additionally, extending the flexibilities
allowed during the PHE for COVID–19
by 4 years would improve MDPP
eligible organizations’ MDPP service
delivery opportunities due to the use of
multiple modalities.
b. Effects on the Market
While we acknowledge that
additional changes will likely be
necessary to improve beneficiary access
to MDPP, we anticipate that the
enhancements proposed in this rule are
likely to result in an increase of MDPP
suppliers and increased beneficiary
access to the Set of MDPP services. We
anticipate that this will assist in
contributing to a reduction of the
incidence of diabetes among eligible
Medicare beneficiaries, and in
particular, those residing in
underserved communities. Currently,
there are approximately 786 in-person
organizations nationally that are eligible
to become MDPP suppliers based on
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their preliminary or full CDC Diabetes
Prevention Recognition Program (DPRP)
status. However, only 25 percent of
eligible in-person organizations are
participating in MDPP, and only onethird of MDPP suppliers have submitted
MDPP-related claims. Through updating
the payment structure to one that is
similar to those of existing CMS
Medicare Preventive Services such as
the Intensive Behavioral Counseling for
Obesity, the MDPP claims submission
process may be more intuitive for
existing Medicare suppliers. In addition,
we anticipate that simplifying the MDPP
payment structure will address some of
the complexities related to the process
for submitting claims, while
encouraging more suppliers to submit
claims for MDPP due to a reduced set
of codes.
Since MDPP was established through
the CY 2017 PFS, we have consistently
heard from interested parties that we
should include virtual delivery of MDPP
as part of the expanded model test,
which would increase beneficiary
access to the Set of MDPP services while
providing flexibility of where both a
beneficiary may take the course and
from where a supplier may deliver the
course. Although we did not allow for
a fully virtual delivery of MDPP until
the COVID–19 PHE, we did allow a
limited number of virtual make-up
sessions, which could be delivered
either synchronously or
asynchronously. The rationale for
allowing a limited number of virtual
make-up sessions was due to the fact
that the data used to certify MDPP were
based upon in-person delivery, thereby
fully virtual delivery was arguably
outside the scope of certification.
The COVID–19 PHE led CMS to
establish MDPP flexibilities that
allowed fully virtual delivery of the Set
of MDPP services by suppliers. We
established several emergency
flexibilities within the IFC–1 that
removed the limit on the number of
virtual makeup sessions, and in the CY
2021 PFS, we finalized the MDPP
flexibilities from the IFC–1 while
establishing the MDPP Emergency
Policy that allowed for virtual delivery
of MDPP, including virtual weight
collection. However, the CY 2021 PFS
stated that MDPP suppliers must retain
the capacity to deliver the Set of MDPP
services in-person, precluding
organizations with CDC DPRP
recognition solely in the distance
learning or online modalities from
participating in MDPP during the
COVID–19 PHE. Interested parties
commented that some beneficiaries may
have limited access or ability to use the
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technology required for participation in
virtual MDPP sessions.
In the CY 2022 PFS, although outside
the scope of rule, interested parties
recommended that we continue the
virtual option following the end of the
COVID–19 PHE to assist in increasing
access to MDPP, especially for those
with transportation needs as well as for
beneficiaries in rural and low-income
communities, who may suffer from a
lack of in-person suppliers. As a result
of these recommendations, in this rule,
we are proposing to extend the PHE
flexibilities, specific to allowing
synchronous virtual delivery of MDPP,
also known as distance learning.
Currently, there are numerous large
geographic gaps of MDPP supplier
locations, and synchronous virtual
delivery may be part of the solution to
increasing the accessibility of MDPP to
more beneficiaries. It is unclear how the
market will respond to the proposed
extension of the PHE flexibilities
allowed during the COVID–19 PHE,
especially since we are still requiring
suppliers to have and maintain an inperson DPRP recognition, but we
believe organizations will be ready to
engage in the delivery of the Set of
MDPP services either in-person, through
distance learning, or through a
combination of in-person and distance
learning. We also believe that having
more flexibility in how the Set of MDPP
services are delivered will make MDPP
more accessible to beneficiaries,
particularly those who live in rural
areas or in communities with gaps in
MDPP supplier locations.
c. Payment for MDPP Services
Regulations at § 414.84 specify MDPP
suppliers may be eligible to receive
payments for furnishing MDPP services
and meeting performance targets related
to beneficiary weight loss and/or
attendance. However, we have
consistently heard from suppliers and
interested parties that the MDPP
performance-based payment structure
has been confusing to some suppliers,
including those new to Medicare as well
as existing suppliers. Approximately 37
percent of MDPP suppliers have
submitted FFS claims for MDPP.395
Confusion with claims submission has
been due, in part, to the MDPP payment
structure, which pays for performancebased milestones versus paying for
traditional fee-for-service. The
performance-based payment structure
requires 15 HCPCS G-codes if including
ongoing maintenance sessions, and 11
G-codes for the 12-month MDPP service
395 Unpublished data from Acumen LLC, Quarter
4 2022 Quarterly Monitoring Report to CMS.
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period. Therefore, we are proposing to
shift this payment structure to pay for
attendance on a fee-for-service basis
while retaining the diabetes risk
reduction performance milestones, for
example 5 percent and 9 percent weight
loss as well as the maintenance of the
5 percent weight loss in months 7–12.
This proposed streamlined payment
structure will allow suppliers to receive
a more consistent set of payments for
their delivery of the Set of MDPP
services and reduce the number of Gcodes for easier billing.
We anticipate that this updated
payment structure will reduce the
upfront beneficiary retention costs
while motivating eligible suppliers to
enroll in Medicare to become MDPP
suppliers and provide the Set of MDPP
services to eligible Medicare
beneficiaries. In the current MDPP
payment structure, suppliers submit
claims after the 1st, 4th, and 9th
sessions attended during the core
sessions interval, and following
attendance of the two (2) sessions
during each of the core maintenance
intervals. Although the proposed per
session payment of $25 is less than the
current per session payment of $38,
suppliers will receive up to 22
payments for attendance in the
proposed payment structure compared
to seven attendance-based payments, for
participants who began participation in
2022 or later, or eleven attendancebased payments for participants whose
first core session was in 2021 or earlier.
The total attendance-based payments
will increase by $54 to $550 in the
proposed payment structure, compared
to $496 in the current one.
This proposed payment schedule
would not only eliminate gaps in
payment by providing smaller but more
frequent per-session payments, it would
also reduce or eliminate some of the
coding challenges related to the number
of existing HCPCS codes. We have
proposed to decrease the one-time
performance payments for beneficiary
achievement of the 5 percent and 9
percent weight loss goals as well as
propose a new HCPCS G-code for the
maintenance of the 5 percent weight
loss during months 7–12. The proposed
total maximum payment of $768
consists of the attendance-based
payments and the weight loss
performance payments. Although the
proposed maximum payment of $768
over a one-year service period is the
same as the current maximum payment,
we believe this simplified payment
structure will lead to fewer claims
rejections while encouraging more
suppliers to submit MDPP claims for the
beneficiaries they serve, as well as
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(a) Estimated 10-Year Impact of MDPP
There are two proposed changes to
the Medicare Diabetes Prevention
Program (MDPP) which are relevant to
this impact analysis. Both changes will
be implemented in 2024 if finalized:
Simplifying the MDPP payment
schedule; and allowing specified Public
Health Emergency (PHE) flexibilities to
continue for 4 years after the PHE
ends—namely, allowing for
synchronous virtual delivery of the Set
of MDPP services.
Table 113 shows the estimated impact
(in millions) of these two proposed
changes on Medicare spending:
(b) Assumptions/Notes
• Simplifying the payment schedule
will lead to fewer claim denials and
more participation from MDPP
suppliers . For example, only 55–62% of
FFS participants listed in the supplier
crosswalks have an associated MDPP
claim over the past 2 years, meaning
that organizations have submitted data
to the CDC as part of their Diabetes
Prevention Recognition Program (DPRP)
requirements, and also have FFS claims
submitted for the same participants for
the same sessions recorded in the DPRP
data. The proposed payment schedule
will reduce the number of HCPCS codes
to from 15 to 6 and eliminate some of
the coding issues. It will also eliminate
the gaps in payment by providing
smaller but more frequent per-session
payments.
• The average payment per MDPP
participant will increase by $150. The
new payment schedule will likely lead
to more successful claim payment
submissions and will motivate MDPP
providers to retain participating
beneficiaries for longer periods of time.
• In 2022, 551 FFS claims were paid
for the initial MDPP session, compared
with 514 in 2021. According to counts
of new FFS participants, there have
been about 700 new entrants per year in
recent years. With the implementation
of a simpler payment schedule and the
extension of PHE flexibilities, we
assume that new participation will be
more in line with claim payments for
HCPCS code G9873 and will increase to
1,000 in 2024 and 1,250 during the
following years until the extended
flexibilities end. We estimate that there
will be 500 new (in-person only)
participants each year starting in 2029.
• Since the start of the PHE,
synchronous virtual delivery of MDPP
services has been more prevalent than
in-person delivery. However, given the
coding/reporting issues during the PHE,
it is difficult to determine how many
beneficiaries are still receiving MDPP
services in-person. Without the
proposed changes, we assume that new
participation will be capped at 400
beneficiaries per year.
• For preventing diabetes
progression, synchronous virtual
delivery of the Set of MDPP services has
the same level of effectiveness as inperson delivery. Following 3 years of
delivering MDPP almost solely virtually,
suppliers and beneficiaries have become
adept at utilizing virtual delivery, as
many providers in numerous healthcare
settings have shifted to utilizing
technology. Furthermore, preliminary
MDPP data collected during the PHE
indicates that beneficiaries have
achieved similar weight loss and
attendance goals as participants in both
the in-person DPP test and MDPP
participants who enrolled in MDPP
prior to the pandemic. This assumption
is revisited in the Sensitivity Analysis
section.
motivate more eligible organizations
enroll in Medicare to participate in
MDPP.
(c) Sensitivity Analysis
On March 14, 2016, the Office of the
Actuary (OACT) published a
certification memorandum setting out
the conditions for expansion of the
Medicare Diabetes Prevention Program
(MDPP), which can be found at https://
www.cms.gov/Research-Statistics-Dataand-Systems/Research/
ActuarialStudies/Downloads/DiabetesPrevention-Certification-2016-03-14.pdf.
Assumptions about the 10-year cost
impacts of virtual delivery of MDPP
services takes into account the
assumptions of the original certification,
and adjusts for diabetes costs in 2023
dollars, and trends those costs over the
next 10 years.
Since both the effectiveness and the
future participation level of
synchronous virtual delivery of MDPP
services are largely unknown, Table 114
shows 10-year cost impacts (in millions)
of varying levels of effectiveness of the
virtual delivery of the Set of MDPP
services relative to the in-person
delivery of the Set of MDPP services,
paired with varying levels of virtual
MDPP participation.
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d. Effects on the Medicare Program
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As indicated in Table 114, virtual
delivery of MDPP services is estimated
to produce savings when it is at least 50
percent as effective as in-person
delivery.
13. Appropriate Use Criteria for
Advanced Diagnostic Imaging
Section 1834(q)(2) of the Act, as
added by section 218(b) of the
Protecting Access to Medicare Act (Pub.
L. 113–93, April 1, 2014) (PAMA),
directs CMS to establish a program to
promote the use of appropriate use
criteria (AUC) for applicable imaging
services furnished in an applicable
setting.
As discussed in detail in section III.J.
of this proposed rule, since 2015, we
have taken a thoughtful, stepwise
approach that maximized engagement
and involvement of interested parties to
implement the statutory provisions set
forth in section 1834(q), as added by
section 218(b) of the PAMA, using
notice and comment rulemaking. As
codified at § 414.94, we established the
first two components of the AUC
statutory requirements—establishment
of AUC and mechanisms for
14. Medicare and Medicaid Provider
and Supplier Enrollment Changes
In this section, we discuss the impact
of our proposed Medicare provider
enrollment revocation provisions and
our Medicaid termination database
proposal. For all provider enrollment
proposals not referenced in this section,
we have determined that they would not
have an economic impact.
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a. Medicare Revocation Reasons
As discussed in section III.J of this
proposed rule, we are proposing several
new or expanded revocation reasons in
§ 424.535(a).
First, we propose to expand
§ 424.535(a)(1) to include instances
where the provider or supplier is noncompliant with the enrollment
requirements in Title 42. Paragraph
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consultation. We began to build the
parameters for the fourth component,
outlier identification and prior
authorization, leading to prior
authorization, by establishing the
priority clinical areas (PCAs). We began
implementing the third component, the
AUC consultation and reporting
requirement, using the ongoing
educational and operations testing
period. However, as discussed
previously in this proposed rule, at this
time, we have exhausted all reasonable
options for fully operationalizing the
AUC program consistent with the
statutory provisions as prescribed in
section 1834(q)(B) of the Act directing
CMS to require real-time claims-based
reporting to collect information on AUC
consultation and imaging patterns for
advanced diagnostic imaging services to
ultimately inform outlier identification
and prior authorization. As a result, we
have proposed to pause implementation
of the AUC program for reevaluation
and to rescind the current AUC program
regulations at § 414.94.
In the CY 2019 PFS final rule (83 FR
59452), we performed an RIA for this
program and updated that RIA in the CY
2022 PFS final rule (86 FR 64996). The
estimated impacts in the CY 2022 PFS
final rule are as follows:
• Cost to ordering clinicians of
required AUC consultation: $51,039,109
annually.
• Cost to Medicare beneficiaries for
additional office visit time: $54,789,518
annually.
• Cost to ordering clinicians of
transmitting consultation information:
$94,495,192 annually.
• Cost to furnishing clinicians to
update processes to report AUC
information: $1,851,356,888 (one time).
• Potential savings to Medicare
program from decrease in imaging
utilization: $700,000,000 annually.
Table 115 also includes the AUC
program-related activities and their
corresponding impact estimates. By
pausing efforts to implement the AUC
program for reevaluation and rescinding
the AUC program regulation at § 414.94,
the Medicare program may not realize
the estimated savings, and clinicians
and beneficiaries will not experience
the estimated costs.
(a)(1) would no longer be restricted to
non-compliance with the provisions of
42 CFR part 424, subpart P.
Second, new § 424.535(a)(15) would
give CMS the authority to revoke
enrollment if the provider or supplier,
an owning or managing employee or
organization thereof, or an officer or
director thereof has had a civil judgment
under the False Claims Act (31 U.S.C.
3729–3733) imposed against them
within the previous 10 years.
Third, § 424.535(a)(16) would permit
CMS to revoke enrollment if a provider
or supplier, or any owner, managing
employee or organization, officer, or
director thereof, has been convicted of
a misdemeanor under Federal or State
law within the previous 10 years that
CMS deems detrimental to the best
interests of the Medicare program and
its beneficiaries.
Fourth, we propose in new
§ 424.535(a)(243) that CMS may revoke
an IDTF’s, DMEPOS supplier’s, OTP’s,
or HIT supplier’s, or MDPP’s enrollment
based on a violation of any standard or
condition in, respectively, §§ 410.33(g),
424.57(c), 424.67(b) or (e), or 424.68(c)
or (e), or 424.205(b) or (d).
Based on CMS statistics concerning
the average annual amount of Medicare
payments a provider or supplier
receives, we project a figure of $50,000.
We note that we have recently used this
figure when estimating the potential
savings associated with several new
revocation reasons.396 For purposes of
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396 For example, see the final rule published in
the Federal Register on November 18, 2022 (87 FR
69404), titled Medicare and Medicaid Programs; CY
2023 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings
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52714
consistency and accuracy, we propose
to use this $50,000 amount in this
proposed rule.
Table 116 outlines the estimated
annual number of revocations that
would ensue with the four
aforementioned revocation proposals:
These revocations would represent a
savings to the Federal Government
because Trust Fund dollars would no
longer be paid to the revoked providers
and suppliers. Accordingly, we project
an annual savings to the Federal
Government of $1,000,000 ($50,000 × 20
revocations).
We anticipate that expanding
coverage of diabetes screening to
include the HbA1c test and expanding
and simplifying the frequency
limitations for diabetes screening to
result in some additional service
utilization, but we also anticipate the
additional utilization may be balanced,
in part, by potential long term benefits
and savings resulting from increased
prevention and early detection
(allowing for less invasive and more
effective treatment). As described earlier
in our proposal, Medicare currently
covers the Fasting Plasma Glucose (FPG)
test and the Glucose Tolerance Test
(GTT) for diabetes screening. The
HbA1c test does not require fasting and
is more convenient than the currently
covered FPG and GTT. We also propose
to expand and simplify the frequency
limitations for diabetes screening by
aligning to the statutory limitation of
‘‘not more often than twice within the
12-month period following the date of
the most recent diabetes screening test
of that individual.’’
We estimate our proposal to expand
diabetes screening to result in
approximately $68.5 million in
additional annual expenditures for the
Medicare Program. Our estimate is
based on the following assumptions.
Based on calendar year 2022 actual
experience, approximately 27.3 percent
of beneficiaries had a blood panel test
that did not include the HbA1c test.
Medicare currently pays approximately
$9.50 per HbA1c test for diabetes
management. The Medicare statutory
and regulatory eligibility factors for an
individual at risk for diabetes (section
1861(yy)(2) of the Act, 42 CFR
410.18(e)) cover much of the current
Medicare beneficiary population. We
assume that approximately 7.6 million
potential additional HbA1c tests for
diabetes screening to be billed under
our proposal in calendar year 2024 and
that the HbA1c test would be billed
with a blood panel 95 percent of the
time. Our estimate does not reflect
secondary effects of the proposed
policies, such as increased utilization of
preventive screening services,
additional follow-up services, and
potential offsetting savings (including
prevention and more effective treatment
through early detection) that may result
from these coverage expansions.
Secondary effects are difficult to
predict, may materialize many years
after the intervention and may, in part,
offset one another.
We do not anticipate that our
proposal to simplify and expand the
regulatory definition of ‘‘diabetes’’ for
diabetes screening, MNT and DSMT to
result in a significant economic impact
on the Medicare program. As described
earlier, we propose to remove the
regulatorily codified clinical test
requirements from the definition of
‘‘diabetes’’ for diabetes screening, MNT
and DSMT and propose a shortened
version of the existing definition that
would simply define diabetes as
diabetes mellitus, a condition of
abnormal glucose metabolism. We
believe that our proposal will empower
health care professionals to apply
clinically accurate and appropriate
criteria and that we can ensure certain
safeguards through medical coding and
claims processing instructions. We do
not anticipate our proposal to simplify
and expand the regulatory definition of
‘‘diabetes’’ for diabetes screening, MNT
and DSMT to result in a significant
economic impact on the Medicare
Program because the regulatory
simplification would not otherwise
change requirements or conditions of
coverage and payment.
dose Container or Single-use Package Drugs To
Provide Refunds With Respect to Discarded
Amounts; and COVID–19 Interim Final Rules’’.
b. Medicaid Termination Database
As discussed in section III.J. of this
proposed rule, we are proposing certain
provisions in 42 CFR part 455
concerning the length of time a provider
remains in the Medicaid termination
database and how this interacts with the
termination periods that States impose
upon terminated providers. We do not
believe these proposals involve any
additional impact or burden on
providers or States. In fact, it could
result in a reduction of burden because
a provider’s potential length of time in
the termination database would be
capped at 10 years, although we have no
data available with which to assist us in
calculating the possible burden
reduction. As a result, since we are
uncertain of how much of the burden
will be reduced, we are seeking public
comments from the public to aid in
understanding how to measure said
burden reduction.
15. Expand Diabetes Screening and
Diabetes Definitions
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As discussed in section III.L. in this
proposed rule, we propose to: (1)
expand coverage of diabetes screening
tests to include the Hemoglobin A1C
test (HbA1c) test, (2) expand and
simplify the frequency limitations for
diabetes screening, and (3) simplify the
regulatory definition of ‘‘diabetes’’ for
diabetes screening, Medical Nutrition
Therapy (MNT) and Diabetes Outpatient
Self-Management Training Services
(DSMT).
Program Requirements; Implementing
Requirements for Manufacturers of Certain Single-
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16. 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)
In section III.M. of this proposed rule,
we are proposing several updates to the
CMS EPCS Program. We are proposing
to remove the same entity exception at
§ 423.160(a)(5)(i) from the CMS EPCS
Program and to add ‘‘subject to the
exemption in paragraph (a)(3)(iii) of this
section’’ to § 423.160(a)(5). Under this
proposal, prescriptions that are
prescribed and dispensed within the
same legal entity are included in CMS
EPCS Program compliance calculations
as part of the 70 percent compliance
threshold at § 423.160(a)(5). This
proposal provides flexibility to
prescribers and dispensing pharmacies
that are the same entity to choose either
of the electronic standards available at
§ 423.160(a)(3)(iii) to conduct eprescribing appropriate for their internal
systems without us having to exclude
these prescriptions completely from the
CMS EPCS Program. This proposal
would affect prescriptions where the
prescriber and the dispensing pharmacy
are part of the same legal entity. Due to
the limitations in identifying these
prescriptions in the Prescription Drug
Event (PDE) data, the ability to quantify
the impact of this proposal is unknown.
Please see section III.M.3.b. of this
proposed rule for our discussion.
We are proposing to specify how we
count prescriptions for the compliance
calculation by proposing to use the
unique identifier given to a prescription
by the pharmacy in the measurement
year and included in the Part D claims
data. We will count renewals as an
additional prescription in the CMS
EPCS Program compliance threshold
calculation, and we will not count
refills as an additional prescription in
the CMS EPCS Program compliance
threshold calculation unless the refill is
the first occurrence of the unique
prescription in the measurement year. If
each refill included on the original
prescription were counted as a separate
prescription, we believe there would be
an incremental impact on small
prescribers. Preliminary analysis of
2021 Part D data shows that
approximately 23,000 prescribers would
no longer qualify for the small
prescriber exception and that
approximately 6,900 additional
prescribers would be noncompliant.
We are proposing updates to the CMS
EPCS Program recognized emergency
exception and waiver exception
presently found at § 423.160(a)(5)(iii)
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and (iv) and proposed to be codified at
§ 423.160(a)(5)(ii) and
§ 423.160(a)(5)(iii) respectively. We are
proposing to have discretion to
determine which emergencies trigger
the recognized emergency exception
starting in the 2024 measurement year
and proposing that prescribers to whom
the exception applies would be
excepted from the CMS EPCS Program
requirements for the entire
measurement year. We are proposing to
modify how we have previously defined
‘‘extraordinary circumstance’’ for
purposes of the waiver exception. We
propose that an ‘‘extraordinary
circumstance’’ means a situation outside
of the control of a prescriber that
prevents the prescriber from
electronically prescribing a Schedule II–
V controlled substance that is a Part D
drug and does not exclude ‘‘cases of an
emergency or disaster.’’ In cases of
extraordinary circumstances, we are
proposing the timeframe that would be
covered by a waiver authorized under
the CMS EPCS Program to be the entire
measurement year. We are proposing
that a prescriber has a period of 60 days
from the date of the notice of noncompliance to request a waiver.
Approved waivers would apply to
prescriptions written by a prescriber for
the entire measurement year, and the
waiver would expire on December 31 of
the applicable measurement year.
Although we are modifying the
situations in which a prescriber can
apply for an extraordinary
circumstances waiver and limiting the
recognized emergencies exception that
applies to the CMS EPCS Program, we
do not anticipate these proposals to
affect many clinicians compared to the
current policies. First, we believe that
the proposal for CMS to identify which
emergencies trigger the recognized
emergency exception would still
capture the vast majority of emergencies
or disasters that affect a prescriber’s
ability to achieve EPCS compliance and
would remove any need for additional
prescribers to apply for a waiver.
Second, some prescribers who
experience an emergency may still meet
the 70 percent compliance threshold by
the end of the emergency period and
would not need to apply for a waiver
exception. Finally, we are unable to
quantify the additional number of
potential disasters or emergencies
prescribers might experience due to
variability in the number of disasters
and emergencies in a given
measurement year. Therefore, we are
not increasing our assumption that 100
waiver requests would be submitted to
the CMS EPCS program, as we
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discussed in the CY 2022 PFS final rule
(86 FR 65562).
We are proposing to continue sending
non-compliance notices to prescribers
identified as non-compliant with the
CMS EPCS Program for any individual
measurement year, and we do not
believe that causes additional costs or
will require additional time. Please see
section III.M.6. of this proposed rule for
our discussion. We do not anticipate the
provisions to have any incremental
impact on the cost or time associated
with prescriber compliance with the
electronic prescribing for controlled
substances requirement or the cost to
interested parties.
17. Proposed Changes to the Regulations
Associated With the Ambulance Fee
Schedule and the Medicare Ground
Ambulance Data Collection System
(GADCS)
As discussed in section III.N.2. of this
proposed rule, section 4103 of the CAA
amended section 1834(l)(12)(A) and
(l)(13) of the Act to extend the payment
add-ons set forth in those subsections
through December 31, 2024. The
ambulance extender provisions are
enacted through legislation that is selfimplementing. A plain reading of the
statute requires only a ministerial
application of the mandated rate
increase and does not require any
substantive exercise of discretion on the
part of the Secretary. As a result, there
are no policy proposals associated with
these legislative provisions legislative
provisions. The Congressional Budget
Office (CBO)’s estimated cost of these
provisions was $55 million in 2023, $91
million in 2024, and $29 million in
2025 (https://www.cbo.gov/system/files/
2023-01/PL117-328_1-12-23.pdf, p. 17).
We are proposing only to revise the
dates in § 414.610(c)(1)(ii) and (c)(5)(ii)
to conform the regulations to these selfimplementing statutory requirements.
In addition, as discussed in section
III.N.3. of this proposed rule, we are
proposing the following changes to the
Medicare Ground Ambulance Data
Collection Instrument: Adding the
ability to address partial year responses
from ground ambulance organizations,
introducing a minor edit to improve the
reporting consistency of hospital-based
ambulance organizations, and four
technical corrections to typos. The
changes and clarifications aim to reduce
burden on respondents, improve data
quality, or both.
While we believe that these changes
and clarifications will be well received
by the ground ambulance interested
parties, we do not believe that these
changes would have any substantive
impact on the cost or time associated
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with completing the Medicare Ground
Ambulance Data Collection Instrument.
We note that the overall length of the
Medicare Ground Ambulance Data
Collection Instrument will be the same
as previously finalized (84 FR 62888)
with these changes. Additionally, some
of the instructions which we propose to
add are intended to improve clarity and
may therefore reduce the time the
ground ambulance organizations spend
addressing the questions.
18. Hospice CoP Changes
a. Permitting MFT and MCH To Serve
as Members of the Interdisciplinary
Group (IDG)
Under the Medicare Program in
accordance with Subtitle C, Section
4121 of the CAA 2023, we are proposing
conforming regulations text changes to
permit MFT or MHC to serve as
members of the IDG. These proposed
changes will require hospices to include
at least one SW, MFT or MHC to serve
as a member of the IDG. Hospices will
have the flexibility to determine which
discipline(s) are appropriate to serve on
the IDG based on the needs of the
patients.
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b. Modification of the Hospice
Personnel Requirements With the
Addition of MFT and MHC
Under the Medicare Program in
accordance with Subtitle C, Section
4121 of the CAA 2023, we are proposing
conforming regulations text changes to
permit MFT or MHC to serve as
members of the IDG. With the proposed
addition of MFT and MHC into the
hospice CoPs, it is important to include
these new disciplines into the personnel
qualifications at § 418.114. However, in
section III.C. of this rule, we are
proposing to add both MHC and MFT to
the provider requirements under 42 CFR
subpart B Medical and Other Health
Services at §§ 410.53 and 410.54.
Therefore, to avoid duplication and
confusion between the CoP and the
provider requirements under the
Medical and Other Health Services
provision, we are proposing to add both
MHC and MFT to the requirements at
§ 418.114(c)(3) and (4) and referencing
the new requirement at §§ 410.53 and
410.54 respectively. We do not expect
any increase in burden for this
modification. In addition, we do not
expect the changes for this provision to
cause any appreciable amount of
expense or anticipated saving and we do
not believe this standard would impose
any additional regulatory burden.
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19. RFI: Histopathology, Cytology, and
Clinical Cytogenetics Regulations Under
the Clinical Laboratory Improvement
Amendments (CLIA) of 1988
AWV would result in a significant
impact to the Medicare Program.
We are publishing this RFI in this
proposed rule to seek comments from
interested parties. There is no impact for
this RFI.
In this section, we estimate the overall
and incremental impacts of the Quality
Payment Program policies proposed in
this rule. We estimate participation,
final scores, and payment adjustment
for clinicians participating through
traditional MIPS, MVPs, and the
Advanced APMs. We also present the
incremental impacts to the number of
expected Qualified Participants (QPs)
and associated APM Incentive Payments
that result from our policies relative to
a baseline model that reflects the status
quo in the absence of any modifications
to the previously finalized policies.
20. Basic Health Program Provisions
In this proposed rule, we are
proposing to update the requirements
for a BHP Blueprint revision. We also
propose to allow a State with a BHP to
suspend its BHP, if necessary, and
provide requirements related to a BHP
suspension. We also propose updates to
the annual report content and timing, if
a BHP is suspended. This proposal
includes requirements for accessible
notices. Finally, we propose changes
related to an individual’s appeals rights.
We do not anticipate that these
provisions would impose any additional
regulatory burden.
21. A Social Determinants of Health
Risk Assessment in the Annual
Wellness Visit
We propose in section III.S. to
exercise our authority in section
1861(hhh)(2)(I) of the Act to add
elements to the Annual Wellness Visit
(AWV) by adding a new Social
Determinants of Health (SDOH) Risk
Assessment as an optional, additional
element with an additional payment.
We propose that the SDOH Risk
Assessment be separately payable with
no beneficiary cost sharing when
furnished as part of the same visit with
the same date of service as the AWV.
Our proposal builds upon our separate
proposal described earlier to establish a
stand-alone G code (GXXX5) for SDOH
Risk Assessment furnished in
conjunction with an Evaluation and
Management (E/M) visit. See section
II.E. of this proposed rule for additional
information on coding, pricing, and
additional conditions of payment for the
proposed new SDOH Risk Assessment
service. We anticipate our proposal to
add a SDOH Risk Assessment as an
optional, additional element with
additional payment within the AWV to
result in some additional service
utilization, but we also anticipate the
additional utilization may be balanced,
in part or in whole, by potential long
term benefits and savings resulting from
a more effective AWV and increased
prevention and early detection
(allowing for less invasive and more
effective treatment). We do not
anticipate that the addition of an
optional SDOH Risk Assessment to the
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22. Updates to the Quality Payment
Program
a. Overall MIPS Modeling Approach
and Data Assessment
(1) MIPS Modeling Approach
For this proposed rule we create two
MIPS RIA models: a baseline and
proposed policy model. Our baseline
model includes previously finalized
policies that would be in effect for the
CY 2024 performance period/2026 MIPS
payment year if none of our proposed
policies are finalized. Examples of
previously finalized policies are an
updated methodology for calculating the
complex patient bonus, and an increase
in the data completeness threshold for
quality measures. The proposed policies
model builds off the baseline model and
incorporates the MIPS policy proposals
for the CY 2024 performance period/
2026 MIPS payment year included in
this proposed rule. The aim of the
baseline and proposed policy models is
to estimate the incremental impacts of
the policies in this proposed rule. We
used a similar approach in the CY 2023
PFS final rule (87 FR 70199 through
70200).
As discussed in the CY 2023 PFS final
rule, our modeling approach utilizes the
same scoring engine that is used to
determine MIPS payment adjustments.
This modeling approach enables our
model to align as much as possible with
actual MIPS scoring and minimizes
differences between our projections and
policy implementation. There are still
some limitations to our model due to
data limitations and assumptions. These
limitations are discussed later in this
RIA. The aim of the baseline model is
to reflect participation, final scores, and
payment adjustments for the upcoming
performance period and associated
MIPS payment year based on previously
finalized policies for the performance
period and MIPS and MIPS payment
year.
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(2) Data Used To Estimate Future MIPS
Performance
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In the 2023 PFS final rule (87 FR
70200), we discussed our decision to
use the submissions data for the CY
2021 performance period to estimate
eligibility, final scoring, and payment
adjustments supplemented by CY 2019
performance period data to estimate
participation and payment adjustments
for the sake of estimating the size of the
budget neutral pool. To mitigate the
potential effect of the PHE on our
engagement estimates for the CY 2024
performance period/2026 MIPS
payment year, for MIPS eligible
clinicians who submitted data for the
CY 2019 performance period and did
not submit data for the CY 2021
performance period, we assigned their
participation status and final score data
from the CY 2023 PFS proposed rule
baseline model (87 FR 46408). This is
because the CY 2023 PFS proposed rule
baseline model (87 FR 46408) is based
on submissions data for the CY 2019
performance period (hereafter called
‘‘2019 data supplement’’).
We indicated that we believed this
approach would reflect data that is
generally more current while mitigating
the impacts of changes in reporting
behavior during the PHE on our
participation estimates. Although we
believe that this is the best data source
to accurately model the impact of our
proposed policies, the use of data from
the CY 2021 performance period
supplemented by data from the CY 2019
performance period, has the same
limitations as discussed in the 2023 PFS
final rule (87 FR 70200). We took a
similar approach this year.
The submissions for the CY 2022
performance period were not available
in time to assess whether the data for
that performance period can be used to
predict future performance. For the final
rule, we will evaluate whether it is
appropriate to use the CY 2022
performance period data and whether
adjustments to this RIA model based on
factors such as clinician behavior or
performance category data availability
would need to be made if CY 2022
performance category submissions data
were used instead.
b. Estimated APM Incentive Payments
to QPs in Advanced APMs and Other
Payer Advanced APMs
For payment years from 2019 through
2025, through the Medicare Option,
eligible clinicians who have a sufficient
percentage of their Medicare Part B
payments for covered professional
services or Medicare patients through
Advanced APMs will be QPs for the
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applicable QP Performance Period for a
year and the corresponding payment
year. In payment years 2019 through
2024 these QPs will receive a lump-sum
APM Incentive Payment equal to 5
percent of their estimated aggregate paid
amounts for covered professional
services furnished during the calendar
year immediately preceding the
payment year. In payment year 2025,
QPs will receive a lump-sum APM
Incentive Payment equal to 3.5 percent
payment of their estimated aggregate
paid amounts for covered professional
services furnished during CY 2024.
Beginning in payment year 2021, in
addition to the Medicare Option,
eligible clinicians may become QPs
through the All-Payer Combination
Option. The All-Payer Combination
Option allows eligible clinicians to
become QPs by meeting the QP payment
amount or patient count threshold
through a pair of calculations that assess
a combination of both Medicare Part B
covered professional services furnished
or patients through Advanced APMs
and services furnished or patients
through Other Payer Advanced APMs.
Eligible clinicians who become QPs for
a year are not subject to MIPS reporting
requirements and payment adjustments.
Eligible clinicians who do not become
QPs but meet a lower threshold to
become Partial QPs for the year may
elect to report to MIPS and, if they elect
to report, will then be scored under
MIPS and receive a MIPS payment
adjustment. Partial QPs are not eligible
to receive the APM Incentive Payment.
If an eligible clinician does not attain
either QP or Partial QP status, and is not
excluded from MIPS on another basis,
the eligible clinician will be subject to
the MIPS reporting requirements and
will receive the corresponding MIPS
payment adjustment.
Beginning in payment year 2026, the
update to the PFS CF for services that
are furnished by clinicians who achieve
QP status for a year is 0.75 percent,
while the update to the PFS CF for
services that are furnished by clinicians
who do not achieve QP status for a year
is 0.25 percent. Thus, eligible clinicians
who are QPs for the year will receive
differentially higher PFS payment rates
than those who are not QPs.
We incorporated this change into our
baseline eligibility determination. In
addition, the thresholds to achieve QP
status beginning in the 2024 QP
Performance Period will increase to 75
percent for the payment amount
method, and 50 percent for the patient
count method. Overall, we estimate that
for the 2024 QP Performance Period
between 187,000 and 241,000 eligible
clinicians will become QPs, and
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therefore be excluded from MIPS
reporting requirements and payment
adjustments.
In section VII.E.23.b of this proposed
rule, we projected the number of eligible
clinicians that will be QPs, and thus
excluded from MIPS, using several
sources of information. First, the
projections are anchored in the most
recently available public information on
Advanced APMs. The projections reflect
Advanced APMs that will be operating
during the 2024 QP Performance Period,
as well as some Advanced APMs
anticipated to be operational during the
2024 QP Performance Period. The
projections also reflect an estimated
number of eligible clinicians that will
attain QP status through the All-Payer
Combination Option. The following
APMs are expected to be Advanced
APMs for the 2024 QP Performance
Period:
• Bundled Payments for Care
Improvement Advanced Model;
• Comprehensive Care for Joint
Replacement Payment Model (CEHRT
Track);
• ACO REACH Model (formerly
Global and Professional Direct
Contracting) Model;
• Kidney Care Choices Model
(Comprehensive Kidney Care
Contracting Options, Professional
Option and Global Option);
• Maryland Total Cost of Care Model
(Care Redesign Program; Maryland
Primary Care Program);
• Medicare Shared Savings Program
(Level E of the BASIC Track and the
ENHANCED Track);
• Primary Care First (PCF) Model;
and,
• Vermont All-Payer ACO Model
(Vermont Medicare ACO Initiative).
• Making Care Primary (MCP) tracks
2 and 3.
We used the Participation Lists and
Affiliated Practitioner Lists, as
applicable, (see 42 CFR 414.1425(a) for
information on the APM Participant
Lists and QP determinations) for the
2022 QP performance period third
snapshot QP determination date to
estimate the number of QPs, total Part
B paid amounts for covered professional
services, and the aggregate total of APM
Incentive Payments for the 2024 QP
Performance Period. We examined the
extent to which Advanced APM
participants will meet the QP
Thresholds of having at least 75 percent
of their Part B covered professional
services or at least 50 percent of their
Medicare beneficiaries furnished Part B
covered professional services through
the APM Entity.
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c. Estimated Number of MIPS Eligible
Clinicians for the CY 2024 Performance
Period/2026 MIPS Payment Year
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(1) Clinicians Included in the RIA
Baseline and Final Policies Models Prior
to Applying the Low-Volume Threshold
Exclusion
For this proposed rule, we applied the
same assumptions as in the CY 2023
PFS final rule (87 FR 70201 through
70202), unless otherwise noted. In the
CY 2023 PFS final rule (87 FR 70202),
we explained that we modified some of
our assumptions to estimate engagement
in MIPS to mitigate the effects of
potential non-engagement due to the
extreme and uncontrollable
circumstances policies related to the
PHE.
In the CY 2023 PFS final rule (87 FR
70201), we explained our use of the
final reconciled eligibility
determination file. This file reconciles
eligibility from two determination
periods and aligns with the CY 2021
performance period submissions data on
which we based this model. In this
proposed rule, we again used the final
reconciled 2021 eligibility
determination file which aligns with CY
2021 performance period submissions
data. We did not propose any
modifications to MIPS eligibility
requirements, therefore the same
eligibility assumptions apply to both the
baseline and proposed policies models.
Our analysis found that there were 1.7
million clinicians who had PFS claims
from October 1, 2020 to September 30,
2021. This initial population of
clinicians was used to determine
eligibility using the processes described
in the following sections.
(2) Estimated Number of MIPS Eligible
Clinicians After Applying Assumptions
for the Low-Volume Threshold
Exclusion and Considering the Extreme
and Uncontrollable Circumstances
Policies Related to COVID–19 PHE
The low-volume threshold policy may
be applied at the individual (TIN/NPI)
or group (TIN) levels based on how data
are submitted to MIPS. Generally, if a
clinician or group does not exceed the
low-volume threshold criteria then that
clinician or group is excluded from
participation in MIPS. The low volume
threshold uses three criteria: allowed
charges, number of Medicare patients
who receive covered professional
services, and number of services
provided. A clinician or group that
exceeds at least one, but not all three
low-volume threshold criteria may
become MIPS eligible by electing to optin and subsequently submitting data to
MIPS, thereby being measured on
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performance and receiving a MIPS
payment adjustment.
We describe below the estimated
MIPS eligibility status and the
associated PFS allowed charges of
clinicians in the initial population of 1.7
million clinicians for the proposed
policies model. We applied the same
assumptions as in the CY 2023 PFS final
rule (87 FR 70201 through 70202) to
apply the low-volume threshold and to
determine whether clinicians
participate in MIPS as a group, virtual
group, APM entity, or as individuals. In
the CY 2023 PFS final rule (87 FR
70202), we explained our use of the CY
2019 performance period data to update
eligibility assumptions to account for
the effects of the extreme and
uncontrollable circumstances (EUC)
policy that was applied due to the PHE.
We noted that the use of CY 2021
performance period data alone might
overstate the number of clinicians with
‘‘required eligibility’’ who do not
participate in MIPS due to the PHE
under the EUC policy and therefore may
not have submitted data. If we assumed
in this RIA model, which estimates of
CY 2024 performance period/CY 2026
payment year, participation and nonparticipation to be similar to the CY
2019 performance period, we would
likely overstate the number of clinicians
receiving a negative payment
adjustment. Since these clinicians
actually would have received a neutral
score under the CY 2021 performance
period EUC reweighting policy but
would receive a negative payment
adjustment in our simulation.
As we noted in section VII.E.22 of this
RIA, in order to mitigate the potential
effect of the PHE on our engagement
estimates for the CY 2024 performance
period, for MIPS eligible clinicians who
submitted data for the CY 2019
performance period and did not submit
data for the CY 2021 performance
period, we followed the same process
described in the CY 2023 PFS final rule
(87 FR 70202) and assigned their
participation status and final score data
from the CY 2023 PFS proposed rule
baseline model (87 FR 46408). This is
because the CY 2023 PFS proposed rule
baseline model (87 FR 46408) is based
on the 2019 data supplement. We
believed these clinicians may
participate and perform more similarly
to the CY 2019 performance period than
the CY 2021 performance period during
the CY 2024 performance period.
We do not have ability to assess the
performance of clinicians reflected in
our 2019 data supplement in our model,
so we used the same score for this final
rule’s baseline and proposed policies
models. Because we used the same score
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for the baseline and proposed policies
model, we were not able to assess the
incremental impact of policies for this
group. However, we believe making this
adjustment is valuable because it helps
mitigate the potential effect of
overestimating the number of clinicians
eligible for, and participating in MIPS,
versus non-participants, which in turn
would affect our estimation of the MIPS
redistribution payment and the size of
the budget neutral pool.
For our RIA model, we established the
‘‘required eligibility’’ category, which
means the clinician exceeds the lowvolume threshold in all 3 criteria and is
subject to a payment adjustment is
separated into three buckets this year:
(1) ‘‘Clinicians who Report’’; (2) ‘‘Did
not report in 2021, but did report in
2019’’; and (3) ‘‘Did not report in either
2021 or 2019.’’ We have done this so
that we can isolate both the effects of
our proposed policies, which are
modeled using 2021 data, the effect of
the 2019 data supplement, and model
the population of clinicians who did not
engage in either year. The year refers to
which population of data we used (that
is, the 2021 population of clinicians or
the 2019 supplement).
(a) MIPS Eligibility Estimates
Table 117 summarizes our eligibility
estimates for the proposed policies
model after applying our assumptions
discussed previously.
We estimate approximately 122,183
MIPS eligible clinicians have the
required eligibility criteria and
submitted data for at least one
performance category in MIPS for the
CY 2019 and 2021 performance periods,
9,906 MIPS eligible clinicians who did
not engage in MIPS based on 2021
performance period MIPS data but did
engage based on 2019 performance
period MIPS data, and 14,289 MIPS
eligible clinicians counted in our model
as ‘‘did not submit in data to MIPS for
the CY 2019 or CY 2021 performance
period.’’ These are clinicians who did
not submit data to MIPS for the CY 2019
or CY 2021 performance periods, or did
not submit data to MIPS for the CY 2021
performance period and do not have CY
2019 performance period data.
We estimate approximately 664,562
MIPS eligible clinicians as having
‘‘group eligibility’’ in Table 117. ‘‘Group
eligibility’’ means that these clinicians
belong to a group that exceeds the lowvolume threshold. If they were not
associated with the group submission,
these clinicians will not be eligible for
MIPS.
Finally, we estimate about 9,107
clinicians will be eligible for MIPS and
participate through ‘‘opt-in eligibility’’
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through the ‘‘opt-in’’ policy. We
updated our opt-in policy to reflect that
a clinician can elect to opt-in into MIPS
and will be scored, even if they do not
submit data to MIPS.
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We estimate a total MIPS eligible
clinician population of approximately
1,741,607 with $9 billion PFS allowed
charges estimated to be included in the
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CY 2024 performance period/2026 MIPS
payment year.
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Furthermore, we estimate there will
be approximately 185,342 clinicians
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who are not MIPS eligible, but could be
if the clinician or their group elects to
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opt-in. We describe this group as
‘‘Potentially MIPS eligible’’ in Table
117. These potentially MIPS clinicians
would all be included as MIPS eligible
in the unlikely scenario in which all
group practices elect to submit data as
a group, or clinicians in a group that
does not submit are eligible to opt-into
MIPS individually and choose to do so.
We do not expect that every potentially
MIPS eligible clinician will elect to
submit data to MIPS. We estimate
another 294,729 clinicians would be
eligible for participation as a group but
do not report data. These assumptions
are important because they quantify the
maximum number of MIPS eligible
clinicians. When this unlikely scenario
is modeled, we estimate the MIPS
eligible clinician population could be as
high as 1,300,118 clinicians. Finally, we
estimate approximately 123,231
clinicians will not be MIPS eligible
because they and their group are below
the low-volume threshold on all three
criteria and another approximately
318,258 will not be MIPS eligible for
other reasons, including 242,422
clinicians with QP status.
Eligibility among many clinicians is
contingent on submission to MIPS as a
group or election to opt-in, therefore we
will not know the number of MIPS
eligible clinicians who submit until the
submission period for the CY 2023
performance period is closed. For the
remaining analysis, we use the
estimated population of 820,047 MIPS
eligible clinicians described above.
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c. Estimated Impacts on Payments to
MIPS Eligible Clinicians for the CY 2023
Performance Period/2025 MIPS
Payment Year
(1) Summary of Approach for MIPS
Value Pathways (MVPs) and Traditional
MIPS
In this proposed rule, we present
several proposals which impact the
measures and activities, the
performance category scores, final score
calculation, and the MIPS payment
adjustment. We discuss these changes in
more detail in section VII.E.23.d.(3) of
this RIA as we describe our
methodology to estimate MIPS
payments for the CY 2024 performance
period/2026 MIPS payment year. We
then present the impact of the overall
proposed policies in the CY 2024
performance period/2026 MIPS
payment year and then compare select
metrics to the baseline model, which
only incorporates previously finalized
policies for the CY 2024 performance
period/2026 MIPS payment year. By
comparing the baseline model to the
proposed policies model, we are able to
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estimate the incremental impact of the
proposed policies for the CY 2024
performance period/2026 MIPS
payment year.
The payment impact for a MIPS
eligible clinician is based on the
clinician’s final score, which is
calculated based on the clinician’s
performance on measures and activities
under the four MIPS performance
categories: quality, cost, improvement
activities, and Promoting
Interoperability. MIPS eligible clinicians
can participate as an individual, group,
virtual group, APM Entity, clinicians
participating in MIPS through the APM
Performance Pathway (APP) or through
an MVP in the four MIPS performance
categories. MIPS APM participants can
participate in the APP as an individual,
group, virtual group, APM Entity and
are only scored on three MIPS
performance categories: quality,
improvement activities, and Promoting
Interoperability.
The average percentage change in
total revenues that clinicians earn is less
than the impact displayed here because
MIPS eligible clinicians generally
furnish services to both Medicare and
non-Medicare patients; MIPS does not
impact payment from non-Medicare
patients. In addition, MIPS eligible
clinicians may receive Medicare
revenues for services under other
Medicare payment systems, such as the
Medicare Federally Qualified Health
Center Prospective Payment System,
that will not be affected by MIPS
payment adjustment factors.
(2) Methodology To Assess Impact for
MIPS Value Pathways
In the CY 2022 PFS final rule (86 FR
65394 through 65397), we finalized
policies at § 414.1365 for implementing
MVPs beginning in the CY 2023
performance period/2025 MIPS
payment year. In this RIA, we take a
similar approach to modeling MVP
participation and scoring as described
in the CY 2022 PFS final rule (87 FR
70204), incorporating changes to our
proposed policies model as described
below.
(a) MVP Participant Assumptions
At § 414.1365(b), we require MVP
Participants (which can be a group,
individual, subgroup, or APM entity) to
register prior to submitting an MVP. As
we do not yet have information on who
will register, we assume for purposes of
this model, that MVP Participants are
MIPS eligible individual clinicians or
groups that currently submit at least
four quality measures that are in an
MVP. For these MVP Participants, we
calculate both an MVP and a traditional
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MIPS score and take the highest score
consistent with the existing scoring
hierarchy which was finalized in the CY
2023 PFS final rule (86 FR 65537). For
the baseline model, we used the quality
measures finalized for MVPs in the CY
2023 PFS final rule Appendix 3: MVP
Inventory.
In section IV.A.4.b and Appendix 3 of
this proposed rule, we propose
modifications to the 12 existing MVPs
finalized in the CY 2022 PFS final rule
(86 FR 65998 through 66031) and CY
2023 PFS final rule (87 FR 70037) and
the consolidation of the previously
finalized Promoting Wellness and
Optimizing Chronic Disease
Management MVPs into a single
consolidated primary care MVP titled
Value in Primary Care.
In section IV.A.4.a of this proposed
rule, we are proposing the inclusion of
5 new MVPs
• Focusing on Women’s Health;
• Prevention and Treatment of
Infectious Disease Including Hepatitis C
and HIV;
• Quality Care in Mental Health and
Substance Use Disorder;
• Quality Care for Ear, Nose, and
Throat (ENT); and
• Rehabilitative Support for
Musculoskeletal Care
For the proposed policies model, we
incorporate the quality measure
revisions for the existing MVPs and use
the quality measures to model scores for
the new MVPs in Appendix 3 of this
proposed rule.
Our MVP Participant assumptions
have limitations: we are not
incorporating subgroups due to a lack of
data, not all of the assumed participants
may elect to register for an MVP, and we
may have additional clinicians or
groups register for an MVP. However,
we believe this is a reasonable approach
to simulate the impact of MVPs and we
sought comment on this assumption,
but did not receive any feedback.
(b) MVP Scoring Methods and
Assumptions
We simulate an MVP score using the
same data sources as we did for
traditional MIPS. We scored according
to § 414.1365(d) and § 414.1365(e) using
the MVP reporting requirements listed
in § 414.1365(c) with one exception. We
did not restrict the improvement
activities to the activities listed in the
MVP inventory. We believed this would
lower our estimated MVP score as
clinicians and groups were not required
to select from a limited inventory in the
CY 2021 performance period (upon
which our model is based). Therefore,
we scored any improvement activities
the MVP Participants submitted in 2021
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the MVP inventory.
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(3) Methodology To Assess Impact for
Traditional MIPS
To estimate the impact of the
proposed policies on MIPS eligible
clinicians, we generally used the CY
2021 performance period’s submissions
data, including data submitted or
calculated for the quality, cost,
improvement activities, and Promoting
Interoperability performance categories.
As discussed in section VII.E.23.a.(2) of
this proposed rule, we supplemented
with 2019 data supplement.
We supplemented this information
with the most recent data available for
CAHPS for MIPS and CAHPS for ACOs,
administrative claims data for the new
quality performance category measures,
and other data sets. We calculated a
hypothetical final score for the CY 2024
performance period/2026 MIPS
payment year for the baseline and
proposed policies scoring models for
each MIPS eligible clinician using score
estimates for quality, cost, Promoting
Interoperability, and improvement
activities performance categories, where
each are described in detail in the
following sections.
(a) Methodology To Estimate the Quality
Performance Category Score
We estimated the quality performance
category score using a methodology like
the one described in the CY 2023 PFS
final rule (87 FR 70205) for the baseline
and proposed policies RIA models for
the CY 2024 performance period/2026
MIPS payment year.
To create the baseline policies RIA
model, which does not reflect the
policies proposed in this rule, we made
the following modifications to the CY
2023 PFS final rule final policies model
to reflect the previously finalized
quality performance category policies
for the CY 2024 performance period/
2026 MIPS payment year:
• As discussed in the CY 2023 PFS
final rule (87 FR 70049), we increased
the data completeness criteria threshold
to at least 75 percent for CY 2024 and
CY 2025 performance periods/2026 and
2027 MIPS payment years.
For the proposed policies model, we
did not implement any changes to the
quality performance category relative to
the baseline model because we use 2021
data and cannot simulate the addition of
new measures.
(b) Methodology To Estimate the Cost
Performance Category Score
We estimated the cost performance
category score using a methodology
similar to the methodology described in
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the CY 2023 PFS final rule (87 FR
70205) for the baseline and the
proposed policies RIA models. For this
proposed rule, the baseline policies RIA
model included the same method used
for the final policies RIA model in the
CY 2023 PFS final rule (87 FR 70205).
Due to technical limitations, we did not
model cost improvement scoring in the
baseline policies RIA model.
The proposed policies RIA model
incorporated and implemented the
following changes:
In section IV.A.4.f.(2).(a) of this
proposed rule, we proposed 5 new
episode-based cost measures.
• In section IV.A.4.g.(1).(c) of this
proposed rule, we proposed to:
++ Determine cost improvement
scoring at the category level;
++ Modify how to calculate cost
improvement scoring and remove
statistical significance requirement; and
++ Set the maximum improvement
scoring to 1 percentage point, beginning
in CY 2023 performance period/2025
MIPS payment year.
(c) Methodology To Estimate the
Facility-Based Measurement Scoring
A limitation of using data from the CY
2021 performance period is that we are
not able to estimate facility-based scores
because there are no Hospital ValueBased Purchasing total performance
scores calculated for the performance
period due the COVID–19 PHE.
However, for clinicians who did not
participate in MIPS during the CY 2021
performance period, we did use the
2019 data supplement to identify final
scores based on the CY 2019
performance period submission and
these scores include facility-based
scores.
(d) Methodology To Estimate the
Promoting Interoperability Performance
Category Score
We estimated the baseline Promoting
Interoperability performance category
score by using the same methodology
that we used in the CY 2023 PFS final
rule (87 FR 70206) final policies. We
incorporated the final policies model
from that rule into our baseline model.
In section IV.A.4.F.(4)(f) of this
proposed rule, we proposed to continue
reweighting clinical social workers. This
is incorporated into our proposed
policies model. We did not incorporate
changes to the performance period or
measure level changes because we are
not able to model this using data for the
CY 2021 performance period.
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(e) Methodology To Estimate the
Improvement Activities Performance
Category Score
For the baseline and proposed
policies model we used the same
method to estimate the improvement
activities performance category score as
described in the CY 2023 PFS final rule
(87 FR 70206).
(f) Methodology To Estimate the
Complex Patient Bonus Points
For the baseline and proposed
policies RIA model, we used the
previously established method to
calculate the complex patient bonus as
described in the CY 2022 PFS final rule
(86 FR 64996).
(g) Methodology To Estimate the Final
Score
We did not propose any changes for
how we calculated the MIPS final score.
Our baseline and proposed policies RIA
models assigned a final score for each
TIN/NPI by multiplying each estimated
performance category score by the
corresponding performance category
weight, adding the products together,
multiplying the sum by 100 points,
adding the complex patient bonus, and
capping at 100 points.
For the baseline policies RIA model,
we applied the performance category
weights and redistribution weights
finalized in the CY 2022 PFS final rule
(86 FR 65519 through 65524).
For both models, after adding any
applicable bonus for complex patients,
we reset any final scores that exceeded
100 points to equal 100 points. For
MIPS eligible clinicians who were
assigned a weight of zero percent for
any performance category, we
redistributed the weights according to
§ 414.1380(c).
(h) Methodology To Estimate the MIPS
Payment Adjustment
For the baseline and proposed
policies RIA models, we applied the
hierarchy as finalized in the CY 2022
PFS final rule (86 FR 65536 through
65537) to determine which final score
should be used for the payment
adjustment for each MIPS eligible
clinician when more than one final
score is available. We then calculated
the parameters of an exchange function
in accordance with the statutory
requirements related to the linear
sliding scale, budget neutrality, and
minimum and maximum adjustment
percentages.
For the baseline model, we applied
the performance threshold of 75 points
finalized in the CY 2023 PFS final rule
(87 FR 70097). In section IV.A.4.h.(2) of
this proposed rule, we are proposing a
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performance threshold of 82 points for
the CY 2024 performance period/2026
MIPS payment year, which we
incorporated into our proposed policies
model. For both the baseline and
proposed policies models, we used
these resulting parameters to estimate
the positive or negative MIPS payment
adjustment based on the estimated final
score and the allowed charges for
covered professional services furnished
by the MIPS eligible clinician.
(4) Impact of Payments
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We noticed minimal changes to the
mean and median final score between
our baseline and proposed policies
models. In our baseline model, the mean
and median final scores are 73.26 and
79.99 points, respectively. In the
proposed policies model, the mean final
score is 73.52 and the median final
score is 80.53. Many clinicians have
scores clustered near the proposed
performance threshold of 82 points. For
instance, 51% of clinicians have a final
score between 80 and 100 points and
63.28% of clinicians have final score
between 75 and 100 points. Because so
many clinicians have final scores near
our proposed performance threshold, a
small change in actual final scores
relative to our model would
significantly impact the number of
clinicians with a positive, neutral, or
negative adjustment.
Our proposed policies are expected to
increase the number of clinicians
receiving a negative adjustment from
36.75 percent of eligible clinicians to
54.31 percent of eligible clinicians, but
decrease the average negative
adjustment from ¥2.89 percent to
¥2.40 percent. This is because the
increased performance threshold will
cause many clinicians who previously
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scored slightly above the performance
threshold to now score slightly below
the performance threshold, shifting their
expected payment from a small positive
adjustment to a small negative
adjustment.
Among MIPS eligible clinicians who
reported data, 35.38 percent receive a
negative adjustment in our baseline
model compared to 52.24 percent in the
proposed policies model. Because many
clinicians’ scores are close to the
performance threshold, the payment
adjustments for these clinicians are
fairly small and many negative
adjustments are much lower in
magnitude than the statutory maximum
negative adjustment of 9 percent. In our
proposed policies model, we project the
maximum negative payment adjustment
of negative 9 percent for clinicians with
a score of 20 points or below compared
to a score of 18 in our baseline model.
In our baseline model, 2.13 percent of
MIPS eligible clinicians and 1.41
percent of clinicians who report
clinicians receive the max negative
adjustment. In our proposed rule model,
1.99 percent of MIPS eligible clinicians
and 1.19 percent of clinicians who
report data receive the max negative
adjustment. This is because, while the
range of scores subject to the maximum
negative adjustment increases slightly
(from 18 to 20 points), slightly fewer
clinicians in our proposed policies
model have a final score below 20
points compared to the baseline model.
The increase in the number of
clinicians receiving a negative score will
contribute to an increase in the size of
the budgetary dollars available, as a
result of the budget neutral nature of the
program. In the baseline model, we
anticipate redistributing $7.4 million
and, in the proposed policies model we
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anticipate, redistributing $8.9 million as
a result of budget neutrality.
Because of this increase in the size of
the budget neutral pool, the size of our
positive payment adjustments increases.
In our baseline model, the average
positive payment adjustment is 1.99
percent among MIPS eligible clinicians.
In the CY 2024 performance period/
2026 MIPS payment year proposed
policies model, the average positive
payment adjustment is 3.35 percent
among MIPS eligible clinicians. The
maximum positive payment adjustment
increased from 4.60 percent in the
baseline model to 8.82 percent in the
proposed rule model.
We want to highlight that we are
primarily using submissions data for the
CY 2021 performance period to simulate
a final score for the CY 2024
performance period/2026 MIPS
payment year, and it is likely that there
will be changes that we cannot account
for at this time. It should also be noted
that the estimated number of clinicians
who do not submit data to MIPS may be
an overestimate of non-engagement in
MIPS for the CY 2023 performance
period/2025 MIPS payment year. This is
because the PHE may have resulted in
fewer clinicians submitting data to
MIPS or more clinicians electing to
apply for the extreme and
uncontrollable circumstances policies
due to the PHE for the CY 2019 and CY
2021 performance periods. Therefore,
engagement levels in MIPS for the CY
2024 performance period/2026 MIPS
payment year may differ from these
reported estimates. We also note this
participation data is generally based off
participation for the CY 2021
performance period/2023 MIPS
payment year, which is associated with
a performance threshold of 60 points.
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(1) Burden Overall
In addition to policies affecting the
payment adjustments, we are proposing
several policies that have an impact on
burden in the CY 2024 performance
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period/2026 MIPS payment year. In
section V.B.11. of this proposed rule, we
outline estimates of the costs of data
collection that includes both the effect
of proposed policy updates and
adjustments due to the use of updated
data sources. For each proposed
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provision included in this proposed rule
which impacts our estimate of
collection burden, the incremental
burden for each is summarized in Table
121. We also provide proposed
additional burden discussions that we
are not able to quantify.
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e. Additional Impacts From Outside
Payment Adjustments
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(2) Additional Impacts to Clinicians
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(a) Impact on Third Party Intermediaries
In section IV.A.4.k of this rule, we are
proposing to: (1) add requirements for
third party intermediaries to obtain
documentation; (2) add requirements for
third party intermediaries to submit
data in the form and manner specified
by CMS; (3) specify the use of a
simplified self-nomination process for
existing QCDRs and qualified registries;
(4) add requirements for QCDRs and
qualified registries to provide measure
numbers and identifiers for performance
categories; (5) Add a requirement for
QCDRs and qualified registries to attest
that information on the qualified
posting is correct; (6) Modify
requirements for QCDRs and qualified
registries to support MVP reporting; (7)
Specify requirements for a transition
plan for QCDRs and qualified registries;
(8) Specify requirements for data
validation execution reports; (9) Add
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additional criteria for rejecting QCDR
measures; (10) Add a requirement for
QCDR measure specifications to be
displayed throughout the performance
period and data submission period; (10)
eliminate the Health IT vendor category;
(11) Add failure to maintain updated
contact information as criteria for
remedial action; (12) Revise corrective
action plan requirements; (13) Specify
the process for publicly posting
remedial action; and (14) Specify the
criteria for audits. Due to the technical
nature of these proposed changes, we
are unable to quantify the burden for
third party intermediaries during the CY
2024 performance period/2026 MIPS
payment year. We refer readers to
section V.B.11.c of this rule for
additional information on proposed
changes to the third party intermediary
requirements.
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(b) Compare Tools: Public Reporting
In section IV.A.4. of this rule, we are
proposing to update our policy for
identifying clinicians furnishing
telehealth services, such that we remain
current with CMS coding changes,
without proposing and finalizing such
coding changes via rulemaking.
Specifically, instead of only using place
of service (POS) codes 02, 10, or
modifier 95 to identify telehealth
services furnished for the telehealth
indicator, we would use the most recent
codes at the time the data are refreshed.
We are proposing that at the time of
such a data refresh we would publish
the details of which codes are used for
the telehealth indicator through
education and outreach, such as via a
fact sheet, listserv, or information
posted on the Care Compare: Doctors
and Clinicians Initiative page, available
at https://www.cms.gov/medicare/
quality-initiatives-patient-assessmentinstruments/care-compare-dac-
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initiative. We are proposing to revise the
policy to publicly report a subset of the
Medicare public use file (PUF) on the
Provider Data Catalog (PDC) to instead
provide a single downloadable dataset
reflecting including the procedure
utilization data that would appear on
clinician profile pages. We are
proposing to modify the existing policy
such that, in addition to the two
previously finalized sources
(Restructured BETOS categorization
system and code sources used in MIPS),
we may use alternate sources to create
clinically meaningful and appropriate
procedural categories, particularly when
no relevant grouping exists. If we
develop new procedure categories for
publicly reporting utilization data on
clinician profile pages, we are proposing
to engage subject matter experts and
interested parties through periodic
requests for feedback using methods
outside of rulemaking, such as but not
limited to listserv emails, listening
sessions, and focus groups, to solicit
feedback on bespoke procedure
categories planned for future releases of
utilization data, as appropriate and
technically feasible. We are also
proposing to publicly report aggregated
counts of procedures performed by
providers based on Medicare Advantage
(MA) encounter data (also known as MA
risk adjustment data) in addition to
Medicare fee-for-service (FFS)
utilization data counts; as part of this
proposal, we are proposing to amend 42
CFR 422.310(f) (the regulation that
addresses permissible uses and releases
of MA risk adjustment data) to permit
use of MA encounter data in developing
the data posted on the Care Compare
website and release of the MA
encounter data as part of the data set
that will be downloadable from the Care
Compare website more quickly than the
regulation would currently permit
releases of MA encounter data. While
the Compare tool provisions do not
increase the burden of collections, we
note that the PRA package may require
relevant modification to reflect the
Compare tool’s new uses and public
display. We refer readers to section
IV.A.I of this rule for additional
information on the proposed changes to
public reporting on Compare tools.
(c) Data Completeness Criteria for the
Quality Measures, Excluding the
Medicare CQMs
In section IV.A.5.a.(1) of this
proposed rule, we are proposing to
maintain the data completeness criteria
threshold at 75 percent for the CY 2025
and 2026 performance periods/2027 and
2028 MIPS payment years, and increase
the data completeness criteria threshold
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by 5 percent from 75 percent to 80
percent for the CY 2027 performance
period/2029 MIPS payment year. We
believe that the proposed policy to
maintain the threshold for data
completeness at 75 percent for the CY
2025 and 2026 performance periods/
2027 and 2028 MIPS payment years is
consistent with the existing data
completeness criteria and therefore,
would not result in additional burden to
the applicable interested parties. We
assume that the proposed increase in
data completeness criteria threshold
from 75 to 80 percent for the CY 2027
performance period/2029 MIPS
payment year would not result in
substantive burden to the applicable
interested parties We believe that the
increase in data completeness criteria
threshold would reduce burden for
clinicians using EHRs and eCQMs as the
collection of eCQM data within the EHR
can allow eligible clinicians to report on
100 percent of the eligible population
with data in the EHR for a measure.
Additionally, we recognize that
individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities that continue to utilize
other means of data collection for MIPS
CQMs, including the collection of MIPS
CQM data reported by registries and/or
QCDRs, would need have the logic code
of their EHRs to be updated to account
for the increased data completeness
criteria threshold. We believe that
increasing the data completeness
criteria threshold would not pose a
substantial burden to MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities, unless
they are manually extracting and
reporting quality data. We refer readers
to section IV.A.4.f.(1)(d) of this rule for
additional information on proposed
changes to the data completeness
threshold criteria.
(d) Modifications to the Improvement
Activities Inventory
As discussed in section
IV.A.4.f.(3).(b)(ii) of this proposed rule,
we are proposing changes to the
improvement activities Inventory for the
CY 2024 performance period/2026 MIPS
payment year and future years as
follows: adding five new improvement
activities; modifying one existing
improvement activity; and removing
three previously adopted improvement
activities. We refer readers to Appendix
2: Improvement Activities of this
proposed rule for further details. We do
not believe these proposed changes to
the improvement activities inventory
would significantly impact time or
financial burden on interested parties
because MIPS eligible clinicians are still
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required to submit the same number of
activities and the per response time for
each activity is uniform. We do not
expect these proposed changes to the
improvement activities inventory to
affect our currently approved
information collection burden estimates
in terms of neither the number of
estimated respondents nor the burden
per response. We anticipate most
clinicians performing improvement
activities, to comply with existing MIPS
policies, would continue to perform the
same activities under the policies in this
proposed rule because previously
finalized improvement activities
continue to apply for the current and
future years unless otherwise modified
per rulemaking (82 FR 54175). Most of
the improvement activities in the
Inventory remain unchanged for the CY
2024 performance period/2026 MIPS
payment year. We refer readers to
section IV.A.4.f.(3)(b) of this rule for
additional information on proposed
changes to the improvement activities
Inventory.
(3) Update to CEHRT Definition for the
Medicare Promoting Interoperability
Program and the Quality Payment
Program
In section III.R of this proposed rule,
we propose to update the definitions of
CEHRT for the Medicare Promoting
Interoperability Program for eligible
hospitals and CAHs and for the MIPS
Promoting Interoperability performance
category. Under this proposal, we would
revise the definitions of CEHRT for the
Medicare Promoting Interoperability
Program at § 495.4, and for the Quality
Payment Program at § 414.1305.
Specifically, we propose to add a
reference to the ‘‘Base EHR Definition’’
where the regulatory text refers to the
‘‘2015 Edition Base EHR definition,’’
remove ‘‘2015 Edition’’ where we
reference ‘‘2015 Edition health IT
certification criteria,’’ and add a crossreference to health IT certification
criteria at § 170.315. We also propose to
specify that technology meeting the
CEHRT definitions must meet ONC’s
certification criteria at § 170.315, ‘‘as
adopted and updated by ONC.’’ We
believe that these revisions to the
CEHRT definitions, if finalized, would
ensure that updates to the definition at
§ 170.102 and updates to applicable
health IT certification criteria in
§ 170.315 would be incorporated into
CEHRT definitions, without requiring
additional regulatory action by CMS.
Finally, we note that while this proposal
is consistent with the approach in
ONC’s HTI–1 proposed rule (88 FR
23746 through 23917), we do not
believe that ONC must finalize their
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proposed revisions for us to be able to
finalize the changes proposed in this
section for our regulatory definitions of
CEHRT. These changes would not
impact EHR requirements in the CY
2024 EHR reporting period or the CY
2024 performance period, and therefore
we predict that it would have no impact
on clinicians.
f. Assumptions & Limitations
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In section VII.E.23.a.(2) of this rule,
we outline several limitations in using
2021 submissions data for estimating
performance in the CY 2024
performance period/CY 2026 payment
year. In addition, because many scores
are clustered between the prior
performance threshold of 75 points and
the proposed threshold of 82 points,
minor variations in actual clinicians
final scores relative to our estimations
could have significant impacts on the
proportion of clinicians receiving a
positive or negative payment
adjustment.
In our MIPS eligible clinician
assumptions, we assumed that
clinicians who elected to opt-in for the
CY 2021 Quality Payment Program and
submitted data will continue to elect to
opt-in for the CY 2023 performance
period/2025 MIPS payment year. It is
difficult to predict whether clinicians
We also considered proposing not to
make separate payment for the O/O E/
M visit inherent complexity add-on
code for CY 2024, continuing to
consider the utilization data, and
seeking comment on not making
separate payment until CY 2025 instead
of CY 2024. While doing so would
reduce the change to the CF and the
redistributive impacts among specialties
our concerns about capturing the work
associated with visits that are part of
ongoing, comprehensive primary care
and/or care management for patients
having a single, serious, or complex
chronic condition would remain
present. We believe separate payment
for the O/O E/M visit inherent
complexity add-on code will improve
accuracy in payment for resource costs
inherent to primary care and other
medical care services that are part of
ongoing care for a patient’s single,
serious or complex condition in the
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will elect to opt-in to participate in
MIPS with the proposed policies.
In addition to the limitations
described throughout the methodology
sections, to the extent that there are
year-to-year changes in the data
submission, volume, and mix of services
provided by MIPS eligible clinicians,
the actual impact on total Medicare
revenues will be different from those
shown in Table 118.
F. Alternatives Considered
This proposed rule contains a range of
policies, including some provisions
related to specific statutory provisions.
The preceding preamble provides
descriptions of the statutory provisions
that are addressed, identifies those
policies when we proposed to exercise
agency discretion, presents rationale for
our policies and, where relevant,
alternatives that were considered. For
purposes of the payment impact on PFS
services of the policies contained in this
proposed rule, we present above the
estimated impact on total allowed
charges by specialty.
1. Alternatives Considered Related to
the O/O E/M Visit Inherent Complexity
Add-On Separate Payment
We considered alternatives to our
proposed policy to make separate
office setting. This would be
particularly important for people
without access to such care. We also
believe that utilization of high-value
preventive services, and promotion of
healthy behaviors leveraged by these
kinds of longitudinal patient
relationships could result in positive
patient outcomes and positive health
equity impacts. Primary care
practitioners and other practitioners
who rely heavily on these visit codes
and would use the add-on code would
likely raise strong objections if CMS did
not propose to make separate payment
for a code that is intended to address
long-standing distortions in PFS
payment that CMS has repeatedly
acknowledged through notice and
comment rulemaking.
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payment for the O/O E/M visit inherent
complexity add-on code, including
proposing to maintain our current
utilization assumptions. Maintaining
our current utilization assumption as
finalized in CY 2021 would result in an
estimated impact or change to the CF of
¥3.2 percent (Table 122). However,
maintaining the CY 2021 policy
utilization assumption would not reflect
our proposed limitation on billing of the
O/O E/M visit inherent complexity addon code for services billed with modifier
25 which is used to indicate that the
service is billed on the same day as a
minor procedure or another E/M visit. It
seems likely that visits reported with
payment modifiers have resources that
are sufficiently distinct from standalone office/outpatient E/M visits (85 FR
84571). Interested parties that are
unlikely to bill for the O/O E/M visit
inherent complexity add-on code have
continued to express concerns about
potential associated reductions to the
CF and redistributive impacts among
specialties. Our proposal to better target
the add-on code would at least partially
allay those concerns. Under our
proposed utilization assumption for CY
2024, we estimate the effect of making
separate payment for the O/O E/M visit
complexity add-on code to be ¥2.0
percent.
2. Alternatives to Provider Enrollment
Provisions
We did not consider alternatives to
our proposed provider enrollment
provisions. We believe these changes
are necessary to help ensure that
payments are made only to qualified
providers and suppliers and/or to
increase the efficiency of the Medicare
and Medicaid provider enrollment
processes.
3. Alternatives Considered Medicare
Diabetes Prevention Program
No alternatives were considered. The
MDPP flexibilities resulting from the
PHE for COVID–19 lasted over 3 years
of the initial 5 years of the expanded
model. During this time, supplier and
beneficiary expectations changed,
resulting in the synchronous virtual
delivery of healthcare services becoming
normalized. Requiring the MDPP
expanded model to return to primarily
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in-person services following over 3
years of synchronous virtual delivery
may have an extremely negative impact
for both MDPP suppliers and
beneficiaries, which could threaten the
success of the entire expanded model.
4. Alternatives Considered for the
Quality Payment Program
For purposes of the payment impact
on the Quality Payment Program, we
view the performance threshold as a
critical factor affecting the distribution
of payment adjustments. We ran
separate proposed policies RIA models
based on the actual mean for the CY
2019 performance period/2021 MIPS
payment year with a performance
threshold of 86. This model has the
same mean and median final score as
our proposed policies RIA model since
the performance threshold does not
change the final score. In our analysis of
the alternative performance threshold of
86, 67.20 percent of MIPS eligible
clinicians who submitted data would
receive a negative payment adjustment.
We also report the findings for the
baseline RIA model which describes the
impact for the CY 2024 performance
period/2026 MIPS payment year if this
proposal is not finalized including
previous polices including a
performance threshold of 75. The
baseline RIA model has a mean final
score of 73.26 and median final score of
79.99. We estimate that $741 million
would be redistributed based on the
budget neutrality requirement. There
would be a maximum payment
adjustment of 4.60. In addition, 36.75
percent of MIPS eligible clinicians
would receive a negative payment
adjustment.
G. Impact on Beneficiaries
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1. Medicare Shared Savings Program
Provisions
As noted previously in this proposed
rule, the proposal to cap an ACO’s
regional service area risk score growth is
expected to increase the incentive for
ACOs to participate in regions with high
risk score growth, improving the
incentive for ACOs to join and/or
sustain participation when serving
regions with increasingly medically
complex beneficiaries. Similarly, the
proposal to use a uniform approach to
calculating both BY and PY prospective
HCC risk scores using the same CMS–
HCC risk adjustment model(s) is
anticipated to increase participation
(and reduce the potential for
disenrollment) particularly from ACOs
serving greater proportions of complex
beneficiaries exhibiting high risk scores.
The proposal to mitigate the impact of
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00:33 Aug 05, 2023
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the negative regional adjustments on
benchmarks is expected to increase
participation from ACOs serving up to
500,000 new assigned beneficiaries per
year. The proposal to revise the
definition of an assignable beneficiary is
expected to allow more than 760,000
additional beneficiaries to be included
in the population of assignable
beneficiaries, many of whom would be
eligible to be assigned to ACOs. In total
these proposals are expected to increase
participation in the Shared Savings
Program over the 2024–2033 period by
roughly 10 to 20 percent.
ACOs have been found to perform
better on certain patient-experience and
performance measures than physician
groups participating in the MIPS. In
addition, ACOs continued to have
higher mean performance than their
MIPS Group counterparts on all 10 of
the CMS Web Interface measures for PY
2021. This includes higher performance
for quality measures related to diabetes
and blood pressure control; depression
screening and depression remission
rates; breast, colorectal and falls risk
screening rates; and flu vaccination,
tobacco screening and smoking
cessation, and statin therapy for the
treatment and prevention of
cardiovascular disease.
Increased participation in the Shared
Savings Program will extend ACO care
coordination and quality improvement
to segments of the beneficiary
population that potentially have more to
benefit from care management.
2. Quality Payment Program
There are several changes in this
proposed rule that are expected to have
a positive effect on beneficiaries. In
general, we believe that many of these
changes, including the MVP and
subgroup provisions, if finalized, will
lead to meaningful feedback to
beneficiaries on the type and scope of
care provided by clinicians.
Additionally, beneficiaries could use
the publicly reported information on
clinician performance in subgroups to
identify and choose clinicians in
multispecialty groups relevant to their
care needs. Consequently, we anticipate
the proposed policies in this proposed
rule will improve the quality and value
of care provided to Medicare
beneficiaries. For example, several of
the proposed new quality measures
include patient-reported outcome-based
measures, which may be used to help
patients make more informed decisions
about treatment options. Patientreported outcome-based measures
provide information on a patient’s
health status from the patient’s point of
view and may also provide valuable
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Fmt 4701
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52731
insights on factors such as quality of
life, functional status, and overall
disease experience, which may not
otherwise be available through routine
clinical data collection. Patient-reported
outcome-based measured are factors
frequently of interest to patients when
making decisions about treatment.
3. Medicare Diabetes Prevention
Program
The proposed changes would have a
positive impact on eligible MDPP
beneficiaries, as it increases the
accessibility of MDPP, particularly
among beneficiaries residing in rural
and underserved areas of the US, where
access to a supplier offering in-person
Set of MDPP services may not exist or
be geographically feasible.
H. Estimating Regulatory
Familiarization Costs
If regulations impose administrative
costs on private entities, such as the
time needed to read and interpret this
rule, we should estimate the cost
associated with regulatory review. Due
to the uncertainty involved with
accurately quantifying the number of
entities that will review the rule, we
assumed that the total number of unique
commenters on this year’s proposed rule
will be the number of reviewers of last
year’s proposed rule. We acknowledge
that this assumption may understate or
overstate the costs of reviewing this
rule. It is possible that not all
commenters will review this year’s
proposed rule in detail, and it is also
possible that some reviewers will
choose not to comment on the proposed
rule. For these reasons we believe that
the number of commenters will be a fair
estimate of the number of reviewers of
last year’s proposed rule.
We also recognized that different
types of entities are in many cases
affected by mutually exclusive sections
of this rule, and therefore for the
purposes of our estimate we assume that
each reviewer reads approximately 50
percent of the rule.
Using the wage information from the
BLS for medical and health service
managers (Code 11–9111), we estimate
that the cost of reviewing this rule is
$123.06, including overhead and fringe
benefits https://www.bls.gov/oes/
current/oes_nat.htm. Assuming an
average reading speed, we estimate that
it would take approximately 8.0 hours
for the staff to review half of this rule.
For each facility that reviews the rule,
the estimated cost is $984.48 (8.0 hours
× $123.06). Therefore, we estimated that
the total cost of reviewing this
regulation is 22,978,748 ($984.48 ×
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07AUP2
Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
23,341 reviewers on last year’s proposed
rule).
As for the Medicare Diabetes
Prevention Program, given that we tried
to align this rule as much as possible
with the CDC DPRP Standards, there
should be minimal regulatory
familiarization costs. This rule impacts
only enrolled MDPP suppliers and
eligible beneficiaries who have started
the MDPP program or are interested in
enrolling in MDPP.
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Tables 123 through
125 (Accounting Statements), we have
prepared an accounting statement. This
estimate includes growth in incurred
benefits from CY 2023 to CY 2024 based
on the FY 2024 President’s Budget
baseline.
J. Conclusion
List of Subjects
42 CFR Part 411
The analysis in the previous sections,
together with the remainder of this
preamble, provided an initial Regulatory
Flexibility Analysis. The previous
analysis, together with the preceding
portion of this preamble, provides an
RIA. In accordance with the provisions
of Executive Order 12866, this
regulation was reviewed by the Office of
Management and Budget.
Chiquita Brooks-LaSure,
Administrator of the Centers for
Medicare & Medicaid Services,
approved this document on July 5, 2023.
42 CFR Part 405
Diseases, Medicare, Reporting and
recordkeeping requirements.
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00:33 Aug 05, 2023
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42 CFR Part 410
Diseases, Health facilities, Health
professions, Laboratories, Medicare,
Reporting and recordkeeping
requirements, Rural areas, X-rays.
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Frm 00472
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42 CFR Part 414
Administrative practice and
procedure, Biologics, Diseases, Drugs,
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 415
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU23.159
Administrative practice and
procedure, Diseases, Health facilities,
Health professions, Medical devices,
Medicare, Reporting and recordkeeping
requirements, Rural areas, and X-rays.
EP07AU23.158
I. Accounting Statement
EP07AU23.157
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
42 CFR Part 418
Health facilities, Hospice care,
Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Medicare, Penalties, Privacy, Reporting
and recordkeeping requirements.
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
42 CFR Part 423
Administrative practice and
procedure, Emergency medical services,
Health facilities, Health maintenance
organizations (HMO), Health
professionals, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
42 CFR Part 424
Health facilities, Health professions,
Medicare Reporting and recordkeeping
requirements.
42 CFR Part 425
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 455
Fraud, Grant programs—health,
Health facilities, Health professions,
Investigations,
Medicaid, Reporting and
recordkeeping requirements.
42 CFR Part 491
Grant programs-health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements, Rural areas.
tkelley on DSK125TN23PROD with PROPOSALS2
42 CFR Part 495
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Health professions, Health records,
Medicaid, Medicare, Penalties, Privacy,
Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and
procedure, Health facilities, Health
professions, Medicare Reporting and
recordkeeping requirements.
42 CFR Part 600
Administrative practice and
procedure, Health care, Health
insurance, Intergovernmental relations,
Penalties, Reporting and recordkeeping
requirements.
00:33 Aug 05, 2023
Jkt 259001
Authority: 42 U.S.C. 263a, 405(a), 1302,
1320b-12, 1395x, 1395y(a), 1395ff, 1395hh,
1395kk, 1395rr, and 1395ww(k).
2. Section 405.800 is amended by
adding paragraph (d) to read as follows:
■
§ 405.800 Appeals of CMS or a CMS
contractor.
*
*
*
*
*
(d) Scope of supplier. For purposes of
this subpart, the term ‘‘supplier’’
includes all of the following:
(1) The individuals and entities that
qualify as suppliers under § 400.202 of
this chapter.
(2) Physical therapists in private
practice.
(3) Occupational therapists in private
practice.
(4) Speech-language pathologists.
■ 3. Section 405.2401 is amended by
adding the definition of ‘‘Marriage and
family therapist (MFT)’’ and ‘‘Mental
health counselor (MHC)’’ to paragraph
(b) in alphabetical order to read as
follows:
§ 405.2401
42 CFR Part 489
Health facilities, Medicare, Reporting
and recordkeeping requirements.
VerDate Sep<11>2014
1. The authority citation for part 405
continues to read as follows:
■
Scope and definitions.
*
*
*
*
*
(b) * * *
Marriage and family therapist (MFT)
means an individual who meets the
applicable education, training, and
other requirements of § 410.53 of this
chapter.
*
*
*
*
*
Mental health counselor (MHC) means
an individual who meets the applicable
education, training, and other
requirements of § 410.54 of this chapter.
*
*
*
*
*
■ 4. Section 405.2411 is amended by
revising paragraphs (a)(4), (a)(6), and
(b)(2) to read as follows:
§ 405.2411
Scope of benefits.
(a) * * *
(4) Services and supplies furnished as
incident to the services of a nurse
practitioner, physician assistant,
certified nurse midwife, clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor.
*
*
*
*
*
(6) Clinical psychologist, clinical
social worker, marriage and family
therapist, and mental health counselor
services as specified in § 405.2450.
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52733
(b) * * *
(2) Covered when furnished during a
Part A stay in a skilled nursing facility
only when provided by a physician,
nurse practitioner, physician assistant,
certified nurse midwife, clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor employed or under
contract with the RHC or FQHC at the
time the services are furnished;
*
*
*
*
*
■ 5. Section 405.2413 is amended by
revising paragraph (a)(5) to read as
follows:
§ 405.2413 Services and supplies incident
to a physician’s services.
(a) * * *
(5) Furnished under the direct
supervision of a physician, except that
services and supplies furnished incident
to Transitional Care Management,
General Care Management, the
Psychiatric Collaborative Care Model,
and behavioral health services can be
furnished under general supervision of
a physician when these services or
supplies are furnished by auxiliary
personnel, as defined in § 410.26(a)(1) of
this chapter.
*
*
*
*
*
■ 6. Section 405.2415 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(3), and (a)(5) and
■ b. Adding paragraphs (b)(6) and (7).
The revisions and additions read as
follows:
§ 405.2415 Incident to services and direct
supervision.
(a) Services and supplies incident to
the services of a nurse practitioner,
physician assistant, certified nurse
midwife, clinical psychologist, clinical
social worker, marriage and family
therapist, or mental health counselor are
payable under this subpart if the service
or supply is all of the following:
*
*
*
*
*
(3) Furnished as an incidental,
although integral part of professional
services furnished by a nurse
practitioner, physician assistant,
certified nurse-midwife, clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor.
*
*
*
*
*
(5) Furnished under the direct
supervision of a nurse practitioner,
physician assistant, or certified nursemidwife, except that services and
supplies furnished incident to
Transitional Care Management, General
Care Management, the Psychiatric
Collaborative Care model, and
behavioral health services can be
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
furnished under general supervision of
a nurse practitioner, physician assistant,
or certified nurse-midwife, when these
services or supplies are furnished by
auxiliary personnel, as defined in
§ 410.26(a)(1) of this chapter.
(b) * * *
(6) Marriage and family therapist.
(7) Mental health counselor.
*
*
*
*
*
■ 7. Section 405.2446 is amended by
revising paragraphs (b)(5) and (6) to read
as follows:
§ 405.2446
Scope of services.
*
*
*
*
*
(b) * * *
(5) Clinical psychologist, clinical
social worker, marriage and family
therapist, and mental health counselor
services specified in § 405.2450.
(6) Services and supplies furnished as
incident to the services of a clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor, as specified in
§ 405.2452.
*
*
*
*
*
■ 8. Section § 405.2448 is amended by
revising paragraphs (a)(2) introductory
text and (a)(2)(i) to read as follows:
§ 405.2448
Preventive primary services.
(a) * * *
(2) Are furnished by a or under the
direct supervision of a physician, nurse
practitioner, physician assistant,
certified nurse midwife, clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor employed by or under
contract with the FQHC.
(i) By a or under the direct
supervision of a physician, nurse
practitioner, physician assistant,
certified nurse midwife, clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor; or
*
*
*
*
*
■ 9. Section 405.2450 is amended by
revising the section heading and
paragraphs (a) introductory text, (a)(2),
(a)(3), and (c) to read as follows:
tkelley on DSK125TN23PROD with PROPOSALS2
§ 405.2450 Clinical psychologist, clinical
social worker, marriage and family
therapist, and mental health counselor
services.
(a) For clinical psychologist, clinical
social worker, marriage and family
therapist, or mental health counselor
professional services to be payable
under this subpart, the services must
be—
*
*
*
*
*
(2) Of a type that the clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
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health counselor who furnishes the
services is legally permitted to perform
by the State in which the service is
furnished;
(3) Performed by a clinical social
worker, clinical psychologist, marriage
and family therapist, or mental health
counselor who is legally authorized to
perform such services under State law
or the State regulatory mechanism
provided by the law of the State in
which such services are performed; and
*
*
*
*
*
(c) The services of clinical
psychologists, clinical social workers,
marriage and family therapist, or mental
health counselors are not covered if
State law or regulations require that the
services be performed under a
physician’s order and no such order was
prepared.
■ 10. Section 405.2452 is amended by
revising the section heading, and
paragraphs (a) introductory text, (a)(3),
(a)(5) and (b) to read as follows:
§ 405.2452 Services and supplies incident
to clinical psychologist, clinical social
worker, marriage and family therapist, and
mental health counselor services.
(a) Services and supplies incident to
a clinical psychologist’s, clinical social
worker’s, marriage and family
therapist’s, and mental health
counselor’s services are reimbursable
under this subpart if the service or
supply is—
*
*
*
*
*
(3) Furnished as an incidental,
although integral part of professional
services furnished by a clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor;
*
*
*
*
*
(5) Furnished under the direct
supervision of a clinical psychologist,
clinical social worker, marriage and
family therapist, or mental health
counselor.
(b) The direct supervision
requirement in paragraph (a)(5) of this
section is met only if the clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor is permitted to
supervise such services under the
written policies governing the FQHC.
■ 11. Section 405.2463 is amended by—
■ a. Adding paragraphs (a)(1)(i)(I) and
(a)(1)(i)(J);
■ b. Revising paragraph (b)(3)
introductory text;
■ c. Redesignating paragraph (b)(3)(iii)
as paragraph (b)(3)(v); and
■ d. Adding paragraphs (b)(3)(iii) and
(b)(3)(iv).
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§ 405.2463
What constitutes a visit.
(a) * * *
(1) * * *
(i) * * *
(I) Marriage and family therapist.
(J) Mental health counselor.
*
*
*
*
*
(b) * * *
(3) A mental health visit is a face-toface encounter or an encounter
furnished using interactive, real-time,
audio and video telecommunications
technology or audio-only interactions in
cases where the patient is not capable
of, or does not consent to, the use of
video technology for the purposes of
diagnosis, evaluation or treatment of a
mental health disorder, including an inperson mental health service, beginning
January 1, 2025, 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, between an RHC or
FQHC patient and one of the following:
*
*
*
*
*
(iii) Marriage and family therapist.
(iv) Mental health counselor.
*
*
*
*
*
■ 12. Section 405.2464 is amended by
revising paragraph (c) to read as follows:
*
*
*
*
*
(c) Payment for care management
services. For chronic care management
services furnished between January 1,
2016 and December 31, 2017, payment
to RHCs and FQHCs is at the physician
fee schedule national non-facility
payment rate. For care management
services furnished between January 1,
2018 and December 31, 2023, payment
to RHCs and FQHCs is at the rate set for
each of the RHC and FQHC payment
codes for care management services. For
general care management services
furnished on or after January 1, 2024,
the payment amount is based on a
weighted average of the services that
comprise HCPCS code G0511 using the
most recently available PFS utilization
data.
*
*
*
*
*
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Proposed Rules
13. Section 405.2468 is amended by
revising paragraphs (b)(1), (b)(3), and
(d)(2)(ii) to read as follows:
■
§ 405.2468
Allowable costs.
*
*
*
*
*
(b) * * *
(1) Compensation for the services of a
physician, physician assistant, nurse
practitioner, certified nurse-midwife,
visiting registered professional or
licensed practical nurse, clinical
psychologist, clinical social worker,
marriage and family therapist, and
mental health counselor who owns, is
employed by, or furnishes services
under contract to a FQHC or RHC.
*
*
*
*
*
(3) Costs of services and supplies
incident to the services of a physician,
physician assistant, nurse practitioner,
nurse-midwife, qualified clinical
psychologist, clinical social worker,
marriage and family therapist, or mental
health counselor.
*
*
*
*
*
(d) * * *
(2) * * *
(ii) Services of physicians, physician
assistants, nurse practitioners, nursemidwives, visiting nurses, qualified
clinical psychologists, clinical social
workers, marriage and family therapists,
and mental health counselors.
*
*
*
*
*
■ 14. Section 405.2469 is amended by
revising paragraph (d) to read as
follows:
§ 405.2469
FQHC supplemental payments.
tkelley on DSK125TN23PROD with PROPOSALS2
*
*
*
*
*
(d) Per visit supplemental payment. A
supplemental payment required under
this section is made to the FQHC when
a covered face-to-face encounter or an
encounter furnished using interactive,
real-time, audio and video
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 § 405.2463.
Additionally, beginning January 1, 2025,
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
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00:33 Aug 05, 2023
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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.
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
15. The authority citation for part 410
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395m,
1395hh, 1395rr, and 1395ddd.
16. Section 410.10 is amended by
revising paragraph (l) and adding
paragraphs (z) and (aa) to read as
follows:
■
§ 410.10 Medical and other health
services: Included services.
*
*
*
*
*
(l) Pneumococcal, influenza, and
COVID–19 vaccines (or monoclonal
antibodies used for preexposure
prophylaxis of COVID–19) and their
administration.
*
*
*
*
*
(z) Marriage and Family Therapist
services, as provided in § 410.53.
(aa) Mental Health Counselor services,
as provided in § 410.54.
■ 17. In § 410.15 amend paragraph (a)
by:
■ a. In the definition of ‘‘First annual
wellness visit providing personalized
prevention plan services’’:
■ i. Redesignating paragraph (xiii) as
paragraph (xiv); and
■ ii. Adding a new paragraph (xiii).
■ b. In the definition of ‘‘Subsequent
annual wellness visit providing
personalized prevention plan services’’:
■ i. Redesignating paragraph (xi) as
paragraph (xii); and
■ ii. Adding a new paragraph (xi).
The additions read as follows:
§ 410.15 Annual wellness visits providing
Personalized Prevention Plan Services:
Conditions for and limitations on coverage.
(a) * * *
First annual wellness visit providing
personalized prevention plan services
* * *
(xiii) At the discretion of the health
professional and beneficiary, furnish a
Social Determinants of Health Risk
Assessment that is standardized,
evidence-based, and furnished in a
manner that all communication with the
patient is appropriate for the
beneficiary’s educational,
developmental, and health literacy
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52735
level, and is culturally and linguistically
appropriate.
*
*
*
*
*
Subsequent annual wellness visit
providing personalized prevention plan
services * * *
(xi) At the discretion of the health
professional and beneficiary, furnish a
Social Determinants of Health Risk
Assessment that is standardized,
evidence-based, and furnished in a
manner that all communication with the
patient is appropriate for the
beneficiary’s educational,
developmental, and health literacy
level, and is culturally and linguistically
appropriate.
*
*
*
*
*
■ 18. Amend § § 410.18 by:
■ a. In paragraph (a):
■ i. In the definition of ‘‘Diabetes’’
removing the text ‘‘diagnosed using the
following criteria: a fasting blood sugar
greater than or equal to 126 mg/dL on
two different occasions; a 2-hour postglucose challenge greater than or equal
to 200 mg/dL on two different
occasions; or a random glucose test over
200 mg/dL for a person with symptoms
of uncontrolled diabetes’’; and
■ ii. Removing the definition of ‘‘Prediabetes’’.
■ b. Redesignating paragraph (c)(3) as
paragraph (c)(4) and adding a new
paragraph (c)(3); and
■ c. Revising paragraph (d).
The revisions and addition read as
follows:
§ 410.18
Diabetes screening tests.
(a) * * *
Diabetes means diabetes mellitus, a
condition of abnormal glucose
metabolism.
*
*
*
*
*
(c) * * *
(3) Hemoglobin A1C test.
(d) Amount of testing covered.
Medicare covers two tests within the 12month period following the date of the
most recent diabetes screening test of
that individual.
*
*
*
*
*
§ 410.32
[Amended]
19. Section 410.32 is amended by
revising paragraphs (a)(2) and (b)(3)(ii)
to read as follow:
■
§ 410.32 Diagnostic x-ray tests, diagnostic
laboratory tests, and other diagnostic tests:
Conditions.
(a) * * *
(2) Application to nonphysician
practitioners. Nonphysician
practitioners (that is, clinical nurse
specialists, clinical psychologists,
clinical social workers, marriage and
family therapists, mental health
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counselors, nurse-midwives, nurse
practitioners, and physician assistants)
who furnish services that would be
physician services if furnished by a
physician, and who are operating within
the scope of their authority under State
law and within the scope of their
Medicare statutory benefit, may be
treated the same as physicians treating
beneficiaries for the purpose of this
paragraph.
*
*
*
*
*
(b) * * *
(3) * * *
(ii) Direct supervision in the office
setting means the physician (or other
supervising practitioner) must be
present in the office suite and
immediately available to furnish
assistance and direction throughout the
performance of the procedure. It does
not mean that the physician (or other
supervising practitioner) must be
present in the room when the procedure
is performed. 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).
■ 20. Section § 410.33 is amended by
revising paragraph (g)(2) to read as
follows:
§ 410.33
facility.
Independent diagnostic testing
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*
*
*
*
*
(g) * * *
(2) Provides complete and accurate
information on its enrollment
application. Changes in ownership,
changes of location (including additions
and deletions of locations), changes in
general supervision, and adverse legal
actions must be reported to the
Medicare fee-for-service contractor on
the Medicare enrollment application
within 30 calendar days of the change.
All other changes to the enrollment
application must be reported within 90
days.
*
*
*
*
*
■ 21. Amend § 410.47 by:
■ a. In paragraph (a):
■ i. Adding the definition of
‘‘Nonphysician practitioner’’ in
alphabetical order;
■ ii. Revising the definitions of
‘‘Pulmonary rehabilitation’’ and
‘‘Supervising physician’’;
■ b. Revising paragraphs (b)(3)(ii)(A)
and (d) introductory text; and
■ c. Removing paragraph (d)(3).
The addition and revisions read as
follows:
§ 410.47 Pulmonary rehabilitation
program: Conditions of coverage.
(a) * * *
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Nonphysician practitioner means a
physician assistant, nurse practitioner,
or clinical nurse specialist as those
terms are defined in section
1861(aa)(5)(A) of the Act.
*
*
*
*
*
Pulmonary rehabilitation means a
physician or nonphysician practitioner
supervised program for COPD and
certain other chronic respiratory
diseases designed to optimize physical
and social performance and autonomy.
Supervising practitioner means a
physician or nonphysician practitioner
that is immediately available and
accessible for medical consultations and
medical emergencies at all times items
and services are being furnished to
individuals under pulmonary
rehabilitation programs.
*
*
*
*
*
(b) * * *
(3) * * *
(ii) * * *
(A) A physician or nonphysician
practitioner immediately available and
accessible for medical consultations and
emergencies at all times when items and
services are being furnished under the
program. This provision is satisfied if
the physician or nonphysician
practitioner meets the requirements for
direct supervision for physician office
services, at § 410.26 of this subpart; and
for hospital outpatient services at
§ 410.27 of this subpart.
*
*
*
*
*
(d) Supervising practitioner
standards. Physicians or nonphysician
practitioners acting as the supervising
practitioner must possess all of the
following:
*
*
*
*
*
■ 22. Amend § 410.49 by:
■ a. In paragraph (a):
■ i. Revising the definitions of ‘‘Cardiac
rehabilitation’’ and ‘‘Intensive cardiac
rehabilitation (ICR) program’’;
■ ii. Adding the definition of
‘‘Nonphysician practitioner’’ in
alphabetical order; and
■ iii. Revising the definition of
‘‘Supervising physician’’;
■ b. Revising paragraphs (b)(3)(ii) and
(e) introductory text; and
■ c. Removing paragraph (e)(3).
The revisions and addition read as
follows:
§ 410.49 Cardiac rehabilitation program
and intensive cardiac rehabilitation
program: Conditions of coverage.
(a) * * *
Cardiac rehabilitation (CR) means a
physician or nonphysician practitioner
supervised program that furnishes
physician prescribed exercise, cardiac
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risk factor modification, psychosocial
assessment, and outcomes assessment.
*
*
*
*
*
Intensive cardiac rehabilitation (ICR)
program means a physician or
nonphysician practitioner supervised
program that furnishes cardiac
rehabilitation and has shown, in peerreviewed published research, that it
improves patients’ cardiovascular
disease through specific outcome
measurements described in paragraph
(c) of this section.
*
*
*
*
*
Nonphysician practitioner means a
physician assistant, nurse practitioner,
or clinical nurse specialist as those
terms are defined in section
1861(aa)(5)(A) of the Act.
*
*
*
*
*
Supervising practitioner means a
physician or nonphysician practitioner
that is immediately available and
accessible for medical consultations and
medical emergencies at all times items
and services are being furnished to
individuals under cardiac rehabilitation
and intensive cardiac rehabilitation
programs.
(b) * * *
(3) * * *
(ii) All settings must have a physician
or nonphysician practitioner
immediately available and accessible for
medical consultations and emergencies
at all times when items and services are
being furnished under the program. This
provision is satisfied if the physician or
nonphysician practitioner meets the
requirements for direct supervision for
physician office services, at § 410.26 of
this subpart; and for hospital outpatient
services at § 410.27 of this subpart.
*
*
*
*
*
(e) Supervising practitioner standards.
Physicians or nonphysician
practitioners acting as the supervising
practitioner must possess all of the
following:
*
*
*
*
*
■ 23. Add § 410.53 to subpart B to read
as follows:
§ 410.53 Marriage and family therapist
services.
(a) Definition: marriage and family
therapist. For purposes of this part, a
marriage and family therapist is defined
as an individual who—
(1) 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;
(2) After obtaining such degree, has
performed at least 2 years or 3,000 hours
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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
(3) Is licensed or certified as a
marriage and family therapist by the
State in which the services are
performed.
(b) Covered marriage and family
therapist services. Medicare Part B
covers marriage and family therapist
services.
(1) Definition: marriage and family
therapist services means services
furnished by a marriage and family
therapist (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 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. 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.
(2) Exception. The following services
are not marriage and family therapist
services for purposes of billing Medicare
Part B under the MFT and MHC
statutory benefit category:
(i) Services furnished by a marriage
and family therapist to an inpatient of
a Medicare-participating hospital.
(ii) [Reserved]
(c) Prohibited billing. (1) A marriage
and family therapist may not bill
Medicare for the services specified in
paragraph (b)(2) of this section.
(2) A marriage and family therapist or
an attending or primary care physician
may not bill Medicare or the beneficiary
for the consultation that is required
under paragraph(b)(2) of this section.
■ 24. Add § 410.54 to subpart B to read
as follows:
tkelley on DSK125TN23PROD with PROPOSALS2
§ 410.54
Mental health counselor services.
(a) Definition: mental health
counselor. For purposes of this part, a
mental health counselor is defined as an
individual who—
(1) 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;
(2) After obtaining such a degree, has
performed at least 2 years or 3,000 hours
of post master’s degree clinical
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supervised experience in mental health
counseling in an appropriate setting
such as a hospital, SNF, private
practice, or clinic; and
(3) Is licensed or certified as a mental
health counselor, clinical professional
counselor, or professional counselor by
the State in which the services are
performed.
(b) Covered mental health counselor
services. Medicare Part B covers mental
health counselor services.
(1) Definition: Mental health
counselor services means 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. 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.
(2) Exception. The following services
are not mental health counselor services
for purposes of billing Medicare Part B:
(i) Services furnished by a mental
health counselor to an inpatient of a
Medicare-participating hospital.
(ii) [Reserved]
(c) Prohibited billing. (1) A mental
health counselor may not bill Medicare
for the services specified in paragraph
(b)(2) of this section.
(2) A mental health counselor or an
attending or primary care physician may
not bill Medicare or the beneficiary for
the consultation that is required under
paragraph(b)(2) of this section.
■ 25. Section 410.57 is amended by
revising paragraph (c) to read as follows:
§ 410.57
Preventive vaccines.
*
*
*
*
*
(c) Medicare Part B pays for the
COVID–19 vaccine (or monoclonal
antibodies used for pre-exposure
prophylaxis of COVID–19) and its
administration.
*
*
*
*
*
■ 26. Section 410.59 is amended by
revising paragraphs (a)(3)(ii) and (c)(2)
to read as follows:
§ 410.59 Outpatient occupational therapy
services: Conditions.
*
*
*
*
*
(a) * * *
(3) * * *
(ii) By, or under the direct supervision
(or as specified otherwise) of, an
occupational therapist in private
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practice as described in paragraph (c) of
this section; or
*
*
*
*
*
(c) * * *
(2) Supervision of occupational
therapy services. Except as otherwise
provided in this paragraph,
occupational therapy services are
performed by, or under the direct
supervision of, an occupational
therapist in private practice. All services
not performed personally by the
therapist must be performed by
employees of the practice, directly
supervised by the therapist, and
included in the fee for the therapist’s
services. Remote therapeutic monitoring
services may be performed by an
occupational therapy assistant under the
general supervision of the occupational
therapist in private practice; services
performed by an unenrolled
occupational therapist must be under
the direct supervision of the
occupational therapist.
*
*
*
*
*
■ 27. Section 410.60 is amended by
revising paragraphs (a)(3)(ii) and (c)(2)
to read as follows:
§ 410.60 Outpatient physical therapy
services: Conditions.
*
*
*
*
*
(a) * * *
(3) * * *
(ii) By, or under the direct supervision
(or as specified otherwise) of, a physical
therapist in private practice as described
in paragraph (c) of this section; or
*
*
*
*
*
(c) * * *
(2) Supervision of physical therapy
services. Except as otherwise provided
in this paragraph, physical therapy
services are performed by, or under the
direct supervision of, a physical
therapist in private practice. All services
not performed personally by the
therapist must be performed by
employees of the practice, directly
supervised by the therapist, and
included in the fee for the therapist’s
services. Remote therapeutic monitoring
services may be performed by a physical
therapist assistant under the general
supervision of the physical therapist in
private practice; services performed by
an unenrolled physical therapist must
be under the direct supervision of the
physical therapist.
*
*
*
*
*
§ 410.67
[Amended]
28. In § 410.67 amend paragraph (vii)
in the definition of ‘‘Opioid use disorder
treatment service’’ in paragraph (b) by
removing the reference ‘‘through the
end of CY 2023’’ and adding in its place
■
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the reference ‘‘through the end of CY
2024’’.
■ 29. Section 410.72 is amended by
revising paragraph (d) to read as
follows:
§ 410.72 Registered dietitians’ and
nutrition professionals’ services.
*
*
*
*
*
(d) Professional services. 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.
*
*
*
*
*
■ 30. Section 410.78 is amended by—
■ a. Adding paragraphs (b)(2)(x) through
(xii);
■ b. Revising paragraphs (b)(3)(xiv)
introductory text, (b)(4)(iv)(D), and
(e)(1); and
■ c. Adding paragraph (e)(3).
The additions and revisions read as
follows:
§ 410.78
Telehealth services.
tkelley on DSK125TN23PROD with PROPOSALS2
*
*
*
*
*
(b) * * *
(2) * * *
(x) Any distant site practitioner who
can appropriately report diabetes selfmanagement training services may do so
on behalf of others who personally
furnish the services as part of the DSMT
entity.
(xi) A marriage and family therapist as
described in 410.53.
(xii) A mental health counselor as
described in 410.54.
(3) * * *
(xiv) The home of a beneficiary for the
purposes of diagnosis, evaluation, and/
or treatment of a mental health disorder
for services that are furnished during
the period beginning on the first day
after the end of the emergency period as
defined in our regulation at § 400.200
and ending on December 31, 2024
except as otherwise provided in this
paragraph. Payment will not be made
for a telehealth service furnished under
this paragraph unless the following
conditions are met:
(4) * * *
(iv) * * *
(D) Services furnished on or after
January 1, 2025 for the purposes of
diagnosis, evaluation, and/or treatment
of a mental health disorder. Payment
will not be made for a telehealth service
furnished under this paragraph unless
the physician or practitioner has
furnished an item or service in person,
without the use of telehealth, for which
Medicare payment was made (or would
have been made if the patient were
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entitled to, or enrolled for, Medicare
benefits at the time the item or service
is furnished) within 6 months prior to
the initial telehealth service and within
6 months of any subsequent telehealth
service.
*
*
*
*
*
(e) * * *
(1) A clinical psychologist and a
clinical social worker, a marriage and
family therapist (MFT), and a mental
health counselor (MHC) may bill and
receive payment for individual
psychotherapy via a
telecommunications system, but may
not seek payment for medical evaluation
and management services.
*
*
*
*
*
(3) The distant site practitioner who
reports the DSMT services may bill and
receive payment when a professional
furnishes injection training for an
insulin-dependent patient using
interactive telecommunications
technology when such training is
included as part of the DSMT plan of
care referenced at § 410.141(b)(2).
*
*
*
*
*
■ 31. Amend § 410.79 by:
■ a. In paragraph (b):
■ i. Adding the definition of
‘‘Combination delivery’’ in alphabetical
order;
■ ii. Removing the definition of ‘‘Core
maintenance session interval’’;
■ iii. Adding the definitions of
‘‘Distance learning’’, ‘‘Extended
flexibilities’’, ‘‘Extended flexibilities
period’’, and ‘‘Full-Plus CDC DPRP
recognition’’ in alphabetical order;
■ iv. Revising the definitions of ‘‘Makeup session’’, ‘‘MDPP services period’’,
and ‘‘MDPP session’’
■ v. Adding the definition ‘‘Online
delivery’’ in alphabetical order;
■ vi. Removing the definition of
‘‘Ongoing maintenance sessions’’;
■ vii. Adding the definition of ‘‘Virtual
session’’ in alphabetical order.
■ b. By removing paragraphs (c)(1)(ii)
and (iii);
■ c. By redesignating paragraph
(c)(1)(iv) as paragraph (c)(1)(ii);
■ d. By revising paragraphs (c)(2)(i)(A)
and (B);
■ e. By removing and reserving
paragraph (c)(2)(ii);
■ f. By revising paragraph (c)(3)(i);
■ g. By removing and reserving
paragraph (c)(3)(ii); removing paragraph
(c)(3)(iii), removing and reserving
paragraphs (d)(2)(iii)(B) and (d)(3)(ii);
■ h. Revising paragraphs (e)(3)(iv)
introductory text, (e)(3)(iv)(D),
(e)(3)(iv)(F)(1) and (2).
The additions and revisions read as
follows:
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§ 410.79 Medicare Diabetes Prevention
Program expanded model: Conditions of
coverage.
*
*
*
*
*
(b) * * *
Combination delivery. MDPP sessions
that are delivered by trained Coaches
and are furnished in a manner
consistent with the DPRP Standards for
distance learning and in-person sessions
for each individual participant.
*
*
*
*
*
Distance learning refers to an MDPP
session that is delivered by trained
Coaches via remote classroom and is
furnished in a manner consistent with
the DPRP Standards for distance
learning sessions. The Coach provides
live (synchronous) delivery of session
content in one location and participants
call-in or video-conference from another
location.
Extended flexibilities refer to the
flexibilities as described in paragraphs
(e)(3)(iii) and (iv) of this section.
Extended flexibilities period refers to
the 4-year period (January 1, 2024 to
December 31, 2027) for the Extended
flexibilities to apply.
*
*
*
*
*
Full-Plus CDC DPRP recognition refers
to organizations that have met the Full
CDC DPRP recognition, and at the time
full recognition is achieved, has met the
following retention criterion: Eligible
participants in the evaluation cohort
must have been retained at the
following percentages: A minimum of
50 percent at the beginning of the fourth
month since the cohorts held their first
sessions; A minimum of 40 percent at
the beginning of the seventh month
since the cohorts held their first
sessions; and A minimum of 30 percent
at the beginning of the tenth month
since the cohorts held their first
sessions.
*
*
*
*
*
Make-up session means a core session
or a core maintenance session furnished
to an MDPP beneficiary when the MDPP
beneficiary misses a regularly scheduled
core session or core maintenance
session.
MDPP services period means the time
period, beginning on the date an MDPP
beneficiary attends his or her first core
session, over which the Set of MDPP
services is furnished to the MDPP
beneficiary, to include the core services
period described in paragraph (c)(2)(i)
and, subject to paragraph (c)(3) of this
section.
MDPP session means a core session or
a core maintenance session.
*
*
*
*
*
Online delivery refers to an MDPP
session that is delivered online for all
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participants and is furnished in a
manner consistent with the DPRP
Standards for online sessions. The
program is experienced through the
internet via phone, tablet, laptop, in an
asynchronous classroom where
participants are experiencing the
content on their own time without a live
Coach teaching the content. However,
live Coach interaction should be
provided to each participant no less
than once per week during the first 6
months and once per month during the
second 6 months. Emails and text
messages can count toward the
requirement for live coach interaction as
long as there is bi-directional
communication between coach and
participant.
*
*
*
*
*
Virtual session refers to an MDPP
session that is not furnished in person
and that is furnished in a manner
consistent with the DPRP standards for
distance learning sessions.
(c) * * *
(2) * * *
(i) * * *
(A) Up to 16 core sessions offered at
least 1 week apart during months 1
through 6 of the MDPP services period;
and
(B) Up to 6 core maintenance sessions
offered at least 1 month apart during
months 7 through 12 of the MDPP
services period
(ii) [Reserved]
(3) * * *
(i) The MDPP services period ends
upon completion of the core services
period described in paragraph (c)(2)(i) of
this section.
*
*
*
*
*
(e) * * *
(3) * * *
(iv) The virtual session limits
described in paragraphs (d)(2) and
(d)(3)(i) and (ii) of this section do not
apply, and MDPP suppliers may provide
all MDPP sessions virtually, through
distance learning or a combination of inperson or distance learning, during the
PHE as defined in § 400.200 of this
chapter or applicable 1135 waiver event.
If the beneficiary began the MDPP
services period virtually, or changed
from in-person to virtual services during
the Extended flexibilities period, a PHE
as defined in § 400.200 of this chapter
or applicable 1135 waiver event, he/she
may continue to receive the Set of
MDPP services virtually even after the
PHE or 1135 waiver event has
concluded, until the end of the
beneficiary’s MDPP services period, so
long as the provision of virtual services
complies with all of the following
requirements:
*
*
*
*
*
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(D) Virtual sessions are furnished in a
manner consistent with the DPRP
standards for distance learning sessions.
*
*
*
*
*
(F) * * *
(1) Up to 16 virtual sessions offered
weekly during the core session period,
months 1 through 6 of the MDPP
services period;
(2) Up to 6 virtual sessions offered
monthly during the core maintenance
session interval periods, months 7
through 12 of the MDPP services period.
*
*
*
*
*
§ 410.130
[Amended]
32. Amend § 410.130 in the definition
of ‘‘Diabetes’’ by removing the text
‘‘diagnosed using the following criteria:
A fasting blood sugar greater than or
equal to 126 mg/dL on two different
occasions; a 2 hour post-glucose
challenge greater than or equal to 200
mg/dL on 2 different occasions; or a
random glucose test over 200 mg/dL for
a person with symptoms of uncontrolled
diabetes’’.
■
§ 410.140
[Amended]
33. Amend § 410.140 in the definition
of ‘‘Diabetes’’ by removing the text
‘‘diagnosed using the following criteria:
A fasting blood sugar greater than or
equal to 126 mg/dL on two different
occasions; a 2 hour post-glucose
challenge greater than or equal to 200
mg/dL on 2 different occasions; or a
random glucose test over 200 mg/dL for
a person with symptoms of uncontrolled
diabetes’’.
■ 34. Amend § 410.150 by adding
paragraphs (b)(21) and (22) to read
follows:
■
§ 410.150
To whom payment is made.
*
*
*
*
*
(b) * * *
(21) To a marriage and family
therapist on the individual’s behalf for
marriage and family therapist services.
(22) To a mental health counselor on
the individual’s behalf for mental health
counseling services.
■ 35. Section 410.152 is amended by:
■ a. Revising paragraphs (b)
introductory text, (h)(2) and (h)(3), (h)(4)
introductory text, (h)(5); and
■ b. Adding paragraphs (m) and (n).
The revisions and additions read as
follows:
§ 410.152
Amounts of payment.
*
*
*
*
*
(b) Basic rules for payment. Except as
specified in paragraphs (c) through (h)
and (m) and (n) of this section, Medicare
Part B pays the following amounts:
*
*
*
*
*
(h) * * *
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(2) For the administration of a
COVID–19 vaccine:
(i) Effective January 1, 2022, for
administration of a COVID–19 vaccine,
$40 per dose.
(ii) For services furnished on or after
January 1 of the year following the year
in which the Secretary ends the March
27, 2020 Emergency Use Authorization
declaration for drugs and biologicals
(issued at 85 FR 18250) pursuant to
section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb–3),
for administration of a COVID–19
vaccine, an amount equal to the amount
that would be paid for the
administration of a preventive vaccine
described in paragraph (h)(1) of this
section.
(3) Subject to conditions specified in
this paragraph, in addition to the
payment described in paragraph (h)(1)
or (2) of this section, an additional
payment for preventive vaccine
administration in the patient’s home:
(i) Effective January 1, 2022 for
administration of a COVID–19 vaccine
in the home, an additional payment of
$35.50.
(ii) Effective January 1, 2024, for the
administration of one or more of the
preventive vaccines described in
paragraphs (h)(1) and (2) of this section
in the home, a payment equal to that of
the payment in paragraph (h)(3)(i) of
this section.
(iii) An additional payment for
preventive vaccine administration in the
home can be made if:
(A) The patient has difficulty leaving
the home, or faces barriers to getting a
vaccine in settings other than their
home.
(B) The sole purpose of the visit is to
administer one or more preventive
vaccines.
(C) The home is not an institution that
meets the requirements of sections
1861(e)(1), 1819(a)(1), or 1919(a)(1) of
the Act, or §§ 409.42(a) of this
subchapter.
(4) The payment amount for the
administration of a preventive vaccine
described in paragraphs (h)(1) and (2) of
this section, and the additional payment
for the administration of a preventive
vaccine in the home as described in
paragraph (h)(3) of this section, is
adjusted to reflect geographic cost
variations:
*
*
*
*
*
(5) For services furnished on or after
January 1, 2023, the payment amount
for administration of a preventive
vaccine described in paragraphs (h)(1)
and (2) of this section, and the
additional payment for the
administration of a preventive vaccine
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in the home as described in paragraph
(h)(3) of this section, is updated
annually using the percentage change in
the Medicare Economic Index (MEI), as
described in section 1842(i)(3) of the
Act and § 405.504(d) of this subchapter.
*
*
*
*
*
(m) Amount of payment: Rebatable
drugs. In the case of a rebatable drug (as
defined in section 1847A(i)(2)(A) of the
Act), including a selected drug (as
defined in section 1192(c) of the Act),
furnished by providers on or after April
1, 2023, in a calendar quarter during
which the payment amount for such
drug as specified in section
1847A(i)(3)(A)(ii)(I)(aa) or (bb), as
applicable, exceeds the inflationadjusted amount (as defined in section
1847A(i)(3)(C) of the Act) for such drug,
Medicare Part B pays, subject to the
deductible, the difference between the
allowed payment amount determined
under section 1847A of the Act and 20
percent of the inflation-adjusted
amount, which is applied as a percent
to the payment amount for such
calendar quarter.
(n) Amount of payment: Insulin
furnished through an item of durable
medical equipment. For insulin
furnished on or after July 1, 2023
through an item of durable medical
equipment (as defined in § 414.202),
Medicare Part B pays the difference
between the applicable payment amount
for such insulin and the coinsurance
amount, with the coinsurance amount
not to exceed $35 for a month’s supply.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
36. The authority citation for part 411
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh, and 1395nn.
37. Section 411.15 is amended by
revising paragraph (i)(3)(i)(A) to read as
follows:
■
§ 411.15 Particular services excluded from
coverage.
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*
*
*
*
*
(i) * * *
(3) * * *
(i) * * *
(A) Dental or oral examination
performed as part of a comprehensive
workup prior to, and medically
necessary diagnostic and treatment
services to eliminate an oral or dental
infection prior to, or contemporaneously
with, the following Medicare-covered
services: organ transplant,
hematopoietic stem cell transplant, bone
marrow transplant, cardiac valve
replacement, valvuloplasty procedures,
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chemotherapy when used in the
treatment of cancer, chimeric antigen
receptor (CAR) T-cell therapy when
used in the treatment of cancer,
administration of high-dose bonemodifying agents (antiresorptive
therapy) when used in the treatment of
cancer, and radiation, chemotherapy,
and surgery when used in the treatment
of head and neck cancer.
*
*
*
*
*
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
38. The authority citation for part 414
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr(b)(l).
39. Section 414.53 is added to read as
follows:
■
§ 414.53 Fee schedule for clinical social
worker, marriage and family therapist, and
mental health counselor services.
The fee schedule for clinical social
worker, marriage and family therapist,
and mental health counselor services is
set at 75 percent of the amount
determined for clinical psychologist
services under the physician fee
schedule.
■ 40. Amend § 414.84 by:
■ a. In paragraph (a):
■ i. Adding the definition of
‘‘Attendance payment’’ in alphabetical
order;
■ ii. Revising the definition of
‘‘Performance goal’’;
■ b. Revising paragraph (b) introductory
text;
■ c. Removing paragraphs (b)(1) through
(5);
■ d. Redesignating paragraphs (b)(6) and
(7) as paragraphs (b)(1) and (2),
respectively;
■ e. Revising newly redesignated
paragraphs (b)(1) paragraph heading and
(b)(1)(i);
■ f. Adding paragraph (b)(1)(iii);
■ g. Revising newly redesignated
paragraphs (b)(2) paragraph heading and
(b)(2)(i);
■ h. Redesignating paragraphs (c) and
(d) as paragraphs (d) and (e),
respectively;
■ i. Adding new paragraph (c); and
■ j. Revising newly redesignated
paragraphs (d)(1) and (e).
The additions and revisions read as
follows:
§ 414.84
Payment for MDPP Services.
(a) * * *
Attendance payment means a
payment that is made to an MDPP
supplier for furnishing services to an
MDPP beneficiary when the MDPP
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beneficiary attends an MDPP core or
core maintenance session. CMS will
allow up to 22 sessions (alone or in
combination with other codes, not to
exceed 22 sessions in a 12- month
timeframe).
*
*
*
*
*
Performance goal means a weight loss
goal that an MDPP beneficiary must
achieve during the MDPP services
period for an MDPP supplier to be paid
a performance payment.
*
*
*
*
*
(b) Performance payment. CMS makes
one or more types of performance
payments to an MDPP supplier as
specified in this paragraph (b). Each
type of performance payment is made
only if the beneficiary achieves the
applicable performance goal and only
once per MDPP beneficiary. A
performance payment is made only on
an assignment-related basis in
accordance with § 424.55 of this
chapter, and MDPP suppliers must
accept the Medicare allowed charge as
payment in full and may not bill or
collect from the beneficiary any amount.
CMS will make a performance payment
only to an MDPP supplier that complies
with all applicable enrollment and
program requirements and only for
MDPP services that are furnished by an
eligible coach, on or after his or her
coach eligibility start date and, if
applicable, before his or her coach
eligibility end date. As a condition of
payment, the MDPP supplier must
report the NPI of the coach who
furnished the session on the claim for
the MDPP session. The two types of
performance payments are as follows:
(1) Performance Goal 1: Achieves the
required minimum 5-percent weight
loss. * * *
(i) For a core session or core
maintenance session, as applicable,
furnished January 1, 2024 through
December 31, 2024 the amount is $145.
*
*
*
*
*
(iii) If the beneficiary maintains the
required minimum weight loss during a
core maintenance session, as measured
in-person or described in
§ 410.79(e)(3)(iii) the amount is $8.
(2) Performance Goal 2: Achieves 9percent weight loss. * * *
(i) For a core session or core
maintenance session, as applicable,
furnished January 1, 2024 through
December 31, 2024. $25.
*
*
*
*
*
(c) Attendance payment: Attends a
core session or core maintenance
session. CMS makes a payment to an
MDPP supplier if an MDPP beneficiary
attends a core session or core
maintenance session. An attendance
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payment is made only on an
assignment-related basis in accordance
with § 424.55 of this chapter, and MDPP
suppliers must accept the Medicare
allowed charge as payment in full and
may not bill or collect from the
beneficiary any amount. CMS will make
an attendance payment only to an
MDPP supplier that complies with all
applicable enrollment and program
requirements and only for MDPP
services that are furnished by an eligible
coach, on or after his or her coach
eligibility start date and, if applicable,
before his or her coach eligibility end
date. As a condition of payment, the
MDPP supplier must report the NPI of
the coach who furnished the session on
the claim for the MDPP session.
(1) The first core session attended,
which initiates the MDPP services
period, and that first core session was
furnished by that supplier.
(2) For the Extended flexibilities
period described in § 410.79(e)(2)(iii),
the distance learning HCPCS G-code
applies for any Set of MDPP services
that are delivered by distance learning,
as described in § 410.79(b).
(3) Medicare pays for up to 22
sessions in a 12-month period. The
amount of this payment is determined
as follows:
(i) For a core session or core
maintenance session furnished January
1, 2024 through December 31, 2024.
$25.
(ii) [Reserved]
(d) * * *
(1) For core session or core
maintenance session, as applicable,
furnished January 1, 2024 through
December 31, 2024 the amount is $25.
*
*
*
*
*
(e) Updating performance payments,
attendance payments, and the bridge
payment. The performance payments,
attendance payments, and bridge
payment will be adjusted each calendar
year by the percent change in the
Consumer Price Index for All Urban
Consumers (CPI–U) (U.S. city average)
for the 12-month period ending June
30th of the year preceding the update
year. The percent change update will be
calculated based on the level of
precision of the index as published by
the Bureau of Labor Statistics and
applied based on one decimal place of
precision. The annual MDPP services
payment update will be published by
CMS transmittal.
§ 414.94
[Removed]
41. Remove § 414.94.
42. Section 414.502 is amended by
revising the definitions of ‘‘Data
collection period’’ and ‘‘Data reporting
period’’ to read as follows:
■
■
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§ 414.502
Definitions.
*
*
*
*
*
Data collection period is the 6 months
from January 1 through June 30, during
which applicable information is
collected and that precedes the data
reporting period, except 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.
Data reporting period is the 3-month
period, January 1 through March 31,
during which a reporting entity reports
applicable information to CMS and that
follows the preceding data collection
period, except that for the data
collection period of January 1, 2019
through June 30, 2019, the data
reporting period is January 1, 2024
through March 31, 2024.
*
*
*
*
*
§ 414.504
[Amended]
43. Amend § 414.504 in paragraph
(a)(1) by removing the reference
‘‘January 1, 2023’’ and adding in its
place the reference ‘‘January 1, 2024’’.
■ 44. Section 414.507 is amended by—
■ a. Revising paragraph (d) introductory
text and paragraph (d)(6); and
■ b. Adding paragraph (d)(9).
The revisions and addition read as
follows:
■
§ 414.507 Payment for clinical diagnostic
laboratory tests.
*
*
*
*
*
(d) Phase-in of payment reductions.
For years 2018 through 2026, the
payment rates established under this
section for each CDLT that is not a new
ADLT or new CDLT, may not be
reduced by more than the following
amounts for—
*
*
*
*
*
(6) 2023—0.0 percent of the payment
rate established in 2022.
*
*
*
*
*
(9) 2026—15 percent of the payment
rate established in 2025.
*
*
*
*
*
§ 414.610
[Amended]
45. Amend § 414.610 in paragraphs
(c)(1)(ii) introductory text and (c)(5)(ii)
by removing the date ‘‘December 31,
2022’’ and adding in its place the date
‘‘December 31, 2024’’
■ 46. Section 414.902 is amended by
adding the definitions of ‘‘Applicable
five-year period’’, ‘‘Low volume dose’’,
‘‘New refund quarter’’, ‘‘Qualifying
biosimilar biological product’’, and
‘‘Updated refund quarter’’ in
alphabetical order to read as follows:
■
§ 414.902
*
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Definitions.
*
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*
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*
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52741
Applicable five-year period means:
(1) For a qualifying biosimilar
biological product for which payment
has been made under section
1847A(b)(8) of the Act as of September
30, 2022, the 5-year period beginning on
October 1, 2022; and
(2) For a qualifying biosimilar
biological product for which payment is
first made under section 1847A(b)(8) of
the Act during a calendar quarter during
the period beginning October 1, 2022
and ending December 31, 2027, the 5year period beginning on the first day of
such calendar quarter during which
such payment is first made.
*
*
*
*
*
Low volume dose means, with respect
to determination of whether an
increased applicable percentage is
warranted, an FDA-labeled dose of a
drug for which the volume removed
from the vial or container containing the
labeled dose does not exceed 0.4 mL.
*
*
*
*
*
New refund quarter means a calendar
quarter that is included in a report
described in § 414.940(a) that is sent in
the first year following the year in
which the calendar quarter occurs.
*
*
*
*
*
Qualifying biosimilar biological
product means a biosimilar biological
product (as described in section
1847A(b)(1)(C) of the Act) with an
average sales price (as described in
section 1847A(b)(8)(A)(i) of the Act) less
than the average sales price of the
reference biological for a calendar
quarter during the applicable 5-year
period.
*
*
*
*
*
Updated refund quarter means a
calendar quarter that is included in a
report described in § 414.940(a) that is
sent in the second year following the
year in which the calendar quarter
occurs.
*
*
*
*
*
■ 47. Section 414.904 is amended by
revising paragraphs (e)(4) and (j) to read
as follows:
§ 414.904 Average sales price as the basis
for payment.
*
*
*
*
*
(e) * * *
(4) Payment amount in a case where
the average sales price during the first
quarter of sales is unavailable. During
an initial period (not to exceed a full
calendar quarter) in which data on the
prices for sales of the drug are not
sufficiently available from the
manufacturer to compute an average
sales price:
(i) In general. Except as provided in
paragraph (e)(4)(ii) of this section,
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(A) For dates of service before January
1, 2019, the payment amount for the
drug is based on the wholesale
acquisition cost or the Medicare Part B
drug payment methodology in effect on
November 1, 2003.
(B) For dates of service on or after
January 1, 2019, the payment amount
for the drug is an amount not to exceed
103 percent of the wholesale acquisition
cost or based on the Medicare Part B
drug payment methodologies in effect
on November 1, 2003.
(ii) Limitation on payment amount for
biosimilar biological products during
initial period. For dates of service on or
after July 1, 2024, the payment amount
for a biosimilar biological product (as
defined in § 414.902) during the initial
period is the lesser of the following:
(A) The payment amount for the
biosimilar biological product as
determined under clause (e)(4)(i)(B) of
this section or
(B) 106 percent of the amount
determined under section
1847A(b)(1)(B) of the Act for the
reference biological product (as defined
in § 414.902).
*
*
*
*
*
(j) Biosimilar biological products—(1)
In general. Except as provided in
paragraph (j)(2), effective January 1,
2016, the payment amount for a
biosimilar biological product (as defined
in § 414.902), for all NDCs assigned to
such product, is the sum of the average
sales price of all NDCs assigned to the
biosimilar biological products included
within the same billing and payment
code as determined under section
1847A(b)(6) of the Act, and 6 percent of
the amount determined under section
1847A(b)(4) of the Act for the reference
biological product (as defined in
§ 414.902).
(2) Temporary increase in Medicare
Part B payment for qualifying biosimilar
biological products. In the case of a
qualifying biosimilar biological product
(as defined in § 414.902) that is
furnished during the applicable fiveyear period (as defined in § 414.902) for
such product, the payment amount for
such product with respect to such
period is the sum determined under as
determined under section 1847A(b)(6)
of the Act and 8 percent of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product (as defined in § 414.902).
■ 48. Section 414.940 is amended by—
■ a. Redesignating paragraph (a)(1)(iii)
as paragraph (a)(1)(iv).
■ b. Adding new paragraph (a)(1)(iii).
■ c. Revising paragraphs (a)(3), (b)(1)
and (2), (c), and (d);
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d. Redesignating paragraphs (e) and (f)
as paragraphs (f) and (g), respectively;
and
■ e. Adding new paragraph (e).
The revisions and additions read as
follows:
■
§ 414.940 Refund for certain discarded
single-dose container or single-use
package drugs.
(a) * * *
(1) * * *
(iii) Reports will include information
in paragraphs (a)(1)(i) and (ii) of this
section for new refund quarters and
updated refund quarters (as defined at
§ 414.902).
*
*
*
*
*
(3) Report Timing. Reports are sent
once annually.
(b) * * *
(1) Refund amounts for which the
manufacturer is liable, pursuant to this
paragraph, must be paid by December
31 of the year in which the report
described in paragraph (a) of this
section is sent, except that refund
amounts for which the manufacturer is
liable, pursuant to this paragraph, for
amounts in the initial report for
calendar quarters in 2023 must be paid
no later than February 28, 2025.
(2) In the case that a disputed report
results in a refund amount due, refund
amounts that the manufacturer is liable
for pursuant to this paragraph shall be
paid no later than the dates specified in
paragraph (b)(1) of this section or 30
days following the resolution of the
dispute, whichever is later.
*
*
*
*
*
(c) Refund amount. The amount of the
refund specified in this paragraph is
with respect to a refundable single-dose
container or single-use package drug of
a manufacturer assigned to a billing and
payment code (except as provided in
paragraph (c)(4) of this section) for:
(1) A new refund quarter (as defined
at § 414.902) beginning on or after
January 1, 2023, an amount equal to the
estimated amount (if any) by which:
(i) The product of the total number of
units of the billing and payment code
for such drug that were discarded
during such new refund 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 new refund quarter;
(ii) Exceeds an amount equal to the
applicable percentage of the estimated
total allowed charges for such drug for
the new refund quarter.
(2) The refund amount owed by a
manufacturer for an updated refund
quarter (as defined at § 414.902)
beginning on or after January 1, 2023, an
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amount equal to the estimated amount
(if any) by which:
(i) The product of the total number of
units of the billing and payment code
for such drug that were discarded
during such updated refund 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.
(ii) Exceeds the difference of:
(A) An amount equal to the applicable
percentage of the estimated total
allowed charges for such a drug during
the updated refund quarter; and
(B) The refund amount already paid
for such refundable drug for such
quarter.
(3) Negative refund amount for an
updated refund quarter. If the refund
amount described in paragraph (c)(2) of
this section is negative, the amount will
be netted from refunds owed for other
updated and new refund quarters
included in the same report as such
updated refund quarter.
(4) Exception when there are multiple
manufacturers. If there is more than one
manufacturer of a refundable singledose container or single-use package
drug for a quarter, the refund amount for
which a manufacturer is liable is an
amount equal to the estimated amount
(if any) by which—
(i) The product of the amount
calculated in paragraph (c)(1) of this
section and the percentage of billing
unit sales (of the applicable billing and
payment code attributed to the National
Drug Code; exceeds:
(ii) The product of the amount in
paragraph (c)(2) of this section and
percentage of billing unit sales of the
applicable billing and payment code
attributed to the National Drug Code.
(iii) The number of billing unit sales
for each NDC is 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.
(d) Applicable percentage. For
purposes of paragraph (c) of this section,
and except as provided in paragraph (e)
of this section, the applicable
percentage is:
(1) 10 percent, unless specified
otherwise in this section.
(2) 35 percent for a drug that is
reconstituted with a hydrogel and has
variable dosing based on patientspecific characteristics.
(3) 90 percent for a drug with a low
volume dose (as defined at § 414.902 of
this part) contained within 0.1 mL or
less.
(4) 45 percent for a drug with a low
volume dose (as defined in § 414.902 of
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this part) contained within 0.11 mL up
to 0.4 mL.
(5) 26 percent for a drug designated an
orphan drug under section 526 of the
Federal Food, Drug, and Cosmetic Act
for a rare disease or condition (or
diseases or conditions) and approved by
the FDA only for one or more
indications within such designated rare
disease or condition (or diseases or
conditions) and is furnished to fewer
than 100 unique beneficiaries per
calendar year.
(e) Application process for increased
applicable percentage. Manufacturers
may submit an application to CMS
requesting consideration of an increased
applicable percentage for purposes of
paragraph (c) of this section because of
the drug’s unique circumstances. The
process for submitting such an
application is as follows:
(1) Application. An application must
include:
(i) A written request that a drug be
considered for an increased applicable
percentage based on its unique
circumstances;
(ii) FDA-approved labeling;
(iii) Justification for the consideration
of an increased applicable percentage
based on such unique circumstances;
and
(iv) Justification for the requested
applicable percentage.
(2) Application timeline. An
application must 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.
(3) Application processing. Following
a review of timely applications, CMS
will summarize its analyses of
applications and propose appropriate
increases in rulemaking. If adopted, the
increased applicable percentage will be
the applicable percentage for purposes
of paragraph (c) beginning as of the
following January 1.
*
*
*
*
*
■ 49. Section 414.1305 is amended by—
■ a. In the definition of ‘‘Attestation’’,
by removing the term ‘‘MIPS eligible
clinician or group’’ and adding in its in
place the term ‘‘MIPS eligible clinician,
subgroup, or group’’.
■ b. In the definition of ‘‘Attributioneligible beneficiary’’, by revising
paragraph (6);
■ c. In the definition of ‘‘Certified
Electronic Health Record Technology
(CEHRT)’’, by revising paragraphs (2)
introductory text and (2)(ii), and adding
paragraph (3);
■ d. By revising the definition of
‘‘Collection type’’;
■ e. By adding the definition of
‘‘Qualified posting’’.
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f. In the definition of ‘‘Submitter
type’’, by removing the term ‘‘MIPS
eligible clinician, group, Virtual Group,
APM Entity, or third party
intermediary’’ and adding in its place
the term the ‘‘MIPS eligible clinician,
group, Virtual Group, subgroup, APM
Entity, or third party intermediary.’’
The revisions and addition read as
follows:
■
§ 414.1305
Definitions.
*
*
*
*
*
Attribution-eligible beneficiary * * *
*
*
*
*
*
(6) Has a minimum of one claim for
covered professional services furnished
by an eligible clinician who is on the
Participation List for an Advanced APM
Entity at any determination date during
the QP Performance Period.
*
*
*
*
*
Certified Electronic Health Record
Technology (CEHRT) * * *
*
*
*
*
*
(2) For 2019 and subsequent years,
EHR technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that meets the 2015 Edition Base EHR
definition, or subsequent Base EHR
definition (as defined in 45 CFR
170.102), and has been certified to the
ONC health IT certification criteria as
adopted and updated in 45 CFR
170.315—
*
*
*
*
*
(ii) Necessary to report on applicable
objectives and measures specified for
MIPS including the following:
*
*
*
*
*
(3) For purposes of determinations
under §§ 414.1415 and 414.1420,
beginning for CY 2024, EHR technology
(which could include multiple
technologies) certified under the ONC
Health IT Certification Program that
meets—
(i) The 2015 Edition Base EHR
definition, or subsequent Base EHR
definition (as defined in 45 CFR
170.102); and
(ii) Any such ONC health IT
certification criteria adopted or updated
in 45 CFR 170.315 that are determined
applicable for the APM, for the year,
considering factors such as clinical
practice area, promotion of
interoperability, relevance to reporting
on applicable quality measures, clinical
care delivery objectives of the APM, or
any other factor relevant to
documenting and communicating
clinical care to patients or their health
care providers in the APM.
*
*
*
*
*
Collection type means a set of quality
measures with comparable
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specifications and data completeness
criteria, as applicable, including, but not
limited to: Electronic clinical quality
measures (eCQMs); MIPS clinical
quality measures (MIPS CQMs); QCDR
measures; Medicare Part B claims
measures; CMS Web Interface measures
(except as provided in paragraph (1) of
this definition, for the CY 2017 through
CY 2022 performance periods/2019
through 2024 MIPS payment years); the
CAHPS for MIPS survey measure;
administrative claims measures; and
Medicare Clinical Quality Measures for
Accountable Care Organizations
Participating in the Medicare Shared
Savings Program (Medicare CQMs).
*
*
*
*
*
Qualified Posting means the
document made available that lists
qualified registries or QCDRs available
by CMS for use by MIPS eligible
clinicians, groups, subgroups, virtual
groups, and APM Entities.
*
*
*
*
*
■ 50. Section 414.1320 is amended by—
■ a. Revising paragraph (h) introductory
text; and
■ b. Adding paragraph (i).
The addition and revision read as
follow:
§ 414.1320
MIPS performance period.
*
*
*
*
*
(h) For purposes of the 2024 MIPS
payment year and the 2025 MIPS
payment year, the performance period
for:
*
*
*
*
*
(i) For purposes of the 2026 MIPS
payment year and each subsequent
payment year, the performance period
for:
(1) The Promoting Interoperability
performance category is a minimum of
a continuous 180-day period within the
calendar year that occurs 2 years prior
to the applicable MIPS payment year,
up to and including the full calendar
year.
(2) [Reserved]
■ 51. Section 414.1325 is amended by
revising paragraphs (a)(1), (c)
introductory text, and (d) to read as
follows.
§ 414.1325
Data submission requirements.
(a) * * *
(1) Except as provided in paragraph
(a)(2) of this section, or under
§ 414.1370 or § 414.1365(c), as
applicable, individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities must
submit data on measures and activities
for the quality, improvement activities,
and Promoting Interoperability
performance categories in accordance
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with this section. Except for the
Medicare Part B claims submission type,
the data may also be submitted on
behalf of the individual MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity by a third
party intermediary described at
§ 414.1400.
*
*
*
*
*
(c) Data submission types for groups,
virtual groups, subgroups, and APM
Entities. Groups, virtual groups,
subgroups, and APM Entities may
submit their MIPS data using:
*
*
*
*
*
(d) Use of multiple data submission
types. Beginning with the 2021 MIPS
payment year as applicable to MIPS
eligible clinicians, groups, and virtual
groups, beginning with the 2023 MIPS
payment year as applicable to APM
Entities, and beginning with the 2025
MIPS payment year as applicable to
subgroups, MIPS eligible clinicians,
groups, virtual groups, APM Entities,
and subgroups may submit their MIPS
data using multiple data submission
types for any performance category
described in paragraph (a)(1) of this
section, as applicable; provided,
however, that the MIPS eligible
clinician, group, virtual group, APM
Entity, or subgroup uses the same
identifier for all performance categories
and all data submissions.
■ 52. Section 414.1335 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(1)(i), (a)(1)(ii),
(a)(3) paragraph heading, and (a)(3)(i);
and
■ b. Adding paragraph (a)(4).
The revisions and additions read as
follows:
tkelley on DSK125TN23PROD with PROPOSALS2
§ 414.1335 Data submission criteria for the
quality performance category.
(a) Criteria. A MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity must submit data on MIPS
quality measures in one of the following
manners, as applicable:
(1) * * *
(i) Except as provided in paragraph
(a)(1)(ii) of this section, submits data on
at least six measures, including at least
one outcome measure. If an applicable
outcome measure is not available,
reports one other high priority measure.
If fewer than six measures apply to the
MIPS eligible clinician, group, virtual
group, or APM Entity, reports on each
measure that is applicable.
(A) For eCQMs, the submission of
data requires the utilization of CEHRT,
as defined at § 414.1305.
(B) [Reserved]
(ii) A MIPS eligible clinician, group,
virtual group, and APM Entity that
report on a specialty or subspecialty
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measure set, as designated in the MIPS
final list of quality measures established
by CMS through rulemaking, must
submit data on at least six measures
within that set, including at least one
outcome measure. If an applicable
outcome measure is not available, report
one other high priority measure. If the
set contains fewer than six measures or
if fewer than six measures within the set
apply to the MIPS eligible clinician,
group, virtual group, or APM Entity,
report on each measure that is
applicable.
(A) For eCQMs, the submission of
data requires the utilization of CEHRT,
as defined at § 414.1305.
(B) [Reserved]
*
*
*
*
*
(3) For the CAHPS for MIPS survey
measure. (i) For the 12-month
performance period, a group, virtual
group, subgroup, or APM Entity that
participates in the CAHPS for MIPS
survey must use a survey vendor that is
approved by CMS for the applicable
performance period to transmit survey
measures data to CMS.
*
*
*
*
*
(4) For Medicare CQMs. (i) A MIPS
eligible clinician, group, and APM
Entity reporting on the Medicare CQMs
(reporting quality data on beneficiaries
eligible for Medicare CQMs as defined
at § 425.20) within the APP measure set
and administering the CAHPS for MIPS
Survey as required under the APP.
(ii) [Reserved]
*
*
*
*
*
■ 53. Section 414.1340 is amended by—
■ a. Revising paragraph (a) introductory
text;
■ b. Adding paragraphs (a)(2)(i) and
(a)(3)(i) and (ii);
■ c. Revising paragraph (a)(4);
■ d. Adding paragraph (a)(5);
■ e. Revising paragraph (b) introductory
text;
■ f. Adding paragraphs (b)(2)(i) and (ii)
and (b)(3)(i) and (ii);
■ g. Revising paragraph (b)(4);
■ h. Adding paragraph (b)(5);
■ i. Revising paragraph (d); and
■ j. Adding paragraph (e).
The revisions and additions read as
follows:
§ 414.1340 Data completeness criteria for
the quality performance category.
(a) MIPS eligible clinicians, groups,
virtual groups, subgroups, and APM
Entities submitting quality measures
data on QCDR measures, MIPS CQMs,
or eCQMs must submit data on:
*
*
*
*
*
(2) At least 60 percent of the MIPS
eligible clinician, group, and virtual
group’s patients that meet the measure’s
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denominator criteria, regardless of payer
for MIPS payment years 2020 and 2021.
(3) At least 70 percent of the MIPS
eligible clinician, group, and virtual
group’s patients that meet the measure’s
denominator criteria, regardless of payer
for MIPS payment years 2022, 2023,
2024, and 2025.
(i) Applicable to an APM Entity for
MIPS payment years 2023, 2024, and
2025.
(ii) Applicable to a subgroup for MIPS
payment year 2025.
(4) At least 75 percent of the MIPS
eligible clinician, group, virtual group,
subgroup, and APM Entity’s patients
that meet the measure’s denominator
criteria, regardless of payer for MIPS
payment years 2026, 2027, and 2028.
(5) At least 80 percent of the MIPS
eligible clinician, group, virtual group,
subgroup, or and APM Entity’s patients
that meet the measure’s denominator
criteria, regardless of payer for MIPS
payment year 2029.
(b) MIPS eligible clinicians, groups,
virtual groups, subgroups, and APM
Entities submitting quality measure data
on Medicare Part B claims measures
must submit data on:
*
*
*
*
*
(2) * * *
(i) Applicable to virtual groups
starting with MIPS payment year 2020.
(ii) [Reserved]
(3) * * *
(i) Applicable to APM Entities starting
with MIPS payment year 2023 and
subgroups starting with MIPS payment
year 2025.
(ii) [Reserved].
*
*
*
*
*
(4) At least 75 percent of the
applicable Medicare Part B patients seen
during the performance period to which
the measure applies for MIPS payment
years 2026, 2027, and 2028.
(5) At least 80 percent of the
applicable Medicare Part B patients seen
during the performance period to which
the measure applies for MIPS payment
year 2029.
*
*
*
*
*
(d) APM Entities, specifically
Medicare Shared Savings Program
Accountable Care Organizations
meeting reporting requirements under
the APP, submitting quality measure
data on Medicare CQMs must submit
data on:
(1) At least 75 percent of the
applicable beneficiaries eligible for the
Medicare CQM, as defined at § 425.20,
who meet the measure’s denominator
criteria for MIPS payment years 2026,
2027, and 2028.
(2) At least 80 percent of the
applicable beneficiaries eligible for the
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Medicare CQM, as defined at § 425.20,
who meet the measure’s denominator
criteria for MIPS payment year 2029.
(e) If quality data are submitted
selectively such that the submitted data
are unrepresentative of a MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity’s performance,
any such data would not be true,
accurate, or complete for purposes of
§ 414.1390(b) or § 414.1400(a)(5).
■ 54. Section 414.1350 is amended by
revising paragraphs (c)(4) through (6)
and adding paragraph (c)(7) to read as
follows:
§ 414.1350
Cost performance category.
*
*
*
*
*
(c) * * *
(4) For the procedural episode-based
measures specified beginning with and
after the CY 2019 performance period/
2021 MIPS payment year, the case
minimum is 10, unless otherwise
specified for individual measures.
Beginning with the CY 2022
performance period/2024 MIPS
payment year, the case minimum for
Colon and Rectal Resection procedural
episode-based measure is 20 episodes.
(5) For the acute inpatient medical
condition episode-based measures
specified beginning with and after CY
2019 performance period/2021 MIPS
payment year, the case minimum is 20,
unless otherwise specified for
individual measures.
(6) For the chronic condition episodebased measures specified beginning
with and after the CY 2022 performance
period/2024 MIPS payment year, the
case minimum is 20, unless otherwise
specified for individual measures.
(7) For the care setting episode-based
measures specified beginning with and
after the CY 2024 performance period/
2026 MIPS payment year, the case
minimum is 20, unless otherwise
specified for individual measures.
*
*
*
*
*
■ 55. Section 414.1360 is amended by
revising paragraph (a) introductory text
to read as follows:
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§ 414.1360 Data submission criteria for the
improvement activities performance
category.
(a) For purposes of the transition year
of MIPS and future years, MIPS eligible
clinicians, subgroups, or groups must
submit data on MIPS improvement
activities in one of the following
manners:
*
*
*
*
*
■ 56. Section 414.1365 is amended by—
■ a. Revising paragraphs (e)(2)(ii)
introductory text and (e)(3); and
■ b. Adding paragraphs (e)(4)(i) and (ii).
The revisions and addition read as
follow:
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§ 414.1365
MIPS Value Pathways.
*
*
*
*
*
(e) * * *
(2) * * *
(ii) Subgroups. For an MVP
Participant that is a subgroup, any
reweighting applied to its affiliated
group will also be applied to the
subgroup. In addition, for the CY 2023
performance period/2025 MIPS
payment year, if reweighting is not
applied to the affiliated group, the
subgroup may receive reweighting in
the following circumstances
independent of the affiliated group:
*
*
*
*
*
(3) Facility-based scoring. If an MVP
Participant, that is not an APM Entity or
a subgroup, is eligible for facility-based
scoring, a facility-based score also will
be calculated in accordance with
§ 414.1380(e).
(4) * * *
(i) For subgroups, the affiliated
group’s complex patient bonus will be
added to the final score.
(ii) [Reserved]
■ 57. Section 414.1375 is amended by
revising paragraph (b)(2)(ii)(C), and
adding paragraph (b)(2)(ii)(D) to read as
follows:
§ 414.1375 Promoting Interoperability (PI)
performance category.
*
*
*
*
*
(A) * * *
(B) * * *
(C) Beginning with the 2024 MIPS
payment year through the 2025 MIPS
payment year, submit an attestation,
with either an affirmative or negative
response, with respect to whether the
MIPS eligible clinician completed the
annual self-assessment under the
SAFER Guides measure during the year
in which the performance period
occurs.
(D) Beginning with the 2026 MIPS
payment year, submit an affirmative
attestation regarding the MIPS eligible
clinician’s completion of the annual
self-assessment under the SAFER
Guides measure during the year in
which the performance period occurs.
*
*
*
*
*
■ 58. Section 414.1380 is amended by—
■ a. Revising paragraphs (a)(1)(i) and
(ii), (b)(1)(v)(A), (b)(2)(iv)(A), (B), (C)
and (E), (b)(3)(i), and (c)(2)(i)(A)(4)(iii);
■ b. Adding paragraphs (c)(2)(iv);
■ c. In paragraph (c)(3)(v) removing the
term ‘‘MIPS eligible clinicians, groups,
subgroups, APM Entities and virtual
groups’’ and adding in its place the term
‘‘MIPS eligible clinicians, groups, APM
Entities and virtual groups;’’ and
■ d. In paragraph (c)(3)(vi) removing the
term ‘‘MIPS eligible clinicians, groups,
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52745
and subgroups’’ and adding in its place
the term ‘‘MIPS eligible clinicians and
groups’’.
The revisions and additions read as
follow:
§ 414.1380
Scoring.
(a) * * *
(1) * * *
(i) For the quality performance
category, measures are scored between
zero and 10 measure achievement
points. Performance is measured against
benchmarks. Prior to the CY 2023
performance period/2025 MIPS
payment year, measure bonus points are
available for submitting high-priority
measures and submitting measures
using end-to-end electronic reporting.
Measure bonus points are available for
small practices that submit data on at
least 1 quality measure. Beginning with
the 2020 MIPS payment year,
improvement scoring is available in the
quality performance category.
(ii) For the cost performance category,
measures are scored between 1 and 10
points. Performance is measured against
a benchmark. Beginning with the 2025
MIPS payment year, improvement
scoring is available in the cost
performance category.
*
*
*
*
*
(b) * * *
(1) * * *
(v) * * *
(A) High priority measures. Subject to
paragraph (b)(1)(v)(A)(1) of this section,
for the CY 2017 through 2021 MIPS
performance periods/2019 through 2023
MIPS payment years, MIPS eligible
clinicians receive 2 measure bonus
points for each outcome and patient
experience measure and 1 measure
bonus point for each other high priority
measure. Beginning in the 2021 MIPS
payment year, MIPS eligible clinicians
do not receive such measure bonus
points for CMS Web Interface measures.
Beginning in the 2022 performance
period/2024 MIPS payment year, MIPS
eligible clinicians will no longer receive
these measure bonus points.
*
*
*
*
*
(2) * * *
(iv) * * *
(A) The cost improvement score is
determined at the category level for the
cost performance category.
(B) The cost improvement score is
calculated only when data sufficient to
measure improvement are available.
Sufficient data are available when a
MIPS eligible clinician or group
participates in MIPS using the same
identifier in 2 consecutive performance
periods and is scored on the cost
performance category for 2 consecutive
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performance periods. If the cost
improvement score cannot be calculated
because sufficient data are not available,
then the cost improvement score is zero.
(C) The cost improvement score is
determined at the category-level by
subtracting the cost performance
category score from the previous
performance period from the cost
performance category percent score
from the current performance period,
and then by dividing the difference by
the cost performance category score
from the previous performance period,
and by dividing by 100.
*
*
*
*
*
(E) The maximum cost improvement
score for the 2020, 2021, 2022, 2023,
and 2024 MIPS payment year is zero
percentage points. The maximum cost
improvement score beginning with the
2025 MIPS payment year is 1 percentage
point.
*
*
*
*
*
(3) * * *
(i) For MIPS eligible clinicians
participating in APMs, the improvement
activities performance category score is
at least 50 percent. MIPS eligible
clinicians participating in APMs must
attest to having completed an
improvement activity or submit data for
the quality and Promoting
Interoperability performance categories
in order to receive such credit.
*
*
*
*
*
(c) * * *
(2) * * *
(i) * * *
(A) * * *
(4) * * *
(iii) For the 2024 through 2026 MIPS
payment years, the MIPS eligible
clinician is a clinical social worker. In
the event that a MIPS eligible clinician
submits data for the Promoting
Interoperability performance category,
the scoring weight specified in
paragraph (c)(1) of this section will be
applied and its weight will not be
distributed.
*
*
*
*
*
(iv) If CMS has granted an application
for a hardship exception or any other
type of exception to a MIPS eligible
clinician under paragraph (c)(2)(i)(A)(6)
or (c)(2)(i)(C)(2) of this section, or has
identified a MIPS eligible clinician in a
CMS-designated region as being affected
by an automatic extreme and
uncontrollable circumstances event
under paragraph (c)(2)(i)(A)(8) or
(c)(2)(i)(C)(3) of this section, CMS will
not apply the improvement activities
score described in paragraph (b)(3)(i) of
this section to the MIPS eligible
clinician’s score.
*
*
*
*
*
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59. Section 414.1385 is amended—
a. In paragraph (a) by removing the
term ‘‘MIPS eligible clinician or group’’
and adding in its in place the term
‘‘MIPS eligible clinician, virtual group,
subgroup or group;’’
■ b. In paragraph (a)(1) by removing the
term ‘‘MIPS eligible clinician or group’’
and adding in its place the term ‘‘MIPS
eligible clinician, virtual group,
subgroup, or group;’’
■ c. By revising paragraph (a)(2);
■ d. In paragraph (a)(3) by removing the
term ‘‘MIPS eligible clinician or group’’
and adding in its place the term ‘‘MIPS
eligible clinician, virtual group,
subgroup, group;’’
■ e. By revising paragraph (a)(5); and
■ f. In paragraph (a)(6) by removing the
term ‘‘MIPS eligible clinician or group’’
and adding in its place the term ‘‘MIPS
eligible clinician, virtual group,
subgroup, or group’’.
The revisions read as follows:
■
■
§ 414.1385 Targeted review and review
limitations.
(a) * * *
(2) All requests for targeted review
must be submitted during the targeted
review request submission period,
which begins on the day CMS makes
available the MIPS final score, and ends
30 days after publication of the MIPS
payment adjustment factors for the
MIPS payment year. The targeted review
request submission period may be
extended as specified by CMS.
*
*
*
*
*
(5) A request for a targeted review
may include additional information in
support of the request at the time it is
submitted. If CMS requests additional
information from the MIPS eligible
clinician, subgroup, virtual group, or
group that is the subject of a request for
a targeted review, the information must
be provided and received by CMS
within 15 days of CMS’ request. Nonresponsiveness to CMS’ request for
additional information may result in a
final decision based on the information
available, although another nonduplicative request for targeted review
may be submitted before the end of the
targeted review request submission
period.
*
*
*
*
*
■ 60. Section 414.1400 is amended by—
■ a. Revising paragraphs (a)(1)(iii),
(a)(2)(i), (a)(2)(ii)(A), (a)(3), and (b)(1)(ii);
■ b. Adding paragraphs (b)(1)(iii);
■ c Revising paragraphs (b)(2),
(b)(3)(v)(E)(1) and (2);
■ d. Adding paragraphs (b)(3)(ix)
through (xvii);
■ e. Revising paragraph (b)(4)(i)(B);
■ f. Adding paragraphs (b)(4)(i)(C) and
(b)(4)(iv)(O) and (P);
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g. Revising paragraph (e)(1)
introductory text;
■ h. Adding paragraph (e)(1)(i)(F);
■ i. Revising paragraph (e)(1)(ii);
■ j. Adding paragraphs (e)(2)(iv) and (v);
■ k. Revising paragraphs (e)(3) and (4)
and (f).
The additions and revisions read as
follows:
■
§ 414.1400
Third party intermediaries.
(a)* * *
(1)* * *
(iii) Before the CY 2025 performance
period/2027 payment year, Health IT
vendor;
*
*
*
*
*
(2) * * *
(i) To be approved as a third party
intermediary, an organization must meet
the following requirements:
(A) The organization’s principal place
of business and the location in which it
stores data must be in the U.S.
(B) The organization must have the
ability to indicate the source of any data
it will submit to CMS if the data will be
derived from CEHRT, a QCDR, qualified
registry, or health IT vendor.
(C) The organization must certify that
it intends to provide services
throughout the entire performance
period and applicable data submission
period.
(ii) * * *
(A) Whether the organization failed to
comply with the requirements of this
section for any prior MIPS payment year
for which it was approved as third party
intermediary, including past
compliance; and
*
*
*
*
*
(3) For third-party intermediary
program requirements:
(i) All data submitted to CMS by a
third party intermediary on behalf of a
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity must be
certified by the third party intermediary
as true, accurate, and complete to the
best of its knowledge. Such certification
must be made in a form and manner and
at such time as specified by CMS.
(ii) All data submitted to CMS by a
third party intermediary must be
submitted in the form and manner
specified by CMS.
(A) The submission of data on
measures by a third party intermediary
to CMS must include data on all of the
MIPS eligible clinician’s patients,
regardless of payer, unless otherwise
specified by the collection type.
(B) [Reserved]
(iii) If the clinician chooses to opt-in
to participate in MIPS in accordance
with § 414.130, the third party
intermediary must be able to transmit
that decision to CMS.
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(iv) Prior to discontinuing services to
any MIPS eligible clinician, group,
virtual group, subgroup, or APM Entity
during a performance period, a third
party intermediary must support the
transition of such MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity to an alternate
third party intermediary, submitter type,
or, for any measure on which data has
been collected, collection type
according to a CMS approved transition
plan by a date specified by CMS. The
transition plan must address the
following issues, unless different or
additional information is specified by
CMS:
(A) The issues that contributed to the
withdrawal mid-performance period or
discontinuation of services midperformance period.
(B) Impacted entities:
(1) The number of clinicians, groups,
virtual groups, subgroups or APM
entities (inclusive of MIPS eligible, optin and voluntary participants) that
would need to find another way to
report.
(2) As applicable, identify any QCDRs
that were granted licenses to QCDR
measures which would no longer be
available for reporting due to the
transition.
(C) The steps the third party
intermediary will take to ensure that the
clinicians, groups, virtual groups,
subgroups, or APM Entities identified in
paragraph (a)(3)(iv)(B)(1) of this section
are notified of the transition in a timely
manner, and successfully transitioned to
an alternate third party intermediary,
submitter type, or, for any measure or
activity on which data has been
collected, collection type, as applicable.
(D) A detailed timeline that outlines
timing for communications, the start of
the transition, and completion of the
transition of these clinicians, groups,
virtual groups, subgroups, or APM
Entities.
(E) The third party intermediary must
communicate to CMS that the transition
was completed by the date included in
the detailed timeline.
(v) As a condition of its qualification
and approval to participate in MIPS as
a third party intermediary, a third party
intermediary must:
(A) Make available to CMS the contact
information of each MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity on behalf of
whom it submits data. The contact
information must include, at a
minimum, the MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity phone number, address, and, if
available, email.
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(B) Retain all data submitted to CMS
for purposes of MIPS for 6 years from
the end of the MIPS performance
period.
(C) Upon request, provide CMS with
any records or data retained in
connection with its operation as a third
party intermediary for up to 6 years
from the end of the MIPS performance
period.
(vi) Beginning with the 2023 MIPS
payment year, third party intermediaries
must attend and complete training and
support sessions in the form and
manner, and at the times, specified by
CMS.
(b) * * *
(1) * * *
(ii) Beginning with the CY 2023
performance period/2025 MIPS
payment year, QCDRs and qualified
registries must support MVPs that are
applicable to the MVP participant on
whose behalf they submit MIPS data.
QCDRs and qualified registries may also
support the APP. A QCDR or qualified
registry must support all measures and
activities included in the MVP with the
following exceptions:
(A) If an MVP is intended for
reporting by multiple specialties, a
QCDR or a qualified registry are
required to report those measures
pertinent to the specialty of its MIPS
eligible clinicians.
(B) If an MVP includes a QCDR
measure, it is not required to be
reported by a QCDR other than the
measure owner.
(iii) Beginning with the CY 2023
performance period/2025 MIPS
payment year, A QCDR or qualified
registry must support subgroup
reporting.
(2) Self-nomination. For the CY 2019
performance period/2021 MIPS
payment year and future years, an
existing QCDR or qualified registry that
is in good standing may use the
Simplified Self-Nomination process
form during the self-nomination period,
from July 1 and September 1 of the CY
preceding the applicable performance
period.
(3) * * *
(v) * * *
(E) * * *
(1) Uses a sample size of at least 3
percent of a combination of the
individual MIPS eligible clinicians,
groups, virtual groups, subgroups and
APM entities for which the QCDR or
qualified registry will submit data to
CMS, except that the sample size may
be no fewer than a combination of 10
individual clinicians, groups, virtual
groups, subgroups and APM entities, no
more than a combination of 50
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individual clinicians, groups, virtual
groups, subgroups and APM entities.
(2) Uses a sample that includes at
least 25 percent of the patients of each
individual clinician, group, virtual
group, subgroup or APM entity in the
sample, except that the sample for each
individual clinician, group, virtual
group, subgroup or APM entity must
include a minimum of 5 patients and
need not include more than 50 patients.
*
*
*
*
*
(ix) During the self-nomination
period, a QCDR or a qualified registry
must submit to CMS quality measure
numbers, Promoting Interoperability
identifiers, improvement activity
identifiers and MVP titles.
(x) A QCDR or a qualified registry
must be able to submit to CMS data for
at least six quality measures including
at least one outcome measure.
(A) If no outcome measure is
available, a QCDR or qualified registry
must be able to submit to CMS results
for at least one other high priority
measure.
(B) [Reserved]
(xi) A QCDR or a qualified registry
must submit to CMS risk-adjusted
measure results when submitting data
for measures that include risk
adjustment in the measure specification.
(xii) A QCDRs or qualified registry
must enter into appropriate Business
Associate Agreements with MIPS
eligible clinicians to collect and process
their data.
(xiii) A QCDR or a qualified registry
must maintain records of their
authorization to submit data to CMS for
the purpose of MIPS participation for
each NPI whom the QCDR or qualified
registry will submit data to CMS for.
The records must:
(A) Be annually obtained by the
QCDR or qualified registry at the time
the clinician or group enters into an
agreement with the QCDR or qualified
registry for the submission of MIPS data
to the QCDR or qualified registry.
(B) Be signed by an eligible clinician,
if reporting individually, or by an
authorized representative of the
reporting group, subgroup, Virtual
Group, or APM Entity.
(C) Records of the authorization must
be maintained for 6 years after the
performance period ends.
(xiv) A QCDR or a qualified registry
must attest that the information listed
on the qualified posting is accurate.
(xv) A QCDR or a qualified registry
must provide to CMS, upon request, the
data submitted by the QCDR or qualified
registry for purposes of MIPS.
(xvi) A QCDR or qualified registry
must attest to the following:
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(A) A QCDR or a qualified registry
must attest that it has required each
MIPS eligible clinician on whose behalf
it reports to provide the QCDR or
qualified registry with all
documentation necessary to verify the
accuracy of the data on quality measures
that the eligible clinician submitted to
the QCDR or qualified registry.
(B) A QCDR or qualified registry must
also attest that it has required each
MIPS eligible clinician to permit the
QCDR or qualified registry to provide
the information described in paragraph
(b)(3)(xviii)(A) of this section to CMS
upon request.
(xvii) A QCDR or a qualified registry
must accept and maintain clinician data
by January 1 of the applicable
performance period.
(4) * * *
(i) * * *
(B) For a QCDR measure, the entity
must submit for CMS approval measure
specifications including: Name/title of
measure, descriptions of the
denominator, numerator, and when
applicable, denominator exceptions,
denominator exclusions, risk
adjustment variables, and risk
adjustment algorithms. In addition, no
later than 15 calendar days following
CMS posting of all approved
specifications for a QCDR measure, the
entity must publicly post the CMSapproved measure specifications for the
QCDR measure (including the CMSassigned QCDR measure ID) and provide
CMS with a link to where this
information is posted. The approved
QCDR measure specifications must
remain published through the
performance period and data
submission period.
(C) For a QCDR measure, the QCDR
must provide, if available, data from
years prior before the start of the
performance period.
*
*
*
*
*
(iv) * * *
(O) QCDR measures submitted after
self-nomination.
(P) More than 30 QCDR measures are
submitted by a single QCDR.
*
*
*
*
*
(e) * * *
(1) If CMS determines that a third
party intermediary has ceased to meet
one or more of the applicable criteria for
approval, failed to comply with the
program requirements of this section,
has submitted a false certification under
paragraph (a)(3) of this section, or has
submitted data that are inaccurate,
unusable, or otherwise compromised,
CMS may take one or more of the
following remedial actions after
providing written notice to the third
party intermediary:
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(i) * * *
(F) Once the issue has been resolved,
the detailed final resolution and an
update, if any, to the monitoring plan
provided pursuant to
§ 414.1400(e)(1)(i)(C).
(ii) Publicly disclose as follows:
(A) For the purposes of the CY 2025
performance period/2027 MIPS
payment year and prior reporting
periods and payment years, publicly
disclose the entity’s data error rate on
the CMS website until the data error rate
falls below 3 percent.
(B) Beginning with the CY 2025
performance period/2027 MIPS
payment year, publicly disclose on the
CMS website that CMS took remedial
action against or terminated the third
party intermediary.
(2) * * *
(iv) The third party intermediary has
not maintained current contact
information for correspondence.
(v) The third party intermediary is on
remedial action for two consecutive
years.
(3) A data submission that contains
data inaccuracies affecting the third
party intermediary’s clinicians may lead
to remedial action/termination of the
third party intermediary for future
program year(s) based on CMS
discretion.
(4) For purposes of this paragraph (e),
CMS may determine that submitted data
are inaccurate, unusable, or otherwise
compromised, if the submitted data
includes, without limitation, TIN/NPI
mismatches, formatting issues,
calculation errors, or data audit
discrepancies.
*
*
*
*
*
(f) Auditing of entities submitting
MIPS data. Third party intermediaries
may be randomly selected for
compliance evaluation or may be
selected at the suggestion of CMS if
there is an area of concern regarding the
third party intermediary. For example,
areas of concern could include, but are
not limited to: high data errors, support
call absences, delinquent deliverables,
remedial action status, clinician
concerns regarding the third party
intermediary, a continuing pattern of
Quality Payment Program Service
Center inquiries or support call
questions, and/or CMS concerns
regarding the third party intermediary.
■ 61. Section 414.1405 is amended by—
■ a. Adding paragraphs (b)(9)(iii); and
■ b. Revising paragraph (g).
The addition and revision read as
follows:
§ 414.1405
*
Payment.
*
*
(b) * * *
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*
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*
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(9) * * *
(iii) The performance threshold for
2026 MIPS payment year is 82 points.
The prior period to determine the
performance threshold is the 2019
through 2021 MIPS payment years.
*
*
*
*
*
(g) Performance threshold
methodology. (1) For each of the 2024,
2025, and 2026 MIPS payment years,
the performance threshold is the mean
of the final scores for all MIPS eligible
clinicians from a prior period as
specified under paragraph (b) of this
section.
(2) For purposes of establishing a
performance threshold as identified in
§ 414.1405(b), beginning with the 2026
MIPS payment year, a prior period is a
time span of three performance periods.
■ 62. Section 414.1415 is amended by
revising paragraph (a) to read as follows:
§ 414.1415
Advanced APM criteria.
(a) Use of certified electronic health
record technology (CEHRT)—(1)
Required use of CEHRT. To be an
Advanced APM, an APM must:
(i) For QP Performance Periods
ending with 2018, require at least 50
percent, or for QP Performance Periods
beginning with 2019 and ending with
2023, 75 percent, of eligible clinicians
in each participating APM Entity group,
or for APMs in which hospitals are the
APM Entities, each hospital, to use
CEHRT to document and communicate
clinical care to their patients or health
care providers;
(ii) For QP Performance Periods prior
to 2019, for the Shared Savings Program,
apply a penalty or reward to an APM
Entity based on the degree of the use of
CEHRT of the eligible clinicians in the
APM Entity; and
(iii) For QP Performance Periods
beginning with 2024, require use of
CEHRT as defined at paragraph (3)
under CEHRT at § 414.1305.
(2) [Reserved].
*
*
*
*
*
■ 63. Section 414.1420 is amended by
revising paragraph (b) to read as follows:
§ 414.1420
criteria.
Other payer advanced APM
*
*
*
*
*
(b) Use of CEHRT. To be an Other
Payer Advanced APM:
(1) CEHRT must be used, for QP
Performance Periods ending with 2019,
by at least 50 percent; and for QP
Performance Periods for 2020 through
2023, by at least 75 percent, of
participants in each participating APM
Entity group, or each hospital if
hospitals are the APM Entities, in the
other payer arrangement to document
and communicate clinical care; and
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(2) For QP Performance Periods
beginning on or after January 1, 2024,
use of CEHRT (as defined in § 414.1305,
paragraph (3) in the definition of
‘‘Certified Electronic Health Record
Technology (CEHRT)’’), must be a
requirement of participation in the
APM.
*
*
*
*
*
■ 64. Section 414.1425 is amended by
adding paragraph (b)(3) to read as
follows:
§ 414.1425 Qualifying APM participant
determination: In general.
*
*
*
*
(b) * * *
(3) Individual QP determinations. For
QP Performance Periods beginning for
calendar year 2024, except as provided
in paragraph (b)(2) of this section and in
§ 414.1440, QP determinations are made
individually at the eligible clinician
level. To be assessed as a QP, an eligible
clinician’s APM participant identifier
must be included on the Participation
List of an APM Entity participating in
an Advanced APM on one of the
following dates during the QP
Performance Period: March 31, June 30,
or August 31. An eligible clinician
included on such a Participation List on
any one of these dates is assessed as a
QP even if the eligible clinician is not
included on the Participation List at one
of the prior or later listed dates. CMS
performs QP determinations for the
identified eligible clinicians during the
QP Performance Period using claims
data for services furnished from January
1 through each of the respective QP
determination dates for which the
eligible clinician is included on the
Participation List: March 31, June 30,
and August 31.
*
*
*
*
*
■ 65. Section 414.1430 is amended by—
■ a. Revising paragraph (a)(1)(iv);
■ b. Adding paragraph (a)(1)(v);
■ c. Revising paragraph (a)(2)(iv);
■ d. Adding paragraph (a)(2)(v);
■ e. Revising paragraph (a)(3)(iv);
■ f. Adding paragraph (a)(3)(v);
■ g. Revising paragraph (a)(4)(iv);
■ h. Adding paragraph (a)(4)(v); and
■ i. Revising paragraph (b)(1)(i)(A) and
(B), (b)(2)(i)(A) and (B), (b)(3)(i)(A) and
(B), (b)(4)(i)(A) and (B).
The revisions and additions read as
follows:
tkelley on DSK125TN23PROD with PROPOSALS2
*
§ 414.1430 Qualifying APM participant
determination: QP and partial QP
thresholds.
(a) * * *
(1) * * *
(iv) 2025: 50 percent.
(v) 2026 and later: 75 percent.
(2) * * *
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(iv) 2025: 40 percent.
(v) 2026 and later: 50 percent.
(3) * * *
(iv) 2025: 35 percent.
(v) 2026 and later: 50 percent.
(4) * * *
(iv) 2025: 25 percent.
(v) 2026 and later: 35 percent.
(b) * * *
(1) * * *
(i) * * *
(A) 2021 through 2025: 50 percent.
(B) 2026 and later: 75 percent.
*
*
*
*
*
(2) * * *
(i) * * *
(A) 2021 through 2025:40 percent.
(B) 2026 and later: 50 percent.
*
*
*
*
*
(3) * * *
(i) * * *
(A) 2021 through 2025: 35 percent.
(B) 2026 and later: 50 percent.
*
*
*
*
*
(4) * * *
(i) * * *
(A) 2021 through 2025: 25 percent.
(B) 2026 and later: 35 percent.
*
*
*
*
*
■ 66. Section 414.1450 is amended by—
■ a. Adding paragraphs (a)(1)(i) and (ii);
and
■ b. Revising paragraph (b)(1).
The addition and revision read as
follows:
§ 414.1450
APM incentive payment.
(a) * * *
(i) For payment years 2019 through
2025, CMS makes a lump sum payment
to QPs in the amount described in
paragraph (b) of this section in the
manner described in paragraphs (d) and
(e) of this section.
(ii) [Reserved]
*
*
*
*
*
(b) * * *
(1) For payment years 2019 through
2024, the amount of the APM Incentive
Payment is equal to 5 percent or, with
respect to payment year 2025, 3.5
percent of the estimated aggregate
payments for covered professional
services as defined in section
1848(k)(3)(A) of the Act furnished
during the calendar year immediately
preceding the payment year. CMS uses
the paid amounts on claims for covered
professional services to calculate the
estimated aggregate payments on which
CMS will calculate the APM Incentive
Payment.
*
*
*
*
*
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PART 415—SERVICES FURNISHED BY
PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN
TEACHING SETTINGS, AND
RESIDENTS IN CERTAIN SETTINGS
67. The authority for part 415
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
§ 415.140
[Amended]
68. In § 415.140 in paragraph (a)
amend the definition of ‘‘Substantive
portion’’ by removing the reference
‘‘year 2022 and 2023’’ and adding in its
place the reference ‘‘years 2022 through
2024’’.
■
PART 418—HOSPICE CARE
69. The authority citation for part 418
continues to read as follow:
■
Authority: 42 U.S.C. 1302 and 1395hh.
70. Section 418.56 is amended by
revising paragraph (a)(1)(iii) to read as
follows:
■
§ 418.56 Condition of participation:
Interdisciplinary group, care planning, and
coordination of services.
*
*
*
*
*
(a) * * *
(1) * * *
(iii) A social worker, marriage and
family therapist, or a mental health
counselor, depending on the preferences
and needs of the patient.
*
*
*
*
*
■ 71. Section 418.114 is amended by
adding paragraphs (c)(3) and (4) to read
as follows:
§ 418.114 Condition of participation:
Personnel qualifications.
*
*
*
*
*
(c) * * *
(3) Marriage and family counselor as
defined at § 410.53.
(4) Mental health counselor as defined
at § 410.54.
*
*
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*
PART 422—MEDICARE ADVANTAGE
PROGRAM
72. The authority citation for part 422
is revised to read as follows:
■
Authority: 42 U.S.C. 1302, 1306, 1395w–
22 through 1395w–28, and 1395hh.
73. Section 422.310 is amended by
adding paragraph (f)(3)(iv) to read as
follows:
■
§ 422.310
Risk adjustment data.
*
*
*
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*
(f) * * *
(3) * * *
(iv) CMS determines that releasing
aggregated data before reconciliation is
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necessary and appropriate to support
activities or authorized uses under
paragraph (f)(1)(vii) of this section.
*
*
*
*
*
PART 424—CONDITIONS FOR
MEDICARE PAYMENT
76. The authority for part 424
continues to read as follows:
■
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
Authority: 42 U.S.C. 1302 and 1395hh.
74. The authority citation for part 423
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1306, 1395w–
101 through 1395w–152, and 1395hh.
75. Section 423.160 is amended by—
a. Revising paragraph (a)(5)
introductory text;
■ b. Removing paragraph (a)(5)(i);
■ c. Redesignating paragraphs (a)(5)(ii)
through (iv) as paragraphs (a)(5)(i)
through (iii), respectively and revising
newly redesignated paragraph (a)(5)(ii).
The revisions read as follows:
■
■
tkelley on DSK125TN23PROD with PROPOSALS2
§ 423.160 Standards for electronic
prescribing.
(a) * * *
(5) Beginning on January 1, 2021,
prescribers must, except in the
circumstances described in paragraphs
(a)(5)(i) through (iii) of this section,
conduct prescribing for at least 70
percent of their Schedule II, III, IV, and
V controlled substances that are Part D
drugs electronically using the applicable
standards in paragraph (b) of this
section, subject to the exemption in
paragraph (a)(3)(iii) of this section.
Prescriptions written for a beneficiary in
a long-term care facility will not be
included in determining compliance
until January 1, 2025. Compliance
actions against prescribers who do not
meet the compliance threshold based on
prescriptions written for a beneficiary in
a long-term care facility will commence
on or after January 1, 2025. Compliance
actions against prescribers who do not
meet the compliance threshold based on
other prescriptions will commence on
or after January 1, 2023. Prescribers will
be exempt from this requirement in the
following situations:
*
*
*
*
*
(ii) Prescriber has an address in
PECOS in the geographic area of an
emergency or disaster declared by a
Federal, State, or local government
entity. If a prescriber does not have an
address in PECOS, prescriber has an
address in NPPES in the geographic area
of an emergency or disaster declared by
a Federal, State, or local government
entity. Starting in the 2024
measurement year, CMS will identify
which emergencies or disasters qualify
for this exception.
*
*
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77. Section 424.205 is amended by—
a. In paragraph (a), by removing the
definition of ‘‘MDPP interim
preliminary recognition’’;
■ b. Revising paragraph (b)(1);
■ c. Removing paragraph (c);
■ d. Redesignating paragraphs (d)
through (i) as paragraphs (c) through (h),
respectively; and
■ e. Revising newly designated
paragraph (c)(1);
■ f. Removing newly redesignated
paragraph (c)(10)(iii);
■ g. Revising newly redesignated
paragraph (c)(14);
■ h. Revising newly redesignated
paragraphs (f)(2)(i);
■ i. Removing newly redesignated
paragraph (f)(5)(iii);
■ j. Redesignating newly redesignated
paragraphs (f)(5)(iv) and (v) as
paragraphs (f)(5)(iii) and (iv),
respectively;
■ k. Revising newly redesignated
paragraph (f)(5)(iii) and paragraph
(g)(1)(i)(C).
The revisions read as follows:
■
■
§ 424.205 Requirements for Medicare
Diabetes Prevention Program suppliers.
*
*
*
*
*
(b) * * *
(1) Has either preliminary, full, full
plus CDC DPRP recognition.
*
*
*
*
*
(c) * * *
(1) The MDPP supplier must have and
maintain preliminary, full, or full plus
CDC DPRP recognition.
*
*
*
*
*
(14) The MDPP supplier must submit
performance data for MDPP
beneficiaries who ever attended ongoing
maintenance sessions with data
elements consistent with the CDC’s
DPRP standards for data elements
required for the core services period.
*
*
*
*
*
(f) * * *
(2) * * *
(i) Documentation of the type of
session, whether a core session, a core
maintenance session, an in-person
make-up session, or a virtual make-up
session.
*
*
*
*
*
(5) * * *
(iii) Has achieved at least a 9-percent
weight loss percentage as measured in
accordance with § 410.79(e)(3)(iii) of
this chapter during a core session or
core maintenance session furnished by
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that supplier, if the claim submitted is
for a performance payment under
§ 414.84(b)(7) of this chapter.
*
*
*
*
*
(g) * * *
(1) * * *
(i) * * *
(C) An MDPP supplier that does not
satisfy the requirements in paragraph
(b)(1) of this section may become
eligible to bill for MDPP services again
if it successfully achieves preliminary,
full, or full plus CDC DPRP recognition,
and successfully enrolls again in
Medicare as an MDPP supplier after any
applicable reenrollment bar has expired.
*
*
*
*
*
■ 78. Section 424.210 is amended by
revising paragraphs (b)(2) and (d)(1) to
read as follows:
§ 424.210 Beneficiary engagement
incentives under the Medicare Diabetes
Prevention Program expanded model.
*
*
*
*
*
(b) * * *
(2) The item or service must be
reasonably connected to the CDCapproved National Diabetes Prevention
Program curriculum furnished to the
MDPP beneficiary during a core session
or core maintenance session furnished
by the MDPP supplier.
*
*
*
*
*
(d) * * *
(1) Attendance at core sessions or core
maintenance sessions.
*
*
*
*
*
■ 79. Section 424.502 is amended by—
■ a. Revising the definition of
‘‘Authorized official’’; and
■ b. Adding the definitions of ‘‘Indirect
ownership interest,’’ ‘‘Pattern or
practice,’’ and ‘‘Supplier’’ in
alphabetical order.
The revision and additions read as
follows:
§ 424.502
Definitions.
*
*
*
*
*
Authorized official means an
appointed official (for example, chief
executive officer, chief financial officer,
general partner, chairman of the board,
or direct owner) to whom the
organization has granted the legal
authority to enroll it in the Medicare
program, to make changes or updates to
the organization’s status in the Medicare
program, and to commit the
organization to fully abide by the
statutes, regulations, and program
instructions of the Medicare program.
For purposes of this definition only, the
term ‘‘organization’’ means the enrolling
entity as identified by its legal business
name and tax identification number.
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*
*
*
*
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Indirect ownership interest means as
follows:
(1)(i) Any ownership interest in an
entity that has an ownership interest in
the enrolling or enrolled provider or
supplier.
(ii) Any ownership interest in an
indirect owner of the enrolling or
enrolled provider or supplier.
(2) The amount of indirect ownership
interest is determined by multiplying
the percentages of ownership in each
entity. For example, if A owns 10
percent of the stock in a corporation that
owns 80 percent of the provider or
supplier, A’s interest equates to an 8
percent indirect ownership interest in
the provider or supplier and must be
reported on the enrollment application.
Conversely, if B owns 80 percent of the
stock of a corporation that owns 5
percent of the stock of the provider or
supplier, B’s interest equates to a 4
percent indirect ownership interest in
the provider or supplier and need not be
reported.
*
*
*
*
*
Pattern or practice means:
(1) For purposes of § 424.535(a)(8)(ii),
at least three submitted non-compliant
claims.
(2) For purposes of § 424.535(a)(14), at
least three prescriptions of Part B or Part
D drugs that are abusive, represent a
threat to the health and safety of
Medicare beneficiaries, or otherwise fail
to meet Medicare requirements.
(3) For purposes of § 424.535(a)(21), at
least three orders, certifications,
referrals, or prescriptions of Medicare
Part A or B services, items, or drugs that
are abusive, represent a threat to the
health and safety of Medicare
beneficiaries, or otherwise fail to meet
Medicare requirements.
*
*
*
*
*
Supplier means, for purposes of this
subpart, all of the following:
(1) The individuals and entities that
qualify as suppliers under § 400.202.
(2) Physical therapists in private
practice.
(3) Occupational therapists in private
practice.
(4) Speech-language pathologists.
*
*
*
*
*
■ 80. Section 424.516 is amended by
revising paragraphs (d)(1)(iii) and (e)(1)
to read as follows:
§ 424.516 Additional provider and supplier
requirements for enrolling and maintaining
active enrollment status in the Medicare
program.
*
*
*
(d) * * *
(1) * * *
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(iii) A change, addition, or deletion of
a practice location.
*
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(e) * * *
(1) Within 30 days for a change of
ownership or control (including changes
in authorized official(s) or delegated
official(s)) or a change, addition, or
deletion of a practice location;
*
*
*
*
*
■ 81. Section 424.530 is amended by—
■ a. Revising paragraph (a)(1); and
■ b. Adding paragraphs (a)(16), (17), and
(18).
The revision and additions read as
follows:
§ 424.530 Denial of enrollment in the
Medicare program.
(a) * * *
(1) Noncompliance. The provider or
supplier is determined to not be in
compliance with the enrollment
requirements described in this title 42,
or in the enrollment application
applicable for its provider or supplier
type, and has not submitted a plan of
corrective action as outlined in part 488
of this chapter.
*
*
*
*
*
(16) Certain misdemeanors. (i) The
provider or supplier, or any owner,
managing employee or organization,
officer, or director of the provider or
supplier, has been convicted (as that
term is defined in 42 CFR 1001.2) of a
misdemeanor under Federal or State law
within the previous 10 years that CMS
deems detrimental to the best interests
of the Medicare program and its
beneficiaries.
(ii) Offenses under paragraph (a)(16)(i)
of this section include, but are not
limited in scope or severity to, the
following:
(A) Fraud or other criminal
misconduct involving the provider’s or
supplier’s participation in a Federal or
State health care program or the
delivery of services or items thereunder.
(B) Assault, battery, neglect, or abuse
of a patient (including sexual offenses).
(C) Any other misdemeanor that
places the Medicare program or its
beneficiaries at immediate risk, such as
a malpractice suit that results in a
conviction of criminal neglect or
misconduct.
(17) False Claims Act (FCA). (i) The
provider or supplier, or any owner,
managing employee or organization,
officer, or director of the provider or
supplier, has had a civil judgment under
the FCA (31 U.S.C. 3729 through 3733)
imposed against them within the
previous 10 years.
(ii) In determining whether a denial
under this paragraph is appropriate,
CMS considers the following factors:
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(A) The number of provider or
supplier actions that the judgment
incorporates (for example, the number
of false claims submitted).
(B) The types of provider or supplier
actions involved.
(C) The monetary amount of the
judgment.
(D) When the judgment occurred.
(E) Whether the provider or supplier
has any history of final adverse actions
(as that term is defined in § 424.502 of
this chapter).
(F) Any other information that CMS
deems relevant to its determination.
(18) Supplier standard or condition
violation. (i) The independent
diagnostic testing facility is noncompliant with any provision in
§ 410.33(g).
(ii) The DMEPOS supplier is noncompliant with any provision in
§ 424.57(c).
(iii) The opioid treatment program is
non-compliant with any provision in
§ 424.67(b).
(iv) The home infusion therapy
supplier is non-compliant with any
provision in § 424.68(c).
(v) The Medicare diabetes prevention
program is non-compliant with any
provision in § 424.205(b) or (d).
*
*
*
*
*
■ 82. Section 424.535 is amended by—
■ a. Revising paragraphs (a)(1)
introductory text, (a)(8)(ii) introductory
text, and (a)(14)(i) introductory text and
(ii) introductory text;
■ b. Adding paragraphs (a)(15) and (16);
■ c. Revising paragraph (a)(17)
introductory text;
■ d. Redesignating paragraphs (a)(17)(i)
through (vi) as paragraphs (a)(17)(i)(A)
through (F);
■ e. Adding paragraph (a)(17)(ii);
■ f. Revising paragraph (a)(21)
introductory text;
■ g. Adding paragraph (a)(23); and
■ h. Revising paragraphs (e) and (g).
The additions and revisions read as
follows:
§ 424.535 Revocation of enrollment in the
Medicare program.
(a) * * *
(1) Noncompliance. The provider or
supplier is determined to not be in
compliance with the enrollment
requirements described in this title 42,
or in the enrollment application
applicable for its provider or supplier
type, and has not submitted a plan of
corrective action as outlined in part 488
of this chapter. The provider or supplier
may also be determined not to be in
compliance if it has failed to pay any
user fees as assessed under part 488 of
this chapter.
*
*
*
*
*
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(8) * * *
(ii) CMS determines that the provider
or supplier has a pattern or practice of
submitting claims that fails to meet
Medicare requirements and that a
revocation on this basis is warranted. In
determining whether a revocation is
warranted, CMS considers, as
appropriate or applicable, the following:
*
*
*
*
*
(14) * * *
(i) The pattern or practice is abusive
or represents a threat to the health and
safety of Medicare beneficiaries, or both,
and CMS determines that a revocation
on this basis is warranted. In
determining whether a revocation is
warranted, CMS considers the following
factors:
*
*
*
*
*
(ii) The pattern or practice of
prescribing fails to meet Medicare
requirements and CMS determines that
a revocation on this basis is warranted.
In determining whether a revocation is
warranted, CMS considers the following
factors:
*
*
*
*
*
(15) False Claims Act (FCA). (i) The
provider or supplier, or any owner,
managing employee or organization,
officer, or director of the provider or
supplier, has had a civil judgment under
the FCA (31 U.S.C. 3729 through 3733)
imposed against them within the
previous 10 years.
(ii) In determining whether a
revocation under this paragraph is
appropriate, CMS considers the
following factors:
(A) The number of provider or
supplier actions that the judgment
incorporates (for example, the number
of false claims submitted).
(B) The types of provider or supplier
actions involved.
(C) The monetary amount of the
judgment.
(D) When the judgment occurred.
(E) Whether the provider or supplier
has any history of final adverse actions
(as that term is defined in § 424.502).
(F) Any other information that CMS
deems relevant to its determination.
(16) Certain misdemeanors. (i) The
provider or supplier, or any owner,
managing employee or organization,
officer, or director of the provider or
supplier, has been convicted (as that
term is defined in 42 CFR 1001.2) of a
misdemeanor under Federal or State law
within the previous 10 years that CMS
deems detrimental to the best interests
of the Medicare program and its
beneficiaries.
(ii) Offenses under paragraph (i)
include, but are not limited in scope or
severity to, the following:
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(A) Fraud or other criminal
misconduct involving the provider’s or
supplier’s participation in a Federal or
State health care program or the
delivery of services or items thereunder.
(B) Assault, battery, neglect, or abuse
of a patient (including sexual offenses).
(C) Any other misdemeanor that
places the Medicare program or its
beneficiaries at immediate risk, such as
a malpractice suit that results in a
conviction of criminal neglect or
misconduct.
(17) Debt referred to the United States
Department of Treasury. (i) The
provider or supplier failed to repay a
debt that CMS appropriately referred to
the United States Department of
Treasury. In determining whether a
revocation under this paragraph (a)(17)
is appropriate, CMS considers the
following factors:
*
*
*
*
*
(ii) Paragraph (17)(i) of this paragraph
does not apply to the following
situations:
(A) The provider’s or supplier’s
Medicare debt has been discharged by a
bankruptcy court; or
(B) The administrative appeals
process concerning the debt has not
been exhausted or the timeframe for
filing such an appeal (at the appropriate
level of appeal) has not expired.
*
*
*
*
*
(21) Abusive ordering, certifying,
referring, or prescribing of Part A or B
services, items or drugs. The physician
or eligible professional has a pattern or
practice of ordering, certifying,
referring, or prescribing Medicare Part A
or B services, items, or drugs that is
abusive, represents a threat to the health
and safety of Medicare beneficiaries, or
otherwise fails to meet Medicare
requirements, and CMS determines that
a revocation on this basis is warranted.
In determining whether a revocation is
warranted, CMS considers the following
factors:
*
*
*
*
*
(23) Supplier standard or condition
violation. (i) The independent
diagnostic testing facility is noncompliant with any provision in 42 CFR
410.33(g).
(ii) The DMEPOS supplier is noncompliant with any provision in
§ 424.57(c).
(iii) The opioid treatment program is
non-compliant with any provision in
§ 424.67(b) or (e).
(iv) The home infusion therapy
supplier is non-compliant with any
provision in § 424.68(c) or (e).
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(v) The Medicare diabetes prevention
program is non-compliant with any
provision in § 424.205(b) or (d).
*
*
*
*
*
(e) Reversal of revocation. If the
revocation was due to adverse activity
(sanction, exclusion, or felony) against
the provider’s or supplier’s owner,
managing employee, managing
organization, officer, director,
authorized or delegated official, medical
director, supervising physician, or other
health care or administrative or
management services personnel
furnishing services payable by a Federal
health care program, the revocation may
be reversed if the provider or supplier
terminates and submits proof that it has
terminated its business relationship
with that party within 15 days of the
revocation notification.
*
*
*
*
*
(g) Effective date of revocation. (1)
Except as described in paragraphs (g)(2)
and (g)(3) of this section, a revocation
becomes effective 30 days after CMS or
the CMS contractor mails notice of its
determination to the provider or
supplier.
(2) Except as described in paragraph
(g)(3) of this section, the revocation
effective dates in the situations
identified in this paragraph (g)(2) are as
follows:
(i) For revocations based on a Federal
exclusion or debarment, the date of the
exclusion or debarment.
(ii) For revocations based on a felony
conviction, the date of the felony
conviction.
(iii) For revocations based on a State
license suspension or revocation, the
date of the license suspension or
revocation.
(iv) For revocations based on a CMS
determination that the provider’s or
supplier’s practice location is nonoperational, the date on which the
provider’s or supplier’s practice location
was no longer operational (per CMS’ or
the CMS contractor’s determination).
(v) For revocations based on a
misdemeanor conviction, the date of the
misdemeanor conviction.
(vi) For revocations based on a State
license surrender in lieu of further
disciplinary action, the date of the
license surrender.
(vii) For revocations based on
termination from a Federal health care
program other than Medicare (for
example, Medicaid), the date of the
termination.
(viii) For revocations based on
termination of a provider agreement
under part 489 of this chapter, and as
applicable to the type of provider
involved, the later of the following:
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(A) The date of the provider
agreement termination; or
(B) The date that CMS establishes
under § 489.55.
(ix) For revocations based on
§ 424.535(a)(23), the effective dates are
as follows:
(A) If the standard or condition
violation involves the suspension,
revocation, or termination (or surrender
in lieu of further disciplinary action) of
the provider’s or supplier’s Federal or
State license, certification,
accreditation, or MDPP recognition, the
effective date is the date of the license,
certification, accreditation, or MDPP
recognition suspension, revocation,
termination, or surrender.
(B) If the standard or condition
violation involves a non-operational
practice location, the effective date is
the date the non-operational status
began.
(C) If the standard violation involves
a felony conviction of an individual or
entity described in § 424.67(b)(6)(i), the
effective date is the date of the felony
conviction.
(D) For all standard violations not
addressed in paragraphs (A) through (C),
the effective date in paragraph (g)(1)
applies if the effective date in paragraph
(g)(3) does not.
(3) If the action that resulted in the
revocation occurred prior to the
effective date of the provider’s or
supplier’s enrollment, the effective date
of the revocation is the same as the
effective date of enrollment.
*
*
*
*
*
■ 83. Section 424.541 is added to read
as follows:
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§ 424.541
Stay of enrollment.
(a)(1) CMS may stay an enrolled
provider’s or supplier’s enrollment if
the provider or supplier:
(i) Is non-compliant with at least one
enrollment requirement in Title 42; and.
(ii) Can remedy the non-compliance
via the submission of, as applicable to
the situation, a Form CMS–855, Form
CMS–20134, or Form CMS–588 change
of information or revalidation
application.
(2) During the period of any stay
imposed under this section, the
following apply:
(i) The provider or supplier remains
enrolled in Medicare;
(ii) Claims submitted by the provider
or supplier with dates of service within
the stay period will be denied.
(3) A stay of enrollment lasts no
longer than 60 days from the postmark
date of the notification letter.
(4) CMS notifies the affected provider
or supplier in writing of the imposition
of the stay.
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(b)(1) If a provider or supplier
receives written notice from CMS or its
contractor that the provider or supplier
is subject to a stay under this section,
the provider or supplier has 15 calendar
days from the date of the written notice
to submit a rebuttal to the stay as
described in paragraph (b) of this
section.
(2) CMS may, at its discretion, extend
the 15-day time-period referenced in
paragraph (b)(1) of this section.
(3) Any rebuttal submitted pursuant
to paragraph (b) of this section must:
(i) Be in writing.
(ii) Specify the facts or issues about
which the provider or supplier disagrees
with the stay’s imposition and/or the
effective date, and the reasons for
disagreement.
(iii) Submit all documentation the
provider or supplier wants CMS to
consider in its review of the stay.
(iv) Be submitted in the form of a
letter that is signed and dated by the
individual supplier (if enrolled as an
individual physician or nonphysician
practitioner), the authorized official or
delegated official (as those terms are
defined in 42 CFR 424.502), or a legal
representative (as defined in 42 CFR
498.10). If the legal representative is an
attorney, the attorney must include a
statement that he or she has the
authority to represent the provider or
supplier; this statement is sufficient to
constitute notice of such authority. If
the legal representative is not an
attorney, the provider or supplier must
file with CMS written notice of the
appointment of a representative; this
notice of appointment must be signed
and dated by, as applicable, the
individual supplier, the authorized
official or delegated official, or a legal
representative.
(4) The provider’s or supplier’s failure
to submit a rebuttal that is both timely
under paragraph (b)(1) of this section
and fully compliant with all of the
requirements of paragraph (b)(3) of this
section constitutes a waiver of all
rebuttal rights under this section.
(5) Upon receipt of a timely and
compliant stay rebuttal, CMS reviews
the rebuttal to determine whether the
imposition of the stay and/or the
effective date thereof are correct.
(6) A determination made under
paragraph (b) of this section is not an
initial determination under § 498.3(b)
and therefore not appealable.
(7) Nothing in paragraph (b) of this
section requires CMS to delay the
imposition of a stay pending the
completion of the review described in
paragraph (b)(5) of this section.
(8)(i) Nothing in paragraph (b) of this
section requires CMS to delay the
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52753
imposition of a deactivation or
revocation, pending the completion of
the review described in paragraph (b)(5)
of this section.
(ii)(A) If CMS deactivates the provider
or supplier during the stay, any rebuttal
to the stay that the provider or supplier
submits that meets the requirements of
paragraph (b) of this section is
combined and considered with the
provider’s or supplier’s rebuttal to the
deactivation under § 424.546 if CMS has
not yet made a determination on the
stay rebuttal pursuant to this section.
(B) In all cases other than that
described in paragraph (b)(8)(ii)(A) of
this section, a stay rebuttal that was
submitted in compliance with the
requirements of paragraph (b) of this
section is considered separately and
independently of any review of any
other rebuttal or, for revocations, appeal
under 42 CFR part 498.
■ 84. Section 424.555 is amended by
revising paragraph (b) to read as follows:
§ 424.555
Payment liability.
*
*
*
*
*
(b) No payment may be made for
otherwise Medicare covered items or
services furnished to a Medicare
beneficiary by a provider or supplier if
the billing privileges of the provider or
supplier are deactivated, denied, or
revoked, or if the provider or supplier
is currently under a stay of enrollment.
The Medicare beneficiary has no
financial responsibility for expenses,
and the provider or supplier must
refund on a timely basis to the Medicare
beneficiary any amounts collected from
the Medicare beneficiary for these
otherwise Medicare covered items or
services.
*
*
*
*
*
PART 425—MEDICARE SHARED
SAVINGS PROGRAM
85. The authority citation for part 425
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1306, 1395hh,
and 1395jjj.
86. Section 425.20 is amended—
a. By revising the definitions of
‘‘Assignable beneficiary’’ and
‘‘Assignment window’’;
■ b. In the definition of ‘‘At-risk
beneficiary’’ by—
■ i. Removing the periods at the end of
paragraphs (5) and (6), and adding in
their place semicolons; and
■ ii. Revising paragraph (7);
■ c. By adding the definitions of
‘‘Beneficiary eligible for Medicare
CQMs’’ and ‘‘Expanded window for
assignment’’ in alphabetical order;
■ d. In the definition of ‘‘Experienced
with performance-based risk Medicare
■
■
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ACO initiatives’’ by revising paragraph
(2);
■ e. In the definition of ‘‘Inexperienced
with performance-based risk Medicare
ACO initiatives’’ by revising paragraph
(2);
■ f. In the definition of ‘‘Rural health
center’’ by—
■ i. Removing the word ‘‘center’’ and
adding in its place the word ‘‘clinic’’;
and
■ ii. Removing the phrase ‘‘under
§ 405.2401(b)’’ and adding in its place
the phrase ‘‘under § 405.2401(b) of this
chapter’’.
The revisions and additions read as
follows:
§ 425.20
Definitions.
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Assignable beneficiary means a
Medicare fee-for-service beneficiary
who receives at least one primary care
service with a date of service during a
specified 12-month assignment window
from a Medicare-enrolled physician
who is a primary care physician or who
has one of the specialty designations
included in § 425.402(c). For
performance year 2025 and subsequent
performance years, a Medicare fee-forservice beneficiary who does not meet
this requirement but who meets both of
the following criteria will also be
considered an assignable beneficiary—
(1) Receives at least one primary care
service with a date of service during a
specified 24-month expanded window
for assignment from a Medicare-enrolled
physician who is a primary care
physician or who has one of the
specialty designations included in
§ 425.402(c).
(2) Receives at least one primary care
service with a date of service during a
specified 12-month assignment window
from a Medicare-enrolled practitioner
who is one of the following:
(i) A physician assistant (as defined at
§ 410.74(a)(2) of this chapter).
(ii) A nurse practitioner (as defined at
§ 410.75(b) of this chapter).
(iii) A clinical nurse specialist (as
defined at § 410.76(b) of this chapter).
*
*
*
*
*
Assignment window means the 12month period used to assign
beneficiaries to an ACO, or to identify
assignable beneficiaries, or both.
At-risk beneficiary * * *
(7) Is entitled to Medicare because of
disability; or
*
*
*
*
*
Beneficiary eligible for Medicare
CQMs means 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:
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(1) A Medicare fee-for-service
beneficiary (as defined at § 425.20)
who—
(i) Meets the criteria for a beneficiary
to be assigned to an ACO described at
§ 425.401(a); and
(ii) 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
§ 425.402(c), or who is a physician
assistant, nurse practitioner, or certified
nurse specialist.
(2) A Medicare fee-for-service
beneficiary who is assigned to an ACO
in accordance with § 425.402(e) because
the beneficiary designated an ACO
professional participating in an ACO as
responsible for coordinating their
overall care.
*
*
*
*
*
Expanded window for assignment
means the 24-month period used to
assign beneficiaries to an ACO, or to
identify assignable beneficiaries, or both
that includes the applicable 12-month
assignment window and the preceding
12 months.
Experienced with performance-based
risk Medicare ACO initiatives * * *
(2) Forty percent or more of the ACO’s
ACO participants participated in a
performance-based risk Medicare ACO
initiative, or in an ACO that deferred its
entry into a second Shared Savings
Program agreement period under a twosided model under § 425.200(e), in any
of the 5 most recent performance years.
An ACO participant is considered to
have participated in a performancebased risk Medicare ACO initiative if
the ACO participant TIN was or will be
included in financial reconciliation for
one or more performance years under
such initiative during any of the 5 most
recent performance years.
*
*
*
*
*
Inexperienced with performancebased risk Medicare ACO initiatives
* * *
(2) Less than 40 percent of the ACO’s
ACO participants participated in a
performance-based risk Medicare ACO
initiative, or in an ACO that deferred its
entry into a second Shared Savings
Program agreement period under a twosided model under § 425.200(e), in each
of the 5 most recent performance years.
An ACO participant is considered to
have participated in a performancebased risk Medicare ACO initiative if
the ACO participant TIN was or will be
included in financial reconciliation for
one or more performance years under
such initiative during any of the 5 most
recent performance years.
*
*
*
*
*
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87. Section 425.106 is amended by
revising paragraph (c)(5) to read as
follows:
■
§ 425.106
Shared governance.
*
*
*
*
*
(c) * * *
(5) In cases in which the composition
of the ACO’s governing body does not
meet the requirements of paragraph
(c)(2) of this section, the ACO must
describe why it seeks to differ from
these requirements and how the ACO
will provide meaningful representation
in ACO governance by Medicare
beneficiaries.
*
*
*
*
*
■ 88. Section 425.204 is amended by
revising paragraph (c)(3) to read as
follows:
§ 425.204
Content of the application.
*
*
*
*
*
(c) * * *
(3) If an ACO requests an exception to
the governing body requirement in
§ 425.106(c)(2), the ACO must
describe—
(i) Why it seeks to differ from the
requirement; and
(ii) How the ACO will provide
meaningful representation in ACO
governance by Medicare beneficiaries.
*
*
*
*
*
■ 89. Section 425.302 is amended by
revising paragraph (a)(3)(iii) to read as
follows:
§ 425.302 Program requirements for data
submission and certifications.
(a) * * *
(3) * * *
(iii) For performance years starting on
January 1, 2019 through 2023, the
percentage of eligible clinicians
participating in the ACO that use
CEHRT to document and communicate
clinical care to their patients or other
health care providers meets or exceeds
the applicable percentage specified by
CMS at § 425.506(f).
*
*
*
*
*
■ 90. Section 425.308 is amended by
adding paragraph (b)(9) to read as
follows:
§ 425.308 Public reporting and
transparency.
*
*
*
*
*
(b) * * *
(9) The number of MIPS eligible
clinicians, Qualifying APM Participants
(QPs), and Partial Qualifying APM
Participants (Partial QPs) (each as
defined at § 414.1305 of this chapter)
participating in the ACO that earn a
MIPS performance category score for the
MIPS Promoting Interoperability
performance category at the individual,
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group, virtual group, or APM entity
level as set forth in § 425.507.
*
*
*
*
*
■ 91. Section 425.316 is amended by
revising paragraphs (e)(2) introductory
text and (e)(2)(i) to read as follows:
§ 425.316
Monitoring of ACOs.
*
*
*
*
*
(e) * * *
(2) If CMS determines that an ACO
participating in advance investment
payments became experienced with
performance-based risk Medicare ACO
initiatives during its first or second
performance year of its agreement
period or that the ACO became a high
revenue ACO during any performance
year of its agreement period, CMS—
(i) Will cease payment of advance
investment payments no later than the
quarter after the ACO became
experienced with performance-based
risk Medicare ACO initiatives or became
a high revenue ACO.
*
*
*
*
*
■ 92. Section 425.400 is amended—
■ a. By revising paragraph (a)(2)(ii);
■ b. In paragraph (a)(3)(i), by removing
the phrase ‘‘most recent 12 months’’ and
adding in its place the phrase ‘‘most
recent 12 or 24 months, as applicable,’’;
■ c. By revising paragraph (c)(1)(vii)
introductory text;
■ d. By adding paragraph (c)(1)(viii);
and
■ e. By revising paragraphs (c)(2)(i)
introductory text and (c)(2)(ii).
The revisions and addition read as
follows:
tkelley on DSK125TN23PROD with PROPOSALS2
§ 425.400
General.
(a) * * *
(2) * * *
(ii) Assignment will be updated
quarterly based on the most recent 12 or
24 months of data, as applicable, under
the methodology described in
§§ 425.402 and 425.404.
*
*
*
*
*
(c) * * *
(1) * * *
(vii) For the performance year starting
on January 1, 2023 as follows:
*
*
*
*
*
(viii) For the performance year
starting on January 1, 2024, and
subsequent performance years as
follows:
(A) CPT codes:
(1) 96160 and 96161 (codes for
administration of health risk
assessment).
(2) 96202 and 96203 (codes for
caregiver behavior management
training).
(3) 99201 through 99215 (codes for
office or other outpatient visit for the
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evaluation and management of a
patient).
(4) 99304 through 99318 (codes for
professional services furnished in a
nursing facility; professional services or
services reported on an FQHC or RHC
claim identified by these codes are
excluded when furnished in a SNF).
(5) 99319 through 99340 (codes for
patient domiciliary, rest home, or
custodial care visit).
(6) 99341 through 99350 (codes for
evaluation and management services
furnished in a patient’s home).
(7) 99354 and 99355 (add-on codes,
for prolonged evaluation and
management or psychotherapy services
beyond the typical service time of the
primary procedure; when the base code
is also a primary care service code
under this paragraph (c)(1)(viii)).
(8) 99406 and 99407 (codes for
smoking and tobacco-use cessation
counseling services).
(9) 99421, 99422, and 99423 (codes
for online digital evaluation and
management).
(10) 99424, 99425, 99426, and 99427
(codes for principal care management
services).
(11) 99437, 99487, 99489, 99490 and
99491 (codes for chronic care
management).
(12) 99439 (code for non-complex
chronic care management).
(13) 99457 and 99458 (codes for
remote physiologic monitoring).
(14) 99483 (code for assessment of
and care planning for patients with
cognitive impairment).
(15) 99484, 99492, 99493 and 99494
(codes for behavioral health integration
services).
(16) 99495 and 99496 (codes for
transitional care management services).
(17) 99497 and 99498 (codes for
advance care planning; services
identified by these codes furnished in
an inpatient setting are excluded).
(18) 9X015, 9X016, and 9X017 (codes
for caregiver training services).
(B) HCPCS codes:
(1) G0101 (code for cervical or vaginal
cancer screening).
(2) G0317, G0318, and G2212 (codes
for prolonged office or other outpatient
visit for the evaluation and management
of a patient).
(3) G0402 (code for the Welcome to
Medicare visit).
(4) G0438 and G0439 (codes for the
annual wellness visits).
(5) G0442 (code for alcohol misuse
screening service).
(6) G0443 (code for alcohol misuse
counseling service).
(7) G0444 (code for annual depression
screening service).
(8) G0463 (code for services furnished
in ETA hospitals).
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(9) G0506 (code for chronic care
management).
(10) G2010 (code for the remote
evaluation of patient video/images).
(11) G2012 and G2252 (codes for
virtual check-in).
(12) G2058 (code for non-complex
chronic care management).
(13) G2064 and G2065 (codes for
principal care management services).
(14) G2086, G2087, and G2088 (codes
for office-based opioid use disorder
services).
(15) G2211 (code for complex
evaluation and management services
add-on).
(16) G2214 (code for psychiatric
collaborative care model).
(17) G3002 and G3003 (codes for
chronic pain management).
(18) GXXX1 and GXXX2 (codes for
community health integration services).
(19) GXXX3 and GXXX4 (codes for
principal illness navigation services).
(20) GXXX5 (code for social
determinants of health risk assessment
services).
(C) Primary care service codes include
any CPT code identified by CMS that
directly replaces a CPT code specified
in paragraph (c)(1)(viii)(A) of this
section or a HCPCS code specified in
paragraph (c)(1)(viii)(B) of this section,
when the assignment window (as
defined in § 425.20) for a benchmark or
performance year includes any day on
or after the effective date of the
replacement code for payment purposes
under FFS Medicare.
(2) * * *
(i) Except as otherwise specified in
paragraph (c)(2)(i)(A)(2) of this section,
when the assignment window or
applicable expanded window for
assignment (as defined in § 425.20) for
a benchmark or performance year
includes any month(s) during the
COVID–19 Public Health Emergency
defined in § 400.200 of this chapter, in
determining beneficiary assignment, we
use the primary care service codes
identified in paragraph (c)(1) of this
section, and additional primary care
service codes as follows:
*
*
*
*
*
(ii) Except as otherwise specified in
paragraph (c)(2)(i)(A)(2) of this section,
the additional primary care service
codes specified in paragraph (c)(2)(i) of
this section are applicable to all months
of the assignment window or applicable
expanded window for assignment (as
defined in § 425.20), when the
assignment window or applicable
expanded window for assignment
includes any month(s) during the
COVID–19 Public Health Emergency
defined in § 400.200 of this chapter.
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93. Section 425.402 is amended—
a. By revising paragraph (b)(1);
b. By adding paragraph (b)(5);
c. By revising paragraph (c)
introductory text; and
■ d. In paragraph (e)(2)(ii)(A), by
removing the reference
‘‘§ 425.400(a)(4)(ii)’’ and adding in its
place the reference ‘‘§ 425.226(a)(1)’’.
The revisions and addition read as
follows:
■
■
■
■
§ 425.402
Basic assignment methodology.
tkelley on DSK125TN23PROD with PROPOSALS2
*
*
*
*
*
(b) * * *
(1) Identify all beneficiaries that had
at least one primary care service during
the applicable assignment window with
a physician who is an ACO professional
in the ACO and who is a primary care
physician as defined under § 425.20 or
who has one of the primary specialty
designations included in paragraph (c)
of this section.
*
*
*
*
*
(5) For performance year 2025 and
subsequent performance years, CMS
employs the following third step to
assign Medicare fee-for-service
beneficiaries who were not identified by
the criterion specified in paragraph
(b)(1) of this section:
(i) Identify all beneficiaries who had
at least one primary care service with a
non-physician ACO professional in the
ACO during the applicable assignment
window.
(ii) For the beneficiaries identified in
paragraph (b)(5)(i) of this section,
identify those beneficiaries that had at
least one primary care service with a
physician who is an ACO professional
in the ACO and who is a primary care
physician as defined under § 425.20 or
who has one of the primary specialty
designations included in paragraph (c)
of this section during the applicable
expanded window for assignment.
(iii) Identify all primary care services
furnished to beneficiaries identified in
paragraph (b)(5)(ii) of this section by
ACO professionals in the ACO who are
primary care physicians as defined
under § 425.20, non-physician ACO
professionals, and physicians with
specialty designations included in
paragraph (c) of this section during the
applicable expanded window for
assignment.
(iv) A beneficiary identified in
paragraph (b)(5)(ii) of this section is
assigned to the ACO if the allowed
charges for primary care services
furnished to the beneficiary by ACO
professionals in the ACO who are
primary care physicians, physicians
with specialty designations included in
paragraph (c) of this section, or nonphysician ACO professionals during the
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applicable expanded window for
assignment are greater than the allowed
charges for primary care services
furnished by primary care physicians,
physicians with specialty designations
as specified in paragraph (c) of this
section, nurse practitioners, physician
assistants, and clinical nurse specialists
who are—
(A) ACO professionals in any other
ACO; or
(B) Not affiliated with any ACO and
identified by a Medicare-enrolled billing
TIN.
(c) ACO professionals considered in
the second and third step of the
assignment methodology in paragraphs
(b)(4) and (5) of this section include
physicians who have one of the
following primary specialty
designations:
*
*
*
*
*
■ 94. Section 425.506 is amended by
revising paragraph (f) introductory text
to read as follows:
§ 425.506 Incorporating reporting
requirements related to adoption of certified
electronic health record technology.
*
*
*
*
*
(f) For performance years starting on
January 1, 2019 through 2023, ACOs in
a track that—
*
*
*
*
*
■ 95. Section 425.507 is added to
subpart F to read as follows:
§ 425.507 Incorporating promoting
interoperability requirements related to the
Quality Payment Program for performance
years beginning on or after January 1, 2024.
(a) For performance years beginning
on or after January 1, 2024, unless
otherwise excluded under paragraph (b)
of this section, all MIPS eligible
clinicians, Qualifying APM Participants
(QPs), and Partial Qualifying APM
Participants (Partial QPs) (each as
defined at § 414.1305 of this chapter)
participating in the ACO must satisfy all
of the following:
(1) Report the MIPS Promoting
Interoperability performance category
measures and requirements to MIPS
according to 42 CFR part 414 subpart O
as either of the following—
(i) All MIPS eligible clinicians, QPs,
and Partial QPs participating in the
ACO as an individual, group, or virtual
group; or
(ii) The ACO as an APM entity.
(2) Earn a performance category score
for the MIPS Promoting Interoperability
performance category at the individual,
group, virtual group, or APM entity
level.
(b) A MIPS eligible clinician, QP,
Partial QP, or ACO as an APM entity
may be excluded from the requirements
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set forth in paragraph (a) of this section
if the MIPS eligible clinician, QP, Partial
QP, or ACO as an APM entity—
(1) Does not exceed the low volume
threshold set forth at
§ 414.1310(b)(1)(iii) of this chapter;
(2) Is an eligible clinician as defined
at § 414.1305 of this chapter who is not
a MIPS eligible clinician and has opted
to voluntarily report measures and
activities for MIPS as set forth in
§ 414.1310(b)(2) of this chapter; or
(3) Has not earned a performance
category score for the MIPS Promoting
Interoperability performance category
because the MIPS Promoting
Interoperability performance category
has been reweighted in accordance with
applicable policies set forth at
§ 414.1380(c)(2) of this chapter.
■ 96. Section 425.512 is amended—
■ a. By revising paragraph (a)(2);
■ b. In paragraph (a)(5)(i) introductory
text, by removing the phrase ‘‘paragraph
(a)(2) of this section’’ and adding in its
place the phrase ‘‘paragraphs (a)(2) and
(a)(7) of this section’’;
■ c. By revising paragraph (a)(5)(i)(A)(2),
(a)(5)(iii)(A) and (B);
■ d. By adding paragraph (a)(7);
■ e. In paragraph (b)(1)—
■ i. By adding a new first sentence;
■ ii. By removing the reference
‘‘paragraph (b)(2)’’ and adding in its
place the reference ‘‘paragraph (b)(3)’’;
■ f. By redesignating paragraphs (b)(2)
and (3) as paragraphs (b)(3) and (4),
respectively;
■ g. By adding new paragraph (b)(2);
■ h. By revising the newly redesignated
paragraph (b)(3)(ii)(B);
■ i. In newly redesignated paragraph
(b)(3)(iii), by removing the phrase
‘‘paragraph (b)(2)(ii) of this section’’ and
adding in its place the phrase
‘‘paragraph (b)(3)(ii) of this section’’;
■ j. By revising newly redesignated
paragraph (b)(3)(iv)(A);
■ k. In newly redesignated paragraph
(b)(3)(iv)(B), by removing the phrase
‘‘paragraph (b)(2)(iv)(A) of this section’’
and adding in its place the phrase
‘‘paragraph (b)(3)(iv)(A) of this section’’;
■ l. In newly redesignated paragraph
(b)(3)(v)—
■ i. By removing the phrase ‘‘paragraph
(b)(2)(iv)(B) of this section’’ and adding
in its place the phrase ‘‘paragraph
(b)(3)(iv)(B) of this section’’;
■ ii. By removing the phrase ‘‘paragraph
(b)(2)(iii) of this section’’ and adding in
its place the phrase ‘‘paragraph
(b)(3)(iii) of this section’’;
■ iii. By removing the phrase
‘‘paragraph (b)(2)(iv) of this section’’
and adding in its place the phrase
‘‘paragraph (b)(3)(iv) of this section’’;
■ m. In newly redesignated paragraph
(b)(4) introductory text, by removing the
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phrase ‘‘paragraphs (b)(1) and (b)(2) of
this section’’ and adding in its place the
phrase ‘‘paragraphs (b)(1) through (b)(3)
of this section’’; and
■ n. By revising paragraph (c)(3).
The revisions and additions read as
follows:
tkelley on DSK125TN23PROD with PROPOSALS2
§ 425.512 Determining the ACO quality
performance standard for performance
years beginning on or after January 1, 2021.
(a) * * *
(2) For the first performance year of
an ACO’s first agreement period under
the Shared Savings Program, the ACO
will meet the quality performance
standard if it meets the requirements
under this paragraph (a)(2).
(i) For performance years 2022 and
2023. If the ACO reports data via the
APP and meets the data completeness
requirement at § 414.1340 of this
subchapter and the case minimum
requirement at § 414.1380 of this
subchapter on the ten CMS Web
Interface measures or the three eCQMs/
MIPS CQMs, and the CAHPS for MIPS
survey, for the applicable performance
year.
(ii) For performance year 2024. If the
ACO reports data via the APP and meets
the data completeness requirement at
§ 414.1340 of this subchapter on the ten
CMS Web Interface measures or the
three eCQMs/MIPS CQMs/Medicare
CQMs, and the CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter), and receives a MIPS
Quality performance category score
under § 414.1380(b)(1) of this
subchapter, for the applicable
performance year.
(iii) For performance year 2025 and
subsequent performance years. If the
ACO reports data via the APP and meets
the data completeness requirement at
§ 414.1340 of this subchapter on the
three eCQMs/MIPS CQMs/Medicare
CQMs, and the CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this
subchapter), and receives a MIPS
Quality performance category score
under § 414.1380(b)(1) of this
subchapter, for the applicable
performance year.
*
*
*
*
*
(5) * * *
(i) * * *
(A) * * *
(2) If the ACO reports the three
eCQMs/MIPS CQMs in the APP measure
set, meeting the data completeness
requirement at § 414.1340 of this
subchapter for all three eCQMs/MIPS
CQMs, and achieving a quality
performance score equivalent to or
higher than the 10th percentile of the
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performance benchmark on at least one
of the four outcome measures in the
APP measure set and a quality
performance score equivalent to or
higher than the 40th percentile of the
performance benchmark on at least one
of the remaining five measures in the
APP measure set.
*
*
*
*
*
(iii) * * *
(A) For performance year 2024, the
ACO does not report any of the ten CMS
Web Interface measures, any of the three
eCQMs/MIPS CQMs/Medicare CQMs
and does not administer a CAHPS for
MIPS survey (except as specified in
§ 414.1380(b)(1)(vii)(B) of this chapter)
under the APP.
(B) For performance year 2025 and
subsequent years, the ACO does not
report any of the three eCQMs/MIPS
CQMs/Medicare CQMs and does not
administer a CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this chapter)
under the APP.
*
*
*
*
*
(7) For performance years 2024 and
subsequent performance years, if an
ACO reports all of the required
measures, meeting the data
completeness requirement at § 414.1340
of this chapter for each measure in the
APP measure set and receiving a MIPS
quality performance category score as
described at § 414.1380(b)(1) of this
chapter, and the ACO’s total available
measure achievement points used to
calculate the ACO’s MIPS quality
performance category score is reduced
under § 414.1380(b)(1)(vii)(A) of this
chapter, CMS will use the higher of the
ACO’s health equity adjusted quality
performance score or the equivalent of
the 40th percentile MIPS Quality
performance category score across all
MIPS Quality performance category
scores, excluding entities/providers
eligible for facility-based scoring, for the
relevant performance year.
(b) * * *
(1) For performance year 2023. * * *
(2) For performance year 2024 and
subsequent performance years. For an
ACO that reports the three eCQMs/MIPS
CQMs/Medicare CQMs in the APP
measure set, meeting the data
completeness requirement at § 414.1340
of this chapter for all three eCQMs/
MIPS CQMs/Medicare CQMs, and
administers the CAHPS for MIPS survey
(except as specified in
§ 414.1380(b)(1)(vii)(B) of this chapter),
CMS calculates the ACO’s health equity
adjusted quality performance score as
the sum of the ACO’s MIPS Quality
performance category score for all
measures in the APP measure set and
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the ACO’s health equity adjustment
bonus points calculated in accordance
with paragraph (b)(3) of this section.
The sum of these values may not exceed
100 percent.
(3) * * *
(ii) * * *
(B) Values of zero for each measure
that CMS does not evaluate because the
measure is unscored or the ACO does
not meet the case minimum or the
minimum sample size for the measure.
*
*
*
*
*
(iv) * * *
(A) (1) CMS determines the
proportion ranging from zero to one of
the ACO’s assigned beneficiary
population for the performance year that
is considered underserved based on the
highest of either of the following:
(i) The proportion of the ACO’s
assigned beneficiaries residing in a
census block group with an Area
Deprivation Index (ADI) national
percentile rank of at least 85. An ACO’s
assigned beneficiaries without an
available numeric ADI national
percentile rank are excluded from the
calculation of the proportion of the
ACO’s assigned beneficiaries residing in
a census block group with an ADI
national percentile rank of at least 85.
(ii) The proportion of the ACO’s
assigned beneficiaries who are enrolled
in the Medicare Part D low-income
subsidy (LIS); or are dually eligible for
Medicare and Medicaid.
(2) CMS calculates the proportions
specified in paragraph (b)(3)(iv)(A)(1)(ii)
of this section as follows:
(i) For performance year 2023, the
proportion of the ACO’s assigned
beneficiaries who are enrolled in the
Medicare Part D LIS or are dually
eligible for Medicare and Medicaid
divided by the total number of the
ACO’s assigned beneficiaries’ person
years.
(ii) For performance year 2024 and
subsequent performance years, the
proportion of the ACO’s assigned
beneficiaries with any months enrolled
in LIS or dually eligible for Medicare
and Medicaid divided by the total
number of the ACO’s assigned
beneficiaries.
*
*
*
*
*
(c) * * *
(3) If CMS determines the ACO meets
the requirements of paragraph (c)(1) of
this section and the ACO reports quality
data via the APP, CMS calculates the
ACO’s quality score as follows:
(i) For performance years 2021 and
2022, if the ACO reports quality data via
the APP and meets data completeness
and case minimum requirements, CMS
will use the higher of the ACO’s quality
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performance score or the equivalent of
the 30th percentile MIPS Quality
performance category score across all
MIPS Quality performance category
scores, excluding entities/providers
eligible for facility-based scoring, for the
relevant performance year.
(ii) For performance year 2023, if the
ACO reports quality data via the APP
and meets data completeness and case
minimum requirements, CMS will use
the higher of the ACO’s health equity
adjusted quality performance score or
the equivalent of the 30th percentile
MIPS Quality performance category
score across all MIPS Quality
performance category scores, excluding
entities/providers eligible for facilitybased scoring, for the relevant
performance year.
(iii) For performance year 2024 and
subsequent performance years, if the
ACO reports quality data via the APP
and meets the data completeness
requirement at § 414.1340 of this
chapter and receives a MIPS Quality
performance category score under
§ 414.1380(b)(1) of this chapter, CMS
will use the higher of the ACO’s health
equity adjusted quality performance
score or the equivalent of the 40th
percentile MIPS Quality performance
category score across all MIPS Quality
performance category scores, excluding
entities/providers eligible for facilitybased scoring, for the relevant
performance year.
*
*
*
*
*
§ 425.600
[Amended]
97. Amend § 425.600 in paragraph
(f)(4)(ii) by removing the reference
‘‘425.656(d)’’ and adding in its place the
reference ‘‘425.656(e)’’.
■
§ 425.601
[Amended]
98. Amend § 425.601 in paragraph (a)
introductory text by removing the
reference ‘‘§ 425.226(a)(1)’’ and adding
in its place the reference
‘‘§ 425.400(a)(4)(ii)’’.
■
§ 425.611
[Amended]
99. Amend § 425.611 in paragraph
(c)(2)(iii) by removing the reference
‘‘§ 425.652(a)(8)(iv)’’ and adding in its
place the reference ‘‘§ 425.658(c)(1)(ii)’’.
■ 100. Section 425.630 is amended—
■ a. By revising paragraphs (b)(2) and
(3), (e)(3), (f) introductory text, and
(g)(4);
■ b. In paragraph (h)(1)(i), by removing
‘‘or’’ at the end of the paragraph;
■ c. In paragraph (h)(1)(ii), by removing
‘‘.’’ at the end of the paragraph, and
adding in its place ‘‘; or’’; and
■ d. By adding paragraphs (h)(1)(iii) and
(i).
The revisions and additions read as
follows:
tkelley on DSK125TN23PROD with PROPOSALS2
■
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§ 425.630 Option to receive advance
investment payments.
*
*
*
*
*
(b) * * *
(2) CMS has determined that the ACO
is eligible to participate in the Shared
Savings Program.
(3) The ACO is inexperienced with
performance-based risk Medicare ACO
initiatives during its first two
performance years and participates in
the BASIC track’s glide path as follows:
(i) For performance year 1, the ACO
must participate in Level A of the
BASIC track’s glide path.
(ii) For performance year 2, the ACO
may participate in Level A of the BASIC
track’s glide path (in accordance with
§ 425.600(a)(4)(i)(C)(3)) or Level B.
(iii) For performance years 3 through
5, the ACO may participate in Level A
of the BASIC track’s glide path (in
accordance with
§ 425.600(a)(4)(i)(C)(3)), or Levels B
through E.
*
*
*
*
*
(e) * * *
(3) Duration for spending payments.
An ACO may spend an advance
investment payment over its entire
agreement period. An ACO must repay
to CMS any unspent funds remaining at
the end of the ACO’s agreement period,
except if the ACO terminated its current
participation agreement under § 425.220
beginning with the third or fourth
performance year and immediately
enters a new agreement period to
continue its participation in the Shared
Savings Program, the ACO must spend
its advance investment payments within
5 performance years of when it first
received advance investment payments
and repay to CMS any unspent funds
remaining at the end of that fifth
performance year.
*
*
*
*
*
(f) Payment methodology. An ACO
receives two types of advance
investment payments: a one-time
payment of $250,000 and quarterly
payments calculated pursuant to the
methodology defined in paragraph (f)(2)
of this section. CMS notifies in writing
each ACO of its determination of the
amount of advance investment payment
and the notice will inform the ACO of
its right to request reconsideration
review in accordance with the
procedures specified in subpart I of this
part. If CMS does not make any advance
investment payment, the notice will
specify the reason(s) why and inform
the ACO of its right to request
reconsideration review in accordance
with the procedures specified in subpart
I of this part.
*
*
*
*
*
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(g) * * *
(4) If an ACO terminates its
participation agreement during the
agreement period in which it received
an advance investment payment, the
ACO must repay all advance investment
payments it received, unless the ACO
terminated its current participation
agreement under § 425.220 at the end of
performance year 2 or later during the
agreement period in which it received
advance investment payments and
immediately enters a new agreement
period to continue its participation in
the program. CMS will provide written
notification to the ACO of the amount
due and the ACO must pay such amount
no later than 90 days after the receipt of
such notification.
*
*
*
*
*
(h) * * *
(1) * * *
(iii) Voluntarily terminates its
participation agreement in accordance
with § 425.220(a).
*
*
*
*
*
(i) Reporting information on advance
investment payments. The ACO must
report information on its receipt of and
use of advance investment payments, as
follows:
(1) The ACO must publicly report
information about the ACO’s use of
advance investment payments for each
performance year, in accordance with
§ 425.308(b)(8).
(2) In a form and manner and by a
deadline specified by CMS, the ACO
must report to CMS the same
information it is required to publicly
report under § 425.308(b)(8).
§ 425.650
[Amended]
101. Amend § 425.650 in paragraph
(a) by removing the references
‘‘§§ 425.601, 425.602, and 425.603’’ and
adding in their place the references
‘‘§§ 425.601, 425.602, 425.603, and
425.659’’.
■ 102. Section 425.652 is amended—
■ a. In paragraph (a) introductory text,
by removing the reference
‘‘§ 425.226(a)(1)’’ and adding in its place
the reference ‘‘§ 425.400(a)(4)(ii)’’;
■ b. By revising paragraphs (a)(5)(v)(A),
(a)(8), (a)(9) introductory text, and
(a)(9)(ii);
■ c. In paragraph (a)(9)(iv), by removing
the reference ‘‘§ 425.400(a)(4)(ii)’’ and
adding in its place the reference
‘‘§ 425.226(a)(1)’’;
■ d. In paragraph (a)(9)(v), by removing
the phrase ‘‘, or a combination of these
two adjustments’’;
■ e. By adding paragraphs (a)(9)(vi) and
(b)(2)(ii)(C); and
■ f. By revising paragraph (b)(2)(iv)(A).
The revisions and additions read as
follows:
■
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§ 425.652 Establishing, adjusting, and
updating the benchmark for agreement
periods beginning on January 1, 2024, and
in subsequent years.
(a) * * *
(5) * * *
(v) * * *
(A) Calculating the county-level share
of assignable beneficiaries that are
assigned to the ACO for each county in
the ACO’s regional service area. The
assignable population of beneficiaries is
identified for BY3 using the assignment
window or expanded window for
assignment that is consistent with the
beneficiary assignment methodology
selected by the ACO for the performance
year according to § 425.400(a)(4)(ii).
*
*
*
*
*
(8) Except as provided in paragraph
(a)(8)(iii) of this section, adjusts the
historical benchmark based on the
ACO’s regional service area
expenditures (as specified under
§ 425.656), or for savings generated by
the ACO, if any, in the 3 most recent
years prior to the start of the agreement
period (as specified under § 425.658).
CMS does all of the following to
determine the adjustment, if any,
applied to the historical benchmark:
(i) Computes the regional adjustment
in accordance with § 425.656 and the
prior savings adjustment in accordance
with § 425.658.
(ii) If an ACO is not eligible to receive
a prior savings adjustment under
§ 425.658(b)(3)(i), and the regional
adjustment, expressed as a single per
capita value as described in
§ 425.656(d), is positive, the ACO will
receive an adjustment to its benchmark
equal to the positive regional
adjustment amount. The adjustment
will be calculated as described in
§ 425.656(c) and applied separately to
the following populations of
beneficiaries: ESRD, disabled, aged/dual
eligible Medicare and Medicaid
beneficiaries, and aged/non-dual
eligible Medicare and Medicaid
beneficiaries.
(iii) If an ACO is not eligible to
receive a prior savings adjustment under
§ 425.658(b)(3)(i), and the regional
adjustment, expressed as a single per
capita value as described in
§ 425.656(d), is negative or zero, the
ACO will not receive an adjustment to
its benchmark.
(iv) If an ACO is eligible to receive a
prior savings adjustment and the
regional adjustment, expressed as a
single value as described in
§ 425.656(d), is positive, the ACO will
receive an adjustment to its benchmark
equal to the higher of the following:
(A) The positive regional adjustment
amount. The adjustment will be
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calculated as described in § 425.656(c)
and applied separately to the following
populations of beneficiaries: ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries.
(B) A prior savings adjustment. The
adjustment will be calculated as
described in § 425.658(c) and applied as
a flat dollar amount to the following
populations of beneficiaries: ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries.
(v) If an ACO is eligible to receive a
prior savings adjustment and the
regional adjustment, expressed as a
single value as described in
§ 425.656(d), is negative or zero, the
ACO will receive an adjustment to its
benchmark equal to the prior savings
adjustment. The adjustment will be
calculated as described in § 425.658(c)
and applied as a flat dollar amount to
the following populations of
beneficiaries: ESRD, disabled, aged/dual
eligible Medicare and Medicaid
beneficiaries, and aged/non-dual
eligible Medicare and Medicaid
beneficiaries.
(9) For the first performance year
during the term of the agreement period,
the ACO’s benchmark is adjusted for the
following, as applicable: For changes in
values used in benchmark calculations
in accordance with § 425.316(b)(2)(ii)(B)
or (C) due to compliance action to
address avoidance of at-risk
beneficiaries or as a result of issuance of
a revised initial determination under
§ 425.315. For the second and each
subsequent performance year during the
term of the agreement period, the ACO’s
benchmark is adjusted for the following,
as applicable: For the addition and
removal of ACO participants or ACO
providers/suppliers in accordance with
§ 425.118(b), for a change to the ACO’s
beneficiary assignment methodology
selection under § 425.226(a)(1), for a
change to the beneficiary assignment
methodology specified in subpart E of
this part, for a change in the CMS–HCC
risk adjustment methodology used to
calculate prospective HCC risk scores
under § 425.659, and for changes in
values used in benchmark calculations
in accordance with § 425.316(b)(2)(ii)(B)
or (C) due to compliance action to
address avoidance of at-risk
beneficiaries or as a result of issuance of
a revised initial determination under
§ 425.315. To adjust the benchmark,
CMS does the following:
*
*
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*
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(ii) Redetermines the regional
adjustment amount under § 425.656
according to the ACO’s assigned
beneficiaries for BY3, and based on the
assignable population of beneficiaries
identified for BY3 using the assignment
window or expanded window for
assignment that is consistent with the
beneficiary assignment methodology
selected by the ACO for the performance
year according to § 425.400(a)(4)(ii).
*
*
*
*
*
(vi) Redetermines factors based on
prospective HCC risk scores calculated
for benchmark years by calculating the
prospective HCC risk scores using the
CMS–HCC risk adjustment methodology
that applies for the calendar year
corresponding to the applicable
performance year in accordance with
§ 425.659(b)(1).
*
*
*
*
*
(b) * * *
(2) * * *
(ii) * * *
(C) Multiply the growth rate
calculated in this paragraph (b)(2)(ii) by
a regional risk score growth cap
adjustment factor computed as
described in § 425.655.
*
*
*
*
*
(iv) * * *
(A) Calculating the county-level share
of assignable beneficiaries that are
assigned to the ACO for each county in
the ACO’s regional service area. The
assignable population of beneficiaries is
identified for the performance year
using the assignment window or
expanded window for assignment that is
consistent with the beneficiary
assignment methodology selected by the
ACO for the performance year according
to § 425.400(a)(4)(ii).
*
*
*
*
*
■ 103. Section 425.654 is amended by
revising paragraph (a)(1)(i) to read as
follows:
§ 425.654 Calculating county expenditures
and regional expenditures.
(a) * * *
(1) * * *
(i) Determines average county fee-forservice expenditures based on
expenditures for the assignable
population of beneficiaries in each
county in the ACO’s regional service
area. The assignable population of
beneficiaries is identified for the
relevant benchmark or performance year
using the assignment window or
expanded window for assignment that is
consistent with the beneficiary
assignment methodology selected by the
ACO for the performance year according
to § 425.400(a)(4)(ii).
*
*
*
*
*
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104. Section 425.655 is added to
subpart G to read as follows:
■
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§ 425.655 Calculating the regional risk
score growth cap adjustment factor.
(a) General. This section describes the
methodology for calculating the regional
risk score growth cap adjustment factor
that will be applied to the regional
growth rate component of the three-way
blend used to update the historical
benchmark as described in § 425.652(b)
for agreement periods beginning on
January 1, 2024, and in subsequent
years.
(b) Calculating county risk scores.
CMS does all of the following to
determine county prospective HCC and
demographic risk scores for use in
calculating the ACO’s regional risk
scores:
(1) Determines average county
prospective HCC and demographic risk
scores for the assignable population of
beneficiaries in each county in the
ACO’s regional service area. The
assignable population of beneficiaries is
identified for the relevant benchmark or
performance year using the assignment
window or expanded window for
assignment that is consistent with the
beneficiary assignment methodology
selected by the ACO for the performance
year according to § 425.400(a)(4)(ii).
(2) Makes separate risk score
calculations for each of the following
populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and
Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare
and Medicaid beneficiaries.
(c) Calculating regional risk scores.
CMS calculates an ACO’s regional
prospective HCC and demographic risk
scores by:
(1) Weighting the county-level risk
scores determined under paragraph (b)
of this section according to the ACO’s
proportion of assigned beneficiaries in
the county, determined by the number
of the ACO’s assigned beneficiaries in
the applicable population (according to
Medicare enrollment type) residing in
the county in relation to the ACO’s total
number of assigned beneficiaries in the
applicable population (according to
Medicare enrollment type) for the
relevant benchmark or performance year
for each of the following populations of
beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and
Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare
and Medicaid beneficiaries.
(2) Aggregating the values determined
under paragraph (c)(1) of this section for
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each population of beneficiaries
(according to Medicare enrollment type)
across all counties within the ACO’s
regional service area.
(d) Determining aggregate growth in
regional risk scores. CMS determines
aggregate growth in regional prospective
HCC and demographic risk scores by:
(1) Determining growth in regional
prospective HCC and demographic risk
scores determined in paragraph (c) of
this section (expressed as a ratio of the
performance year regional risk score to
the BY3 regional risk score) for each of
the following populations of
beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and
Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare
and Medicaid beneficiaries.
(2) Determines the aggregate growth in
regional risk scores by calculating a
weighted average of the growth in
regional prospective HCC risk scores or
demographic risk scores, as applicable,
across the populations described in
paragraph (d)(1) of this section. When
calculating the weighted average growth
in prospective HCC risk scores or
demographic risk scores, as applicable,
the weight applied to the growth in risk
scores for each Medicare enrollment
type is equal to the product of the
ACO’s regionally adjusted historical
benchmark expenditures for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type.
(e) Determining the cap on regional
risk score growth. CMS determines the
cap on regional prospective HCC risk
score growth by:
(1) Computing the sum of the
aggregate growth in regional
demographic risk scores as determined
in paragraph (d)(2) of this section and 3
percentage points.
(2) Calculating the ACO’s aggregate
market share by calculating the
weighted average of the share of
assignable beneficiaries in the ACO’s
regional service area that are assigned to
the ACO for the performance year as
determined in § 425.652(b)(2)(iv) across
the populations described in
§ 425.652(b)(1). In calculating this
weighted average, the weight applied to
the share for each Medicare enrollment
type is equal to the ACO’s performance
year assigned beneficiary person years
for that enrollment type.
(3) Adding to the sum computed in
paragraph (e)(1) of this section an
amount equal to the product of:
(i) The ACO’s aggregate market share
as determined in paragraph (e)(2) of this
section.
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(ii) The difference between the
aggregate growth in regional prospective
HCC risk scores as determined in
paragraph (d)(2) of this section and the
sum determined in paragraph (e)(1) of
this section. This difference is subject to
a floor of zero.
(f) Determining the regional risk score
growth cap adjustment factor. CMS
determines the regional risk score
growth cap adjustment factor for each
Medicare enrollment type to be applied
in calculating the regional growth rate
described in § 425.652(b) by comparing
the aggregate growth in regional
prospective HCC risk scores determined
in paragraph (d)(2) of this section and,
if applicable, the growth in regional
prospective HCC risk scores for
individual Medicare enrollment types as
determined in paragraph (d)(1) of this
section with the cap determined in
paragraph (e) of this section.
(1) If the aggregate growth in regional
prospective HCC risk scores determined
in paragraph (d)(2) of this section does
not exceed the cap on regional risk score
growth determined in paragraph (e) of
this section, CMS will set the regional
risk score growth cap adjustment factor
equal to 1 for each of the following
populations of beneficiaries:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and
Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare
and Medicaid beneficiaries.
(2) If the aggregate growth in regional
prospective HCC risk scores determined
in paragraph (d)(2) of this section
exceeds the cap determined in
paragraph (e) of this section, CMS will
compare the growth in regional
prospective HCC risk scores for each
Medicare enrollment type as determined
in paragraph (d)(1) of this section with
the cap on regional risk score growth
determined in paragraph (e) of this
section.
(i) If the growth in regional
prospective HCC risk scores for the
enrollment type determined in
paragraph (d)(1) of this section does not
exceed the cap on regional risk score
growth determined in paragraph (e) of
this section, CMS will set the regional
risk score growth cap adjustment factor
equal for that enrollment type equal to
1.
(ii) If the growth in regional
prospective HCC risk scores determined
in paragraph (d)(1) for the enrollment
type exceeds the cap on regional risk
score growth determined in paragraph
(e) of this section, CMS will set the
regional risk score growth cap
adjustment factor for that enrollment
type equal to the growth in regional
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prospective HCC risk scores for the
enrollment type determined in
paragraph (d)(1) of this section divided
by the cap on regional risk score growth
determined in paragraph (e) of this
section.
■ 105. Section 425.656 is amended—
■ a. By revising paragraph (b)(3);
■ b. In paragraph (c)(2), by removing the
phrase ‘‘paragraph (d) of this section’’
and adding in its place the phrase
‘‘paragraph (e) of this section’’;
■ c. By redesignating paragraphs (d) and
(e) as paragraphs (e) and (f),
respectively;
■ d. By adding new paragraph (d);
■ e. In newly redesignated paragraph
(e)(5)(ii), by removing the phrase
‘‘paragraph (d)(5)(i) of this section’’ and
adding in its place the phrase
‘‘paragraph (e)(5)(i) of this section’’;
■ f. In newly redesignated paragraph
(e)(5)(iv), by removing the phrase
‘‘paragraphs (d)(1) through (3)’’ and
adding in its place the phrase
‘‘paragraphs (e)(1) through (3)’’; and
■ g. In newly redesignated paragraph (f)
introductory text, by removing the
phrase ‘‘paragraphs (b) through (d)’’ and
adding in its place the phrase
‘‘paragraphs (b) through (e)’’.
The revision and addition read as
follows:
§ 425.656 Calculating the regional
adjustment to the historical benchmark.
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*
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(b) * * *
(3) Adjusts for differences in severity
and case mix between the ACO’s
assigned beneficiary population for BY3
and the assignable population of
beneficiaries for the ACO’s regional
service area for BY3. The assignable
population of beneficiaries is identified
for BY3 using the assignment window
or expanded window for assignment
that is consistent with the beneficiary
assignment methodology selected by the
ACO for the performance year according
to § 425.400(a)(4)(ii).
*
*
*
*
*
(d) Expression of the regional
adjustment as a single value. (1) CMS
expresses the regional adjustment as a
single value by taking a person-year
weighted average of the Medicare
enrollment type-specific regional
adjustment values determined in
paragraph (c) of this section.
(2) CMS uses the regional adjustment
expressed as a single value for purposes
of determining the adjustment, if any,
that will be applied to the benchmark in
accordance with § 425.652(a)(8).
*
*
*
*
*
■ 106. Section 425.658 is amended—
■ a. In paragraph (b)(3)(i), by removing
the sentence ‘‘The ACO will receive the
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regional adjustment to its benchmark as
described in § 425.656.’’;
■ b. By redesignating paragraph (c) as
paragraph (d);
■ c. By adding new paragraph (c);
■ d. By revising newly redesignated
paragraph (d); and
■ e. By adding new paragraph (e).
The revision and additions read as
follows:
§ 425.658 Calculating the prior savings
adjustment to the historical benchmark.
*
*
*
*
*
(c) Calculate the per capita savings
adjustment.
(1) If an ACO is eligible for the prior
savings adjustment as determined in
paragraph (b)(3) of this section, the prior
savings adjustment will equal the lesser
of the following:
(i) 50 percent of the pro-rated average
per capita amount computed in
paragraph (b)(3)(ii) of this section.
(ii) 5 percent of national per capita
expenditures for Parts A and B services
under the original Medicare fee-forservice program in BY3 for assignable
beneficiaries identified for the 12-month
calendar year corresponding to BY3
using data from the CMS Office of the
Actuary and expressed as a single value
by taking a person-year weighted
average of the Medicare enrollment
type-specific values.
(2) [Reserved]
(d) Applicability of the prior savings
adjustment. CMS compares the per
capita prior savings adjustment
determined in paragraph (c)(1) of this
section with the regional adjustment,
expressed as a single value as described
in § 425.656(d), to determine the
adjustment, if any, that will be applied
to the ACO’s benchmark in accordance
with § 425.652(a)(8).
(e) Recalculation of the prior savings
adjustment during an agreement period.
(1) The ACO’s prior savings
adjustment is recalculated for changes
to the ACO’s savings or losses for a
performance year used in the prior
savings adjustment calculation in
accordance with § 425.316(b)(2)(ii)(B) or
(C) due to compliance action to address
avoidance of at-risk beneficiaries or as a
result of issuance of a revised initial
determination under § 425.315.
(2) For a new ACO identified as a reentering ACO, the prior savings
adjustment is recalculated for changes
to savings or losses for a performance
year used in the prior savings
adjustment calculation, if the savings or
losses of the ACO in which the majority
of the new ACO’s participants were
participating change in accordance with
§ 425.316(b)(2)(ii)(B) or (C) due to
compliance action to address avoidance
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52761
of at-risk beneficiaries or as a result of
issuance of a revised initial
determination under § 425.315.
■ 107. Section 425.659 is added to
subpart G to read as follows:
§ 425.659 Calculating risk scores used in
Shared Savings Program benchmark
calculations.
(a) General. CMS accounts for
differences in severity and case mix of
the ACO’s assigned beneficiaries and
assignable beneficiaries (as defined
under § 425.20) in calculations used in
establishing, adjusting and updating the
ACO’s historical benchmark.
(b) Prospective Hierarchical Condition
Category (HCC) risk score calculation. In
determining Medicare FFS beneficiary
prospective HCC risk scores for a
performance year and each benchmark
year of the ACO’s agreement period,
CMS does the following:
(1) CMS specifies the CMS–HCC risk
adjustment methodology used to
calculate prospective HCC risk scores
for Medicare FFS beneficiaries (as
defined under § 425.20) for use in
Shared Savings Program calculations as
follows:
(i) In calculating risk scores for
Medicare FFS beneficiaries for a
performance year, CMS applies the
CMS–HCC risk adjustment methodology
applicable for the corresponding
calendar year.
(ii) For agreement periods beginning
before January 1, 2024, CMS applies the
CMS–HCC risk adjustment methodology
for the calendar year corresponding to
benchmark year in calculating risk
scores for Medicare FFS beneficiaries
for each benchmark year of the
agreement period.
(iii) For agreement periods beginning
on January 1, 2024, and in subsequent
years, CMS applies the CMS–HCC risk
adjustment methodology for the
calendar year corresponding to the
performance year, as specified under
paragraph (b)(1)(i) of this section, in
calculating risk scores for Medicare FFS
beneficiaries for each benchmark year of
the agreement period.
(2) CMS does the following to
calculate the prospective HCC risk
scores identified in paragraph (b)(1) of
this section for a benchmark or
performance year:
(i) Removes the Medicare Advantage
coding intensity adjustment, if
applicable.
(ii) Renormalizes prospective HCC
risk scores by Medicare enrollment type
(ESRD, disabled, aged/dual eligible
Medicare and Medicaid beneficiaries,
and aged/non-dual eligible Medicare
and Medicaid beneficiaries) based on a
national assignable FFS population for
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the relevant benchmark or performance
year.
(iii) Calculates the average
prospective HCC risk score by Medicare
enrollment type (ESRD, disabled, aged/
dual eligible Medicare and Medicaid
beneficiaries, and aged/non-dual
eligible Medicare and Medicaid
beneficiaries).
■ 108. Section 425.702 is amended—
■ a. In paragraph (c)(1)(ii) introductory
text, by removing the phrase ‘‘process
development’’ and adding in its place
the phrase ‘‘protocol development’’;
■ b. By revising paragraph
(c)(1)(ii)(A)(3); and
■ c. By adding paragraph (c)(1)(iii).
The revision and addition read as
follows:
§ 425.702
Aggregate reports.
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*
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*
(c) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) Beneficiary identifier.
*
*
*
*
*
(iii) 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 populationbased 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.
(A) The following information is
made available to ACOs regarding
beneficiaries eligible for Medicare
CQMs as defined at § 425.20:
(1) Beneficiary name.
(2) Date of birth.
(3) Beneficiary identifier.
(4) Sex.
(B) 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 § 425.20:
(1) Demographic data such as
enrollment status.
(2) Health status information such as
risk profile and chronic condition
subgroup.
(3) 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.
*
*
*
*
*
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PART 455—PROGRAM INTEGRITY:
MEDICAID
109. The authority citation for part
455 continues to read as follows:
■
Authority: 42 U.S.C. 1302.
110. Section 455.416 is amended by
revising paragraph (c) to read as follows:
■
§ 455.416 Termination or denial of
enrollment.
*
*
*
*
*
(c) Must deny enrollment or terminate
the enrollment of any provider that is
terminated on or after January 1, 2011,
under title XVIII of the Act and under
the Medicaid program or CHIP of any
other State, and is currently included in
the termination database under
§ 455.417.
*
*
*
*
*
■ 111. Section 455.417 is added to read
follows:
§ 455.417 Termination periods and
termination database periods.
(a)(1) Subject to paragraph (c) of this
section, a provider remains in the
termination notification database
referenced in section 1902(ll) of the Act
for a period that is the lesser of:
(i) The length of the termination
period imposed by the State that
initially terminated the provider or the
reenrollment bar (as described in
§ 424.535(c) of this chapter) imposed by
the Medicare program in the case of a
Medicare revocation; or
(ii) 10 years (for those Medicaid or
CHIP terminations that are greater than
10 years).
(2) All other State Medicaid agencies
or CHIPs must terminate or deny the
provider from their respective programs
(pursuant to § 455.416(c)) for at least the
same length of time as the termination
database period described in paragraph
(a)(1) of this section.
(b)(1) Nothing in paragraph (a) of this
section prohibits:
(i) The initially terminating State from
imposing a termination period of greater
than 10 years consistent with that
State’s laws, or
(ii) Another State from terminating
the provider, based on the original
State’s termination, for a period:
(A) Of greater than 10 years; or
(B) That is otherwise longer than that
imposed by the initially terminating
State.
(2) The period established under
paragraph (b)(1)(ii) of this section must
be no shorter than the period in which
the provider is to be included in the
termination database under paragraph
(a) of this section.
(c)(1) If the initially terminating State
agency or the Medicare program
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reinstates the provider prior to the end
of the termination period originally
imposed by the initially terminating
State agency or Medicare, CMS removes
the provider from the termination
database after the reinstatement has
been reported to CMS.
(2) If the provider is removed from the
database pursuant to paragraph (c)(1),
CMS may immediately reinclude the
provider in the database (with no
interval between the two periods) if a
basis for doing so exists under part 455
or 424 of this chapter.
(d) For purposes of this section only,
terminations under § 455.416(c) are not
considered ‘‘for cause’’ terminations and
therefore need not be reported to CMS
for inclusion in the termination
database.
PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
112. The authority citation for part
489 continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395i–3, 1395x,
1395aa(m), 1395cc, 1395ff, and 1395hh.
113. Section 489.30 is amended by—
a. Revising paragraph (b)(1); and
b. Adding paragraphs (b)(6) and (7).
The revision and additions read as
follows:
■
■
■
§ 489.30 Allowable charges: Deductibles
and coinsurance.
*
*
*
*
*
(b) * * *
(1) The basic allowable charges are
the Part B annual deductible and 20
percent of the customary (insofar as
reasonable) charges in excess of that
deductible, except as specified in
paragraphs (b)(6) and (7) of this section.
*
*
*
*
*
(6) In the case of a rebatable drug (as
defined in section 1847A(i)(2)(A) of the
Act), including a selected drug (as
defined in section 1192(c) of the Act),
furnished on or after April 1, 2023, in
a calendar quarter in which the payment
amount for such drug as specified in
section 1847A(i)(3)(A)(ii)(I)(aa) or (bb),
as applicable, exceeds the inflationadjusted amount (as defined in section
1847A(i)(3)(C) of the Act) for such drug,
the basic allowable charges are the Part
B annual deductible and 20 percent of
the of the inflation-adjusted payment
amount for the rebatable drug in excess
of that deductible, which is applied as
a percent to the payment amount for
such calendar quarter.
(7) In the case of insulin furnished on
or after July 1, 2023 through an item of
durable medical equipment covered
under section 1861(n) of the Act, the
coinsurance amount shall not exceed
$35 for a month’s supply of such insulin
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each calendar month. This limitation on
the coinsurance amount shall apply for
the duration of the calendar month in
which the date of service (or services)
occurs. In addition, the coinsurance
amount shall not exceed $105.00 for
three months’ supply of insulin. This
limitation on the coinsurance amount
shall apply for the duration of the
calendar month in which the date of
service (or services) occurs and the two
following calendar months.
PART 491—CERTIFICATION OF
CERTAIN HEALTH FACILITIES
114. The authority citation for part
491 continues to read as follows:
■
Authority: 42 U.S.C. 263a and 1302.
115. Section 491.2 is amended by—
a. Adding the definitions of ‘‘Certified
nurse-midwife (CNM)’’, ‘‘Clinical
psychologist (CP)’’, ‘‘Clinical social
worker’’, ‘‘Marriage and family
therapist’’, and ‘‘Mental health
counselor’’ in alphabetical order; and
■ b. Revising the definition of ‘‘Nurse
practitioner’’.
The additions and revisions read as
follows:
■
■
§ 491.2
Definitions.
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*
Certified nurse-midwife (CNM) means
an individual who meets the applicable
education, training, and other
requirements at § 410.77(a) of this
chapter.
Clinical psychologist (CP) means an
individual who meets the applicable
education, training, and other
requirements of § 410.71(d) of this
chapter.
Clinical social worker means an
individual who meets the applicable
education, training, and other
requirements at § 410.73(a) of this
chapter.
*
*
*
*
*
Marriage and family therapist means
an individual who meets the applicable
education, training, and other
requirements at 410.53 of this chapter.
Mental health counselor means an
individual who meets the applicable
education, training, and other
requirements at 410.54 of this chapter.
Nurse practitioner means a person
who meets the applicable State
requirements governing the
qualifications for nurse practitioners,
and who meets at least one of the
following conditions:
(1) Is currently certified as a primary
care nurse practitioner by a recognized
national certifying body that has
established standards for nurse
practitioners and possesses a master’s
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degree in nursing or a Doctor of Nursing
Practice (DNP) doctoral degree.
*
*
*
*
*
■ 116. Section 491.8 is amended by
revising paragraphs (a)(3) and (6) to read
as follows:
§ 491.8
Staffing and staff responsibilities.
(a) * * *
(3) The physician assistant, nurse
practitioner, certified nurse-midwife,
clinical social worker,-clinical
psychologist, marriage and family
therapist, or mental health counselor
member of the staff may be the owner
or an employee of the clinic or center,
or may furnish services under contract
to the clinic or center. In the case of a
clinic, at least one physician assistant or
nurse practitioner must be an employee
of the clinic.
*
*
*
*
*
(6) A physician, nurse practitioner,
physician assistant, certified nursemidwife, clinical social worker, clinical
psychologist, marriage and family
therapist, or a mental health counselor
is available to furnish patient care
services at all times the clinic or center
operates. In addition, for RHCs, a nurse
practitioner, physician assistant, or
certified nurse-midwife is available to
furnish patient care services at least 50
percent of the time the RHC operates.
*
*
*
*
*
PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
117. The authority citation for part
495 continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
118. Section 495.4 is amended in the
definition of ‘‘Certified electronic health
record technology (CEHRT)’’ by revising
paragraph (2) introductory text to read
as follows:
■
§ 495.4
Definitions.
*
*
*
*
*
Certified electronic health record
technology (CEHRT) * * *
(2) For 2019 and subsequent years,
EHR technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that meets the 2015 Edition Base EHR
definition, or subsequent Base EHR
definition (as defined at 45 CFR
170.102) and has been certified to the
ONC health IT certification criteria, as
adopted and updated in 45 CFR
170.315—
*
*
*
*
*
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PART 498—APPEALS PROCEDURES
FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE
PROGRAM AND FOR
DETERMINATIONS THAT AFFECT THE
PARTICIPATION OF ICFs/IID AND
CERTAIN NFs IN THE MEDICAID
PROGRAM
119. The authority citation for part
498 continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1320a–7j, and
1395hh.
120. In § 498.2 amend the definition
of ‘‘Supplier’’ by revising paragraph (6)
to read as follows:
■
§ 498.2
Definitions.
*
*
*
*
*
Supplier * * *
(6) For purposes of this part, a
physical therapist in private practice, an
occupational therapist in private
practice, or a speech-language
pathologist.
*
*
*
*
*
PART 600—ADMINISTRATION,
ELIGIBILITY, ESSENTIAL HEALTH
BENEFITS, PERFORMANCE
STANDARDS, SERVICE DELIVERY
REQUIREMENTS, PREMIUM AND
COST SHARING, ALLOTMENTS, AND
RECONCILIATION
121. The authority citation for part
600 continues to read as follows:
■
Authority: Section 1331 of the Patient
Protection and Affordable Care Act of 2010
(Pub. L. 111–148, 124 Stat. 119), as amended
by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–152,
124 State. 1029).
122. Revise § 600.125 to read as
follows:
■
§ 600.125 Revisions to a certified BHP
Blueprint.
(a) Submission of revisions. A State
may seek to revise its certified Blueprint
in whole or in part at any time through
the submission of a revised Blueprint to
HHS. A State must submit a revised
Blueprint to HHS whenever necessary to
reflect—
(1) Changes in Federal law,
regulations, policy interpretations, or
court decisions that affect provisions in
the certified Blueprint;
(2) Significant changes that alter core
program operations under 600.145(f) or
the BHP benefit package; or
(3) Changes to enrollment,
disenrollment, and verification policies
described in the certified Blueprint.
(b) Submission and effective dates.
The effective date of a revised Blueprint
may not be earlier than the first day of
the quarter in which an approvable
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revision is submitted to HHS. A revised
Blueprint is deemed received when
HHS receives an electronic copy of a
cover letter signed by the Governor or
Governor’s designee and a copy of the
currently approved Blueprint with
proposed changes in track changes.
(c) Timing of HHS review. (1) A
revised Blueprint will be deemed
approved unless HHS, within 90
calendar days after receipt of the revised
Blueprint, sends the State—
(i) Written notice of disapproval; or
(ii) Written notice of additional
information it needs in order to make a
final determination.
(2) If HHS requests additional
information, the 90-day review period
for HHS action on the revised
Blueprint—
(i) Stops on the day HHS sends a
written request for additional
information or the next business day if
the request is sent on a Federal holiday
or weekend; and
(ii) Resumes on the next calendar day
of the original 90-day review period
after HHS receives an a complete
response from the State of all the
requested additional information, unless
the information is received after 5 p.m.
eastern standard time on a day prior to
a non-business day or any time on a
non-business day, in which case the
review period resumes on the following
business day.
(3) The 90-day review period cannot
stop or end on a non-business day. If the
90th calendar day falls on a nonbusiness day, HHS will consider the
90th day to be the next business day.
(4) HHS may send written notice of its
need for additional information as many
times as necessary to obtain the
complete information necessary to
review the revised Blueprint.
(5) HHS may disapprove a Blueprint
that is not consistent with section 1331
of the ACA or the regulations set forth
in this Part at any time during the
review process, including when the 90day review clock is stopped due to a
request for additional information.
(d) Continued operation. The State is
responsible for continuing to operate
under the terms of the existing certified
Blueprint until and unless—
(1) The State adopts a revised
Blueprint by obtaining approval by HHS
under this section;
(2) The State follows the procedures
described in § 600.140(a) for terminating
a BHP;
(3) The State follows the procedures
described in § 600.140(b) for suspending
a BHP;
(4) The Secretary withdraws
certification of a BHP under 600.142.
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(e) Withdrawal of a revised Blueprint.
A State may withdraw a proposed
Blueprint revision during HHS’ review
if the State has not yet implemented the
proposed changes and provides written
notice to HHS.
(f) Reconsideration of decision. HHS
will accept a State request for
reconsideration of a decision not to
certify a revised Blueprint and provide
an impartial review against the
standards for certification if requested.
(g) Public health emergency. For the
Public Health Emergency, as defined in
§ 400.200 of this chapter, the State may
submit to the Secretary for review and
certification a revised Blueprint, in the
form and manner specified by HHS, that
makes temporary significant changes to
its BHP that are directly related to the
Public Health Emergency and would
increase enrollee access to coverage.
Such revised Blueprints may have an
effective date retroactive to the first day
of the Public Health Emergency and
through the last day of the Public Health
Emergency, or a later date if requested
by the State and certified by HHS. Such
revised Blueprints are not subject to the
public comment requirements under
§ 600.115(c).
■ 123. Section 600.135 is amended by
revising the section heading and
paragraph (a) to read as follows:
§ 600.135 Notice and timing of HHS action
on an initial BHP Blueprint submission.
(a) Timely response. HHS will act on
all initial Blueprint certification
requests in a timely manner.
*
*
*
*
*
■ 124. Section 600.140 is amended by
adding introductory text and paragraphs
(b) through (d) to read as follows:
§ 600.140 State termination or suspension
of a BHP.
A State that no longer wishes to
operate a BHP may terminate or
suspend its BHP:
*
*
*
*
*
(b) If a State decides to suspend its
BHP, or to request an extension of a
previously-approved suspension, the
State must:
(1) Submit to the Secretary a
suspension application or a suspension
extension application, as applicable.
The suspension or suspension extension
application must:
(i) Demonstrate that the benefits BHPeligible individuals will receive during
the suspension are equal to the benefits
provided under the certified BHP
Blueprint in effect on the effective date
of suspension;
(ii) Demonstrate that the median
actuarial value of the coverage provided
to the BHP-eligible individuals during
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the suspension is no less than the
median actuarial value of the coverage
under the certified BHP Blueprint in
effect on the effective date of
suspension;
(iii) Demonstrate that the premiums
imposed on BHP-eligible individuals
during the suspension are no higher
than the premiums charged under the
certified BHP Blueprint in effect on the
effective date of suspension, except that
premiums imposed during the
suspension may be adjusted for
inflation, as measured by the Consumer
Price Index;
(iv) Demonstrate that the eligibility
criteria for coverage during the
suspension is not more restrictive than
the criteria described in § 600.305;
(v) Describe the period, not to exceed
5 years, that the State intends to
suspend its BHP or to extend a
previously-approved suspension;
(vi) Be submitted at least 9 months in
advance of the proposed effective date
of the suspension or extension, except
for States seeking to suspend a BHP in
the first plan year that begins following
publication of this rule must submit an
application within 30 days of
publication of this rule; and
(vii) Include an evaluation of the
coverage provided to BHP eligible
individuals during the suspension
period, if the State is seeking an
extension.
(2) Resolve concerns expressed by
HHS and obtain approval by the
Secretary of the suspension or
suspension extension application.
Suspensions may not be in effect prior
to approval by HHS, except for States
seeking to suspend a BHP in the first
plan year that begins following
publication of this rule.
(3) At least 90 days prior to the
effective date of the suspension, submit
written notice to all enrollees and
participating standard health plan
offerors that it intends to suspend the
program, if the enrollees will experience
a change in coverage, or standard health
plan offerors will experience a change
in the terms of coverage. The notices to
enrollees must include information
regarding the State’s assessment of their
eligibility for all other insurance
affordability programs in the State.
Notices must meet the accessibility and
readability standards at 45 CFR
155.230(b).
(4) Within 12 months of the
suspension effective date, submit to
HHS the data required by § 600.610
needed to complete the financial
reconciliation process with HHS.
(5) Submit the annual report required
by § 600.170(a)(2), describing the
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balance of the trust fund, and any
interest accrued on such amount.
(6) Annually, remit to HHS any
interest that has accrued on the balance
of the BHP trust fund during the
suspension period in the form and
manner specified by HHS.
(7) At least 9 months before the end
of the suspension period described in
paragraph (b)(1)(iv) of this section, or
earlier date elected by the State, the
State must submit to HHS a transition
plan that describes how the State will be
reinstate its BHP consistent with the
requirements of this part, or terminate
the program in accordance with
paragraph (a) of this section. The State
must meet the noticing requirements of
paragraph (b)(3) of this section prior to
terminating or reinstating the BHP.
(c) The State cannot implement the
suspension or extension of the
suspension without prior approval by
the Secretary.
(d) The Secretary may withdraw
approval of the suspension plan, if the
terms of paragraph (b) of this section are
not met, if the State ends
implementation of the alternative
coverage program for any reason, or if
HHS finds significant evidence of
beneficiary harm, financial malfeasance,
fraud, waste, or abuse by the BHP
agency or the State consistent with
§ 600.142 of this part. If HHS withdraws
the approved suspension plan, the State
must reinstate its BHP under the terms
of this Part, or terminate the program
under paragraph (a) of this section.
(1) Withdrawal of approval of a
suspension under this section must
occur only after the Secretary provides
the State with notice of the findings
upon which the Secretary is basing the
withdrawal; a reasonable period for the
State to address the finding; and an
opportunity for a hearing before issuing
a final finding.
(2) The Secretary must make every
reasonable effort to work with the State
to resolve proposed findings without
withdrawing approval of a suspension
and in the event of a decision to
withdraw approval, will accept a
request from the State for
reconsideration.
(3) The effective date of an HHS
determination withdrawing approval of
the suspension plan shall not be earlier
than 120 days following issuance of a
final finding under paragraph (b)(6)(i) of
this section.
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(4) Within 30 days following a final
finding under paragraph (b)(6)(i) of this
section, the State must submit a
transition plan to HHS.
■ 125. Section 600.145 is amended by
revising paragraphs (a) and (f)(2) to read
as follows:
§ 600.145 State program administration
and operation.
(a) Program operation. The State must
implement its BHP in accordance with:
(1) The approved and fully certified
State BHP Blueprint, any approved
modifications to the State BHP
Blueprint and the requirements of this
chapter and applicable law; or
(2) The approved suspension
application described in § 600.140.
*
*
*
*
*
(f) * * *
(2) Eligibility and health services
appeals as specified in 600.335.
*
*
*
*
*
■ 126. Section 600.170 amended by
revising paragraph (a) to read as follows:
§ 600.170
timing.
Annual report content and
(a) Content. (1) The State that is
operating a BHP must submit an annual
report that includes any evidence of
fraud, waste, or abuse on the part of
participating providers, plans, or the
State BHP agency known to the State,
and a detailed data-driven review of
compliance with the following:
(i) Eligibility verification
requirements for program participation
as specified in § 600.345.
(ii) Limitations on the use of Federal
funds received by the BHP as specified
in § 600.705.
(iii) Requirements to collect quality
and performance measures from all
participating standard health plans
focusing on quality of care and
improved health outcomes as specified
in sections 1311(c)(3) and (4) of the
Affordable Care Act and as further
described in § 600.415.
(iv) Requirements specified by the
Secretary at least 120 days prior to the
date of the annual report as requiring
further study to assess continued State
compliance with Federal law,
regulations and the terms of the State’s
certified Blueprint, based on a Federal
review of the BHP pursuant to
§ 600.200, and/or a list of any
outstanding recommendations from any
audit or evaluation conducted by the
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HHS Office of Inspector General that
have not been fully implemented,
including a statement describing the
status of implementation and why
implementation is not complete.
(2) A State that has suspended its BHP
under § 600.140(b) of this part must
submit an annual report that includes
the following:
(i) The balance of the BHP trust fund
and any interest accrued on that
balance;
(ii) An assurance that the coverage
provided to individuals who would be
eligible for a BHP under § 600.305 of
this part continues to meet the
standards described in
§ 600.140(b)(1)(i), (ii), and (iii) of this
part; and
(iii) Any additional information
specified by the Secretary at least 120
days prior to the date of the annual
report.
*
*
*
*
*
■ 127. Section 600.330 is amended by
adding paragraph (f) to read as follows:
§ 600.330 Coordination with other
insurance affordability programs.
*
*
*
*
*
(f) Accessibility. Eligibility notices
must be written in plain language and
be provided in a manner which ensures
individuals with disabilities are
provided with effective communication
and takes steps to provide meaningful
access to eligible individuals with
limited English proficiency.
■ 128. Section 600.335 is amended by
revising paragraph (b) to read as follows:
§ 600.335
Appeals.
*
*
*
*
*
(b) Appeals process. Individuals must
be given the opportunity to appeal
through the appeals rules of the State’s
Medicaid program:
(1) BHP eligibility determinations;
and
(2) Delay, denial, reduction,
suspension, or termination of health
services, in whole or in part, including
a determination about the type or level
of service.
*
*
*
*
*
Xavier Becerra,
Secretary, Department of Health and Human
Services.
BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C
Agencies
[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
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
[[Page 52263]]
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: https://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/. 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
[[Page 52264]]
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
[[Page 52265]]
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 https://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 https://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 https://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 https://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 (https://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 (https://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.)
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[[Page 52284]]
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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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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/.
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/.
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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[[Page 52289]]
[GRAPHIC] [TIFF OMITTED] TP07AU23.010
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/).
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 https://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 https://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\
---------------------------------------------------------------------------
\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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[GRAPHIC] [TIFF OMITTED] TP07AU23.027
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/.
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.
https://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.
https://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
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\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\
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\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.
https://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.
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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
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\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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\109\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
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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/.
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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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\140\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we
solicited public comments from applicable laboratories and reporting
entities to better understand the applicable laboratories' experiences
with data reporting, data collection, and other compliance requirements
for the first data collection and reporting periods. We discussed these
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and
stated that we would consider the comments for potential future
rulemaking or guidance.
As part of the CY 2019 Medicare PFS rulemaking, we finalized two
changes to the definition of ``applicable laboratory'' at Sec. 414.502
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850, 35855
through 35862). First, we excluded Medicare Advantage 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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\141\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
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3. Previous Statutory Revisions to the Data Reporting Period and Phase-
In of Payment Reductions
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:
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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.